WorldWideScience

Sample records for q10 pharmaceutical quality

  1. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

    Science.gov (United States)

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

  2. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Science.gov (United States)

    2011-09-16

    ... HUMAN SERVICES Food and Drug Administration Conference on the International Conference on Harmonisation... teaching the principles of the International Conference on Harmonisation of Technical Requirements for... Systems and Processes for Pharmaceutical Manufacturing; Public Conference AGENCY: Food and...

  3. Coenzyme Q10 analytical determination in biological matrices and pharmaceuticals.

    Science.gov (United States)

    Lucangioli, Silvia; Martinefski, Manuela; Tripodi, Valeria

    2016-06-01

    In recent years, the analytical determination of coenzyme Q10 (CoQ10) has gained importance in clinical diagnosis and in pharmaceutical quality control. CoQ10 is an important cofactor in the mitochondrial respiratory chain and a potent endogenous antioxidant. CoQ10 deficiency is often associated with numerous diseases and patients with these conditions may benefit from administration of supplements of CoQ10. In this regard, it has been observed that the best benefits are obtained when CoQ10 deficiency is diagnosed and treated early. Therefore, it is of great value to develop analytical methods for the detection and quantification of CoQ10 in this type of disease. The methods above mentioned should be simple enough to be used in routine clinical laboratories as well as in quality control of pharmaceutical formulations containing CoQ10. Here, we discuss the advantages and disadvantages of different methods of CoQ10 analysis.

  4. IPRO, New York Q10, wins prestigious quality award.

    Science.gov (United States)

    2007-05-01

    Registration to the ISO-9001 Quality System Standard helps QIO stand out. IPRO leaders say they have to walk the 'quality walk' if they are to serve hospitals. Organization stresses effective employee communications, training, and rewards and recognition.

  5. Densitometric HPTLC method for qualitative, quantitative analysis and stability study of Coenzyme Q10 in pharmaceutical formulations utilizing normal and reversed-phase silica gel plates.

    Science.gov (United States)

    Abdel-Kader, Maged Saad; Alam, Prawez; Alqasoumi, Saleh Ibrahim

    2016-03-01

    Two simple, precise and stability-indicating densitometric HPTLC method were developed and validated for qualitative and quantitative analysis of Coenzyme Q10 in pharmaceutical formulations using normal-phase (Method I) and reversed phase (Method II) silica gel TLC plates. Both methods were developed and validated with 10×20 cm glass-backed plates coated with 0.2 mm layers of either silica gel 60 F254 (E-Merck, Germany) using hexane-ethyl acetate (8.5:1.5 v/v) as developing system (Method I) or RP-18 silica gel 60 F254 (E-Merck, Germany) using methanol-acetone (4:6 v/v) as mobile phase (Method II). Both analyses were scanned with a densitometer at 282 nm. Linearity was found in the ranges 50-800 ng/spot (r(2)=0.9989) and 50-800 ng/spot (r(2)=0.9987) for Method I and Method II respectively. Stability of Coenzyme Q10 was explored by the two methods using acid, base, hydrogen peroxide, temperature and different solvents. Due to the efficiency of the method in separating Coenzyme Q10 from other ingredients including its degradation products, it can be applied for quality control, standardization of different pharmaceutical formulations and stability study.

  6. Progress on New Pharmaceutical Preparation Technology of Coenzyme Q10%辅酶Q10制剂新技术研究进展

    Institute of Scientific and Technical Information of China (English)

    易德平; 田治科; 侯国枝; 徐亚婷

    2007-01-01

    目的 介绍辅酶Q10制剂新技术研究最新进展.方法 检索近年来国内外相关文献并整理、分析.结果与结论 通过固体分散体技术、环糊精包合技术、乳化技术、自微乳化技术、脂质体技术等物理改性方式可显著提高其生物利用度,丰富辅酶Q10的使用途径.

  7. The pharmaceutical quality revolution

    Directory of Open Access Journals (Sweden)

    Jordi Botet

    2016-01-01

    Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality

  8. A Review on quality by design approach (QBD for Pharmaceuticals

    Directory of Open Access Journals (Sweden)

    Vemuri Pavan Kumar

    2015-03-01

    Full Text Available Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines.

  9. Coenzyme Q10 (PDQ)

    Science.gov (United States)

    ... Liver Lung Cancer Lymphoma Pancreatic Cancer Prostate Cancer Skin Cancer Thyroid Cancer Uterine Cancer All Cancer Types ... healthy. The body also uses CoQ10 as an antioxidant . An antioxidant is a substance that protects cells ...

  10. [Pharmaceutical product quality control and good manufacturing practices].

    Science.gov (United States)

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

  11. Mixture-process variable approach to optimize a microemulsion electrokinetic chromatography method for the quality control of a nutraceutical based on coenzyme Q10.

    Science.gov (United States)

    Piepel, G; Pasquini, B; Cooley, S; Heredia-Langner, A; Orlandini, S; Furlanetto, S

    2012-08-15

    In recent years, multivariate optimization has played an increasing role in analytical method development. ICH guidelines recommend using statistical design of experiments to identify the design space, in which multivariate combinations of composition variables and process variables have been demonstrated to provide quality results. Considering a microemulsion electrokinetic chromatography method (MEEKC), the performance of the electrophoretic run depends on the proportions of mixture components (MCs) of the microemulsion and on the values of process variables (PVs). In the present work, for the first time in the literature, a mixture-process variable (MPV) approach was applied to optimize a MEEKC method for the analysis of coenzyme Q10 (Q10), ascorbic acid (AA), and folic acid (FA) contained in nutraceuticals. The MCs (buffer, surfactant-cosurfactant, oil) and the PVs (voltage, buffer concentration, buffer pH) were simultaneously changed according to a MPV experimental design. A 62-run MPV design was generated using the I-optimality criterion, assuming a 46-term MPV model allowing for special-cubic blending of the MCs, quadratic effects of the PVs, and some MC-PV interactions. The obtained data were used to develop MPV models that express the performance of an electrophoretic run (measured as peak efficiencies of Q10, AA, and FA) in terms of the MCs and PVs. Contour and perturbation plots were drawn for each of the responses. Finally, the MPV models and criteria for the peak efficiencies were used to develop the design space and an optimal subregion (i.e., the settings of the mixture MCs and PVs that satisfy the respective criteria), as well as a unique optimal combination of MCs and PVs.

  12. Mixture-process variable approach to optimize a microemulsion electrokinetic chromatography method for the quality control of a nutraceutical based on coenzyme Q10

    Energy Technology Data Exchange (ETDEWEB)

    Piepel, Gregory F.; Pasquini, Benedetta; Cooley, Scott K.; Heredia-Langner, Alejandro; Orlandini, Serena; Furlanetto, Sandra

    2012-08-15

    In recent years, multivariate optimization has played an increasing role in analytical method development. ICH guidelines recommend using statistical design of experiments to identify the design space, in which multivariate combinations of composition variables and process variables have been demonstrated to provide quality results. Considering a microemulsion electrokinetic chromatography method (MEEKC), the performance of the electrophoretic run depends on the proportions of mixture components (MCs) of the microemulsion and on the values of process variables (PVs). In the present work, for the first time in the literature, a mixture-process variable (MPV) approach was applied to optimize a MEEKC method for the analysis of coenzyme Q10 (Q10), ascorbic acid (AA), and folic acid (FA) contained in nutraceuticals. The MCs (buffer, surfactant-cosurfactant, oil) and the PVs (voltage, buffer concentration, buffer pH) were simultaneously changed according to a MPV experimental design. A 62-run MPV design was generated using the I-optimality criterion, assuming a 46-term MPV model allowing for special-cubic blending of the MCs, quadratic effects of the PVs, and some MC-PV interactions. The obtained data were used to develop MPV models that express the performance of an electrophoretic run (measured as peak efficiencies of Q10, AA, and FA) in terms of the MCs and PVs. Contour and perturbation plots were drawn for each of the responses. Finally, the MPV models and criteria for the peak efficiencies were used to develop the design space and an optimal subregion (i.e., the settings of the mixture MCs and PVs that satisfy the respective criteria), as well as a unique optimal combination of MCs and PVs.

  13. 辅酶Q10长循环脂质体及冻干制剂的制备与质量控制%Preparation and Quality Control of Coenzyme Q10 Long-circulating Liposomes and Lyophilized Prepara-tion

    Institute of Scientific and Technical Information of China (English)

    杨硕晔; 王乐; 刘娜; 王贯宇; 潘梦宇; 胡元森

    2016-01-01

    OBJECTIVE:To prepare Coenzyme Q10 long-circulating liposomes,establish the determination method of content and entrapment efficiency,and prepare it into lyophilized preparation to improve its stability. METHODS:Coenzyme Q10 long-cir-culating liposomes were prepared by film dispersion method. Particle size and Zeta potential of liposomes were determined,and HPLC assay was used to determine the content of coenzyme Q10. Free drugs and liposomes were separated using protamine aggre-gation method,and the encapsulation efficiency was calculated. Lyophilized preparation was prepared by coenzyme Q10 long-circu-lating liposomes,and the changes of content and encapsulation efficiency of drugs were determined 0,30 and 90 days after lyophi-lization. RESULTS:The liposomes were homogeneous in size with mean diameter of(166.0±5.3)nm and Zeta potential of(-22.2± 1.4)mV. Average content(the percentage of content accounted for labeled amount)and entrapment efficiency of 3 batches of sam-ple were 98.2%(RSD=2.8%) and 93.2%(RSD=4.6%),respectively. Compared with 0 d after lyophilization,coenzyme Q10 long-circulating liposomes had no obvious change in the content and encapsulation efficiency 90 d after lyophilization. CONCLU-SIONS:Coenzyme Q10 long-circulating liposomes with high quality and entrapment efficiency and lyophilized preparation being stored stably for 90 d have been prepared successfully.%目的:制备辅酶Q10长循环脂质体,建立含量与包封率测定方法,并将其制成冻干制剂以提高稳定性。方法:以薄膜分散法制备辅酶Q10长循环脂质体。检测所制脂质体的粒径和Zeta电位;采用高效液相色谱法测定药物含量;鱼精蛋白沉淀法分离脂质体与游离药物,计算包封率。将辅酶Q10长循环脂质体制成冻干制剂,检测其冻干0、30、90 d后药物含量与包封率变化。结果:所制备的辅酶Q10长循环脂质体大小均匀,粒径约为(166.0±5.3

  14. Understanding pharmaceutical quality by design.

    Science.gov (United States)

    Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet

    2014-07-01

    This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

  15. Quality of pharmaceutical care in surgical patients.

    Directory of Open Access Journals (Sweden)

    Monica de Boer

    Full Text Available BACKGROUND: Surgical patients are at risk for preventable adverse drug events (ADEs during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements. OBJECTIVE: To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements. METHODS: For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients. RESULTS: Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and 'sensitivity to change'. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate. The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%. Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%. CONCLUSIONS: This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced.

  16. Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide

    Directory of Open Access Journals (Sweden)

    Marcelo Antonio de Oliveira

    2014-10-01

    Full Text Available Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations.

  17. Quality evaluation of pharmaceutical formulations containing hydrochlorothiazide.

    Science.gov (United States)

    de Oliveira, Marcelo Antonio; Yoshida, Maria Irene; Silva, Daphne Carina Gonçalves Monteiro da

    2014-10-20

    Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations.

  18. [Quality improvement potential in the pharmaceutical industry].

    Science.gov (United States)

    Nusser, Michael

    2007-01-01

    The performance of the German pharmaceutical industry, future challenges and obstacles to quality improvement are assessed from a systems-of-innovation perspective, using appropriate innovation indicators. The current close-to-market performance indicators paint an unfavourable picture. Early R&D indicators (e.g., publications, patents), however, reveal a positive trend. A lot of obstacles to quality improvements are identified with respect to knowledge base, knowledge/technology transfer, industrial R&D processes, capital markets, market attractiveness and both regulatory and political framework conditions. On this basis, recommendations will finally be derived to improve quality in the pharmaceutical industry.

  19. [Production of coenzyme Q10 by metabolically engineered Escherichia coli].

    Science.gov (United States)

    Dai, Guanping; Miao, Liangtian; Sun, Tao; Li, Qingyan; Xiao, Dongguang; Zhang, Xueli

    2015-02-01

    Coenzyme Q10 (CoQ10) is a lipophilic antioxidant that improves human immunity, delays senility and enhances the vitality of the human body and has wide applications in pharmaceutical and cosmetic industries. Microbial fermentation is a sustainable way to produce CoQ10, and attracts increased interest. In this work, the native CoQ8 synthetic pathway of Escherichia coli was replaced by the CoQ10 synthetic pathway through integrating decaprenyl diphosphate synthase gene (dps) from Rhodobacter sphaeroides into chromosome of E. coli ATCC 8739, followed by deletion of the native octaprenyl diphosphate synthase gene (ispB). The resulting strain GD-14 produced 0.68 mg/L CoQ10 with a yield of 0.54 mg/g DCW. Modulation of dxs and idi genes of the MEP pathway and ubiCA genes in combination led to 2.46-fold increase of CoQ10 production (from 0.54 to 1.87 mg/g DCW). Recruiting glucose facilitator protein of Zymomonas mobilis to replace the native phosphoenolpyruvate: carbohydrate phosphotransferase systems (PTS) further led to a 16% increase of CoQ10 yield. Finally, fed-batch fermentation of the best strain GD-51 was performed, which produced 433 mg/L CoQ10 with a yield of 11.7 mg/g DCW. To the best of our knowledge, this was the highest CoQ10 titer and yield obtained for engineered E. coli.

  20. Statistical thinking and knowledge management for quality-driven design and manufacturing in pharmaceuticals.

    Science.gov (United States)

    Korakianiti, Evdokia; Rekkas, Dimitrios

    2011-07-01

    The purpose of this article is to present the evolution of quality principles and how they have been implemented in the pharmaceutical industry. The article discusses the challenges that the FDA PAT Guidance and the ICH Q8, Q9 and Q10 Guidelines present to industry and provides a comprehensive overview of the basic tools that can be used to effectively build quality into products. The principles of the design of experiments, the main tools for statistical process analysis and control, and the requisite culture change necessary to facilitate statistical, knowledge-based management are also addressed.

  1. Quality Systems Implementation in the Pharmaceutical Industry

    African Journals Online (AJOL)

    Nafiisah

    competition amongst themselves, and to survive, one of the important issues to consider is the ... that pharmaceutical products reaching patients comply with quality standards ... found in the Pharmacy Act 1983 of Mauritius. According to the ... delegations from several countries and have registered its product for safety,.

  2. A randomized trial of coenzyme Q10 in mitochondrial disorders.

    Science.gov (United States)

    Glover, Elisa I; Martin, Joan; Maher, Amy; Thornhill, Rebecca E; Moran, Gerald R; Tarnopolsky, Mark A

    2010-11-01

    Case reports and open-label studies suggest that coenzyme Q(10) (CoQ(10)) treatment may have beneficial effects in mitochondrial disease patients; however, controlled trials are warranted to clinically prove its effectiveness. Thirty patients with mitochondrial cytopathy received 1200 mg/day CoQ(10) for 60 days in a randomized, double-blind, cross-over trial. Blood lactate, urinary markers of oxidative stress, body composition, activities of daily living, quality of life, forearm handgrip strength and oxygen desaturation, cycle exercise cardiorespiratory variables, and brain metabolites were measured. CoQ(10) treatment attenuated the rise in lactate after cycle ergometry, increased (∽1.93 ml) VO(2)/kg lean mass after 5 minutes of cycling (P exercise aerobic capacity and post-exercise lactate but did not affect other clinically relevant variables such as strength or resting lactate.

  3. Coenzyme Q10 and Neurological Diseases

    Directory of Open Access Journals (Sweden)

    Gabriele Siciliano

    2009-12-01

    Full Text Available Coenzyme Q10 (CoQ10, or ubiquinone is a small electron carrier of the mitochondrial respiratory chain with antioxidant properties. CoQ10 supplementation has been widely used for mitochondrial disorders. The rationale for using CoQ10 is very powerful when this compound is primary decreased because of defective synthesis. Primary CoQ10 deficiency is a treatable condition, so heightened “clinical awareness” about this diagnosis is essential. CoQ10 and its analogue, idebenone, have also been widely used in the treatment of other neurodegenerative disorders. These compounds could potentially play a therapeutic role in Parkinson’s disease, Huntington’s disease, amyotrophic lateral sclerosis, Friedreich’s ataxia, and other conditions which have been linked to mitochondrial dysfunction. This article reviews the physiological roles of CoQ10, as well as the rationale and the role in clinical practice of CoQ10 supplementation in different neurological diseases, from primary CoQ10 deficiency to neurodegenerative disorders.

  4. Biochemical Assessment of Coenzyme Q10 Deficiency

    Directory of Open Access Journals (Sweden)

    Juan Carlos Rodríguez-Aguilera

    2017-03-01

    Full Text Available Coenzyme Q10 (CoQ10 deficiency syndrome includes clinically heterogeneous mitochondrial diseases that show a variety of severe and debilitating symptoms. A multiprotein complex encoded by nuclear genes carries out CoQ10 biosynthesis. Mutations in any of these genes are responsible for the primary CoQ10 deficiency, but there are also different conditions that induce secondary CoQ10 deficiency including mitochondrial DNA (mtDNA depletion and mutations in genes involved in the fatty acid β-oxidation pathway. The diagnosis of CoQ10 deficiencies is determined by the decrease of its content in skeletal muscle and/or dermal skin fibroblasts. Dietary CoQ10 supplementation is the only available treatment for these deficiencies that require a rapid and distinct diagnosis. Here we review methods for determining CoQ10 content by HPLC separation and identification using alternative approaches including electrochemical detection and mass spectrometry. Also, we review procedures to determine the CoQ10 biosynthesis rate using labeled precursors.

  5. Quality risk management in pharmaceutical development.

    Science.gov (United States)

    Charoo, Naseem Ahmad; Ali, Areeg Anwer

    2013-07-01

    The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

  6. Coenzyme Q10 effects in neurodegenerative disease

    Directory of Open Access Journals (Sweden)

    Meredith Spindler

    2009-11-01

    Full Text Available Meredith Spindler1, M Flint Beal1,2, Claire Henchcliffe1,21Department of Neurology, 2Department of Neuroscience, Weill Medical College of Cornell University, New York, NY, USAAbstract: Coenzyme Q10 (CoQ10 is an essential cofactor in the mitochondrial respiratory chain, and as a dietary supplement it has recently gained attention for its potential role in the treatment of neurodegenerative disease. Evidence for mitochondrial dysfunction in neurodegenerative disorders derives from animal models, studies of mitochondria from patients, identification of genetic defects in patients with neurodegenerative disease, and measurements of markers of oxidative stress. Studies of in vitro models of neuronal toxicity and animal models of neurodegenerative disorders have demonstrated potential neuroprotective effects of CoQ10. With this data in mind, several clinical trials of CoQ10 have been performed in Parkinson’s disease and atypical Parkinson’s syndromes, Huntington’s disease, Alzheimer disease, Friedreich’s ataxia, and amyotrophic lateral sclerosis, with equivocal findings. CoQ10 is widely available in multiple formulations and is very well tolerated with minimal adverse effects, making it an attractive potential therapy. Phase III trials of high-dose CoQ10 in large sample sizes are needed to further ascertain the effects of CoQ10 in neurodegenerative diseases.Keywords: coenzyme Q10, neurodegenerative disease, Parkinson’s disease, Huntington’s disease, mitochondrial dysfunction

  7. Coenzyme Q10 and male infertility.

    Science.gov (United States)

    Balercia, G; Mancini, A; Paggi, F; Tiano, L; Pontecorvi, A; Boscaro, M; Lenzi, A; Littarru, G P

    2009-07-01

    We had previously demonstrated that Coenzyme Q10 [(CoQ10) also commonly called ubiquinone] is present in well-measurable levels in human seminal fluid, where it probably exerts important metabolic and antioxidant functions; seminal CoQ10 concentrations show a direct correlation with seminal parameters (count and motility). Alterations of CoQ10 content were also shown in conditions associated with male infertility, such as asthenozoospermia and varicocele (VAR). The physiological role of this molecule was further clarified by inquiring into its variations in concentrations induced by different medical or surgical procedures used in male infertility treatment. We therefore evaluated CoQ10 concentration and distribution between seminal plasma and spermatozoa in VAR, before and after surgical treatment, and in infertile patients after recombinant human FSH therapy. The effect of CoQ10 on sperm motility and function had been addressed only through some in vitro experiments. In two distinct studies conducted by our group, 22 and 60 patients affected by idiopathic asthenozoospermia were enrolled, respectively. CoQ10 and its reduced form, ubiquinol, increased significantly both in seminal plasma and sperm cells after treatment, as well as spermatozoa motility. A weak linear dependence among the relative variations, at baseline and after treatment, of seminal plasma or intracellular CoQ10, ubiquinol levels and kinetic parameters was found in the treated group. Patients with lower baseline value of motility and CoQ10 levels had a statistically significant higher probability to be responders to the treatment. In conclusion, the exogenous administration of CoQ10 increases both ubiquinone and ubiquinol levels in semen and can be effective in improving sperm kinetic features in patients affected by idiopathic asthenozoospermia.

  8. Pharmacy specialists' attitudes toward pharmaceutical service quality at community pharmacies

    OpenAIRE

    Urbonas, Gvidas; Jakušovaitė, Irayda; Savickas, Arūnas

    2010-01-01

    Objective. The main objective of this study was to analyze pharmacy specialists’ attitudes toward the quality of pharmaceutical services at Lithuanian community pharmacies. Material and methods. Between April and June 2009, a total of 471 Lithuanian community pharmacy specialists completed a questionnaire designed to evaluate their attitudes toward the quality of pharmaceutical services at community pharmacies. The main dimensions of pharmaceutical service quality were extracted by principal ...

  9. PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes.

    Science.gov (United States)

    Ramnarine, Emma; Busse, Ursula; Chassant, Franck; Colao, Marcello; Edwards, Julia; O'Donnell, Kevin; Jornitz, Maik; Munk, Morten; Seymour, Melissa; Simianu, Mihaela; Skeens, Lisa; Vinther, Anders

    2017-02-14

    The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1). But what exactly constitutes an effective PQS? And how does it support change management for PACs? This paper intends to answer these questions and guide companies to seize the opportunities outlined in ICH Q10-Annex 1, to manage product and process changes within the PQS, and downgrade the level of regulatory submission required. This is the second of a series of PDA "Points to Consider" papers on technical product lifecycle management; the first paper focused on the technical product lifecycle management strategy including communication and knowledge exchange between Marketing Authorization Holders and Health Authorities.

  10. Coenzyme Q10 and spinocerebellar ataxias.

    Science.gov (United States)

    Lo, Raymond Y; Figueroa, Karla P; Pulst, Stefan M; Lin, Chi-Ying; Perlman, Susan; Wilmot, George; Gomez, Christopher; Schmahmann, Jeremy; Paulson, Henry; Shakkottai, Vikram G; Ying, Sarah; Zesiewicz, Theresa; Bushara, Khalaf; Geschwind, Michael; Xia, Guangbin; Subramony, S H; Ashizawa, Tetsuo; Kuo, Sheng-Han

    2015-02-01

    The aim of this study was to investigate the association between drug exposure and disease severity in SCA types 1, 2, 3 and 6. The Clinical Research Consortium for Spinocerebellar Ataxias (CRC-SCA) enrolled 319 participants with SCA1, 2, 3, and 6 from 12 medical centers in the United States and repeatedly measured clinical severity by the Scale for Assessment and Rating of Ataxia (SARA), the Unified Huntington's Disease Rating Scale part IV (UHDRS-IV), and the 9-item Patient Health Questionnaire during July 2009 to May 2012. We employed generalized estimating equations in regression models to study the longitudinal effects of coenzyme Q10 (CoQ10), statin, and vitamin E on clinical severity of ataxia after adjusting for age, sex, and pathological CAG repeat number. Cross-sectionally, exposure to CoQ10 was associated with lower SARA and higher UHDRS-IV scores in SCA1 and 3. No association was found between statins, vitamin E, and clinical outcome. Longitudinally, CoQ10, statins, and vitamin E did not change the rates of clinical deterioration indexed by SARA and UHDRS-IV scores within 2 years. CoQ10 is associated with better clinical outcome in SCA1 and 3. These drug exposures did not appear to influence clinical progression within 2 years. Further studies are warranted to confirm the association.

  11. Pharmaceutical product development: A quality by design approach

    OpenAIRE

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls s...

  12. Pharmaceutical product development: A quality by design approach

    OpenAIRE

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Shahid H. Ansari; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls s...

  13. Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

    Science.gov (United States)

    Calnan, Nuala; O'Donnell, Kevin; Greene, Anne

    2013-01-01

    This article is the first in a series of articles that will focus on understanding the implementation essentials necessary to deliver operational excellence through a International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10-based pharmaceutical quality system (PQS). The authors examine why, despite the fact that the ICH Q10 guideline has been with us since 2008, the transformation of the traditional Quality Management Systems QMS in use within the pharmaceutical industry is a work in progress for only a few forward-thinking organisations. Unfortunately, this transformation remains a mere aspiration for the majority of organisations. We explore the apparent lack of progress by the pharmaceutical sector in adopting six sigma and related quality management techniques to ensure the availability of high-quality medicines worldwide. The authors propose that the desired progress can be delivered through two key shifts in our current practices; by embodying the principles of operational excellence in every aspect of our business and by learning how to unlock the scientific and tacit knowledge within our organisations. It has been ten years since The Wall Street Journal revealed the pharmaceutical industry's "little secret" comparing the perceived level of manufacturing expertise in the industry as lagging far behind those of potato-chip and laundry-soap makers. Would you consider the quality and manufacturing strategies in place today in your organisation to be more efficient and scientifically based than those of 2003? If so, what evidence exists for you to draw any conclusion regarding enhanced performance? Do your current practices drive innovation and facilitate continual improvement and if so, how? Ultimately, can you confidently affirm that patient-related risks associated with the product(s) manufactured by your organisation have been reduced due to the quality assurance program now applied

  14. Genetic bases and clinical manifestations of coenzyme Q10 (CoQ 10) deficiency.

    Science.gov (United States)

    Desbats, Maria Andrea; Lunardi, Giada; Doimo, Mara; Trevisson, Eva; Salviati, Leonardo

    2015-01-01

    Coenzyme Q(10) is a remarkable lipid involved in many cellular processes such as energy production through the mitochondrial respiratory chain (RC), beta-oxidation of fatty acids, and pyrimidine biosynthesis, but it is also one of the main cellular antioxidants. Its biosynthesis is still incompletely characterized and requires at least 15 genes. Mutations in eight of them (PDSS1, PDSS2, COQ2, COQ4, COQ6, ADCK3, ADCK4, and COQ9) cause primary CoQ(10) deficiency, a heterogeneous group of disorders with variable age of onset (from birth to the seventh decade) and associated clinical phenotypes, ranging from a fatal multisystem disease to isolated steroid resistant nephrotic syndrome (SRNS) or isolated central nervous system disease. The pathogenesis is complex and related to the different functions of CoQ(10). It involves defective ATP production and oxidative stress, but also an impairment of pyrimidine biosynthesis and increased apoptosis. CoQ(10) deficiency can also be observed in patients with defects unrelated to CoQ(10) biosynthesis, such as RC defects, multiple acyl-CoA dehydrogenase deficiency, and ataxia and oculomotor apraxia.Patients with both primary and secondary deficiencies benefit from high-dose oral supplementation with CoQ(10). In primary forms treatment can stop the progression of both SRNS and encephalopathy, hence the critical importance of a prompt diagnosis. Treatment may be beneficial also for secondary forms, although with less striking results.In this review we will focus on CoQ(10) biosynthesis in humans, on the genetic defects and the specific clinical phenotypes associated with CoQ(10) deficiency, and on the diagnostic strategies for these conditions.

  15. A comparative evaluation of coenzyme Q10-loaded liposomes and solid lipid nanoparticles as dermal antioxidant carriers

    Directory of Open Access Journals (Sweden)

    Gokce EH

    2012-09-01

    Full Text Available Evren H Gokce,1 Emrah Korkmaz,1 Sakine Tuncay-Tanriverdi,1 Eleonora Dellera,2 Giuseppina Sandri,2 M Cristina Bonferoni,2 Ozgen Ozer11Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ege, Izmir, Turkey; 2Department of Drug Sciences, University of Pavia, Pavia, ItalyBackground: The effective delivery of coenzyme Q10 (Q10 to the skin has several benefits in therapy for different skin pathologies. However, the delivery of Q10 to deeper layers of skin is challenging due to low aqueous solubility of Q10. Liposomes and solid lipid nanoparticles (SLN have many advantages to accomplish the requirements in topical drug delivery. This study aims to evaluate the influence of these nanosystems on the effective delivery of Q10 into the skin.Methods: Q10-loaded liposomes (LIPO-Q10 and SLNs (SLN-Q10 were prepared by thin film hydration and high shear homogenization methods, respectively. Particle size (PS, polydispersity index (PI, zeta potential (ZP, and drug entrapment efficiency were determined. Differential scanning calorimetry analysis and morphological transmission electron microscopy (TEM examination were conducted. Biocompatibility/cytotoxicity studies of Q10-loaded nanosystems were performed by means of cell culture (human fibroblasts under oxidative conditions. The protective effect of formulations against production of reactive oxygen species were comparatively evaluated by cytofluorometry studies.Results: PS of uniform SLN-Q10 and LIPO-Q10 were determined as 152.4 ± 7.9 nm and 301.1 ± 8.2 nm, respectively. ZPs were −13.67 ± 1.32 mV and −36.6 ± 0.85 mV in the same order. The drug entrapment efficiency was 15% higher in SLN systems. TEM studies confirmed the colloidal size. SLN-Q10 and LIPO-Q10 showed biocompatibility towards fibroblasts up to 50 µM of Q10, which was determined as suitable for cell proliferation. The mean fluorescence intensity % depending on ROS production determined in cytofluorometric studies

  16. Coenzyme Q10 therapy in current clinical practice

    Directory of Open Access Journals (Sweden)

    Abhishek Soni

    2015-04-01

    Full Text Available Coenzyme Q10 (CoQ10 is a naturally occurring, lipid soluble, essential compound and is also known as ubiquinone. CoQ10 acts as an intermediate of the electron transport chain situated in membrane of mitochondria and vital for ATP production and cellular respiration. CoQ10 also serves as an intercellular antioxidant. All the clinical use of CoQ10 are based upon these two functions. CoQ10 levels are altered in a number of oncological as well as non-oncological diseases. Furthermore, recent data indicate that CoQ10 has an impact on the expression of many genes involved in metabolism, cellular transport, transcription control, and cell signaling, making CoQ10 a potent gene regulator. CoQ10 supplementation is useful in diseases associated with CoQ10 deficiency which includes primary and secondary CoQ10 deficiencies, fibromyalgia, diabetes mellitus, mitochondrial diseases, neurodegenerative diseases, cardiovascular disease, cancer, male infertility and periodontal disease. Clinical presentations of severe CoQ10 deficiency include severe infantile multisystemic disease, encephalomyopathy, isolated myopathy cerebellar ataxia and Leigh syndrome with growth retardation. Oral CoQ10 administration can correct CoQ10 deficiency since it increases CoQ10 tissue levels. CoQ10 therapy has no serious side effects in humans and new formulations have been developed that increase CoQ10 absorption and tissue distribution. Future trends involving CoQ10 in many diseases needs more clinical trials for better understanding of CoQ10 efficacy. [Int J Res Med Sci 2015; 3(4.000: 817-825

  17. Pharmacy specialists' attitudes toward pharmaceutical service quality at community pharmacies.

    Science.gov (United States)

    Urbonas, Gvidas; Jakušovaitė, Irayda; Savickas, Arūnas

    2010-01-01

    The main objective of this study was to analyze pharmacy specialists' attitudes toward the quality of pharmaceutical services at Lithuanian community pharmacies. Between April and June 2009, a total of 471 Lithuanian community pharmacy specialists completed a questionnaire designed to evaluate their attitudes toward the quality of pharmaceutical services at community pharmacies. The main dimensions of pharmaceutical service quality were extracted by principal component analysis. Two main dimensions of pharmaceutical service quality were extracted: pharmacotherapeutic aspects (provision of information about drug therapy, possible side effects, health promotion, the amount of time spent with a patient, and the ascertainment that a patient understood the provided information) and socioeconomic aspects (considering patient's needs and financial capabilities, making a patient confident with the services provided). Pharmacy specialists evaluated the quality of both dimensions positively, but the quality of the first dimension was rated significantly worse than that of the second dimension. The attitudes of pharmacy specialists working at independent pharmacies were more positive toward pharmacotherapeutic aspects as compared to the specialists working at chain or state pharmacies. Pharmacotherapeutic aspects were rated better by pharmacy specialists, aged ≥ 55 years, than those younger than 45 years. Moreover, the attitudes of 45-54-year-old pharmacy specialists toward the socioeconomic aspects were more positive as compared with those of 35-44-year olds. Pharmacists rated the socioeconomic aspects of pharmaceutical service quality worse as compared with pharmacy technicians. The attitudes of pharmacy specialists working at pharmacies with 6-9 specialists were more negative toward pharmacotherapeutic aspects than those of the pharmacies with 1-2 specialists. Pharmacy specialists working at pharmacies with ≥ 10 specialists reported lower scores of socioeconomic

  18. Molecular diagnosis of coenzyme Q10 deficiency.

    Science.gov (United States)

    Yubero, Delia; Montero, Raquel; Armstrong, Judith; Espinós, Carmen; Palau, Francesc; Santos-Ocaña, Carlos; Salviati, Leonardo; Navas, Placido; Artuch, Rafael

    2015-01-01

    Coenzyme Q10 (CoQ) deficiency syndromes comprise a growing number of neurological and extraneurological disorders. Primary-genetic but also secondary CoQ deficiencies have been reported. The biochemical determination of CoQ is a good tool for the rapid identification of CoQ deficiencies but does not allow the selection of candidate genes for molecular diagnosis. Moreover, the metabolic pathway for CoQ synthesis is an intricate and not well-understood process, where a large number of genes are implicated. Thus, only next-generation sequencing techniques (either genetic panels of whole-exome and -genome sequencing) are at present appropriate for a rapid and realistic molecular diagnosis of these syndromes. The potential treatability of CoQ deficiency strongly supports the necessity of a rapid molecular characterization of patients, since primary CoQ deficiencies may respond well to CoQ treatment.

  19. Characterization of CoQ 10-lauric acid eutectic system

    Energy Technology Data Exchange (ETDEWEB)

    Tarate, Bapurao; Bansal, Arvind K., E-mail: akbansal@niper.ac.in

    2015-04-10

    Highlights: • Two polymorphic forms of CoQ 10. • CoQ 10 forms eutectic mixture with LA. • Experimental and predicted values of eutectic points are 70% CoQ 10 at 37.93 °C and 87.7% CoQ 10 at 38.98 °C, respectively. • Attraction exists between CoQ 10 and LA molecules. - Abstract: Solid state characterization of coenzyme Q10 (CoQ 10) was carried out using differential scanning calorimetry (DSC), variable temperature X-ray diffractometry (VT-XRD) and hot/cold stage microscopy (H/CSM). It revealed that CoQ 10 exists in two polymorphic forms. The recrystallized samples of CoQ 10 melted at different temperatures either due to the wide crystal size variation or change in crystallinity. Further, the binary mixture of CoQ 10 and lauric acid (LA) formed eutectic mixture in the ratio 70:30 melting at 37.93 °C, which was close to the predicted eutectic composition of 87.7:12.3 melting at 38.98 °C. The values of actual liquidus temperatures for CoQ 10 are higher than the predicted liquidus temperatures. The experimental heat of fusion at eutectic point was less than the calculated heat of fusion. Activity coefficient of CoQ 10 in the binary mixture was less than unity, which indicates the attraction between the components of eutectic mixture.

  20. Novel formulation and evaluation of a Q10-loaded solid lipid nanoparticle cream: in vitro and in vivo studies

    Directory of Open Access Journals (Sweden)

    Farboud ES

    2011-03-01

    Full Text Available Effat Sadat Farboud, Saman Ahmad Nasrollahi, Zahra TabbakhiDepartment of Pharmaceutics, School of Pharmacy, Tehran University of Medical Sciences, Tehran, IranAbstract: Solid lipid nanoparticles (SLNs of coenzyme Q10 (CoQ10 were formulated by a high-pressure homogenization method. The best formulation of SLN dispersion consisted of 13% lipid (cetyl palmitate or stearic acid, 8% surfactant (Tween 80 or Tego Care 450, and water. Stability tests, particle size analysis, differential scanning calorimetry, transmission electron microscopy, and release study were conducted to find the best formulation. A simple cream of CoQ10 and a cream containing CoQ10-loaded SLNs were prepared and compared on volunteers aged 20–30 years. SLNs with particle size between 50 nm and100 nm exhibited the most suitable stability. In vitro release profiles of CoQ10 from simple cream, SLN alone, and CoQ10-loaded SLN cream showed prolonged release for SLNs compared with the simple cream, whereas there was no significant difference between SLN alone and SLN in cream. In vitro release studies also demonstrated that CoQ10-loaded SLN and SLN cream possessed a biphasic release pattern in comparison with simple cream. In vivo skin hydration and elasticity studies on 25 volunteers suggested good dermal penetration and useful activity of Q10 on skin as a hydratant and antiwrinkle cream.Keywords: coenzyme Q10, SLN, release study 

  1. Quality Control: microbial limit tests for nonsterile pharmaceuticals, part 2.

    Science.gov (United States)

    Vu, Nicole; Lou, Jessica R; Kupiec, Thomas C

    2014-01-01

    Cases of contaminated nonsterile products have been reported in increasing numbers. Often, these contaminated products are associated with the presence of objectionable microorganisms. The major contaminants of nonsterile pharmaceutical products and ingredients are bacteria, yeasts, and molds. The combination of parts 1 and 2 of this series of articles provides a thorough examination of microbiological quality testing for nonsterile products.

  2. Pharmaceutical product development: A quality by design approach.

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  3. Pharmaceutical product development: A quality by design approach

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  4. Topical treatment with coenzyme Q10-containing formulas improves skin's Q10 level and provides antioxidative effects.

    Science.gov (United States)

    Knott, Anja; Achterberg, Volker; Smuda, Christoph; Mielke, Heiko; Sperling, Gabi; Dunckelmann, Katja; Vogelsang, Alexandra; Krüger, Andrea; Schwengler, Helge; Behtash, Mojgan; Kristof, Sonja; Diekmann, Heike; Eisenberg, Tanya; Berroth, Andreas; Hildebrand, Janosch; Siegner, Ralf; Winnefeld, Marc; Teuber, Frank; Fey, Sven; Möbius, Janne; Retzer, Dana; Burkhardt, Thorsten; Lüttke, Juliane; Blatt, Thomas

    2015-01-01

    Ubiquinone (coenzyme Q10, Q10) represents an endogenously synthesized lipid-soluble antioxidant which is crucial for cellular energy production but is diminished with age and under the influence of external stress factors in human skin. Here, it is shown that topical Q10 treatment is beneficial with regard to effective Q10 replenishment, augmentation of cellular energy metabolism, and antioxidant effects. Application of Q10-containing formulas significantly increased the levels of this quinone on the skin surface. In the deeper layers of the epidermis the ubiquinone level was significantly augmented indicating effective supplementation. Concurrent elevation of ubiquinol levels suggested metabolic transformation of ubiquinone resulting from increased energy metabolism. Incubation of cultured human keratinocytes with Q10 concentrations equivalent to treated skin showed a significant augmentation of energy metabolism. Moreover, the results demonstrated that stressed skin benefits from the topical Q10 treatment by reduction of free radicals and an increase in antioxidant capacity.

  5. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

    Science.gov (United States)

    Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

    2016-12-30

    Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

  6. Effekt og sikkerhed af kosttilskud indeholdende Q10

    DEFF Research Database (Denmark)

    Overvad, O.K; Diamant, B; Holm, L

    1997-01-01

    The literature concerning the importance of Q10 for health and disease has been reviewed. Dietary intake together with normal in vivo synthesisseems to fulfil the body's demands for Q10 in younger, healthy individuals. The importance of Q10 in general well-being has not been investigated...... incontrolled experiments. The literature allows no firm conclusions about the significance of Q10 in physical activity. In different cardiovasculardiseases a positive effect of oral Q10 supplementation has been reported, especially in chronic heart failure. These effects should be furtherexamined. No important...... adverse side effects have been reported from experiments using daily supplements of up to 200 mg of Q10 for six to twelvemonths, and 100 mg daily for up to six years....

  7. Coenzyme Q10 and soyphosphatidylcholine in EK extender on preservation of Rhode Island Red poultry semen

    Directory of Open Access Journals (Sweden)

    Amit Kumar Nath

    2015-06-01

    Full Text Available The objective of this study was to evaluate the efficacy of EK extender alone or incorporation with CoenzymeQ10 (CoQ10 and/or soyphosphatidylcholine (SPC in poultry semen and their effects on seminal traits during temporal storage at 4⁰C for different time intervals (12 h, 24 h, and 36 h. Heterospermic pooled semen samples diluted (1:4 with EK, EK + SPC, EK+ CoQ10 and EK + SPC + CoQ10 extenders separately, preserved and different spermiogram were assessed. Various seminal traits within the same extender differ significantly (p<0.05 among different groups and with different time intervals of storage. CoQ10 and SPC in the EK extender exhibited favorable synergistic effect on sperm quality and were able to protect the male gametes against cold-stress up to 36h at 4⁰C. In this study, we concluded that incorporation of SPC and CoQ10 together in EK extender possess novel potentiality to maintain seminal quality during liquid storage of poultry semen at 4⁰C and for their safe transportation and further use for Artificial Reproductive technologies (ARTs.

  8. 辅酶Q10小常识

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    辅酶Q10存在人体的每一个细胞中,随着年龄的增一加,人体内辅酶Q10的含量逐渐减少,50岁时体内辅酶。Q10的含量是年轻时的60%,70岁时只有年轻时的40%。

  9. 辅酶Q10市场剧增

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    鉴于对抗氧化剂辅酶Q10的需求急剧上升,原料供应商ZMC公司预计.今年辅酶Q10市场的增长率将达到两位数。据该公司估计,2007年,大约有170吨辅酶Q10在美国市场上销售。

  10. Coenzyme Q10 protects hair cells against aminoglycoside.

    Directory of Open Access Journals (Sweden)

    Kazuma Sugahara

    Full Text Available It is well known that the production of free radicals is associated with sensory cell death induced by an aminoglycoside. Many researchers have reported that antioxidant reagents protect sensory cells in the inner ear, and coenzyme Q10 (CoQ10 is an antioxidant that is consumed as a health food in many countries. The purpose of this study was to investigate the role of CoQ10 in mammalian vestibular hair cell death induced by aminoglycoside. Cultured utricles of CBA/CaN mice were divided into three groups (control group, neomycin group, and neomycin + CoQ10 group. In the neomycin group, utricles were cultured with neomycin (1 mM to induce hair cell death. In the neomycin + CoQ10 group, utricles were cultured with neomycin and water-soluble CoQ10 (30-0.3 µM. Twenty-four hours after exposure to neomycin, the cultured tissues were fixed, and vestibular hair cells were labeled using an anti-calmodulin antibody. Significantly more hair cells survived in the neomycin + CoQ10 group than in the neomycin group. These data indicate that CoQ10 protects sensory hair cells against neomycin-induced death in the mammalian vestibular epithelium; therefore, CoQ10 may be useful as a protective drug in the inner ear.

  11. 什么是辅酶Q10

    Institute of Scientific and Technical Information of China (English)

    钱晨凯

    2012-01-01

    倘若问辅酶Q10是什么,普通百姓估计十人九不知,但在医院中,辅酶Q10已是心脑血管医生所开的常见药,在欧美国家,辅酶Q10甚至成了老年人的每日必服保健品。辅酶Q10究竟是什么?为何能赢得如此厚爱呢?

  12. Rapid determination of coenzyme Q10 in food supplements using 1H NMR spectroscopy.

    Science.gov (United States)

    Monakhova, Yulia B; Ruge, Ingrid; Kuballa, Thomas; Lerch, Christiane; Lachenmeier, Dirk W

    2013-01-01

    A methodology utilizing 1H NMR spectroscopy has been developed to measure the concentration of coenzyme Q10 (CoQ10) in dietary supplements. For sample preparation, a very simple dilution with deuterated chloroform and addition of internal standard is sufficient. CoQ10 produces a distinct peak of the CH groups in the isoprene side chain of the molecule in the δ 5.15 - 5.05 ppm range, where it can be distinguished from other matrix compounds. The method was shown to be of adequate sensitivity with a limit of detection (LOD) of 7.8 mg/L, to control the CoQ10 content in the majority of the products. The precision expressed as relative standard deviation was around 5 %; linearity was observed from 14 to 2000 mg/L (R = 0.99). The developed methodology was applied for the analysis of 21 food supplements (capsules, tablets, and liquid products). On the basis of the labeled amounts, only two products contained substantially lower concentrations of CoQ10 (57 % and 51 %). All other concentrations varied between 83 % and 190 % with respect to labeling. The developed NMR method may be used by quality assurance laboratories for routine control of CoQ10 products.

  13. Application and progress of coenzyme Q10 in statin myopathy

    Directory of Open Access Journals (Sweden)

    Bo LI

    2013-11-01

    Full Text Available Statins have been widely used, however, the reports of muscle toxicity caused by statins are increasing. Coenzyme Q10 is a quinone substance which is in the cell membrane, and it is important material of intercellular signaling, mitochondrial respiratory chain and muscle activity energy. The myopathic symptoms can be significantly improved by taking coenzyme Q10.

  14. Breeding of Coenzyme Q10 Produced Strain by Low-Energy Ion Implantation and Optimization of Coenzyme Q10 Fermentation

    Institute of Scientific and Technical Information of China (English)

    XU Dejun; ZHENG Zhiming; WANG Peng; WANG Li; YUAN Hang; YU Zengliang

    2008-01-01

    In order to increase the production efficiency of coenzyme Q10, the original strain Agrobacterium tumefaciens ATCC 4452 was mutated by means of Nitrogen ions implantation. A mutant strain, ATX 12, with high contents of coenzyme Q10 was selected. Subsequently, the conditions such as carbohydrate concentration, nitrogen source concentration, inoculum's size, seed age, aeration and temperature which might affect the production of CoQ10 were investigated in detail. Under optimal conditions, the maximum concentration of the intracellular CoQ10 reached 200.3 mg/L after 80 h fed-batch fermentation, about 245% increasing in CoQ10 production after ion implantation, compared to the original strain.

  15. Coenzyme Q-10 in Human Health: Supporting Evidence?

    Science.gov (United States)

    Saha, Sibu P; Whayne, Thomas F

    2016-01-01

    Coenzyme Q-10 (CoQ10) is a widely used alternative medication or dietary supplement and one of its roles is as an antioxidant. It naturally functions as a coenzyme and component of oxidative phosphorylation in mitochondria. Decreased levels have been demonstrated in diseased myocardium and in Parkinson disease. Farnesyl pyrophosphate is a critical intermediate for CoQ10 synthesis and blockage of this step may be important in statin myopathy. Deficiency of CoQ10 also has been associated with encephalomyopathy, severe infantile multisystemic disease, cerebellar ataxia, nephrotic syndrome, and isolated myopathy. Although supplementation with CoQ10 has been reported to be beneficial in treating hypertension, congestive heart failure, statin myopathy, and problems associated with chemotherapy for cancer treatement, this use of CoQ10 as a supplement has not been confirmed in randomized controlled clinical trials. Nevertheless, it appears to be a safe supplementary medication where usage in selected clinical situations may not be inappropriate. This review is an attempt to actualize the available information on CoQ10 and define its potential benefit and appropriate usage.

  16. Functions of coenzyme Q10 in inflammation and gene expression.

    Science.gov (United States)

    Schmelzer, Constance; Lindner, Inka; Rimbach, Gerald; Niklowitz, Petra; Menke, Thomas; Döring, Frank

    2008-01-01

    Clinical studies demonstrated the efficacy of Coenzyme Q10 (CoQ10) as an adjuvant therapeutic in cardiovascular diseases, mitochondrial myopathies and neurodegenerative diseases. More recently, expression profiling revealed that Coenzyme Q10 (CoQ10) influences the expression of several hundred genes. To unravel the functional connections of these genes, we performed a text mining approach using the Genomatix BiblioSphere. We identified signalling pathways of G-protein coupled receptors, JAK/STAT, and Integrin which contain a number of CoQ10 sensitive genes. Further analysis suggested that IL5, thrombin, vitronectin, vitronectin receptor, and C-reactive protein are regulated by CoQ10 via the transcription factor NFkappaB1. To test this hypothesis, we studied the effect of CoQ10 on the NFkappaB1-dependent pro-inflammatory cytokine TNF-alpha. As a model, we utilized the murine macrophage cell lines RAW264.7 transfected with human apolipoprotein E3 (apoE3, control) or pro-inflammatory apoE4. In the presence of 2.5 microM or 75 microM CoQ10 the LPS-induced TNF-alpha response was significantly reduced to 73.3 +/- 2.8% and 74.7 +/- 8.9% in apoE3 or apoE4 cells, respectively. Therefore, the in silico analysis as well as the cell culture experiments suggested that CoQ10 exerts anti-inflammatory properties via NFkappaB1-dependent gene expression.

  17. Coenzyme Q10 Deficiency and Migraine Response to Supplementation

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2007-02-01

    Full Text Available The prevalence of coenzyme Q10 (CoQIO deficiency and effectiveness of CoQIO supplements in treatment of migraine were assessed in a study at the Cincinnati Children’s Hospital, OH.

  18. Association between genetic variants in the Coenzyme Q10 metabolism and Coenzyme Q10 status in humans

    Directory of Open Access Journals (Sweden)

    Menke Thomas

    2011-07-01

    Full Text Available Abstract Background Coenzyme Q10 (CoQ10 is essential for mitochondrial energy production and serves as an antioxidants in extra mitochondrial membranes. The genetics of primary CoQ10 deficiency has been described in several studies, whereas the influence of common genetic variants on CoQ10 status is largely unknown. Here we tested for non-synonymous single-nucleotidepolymorphisms (SNP in genes involved in the biosynthesis (CoQ3G272S , CoQ6M406V, CoQ7M103T, reduction (NQO1P187S, NQO2L47F and metabolism (apoE3/4 of CoQ10 and their association with CoQ10 status. For this purpose, CoQ10 serum levels of 54 healthy male volunteers were determined before (T0 and after a 14 days supplementation (T14 with 150 mg/d of the reduced form of CoQ10. Findings At T0, the CoQ10 level of heterozygous NQO1P187S carriers were significantly lower than homozygous S/S carriers (0.93 ± 0.25 μM versus 1.34 ± 0.42 μM, p = 0.044. For this polymorphism a structure homology-based method (PolyPhen revealed a possibly damaging effect on NQO1 protein activity. Furthermore, CoQ10 plasma levels were significantly increased in apoE4/E4 genotype after supplementation in comparison to apoE2/E3 genotype (5.93 ± 0.151 μM versus 4.38 ± 0.792 μM, p = 0.034. Likewise heterozygous CoQ3G272S carriers had higher CoQ10 plasma levels at T14 compared to G/G carriers but this difference did not reach significance (5.30 ± 0.96 μM versus 4.42 ± 1.67 μM, p = 0.082. Conclusions In conclusion, our pilot study provides evidence that NQO1P187S and apoE polymorphisms influence CoQ10 status in humans.

  19. 辅酶Q10,从药品到护肤品%Co Q10 Turn to Do Skincare

    Institute of Scientific and Technical Information of China (English)

    木兰

    2006-01-01

    辅酶Q10被炒得很红是近一两年的事。据说它是日本目前最流行的皮肤保养元素,很多大牌的护肤品都会在其中添加辅酶Q10,借以达到紧致肌肤和抗衰老的目的。那么辅酶Q10到底是什么?它的护肤功效真的像传说中那么神奇吗?

  20. Paper analytical devices for detection of low-quality pharmaceuticals

    Science.gov (United States)

    Weaver, A.; Lieberman, M.

    2014-03-01

    There is currently no global screening system to detect low quality pharmaceuticals, despite widespread recognition of the public health problems caused by substandard and falsified medicines. In order to fill this void, we designed a rapid field screening test that is interfaced with the mobile phone network. The user scrapes a pill over several reaction areas on a paper test card, and then dips one edge of the card into water to activate dried reagents stored on the paper. These reagents carry out multiple color tests and result in a pattern of colored stripes that give information about the chemical content of the pill. The test cards are inexpensive and instrument-free, and we think they will be a scalable testing option in low resource settings. Studies on falsified drugs archived at the FDA show that the test cards are effective at detecting a wide variety of low-quality formulations of many classes of pharmaceuticals, and field tests are currently under way in Kenya.

  1. Quality of pharmaceutical advertisements in medical journals: a systematic review.

    Science.gov (United States)

    Othman, Noordin; Vitry, Agnes; Roughead, Elizabeth E

    2009-07-22

    Journal advertising is one of the main sources of medicines information to doctors. Despite the availability of regulations and controls of drug promotion worldwide, information on medicines provided in journal advertising has been criticized in several studies for being of poor quality. However, no attempt has been made to systematically summarise this body of research. We designed this systematic review to assess all studies that have examined the quality of pharmaceutical advertisements for prescription products in medical and pharmacy journals. Studies were identified via searching electronic databases, web library, search engine and reviewing citations (1950 - February 2006). Only articles published in English and examined the quality of information included in pharmaceutical advertisements for prescription products in medical or pharmacy journals were included. For each eligible article, a researcher independently extracted the data on the study methodology and outcomes. The data were then reviewed by a second researcher. Any disagreements were resolved by consensus. The data were analysed descriptively. The final analysis included 24 articles. The studies reviewed advertisements from 26 countries. The number of journals surveyed in each study ranged from four to 24 journals. Several outcome measures were examined including references and claims provided in advertisements, availability of product information, adherence to codes or guidelines and presentation of risk results. The majority of studies employed a convenience-sampling method. Brand name, generic name and indications were usually provided. Journal articles were commonly cited to support pharmaceutical claims. Less than 67% of the claims were supported by a systematic review, a meta-analysis or a randomised control trial. Studies that assessed misleading claims had at least one advertisement with a misleading claim. Two studies found that less than 28% of claims were unambiguous clinical claims

  2. Quality of pharmaceutical advertisements in medical journals: a systematic review.

    Directory of Open Access Journals (Sweden)

    Noordin Othman

    Full Text Available BACKGROUND: Journal advertising is one of the main sources of medicines information to doctors. Despite the availability of regulations and controls of drug promotion worldwide, information on medicines provided in journal advertising has been criticized in several studies for being of poor quality. However, no attempt has been made to systematically summarise this body of research. We designed this systematic review to assess all studies that have examined the quality of pharmaceutical advertisements for prescription products in medical and pharmacy journals. METHODS AND FINDINGS: Studies were identified via searching electronic databases, web library, search engine and reviewing citations (1950 - February 2006. Only articles published in English and examined the quality of information included in pharmaceutical advertisements for prescription products in medical or pharmacy journals were included. For each eligible article, a researcher independently extracted the data on the study methodology and outcomes. The data were then reviewed by a second researcher. Any disagreements were resolved by consensus. The data were analysed descriptively. The final analysis included 24 articles. The studies reviewed advertisements from 26 countries. The number of journals surveyed in each study ranged from four to 24 journals. Several outcome measures were examined including references and claims provided in advertisements, availability of product information, adherence to codes or guidelines and presentation of risk results. The majority of studies employed a convenience-sampling method. Brand name, generic name and indications were usually provided. Journal articles were commonly cited to support pharmaceutical claims. Less than 67% of the claims were supported by a systematic review, a meta-analysis or a randomised control trial. Studies that assessed misleading claims had at least one advertisement with a misleading claim. Two studies found that less

  3. Hormonal Influence on Coenzyme Q10 Levels in Blood Plasma

    Directory of Open Access Journals (Sweden)

    Alfredo Pontecorvi

    2011-12-01

    Full Text Available Coenzyme Q10 (CoQ10, also known as ubiquinone for its presence in all body cells, is an essential part of the cell energy-producing system. However, it is also a powerful lipophilic antioxidant protecting lipoproteins and cell membranes. Due to these two actions, CoQ10 is commonly used in clinical practice in chronic heart failure, male infertility, and neurodegenerative disease. However, it is also taken as an anti-aging substance by healthy people aiming for long-term neuroprotection and by sportsmen to improve endurance. Many hormones are known to be involved in body energy regulation, in terms of production, consumption and dissipation, and their influence on CoQ10 body content or blood values may represent an important pathophysiological mechanism. We summarize the main findings of the literature about the link between hormonal systems and circulating CoQ10 levels. In particular the role of thyroid hormones, directly involved in the regulation of energy homeostasis, is discussed. There is also a link with gonadal and adrenal hormones, partially due to the common biosynthetic pathway with CoQ10, but also to the increased oxidative stress found in hypogonadism and hypoadrenalism.

  4. The efficacy and safety of coenzyme Q10 in Parkinson's disease: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhu, Zhen-Guo; Sun, Miao-Xuan; Zhang, Wan-Li; Wang, Wen-Wen; Jin, Yi-Mei; Xie, Cheng-Long

    2017-02-01

    The objective of this meta-analysis was to evaluate the effects of coenzyme Q10 (CoQ10) for the treatment of Parkinson's disease (PD) patients in order to arrive at qualitative and quantitative conclusions about the efficacy of CoQ10. Databases searched included PubMed, Google scholar, CNKI, Wan-Fang, and the Cochrane Library from inception to March 2016. We only included sham-controlled, randomized clinical trials of CoQ10 intervention for motor dysfunction in patients with PD. Relevant measures were extracted independently by two investigators. Weighted mean differences (WMD) were calculated with random-effects models. Eight studies with a total of 899 patients were included. Random-effects analysis revealed a pooled WMD of 1.02, indicating no significant difference when CoQ10 treatment compared with placebo in terms of UPDRS part 3 (p = 0.54). Meanwhile, the effect size of UPDRS part 1, UPDRS part 2, and total UPDRS scores were similar in CoQ10 group with in placebo group (p > 0.05). Moreover, we found CoQ10 was well tolerated compared with placebo group. Subgroup analysis showed that the effect size of CoQ10 in monocentric studies was larger than in multicenter studies. Using the GRADE criteria, we characterized the quality of evidence presented in this meta-analysis as moderate to high level. The current meta-analysis provided evidence that CoQ10 was safe and well tolerated in participants with PD and no superior to placebo in terms of motor symptoms. According to these results, we cannot recommend CoQ10 for the routine treatment of PD right now.

  5. Molecular rational for riboflavin and CoQ10

    DEFF Research Database (Denmark)

    Cornelius, Nanna

    2013-01-01

    A new PhD project from Health, Aarhus University, shows that there is a molecular rationale for riboflavin and CoQ10 treatment in patients with Riboflavin Responsive Multiple acyl-CoA dehydrogenation deficiency. The project was carried out by Nanna Cornelius, a molecular biologist who defended her...... a chaperone-like effect on the ETF-QO protein helping the ETF-QO protein to fold correctly, hereby increasing the activity of the protein. Furthermore, studies showed that RR-MADD patient cells show indications of increased oxidative stress and that treatment of the patient cells with CoQ10 can reduce...... the oxidative stress. These results indicate that a combined treatment of riboflavin and CoQ10 might be the best treatment for the patients....

  6. Temperature-related changes in respiration and Q10 coefficient of Guava

    Directory of Open Access Journals (Sweden)

    Bron Ilana Urbano

    2005-01-01

    Full Text Available Guava (Psidium guajava L. is a tropical fruit that presents fast post-harvest ripening; therefore it is a very perishable product. Inappropriate storage temperature and retail practices can accelerate fruit quality loss. The objective of this study was to evaluate the respiratory activity (RA, the ethylene production (EP and Q10 of guava fruit at different storage temperatures. 'Paluma' guava fruits were harvested at maturity stage 1 (dark-green skin and stored at either 1, 11, 21, 31 or 41ºC; RA and EP were determined after 12, 36, 84 and 156 h of storage. RA and EP rates at 1 and 11ºC were the lowest - 0.16 and 0.43 mmol CO2 kg-1 h-1 and 0.003 and 0.019 µmol C2H4 kg-1 h-1, respectively. When guavas were stored at 21ºC, a gradual increase occurred in RA and EP, reaching 2.24 mmol CO2 kg-1 h-1 and 0.20 µmol C2H4 kg-1 h-1, after 156 h of storage. The highest RA and EP were recorded for guavas stored at 31ºC. In spite of high RA, guavas stored at 41ºC presented EP similar to guavas stored at 11ºC, an indicator of heat-stress injury. Considering the 1-11ºC range, the mean Q10 value was around 3.0; the Q10 value almost duplicated at 11-21ºC range (5.9. At 21-31ºC and 31-41ºC, Q10 was 1.5 and 0.8, respectively. Knowing Q10, respiratory variation and ripening behavior in response to different temperatures, fruit storage and retail conditions can be optimized to reduce quality losses.

  7. Short review on Quality by design: A new Era of Pharmaceutical drug development

    Directory of Open Access Journals (Sweden)

    Gupta Anuj

    2012-09-01

    Full Text Available The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD and describe how it can be help to ensure pharmaceutical quality. Quality by design is an essential part of the modern approach to pharmaceutical quality. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability & controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables.

  8. Acute Promyelocytic Leukemia with i(17)(q10)

    Science.gov (United States)

    Inamura, Junki; Ikuta, Katsuya; Tsukada, Nodoka; Hosoki, Takaaki; Shindo, Motohiro; Sato, Kazuya

    2016-01-01

    We herein report a rare chromosomal abnormality observed in an acute promyelocytic leukemia (APL) patient. She had several APL derivative clones including a clone with i(17)(q10) abnormality, which consists of two kinds of structural abnormalities, a cryptic translocation of t(15;17) and an isochromosome of 17q. Although an obvious microscopic t(15;17) change was not observed on either arms of the isochromosome, PML/RARα fusion signals were detected on an interphase fluorescence in situ hybridization analysis. By several cytogenetic analyses of her bone marrow cells, it was confirmed that the i(17)(q10) clone was derived from the classic t(15;17) clone via another intervening clone, cryptic t(15;17). PMID:27853080

  9. Relational Capital Quality and Client Loyalty: Firm-Level Evidence from Pharmaceuticals, Pakistan

    Science.gov (United States)

    Mubarik, Shujaat; Chandran, V. G. R.; Devadason, Evelyn S.

    2016-01-01

    Purpose: This study aims to examine the influence of relational capital quality on client loyalty, comprising both behavioral and attitudinal, in the pharmaceutical industry of Pakistan. Design/methodology/approach: The partial least squares technique is used to test the relationship using a sample of 111 pharmaceutical firms. We applied a…

  10. Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).

    OpenAIRE

    Taylor, P. W.; Arnet, I; Fischer, A; Simpson, I N

    2010-01-01

    OBJECTIVE: To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes. METHODS: Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and disso...

  11. influence of manufacturing practices on quality of pharmaceutical ...

    African Journals Online (AJOL)

    hi-tech

    2004-06-01

    Jun 1, 2004 ... Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of. Nairobi ... The registration of pharmaceutical ... system consisted of an L-6000 A pump (Merck-Hitachi,.

  12. Pharmaceutical quality by design: product and process development, understanding, and control.

    Science.gov (United States)

    Yu, Lawrence X

    2008-04-01

    The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

  13. Molecular rational for riboflavin and CoQ10

    DEFF Research Database (Denmark)

    Cornelius, Nanna

    2013-01-01

    A new PhD project from Health, Aarhus University, shows that there is a molecular rationale for riboflavin and CoQ10 treatment in patients with Riboflavin Responsive Multiple acyl-CoA dehydrogenation deficiency. The project was carried out by Nanna Cornelius, a molecular biologist who defended her......-QO) protein. High dosis Riboflavin treatment nearly normalizes the clinical and biochemical symptoms of these patients. Until now, no studies have investigated the molecular effect of riboflavin in the patients. However, in her recently completed PhD project, Nanna Cornelius shows that riboflavin has...

  14. Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

    Science.gov (United States)

    O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

    2016-07-25

    Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies.

  15. Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

    2013-01-01

    This paper is the fourth in a series that explores ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. The aim of this paper is to validate proposed quality risks through elicitation of expert opinion and define the resultant quality risk model. Expert opinion was obtained using a questionnaire-based survey with participants with recognized expertise in pharmaceutical regulation, product lifecycle, or technology. The results of the survey validate the theoretical and operational evidence in support of the four main pharmaceutical transformation triggers previously identified. The quality risk model resulting from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. In this paper through conduct of an expert opinion survey the proposed quality risks carried forward from an earlier part of the research are validated and resultant quality risk model is defined. The survey results validate the theoretical and operational evidence previously identified. The quality risk model indicates that transformation-related risks have a larger regulatory compliance impact during product approval, manufacturing, distribution, and commercial use than during the development phase.

  16. Reversal of statin-induced memory dysfunction by co-enzyme Q10: a case report

    Directory of Open Access Journals (Sweden)

    Okeahialam BN

    2015-11-01

    Full Text Available Basil N Okeahialam Cardiology Sub-Unit 1, Department of Medicine, Jos University Teaching Hospital, Jos, Nigeria Abstract: Statins are useful in the armamentarium of the clinician dealing with dyslipidemia, which increases cardiovascular morbi-mortality in hypertensive and diabetic patients among others. Dyslipidemia commonly exists as a comorbidity factor in the development of atherosclerotic cardiovascular disease. Use of statins is however associated with side effects which at times are so disabling as to interfere with activities of daily living. There are various ways of dealing with this, including use of more water-soluble varieties, intermittent dosing, or use of statin alternatives. Of late, use of co-enzyme Q10 has become acceptable for the muscle side effects. Only one report of any benefit on the rarely reported memory side effect was encountered by the author in the search of English medical literature. This is a report of a documented case of a Nigerian woman with history of statin intolerance in this case, memory dysfunction despite persisting dyslipidemia comorbidity. Her memory dysfunction side effect which interfered with activities of daily living and background muscle pain cleared when coenzyme Q10 was administered alongside low dose statin. Her lipid profile normalized and has remained normal. It is being recommended for use when statin side effects (muscle- and memory-related impair quality of life and leave patient at dyslipidemia-induced cardiovascular morbi-mortality. Keywords: statin, memory dysfunction, co-enzyme Q10, improvement

  17. Quality of pharmaceutical print advertising in South Africa ...

    African Journals Online (AJOL)

    represented the period prior to legislation being developed and the period during which the .... extensive experience in the marketing of pharmaceutical products, ... in regard to the placement and size of the proprietary name was seen in .... Denderen JS, Vossen CY, Huizinga TWJ, Dekker FW for the SEDUCE study group.

  18. The future of pharmaceutical quality and the path to get there.

    Science.gov (United States)

    Yu, Lawrence X; Kopcha, Michael

    2017-08-07

    While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six sigma quality pharmaceuticals with minimal risks of shortages or recalls. We propose that the future of pharmaceutical quality is six sigma, meaning that no more than 3.4 defects occur per million opportunities. We discuss the path to get there, including economic drivers, performance-based regulation, Quality by Design, advanced manufacturing technologies, and continuous improvement and operational excellence. This article outlines an ambitious goal and is intended to be thought-provoking in spite of the challenging path to get there. This goal is envisioned because it is in the best interest of patients and consumers and is realizable with continued advances and investments in science and technology. The fundamental destination of pharmaceutical quality has been long envisioned: a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight. Published by Elsevier B.V.

  19. Intestinal absorption of coenzyme Q(10) administered in a meal or as capsules to healthy subjects

    DEFF Research Database (Denmark)

    Weber, Christine; Bysted, Anette; Hølmer, Gunhild Kofoed

    1997-01-01

    A randomized cross-over study by supplementation with single doses of coenzyme Q(10) (30 mg/person), administered either as a meal consisting of cooked pork heart or as 30 mg coenzyme Q(10) capsules was performed to investigate the bioavailability of dietary coenzyme Q(10) in humans. The increase...... in serum coenzyme Q(10) concentration was used as an index of the absorption, and reached a maximum six hours after the ingestion of either meal or capsules. Following intake of coenzyme Q(10) capsules, the serum coenzyme Q(10) concentrations increased significantly (p...

  20. Effect of particle size on solubility, dissolution rate, and oral bioavailability: evaluation using coenzyme Q10 as naked nanocrystals

    Directory of Open Access Journals (Sweden)

    Sun J

    2012-11-01

    Full Text Available Jiao Sun,1 Fan Wang,1,2 Yue Sui,1 Zhennan She,1 Wenjun Zhai,1 Chunling Wang,1 Yihui Deng11College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, China; 2Beijing Zhijianjinrui Applied Pharmaceutical Science Inc, Beijing, ChinaAbstract: In this paper work, four naked nanocrystals (size range 80–700 nm were prepared without any surfactant or polymer using the solvent/nonsolvent method. The effects of particle size on their solubility, dissolution, and oral bioavailability were investigated. Solubility and dissolution testing were performed in three types of dissolution medium, and the studies demonstrated that the equilibrium solubilities of coenzyme Q10 nanocrystals and bulk drugs were not affected by the dissolution media but the kinetic solubilities were. Kinetic solubility curves and changes in particle size distribution were determined and well explained by the proposed solubilization model for the nanocrystals and bulk drugs. The particle size effect on dissolution was clearly influenced by the diffusion coefficients of the various dissolution media, and the dissolution velocity of coenzyme Q10 increased as particle size decreased. The bioavailability of coenzyme Q10 after oral administration in beagle dogs was improved by reducing the particle size. For 700 nm nanocrystals, the AUC0–48 was 4.4-fold greater than that for the coarse suspensions, but a further decrease in particle size from 700 nm to 120 nm did not contribute to improvement in bioavailability until the particle size was reduced to 80 nm, when bioavailability was increased by 7.3-fold.Keywords: particle size, solubility, dissolution, nanocrystal, bioavailability, coenzyme Q10

  1. A case of the rare variant of Klinefelter syndrome 47,XY,i(X)(q10).

    Science.gov (United States)

    Song, Seung-Hun; Won, Hyung Jae; Yoon, Tae Ki; Cha, Dong Hyun; Shim, Jeong Yun; Shim, Sung Han

    2013-12-01

    Klinefelter syndrome is the most common genetic form of male hypogonadism, but the phenotype becomes evident only after puberty. It is characterized by infertility, small testes, sparse body and facial hair, increased body weight, gynecomastia, increased LH and FSH, and a low level of testosterone. Early recognition and treatment of Klinefelter syndrome can significantly improve the patient's quality of life and prevent serious consequences. Here, we report an infertile man with a rare variant of Klinefelter syndrome with a 47, XY, i(X)(q10) karyotype.

  2. Research on Screening of Coenzyme Q10 Production Strain and Coenzyme Q10 Quantification%辅酶Q10产生菌的筛选及产物的定量检测

    Institute of Scientific and Technical Information of China (English)

    陈锐; 孙晓宇; 韩丽萍; 沈俭; 门欣; 路鹏鹏; 沈卫荣

    2012-01-01

    In order to Screen out coenzyme Q10 production strain from the saved yeast strains,the paper cultured yeast strain with wort medium and extracted coenzyme Q10 with the alkaline alcohol saponification processes,and then spectrophotometer and HPLC were used to analyze the quantificate of coenzyme Q10 in this thesis.Results showed that two strain could express coenzyme Q10:C.tropicalis(cast).Berkhout B021(7.420 mg/L),Schizosaccheromyces pombe Lindner B147(7.488 mg/L),respectively.%为了从实验室保存的酵母菌株中筛选产生辅酶Q10的菌株,采用麦芽汁培养酵母菌,皂化法萃取菌体中的辅酶Q10,可见光比色法和高压液相色谱法测定酵母菌中的辅酶Q10的含量。结果表明:筛选出2株较高产量的辅酶Q10产生菌,热带假丝酵母(C.tropicalis(cast).Berkhout)B021产量为7.420 mg/L、粟酒酵母(Schizosaccheromyces pombe Lindner)B147产量为7.488 mg/L。

  3. The Effect of Coenzyme Q10 and Lipoic Acid Added to the Feed of Hens on Physical Characteristics of Eggs

    Directory of Open Access Journals (Sweden)

    Dušan Terčič

    2011-10-01

    Full Text Available This study was designed to investigate whether inclusions of coenzyme Q10, alpha lipoic acid and their combination into diets of hens improve egg quality characteristics. Forty-eight, 33 weeks old Lohmann Brown hens were assigned randomly to four groups of 12 hens each and fed either a basal diet or basal diet supplemented with 2 g/kg coenzyme Q10, 0.4 g/kg alpha lipoic acid and 2 g/kg coenzyme Q10 plus 0.4 g/kg alpha lipoic acid. The diets were fed for 12 weeks. Eggs were weekly examined for interior or exterior quality characteristics. There were no effects of dietary treatments on egg shape index. Coenzyme Q10 supplementation resulted in a reduction in egg shell colour (darker shells and yolk colour (paler yolks and higher incidence of blood and meat spots, which reduce the internal quality of the egg. Alpha lipoic acid had no effect on egg weight, egg shell colour, egg shell density, egg shell weight, egg shell thickness, yolk colour, incidence of blood and meat spots but increased shell strength, albumen height and Haugh units values were noted. Egg shell strength for hens supplemented with alpha lipoic acid was greater than for control hens. The results of the experiment indicated that alpha lipoic acid supplementation to the diet of layers may be of practical value due to the increased egg shell strength and better albumen characteristics without any adverse effect on other egg quality traits.

  4. Review on development of coenzyme Q10 in the food industry%食品中应用辅酶Q10的研究进展

    Institute of Scientific and Technical Information of China (English)

    马菊; 石宁

    2009-01-01

    介绍辅酶Q10的定义、特点、用途、生理活性,简要回顾了辅酶Q10的发展历程.全面阐述国内外关于辅酶Q10在食品行业的应用情况,并对其在食品行业的应用前景做了展望.

  5. Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals.

    Science.gov (United States)

    Küster, A; Bachmann, J; Brandt, U; Ebert, I; Hickmann, S; Klein-Goedicke, J; Maack, G; Schmitz, S; Thumm, E; Rechenberg, B

    2009-12-01

    The evaluation of the quality of data and their use within the review of environmental risk assessment of human as well as veterinary pharmaceuticals is described from a regulatory point of view. A definition and differentiation in three categories for the reliability of data are given. Existing criteria relating to international testing standards for categorising reliability are adopted for their use within the environmental risk assessment of pharmaceuticals. A systematic documentation of evaluating reliability for literature data as well as for experimental studies (effect and environmental fate studies) is proposed. The data quality criteria are defined in order to increase the transparency of the evaluation process in Germany and thus the quality of the environmental risk assessment of pharmaceuticals.

  6. [Accession to the PIC/S and pharmaceutical quality system in Japan].

    Science.gov (United States)

    Katori, Noriko

    2014-01-01

    In March, 2012, Japan made the application for membership of the Pharmaceutical Inspection convention and Pharmaceutical Inspection Co-operation scheme (PIC/S) which is an international body of a GMP inspection. The globalization of pharmaceutical manufacturing and sales has been a driving force behind the decision to become a PIC/S member. For the application for membership, Japan's GMP inspectorate needs to fulfill PIC/S requirements, for example, the inspection organization has to have a quality system as a global standard. One of the other requirements is that the GMP inspectorate can access Official Medicines Control Laboratories (OMCL) having high analytical skills and also have a quality system based on ISO 17025. I would like to describe the process to make up a quality system in the National Institute of Health Sciences and also the circumstances around the PIC/S application in Japan.

  7. Relative bioavailability and antioxidant potential of two coenzyme q10 preparations.

    Science.gov (United States)

    Kurowska, Elzbieta M; Dresser, George; Deutsch, Luisa; Bassoo, Errol; Freeman, David J

    2003-01-01

    Coenzyme Q10 (CoQ10) is synthesized by the human body and found in certain foods. Daily supplementation of CoQ10 could protect against heart disease but the bioavailability of CoQ10 supplements depends on the formulation taken. We compared the bioavailability and antioxidant properties of two commercial CoQ10 formulations, a commercial grade CoQ10 powder (commercial grade CoQ) and a new BT-CoQ10 BIO-TRANSFORMED (BT-CoQ10) obtained by fermentation of a soy-based, CoQ10-rich media with baker's yeast. Eleven healthy individuals participated in a randomized two-way crossover trial, with a 3-week washout period. Capsules containing 300 mg of either BT-CoQ10 or commercial grade CoQ10 were given daily for 1 week and multiple blood samples were taken for CoQ10, glutathione and glutathione peroxidase (GPx) determination. In 3 subjects, baseline plasma CoQ10 levels were lower prior to BT than prior to commercial grade CoQ treatment. In the remaining participants, ingestion of BT vs. commercial grade CoQ significantly increased maximum plasma CoQ10 concentration (+126%, p = 0.04) and tended to increase CoQ10 area under the curve from 0 to 24 h (+160%, p = 0.07). One week of treatment with each formulation increased plasma CoQ10 but did not alter plasma glutathione or GPx activity. The enhanced bioavailability of the BT product might be due to its predominantly reduced, hydrophilic membrane-complex form. Copyright 2003 S. Karger AG, Basel

  8. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review

    Science.gov (United States)

    Spurling, Geoffrey K.; Mansfield, Peter R.; Montgomery, Brett D.; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I.

    2010-01-01

    Background Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. Methods and Findings We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses

  9. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

    Directory of Open Access Journals (Sweden)

    Geoffrey K Spurling

    2010-10-01

    Full Text Available BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise. Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008, International Pharmaceutical Abstracts (1970 to February 2008, Embase (1997 to February 2008, Current Contents (2001 to 2008, and Central (The Cochrane Library Issue 3, 2007 using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies and other sources (138 studies. Articles were then excluded because they did not fulfil inclusion criteria (179 or quality appraisal criteria (18, leaving 58 included studies with 87 distinct

  10. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

    Science.gov (United States)

    Spurling, Geoffrey K; Mansfield, Peter R; Montgomery, Brett D; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I

    2010-10-19

    Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently

  11. Decreased coenzyme Q10 concentration in plasma of children with cystic fibrosis

    NARCIS (Netherlands)

    Oudshoorn, J.H.; Lecluse, A.L.Y.; Berg, R. van den; Vaes, W.H.J.; Laag, J. van der; Houwen, R.H.J.

    2006-01-01

    OBJECTIVES: Coenzyme Q10 (CoQ10) is an effective lipophilic antioxidant and protects against lipid peroxidation by scavenging radicals. Patients with cystic fibrosis generally have fat malabsorption; thus, we hypothesized that overall plasma CoQ10 concentration in pediatric patients with cystic fibr

  12. Decreased coenzyme Q10 concentration in plasma of children with cystic fibrosis

    NARCIS (Netherlands)

    Oudshoorn, J.H.; Lecluse, A.L.Y.; Berg, R. van den; Vaes, W.H.J.; Laag, J. van der; Houwen, R.H.J.

    2006-01-01

    OBJECTIVES: Coenzyme Q10 (CoQ10) is an effective lipophilic antioxidant and protects against lipid peroxidation by scavenging radicals. Patients with cystic fibrosis generally have fat malabsorption; thus, we hypothesized that overall plasma CoQ10 concentration in pediatric patients with cystic

  13. Internal Structure Quality Control of Solid Pharmaceuticals. A Comparative Study

    Directory of Open Access Journals (Sweden)

    Imre Silvia

    2016-03-01

    Full Text Available Objective: The aim of the study was a comparative investigation by spectral and thermal analysis in order to asses a number of characteristics of different varieties ofrawmaterials of ursodeoxycholic acid and ibuprofen. The different dissolution behavior of two ursodeoxycholic acid pharmaceutical product by crystallinity pattern was investigated. Methods: Raw materials of ursodeoxycholic acid and ibuprofen were used. IR spectroscopy, differential scanning calorimetry and X-Ray Diffraction Analysis were applied. Results: The results show no crystallinitydifferences for different batches of the tested drugs. No solid solid transition was proved during sample preparation for transmission IR analysis. Conclusions: A combination of two more affordabletests by IR spectrometry and differential scanning calorimetry lead to the same results as X-Ray diffraction analysis for crystallinity similarity assessment of the studied substances. The dissolution differences of test drugs were not related to the polymorphism of the raw materials.

  14. Breeding of Coenzyme Q10 High Yield Strain%发酵生产辅酶Q10高产菌株的选育

    Institute of Scientific and Technical Information of China (English)

    陈金卿

    2016-01-01

    以实验室保存的类球红细菌(Rhodobacter sphaeroides)JDW61为出发菌株,考察了紫外、紫外结合氯化锂和亚硝基胍对菌株产生辅酶Q10能力的诱变效应,并结合辅酶Q10的合成途径设计了快速筛选辅酶Q10高产菌株的模型,获得一株辅酶Q10产量提高的突变株CP222,该菌株摇瓶发酵的辅酶Q10产量为276.14 mg·L-1,较出发菌株提高了190%,并且遗传性能稳定.

  15. [Reduced synthesis of coenzyme Q10 may cause statin related myopathy].

    Science.gov (United States)

    Nielsen, Mette Lundgren; Pareek, Manan; Henriksen, Jan Erik

    2011-11-14

    Statin treatment can cause muscular side effects. It has been suggested that the mechanism is reduced synthesis of coenzyme Q10 (coQ10) and a subsequent dysfunction of the respiratory chain. A literature review resulted in insufficient evidence supporting this theory. It is uncertain whether intramuscular levels of coQ10 and mitochondrial function are affected by statin therapy and whether the symptoms of myopathy can be alleviated with coQ10 supplementation. Nevertheless, due to a favourable safety profile, coQ10 can be tested in patients whose muscular symptoms cannot be managed otherwise.

  16. Nedsat koenzym Q10 kan være årsag til statinassocieret myopati

    DEFF Research Database (Denmark)

    Nielsen, Mette Lundgren; Pareek, Manan; Henriksen, Jan Erik

    2011-01-01

    Statin treatment can cause muscular side effects. It has been suggested that the mechanism is reduced synthesis of coenzyme Q10 (coQ10) and a subsequent dysfunction of the respiratory chain. A literature review resulted in insufficient evidence supporting this theory. It is uncertain whether...... intramuscular levels of coQ10 and mitochondrial function are affected by statin therapy and whether the symptoms of myopathy can be alleviated with coQ10 supplementation. Nevertheless, due to a favourable safety profile, coQ10 can be tested in patients whose muscular symptoms cannot be managed otherwise....

  17. Serum levels of coenzyme Q10 in patients with Parkinson's disease.

    Science.gov (United States)

    Jiménez-Jiménez, F J; Molina, J A; de Bustos, F; García-Redondo, A; Gómez-Escalonilla, C; Martínez-Salio, A; Berbel, A; Camacho, A; Zurdo, M; Barcenilla, B; Enríquez de Salamanca, R; Arenas, J

    2000-01-01

    We compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio in 33 patients with Parkinson's disease (PD) and 31 matched controls. The mean serum coenzyme Q10 levels did not differ significantly between the 2 study groups. Coenzyme Q10 levels were not correlated with age, age at onset, duration of the disease, scores of the Unified Parkinson Disease Rating Scale (UPDRS) or the Hoehn and Yahr staging in the PD group. The coenzyme Q10/cholesterol ratio had a significant correlation (although low) with duration of the disease (r = -0.46), total UPDRS score (r = -0.39), motor examination of the UPDRS (r = 0.45). These values were not influenced significantly by therapy with levodopa or dopamine agonists. The normality of serum coenzyme Q10 and coenzyme Q10/cholesterol ratio suggest that these values are not related with the risk for PD.

  18. Dispensing doctor practices and community pharmacies: exploring the quality of pharmaceutical services.

    Science.gov (United States)

    Weiss, Marjorie C; Grey, Elisabeth; Harris, Michael; Rodham, Karen

    2016-01-01

    This research sought (a) to investigate the similarities and differences in how pharmaceutical services are provided by community pharmacies (CPs) and dispensing doctor practices (DPs) and (b) to identify the issues relevant to determining the quality of pharmaceutical services in these settings. UK pharmaceutical services, including dispensing prescriptions and public health advice, can be provided from both (CP) and, in rural areas, (DP). While there is much similarity between CPs and DPs in the types of services provided, there is also the potential for variation in service quality across settings. A postal questionnaire of DPs and CPs in South West England was conducted to provide a descriptive overview of pharmaceutical services across the settings. A subsection of questionnaire respondent sites were selected to take part in case studies, which involved documentary analyses, observation and staff interviews. Survey response was 39% for CPs (52/134) and 48% (31/64) for DPs. There were three CP and four DP case study sites, with 17 staff interviews. More pharmacies than practices were open at the weekend and they had more staff trained above NVQ level 2. Both doctors and pharmacists saw themselves as medicines experts, as being accessible and having good relationships with patients. Workplace practices and organisational ethos varied both within and across settings, with good practice observed in both. Overall, CPs and DPs have much in common. Workplace culture and an evidence-based approach to checking prescriptions and error reporting need to be considered in future assessments of service quality.

  19. Comparison of biologic activity of two coenzyme Q10 prepargations%两种辅酶Q10制剂生物学活性比较

    Institute of Scientific and Technical Information of China (English)

    徐彩菊; 丁钢强; 夏勇; 孟佳; 傅剑云; 陈玉满

    2008-01-01

    目的:研究两种辅酶Q10制剂对老龄小鼠混合功能氧化酶及高脂血症大鼠血脂水平的影响.方法:老龄小鼠随机分为正常对照组、辅酶Q10软胶囊组和辅酶Q10咀嚼片组(剂量均为60.0 mg/kg·BW,以辅酶Q10含量计);将SD雄性高血脂模型大鼠随机分为模型对照组、辅酶Q10软胶囊组和辅酶Q10咀嚼片组(剂量均为60.0 mg/kg·BW,以辅酶Q10含量计);实验结束后测老龄小鼠血中丙二醛(MDA)含量、超氧化物歧化酶(SOD)和谷胱甘肽过氧化物酶(GSH-PX)的活力及高脂血症大鼠血清中总胆固醇(TC)含量、甘油三脂(TG)含量和高密度脂蛋白胆固醇(HDL-C)水平.结果:与正常老龄小鼠对照组比较,辅酶Q10软胶囊组和辅酶Q10咀嚼片组均能显著提高老龄小鼠血中的SOD活性,明显降低MDA含量,辅酶Q10咀嚼片组对MDA的清除能力比辅酶Q10软胶囊组更强;与高血脂模型对照组比较,辅酶Q10软胶囊组和辅酶Q10咀嚼片组均能明显降低高脂血症大鼠血清TG和TC含量,但两种制剂辅酶Q10的降血脂效果无显著性差异.结论:两种辅酶Q10制剂在剂量为60.0 mg/kg·BW时均具有对抗老龄小鼠脂质过氧化和降低高脂血症大鼠的血脂水平的能力,且辅酶Q10咀嚼片组在抗氧化作用及对免疫器官的保护作用方面比辅酶Q10软胶囊组效果更为明显.

  20. Micronutrient special issue: coenzyme Q(10) requirements for DNA damage prevention.

    Science.gov (United States)

    Schmelzer, Constance; Döring, Frank

    2012-05-01

    Coenzyme Q(10) (CoQ(10)) is an essential component for electron transport in the mitochondrial respiratory chain and serves as cofactor in several biological processes. The reduced form of CoQ(10) (ubiquinol, Q(10)H(2)) is an effective antioxidant in biological membranes. During the last years, particular interest has been grown on molecular effects of CoQ(10) supplementation on mechanisms related to DNA damage prevention. This review describes recent advances in our understanding about the impact of CoQ(10) on genomic stability in cells, animals and humans. With regard to several in vitro and in vivo studies, CoQ(10) provides protective effects on several markers of oxidative DNA damage and genomic stability. In comparison to the number of studies reporting preventive effects of CoQ(10) on oxidative stress biomarkers, CoQ(10) intervention studies in humans with a direct focus on markers of DNA damage are limited. Thus, more well-designed studies in healthy and disease populations with long-term follow up results are needed to substantiate the reported beneficial effects of CoQ(10) on prevention of DNA damage. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. Protective effect of Co-enzyme Q10 On doxorubicin-induced cardiomyopathy of rat hearts.

    Science.gov (United States)

    Chen, Pei-Yu; Hou, Chien-Wen; Shibu, Marthandam Asokan; Day, Cecilia Hsuan; Pai, Peiying; Liu, Zhao-Rong; Lin, Tze-Yi; Viswanadha, Vijaya Padma; Kuo, Chia-Hua; Huang, Chih-Yang

    2017-02-01

    Q10 is a powerful antioxidant often used in medical nutritional supplements for cancer treatment. This study determined whether Q10 could effectively prevent cardio-toxicity caused by doxorubicin treatment. Four week old SD rats were segregated into groups namely control, doxorubicin group (challenged with doxorubicin), Dox + Q10 group (with doxorubicin challenge and oral Q10 treatment), and Q10 group (with oral Q10 treatment). Doxorubicin groups received IP doxorubicin (2.5 mg/kg) every 3 days and Q10 groups received Q10 (10 mg/kg) every day. Three weeks of doxorubicin challenge caused significant reduction in heart weight, disarray in cardiomyocyte arrangement, elevation of collagen accumulation, enhancement of fibrosis and cell death associated proteins, and inhibition of survival proteins. However, Q10 effectively protected cardiomyocytes and ameliorated fibrosis and cell death induced by doxorubicin. Q10 is, therefore, evidently a potential drug to prevent heart damage caused by doxorubicin. © 2016 Wiley Periodicals, Inc. Environ Toxicol 32: 679-689, 2017. © 2016 Wiley Periodicals, Inc.

  2. Characterisation and Skin Distribution of Lecithin-Based Coenzyme Q10-Loaded Lipid Nanocapsules

    Directory of Open Access Journals (Sweden)

    Yan Zemin

    2010-01-01

    Full Text Available Abstract The purpose of this study was to investigate the influence of the inner lipid ratio on the physicochemical properties and skin targeting of surfactant-free lecithin-based coenzyme Q10-loaded lipid nanocapsules (CoQ10-LNCs. The smaller particle size of CoQ10-LNCs was achieved by high pressure and a lower ratio of CoQ10/GTCC (Caprylic/capric triglyceride; however, the zeta potential of CoQ10-LNCs was above /− 60 mV/ with no distinct difference among them at different ratios of CoQ10/GTCC. Both the crystallisation point and the index decreased with the decreasing ratio of CoQ10/GTCC and smaller particle size; interestingly, the supercooled state of CoQ10-LNCs was observed at particle size below about 200 nm, as verified by differential scanning calorimetry (DSC in one heating–cooling cycle. The lecithin monolayer sphere structure of CoQ10-LNCs was investigated by cryogenic transmission electron microscopy (Cryo-TEM. The skin penetration results revealed that the distribution of Nile red-loaded CoQ10-LNCs depended on the ratio of inner CoQ10/GTCC; moreover, epidermal targeting and superficial dermal targeting were achieved by the CoQ10-LNCs application. The highest fluorescence response was observed at a ratio of inner CoQ10/GTCC of 1:1. These observations suggest that lecithin-based LNCs could be used as a promising topical delivery vehicle for lipophilic compounds.

  3. Characterisation and Skin Distribution of Lecithin-Based Coenzyme Q10-Loaded Lipid Nanocapsules

    Science.gov (United States)

    Zhou, Huafeng; Yue, Yang; Liu, Guanlan; Li, Yan; Zhang, Jing; Yan, Zemin; Duan, Mingxing

    2010-10-01

    The purpose of this study was to investigate the influence of the inner lipid ratio on the physicochemical properties and skin targeting of surfactant-free lecithin-based coenzyme Q10-loaded lipid nanocapsules (CoQ10-LNCs). The smaller particle size of CoQ10-LNCs was achieved by high pressure and a lower ratio of CoQ10/GTCC (Caprylic/capric triglyceride); however, the zeta potential of CoQ10-LNCs was above /- 60 mV/ with no distinct difference among them at different ratios of CoQ10/GTCC. Both the crystallisation point and the index decreased with the decreasing ratio of CoQ10/GTCC and smaller particle size; interestingly, the supercooled state of CoQ10-LNCs was observed at particle size below about 200 nm, as verified by differential scanning calorimetry (DSC) in one heating-cooling cycle. The lecithin monolayer sphere structure of CoQ10-LNCs was investigated by cryogenic transmission electron microscopy (Cryo-TEM). The skin penetration results revealed that the distribution of Nile red-loaded CoQ10-LNCs depended on the ratio of inner CoQ10/GTCC; moreover, epidermal targeting and superficial dermal targeting were achieved by the CoQ10-LNCs application. The highest fluorescence response was observed at a ratio of inner CoQ10/GTCC of 1:1. These observations suggest that lecithin-based LNCs could be used as a promising topical delivery vehicle for lipophilic compounds.

  4. Quality indicators for pharmaceutical care: a comprehensive set with national scores for Dutch community pharmacies.

    Science.gov (United States)

    Teichert, Martina; Schoenmakers, Tim; Kylstra, Nico; Mosk, Berend; Bouvy, Marcel L; van de Vaart, Frans; De Smet, Peter A G M; Wensing, Michel

    2016-08-01

    Background The quality of pharmaceutical care in community pharmacies in the Netherlands has been assessed annually since 2008. The initial set has been further developed with pharmacists and patient organizations, the healthcare inspectorate, the government and health insurance companies. The set over 2012 was the first set of quality indicators for community pharmacies which was validated and supported by all major stakeholders. The aims of this study were to describe the validated set of quality indicators for community pharmacies and to report their scores over 2012. In subanalyses the score development over 5 years was described for those indicators, that have been surveyed before and remained unchanged. Methods Community pharmacists in the Netherlands were invited in 2013 to provide information for the set of 2012. Quality indicators were mapped by categories relevant for pharmaceutical care and defined for structures, processes and dispensing outcomes. Scores for categorically-measured quality indicators were presented as the percentage of pharmacies reporting the presence of a quality aspect. For numerical quality indicators, the mean of all reported scores was expressed. In subanalyses for those indicators that had been questioned previously, scores were collected from earlier measurements for pharmacies providing their scores in 2012. Multilevel analysis was used to assess the consistency of scores within one pharmacy over time by the intra-class correlation coefficient (ICC). Results For the set in 2012, 1739 Dutch community pharmacies (88 % of the total) provided information for 66 quality indicators in 10 categories. Indicator scores on the presence of quality structures showed relatively high quality levels. Scores for processes and dispensing outcomes were lower. Subanalyses showed that overall indicators scores improved within pharmacies, but this development differed between pharmacies. Conclusions A set of validated quality indicators provided

  5. PREPARATION OF COENZYME Q10 AND ITS PHARMIC FUNCTION%辅酶Q10的制备及其药物功能

    Institute of Scientific and Technical Information of China (English)

    姜传福

    2005-01-01

    在前人工作基础上,选用有机非极性溶剂醚、烷烃,从动物脏器提取辅酶Q10,产率高、质量好,为辅酶Q10的研制提供了实用的方法.采用仪器分析手段,测试了产品纯度,符合国家标准.概要地讨论了辅酶Q10在帕金森氏症、心脑血管疾病等方面的药物功能,以及辅酶Q10的应用领域.

  6. Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

    DEFF Research Database (Denmark)

    Aksu, Buket; De Beer, Thomas; Folestad, Staffan

    2012-01-01

    Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals......, include product design and development for personalized healthcare, continuous-processing in pharmaceutical product manufacture, quantitative quality risk assessment for pharmaceutical development including life cycle management and the downstream processing of biopharmaceutical products. Plans are being...

  7. [Coenzyme Q10--its importance, properties and use in nutrition and cosmetics].

    Science.gov (United States)

    Hojerová, J

    2000-05-01

    Coenzyme Q10, or ubiquinone, is a nutrient--a vitamin-like substance which plays a crucial role in the generation of cellular energy an in free radical scavenging in the human body. After the age of 35 to 40, the organism begins to lose its ability to synthesize Co Q10 from food and its deficiency develops. Ageing, poor eating habits, stress and infection--they all affect our ability to provide adequate amounts of Co Q10. Therefore Co Q10 supplementation may be very helpful for the organism. The present summarizing study reports the history of the discovery and research, properties, biochemical effects, dosage of Co Q10 deficiency in the human body. A possible use of Co Q10 as a dietary supplement and an ingredient for topical cosmetic products is described.

  8. Therapeutic implication of coenzyme Q10 during statin therapy: pros and cons

    Directory of Open Access Journals (Sweden)

    Mir-Jamal Hosseini

    2015-09-01

    Full Text Available Coenzyme Q10 (CoQ10 is a vitamin-like substance, and a natural intermediate of electron transport chain (ETC of mitochondria which can accepts and donates electrons from complex I and complex II. CoQ10 shares a biosynthetic pathway with cholesterol and dolichol thus it can be a potential target of the widely available lipid-lowering drugs. The lipid lowering drugs such as statins, are widely administered to individuals who have high cholesterol levels. This article reviews the a clinical benefits of CoQ10 b association between administration of statin and CoQ10 deficiency and c involvement of CoQ10 in statin-associated myopathy.

  9. Serum levels of coenzyme Q10 in patients with multiple sclerosis.

    Science.gov (United States)

    de Bustos, F; Jiménez-Jiménez, F J; Molina, J A; Gómez-Escalonilla, C; de Andrés, C; del Hoyo, P; Zurdo, M; Tallón-Barranco, A; Berbel, A; Porta-Etessam, J; Parrilla, G; Arenas, J

    2000-03-01

    To elucidate whether serum coenzyme Q10 levels are related with the risk for multiple sclerosis (MS) or are a marker for the activity of the disease, we compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio, in 31 patients with MS (during exacerbations) and 19 matched controls using a high performance liquid chromatography technique. The mean serum coenzyme Q10 levels and the coenzyme Q10/cholesterol ratio did not differ significantly between the 2 study groups. The values did not correlate with age, age at onset, and duration of the disease. These results suggest that serum coenzyme Q10 concentrations are unrelated with the risk for MS and are not a useful marker of activity of the disease.

  10. Serum levels of coenzyme Q10 in patients with Alzheimer's disease.

    Science.gov (United States)

    de Bustos, F; Molina, J A; Jiménez-Jiménez, F J; García-Redondo, A; Gómez-Escalonilla, C; Porta-Etessam, J; Berbel, A; Zurdo, M; Barcenilla, B; Parrilla, G; Enriquez-de-Salamanca, R; Arenas, J

    2000-01-01

    We compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio in 44 patients with Alzheimer's disease (AD), 17 patients with vascular dementia (VD), and 21 matched controls. The mean serum coenzyme Q10 and cholesterol levels and the coenzyme Q10/cholesterol ratio of patients with AD or VD did not differ significantly from those of controls. Coenzyme Q10 levels and coenzyme Q10/cholesterol ratio of AD or VD patients were not correlated with age, age at onset, duration of the disease or scores of the MiniMental State Examination. These results suggest that these values are not related with the risk for AD or VD.

  11. Combination therapy with metformin and coenzyme Q10 in murine experimental autoimmune arthritis.

    Science.gov (United States)

    Jhun, JooYeon; Lee, SeungHoon; Kim, Se-Young; Na, Hyun Sik; Kim, Eun-Kyung; Kim, Jae-Kyung; Jeong, Jeong-Hee; Park, Sung Hwan; Cho, Mi-La

    2016-01-01

    Metformin (Met) and coenzyme Q10 (CoQ10) are reported to have therapeutic functions in several inflammatory diseases. These drugs have shown anti-inflammatory effects and have been utilized in mouse models of rheumatoid arthritis (RA). However, there is no evidence of the additive effect of Met and CoQ10 in RA. Although Met and CoQ10 may be involved in the improvement of mitochondrial dysfunction, limited information is available regarding whether this effect can improve mitochondrial dysfunction in RA in particular. In this study, we sought to determine whether Met and CoQ10 attenuate the severity of collagen-induced arthritis (CIA) and show an additive effect in a mouse model. The combination of Met and CoQ10 improved CIA, reducing joint inflammation, Th17 differentiation and IgG production. In contrast, the combination of Met and CoQ10 induced Treg differentiation. Osteoclastogenesis was reduced by the combination of Met and CoQ10. The protein expression of interleukin-1β, interleukin-6 and tumor necrosis factor-alpha in mice splenocytes exposed to lipopolysaccharide decreased after drug combination therapy. We also found that the expression of JC-1 and COX IV were enhanced by treatment with the combination of Met and CoQ10. Moreover, the combination of Met and CoQ10 promoted mitochondrial O2 consumption. These findings suggest that the combination of Met and CoQ10 reduced CIA severity, improving mitochondrial dysfunction compared to Met or CoQ10 alone. These results present a novel, significant preventive targets in RA and may enhance our understanding of its pathogenesis.

  12. 辅酶Q10 寻找心脏的“加油站”

    Institute of Scientific and Technical Information of China (English)

    赵湘媛

    2010-01-01

    健康成年人每天从日常膳食中摄入大约4—7毫克辅酶Q10,但却消耗10-30毫克辅酶Q10。因此人到50岁时,体内的辅酶Q10含量只有年轻时的75%,体力、精力大不如前。

  13. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation.

    Science.gov (United States)

    Pallagi, Edina; Ambrus, Rita; Szabó-Révész, Piroska; Csóka, Ildikó

    2015-08-01

    Regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities nowadays. The aim of this study was to adapt regulatory science even in the nano-pharmaceutical early development. Authors applied the quality by design (QbD) concept in the early development phase of nano-systems, where the illustration material was meloxicam. The meloxicam nanoparticles produced by co-grinding method for nasal administration were studied according to the QbD policy and the QbD based risk assessment (RA) was performed. The steps were implemented according to the relevant regulatory guidelines (quality target product profile (QTPP) determination, selection of critical quality attributes (CQAs) and critical process parameters (CPPs)) and a special software (Lean QbD Software(®)) was used for the RA, which represents a novelty in this field. The RA was able to predict and identify theoretically the factors (e.g. sample composition, production method parameters, etc.) which have the highest impact on the desired meloxicam-product quality. The results of the practical research justified the theoretical prediction. This method can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation. It makes possible focusing the resources on the selected parameters and area during the practical product development.

  14. Physical activity affects plasma coenzyme Q10 levels differently in young and old humans.

    Science.gov (United States)

    Del Pozo-Cruz, Jesús; Rodríguez-Bies, Elisabet; Ballesteros-Simarro, Manuel; Navas-Enamorado, Ignacio; Tung, Bui Thanh; Navas, Plácido; López-Lluch, Guillermo

    2014-04-01

    Coenzyme Q (Q) is a key lipidic compound for cell bioenergetics and membrane antioxidant activities. It has been shown that also has a central role in the prevention of oxidation of plasma lipoproteins. Q has been associated with the prevention of cholesterol oxidation and several aging-related diseases. However, to date no clear data on the levels of plasma Q during aging are available. We have measured the levels of plasmatic Q10 and cholesterol in young and old individuals showing different degrees of physical activity. Our results indicate that plasma Q10 levels in old people are higher that the levels found in young people. Our analysis also indicates that there is no a relationship between the degree of physical activity and Q10 levels when the general population is studied. However, very interestingly, we have found a different tendency between Q10 levels and physical activity depending on the age of individuals. In young people, higher activity correlates with lower Q10 levels in plasma whereas in older adults this ratio changes and higher activity is related to higher plasma Q10 levels and higher Q10/Chol ratios. Higher Q10 levels in plasma are related to lower lipoperoxidation and oxidized LDL levels in elderly people. Our results highlight the importance of life habits in the analysis of Q10 in plasma and indicate that the practice of physical activity at old age can improve antioxidant capacity in plasma and help to prevent cardiovascular diseases.

  15. 发酵法生产辅酶Q10的研究进展

    Institute of Scientific and Technical Information of China (English)

    邹祥

    2004-01-01

    辅酶Q10是一种重要的生理活性物质,具有很高的临床应用价值,来源于动植物、微生物细胞组织,发酵法生产辅酶Q10是目前最具有产业化前景的生产技术,本文综述了辅酶Q10的生理功能、生产现状及发酵法生产辅酶Q10的应用前景。

  16. [Pharmaceutical procurement by the public sector: the quality/cost relationship].

    Science.gov (United States)

    Luiza, V L; Castro, C G; Nunes, J M

    1999-01-01

    The authors discuss procurement and provision of pharmaceutical products from the perspective of supply management in the public health sector, focusing on two main aspects: quality and cost. The article analyzes issues to be considered by buyers when evaluating drug quality, especially formulation stability, bioequivalence, and the role of generics. Also discussed are factors involving costs and cost management in relation to technological innovations and consumer demands. New alternatives and suggestions are examined and presented for procurement of high-quality, cost-effective drug products.

  17. A first case of primary amenorrhea with i(X(qter---q10::---qter, rob(13;14(q10;q10, inv(9(p13q33 karyotype

    Directory of Open Access Journals (Sweden)

    Seema Korgaonkar

    2011-01-01

    Full Text Available Primary amenorrhea (PA refers to the absence of menarche by the age of 16-18 years although secondary sexual characters are developed. PA occurs in 1-3% of women in the reproductive age group. Various factors such as anatomical, genetic and hormonal factors reported to influence PA. We report triple chromosomal abnormalities of rob(13;14(q10;q10,inv(9(p13q33, i(Xq(qter---q10::---qter in a case of PA and short stature. Though proband has multiple chromosome aberrations, genotypic effect of only i(Xq is evident as proband has PA and short stature. The rob(13;14 and inv(9, which are paternally derived may have role in later reproductive age. Therefore, chromosomal analysis is essential in such cases for the accurate diagnosis and management of the disease.

  18. Coenzyme Q10 (CoQ10) reduce the heart toxicity caused by anthracycline-based chemotherapy drugs%辅酶Q10治疗蒽环类药物致心脏毒性的疗效

    Institute of Scientific and Technical Information of China (English)

    孙玉书; 高德荣

    2012-01-01

    Objective:To study the protective effect of CoQl0 on the cardiovascular toxicity induced by anthracycline, and investigate the possible mechanisms. Methods: Sixty tumor patients were randomly divided into treatment group(30 cases) and control group(30 cases). Receiving chemotherapy,at the same time,CoQ10 and a large dose of vitamin E were given in two groups. Electrocardiography and cardiac enzymes were examined before and after treatment. Results: ECG and myocardial enzyme were all improved significantly in the treatment group, and the changes were superior to those of the control group ( P < 0 05 ) . Conclusion: CoQl0 had protective effects on the cardiovascular toxicity induced by anthracycline.%目的:研究辅酶Q10 (CoQ10)对使用蒽环类化疗药物致心脏毒性的保护作用,并探讨可能的机理.方法:60例肿瘤患者随机分为治疗组(30例)和对照组(30例),化疗同时分别予CoQ10及大剂量维生素E治疗,治疗前后行心电图、心肌酶检查.结果:化疗后CoQ10组心电图和血清心肌酶学指标均优于对照组(P<0.05).结论:CoQ10对蒽环类化疗药物所致心脏毒性有保护作用.

  19. Towards Quality Control in Pharmaceutical Packaging: Screening Folded Boxes for Package Inserts

    Science.gov (United States)

    Brinkmann, S.; Vieweg, N.; Gärtner, G.; Plew, P.; Deninger, A.

    2017-03-01

    We applied a recently developed, ultrafast terahertz measurement technique to screen folded cardboard boxes for package inserts. The presence or absence of an enclosed leaflet could be detected unambiguously in samples moving at velocities up to 21 m/s and, depending on the sample, up to an area overlap of 50-60%. The simple, robust measurement setup may pave the way to new applications of terahertz technology for quality control in pharmaceutical packaging.

  20. Towards Quality Control in Pharmaceutical Packaging: Screening Folded Boxes for Package Inserts

    Science.gov (United States)

    Brinkmann, S.; Vieweg, N.; Gärtner, G.; Plew, P.; Deninger, A.

    2016-11-01

    We applied a recently developed, ultrafast terahertz measurement technique to screen folded cardboard boxes for package inserts. The presence or absence of an enclosed leaflet could be detected unambiguously in samples moving at velocities up to 21 m/s and, depending on the sample, up to an area overlap of 50-60%. The simple, robust measurement setup may pave the way to new applications of terahertz technology for quality control in pharmaceutical packaging.

  1. Quality control analytical methods: microbial limit tests for nonsterile pharmaceuticals, Part 1.

    Science.gov (United States)

    Vu, Nicole; Lou, Jessica R; Kupiec, Thomas C

    2014-01-01

    Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described in three major Pharmacopeias. Their functions and their limitations in the examination of microbiological quality for nonsterile products will be reviewed in this report.

  2. 辅酶Q10纳米脂质体稳定性的研究%Study on Stability of Coenzyme Q10 Nanoliposomes

    Institute of Scientific and Technical Information of China (English)

    夏书芹; 许时婴

    2006-01-01

    辅酶Q10是一种膳食补充剂,在人体细胞呼吸链的电子传递中起重要作用,采用纳米胶囊技术制备辅酶Q10纳米脂质体可防止其发生降解并提高其生物利用率.文中以蛋黄磷脂为主要壁材,采用乙醇注入-超声法制得稳定性较好的辅酶Q10纳米脂质体.制备过程中,搅拌、加热、超声等作用对磷脂的氧化影响很小,芯材辅酶Q10的存在有效地抑制了脂质体中丙二醛的产生,并且辅酶Q10的总量基本不发生变化.贮存稳定性试验表明,较佳的贮存条件为4℃避光.贮存过程中脂质体双分子层对辅酶Q10有明显的保护作用,辅酶Q10也有效抑制了主要壁材磷脂的氧化,并能稳定脂质体双分子层.

  3. Quality assessment of pharmaceutical tablet samples using Fourier transform near infrared spectroscopy and multivariate analysis

    Science.gov (United States)

    Kandpal, Lalit Mohan; Tewari, Jagdish; Gopinathan, Nishanth; Stolee, Jessica; Strong, Rick; Boulas, Pierre; Cho, Byoung-Kwan

    2017-09-01

    Determination of the content uniformity, assessed by the amount of an active pharmaceutical ingredient (API), and hardness of pharmaceutical materials is important for achieving a high-quality formulation and to ensure the intended therapeutic effects of the end-product. In this work, Fourier transform near infrared (FT-NIR) spectroscopy was used to determine the content uniformity and hardness of a pharmaceutical mini-tablet and standard tablet samples. Tablet samples were scanned using an FT-NIR instrument and tablet spectra were collected at wavelengths of 1000-2500 nm. Furthermore, multivariate analysis was applied to extract the relationship between the FT-NIR spectra and the measured parameters. The results of FT-NIR spectroscopy for API and hardness prediction were as precise as the reference high-performance liquid chromatography and mechanical hardness tests. For the prediction of mini-tablet API content, the highest coefficient of determination for the prediction (R2p) was found to be 0.99 with a standard error of prediction (SEP) of 0.72 mg. Moreover, the standard tablet hardness measurement had a R2p value of 0.91 with an SEP of 0.25 kg. These results suggest that FT-NIR spectroscopy is an alternative and accurate nondestructive measurement tool for the detection of the chemical and physical properties of pharmaceutical samples.

  4. Risk identification for quality on stage of pharmaceutical development of combined eye drops for glaucoma treatment

    Directory of Open Access Journals (Sweden)

    Олександр Миколайович Якубчук

    2015-12-01

    Full Text Available Aim: To identify the possible risks associated with critical quality attribute of combined eye drops for the treatment of glaucoma using of common risk evaluation methodologies for plannig a drug quality on the stage of pharmaceutical development. Methods: The paper used method of causal analysis. The maximal number of factors has been define to identify potential factors that provide most significant impact on the drug quality and Ishikawa diagram - graphical representation of causes and effects has been built.Results: Analysis allowed to organize the possible factors affecting the drug quality in the generalized categories: quality control methods, medicines and excipients, primary packaging, proper manufacturing conditions and the stage of the process. The most important factors that are carriers of the risk factors and may lead to negative effects have been identified for the generalized categories.Conclusions: Determined at the stage of pharmaceutical development potential critical quality attribute of AFI, excipients and primary packaging, critical parameters of the process, provide a better understanding, reduction and adoption of risk in subsequent stages of the life cycle of the drug

  5. Functional connections and pathways of coenzyme Q10-inducible genes: an in-silico study.

    Science.gov (United States)

    Schmelzer, Constance; Lindner, Inka; Vock, Christina; Fujii, Kenji; Döring, Frank

    2007-10-01

    Coenzyme Q10 (CoQ10, ubiquinone) is an essential cofactor in the electron transport chain, serves as a potent antioxidant in mitochondria and lipid membranes, and is often used as a dietary supplement for a number of diseases including cardiovascular diseases. Recently, we obtained evidence that CoQ10 (Kaneka Q10) affects the expression of hundreds of human genes. To decipher the functional and regulatory connections of these genes, a literature search combined with transcription factor binding site analysis was performed using Genomatix BiblioSphere and MatInspector. This in-silico analysis revealed 17 CoQ10-inducible genes which are functionally connected by signalling pathways of G-protein coupled receptors, JAK/STAT, integrin, and beta-arrestin. Promoter analysis of these CoQ10-inducible genes showed one group of NF B-regulated genes, namely IL5, thrombin, vitronectin receptor and C-reactive protein (CRP). Furthermore, a common promoter framework containing binding sites of the transcription factor families EVI1, HOXF, HOXC, and CLOX was identified in the promoters of IL5, CRP, and vitronectin receptor. The identified CoQ10-inducible genes and pathways play an important role in inflammatory response. Since these effects are based on an in-vitro study, the effect of CoQ10 on vascular health in vivo needs to be addressed in further animal and/or human intervention studies.

  6. High serum coenzyme Q10, positively correlated with age, selenium and cholesterol in Inuit of Greenland

    DEFF Research Database (Denmark)

    Pedersen, Henning Sloth; Mortensen, S.A.; Rhode, M.

    1999-01-01

    .001) compared to a Danish population. In a linear multiple regression model the S-CoQ10 level is significantly positively associated with age and S-selenium in males, and S-total cholesterol in females. The high level of CoQ10 in Greenlanders probably reflects diet, since no bioaccumulation takes place...

  7. Effect of Coenzyme-Q10 on Doxorubicin-Induced Nephrotoxicity in Rats

    Directory of Open Access Journals (Sweden)

    Azza A. K. El-Sheikh

    2012-01-01

    Full Text Available Nephrotoxicity is one of the limiting factors for using doxorubicin (Dox as an anticancer chemotherapeutic. Here, we investigated possible protective effect of coenzyme-Q10 (CoQ10 on Dox-induced nephrotoxicity and the mechanisms involved. Two doses (10 and 100 mg/kg of CoQ10 were administered orally to rats for 8 days, in the presence or absence of nephrotoxicity induced by a single intraperitoneal injection of Dox (15 mg/kg at day 4 of the experiment. Our results showed that the low dose of CoQ10 succeeded in reversing Dox-induced nephrotoxicity to control levels (e.g., levels of blood urea nitrogen and serum creatinine, concentrations of renal reduced glutathione (GSH and malondialdehyde, catalase activity and caspase 3 expression, and renal histopathology. Alternatively, the high dose of CoQ10 showed no superior nephroprotection over the low dose, as there were no significant improvements in renal histopathology, catalase activity, or caspase 3 expression compared to the Dox-treated group. Interestingly, the high dose of CoQ10 alone significantly decreased renal GSH level as well as catalase activity and caused a mild induction of caspase 3 expression compared to control, probably due to a prooxidant effect at this dose of CoQ10. We conclude that CoQ10 protects from Dox-induced nephrotoxicity with a precaution to dosage adjustment.

  8. FERMENTATION, MEDIA OPTIMIZATION STUDIES FOR COENZYME Q10 PRODUCTION BY Saccharomyces cerevisiae

    Directory of Open Access Journals (Sweden)

    Narendra Kumar S

    2012-01-01

    Full Text Available To establish the fermentation process for CoQ10 production by using Saccharomyces cerevisiae with subsequent bioprocess media optimization studies. Coenzyme Q10 (CoQ10 is a vitamin-like nutrient that plays a vital role in cellular energy production. Coenzyme Q10, apart from playing an important role in electron transfer for ATP synthesis, also acts as antioxidant. Therefore it is preferred as a potential therapeutic supplement to many critical diseases besides being used as dietary supplement in the energy drinks, anti-aging etc. This has driven the demand for Coenzyme Q10 supply to meet the market requirements. The method adapted for Coenzyme Q10 is batch fermentation route and preferred over synthetic method due to low production cost, safe environmental issue. The optimization of media for better yield of CoQ10 during fermentation and it was found that a maximum CoQ10 5mg/600ml is obtained at 4% of limiting substrate, 150 rpm at 30oC.

  9. 辅酶Q10片与辅酶Q10胶囊溶出度试验方法的探讨%Discussion on the Dissolution Testing Methods for Coenzyme Q10 Tablets and Coenzyme Q10 Capsules

    Institute of Scientific and Technical Information of China (English)

    梁翠荣; 董蓬; 孙吉令

    2003-01-01

    @@ 辅酶Q10是一种脂溶性药物,临床主要用于慢性缺血性心脏病及高血压性心脏病的治疗.辅酶Q10片和胶囊是2001年国家重点考察品种之一,作者在崩解时限检查时发现,辅酶Q10胶囊样品囊壳虽已崩解,但胶囊内容物聚结成小颗粒通过筛网后仍悬浮在水面.因此,作者对辅酶Q10片与辅酶Q10胶囊的溶出度方法进行了探讨.

  10. 辅酶Q10低成本生产的技术支持

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    1辅酶Q10合成方法存在的问题 目前,国内外化学合成法生产辅酶Q10有两个重要步骤,一是从烟叶中分离纯化一种三倍半萜烯醇——茄尼醇,将茄尼醇延长成为十聚癸异戊二烯,用它作为辅酶Q10的“侧链”;二是人工合成一种称为辅酶Q10的化合物,即2,3-二甲氧基-5-甲基-1,4-苯醌,然后将两者缩合成为辅酶Q10

  11. Coenzyme Q10 suppresses Th17 cells and osteoclast differentiation and ameliorates experimental autoimmune arthritis mice.

    Science.gov (United States)

    Jhun, JooYeon; Lee, Seung Hoon; Byun, Jae-Kyeong; Jeong, Jeong-Hee; Kim, Eun-Kyung; Lee, Jennifer; Jung, Young-Ok; Shin, Dongyun; Park, Sung Hwan; Cho, Mi-La

    2015-08-01

    Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant synthesized in human body. This enzyme promotes immune system function and can be used as a dietary supplement. Rheumatoid arthritis (RA) is an autoimmune disease leading to chronic joint inflammation. RA results in severe destruction of cartilage and disability. This study aimed to investigate the effect of CoQ10 on inflammation and Th17 cell proliferation on an experimental rheumatoid arthritis (RA) mice model. CoQ10 or cotton seed oil as control was orally administrated once a day for seven weeks to mice with zymosan-induced arthritis (ZIA). Histological analysis of the joints was conducted using immunohistochemistry. Germinal center (GC) B cells, Th17 cells and Treg cells of the spleen tissue were examined by confocal microscopy staining. mRNA expression was measured by real-time PCR and protein levels were estimated by enzyme-linked immunosorbent assay (ELISA). Flow cytometric analysis (FACS) was used to evaluate Th17 cells and Treg cells. CoQ10 mitigated the severity of ZIA and decreased serum immunoglobulin concentrations. CoQ10 also reduced RANKL-induced osteoclastogenesis, inflammatory mediators and oxidant factors. Th17/Treg axis was reciprocally controlled by CoQ10 treatment. Moreover, CoQ10 treatment on normal mouse and human cells cultured in Th17 conditions decreased the number of Th17 cells and enhanced the number of Treg cells. CoQ10 alleviates arthritis in mice with ZIA declining inflammation, Th17 cells and osteoclast differentiation. These findings suggest that CoQ10 can be a potential therapeutic substance for RA.

  12. Coenzyme Q10 and Heart Failure: A State-of-the-Art Review.

    Science.gov (United States)

    Sharma, Abhinav; Fonarow, Gregg C; Butler, Javed; Ezekowitz, Justin A; Felker, G Michael

    2016-04-01

    Heart failure (HF) with either preserved or reduced ejection fraction is associated with increased morbidity and mortality. Evidence-based therapies are often limited by tolerability, hypotension, electrolyte disturbances, and renal dysfunction. Coenzyme Q10 (CoQ10) may represent a safe therapeutic option for patients with HF. CoQ10 is a highly lipophilic molecule with a chemical structure similar to vitamin K. Although being a common component of cellular membranes, CoQ10's most prominent role is to facilitate the production of adenosine triphosphate in the mitochondria by participating in redox reactions within the electron transport chain. Numerous trials during the past 30 years examining CoQ10 in patients with HF have been limited by small numbers and lack of contemporary HF therapies. The recent publication of the Q-SYMBIO randomized controlled trial demonstrated a reduction in major adverse cardiovascular events with CoQ10 supplementation in a contemporary HF population. Although having limitations, this study has renewed interest in evaluating CoQ10 supplementation in patients with HF. Current literature suggests that CoQ10 is relatively safe with few drug interactions and side effects. Furthermore, it is already widely available as an over-the-counter supplement. These findings warrant future adequately powered randomized controlled trials of CoQ10 supplementation in patients with HF. This state-of-the-art review summarizes the literature about the mechanisms, clinical data, and safety profile of CoQ10 supplementation in patients with HF.

  13. The lay user perspective on the quality of pharmaceuticals, drug therapy and pharmacy services--results of focus group discussions

    DEFF Research Database (Denmark)

    Traulsen, Janine Marie; Almarsdóttir, Anna Birna; Björnsdóttir, Ingunn

    2002-01-01

    This article presents the results of a study on quality of pharmacy services and perceived risk of pharmaceuticals. The results presented here are part of a multi-study evaluation of major changes in drug distribution in Iceland.......This article presents the results of a study on quality of pharmacy services and perceived risk of pharmaceuticals. The results presented here are part of a multi-study evaluation of major changes in drug distribution in Iceland....

  14. Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar

    Directory of Open Access Journals (Sweden)

    Emilia Sawicki

    2016-08-01

    Full Text Available Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are substrates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein. Elacridar is a strong inhibitor of these two drug efflux pumps and therefore has great potential to improve oral absorption and brain penetration of many anticancer drugs. Currently, a clinical formulation of elacridar is unavailable and therefore the pharmaceutical development of a drug product is highly warranted. This also necessitates the availability of an analytical method for its quality control. A reverse-phase high-performance liquid chromatographic method with ultraviolet detection was developed for the pharmaceutical quality control of products containing elacridar as the active pharmaceutical ingredient. The analytical method was validated for linearity, accuracy, precision, selectivity, carry-over, stability of stock and reference solutions, stability of the final extract, stability-indicating capability and impurity testing. We found that elacridar is unstable in aqueous solutions that are exposed to light because a hydroxylation product of elacridar is formed. Therefore, sample solutions with elacridar must be protected from light.

  15. Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar$

    Institute of Scientific and Technical Information of China (English)

    Emilia Sawicki; Michel J. Hillebrand; Hilde Rosing; Jan H.M. Schellens; Bastiaan Nuijen; Jos H. Beijnen

    2016-01-01

    Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are sub-strates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein. Elacridar is a strong inhibitor of these two drug efflux pumps and therefore has great potential to improve oral absorption and brain penetration of many anticancer drugs. Currently, a clinical formulation of elacridar is unavailable and therefore the pharmaceutical development of a drug product is highly warranted. This also necessitates the availability of an analytical method for its quality control. A reverse-phase high-performance liquid chro-matographic method with ultraviolet detection was developed for the pharmaceutical quality control of products containing elacridar as the active pharmaceutical ingredient. The analytical method was validated for linearity, accuracy, precision, selectivity, carry-over, stability of stock and reference solutions, stability of the final extract, stability-indicating capability and impurity testing. We found that elacridar is unstable in aqueous solutions that are exposed to light because a hydroxylation product of elacridar is formed. Therefore, sample solutions with elacridar must be protected from light.

  16. A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

    Science.gov (United States)

    Lourenço, Vera; Lochmann, Dirk; Reich, Gabriele; Menezes, José C; Herdling, Thorsten; Schewitz, Jens

    2012-06-01

    The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described. Copyright © 2012 Elsevier B.V. All rights reserved.

  17. Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies.

    Science.gov (United States)

    Xu, Wei; Boehm, Garth; Zheng, Qiang

    2016-01-01

    Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution.

  18. Preparation and Characterization of Mucoadhesive Nanoparticles for Enhancing Cellular Uptake of Coenzyme Q10.

    Science.gov (United States)

    Lee, Ji-Soo; Suh, Ji Woon; Kim, Eun Suh; Lee, Hyeon Gyu

    2017-10-02

    The mucoadhesive nanoparticles (NPs) for oral delivery of coenzyme Q10 (CoQ10) were prepared using natural mucoadhesive polysaccharides, chitosan (CS), and dextran sulfate sodium salt (DS) in order to improve the solubility, cellular uptake, and thermo- and photostability of CoQ10. CoQ10-loaded NPs were prepared in the range of 340-450 nm with an entrapment efficiency of 60-98%. The mucoadhesiveness and cellular uptake of NPs were evaluated by measuring the amount of mucin adsorbed on NPs and CoQ10 absorbed in Caco-2 cells, respectively. CS/DS NPs had higher mucoadhesive strength than CS/sodium triphosphate pentabasic NPs (control group). Moreover, the solubility, cellular uptake, thermo- and photostability of CS/DS NPs were significantly improved compared with non-nanoencapsulated free CoQ10. Particularly, CS/DS NPs prepared with 0.5 mg/mL of CS and DS produced the highest mucoadhesiveness, solubility, cellular uptake, and cellular antioxidant activity. Thus, mucoadhesive CS/DS NPs may be an effective oral delivery platform for improving bioavailability of CoQ10.

  19. Statins' effect on plasma levels of Coenzyme Q10 and improvement in myopathy with supplementation.

    Science.gov (United States)

    Littlefield, Nate; Beckstrand, Renea L; Luthy, Karlen E

    2014-02-01

    Heart disease is the leading cause of death in the United States. HMG-CoA reductase inhibitors, or statins, are medications at the forefront of the battle against cardiovascular disease. Despite their effectiveness, patient compliance with statins has lagged because of medication cost and adverse effects, namely myopathy. Myopathy is the most common side effect of statin use. The purpose of this review is to report plasma levels of CoQ10 in patients taking statins and then to determine the benefit of Coenzyme Q10 (CoQ10) supplementation on statin-related myopathy as evidenced by symptomatic improvement and increase in serum levels of CoQ10. CINAHL, Medline, Health Source: Nursing/Academic Edition, and Cochrane Library. Evidence from this review suggests that studies showed a significant relationship between statin intake and decreased serum levels of CoQ10. A few studies showed a benefit in symptoms of myalgia or improvement of serum levels of CoQ10 with supplementation. One study showed no benefit of CoQ10 supplementation when taken with statins. There were no risks of supplementation reported in any of the studies. CoQ10 supplementation might benefit those patients suffering from statin-induced myopathy as evidenced by the results of these studies. Supplementation of CoQ10 at a dose of between 30 and 200 mg daily has shown to have beneficial effects on statin myopathy with no noted side effects. Further research is necessary. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

  20. Study on the Intracellular Coenzyme Q10 Extraction with Saponification Method%皂化法提取胞内辅酶Q10的研究

    Institute of Scientific and Technical Information of China (English)

    李聚海; 岳田利; 袁亚宏

    2007-01-01

    以根癌土壤杆菌为出发菌株,采用发酵法生产辅酶Q10,考察了破壁方法、皂化温度、皂化时间、加碱量、皂化顺序对辅酶Q10提取率的影响,试验得到皂化的最佳条件为:皂化温度60℃,皂化时间30min,皂化液与破碎液比例为5∶2.与未皂化相比,皂化后的细胞碎片经固液萃取后得到的辅酶Q10提取量提高了39.65%,并且消除了杂质对辅酶Q10测定的影响,该方法可行性强,具有广阔的发展前景.

  1. An Overview on Novel Microbial Determination Methods in Pharmaceutical and Food Quality Control

    Directory of Open Access Journals (Sweden)

    Mahboob Nemati

    2016-09-01

    Full Text Available Traditional microbiological methods tend to be labor-intensive and time-consuming. Rapid and novel methods in microbiological tests provide more sensitive, precise and reproducible results compared with conventional methods. In microbiology, the most rapid testing methods belong to the field of biotechnology such as PCR, ELISA, ATP bioluminescence and etc. Nevertheless impedance microbiology, biosensors and analytical procedures to determine microbial constituents are of significance. The present review article was conducted using internet databases and related scientific literatures and articles that provide information on developments in the rapid methods in microbiology. The main focus is on the application of rapid methods in microbial quality control of pharmaceutical products. Reviewed literature showed that rapid methods and automation in microbiology is an advanced area for studying and applying of improved methods in the early detection, and characterization of microorganisms and their products in food, pharmaceutical and cosmetic industrials as well as environmental monitoring and clinical applications. It can be concluded that rapid methods and automation in microbiology should continue as potent and efficient technologies to develop the novel tests to be performed in the future because of the ever-increasing concerns about the safety of food and pharmaceutical products. However the main issues to be considered are the scale up of developed methods and the regulatory requirements.

  2. Towards quality by design in pharmaceutical manufacturing: modelling and control of air jet mills

    Science.gov (United States)

    Bhonsale, Satyajeet; Telen, Dries; Stokbroekx, Bard; Van Impe, Jan

    2017-06-01

    Milling is an important step in pharmaceutical manufacturing as it not only determines the final formulation of the drug product, but also influences the bioavailability and dissolution rate of the active pharmaceutical ingredient (API). In this respect, the air jet mill (AJM) is most commonly used in the pharmaceutical industry as it is a non-contaminating and non-degrading self-classifying process capable of delivering narrow particle size distributions (PSD). Keeping the principles of Quality by Design in mind, the Critical Process Parameters (CPPs) of the AJM have been identified to be the pressures at the grinding nozzles, and the feed rate which affect the PSD, surface charge and the morphology of the product (i.e. the Critical Material Attributes (CMAs)). For the purpose of this research, the PSD is considered to be the only relevant CMA. A population balance based model is proposed to simulate the dynamics milling operation by utilizing the concept of breakage functions. This model agrees qualitatively with experimental observations of the air jet mill unit present at Janssen Pharmaceutica but further steps for model validation need to be carried out.

  3. Towards quality by design in pharmaceutical manufacturing: modelling and control of air jet mills

    Directory of Open Access Journals (Sweden)

    Bhonsale Satyajeet

    2017-01-01

    Full Text Available Milling is an important step in pharmaceutical manufacturing as it not only determines the final formulation of the drug product, but also influences the bioavailability and dissolution rate of the active pharmaceutical ingredient (API. In this respect, the air jet mill (AJM is most commonly used in the pharmaceutical industry as it is a non-contaminating and non-degrading self-classifying process capable of delivering narrow particle size distributions (PSD. Keeping the principles of Quality by Design in mind, the Critical Process Parameters (CPPs of the AJM have been identified to be the pressures at the grinding nozzles, and the feed rate which affect the PSD, surface charge and the morphology of the product (i.e. the Critical Material Attributes (CMAs. For the purpose of this research, the PSD is considered to be the only relevant CMA. A population balance based model is proposed to simulate the dynamics milling operation by utilizing the concept of breakage functions. This model agrees qualitatively with experimental observations of the air jet mill unit present at Janssen Pharmaceutica but further steps for model validation need to be carried out.

  4. An Overview on Novel Microbial Determination Methods in Pharmaceutical and Food Quality Control

    Science.gov (United States)

    Nemati, Mahboob; Hamidi, Aliasghar; Maleki Dizaj, Solmaz; Javaherzadeh, Vahid; Lotfipour, Farzaneh

    2016-01-01

    Traditional microbiological methods tend to be labor-intensive and time-consuming. Rapid and novel methods in microbiological tests provide more sensitive, precise and reproducible results compared with conventional methods. In microbiology, the most rapid testing methods belong to the field of biotechnology such as PCR, ELISA, ATP bioluminescence and etc. Nevertheless impedance microbiology, biosensors and analytical procedures to determine microbial constituents are of significance. The present review article was conducted using internet databases and related scientific literatures and articles that provide information on developments in the rapid methods in microbiology. The main focus is on the application of rapid methods in microbial quality control of pharmaceutical products. Reviewed literature showed that rapid methods and automation in microbiology is an advanced area for studying and applying of improved methods in the early detection, and characterization of microorganisms and their products in food, pharmaceutical and cosmetic industrials as well as environmental monitoring and clinical applications. It can be concluded that rapid methods and automation in microbiology should continue as potent and efficient technologies to develop the novel tests to be performed in the future because of the ever-increasing concerns about the safety of food and pharmaceutical products. However the main issues to be considered are the scale up of developed methods and the regulatory requirements. PMID:27766214

  5. Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).

    Science.gov (United States)

    Taylor, Peter W; Arnet, Isabelle; Fischer, Anton; Simpson, Iain N

    2010-08-01

    To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes. Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical. All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern. Copyright © 2010 S. Karger AG, Basel.

  6. Quality Assessment of Persian Translation of English Pharmaceutical Leaflets Based on House’s Model

    Directory of Open Access Journals (Sweden)

    Atefeh Zekri

    2016-11-01

    Full Text Available This research attempted to evaluate the quality of Persian translation of drug leaflets. The researchers randomly selected a set of 30 pharmaceutical leaflets collected between March-August, 2015. The leaflets were analyzed based on House’s functional-pragmatic model of translation quality assessment. At first, the profiles of both source texts and target texts were collected. Then, their overtly and covertly erroneous errors and the kinds of strategies used by the translators in translating the pharmaceutical leaflets into Persian were identified. The results indicate that out of 90 selected sentences of English leaflets, 47 were overtly erroneous and 43 were error-free. These overtly erroneous translations had 27 instances of “mistranslation”, 15 instances of “grammatical mistakes”, six instances of “addition”, six instances of “omission” and four instances of “substitution”. The only covert error was “tenor mismatch” in all sample sentences. The study findings can help teachers in translation studies to improve the quality of students’ translation. Moreover, awareness of the errors in the current leaflet translations can assist students in performing their future jobs as translators. The findings may directly and indirectly affect the health of patients in an efficient and effective way.

  7. CoQ10 supplementation: a new treatment modality in steroid ...

    African Journals Online (AJOL)

    Cetin Dincel

    2014-08-09

    Aug 9, 2014 ... CoQ10 supplementation in steroid-resistant nephrotic syndrome. Int J Med Biomed Res 2014 ... mitochondria.[17] A small proportion is taken by diet.[18] It has an important role in the .... Metabolic disturbances. (hypothermia,.

  8. Supplementation of Coenzyme Q10 among Patients with Type 2 Diabetes Mellitus

    Directory of Open Access Journals (Sweden)

    Qiuhua Shen

    2015-05-01

    Full Text Available Type 2 diabetes mellitus (T2DM is a major cause of morbidity and mortality with ever increasing prevalence in the United States and worldwide. There is growing body of evidence suggesting that mitochondrial dysfunction secondary to oxidative stress plays a critical role in the pathogenesis of T2DM. Coenzyme Q10 is an important micronutrient acting on the electron transport chain of the mitochondria with two major functions: (1 synthesis of adenosine triphosphate (ATP; and (2 a potent antioxidant. Deficiency in coenzyme Q10 is often seen in patients with T2DM. Whether restoration of coenzyme Q10 will help alleviate oxidative stress, preserve mitochondrial function, and thus improve glycemic control in T2DM is unclear. This article reviews the relationships among oxidative stress, mitochondrial dysfunction, and T2DM and examines the evidence for potential use of coenzyme Q10 as a supplement for the treatment of T2DM.

  9. 辅酶Q10的抗衰老作用

    Institute of Scientific and Technical Information of China (English)

    李刚

    2010-01-01

    @@ 辅酶Q10又名泛醌10,是一种脂溶性醌.它既是生物细胞能量催化剂和细胞代谢的激活剂,又是自身生成的抗氧化剂和非特异性免疫增强剂. 一、人体衰老的原因 辅酶Q10位于细胞线粒体内膜上,大部分细胞含有500~2000的线粒体.人体吸收营养物质在线粒体内转化为能量,需要辅酶Q10的催化作用,辅酶Q10是细胞能量的催化剂.

  10. 类维生素——辅酶Q10

    Institute of Scientific and Technical Information of China (English)

    杜冠华

    2009-01-01

    @@ 辅酶Q10的化学性质 辅酶Q10最初从患有维生素A缺乏症的大鼠肝脏中分离得到,并称之为泛醌,意即广泛存在的醌.它以极低的含量广泛存在于动物、植物、微生物等细胞内.辅酶Q10在室温下呈橙黄色结晶,无臭无味,受光易分解.辅酶Q10是一种脂溶性醌环类化合物.

  11. 神奇的营养素——辅酶Q10

    Institute of Scientific and Technical Information of China (English)

    杜慧真

    2012-01-01

    辅酶Q10的功能用途1.抗氧化性 对心血管系统应用辅酶Q10最主要集中在心肌细胞负责制造能量的线粒体中.辅酶Q10可以帮助心肌细胞产生能量,显著提升心肌的带氧量,对心力衰蝎的病情有很好的改善效果,可以延长心肌寿命.因其显著的保护心脏的作用,在许多国家辅酶Q10被列为药品而非食品.

  12. 辅酶Q10来了,心衰、健忘走了

    Institute of Scientific and Technical Information of China (English)

    杨绪军

    2012-01-01

    受访专家:和渝斌 北京军区总医院心肺血管中心副主任、主任医师高键 复旦大学附属中山医院营养科副主任冯翔 广东中山大学公共卫生学院副教授什么是辅酶Q10?倘若在大街上问辅酶Q10是什么,我国普通百姓估计十人九不知.在欧美国家,辅酶Q10成了老年人常用的保健品.也许你会问了,辅酶Q10究竟是什么?为何赢得如此厚爱呢?

  13. Coenzyme Q10 Supplementation Modulates NFκB and Nrf2 Pathways in Exercise Training.

    Science.gov (United States)

    Pala, Ragip; Orhan, Cemal; Tuzcu, Mehmet; Sahin, Nurhan; Ali, Shakir; Cinar, Vedat; Atalay, Mustafa; Sahin, Kazim

    2016-03-01

    This study reports the effects of Q10, coenzyme Q10 or ubiquinone, a component of the electron transport chain in mitochondria, on nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB), inhibitors of kappa B (IκB), nuclear factor (erythroid-derived 2)-like 2 (Nrf2) and hemeoxygenase 1 (HO-1) in rats after chronic exercise training for 6 weeks. 8-week old male Wistar rats were assigned randomly to one of four treatments planned in a 2 x 2 factorial arrangement of two condition (sedentary vs. exercise training), and two coenzyme Q10 levels (0 and 300 mg/kg per day for 6 weeks). The expression levels of the target proteins were determined in the heart, liver and muscle, and biochemical parameters including creatinine, urea, glucose and lipid profile were investigated in plasma. When compared with sedentary group, significant decreases in heart, liver and muscle NFκB levels by 45%, 26% and 44% were observed in Q10 supplemented rats after exercise training, respectively, while the inhibitory protein IκB increased by 179%, 111% and 127% in heart, liver and muscle tissues. Q10 supplementation caused an increase in Nrf2 (167%, 165% and 90%) and HO-1 (107%, 156% and 114%) after exercise training in heart, liver and muscle tissues (p < 0.05). No significant change was observed in any of the parameters associated with protein, carbohydrate and lipid metabolism, except that exercise caused a decrease in plasma triglyceride, which was further decreased by Q10. In conclusion, these results suggest that Q10 modulates the expression of NFκB, IκB, Nrf2 and HO-1 in exercise training, indicating an anti-inflammatory effect of Q10 and emphasizes its role in antioxidant defense. Key pointsCoenzyme Q10 is a component of the electron transport chain in mitochondria which is linked to the generation of energy in the cell.Coenzyme Q10 may inhibit the peroxidation of lipids, thus acting as an antioxidant and protects tissue against oxidative injury.Using of coenzyme Q

  14. Effects of Coenzyme Q10 on Markers of Inflammation: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Zhai, Junya; Bo, Yacong; Lu, Yan; Liu, Chunli; Zhang, Lishi

    2017-01-01

    Background/Objective Chronic inflammation contributes to the onset and development of metabolic diseases. Clinical evidence has suggested that coenzyme Q10 (CoQ10) has some effects on inflammatory markers. However, these results are equivocal. The aim of this systematic review was to assess the effects of CoQ10 on serum levels of inflammatory markers in people with metabolic diseases. Methods Electronic databases were searched up to February 2016 for randomized controlled trials (RCTs). The outcome parameters were related to inflammatory factors, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α) and C reactive protein (CRP). RevMan software was used for meta-analysis. Meta-regression analysis, Egger line regression test and Begg rank correlation test were performed by STATA software. Results Nine trials involving 428 subjects were included in this meta-analysis. The results showed that compared with control group, CoQ10 supplementation has significantly improved the serum level of CoQ10 by 1.17μg/ml [MD = 1.17, 95% CI (0.47 to 1.87) μg/ml, I2 = 94%]. Meanwhile, it has significantly decreased TNF-α by 0.45 pg/ml [MD = -0.45, 95% CI (-0.67 to -0.24) pg/ml, I2 = 0%]. No significant difference was observed between CoQ10 and placebo with regard to CRP [MD = -0.21, 95% CI (-0.60 to 0.17) mg/L, I2 = 21%] and IL-6 [MD = -0.89, 95% CI (-1.95 to 0.16) pg/ml, I2 = 84%]. Conclusions CoQ10 supplementation may partly improve the process of inflammatory state. The effects of CoQ10 on inflammation should be further investigated by conducting larger sample size and well-defined trials of long enough duration. PMID:28125601

  15. 辅酶Q10市场为何变脸

    Institute of Scientific and Technical Information of China (English)

    张伦

    2007-01-01

    辅酶Q10为近年来国内外市场上的明星产品,市场需求强劲上升,时常呈现供不应求局面.售价也高高在上。市场的热俏引来国内众多企业争相开发,一时辅酶Q10成了香饽饽。

  16. Coenzyme Q10 Supplementation Modulates NFκB and Nrf2 Pathways in Exercise Training

    Directory of Open Access Journals (Sweden)

    Ragip Pala, Cemal Orhan, Mehmet Tuzcu, Nurhan Sahin, Shakir Ali, Vedat Cinar, Mustafa Atalay, Kazim Sahin

    2016-03-01

    Full Text Available This study reports the effects of Q10, coenzyme Q10 or ubiquinone, a component of the electron transport chain in mitochondria, on nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB, inhibitors of kappa B (IκB, nuclear factor (erythroid-derived 2-like 2 (Nrf2 and hemeoxygenase 1 (HO-1 in rats after chronic exercise training for 6 weeks. 8-week old male Wistar rats were assigned randomly to one of four treatments planned in a 2 x 2 factorial arrangement of two condition (sedentary vs. exercise training, and two coenzyme Q10 levels (0 and 300 mg/kg per day for 6 weeks. The expression levels of the target proteins were determined in the heart, liver and muscle, and biochemical parameters including creatinine, urea, glucose and lipid profile were investigated in plasma. When compared with sedentary group, significant decreases in heart, liver and muscle NFκB levels by 45%, 26% and 44% were observed in Q10 supplemented rats after exercise training, respectively, while the inhibitory protein IκB increased by 179%, 111% and 127% in heart, liver and muscle tissues. Q10 supplementation caused an increase in Nrf2 (167%, 165% and 90% and HO-1 (107%, 156% and 114% after exercise training in heart, liver and muscle tissues (p < 0.05. No significant change was observed in any of the parameters associated with protein, carbohydrate and lipid metabolism, except that exercise caused a decrease in plasma triglyceride, which was further decreased by Q10. In conclusion, these results suggest that Q10 modulates the expression of NFκB, IκB, Nrf2 and HO-1 in exercise training, indicating an anti-inflammatory effect of Q10 and emphasizes its role in antioxidant defense.

  17. Application of Coenzyme Q10 for Accelerating Soft Tissue Wound Healing after Tooth Extraction in Rats

    Directory of Open Access Journals (Sweden)

    Toshiki Yoneda

    2014-12-01

    Full Text Available Accelerating wound healing after tooth extraction is beneficial in dental treatment. Application of antioxidants, such as reduced coenzyme Q10 (rCoQ10, may promote wound healing after tooth extraction. In this study, we examined the effects of topical application of rCoQ10 on wound healing after tooth extraction in rats. After maxillary first molars were extracted, male Fischer 344 rats (8 weeks old (n = 27 received topical application of ointment containing 5% rCoQ10 (experimental group or control ointment (control group to the sockets for 3 or 8 days (n = 6–7/group. At 3 days after extraction, the experimental group showed higher collagen density and lower numbers of polymorphonuclear leukocytes in the upper part of socket, as compared to the control group (p < 0.05. Gene expression of interleukin-1β, tumor necrosis factor-α and nuclear factor-κB were also lower in the experimental group than in the control group (p < 0.05. At 8 days after tooth extraction, there were no significant differences in collagen density, number of polymorphonuclear leukocytes and bone fill between the groups. Our results suggest that topical application of rCoQ10 promotes wound healing in the soft tissue of the alveolar socket, but that rCoQ10 has a limited effect on bone remodeling in rats.

  18. Coenzyme Q10 and Oxidative Stress: Inflammation Status in Hepatocellular Carcinoma Patients after Surgery

    Science.gov (United States)

    Liu, Hsiao-Tien; Cheng, Shao-Bin; Huang, Yi-Chia; Huang, Yin-Tzu; Lin, Ping-Ting

    2017-01-01

    (1) Background: Hepatocellular carcinoma (HCC) is the second leading cause of cancer deaths worldwide, and surgical resection is the main treatment for HCC. To date, no published study has examined the status of coenzyme Q10 in patients with HCC after surgery. Thus, the purpose of this study was to investigate the correlations between the level of coenzyme Q10, oxidative stress, and inflammation in patients with HCC after surgery; (2) Methods: 71 primary HCC patients were recruited. Levels of coenzyme Q10, vitamin E, oxidative stress (malondialdehyde), antioxidant enzymes activity (superoxidase dismutase, catalase, and glutathione peroxidase), and inflammatory markers (high sensitivity C-reactive protein; tumor necrosis factor-α; and interleukin-6) were measured; (3) Results: Patients with HCC had a significantly lower levels of coenzyme Q10 (p = 0.01) and oxidative stress (p < 0.01), and significantly higher levels of antioxidant enzymes activities and inflammation after surgery (p < 0.05). The level of coenzyme Q10 was significantly positively correlated with antioxidant capacity (vitamin E and glutathione peroxidase activity) and negatively correlated with inflammation markers after surgery; (4) Conclusion: Hepatocarcinogenesis is associated with oxidative stress, and coenzyme Q10 may be considered an antioxidant therapy for patients with HCC, particularly those with higher inflammation after surgery. PMID:28054958

  19. Application of coenzyme Q10 for accelerating soft tissue wound healing after tooth extraction in rats.

    Science.gov (United States)

    Yoneda, Toshiki; Tomofuji, Takaaki; Kawabata, Yuya; Ekuni, Daisuke; Azuma, Tetsuji; Kataoka, Kota; Kunitomo, Muneyoshi; Morita, Manabu

    2014-12-10

    Accelerating wound healing after tooth extraction is beneficial in dental treatment. Application of antioxidants, such as reduced coenzyme Q10 (rCoQ10), may promote wound healing after tooth extraction. In this study, we examined the effects of topical application of rCoQ10 on wound healing after tooth extraction in rats. After maxillary first molars were extracted, male Fischer 344 rats (8 weeks old) (n = 27) received topical application of ointment containing 5% rCoQ10 (experimental group) or control ointment (control group) to the sockets for 3 or 8 days (n = 6-7/group). At 3 days after extraction, the experimental group showed higher collagen density and lower numbers of polymorphonuclear leukocytes in the upper part of socket, as compared to the control group (p tooth extraction, there were no significant differences in collagen density, number of polymorphonuclear leukocytes and bone fill between the groups. Our results suggest that topical application of rCoQ10 promotes wound healing in the soft tissue of the alveolar socket, but that rCoQ10 has a limited effect on bone remodeling in rats.

  20. Coenzyme Q10 production in a 150-l reactor by a mutant strain of Rhodobacter sphaeroides.

    Science.gov (United States)

    Kien, Nguyen Ba; Kong, In-Soo; Lee, Min-Gyu; Kim, Joong Kyun

    2010-05-01

    For the commercial production of CoQ(10), batch-type fermentations were attempted in a 150-l fermenter using a mutant strain of R. sphaeroides. Optimum temperature and initial aeration rate were found to be 30 degrees C and 2 vvm, respectively. Under optimum fermentation conditions, the maximum value of specific CoQ(10) content was achieved reproducibly as 6.34 mg/g DCW after 24 h, with 3.02 g/l of DCW. During the fermentation, aeration shift (from the adequate aeration at the early growth phase to the limited aeration in active cellular metabolism) was a key factor in CoQ(10) production for scale-up. A higher value of the specific CoQ(10) content (8.12 mg/g DCW) was achieved in fed-batch fermentation and comparable to those produced by the pilot-scale fed-batch fermentations of A. tumefaciens, which indicated that the mutant strain of R. sphaeroides used in this study was a potential high CoQ(10) producer. This is the first detailed study to demonstrate a pilot-scale production of CoQ(10) using a mutant strain of R. sphaeroides.

  1. Behavioral improvement after chronic administration of coenzyme Q10 in P301S transgenic mice.

    Science.gov (United States)

    Elipenahli, Ceyhan; Stack, Cliona; Jainuddin, Shari; Gerges, Meri; Yang, Lichuan; Starkov, Anatoly; Beal, M Flint; Dumont, Magali

    2012-01-01

    Coenzyme Q10 is a key component of the electron transport chain which plays an essential role in ATP production and also has antioxidant effects. Neuroprotective effects of coenzyme Q10 have been reported in both in vitro and in vivo models of neurodegenerative diseases. However, its effects have not been studied in cells or in animals with tau induced pathology. In this report, we administered coenzyme Q10 to transgenic mice with the P301S tau mutation, which causes fronto-temporal dementia in man. These mice develop tau hyperphosphorylation and neurofibrillary tangles in the brain. Coenzyme Q10 improved survival and behavioral deficits in the P301S mice. There was a modest reduction in phosphorylated tau in the cortex of P301S mice. We also examined the effects of coenzyme Q10 treatment on the electron transport chain enzymes, the mitochondrial antioxidant enzymes, and the tricarboxylic acid cycle. There was a significant increase in complex I activity and protein levels, and a reduction in lipid peroxidation. Our data show that coenzyme Q10 significantly improved behavioral deficits and survival in transgenic mice with the P301S tau mutation, upregulated key enzymes of the electron transport chain, and reduced oxidative stress.

  2. Hepatoprotective effect of coenzyme Q10 in rats with acetaminophen toxicity.

    Science.gov (United States)

    Fouad, Amr A; Jresat, Iyad

    2012-03-01

    The potential protective effect of coenzyme Q10 against acute liver injury induced by a single dose of acetaminophen (700 mg/kg, p.o.) was investigated in rats. Coenzyme Q10 treatment was given as two i.p. injections, 10 mg/kg each, at 1 and 12 h following acetaminophen administration. Coenzyme Q10 significantly reduced the levels of serum aminotransferases, suppressed lipid peroxidation, prevented the decreases of reduced glutathione and catalase activity, decreased the elevations of tumor necrosis factor-α and nitric oxide as well as attenuating the reductions of selenium and zinc ions in liver tissue resulting from acetaminophen administration. Histopathological liver tissue damage mediated by acetaminophen was ameliorated by coenzyme Q10. Immunohistochemical analysis revealed that coenzyme Q10 significantly decreased the acetaminophen-induced overexpression of inducible nitric oxide synthase, nuclear factor-κB, caspase-3 and p53 in liver tissue. It was concluded that coenzyme Q10 protects rat liver against acute acetaminophen hepatotoxicity, most probably through its antioxidant, anti-inflammatory and antiapoptotic effects.

  3. Therapeutic effect of coenzyme Q10 against experimentally-induced hepatocellular carcinoma in rats.

    Science.gov (United States)

    Fouad, Amr A; Al-Mulhim, Abdulruhman S; Jresat, Iyad

    2013-01-01

    The therapeutic potential of coenzyme Q10 was investigated in rats with hepatocellular carcinoma induced by trichloroacetic acid (0.5g/kg/day, p.o., for five days). Coenzyme Q10 treatment (0.4mg/kg/day, i.p.) was applied for four weeks following trichloroacetic acid administration. Coenzyme Q10 significantly suppressed lipid peroxidation, prevented the depletion of reduced glutathione and superoxide dismutase activity, and decreased the elevations of tumor necrosis factor-α and nitric oxide in liver tissue of rats with hepatocellular carcinoma. Also, the histopathological dysplastic changes induced by trichloroacetic acid in liver tissue were ameliorated by coenzyme Q10. Immunohistochemical analysis revealed that coenzyme Q10 significantly decreased the expression of hepPar-1, alpha-fetoprotein, inducible nitric oxide synthase, cyclooxygenase-2 and nuclear factor-κB in liver tissue of rats with hepatocellular carcinoma. It was concluded that coenzyme Q10 may represent a potential therapeutic option for liver carcinogenesis.

  4. Severe encephalopathy associated to pyruvate dehydrogenase mutations and unbalanced coenzyme Q10 content.

    Science.gov (United States)

    Asencio, Claudio; Rodríguez-Hernandez, María A; Briones, Paz; Montoya, Julio; Cortés, Ana; Emperador, Sonia; Gavilán, Angela; Ruiz-Pesini, Eduardo; Yubero, Dèlia; Montero, Raquel; Pineda, Mercedes; O'Callaghan, María M; Alcázar-Fabra, María; Salviati, Leonardo; Artuch, Rafael; Navas, Plácido

    2016-03-01

    Coenzyme Q10 (CoQ10) deficiency is associated to a variety of clinical phenotypes including neuromuscular and nephrotic disorders. We report two unrelated boys presenting encephalopathy, ataxia, and lactic acidosis, who died with necrotic lesions in different areas of brain. Levels of CoQ10 and complex II+III activity were increased in both skeletal muscle and fibroblasts, but it was a consequence of higher mitochondria mass measured as citrate synthase. In fibroblasts, oxygen consumption was also increased, whereas steady state ATP levels were decreased. Antioxidant enzymes such as NQO1 and MnSOD and mitochondrial marker VDAC were overexpressed. Mitochondria recycling markers Fis1 and mitofusin, and mtDNA regulatory Tfam were reduced. Exome sequencing showed mutations in PDHA1 in the first patient and in PDHB in the second. These genes encode subunits of pyruvate dehydrogenase complex (PDH) that could explain the compensatory increase of CoQ10 and a defect of mitochondrial homeostasis. These two cases describe, for the first time, a mitochondrial disease caused by PDH defects associated with unbalanced of both CoQ10 content and mitochondria homeostasis, which severely affects the brain. Both CoQ10 and mitochondria homeostasis appears as new markers for PDH associated mitochondrial disorders.

  5. A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion processes.

    Science.gov (United States)

    Patwardhan, Ketaki; Asgarzadeh, Firouz; Dassinger, Thomas; Albers, Jessica; Repka, Michael A

    2015-05-01

    In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Selected variables were further assessed using a Plackett-Burman screening study, which was upgraded to a response surface design consisting of the critical factors to study the interactions between the study variables. In process torque, glass transition temperature (Tg ) of the extrudates, assay, dissolution and phase change were measured as responses to evaluate the critical quality attributes (CQAs) of the extrudates. The effect of each study variable on the measured responses was analysed using multiple regression for the screening design and partial least squares for the optimization design. Experimental limits for formulation and process parameters to attain optimum processing have been outlined. A design space plot describing the domain of experimental variables within which the CQAs remained unchanged was developed. A comprehensive approach for melt extrusion product development based on the QbD methodology has been demonstrated. Drug loading concentrations between 40- 48%w/w and extrusion temperature in the range of 90-130°C were found to be the most optimum. © 2015 Royal Pharmaceutical Society.

  6. Oxidative Stress Correlates with Headache Symptoms in Fibromyalgia: Coenzyme Q10 Effect on Clinical Improvement

    Science.gov (United States)

    Cordero, Mario D.; Cano-García, Francisco Javier; Alcocer-Gómez, Elísabet; De Miguel, Manuel; Sánchez-Alcázar, José Antonio

    2012-01-01

    Background Fibromyalgia (FM) is a chronic pain syndrome with unknown etiology and a wide spectrum of symptoms such as allodynia, debilitating fatigue, joint stiffness and migraine. Recent studies have shown some evidences demonstrating that oxidative stress is associated to clinical symptoms in FM of fibromyalgia. We examined oxidative stress and bioenergetic status in blood mononuclear cells (BMCs) and its association to headache symptoms in FM patients. The effects of oral coenzyme Q10 (CoQ10) supplementation on biochemical markers and clinical improvement were also evaluated. Methods We studied 20 FM patients and 15 healthy controls. Clinical parameters were evaluated using the Fibromyalgia Impact Questionnaire (FIQ), visual analogues scales (VAS), and the Headache Impact Test (HIT-6). Oxidative stress was determined by measuring CoQ10, catalase and lipid peroxidation (LPO) levels in BMCs. Bioenergetic status was assessed by measuring ATP levels in BMCs. Results We found decreased CoQ10, catalase and ATP levels in BMCs from FM patients as compared to normal control (P<0.05 and P<0.001, respectively) We also found increased level of LPO in BMCs from FM patients as compared to normal control (P<0.001). Significant negative correlations between CoQ10 or catalase levels in BMCs and headache parameters were observed (r = −0.59, P<0.05; r = −0.68, P<0.05, respectively). Furthermore, LPO levels showed a significant positive correlation with HIT-6 (r = 0.33, P<0.05). Oral CoQ10 supplementation restored biochemical parameters and induced a significant improvement in clinical and headache symptoms (P<0.001). Discussion The results of this study suggest a role for mitochondrial dysfunction and oxidative stress in the headache symptoms associated with FM. CoQ10 supplementation should be examined in a larger placebo controlled trial as a possible treatment in FM. PMID:22532869

  7. The Antioxidant Status and Concentrations of Coenzyme Q10 and Vitamin E in Metabolic Syndrome

    Directory of Open Access Journals (Sweden)

    Chi-Hua Yen

    2013-01-01

    Full Text Available The purpose of this study was to investigate the levels of coenzyme Q10 and vitamin E and the antioxidant status in subjects with metabolic syndrome (MS. Subjects with MS (n=72 were included according to the criteria for MS. The non-MS group (n=105 was comprised of healthy individuals with normal blood biochemical values. The plasma coenzyme Q10, vitamin E concentrations, lipid profiles, and antioxidant enzymes levels (catalase, superoxide dismutase, and glutathione peroxidase were measured. The subjects with MS had significantly higher concentrations of plasma coenzyme Q10 and vitamin E than those in the non-MS group, but these differences were not significant after being normalized for triglyceride level. The levels of antioxidant enzymes were significantly lower in the MS group than in the non-MS group. The subjects with the higher antioxidant enzymes activities had significant reductions in the risk of MS (P<0.01 after being adjusted for coenzyme Q10 and vitamin E. In conclusion, the subjects with MS might be under higher oxidative stress resulting in low levels of antioxidant enzyme activities. A higher level of antioxidant enzymes activities was significantly associated with a reduction in the risk of MS independent of the levels of coenzyme Q10 and vitamin E.

  8. Gastroprotective effects of CoQ10 on ethanol-induced acute gastric lesions.

    Science.gov (United States)

    Karakaya, K; Barut, F; Hanci, V; Can, M; Comert, M; Ucan, H B; Cakmak, G K; Irkorucu, O; Tascilar, O; Emre, A U

    2015-01-01

    Alcohol consumption is frequently associated with gastric mucosal lesions. The purpose of this study was to determine the effect of Coenzyme-Q10 (CoQ10) supplementation on the ethanol-induced gastric mucosal damage in a rat model. Sixty-four female wistar albino rats were randomly divided into 8 groups (n = 8). Studies were performed in ethanol induced gastric ulcer model in Wistar albino rats. Famotidine at a dose of 5 mg/kg or 20 mg/kg and CoQ10 at a single dose of 10 mg/kg or 20 mg/kg and 30 mg/kg for 7 days were administered as pretreatment. All the rats in study groups received 2 ml/kg ethanol 95 % intragastrically, 30 minutes after pretreatment. Four hour after ethanol administration, all rats were sacrificed and their stomachs were removed under ketamin anaesthesia. Gastric protection was evaluated by measuring the ulcer index, MDA concentrations, and histopathological studies. Rats pretreated either with famotidine or CoQ10 had significantly diminished gastric mucosal damage which was assessed with gross and microscopic analysis (p < 0.00625). MDA levels were significantly lower in famotidine 20 mg/kg and CoQ10 pretreatment for 7 days group (p < 0.00625).

  9. Coenzyme q10 abrogated the 28 days aluminium chloride induced oxidative changes in rat cerebral cortex.

    Science.gov (United States)

    Majumdar, Anuradha S; Nirwane, Abhijit; Kamble, Rahul

    2014-05-01

    The present study was designed to elucidate the impact of oral administration of aluminium chloride for 28 days with respect to oxidative stress in the cerebral cortex of female rats. Further, to investigate the potentials of Coenzyme (Co) Q10 (4, 8, and 12 mg/kg, i.p.) in mitigating the detrimental changes. Biochemical estimations of cerebral lipid peroxidation (LPO), reduced glutathione (GSH), vitamin E and activities of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx) were carried out after 28 days of aluminium chloride (AlCl3) and Co Q10 exposures along with histopathological examination of cerebral cortex of the rats. Subacute exposure to AlCl3(5 mg/kg) led to significant decrease in levels of GSH, vitamin E and activities of SOD, CAT, GPx, and an increase in LPO of cerebral cortex. These aberrations were restored by Co Q10 (12 mg/kg, i.p.). This protection offered was comparable to that of L-deprenyl (1 mg/kg, i.p.) which served as a reference standard. Histopathological evaluations confirmed that the normal cerebral morphology was maintained by Co Q10. Thus, AlCl3 exposure hampers the activities of various antioxidant enzymes and induces oxidative stress in cerebral cortex of female Wistar rats. Supplementation with intraperitoneal Co Q10 abrogated these deleterious effects of AlCl3.

  10. Acute Hypoglycemia Induces Painful Neuropathy and the Treatment of Coenzyme Q10

    Directory of Open Access Journals (Sweden)

    Yan Ping Zhang

    2016-01-01

    Full Text Available Diabetic neuropathic pain is reduced with tight glycemic control. However, strict control increases the risk of hypoglycemic episodes, which are themselves linked to painful neuropathy. This study explored the effects of hypoglycemia-related painful neuropathy. Pretreatment with coenzyme Q10 (CoQ10 was performed to explore the preventive effect of CoQ10 on hypoglycemia-related acute neuropathic pain. Two strains of mice were used and 1 unit/kg of insulin was given to induce hypoglycemia. Mechanical sensitivity of hindpaw withdrawal thresholds was measured using von Frey filaments. Blood glucose levels were clamped at normal levels by joint insulin and glucose injection to test whether insulin itself induced hypersensitivity. Results suggest that the increased mechanical sensitivity after insulin injection is related to decreased blood glucose levels. When blood glucose levels remained at a normal level by the linked administration of insulin and glucose, mice demonstrated no significant change in mechanical sensitivity. Pretreatment with CoQ10 prevented neuropathic pain and the expression of the stress factor c-Fos. These results support the concept that pain in the diabetic scenario can be the result of hypoglycemia and not insulin itself. Additionally, pretreatment with CoQ10 may be a potent preventive method for the development of neuropathic pain.

  11. Coenzyme Q10 Levels Are Decreased in the Cerebellum of Multiple-System Atrophy Patients.

    Directory of Open Access Journals (Sweden)

    Lucia V Schottlaender

    Full Text Available The objective of this study was to evaluate whether the levels of coenzyme Q10 (CoQ10 in brain tissue of multiple system atrophy (MSA patients differ from those in elderly controls and in patients with other neurodegenerative diseases.Flash frozen brain tissue of a series of 20 pathologically confirmed MSA patients [9 olivopontocerebellar atrophy (OPCA type, 6 striatonigral degeneration (SND type, and 5 mixed type] was used for this study. Elderly controls (n = 37 as well as idiopathic Parkinson's disease (n = 7, dementia with Lewy bodies (n = 20, corticobasal degeneration (n = 15 and cerebellar ataxia (n = 18 patients were used as comparison groups. CoQ10 was measured in cerebellar and frontal cortex tissue by high performance liquid chromatography.We detected a statistically significant decrease (by 3-5% in the level of CoQ10 in the cerebellum of MSA cases (P = 0.001, specifically in OPCA (P = 0.001 and mixed cases (P = 0.005, when compared to controls as well as to other neurodegenerative diseases [dementia with Lewy bodies (P<0.001, idiopathic Parkinson's disease (P<0.001, corticobasal degeneration (P<0.001, and cerebellar ataxia (P = 0.001].Our results suggest that a perturbation in the CoQ10 biosynthetic pathway is associated with the pathogenesis of MSA but the mechanism behind this finding remains to be elucidated.

  12. Validation of a tool for assessing the quality of pharmaceutical services

    Directory of Open Access Journals (Sweden)

    Cosendey Marly Aparecida E.

    2003-01-01

    Full Text Available This paper presents the validation process for a tool assessing basic pharmaceutical services through an analysis of the implementation of a Basic Pharmaceuticals Distribution Program by the Brazilian Federal government. The process began with the drafting of a theoretical model, based on a state-of-the-art review and allowing the selection of various conceptual dimensions and respective criteria that best represented the construct. The second step involved weighting indicators for the construction of quality scores. Three models were tested for ranking implementation levels, and seven simulations were conducted, determining the score most closely reflecting the selected indicators in two different matrices. The objective was to select the most coherent and consistent version between implementation levels and expected outcomes, while simultaneously enhancing validity of chosen criteria. Testing of the various models and the results obtained showed that augmenting the validity of the study was possible without altering data. This endeavor is justified in understanding the scope and limitations of these measurements and of the choices involved in issues concerning their weighting and interpretation.

  13. Assesment of diabetes related quality of life and the impact of pharmaceutical care in its improvement

    Institute of Scientific and Technical Information of China (English)

    Ruksana Faizal; Lincy George; Panayappan Lakshmanan; Treesa P Varghese

    2016-01-01

    Objective:To assess the role of pharmaceutical care in improving quality of life in type II diabetes mellitus patients in a tertiary care hospital. Methods:A prospective observational survey study was carried out for a period of 9 months in the General Medicine Department of the hospital. A total of 106 patients were enrolled and were randomly allocated to the control and intervention groups with 53 patients in each group. Version-19 of audit on diabetes-dependent quality of life questionnaire were provided to the patients, at the time of admission and during review. At the time of admission the intervention group was provided with counseling for diabetes and with patient information leaflets on the disease. A data entry format comprising the socio-demographic details of the patients, their medical and medication history, laboratory results, etc. were used to note down the patient details. The prescribing patterns of different oral hypoglycemic agents were noted. Results:A total of 106 patients were recruited, 51% being male. Age ranged from 32 to 80 years with a mean age of 60.210 ± 10.045. The duration since diagnosis was 5–10 years for most of the participants (67%), 10–20 years for 29% and > 20 years for the remaining. At the time of study, 17.9% of participants were received insulin treatment, and 82.1% on oral hypoglycemic agent. The average weighted impact of intervention group which improved from-1.752 6 ± 0.563 0 to -1.668 800 ± 0.048 013 was found to be statistically significant. Thus the study showed that pharmaceutical care has a positive impact on the quality of life of diabetes patients. Conclusions:Quality of life is worsened in diabetes mellitus patients, particularly for the 'freedom to eat' domain, indicating that an intervention to improve dietary freedom might be a good way of improving quality of life. The study also showed that patient counseling played an important role in improving quality of life of diabetes patients.

  14. Does a General Temperature-Dependent Q10 Model of Soil Respiration Exist at Biome and Global Scale?

    Institute of Scientific and Technical Information of China (English)

    Hua CHEN; Han-Qin TIAN

    2005-01-01

    Soil respiration (SR) is commonly modeled by a Q10 (an indicator of temperature sensitivity)function in ecosystem models. Q10is usually treated as a constant of 2 in these models, although Q10 value of SR often decreases with increasing temperatures. It remains unclear whether a general temperaturedependent Q10 model of SR exists at biome and global scale. In this paper, we have compiled the long-term Q10 data of 38 SR studies ranging from the Boreal, Temperate, to Tropical/Subtropical biome on four continents.Our analysis indicated that the general temperature-dependent biome Q10 models of SR existed, especially in the Boreal and Temperate biomes. A single-exponential model was better than a simple linear model in fitting the average Q10 values at the biome scale. Average soil temperature is a better predictor of Q10 value than average air temperature in these models, especially in the Boreal biome. Soil temperature alone could explain about 50% of the Q10 variations in both the Boreal and Temperate biome single-exponential Q10 model. Q10 value of SR decreased with increasing soil temperature but at quite different rates among the three biome Q10 models. The k values (Q10 decay rate constants) were 0.09, 0.07, and 0.02/℃ in the Boreal, Temperate, and Tropical/Subtropical biome, respectively, suggesting that Q10 value is the most sensitive to soil temperature change in the Boreal biome, the second in the Temperate biome, and the least sensitive in the Tropical/Subtropical biome. This also indirectly confirms that acclimation of SR in many soil warming experiments probably occurs. The k value in the "global" single-exponential Q10 model which combined both the Boreal and Temperate biome data set was 0.08/℃. However, the global general temperature-dependent Q10model developed using the data sets of the three biomes is not adequate for predicting Q10 values of SR globally.The existence of the general temperature-dependent Q10 models of SR in the Boreal and

  15. Ubisol-Q10 Prevents Glutamate-Induced Cell Death by Blocking Mitochondrial Fragmentation and Permeability Transition Pore Opening

    OpenAIRE

    Kumari, Santosh; Mehta, Suresh L.; Milledge, Gaolin Z.; Huang, Xinyu; Li, Haining; Li, P. Andy

    2016-01-01

    Mitochondrial dysfunction and oxidative stress are the major events that lead to the formation of mitochondrial permeability transition pore (mPTP) during glutamate-induced cytotoxicity and cell death. Coenzyme Q10 (CoQ10) has widely been used for the treatment of mitochondrial disorders and neurodegenerative diseases. Comparing to traditional lipid-soluble CoQ10, water soluble CoQ10 (Ubisol-Q10) has high intracellular and intra-mitochondrial distribution. The aims of the present study are to...

  16. The lay user perspective on the quality of pharmaceuticals, drug therapy and pharmacy services--results of focus group discussions

    DEFF Research Database (Denmark)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna; Björnsdóttir, Ingunn

    2002-01-01

    : The lay perspective emphasizes a definite split between lay and expert views on the value and quality of pharmaceuticals, drug therapy and pharmacy services, as well as in their assessment of risk. Participants voiced spontaneous criticism of the roles of both physicians and pharmacists in drug therapy......BACKGROUND: This article presents the results of a study on quality of pharmacy services and perceived risk of pharmaceuticals. The results presented here are part of a multi-study evaluation of major changes in drug distribution in Iceland. OBJECTIVES: This sub-study addressed the question: what...... is the lay user perspective on pharmaceuticals and pharmacy services, including their perception of risk? METHODS: To answer this question, seven focus group discussions were conducted with pharmacy customers in different locations in Iceland following new drug distribution legislation in 1996. RESULTS...

  17. 辅酶Q10工艺开发全球大热

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    目前临床上辅酶Q10通常以辅助药物形式出现,但是具备如此众多疗效的辅助药物并不多见,由此也使得其成为近年来国内外市场的热门产品,我国已有多家企业参与开发和生产辅酶Q10

  18. 反相高效液相色谱法分析辅酶Q10

    Institute of Scientific and Technical Information of China (English)

    党伟; 李丹; 李晓磊

    2011-01-01

    本实验应用色谱技术,建立了辅酶Q10的检测方法。采用反相高效液相色谱法,以十八烷基硅烷键舍硅胶为固定相,以无水乙醇-甲醇(1:1)为流动相;柱温35℃,检测波长275nm。结果表明:辅酶Q10的含量为6mg/g。

  19. 辅酶Q10防治心脑血管疾病

    Institute of Scientific and Technical Information of China (English)

    李刚

    2010-01-01

    辅酶Q10又名“泛醌10”,是人体中必不可少的一种辅酶.它存在于人体的每一个细胞中,而在心脏、肝脏、肾脏、胰脏中含量较高。辅酶Q10是细胞代谢和呼吸的激活剂.同时又是重要的抗氧化剂。

  20. Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

    Directory of Open Access Journals (Sweden)

    Marinković Valentina D.

    2013-01-01

    Full Text Available International quality management standard (QMS ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ, Quality/strategy planning (QP, Human resource management (HR, Supply management (SM, Customer focus (CF, Process management (PM, Continuous improvement (CI, and Business results (BR. The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI that present various aspects of the implementation of PQS, on the elements of business results (BR. Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR. The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory

  1. Quality of pharmaceutical advertising and gender bias in medical journals (1998-2008): a review of the scientific literature.

    Science.gov (United States)

    Cambronero Saiz, Belén; Ruiz Cantero, María Teresa; Papí Gálvez, Natalia

    2012-01-01

    To review the scientific literature on pharmaceutical advertising aimed at health professionals in order to determine whether gender bias has decreased and the quality of information in pharmaceutical advertising has improved over time. We performed a content analysis of original articles dealing with medical drug promotion (1998-2008), according to quality criteria such as (a) the number, validity and accessibility of bibliographic references provided in pharmaceutical advertising and (b) the extent to which gender representations were consistent with the prevalence of the diseases. Databases: PUBMED, Medline, Scopus, Sociological Abstract, Eric and LILACS. We reviewed 31 articles that analyzed advertising in medical journals from 1975-2005 and were published between 1998 and 2008. We found that the number of references used to support pharmaceutical advertising claims increased from 1975 but that 50% of these references were not valid. There was a tendency to depict men in paid productive roles, while women appeared inside the home or in non-occupational social contexts. Advertisements for psychotropic and cardiovascular drugs overrepresented women and men respectively. The use of bibliographic references increased between 1998 and 2008. However, representation of traditional male-female roles was similar in 1975 and 2005. Pharmaceutical advertisements may contribute to reinforcing the perception that certain diseases are associated with the most frequently portrayed sex. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

  2. Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives.

    Science.gov (United States)

    Donelan, Ronan; Walker, Stuart; Salek, Sam

    2015-03-01

    Currently, there is no qualified understanding of the influences, behaviours and other factors that impact the decision-making of individuals and organisations involved in the development of new medicines. The aim of this qualitative study was to investigate and identify the important issues that influence quality decision-making. Semi-structured interviews were carried out with 29 senior decision-makers from the pharmaceutical industry and regulatory authorities. The study participants were invited to discuss and review their perception of decision-making within their organisation, its role in drug development and the regulatory review and their awareness and use of decision-making techniques and the impact and monitoring of decisions. The analyses (using NVivo 8(©) software) resulted in the identification of 32 major and 97 sub-themes that were consolidated into 19 overarching themes. These included items such as quality and validity of data, time considerations, organisational and cultural influences, analytical and logical approach, qualification and experience, subjective and personal considerations, political influences, precedents for similar previous decisions, understanding of the decision in question, impact analyses, audit trail, education and awareness, individual versus corporate decision-making and frameworks. Relationships between themes were identified. The 19 overarching decision-making themes were integrated into a framework for quality decision-making. This study has achieved its aim of exploring decision-making from the perspective of the individual and the organisation working in drug development and the regulatory review and has identified issues and considerations relating to making good quality decisions and allowed for the generation of a framework to aid quality decision-making. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Chromosomal Engineering of Escherichia coli for Efficient Production of Coenzyme Q10

    Institute of Scientific and Technical Information of China (English)

    黄明涛; 陈韵妍; 刘建忠

    2014-01-01

    The plasmid-expression system is routinely plagued by potential plasmid instability. Chromosomal in-tegration is one powerful approach to overcome the problem. Herein we report a plasmid-free hyper-producer E. coli strain for coenzyme Q10 production. A series of integration expression vectors, pxKC3T5b and pxKT5b, were constructed for chemically inducible chromosomal evolution (multiple copy integration) and replicon-free and markerless chromosomal integration (single copy integration), respectively. A coenzyme Q10 hyper-producer Es-cherichia coli TBW20134 was constructed by applying chemically inducible chromosomal evolution, replicon-free and markerless chromosomal integration as well as deletion of menaquinone biosynthetic pathway. The engineered E. coli TBW20134 produced 10.7 mg per gram of dry cell mass (DCM) of coenzyme Q10 when supplemented with 0.075 g·L-1 of 4-hydroxy benzoic acid;this yield is unprecedented in E. coli and close to that of the commercial producer Agrobacterium tumefaciens. With this strain, the coenzyme Q10 production capacity was very stable after 30 sequential transfers and no antibiotics were required during the fermentation process. The strategy presented may be useful as a general approach for construction of stable production strains synthesizing natural products where various copy numbers for different genes are concerned.

  4. Effects of ubiquinone (coenzyme Q10) on myopathy in statin users.

    NARCIS (Netherlands)

    Schaars, C.F.; Stalenhoef, A.F.H.

    2008-01-01

    PURPOSE OF REVIEW: Statins are associated with muscle complaints, including myositis. The mechanism through which statin use causes muscle toxicity is unknown. One of the theories is that statin therapy reduces coenzyme Q10 levels in muscle mitochondria, which leads to muscle injury and myopathy. Th

  5. Preparation, characterization and in silico modeling of biodegradable nanoparticles containing cyclosporine A and coenzyme Q10

    Science.gov (United States)

    Ankola, D. D.; Durbin, E. W.; Buxton, G. A.; Schäfer, J.; Bakowsky, U.; Kumar, M. N. V. Ravi

    2010-02-01

    Combination therapy will soon become a reality, particularly for those patients requiring poly-therapy to treat co-existing disease states. This becomes all the more important with the increasing cost, time and complexity of the drug discovery process prompting one to look at new delivery systems to increase the efficacy, safety and patient compliance of existing drugs. Along this line, we attempted to design nano-scale systems for simultaneous encapsulation of cyclosporine A (CsA) and coenzyme Q10 (CoQ10) and model their encapsulation and release kinetics. The in vitro characterization of the co-encapsulated nanoparticles revealed that the surfactant nature, concentration, external phase volume, droplet size reduction method and drug loading concentration can all influence the overall performance of the nanoparticles. The semi-quantitative solubility study indicates the strong influence of CoQ10 on CsA entrapment which was thought to be due to an increase in the lipophilicity of the overall system. The in vitro dissolution profile indicates the influence of CoQ10 on CsA release (64%) to that of individual particles of CsA, where the release is faster and higher (86%) on 18th day. The attempts to model the encapsulation and release kinetics were successful, offering a possibility to use such models leading to high throughput screening of drugs and their nature, alone or in combination for a particular polymer, if chi-parameters are understood.

  6. Water-Soluble Coenzyme Q10 Reduces Rotenone-Induced Mitochondrial Fission.

    Science.gov (United States)

    Li, Hai-Ning; Zimmerman, Mary; Milledge, Gaolin Z; Hou, Xiao-Lin; Cheng, Jiang; Wang, Zhen-Hai; Li, P Andy

    2017-02-11

    Parkinson's disease is a neurodegenerative disorder characterized by mitochondrial dysfunction and oxidative stress. It is usually accompanied by an imbalance in mitochondrial dynamics and changes in mitochondrial morphology that are associated with impaired function. The objectives of this study were to identify the effects of rotenone, a drug known to mimic the pathophysiology of Parkinson's disease, on mitochondrial dynamics. Additionally, this study explored the protective effects of water-soluble Coenzyme Q10 (CoQ10) against rotenone-induced cytotoxicity in murine neuronal HT22 cells. Our results demonstrate that rotenone elevates protein expression of mitochondrial fission markers, Drp1 and Fis1, and causes an increase in mitochondrial fragmentation as evidenced through mitochondrial staining and morphological analysis. Water-soluble CoQ10 prevented mitochondrial dynamic imbalance by reducing Drp1 and Fis1 protein expression to pre-rotenone levels, as well as reducing rotenone treatment-associated mitochondrial fragmentation. Hence, water-soluble CoQ10 may have therapeutic potential in treating patients with Parkinson's disease.

  7. Coenzyme Q10 and its effects in the treatment of neurodegenerative diseases

    Directory of Open Access Journals (Sweden)

    Graciela Cristina dos Santos

    2009-12-01

    Full Text Available According to clinical and pre-clinical studies, oxidative stress and its consequences may be the cause or, at least, a contributing factor, to a large number of neurodegenerative diseases. These diseases include common and debilitating disorders, characterized by progressive and irreversible loss of neurons in specific regions of the brain. The most common neurodegenerative diseases are Parkinson's disease, Huntington's disease, Alzheimer's disease and amyotrophic lateral sclerosis. Coenzyme Q10 (CoQ10 has been extensively studied since its discovery in 1957. It is a component of the electron transportation chain and participates in aerobic cellular respiration, generating energy in the form of adenosine triphosphate (ATP. The property of CoQ10 to act as an antioxidant or a pro-oxidant, suggests that it also plays an important role in the modulation of redox cellular status under physiological and pathological conditions, also performing a role in the ageing process. In several animal models of neurodegenerative diseases, CoQ10 has shown beneficial effects in reducing disease progression. However, further studies are needed to assess the outcome and effectiveness of CoQ10 before exposing patients to unnecessary health risks at significant costs.De acordo com estudos clínicos e pré-clínicos, o estresse oxidativo e suas conseqüências podem ser a causa, ou, no mínimo, o fator que contribui para grande número de doenças degenerativas. Estas doenças incluem problemas comuns e debilitantes, caracterizados por perda progressiva e irreversível de neurônios em regiões específicas do cérebro. As doenças degenerativas mais comuns são doença de Parkinson, de Hutington, de Alzheimer e esclerose amiotrófica lateral. A Coenzima Q10 (CoQ10 tem sido intensamente estudada desde sua descoberta, em 1957. É um componente da cadeia de transporte eletrônico e participa da respiração aeróbica celular, gerando energia na forma de trifosfato de

  8. In vitro effects of zinc, D-aspartic acid, and coenzyme-Q10 on sperm function.

    Science.gov (United States)

    Giacone, Filippo; Condorelli, Rosita A; Mongioì, Laura M; Bullara, Valentina; La Vignera, Sandro; Calogero, Aldo E

    2016-07-15

    Reactive oxygen species favor reproductive processes at low concentrations, but damage spermatozoa and decrease their fertilizing capacity at high concentrations. During infection and/or inflammation of the accessory sex glands reactive oxygen species overproduction may occur which, in turn, may negatively impact on sperm motility, sperm DNA fragmentation, and lipid peroxidation. A number of nutraceutical formulations containing antioxidant molecules have been developed to counteract the deleterious effects of the oxidative stress. A recent formulation containing zinc, D-aspartic acid, and coenzyme-Q10 is present in the pharmaceutical market. Based on these premises, the aim of the present study was to evaluate the effects of this combination on spermatozoa in vitro. The study was conducted on 24 men (32.2 ± 5.5 years): 12 normozoospermic men and 12 asthenozoospermic patients. Spermatozoa from each sample were divided into two control aliquots (aliquot A and B) and an aliquot incubated with zinc, D-aspartic acid, and coenzyme-Q10 (aliquot C). After 3 h of incubation, the following parameters were evaluated: progressive motility, number of spermatozoa with progressive motility recovered after swim-up, lipid peroxidation, and DNA fragmentation. Incubation with zinc, D-aspartic acid, and coenzyme-Q10 maintained sperm motility in normozoospermic men (37.7 ± 1.2 % vs. 35.8 ± 2.3 % at time zero) and improved it significantly in asthenozoospermic patients (26.5 ± 1.9 % vs. 18.8 ± 2.0 % at time zero) (p < 0.01). This resulted in a significantly higher (p < 0.01) number of spermatozoa with progressive motility recovered after swim-up in both normozospermic men (4.1 ± 0.9 vs. 3.3 ± 1.0 millions) and asthenozooseprmic patients (3.2 ± 0.8 vs. 1.6 ± 0.5 millions). Finally, a statistically significant lower sperm lipid peroxidation was found after incubation with zinc, D-aspartic acid, and coenzyme-Q10 (p < 0

  9. The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian; Buettiker, Jean-Pierre; Roehl, Holger; Lam, Philippe; Brown, Helen; Luemkemann, Joerg; Adler, Michael; Huwyler, Joerg; Streubel, Alexander; Mohl, Silke

    2016-02-01

    Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process. In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described. Different capping techniques are critically compared: The most common capping equipment with a rotating capping plate produces the lowest amount of particle. The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process.

  10. The existing form's and related determination on coenzyme Q10 in coenzyme Q10 soft capsule%辅酶Q10在软胶囊中的存在形态和相应含量测定研究

    Institute of Scientific and Technical Information of China (English)

    陈志霞; 宋春花; 陈延蕾

    2014-01-01

    目的 研究辅酶Q10在软胶囊中的存在形态从而确定合适的含量测定方法.方法 根据辅酶Q10的化学性质,通过不同测试方法的色谱行为和测试结果,确定辅酶Q10的存在形态,从而选择和建立相应的测试方法对不同形态的Q10进行含量测定.结果 辅酶Q10同时以辅酶Q10(氧化型)和还原型辅酶Q10两种形态共存.国内主要测试方法包括国家标准(GB)、中国药典(ChP)等仅对氧化型进行测定;国外主要测试方法包括美国官方分析化学师协会(AOAC)、美国药典(USP)等先用FeCl3将还原型辅酶Q10转化为辅酶Q10后再对总量进行测定.结论 软胶囊中辅酶Q10同时以辅酶Q10(氧化型)和还原型辅酶Q10两种形态共存,并在一定条件下可互相转化.对辅酶Q10测定时,需先确定待测物为氧化型还是是氧化型和还原型的总量,从而选择合适的含量测定方法.

  11. Coenzyme Q10 does not prevent oral dyskinesias induced by long-term haloperidol treatment of rats

    DEFF Research Database (Denmark)

    OA, Andreassen; Weber, Christine; HA, Jorgensen

    1999-01-01

    dyskinesias in rats, a putative analogue to human TD, could be prevented by the antioxidant coenzyme Q10 (CoQ10). Rats received 16 weeks of treatment with haloperidol decanoate (HAL) IM alone or together with orally administered CoQ10, and the behavior was recorded during and after treatment. HAL...... significantly increased the level of oral dyskinesias, and the increase persisted for 12 weeks after drug withdrawal. Cotreatment with CoQ10 did not attenuate the development of HAL-induced oral dyskinesia. Despite adequate absorption of orally administered CoQ10, shown by the increased serum levels of CoQ10......, no increase of either CoQ10 or coenzyme Q9 was detected in the brain. These results suggest that cotreatment with CoQ10 does not inhibit the development of HAL-induced oral dyskinesias in rats, and that further studies seem to be needed in order to clarify the pharmakokinetics of CoQ10 in rats...

  12. Coenzyme Q10 treatments influence the lifespan and key biochemical resistance systems in the honeybee, Apis mellifera.

    Science.gov (United States)

    Strachecka, Aneta; Olszewski, Krzysztof; Paleolog, Jerzy; Borsuk, Grzegorz; Bajda, Milena; Krauze, Magdalena; Merska, Malwina; Chobotow, Jacek

    2014-07-01

    Natural bioactive preparations that will boost apian resistance, aid body detoxification, or fight crucial bee diseases are in demand. Therefore, we examined the influence of coenzyme Q10 (CoQ10, 2,3-dimethoxy, 5-methyl, 6-decaprenyl benzoquinone) treatment on honeybee lifespan, Nosema resistance, the activity/concentration of antioxidants, proteases and protease inhibitors, and biomarkers. CoQ10 slows age-related metabolic processes. Workers that consumed CoQ10 lived longer than untreated controls and were less infested with Nosema spp. Relative to controls, the CoQ10-treated workers had higher protein concentrations that increased with age but then they decreased in older bees. CoQ10 treatments increased the activities of antioxidant enzymes (superoxide dismutase, GPx, catalase, glutathione S-transferase), protease inhibitors, biomarkers (aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase), the total antioxidant potential level, and concentrations of uric acid and creatinine. The activities of acidic, neutral, and alkaline proteases, and concentrations of albumin and urea were lower in the bees that were administered CoQ10. CoQ10 could be taken into consideration as a natural diet supplement in early spring before pollen sources become available in the temperate Central European climate. A response to CoQ10 administration that is similar to mammals supports our view that Apis mellifera is a model organism for biochemical gerontology.

  13. Model-Based PAT for Quality Management in Pharmaceuticals Freeze-Drying: State of the Art

    Science.gov (United States)

    Fissore, Davide

    2017-01-01

    Model-based process analytical technologies can be used for the in-line control and optimization of a pharmaceuticals freeze-drying process, as well as for the off-line design of the process, i.e., the identification of the optimal operating conditions. This paper aims at presenting the state of the art in this field, focusing, particularly, on three groups of systems, namely, those based on the temperature measurement (i.e., the soft sensor), on the chamber pressure measurement (i.e., the systems based on the test of pressure rise and of pressure decrease), and on the sublimation flux estimate (i.e., the tunable diode laser absorption spectroscopy and the valveless monitoring system). The application of these systems for in-line process optimization (e.g., using a model predictive control algorithm) and to get a true quality by design (e.g., through the off-line calculation of the design space of the process) is presented and discussed. PMID:28224123

  14. Coenzyme Q10 Effects on Creatine Kinase Activity and Mood in Geriatric Bipolar Depression

    Science.gov (United States)

    Forester, Brent P.; Zuo, Chun S.; Ravichandran, Caitlin; Harper, David G.; Du, Fei; Kim, Susan; Cohen, Bruce M.; Renshaw, Perry F.

    2015-01-01

    Introduction Despite the prevalence, associated comorbidities, and functional consequences of bipolar depression (BPD), underlying disease mechanisms remain unclear. Published studies of individuals with bipolar disorder implicate abnormalities in cellular energy metabolism. This study tests the hypotheses that the forward rate constant (kfor) of creatine kinase (CK) is altered in older adults with BPD and that CoEnzyme Q10 (CoQ10), known to have properties that enhance mitochondrial function, increases kfor in elderly individuals with BPD treated with CoQ10 compared with untreated age- and sex-matched controls. Methods Ten older adults (ages 55 and above) with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition [DSM IV]) bipolar disorder, current episode depressed and 8 older controls underwent two 4 Tesla 31Phosphorus magnetic resonance spectroscopy (31PMRS) scans 8 weeks apart using a magnetization transfer (MT) acquisition scheme to calculate kfor. The BPD group was treated with open-label CoEnzyme Q10 400 mg/d titrated up by 400 mg/d every 2 weeks to a maximum of 1200 mg/d. The Montgomery Asberg Depression Rating Scale (MADRS) was used to measure depression symptom severity. Baseline kfor and changes in kfor were compared between individuals with BPD and controls, not receiving CoQ. Clinical ratings were compared across time and associated with kfor changes using repeated measures linear regression. Results The kfor of CK was non-significantly lower for BPD than healthy controls at baseline (BPD mean (standard deviation [SD]) = 0.19 (0.02), control mean (SD) = 0.20 (0.02), Wilcoxon rank sum exact P = .40). The kfor for both CoQ10-treated BPD and controls increased after 8 weeks (mean increase (SD) = 0.03 (0.04), Wilcoxon signed rank exact P = .01), with no significant difference in 8-week changes between groups (BPD mean change (SD) = 0.03 (0.03), control mean change (SD) = 0.03 (0.05), Wilcoxon rank sum exact P = .91). In an exploratory

  15. Association between coenzyme Q10 and glucose transporter (GLUT1) deficiency

    OpenAIRE

    Yubero, Delia; O’Callaghan, Mar; Montero, Raquel; Ormazabal, Aida; Armstrong, Judith; Espinos, Carmina; Rodríguez, Maria A; Jou, Cristina; Castejon, Esperanza; Aracil, Maria A; Cascajo, Maria V; Gavilan, Angela; Briones, Paz; Jimenez-Mallebrera, Cecilia; Pineda, Mercedes

    2014-01-01

    Background It has been demonstrated that glucose transporter (GLUT1) deficiency in a mouse model causes a diminished cerebral lipid synthesis. This deficient lipid biosynthesis could contribute to secondary CoQ deficiency. We report here, for the first time an association between GLUT1 and coenzyme Q10 deficiency in a pediatric patient. Case presentation We report a 15 year-old girl with truncal ataxia, nystagmus, dysarthria and myoclonic epilepsy as the main clinical features. Blood lactate ...

  16. Coenzyme Q10 supplementation and exercise-induced oxidative stress in humans

    DEFF Research Database (Denmark)

    Östman, Bengt; Sjödin, Anders Mikael; Michaëlsson, Karl

    2012-01-01

    Objective: The theoretically beneficial effects of coenzyme Q10 (Q10) on exercise-related oxidative stress and physical capacity have not been confirmed to our knowledge by interventional supplementation studies. Our aim was to investigate further whether Q10 supplementation at a dose recommended...... of individualized performance tests to physical exhaustion were performed before and after the intervention. Primary outcomes were maximal oxygen uptake, workload, and heart rate at the lactate threshold. Secondary outcomes were creatine kinase, hypoxanthine, and uric acid. Results: No significant differences...... between the groups were discerned after the intervention for maximal oxygen uptake (0.11 L/min, 95% confidence interval 0.31 to 0.08, P ¼ 0.44), workload at lactate threshold (6.3 W, 13.4 to 25.9, P ¼ 0.36), or heart rate at lactate threshold (2.0 beats/min, 4.9 to 8.9, P ¼ 0.41). No differences between...

  17. Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial

    Directory of Open Access Journals (Sweden)

    da Silva Gilberto M Sperandio

    2012-12-01

    Full Text Available Abstract Background Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. Methods/design A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance. Discussion Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are

  18. Controls on the Temperature Sensitivity of Soil Heterotrophic Respiration: Q10 Variability and Analysis%土壤异养呼吸温度敏感性(Q10)的影响因子

    Institute of Scientific and Technical Information of China (English)

    盛浩; 杨玉盛; 陈光水; 高人; 曾宏达; 杜紫贤; 张静

    2006-01-01

    首先对国内外土壤异养呼吸Q10的研究成果进行了全面的综合述评.影响土壤异养呼吸Q10的因子主要包括环境因子(主要是温度和湿度)、呼吸底物和土壤生物等.较多的研究表明土壤异养呼吸的Q10在低温时较高,高温时较低,但Q10也可随温度升高而增加,或随温度变化而保持稳定;通常土壤异养呼吸的Q10与土壤水分成正相关,但极端水分条件下(干旱胁迫或渍水)Q10较低;有限的研究表明呼吸底物和土壤生物对土壤异养呼吸Q10的影响还具有很大的不确定性;调控土壤异养呼吸Q10的机理目前还不清楚.然后从温度、水分、呼吸底物、土壤微生物对土壤异养呼吸Q10的影响等方面对影响土壤异养呼吸温度敏感性的原因进行了深入的探讨,并提出未来应重点开展的研究:(1)加强不同尺度土壤异养呼吸Q10的影响因子及调控机理研究;(2)扩大土壤异养呼吸Q10的野外研究;(3)扩大热带、亚热带土壤异养呼吸Q10的研究;(4)深入探讨呼吸底物有效性和土壤生物对土壤异养呼吸Q10的影响;(5)加强其他因子对土壤异养呼吸Q10影响的研究.

  19. PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

    Science.gov (United States)

    Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

    2016-01-01

    Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

  20. Determination of peroxide value in soft capsule containing coenzyme Q10 by titration combined with HPLC%HPLC辅助滴定法测定含辅酶Q10保健食品中过氧化值

    Institute of Scientific and Technical Information of China (English)

    何小稳; 黎承; 鲁燕妮; 曾德斌; 邢奇芬

    2013-01-01

    目的 通过研究含辅酶Q10软胶囊保健食品中过氧化值含量偏高的现象,建立了一种可排除辅酶Q10干扰的HPLC辅助滴定法测定该类样品中过氧化值的方法. 方法 采用GB/T5009.56中方法提取辅酶Q10软胶囊中的油脂,HPLC法测定油脂中辅酶Q10的含量,并采用GB/T5009.37中硫代硫酸钠滴定法分别滴定油脂和辅酶Q10的过氧化值,通过计算排除辅酶Q10的干扰达到测定含辅酶Q10软胶囊保健食品中过氧化值的目的. 结果 HPLC方法中辅酶Q10在2.00~32.0μg·mL-1(r=0.9998)的范围内线性关系良好.所建的HPLC辅助滴定法通过植物油中添加定量的辅酶Q10标准品验证了所建方法的可行性,含辅酶Q10软胶囊保健食品中过氧化值含量的加标回收率为98.4%,RSD为0.88%. 结论 该方法排除了辅酶Q10的干扰,解决了该类样品中过氧化值含量偏高的问题,结果准确,适用于含辅酶Q10软胶囊保健食品中过氧化值的测定.%Objective To determine peroxide value in soft capsule containing coenzyme Q10 by studying the high peroxide value in these samples. Methods The HPLC was used to determining the content of coenzyme Q10 in the grease in soft capsule containing coenzyme Q10 based on GB/T5009.56 and sodium thiosulfate titration method was used to determine the peroxide value in soft capsule coenzyme containing Q10 was obtained by getting rid of the interference based on GB/T5009.37. Results A good linear relation was obtained in the range of 2.00~32.0 μg·mL-l for coenzyme Q10 (r=0.9998)by HPLC. The feasibility of HPLC auxiliary titration method was verified by adding quantitative coenzyme Q10 in oil. The recovery was 98.4% with the relative standard deviations of 0.88%. Conclusions The proposed method is proved to be accurate with no interference of coenzyme Q10. It is suitable for the determination of peroxide value in soft capsule containing coenzyme Q10.

  1. Clinical researches of coenzyme Q10 in diabetes mellitus%辅酶Q10在糖尿病中的研究及临床应用进展

    Institute of Scientific and Technical Information of China (English)

    王曦; 任艳

    2010-01-01

    Coenzyme Q10(CoQ10)acts as a necessary part for oxidative phosphorylation and the synthesis of ATP.It has been confirmed so far as the effective treatment to mitochondrial diabetes mellitus.Studies suggest that CoQ10 supplements not only improve insulin resistance and cellular mitochondrial respiration by decreasing oxidative stress,but also attenuate atherosclerosis by reacting with oxygen radicals,reducing lipid peroxidation,and enhancing the synthesis of NO.Furthermore,CoQ10 can also mitigate side effects caused by statins,and co-activate PPAR α with fibrates to enhance its hypolipidemic effect.CoQ10 appears most promising for the prevention and delay of diabetes and its complications.%辅酶Q10(CoQ10)在细胞氧化磷酸化及ATP产生过程中起关键作用,是目前证实治疗线粒体糖尿病有效的药物.研究发现补充CoQ10不仅能通过减轻氧化应激来改善胰岛素抵抗、保护线粒体功能,而且还能通过清除氧自由基、抑制脂质过氧化、增加一氧化氮的合成来对抗动脉粥样硬化.此外,CoQ10还能减轻他汀类药物的不良反应、协同贝特类药物激活过氧化物酶体增殖物活化受体(PPAR)α,达到辅助降脂的同的.CoQ10可为预防及延缓糖尿病及其并发症提供新的治疗方法 .

  2. Knowledge management and process monitoring of pharmaceutical processes in the quality by design paradigm.

    Science.gov (United States)

    Rathore, Anurag S; Bansal, Anshuman; Hans, Jaspinder

    2013-01-01

    Pharmaceutical processes are complex and highly variable in nature. The complexity and variability associated with these processes result in inconsistent and sometimes unpredictable process outcomes. To deal with the complexity and understand the causes of variability in these processes, in-depth knowledge and thorough understanding of the process and the various factors affecting the process performance become critical. This makes knowledge management and process monitoring an indispensable part of the process improvement efforts for any pharmaceutical organization.

  3. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

    OpenAIRE

    Spurling, Geoffrey K.; Mansfield, Peter R; Montgomery, Brett D.; Joel Lexchin; Jenny Doust; Noordin Othman; Vitry, Agnes I

    2010-01-01

    Editors' Summary Background A prescription drug is a medication that can be supplied only with a written instruction (“prescription”) from a physician or other licensed healthcare professional. In 2009, 3.9 billion drug prescriptions were dispensed in the US alone and US pharmaceutical companies made US$300 billion in sales revenue. Every year, a large proportion of this revenue is spent on drug promotion. In 2004, for example, a quarter of US drug revenue was spent on pharmaceutical promotio...

  4. Rosuvastatin lowers coenzyme Q10 levels, but not mitochondrial adenosine triphosphate synthesis, in children with familial hypercholesterolemia

    NARCIS (Netherlands)

    H.J. Avis; I.P. Hargreaves; J.P.N. Ruiter; J.M. Land; R.J. Wanders; F.A. Wijburg

    2011-01-01

    To investigate whether statin therapy affects coenzyme Q10 (CoQ10) status in children with heterozygous familial hypercholesterolemia (FH). Samples were obtained at baseline (treatment naïve) and after dose titration with rosuvastatin, aiming for a low-density lipoprotein cholesterol level of 110 mg

  5. Novel recessive mutations in COQ4 cause severe infantile cardiomyopathy and encephalopathy associated with CoQ10 deficiency

    Directory of Open Access Journals (Sweden)

    Neal Sondheimer

    2017-09-01

    Full Text Available Coenzyme Q10 (CoQ10 or ubiquinone is one of the two electron carriers in the mitochondrial respiratory chain which has an essential role in the process of oxidative phosphorylation. Defects in CoQ10 synthesis are usually associated with the impaired function of CoQ10–dependent complexes I, II and III. The recessively transmitted CoQ10 deficiency has been associated with a number of phenotypically and genetically heterogeneous groups of disorders manifesting at variable age of onset. The infantile, multisystemic presentation is usually caused by mutations in genes directly involved in CoQ10 biosynthesis. To date, mutations in COQ1 (PDSS1 and PDSS2, COQ2, COQ4, COQ6, COQ7, COQ8A/ADCK3, COQ8B/ADCK4, and COQ9 genes have been identified in patients with primary form of CoQ10 deficiency. Here we report novel mutations in the COQ4 gene, which were identified in an infant with profound mitochondrial disease presenting with perinatal seizures, hypertrophic cardiomyopathy and severe muscle CoQ10 deficiency.

  6. Stabilizing effects of coenzyme Q10 on potassium ion release, membrane potential and fluidity of rabbit red blood cells.

    Directory of Open Access Journals (Sweden)

    Shinozawa,Shinya

    1980-09-01

    Full Text Available The effects of coenzyme Q10 (Co Q10 on potassium ion release, membrane potential and fluidity of rabbit red blood cells were studied. Co Q10 inhibited the increased potassium ion release induced by cetylamine or lysolecithin from the cells. Co Q10 slightly decreased the membrane potential monitored by changes in fluorescence intensity of cyanine dye, 3,3'-dipropyl-2,2'-thiodicarbocyanine iodide [diS-C3-(5], and also slightly decreased the membrane fluidity measured by using 1,6-diphenyl-1,3,5-hexatriene (DPH. These effects of Co Q10 on the membrane are considered to be due to its membrane stabilizing activity by interaction with lipid bilayers of the membrane.

  7. Effect of Coenzyme Q10 on Acute Pulmonary Damage Following the Experimental Thoracic Trauma

    Directory of Open Access Journals (Sweden)

    Murat Koyuncu

    2016-04-01

    Full Text Available Aim: Pulmonary contusion negatively affects prognosis in the case of damages following a trauma. Objective of this experimental study performed in Turkey was to evaluate effects of coenzyme Q10 on primary and secondary damages of pulmonary contusion following experimental thoracic blunt trauma using biochemical and histopathological parameters. Material and Method: A total of 56 Wistar Albino female rats with a mean weight of 205±45 g were included in this study. Rats were randomly divided into seven groups with each group having eight rats. A trauma device which consisted of a fixed platform, and an aluminium tube was prepared. Rats were administered 2.45 J of chest impact energy in order to generate pulmonary contusion. Control and Study groups were named according to the sacrificed time. No process (trauma and/or medication was performed in the sham group, while only trauma was induced in the controls. On the other hand, after induced trauma, intraperitoneal Q10 (0. - 24. - 48. hours was administered to study group. Rats were sacrificed at the end of the after trauma 24, 48 and 72 hours, and their blood and lung tissue samples were analyzed. Results: No significant difference was found between sham and Study-72 groups in terms of high-sensitivity C-reactive protein. On the histopathological examination, no significant difference was found between study and control groups. While no significant difference was found between the sham and study groups, significant difference was observed between sham and control groups. Discussion: Coenzyme Q10, an antioxidant agent, can be used as an antioxidant agent in order to reduce the secondary damage in blunt thoracic trauma.

  8. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure

    DEFF Research Database (Denmark)

    Mortensen, Svend A; Rosenfeldt, Franklin; Kumar, Adarsh

    2014-01-01

    . The primary short-term endpoints at 16 weeks were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro-B type natriuretic peptide. The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined...... by a time to first event analysis. RESULTS: A total of 420 patients were enrolled. There were no significant changes in short-term endpoints. The primary long-term endpoint was reached by 15% of the patients in the CoQ10 group versus 26% in the placebo group (hazard ratio: 0.50; 95% confidence interval: 0...

  9. 辅酶Q10竞争剧烈需求潜力巨大

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    1研发工艺逐步提高 与现有生产厂家纷纷扩产相对应的是,辅酶Q10市场也在接纳新的加盟者。这其中就包括台湾Pharm Essentia公司。过去两年来,Pharm Essentia公司为了规避日本厂家的专利工艺,一直在完善其有机合成生产工艺,提高散装产品的生产量。

  10. Impact of coenzyme Q-10 on parameters of cardiorespiratory fitness and muscle performance in older athletes taking statins.

    Science.gov (United States)

    Deichmann, Richard E; Lavie, Carl J; Dornelles, Adriana C

    2012-11-01

    Many older athletes take statins, which are known to have potential for muscle toxicity. The adverse effects of statins on muscles and the influence thereof on athletic performance remain uncertain. Coenzyme Q-10 (CoQ10) may improve performance and reduce muscle toxicity in older athletes taking statins. This trial was designed to evaluate the benefits of CoQ10 administration for mitochondrial function in this population. Twenty athletes aged ≥ 50 years who were taking stable doses of statins were randomized to receive either CoQ10 (200 mg daily) or placebo for 6 weeks in a double-blind, placebo-controlled, crossover study to evaluate the impact of CoQ10 on the anaerobic threshold (AT). Several secondary endpoints, including muscle function, cardiopulmonary exercise function, and subjective feelings of fitness, were also assessed. The mean (SD) change in AT from baseline was -0.59 (1.2) mL/kg/min during placebo treatment and 2.34 (0.8) mL/kg/min during CoQ10 treatment (P = 0.116). The mean change in time to AT from baseline was significantly greater during CoQ10 treatment than during placebo treatment (40.26 s vs 0.58 s, P = 0.038). Furthermore, muscle strength as measured by leg extension repetitions (reps) increased significantly during CoQ10 treatment, with a mean (SD) increase from baseline of 1.73 (2.9) reps during placebo treatment versus 3.78 (5.0) reps during CoQ10 treatment (P = 0.031). Many other parameters also tended to improve in response to CoQ10 treatment. Treatment with CoQ10 improved AT in comparison with baseline values in 11 of 19 (58%) subjects and in comparison with placebo treatment values in 10 of 19 (53%) subjects. Treatment with CoQ10 (200 mg daily) did not significantly improve AT in older athletes taking statins. However, it did improve muscle performance as measured by time to AT and leg strength (quadriceps muscle reps). Many other measures of mitochondrial function also tended to improve during CoQ10 treatment.

  11. The reduced form of coenzyme Q10 decreases the expression of lipopolysaccharide-sensitive genes in human THP-1 cells.

    Science.gov (United States)

    Schmelzer, Constance; Kohl, Christine; Rimbach, Gerald; Döring, Frank

    2011-04-01

    Monocytes are key players in inflammatory processes that are triggered by lipopolysaccharide (LPS), the major outer membrane component of Gram-negative bacteria. The present study in human monocytic THP-1 cells was designed in order to identify LPS-inducible genes that are down-regulated by the reduced form of coenzyme Q(10) (ubiquinol, Q(10)H(2)). For this purpose, THP-1 cells were incubated with 10 μM Q(10)H(2) for 24 hours. Subsequently, cells were stimulated for 4 hours with 1 μg/mL LPS, and the resulting gene expression levels were determined using microarrays. Fourteen LPS-inducible genes were identified to be significantly (P ≤ .05) down-regulated by Q(10)H(2) pretreatment between a factor of 1.32 and 1.65. The strongest effect of Q(10)H(2) incubation was found for the nuclear receptor coactivator 2 gene (NCOA2). Gene ontology terms revealed for the Q(10)H(2)-sensitive genes an involvement in, e.g., signal transduction processes (centaurin, delta 1; NCOA2; pleckstrin and Sec7 domain containing 3; protein phosphatase 2, regulatory subunit B [B56], γ isoform), transcriptional regulation (NCOA2; POU domain, class 2, transcription factor 1; ETS variant gene 3), and cell proliferation pathways (hypothetical protein FLJ36090, epidermal growth factor receptor pathway substrate 15). In conclusion, we provide evidence in THP-1 cells that Q(10)H(2) modulates LPS-induced gene expression.

  12. Red yeast rice and coenzyme Q10 as safe alternatives to surmount atorvastatin-induced myopathy in hyperlipidemic rats.

    Science.gov (United States)

    Abdelbaset, Marwan; Safar, Marwa M; Mahmoud, Sawsan S; Negm, Seham A; Agha, Azza M

    2014-06-01

    Statins are the first line treatment for the management of hyperlipidemia. However, the primary adverse effect limiting their use is myopathy. This study examines the efficacy and safety of red yeast rice (RYR), a source of natural statins, as compared with atorvastatin, which is the most widely used synthetic statin. Statin interference with the endogenous synthesis of coenzyme Q10 (CoQ10) prompted the hypothesis that its deficiency may be implicated in the pathogenesis of statin-associated myopathy. Hence, the effects of combination of CoQ10 with either statin have been evaluated. Rats were rendered hyperlipidemic through feeding them a high-fat diet for 90 days, during the last 30 days of the diet they were treated daily with either atorvastatin, RYR, CoQ10, or combined regimens. Lipid profile, liver function tests, and creatine kinase were monitored after 15 and 30 days of drug treatments. Heart contents of CoQ9 and CoQ10 were assessed and histopathological examination of the liver and aortic wall was performed. RYR and CoQ10 had the advantage over atorvastatin in that they lower cholesterol without elevating creatine kinase, a hallmark of myopathy. RYR maintained normal levels of heart ubiquinones, which are essential components for energy production in muscles. In conclusion, RYR and CoQ10 may offer alternatives to overcome atorvastatin-associated myopathy.

  13. JVC UX-Q10迷你台式音响

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    UX-Q10是“Lip Lap”系列的最新产品,该机兼容CD、MD、卡带以及调频收音功能,该机大量采用了触摸式控制设计,而且液晶显示屏具有多种不同可变色。UX-Q10从CDMD转录最大支持5倍速,MD部分支持LP2/4模式录音,而DD部分则对应CD-R/RW碟片播放,但是并没有支持MP3格式的音乐播放。在音效方面,该机提供了6种不同的EQ均衡器模式以及3种不同的声场模式。

  14. Ultra-small lipid nanoparticles promote the penetration of coenzyme Q10 in skin cells and counteract oxidative stress.

    Science.gov (United States)

    Lohan, Silke B; Bauersachs, Sonja; Ahlberg, Sebastian; Baisaeng, Nuttakorn; Keck, Cornelia M; Müller, Rainer H; Witte, Ellen; Wolk, Kerstin; Hackbarth, Steffen; Röder, Beate; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    UV irradiation leads to the formation of reactive oxygen species (ROS). An imbalance between the antioxidant system and ROS can lead to cell damage, premature skin aging or skin cancer. To counteract these processes, antioxidants such as coenzyme Q10 (CoQ10) are contained in many cosmetics. To improve and optimize cell/tissue penetration properties of the lipophilic CoQ10, ultra-small lipid nanoparticles (usNLC) were developed. The antioxidant effectiveness of CoQ10-loaded usNLC compared to conventional nanocarriers was investigated in the human keratinocyte cell line HaCaT. Using confocal laser scanning microscopy investigations of the carriers additionally loaded with nile red showed a clear uptake into cells and their distribution within the cytoplasm. By use of the XTT cell viability test, CoQ10 concentrations of 10-50 μg/ml were shown to be non-toxic, and the antioxidant potential of 10 μg/ml CoQ10 loaded usNLC in the HaCaT cells was analyzed via electron paramagnetic resonance spectroscopy after cellular exposure to UVA (1J/cm(2)) and UVB (18 mJ/cm(2)) irradiation. In comparison with the CoQ10-loaded conventional carriers, usNLC-CoQ10 demonstrated the strongest reduction of the radical formation; reaching up to 23% compared to control cells without nanocarrier treatment. Therefore, usNLC-CoQ10 are very suitable to increase the antioxidant potential of skin.

  15. Evaluation of Bioactive Compounds, Pharmaceutical Quality, and Anticancer Activity of Curry Leaf (Murraya koenigii L.

    Directory of Open Access Journals (Sweden)

    Ali Ghasemzadeh

    2014-01-01

    Full Text Available In this study, we investigated some bioactive compounds and pharmaceutical qualities of curry leaf (Murraya koenigii L. extracts from three different locations in Malaysia. The highest TF and total phenolic (TP contents were observed in the extracts from Kelantan (3.771 and 14.371 mg/g DW, followed by Selangor (3.146 and 12.272 mg/g DW and Johor (2.801 and 12.02 mg/g DW, respectively. High quercetin (0.350 mg/g DW, catechin (0.325 mg/g DW, epicatechin (0.678 mg/g DW, naringin (0.203 mg/g DW, and myricetin (0.703 mg/g DW levels were observed in the extracts from Kelantan, while the highest rutin content (0.082 mg/g DW was detected in the leaves from Selangor. The curry leaf extract from Kelantan exhibited higher concentration of gallic acid (0.933 mg/g DW than that from Selangor (0.904 mg/g DW and Johor (0.813 mg/g DW. Among the studied samples, the ones from Kelantan exhibited the highest radical scavenging activity (DPPH, 66.41% and ferric reduction activity potential (FRAP, 644.25 μm of Fe(II/g followed by those from Selangor (60.237% and 598.37 μm of Fe(II/g and Johor (50.76% and 563.42 μm of Fe(II/g, respectively. A preliminary screening showed that the curry leaf extracts from all the locations exhibited significant anticarcinogenic effects inhibiting the growth of breast cancer cell line (MDA-MB-231 and maximum inhibition of MDA-MB-231 cell was observed with the curry leaf extract from Kelantan. Based on these results, it is concluded that Malaysian curry leaf collected from the North (Kelantan might be potential source of potent natural antioxidant and beneficial chemopreventive agents.

  16. Determination of Coenzyme Q10 and Its Concentration-Time Curve in Human Plasma by HPLC-UV%HPLC-UV测定人体血浆中辅酶Q10浓度及其动态研究

    Institute of Scientific and Technical Information of China (English)

    王胜峰; 邹永华; 周彦彬; 田娟; 左英; 冉黎灵; 丁劲松

    2011-01-01

    目的 建立人血浆中辅酶Q10的HPLC-UV测定法,考察正常人内源性辅酶Q10的经时变化过程,并研究辅酶Q10胶囊连续给药后血浆中辅酶Q10变化规律.方法 无辅酶Q10血浆经低温光照后获得,作为方法学建立的空白背景.血浆样品经正己烷-乙醇=9:1提取后,由迪马Diamonsil C18柱(4.6 mm ×200 mm,5μm)分离,流动相为甲醇·乙醇(10:90),维生素K1为内标,检测波长为275 nm.18名志愿者在控制饮食2 d后,不同时间点采血并测定血浆中内源性辅酶Q10的变化规律,随后连续给予辅酶Q10胶囊同时间点采血,考察血浆中辅酶Q10浓度的升高情况.结果 血浆中杂质不干扰样品峰,线性范围为0.156~10.0μg·mL-1(r=0.999 9),定量下限为0.156μg·mL-1.受试者经控制饮食2 d后血浆中内源性辅酶Q10浓度达到稳定状态,连续给予辅酶Q10胶囊后血浆中辅酶Q10的浓度增加明显.结论 新建立的人血浆中辅酶Q10测定法,简单快速,准确度高,空白基质选择合理,处理恰当.连续给药的方法可用于评价辅酶Q10的生物利用度.%OBJECTIVE To develop and validate a simple HPLC-UV method for the determination of coenzyme Q10 and to investigate the concentration-time curve of coenzyme Q10 in human plasma before and after multiple doses administration.METHODS Coenzyme Q10 inblank plasma was decomposed by light and the plasma was applied as the blank background correction.Coenzyme Q10 inplasma was extracted with n-hexane-ethanol (9∶1 ), and then the separation was performed on a Diamonsil C18 column (4.6 mm ×200 mm, 5 μm) with a mixture of methanol-ethanol (10∶90 v/v) as mobile phase.The internal standard was vitamin K1.The detection wavelength was 275 nm.The concentration-time curve of endogenous coenzyme Q10 was determined in 18 volunteers with the controlled diet for 2 d.The incremental coenzyme Q10 was determined after multiple doses of coenzyme Q10capsules.RESULTS Coenzyme Q10was separated from the

  17. 极谱法研究辅酶Q10与β-环糊精的包结行为%Inclusion of coenzyme Q10 with β-cyclodextrin studied by polarography

    Institute of Scientific and Technical Information of China (English)

    杨海英; 宋俊峰

    2006-01-01

    目的研究辅酶Q10与β-环糊精(β-CD)的包结行为.方法用极谱法考察主体分子β-CD与电活性客体分子辅酶Q10发生包结反应时,包结物还原波峰电流随时间的变化,峰电位随β-CD浓度的变化,并在自然光照条件下分别考察辅酶Q10和包结物的还原波峰电流随时间的变化.结果在0.1 mol·L-1 HAc/NaAc(pH 4.7)的乙醇-水(60:40)介质中,辅酶Q10与β-CD形成1:1的包结物,测得其包结常数Kf为1.26×104L·mol-1,包结反应的表观速率常数k为6.64×10-2 min-1.并测得辅酶Q10的光降解表观速率常数k为7.77×10-3 min-1,辅酶Q10-β-CD包结物的k为3.38×10-3 min-1.结论辅酶Q10和β-CD可形成包结物,并在一定程度上提高了辅酶Q10的光稳定性.

  18. Comparison of pharmaceutical properties of topical non-steroidal anti-inflammatory drug preparations on quality of life.

    Science.gov (United States)

    Shibata, Yuuka; Ikeda, Hiroaki; Kondou, Yoshihiro; Kihira, Kenji

    2005-05-01

    To compare the effects of different pharmaceutical properties of commercially available topical nonsteroidal antiinflammatory drugs (NSAIDs) on the quality of life, we administered a questionnaire to 65 healthy volunteers. We investigated five creams, five gels, and four solutions of topical NSAID preparations in this study. The survey was conducted to clarify the relationship of their answers and pharmaceutical properties of the topical NSAID preparations. Questions addressed spreadability, smell, viscosity, and comfort level of the topical NSAID preparations. Among the five creams, Napageln had lower spreadability, less smell, and greater viscosity than the other preparations. Because of its easy spreadability, weak smell, and low viscosity, the volunteers favored Sector cream among the cream preparations. Among the five gel preparations, Inteban had less spreadability, stronger smell, and higher viscosity than the other preparations. The volunteers favored Epatec over the other gel preparations. All four solutions had the odor of menthol and other artificial ingredients, except for Napageln. These findings indicate that information on the pharmaceutical properties of commercially available topical NSAID preparations will be helpful to physicians and pharmacists in conducting medical treatment and prescribing.

  19. Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

    Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

  20. 促进剂对辅酶Q10生物合成的影响

    Institute of Scientific and Technical Information of China (English)

    岳小飞; 姚金凤; 许激扬

    2006-01-01

    目的研究不同的添加物对辅酶Q10发酵合成的影响。方法辅酶Q10用皂化法提取,高效液相法检测。结果添加与辅酶Q10的合成有关物质如对羟基苯甲酸、胡萝卜汁、西红柿汁及烟叶,均能提高辅酶Q10的产量,分别提高6.3%、9.0%、18.1%、12.1%。

  1. 辅酶Q10及其中间体工业现状与发展

    Institute of Scientific and Technical Information of China (English)

    阚志强; 赵美法

    2005-01-01

    辅酶Q10生产工艺进展 辅酶Q10,别名:癸烯醌、泛醌、万有醌,化学名:2,3-二甲氧基-5-甲基-6[3-甲基丁烯基-2]-苯醌,2,3-二甲氧基-5-甲基-6-癸异戊烯基苯醌。英文名称:Coenzyme Q10;Co Q10;Ubiquinone -10;Ubidecarenone;2,3-dimethoxy -5 -metyl -6-decaprenylbenzoq-uinone.

  2. TPGS-chitosome as an effective oral delivery system for improving the bioavailability of Coenzyme Q10.

    Science.gov (United States)

    Shao, Yating; Yang, Liang; Han, Hyo-Kyung

    2015-01-01

    This study aimed to design the chitosan coated TPGS liposome to enhance the bioavailability of Coenzyme Q10 (CoQ10). Optimization of formulation variables for the preparation of the liposome was performed and then three liposomal formulations (TPGS-liposome, TPGS-chitosome, chitosome) were prepared with narrow size distribution and high encapsulation efficiency. All of three liposomal formulations were stable at pH 1.2 and 7.0 for 24h without any significant drug leakage. Furthermore, chitosan-coated liposomes showed the strong mucoadhesive properties. All the tested liposomal formulations significantly enhanced the cellular uptake of CoQ10 as compared to the untreated drug. Particularly, TPGS-chitosome appeared to be most effective in improving the cellular uptake of CoQ10 in Caco-2 cells (about 30-folds greater than the untreated powder formulation). In oral pharmacokinetic studies, TPGS-chitosome enhanced the systemic exposure of CoQ10 by 3.4 folds as compared to the untreated powder and also displayed the extended drug release profile for up to 24h in rats. Compared to the untreated powder CoQ10, TPGS-chitosome significantly improved the antioxidant effect of CoQ10 and reduced the intracellular ROS level. In conclusion, TPGS-chitosome significantly enhanced the oral bioavailability of CoQ10 and prolonged drug release profile in rats, suggesting that TPGS-chitosome could be an effective oral delivery platform to improve the oral bioavailability of poorly absorbable drugs.

  3. Coenzyme Q10 Attenuates High Glucose-Induced Endothelial Progenitor Cell Dysfunction through AMP-Activated Protein Kinase Pathways

    Science.gov (United States)

    Tsai, Hsiao-Ya; Lin, Chih-Pei; Huang, Po-Hsun; Li, Szu-Yuan; Chen, Jia-Shiong; Lin, Feng-Yen; Chen, Jaw-Wen; Lin, Shing-Jong

    2016-01-01

    Coenzyme Q10 (CoQ10), an antiapoptosis enzyme, is stored in the mitochondria of cells. We investigated whether CoQ10 can attenuate high glucose-induced endothelial progenitor cell (EPC) apoptosis and clarified its mechanism. EPCs were incubated with normal glucose (5 mM) or high glucose (25 mM) enviroment for 3 days, followed by treatment with CoQ10 (10 μM) for 24 hr. Cell proliferation, nitric oxide (NO) production, and JC-1 assay were examined. The specific signal pathways of AMP-activated protein kinase (AMPK), eNOS/Akt, and heme oxygenase-1 (HO-1) were also assessed. High glucose reduced EPC functional activities, including proliferation and migration. Additionally, Akt/eNOS activity and NO production were downregulated in high glucose-stimulated EPCs. Administration of CoQ10 ameliorated high glucose-induced EPC apoptosis, including downregulation of caspase 3, upregulation of Bcl-2, and increase in mitochondrial membrane potential. Furthermore, treatment with CoQ10 reduced reactive oxygen species, enhanced eNOS/Akt activity, and increased HO-1 expression in high glucose-treated EPCs. These effects were negated by administration of AMPK inhibitor. Transplantation of CoQ10-treated EPCs under high glucose conditions into ischemic hindlimbs improved blood flow recovery. CoQ10 reduced high glucose-induced EPC apoptosis and dysfunction through upregulation of eNOS, HO-1 through the AMPK pathway. Our findings provide a potential treatment strategy targeting dysfunctional EPC in diabetic patients. PMID:26682233

  4. Electrochemical Investigation of Coenzyme Q10 on Silver Electrode in Ethanol Aqueous Solution and Its Determination Using Differential Pulse Voltammetry.

    Science.gov (United States)

    Li, Dan; Deng, Wei; Xu, Hu; Sun, Yinxing; Wang, Yuhong; Chen, Shouhui; Ding, Xianting

    2016-08-01

    The electrochemistry reduction of coenzyme Q10 (CoQ10) on silver electrodes has been investigated in mixed solvent containing 95 vol. % ethanol and 5 vol. % water. A combination of cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS) is employed to explore the mechanism of redox processes of CoQ10 in the presence and absence of oxygen, respectively. It has been proved that the redox reaction of CoQ10 is highly dependent on the oxygen in the solution compared with that of CoQ0, which may be attributed to the isoprenoid side chain effect of CoQ10 Moreover, the effects of experimental variables such as electrolyte component, pH, temperature, and sonication time on the amperometric and potentiometric responses of CoQ10 are presented. The differential pulse voltammetry method has been developed for the quantification of the CoQ10 in the complex samples. Under the optimum conditions, the method is linear over the concentration range of 1.00 × 10(-7) to 1.00 × 10(-3) mol/L (8.63 × 10(-2) to 8.63 × 10(2) mg/kg). The limit of detection (3σ/k) is 3.33 × 10(-8) mol/L (2.88 × 10(-2) mg/kg). The recoveries of the spiked samples are between 91% and 108%. The presented method can be applied to the analysis of CoQ10 in real samples without any pretreatment.

  5. [Effect of phlebodium decumanum and coenzyme Q10 on sports performance in professional volleyball players].

    Science.gov (United States)

    García Verazaluce, Juan José; Vargas Corzo, María Del Carmen; Aguilar Cordero, María José; Ocaña Peinado, Francisco; Sarmiento Ramírez, Álvaro; Guisado Barrilao, Rafael

    2014-10-03

    Introducción: Los programas de entrenamiento físico, se basan en provocar estados de fatiga transitoria para inducir supercompensaciones de los sistemas biológicos implicados en la actividad, con el objeto mejorar el rendimiento del deportista a medio-largo plazo. La administración de suplementos nutricionales con propiedades antioxidantes e inmunomoduladoras, como Phlebodium decumanum y Coenzima Q10, constituyen medidas muy ventajosas para la recuperación de la inflamación y el daño tisular originados por el estrés del ejercicio intenso y mantenido. Metodología: Se llevó a cabo un diseño experimental, longitudinal, a doble ciego, con tres grupos randomizados a partir de una muestra de 30 jugadores varones de voleibol (22-32 años) de la Universidad de Granada, con un nivel de entrenamiento alto (17 horas por semana en los 6 meses previos a la investigación). Se evaluaron los efectos de un programa de entrenamiento físico de un mes de duración, común a todos los grupos de estudio, asociado a la administración simultánea de suplementos nutricionales a base de Phlebodium decumanum (4 cápsulas de 400 mg/ cáp. al día) el Grupo Experimental 1, Phlebodium decumanum (la misma dosis y posología que el grupo 1) más Coenzima Q10 (4 cápsulas de 30 mg/cáp al día) el Grupo Experimental 2, y sustancia placebo, el Grupo Control. Las variables dependientes sanguíneas para valorar los efectos de dicha intervención sobre el perfil endocrinometabólico e inmunológico basales fueron: cortisol e interleuquina 6 relacionados ambos con el eje del estrés inducido por el ejercicio, y ácido láctico y amonio, vinculados esencialmente, al metabolismo energético anaeróbio. Resultados: Todos los grupos del estudio manifestaron cambios adaptativos favorables sobre el perfil endocri no- metabólico e inmunológico, que se objetivaron a través de un descenso significativo basal postest de las concentraciones de cortisol, interleuquina 6, ácido láctico y amoniaco

  6. Effect of cooking and in vitro digestion on the stability of co-enzyme Q10 in processed meat products.

    Science.gov (United States)

    Tobin, Brian D; O'Sullivan, Maurice G; Hamill, Ruth; Kerry, Joseph P

    2014-05-01

    The use of CoQ10 fortification in the production of a functional food has been demonstrated in the past but primarily for dairy products. This study aimed to determine the bio-accessibility of CoQ10 in processed meat products, beef patties and pork breakfast sausages, fortified with CoQ10. Both the patties and sausages were fortified with a micellarized form of CoQ10 to enhance solubility to a concentration of 1mg/g of sample (NovaSolQ®). An assay was developed combining in vitro digestion and HPLC analysis to quantify the CoQ10 present in fortified products (100mg/g). The cooking retention level of CoQ10 in the products was found to be 74±1.42% for patties and 79.69±0.75% for sausages. The digestibility for both products ranged between 93% and 95%, sausages did have a higher digestibility level than patties but this was not found to be significant (P<0.01).

  7. Exogenous coenzyme Q10 modulates MMP-2 activity in MCF-7 cell line as a breast cancer cellular model

    Directory of Open Access Journals (Sweden)

    Mirmiranpour Hossein

    2010-11-01

    Full Text Available Abstract Background/Aims Matrix Metalloproteinases 2 is a key molecule in cellular invasion and metastasis. Mitochondrial ROS has been established as a mediator of MMP activity. Coenzyme Q10 contributes to intracellular ROS regulation. Coenzyme Q10 beneficial effects on cancer are still in controversy but there are indications of Coenzyme Q10 complementing effect on tamoxifen receiving breast cancer patients. Methods In this study we aimed to investigate the correlation of the effects of co-incubation of coenzyme Q10 and N-acetyl-L-cysteine (NAC on intracellular H2O2 content and Matrix Metalloproteinase 2 (MMP-2 activity in MCF-7 cell line. Results and Discussion Our experiment was designed to assess the effect in a time and dose related manner. Gelatin zymography and Flowcytometric measurement of H2O2 by 2'7',-dichlorofluorescin-diacetate probe were employed. The results showed that both coenzyme Q10 and N-acetyl-L-cysteine reduce MMP-2 activity along with the pro-oxidant capacity of the MCF-7 cell in a dose proportionate manner. Conclusions Collectively, the present study highlights the significance of Coenzyme Q10 effect on the cell invasion/metastasis effecter molecules.

  8. 芳香族氨基酸对沼泽红假单胞菌合成CoQ10的影响%Effects of aromatic amino acids on the biosynthesis of CoQ10 in Rhodopseudomonas palustris

    Institute of Scientific and Technical Information of China (English)

    蒋世云; 余龙江; 申晓林; 熊欣; 简艳

    2008-01-01

    CoQ10 has been used not only as a drug but also as a food supplement because of its various Dhysi ological and biochemical activities.Microbial fermentation is a main way for the commercial production of CoQ10.The quinoid nucleus of CoQ10 and aromatic amino acids are synthesized from the shikimate pathway in bacteria and there are some effects of them on another biosynthesis.The impacts of aromatic amino acids on the biosynthesis of CoQ10 in Rhodopseudomnas palustris J001 were investigated with feeding aromatic amino acids at the end of the logarithmic phase during incubation.The results showed that the feeding of tryptophan(above 15 mg/L) strongly repressed the biosynthesis of CoQ10.There were also some slightly unfavorable effects of feeding of phenylalanine(50 mg/L)and tyrosine(above 200 rag/L)on the biosynthesis of CoQl0.However,the biosynthe sis of CoQ10 could be enhanced by feeding phenylalanine(above 75 mg/L)Or tyrosine(from 75 to 1 75 mg/L).The content of CoQ10 in the strain was found to be the highest up tO(25.6±1.3)mg CoQ10/g dried biomass when feeding phenylalanine(1 00 mg/L)+tyrosine(1 50 mg/L),which was 52.2% higher than that in the control with no additional amino acids in the medium.The results indicated that the biosynthesis of CoqIo was affected by the three aromatic amino acids.It can be concluded that the biosynthesis of CoQ10 in strain is favorable by feeding appropriate amount of phenylalanien and tyrosine without tryptophan.%CoQ10具有呼吸链电子传递者、抗氧化性、调控基因表达等多种生理生化功能.目前不仅用作药物也用作食品添加剂.微生物发酵法是当前生产CoQ10的主要方法.在细菌中,芳香族氨基酸和CoQ10的苯核环都是通过莽草酸途径合成;它们在生物体中各自的合成存在着相互调控作用.本试验通过在培养过程中添加芳香族氨基酸来考察了其对沼泽红假单胞菌J001合成CoQ10的影响.结果表明:当色氨酸添加量≥15 mg/L时对CoQ10

  9. Quality by design approach of a pharmaceutical gel manufacturing process, part 2: near infrared monitoring of composition and physical parameters.

    Science.gov (United States)

    Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalá, Manel

    2011-10-01

    We applied the principles of quality by design to the production process of a pharmaceutical gel by using the near infrared spectroscopy (NIRS) technique in combination with multivariate chemometric tools. For this purpose, we constructed a D-optimal experimental design having normal operational condition (NOC) batches as central point. The primary aim here was to develop an expeditious NIRS method for determining the composition of a pharmaceutical gel and assess the temporal changes in major physical factors affecting the quality of the product (specifically, viscosity and pH). Gel components were quantified by using partial least squares (PLS) calibration models of the PLS1 type. The study was completed by using the batch statistical process control method to compare product batches included in the experimental design with NOC batches. Similarities and differences between the two types of batches were identified by using control charts for residuals (Q-statistic) and Hotteling's T2 (D-statistic). The ensuing models, which were subject to errors less than 5%, allowed the gel production process to be effectively monitored. As shown in this work, the NIRS technique is a highly suitable tool for process analytical technology.

  10. [Theoretical and experimental aspects of detection of counterfeit and inferior quality products among pharmaceuticals produced from oilplants].

    Science.gov (United States)

    Fetisova, A N; Popkov, V A

    2008-01-01

    On the basis of their own empiric studies, the authors substantiate principle approaches to and criteria of the detection of counterfeit and inferior quality products among pharmaceuticals and biologically active food supplements produced of oilplants with a non-specific composition of fatty acid acylglyceroles. To detect counterfeit and inferior quality products effectively, the authors offer the optimal sequence of procedures including the following steps: organoleptic analysis; measurement of the main compositional and qualitative parameters (density, refractive index, saponification number, acid number, iodine number, oxidability index, percentage of unsaponifiables, and total content of carotenes converting into beta-carotene); theoretical calculation of the composition of fatty acids and glyceroles based on the empiric compositional and qualitative values, including the calculation of average relative molecular mass of the fatty acids, and the proportion of acylglyceroles and glycerin in the objects.

  11. Determination of coenzyme Q10 level in human retina by the high-performance liquid chromatography%反相高效液相色谱法测定人视网膜中辅酶Q10的含量

    Institute of Scientific and Technical Information of China (English)

    曲进锋; 黎晓新; Ilyas Washington

    2010-01-01

    Background Researches have demonstrated that age-related macular degeneration (AMD) is associated with the oxidative stress injury of retina.Coenzyme Q10 (CoQ10) is an important antioxidant agent.CoQ10 level in blood plasma is a primary index of reflecting the oxidative stress ability of human.However,the study on CoQ10 content in retina has not been seen yet.ObjectiveThe aim of this study is to establish a method of detecting CoQ10 content in retina by the high-performance liquid chromatography (HPLC). Methods The retinas were isolated from 10 healthy eyes of donors aged 20-28 years.The donor eyes were obtained from National Development and Research Institute,Inc.USA.Isolated retina tissue was prepared into homogenate then lyophilized and deproteinized with methanol.Samples were extracted with heptane prior to the HPLC analysis with the chromatographic conditions as follows:RP-18 column,a mobile phase consisted of methanol-hexane-acetic acid-isopropanol (V/V=55:9:1:1) and 0.42% sodium acetate,ultraviolet rays (UV) detector at 275 nm.Results CoQ10 was effectively isolated from human retina.The limit of detection of CoQ10 was 0.14mg/L.The peak area and concentration of CoQ10 showed a good linear correlation within the concentration range of 0.2-395.00mg/L (R~2=0.9943).Repeatability study showed that the relative standard deviations for CoQ10 at the concentration of 0.86mg/L,2.59mg/L and 3.45mg/L were 2.7%,0.1% and 3.3%,respectively.The within- and inter-day standard deviations for the analysis of CoQ10 were 1.6% and 3.7%,respectively.The recovery was 101%-113% for the human retina samples.The concentration of CoQ10 in 10 retinas from human donors was 0.51±0.20μg/eye in average.Conclusion A HPLC method for the quantified analysis of CoQ10 in human retina is developed.%目的 建立一种通过高效液相色谱法(HPLC)检测人视网膜中辅酶Q10(CoQ10)含量的方法 .方法 10例新鲜健康人尸眼(年龄20~28岁)视网膜经分离、匀浆、冻干后,

  12. Antioxidant vitamins C, E and coenzyme Q10 vs Dexamethasone: comparisons of their effects in pulmonary contusion model

    Directory of Open Access Journals (Sweden)

    Gokce Mertol

    2012-09-01

    Full Text Available Abstract Background The goal of our study is to evaluate the effects of antioxidant vitamins (vitamin C and E, Coenzyme Q10 (CoQ10 and dexamethasone (Dxm in experimental rat models with pulmonary contusion (PC. Methods Rats were randomly divided into six groups. Except for the control, all subgroups had a moderate pulmonary contusion. Animals in the group I and group II received intraperitoneal saline, group III received 10mg.kg-1 CoQ10 group IV received 100mg.kg-1 vitamin C, group V received 150mg.kg-1 vitamin E, and group VI received 10mg.kg-1 Dxm. Blood gas analysis, serum nitric oxide (NO and malondialdehyde (MDA levels as well as superoxide dismutase (SOD activity assays, bronchoalveolar lavage (BAL fluid and histopathological examination were performed. Results Administration of CoQ10 resulted in a significant increase in PaO2 values compared with the group I (p = 0.004. Levels of plasma MDA in group II were significantly higher than those in the group I (p = 0.01. Early administration of vitamin C, CoQ10, and Dxm significantly decreased the levels of MDA (p = 0.01. Lung contusion due to blunt trauma significantly decreased SOD activities in rat lung tissue compared with group I (p = 0.01. SOD levels were significantly elevated in animals treated with CoQ10, Vitamin E, or Dxm compared with group II (p = 0.01. Conclusions In our study, CoQ10, vitamin C, vitamin E and Dxm had a protective effect on the biochemical and histopathological outcome of PC after experimental blunt thorax trauma.

  13. 辅酶Q10——人类健康食品的新资源%Coenzyme Q10 -C A New Source of Nutritional Supplement for Mankind

    Institute of Scientific and Technical Information of China (English)

    杨则宜

    2007-01-01

    辅酶Q10作为一种维生素类的辅酶在人体内发挥重要的生理功能.本文就辅酶Q10作为治疗药物的用途和保持动脉健康、增强维生素E效果、提高运动能力、抗衰老等方面的作用作了详细的介绍.同时,阐述了辅酶Q10使用的推荐量及安全性,并展示了它的应用前景.

  14. 辅酶Q10对大鼠再生肝细胞线粒体通透性转换的影响%Effects of coenzyme Q10 on mitochondrial permeability transition of regenerating hepatocytes in rats

    Institute of Scientific and Technical Information of China (English)

    翟心慧; 来小海; 吴清华; 赵爱景; 徐存拴

    2013-01-01

    目的 了解辅酶Q10(CoQ10)对大鼠再生肝细胞线粒体通透性转换(MPT)的影响.方法 雌性SD大鼠120只,用不同剂量CoQ10灌胃后行部分肝切除术(PH),于术后不同时间取肝组织分离线粒体,分光光度计法测定线粒体悬液的A540nm值,之后再加入钙离子诱导并检测A540nm值.结果 PH后6~ 48h,高剂量(60mg/kg) CoQ10处理组的再生肝线粒体通透性明显低于对照组,而低剂量(6mg/kg)处理组只在48h明显低于对照组,其他时间均无显著差异.用钙离子诱导后,各组各时间点的线粒体通透性随时间延长而不同程度的增强,但PH后6~48 h的CoQ10处理组的再生肝线粒体通透性稍小于对照组.结论 一定剂量的CoQ10能降低大鼠再生肝线粒体通透性,作用主要体现在肝再生的细胞增殖阶段.%Objective Effects of coenzyme Q10 ( CoQ10) on mitochondrial permeability transition ( MPT) of regenerating hepatocytes in rats were surveyed in this paper. Methods 120 Sprague-Dawely female rats were randomized to receive three different doses of CoQ10 by gastric lavage daily starting on the day of partial hepatectomy (PH). The rats were killed at different times and the livers were processed for mitochondrial suspension, which was tested with or without Ca2+ induction by using spectrophotometer. Results During 6-48hours after PH, the mitochondrial permeability of the group treated with high dose(60mg/kg CoQ10) was much lower than that of the control group. The group treated with low dose(6mg/kg CoQ10)was much lower than the control at 48 hours only. However, no statistically significant difference was found among all the groups at 72 hours after PH and later; The mitochondrial permeability of each group was enhanced along with time after the mitochondrial suspension was induced by calcium ion, but the variation of the group treated with CoQ10was less than the control during 6-48 hours after PH. Conclusion Treating with proper dose of CoQl0 may reduce

  15. Effect of concomitant administration of coenzyme Q10 with sitagliptin on experimentally induced diabetic nephropathy in rats.

    Science.gov (United States)

    Maheshwari, Rajesh; Balaraman, Ramachandran; Sen, Ashim Kumar; Shukla, Disha; Seth, Avinash

    2017-11-01

    This study was aimed to investigate the therapeutic potential of coenzyme Q10 and its combination with sitagliptin in experimentally induced diabetic nephropathy. The diabetic rats were treated with coenzyme Q10 or sitagliptin and their concomitant administration. Various parameters of renal function like serum creatinine, urea, uric acid and markers of oxidative stress such as renal malondialdehyde content (MDA), glutathione (GSH) level and superoxide dismutase (SOD), catalase activities were measured. TNF-α, TGF-β, MPO activity and nitrite content were estimated in renal tissue with histopathological observation. Diabetic rats showed a significant reduction in renal function, which was reflected with an increase in serum creatinine, urea and uric acid levels. Streptozotocin-nicotinamide caused renal tubular damage with a higher MDA level, depletion of SOD and CAT activity and GSH level. In addition, TNF-α, TGF- β, MPO activity and nitrite content were significantly increased in diabetic rats. Treatment with coenzyme Q10 or sitagliptin and their co-administration ameliorated STZ-nicotinamide-induced renal damage which was reflected by decreased oxidative stress, TNF-α, TGF-β, MPO activity, nitrite content along with histopathological changes. To conclude, concomitant administration of coenzyme Q10 and sitagliptin showed a better renoprotective effect than coenzyme Q10 or sitagliptin when given alone.

  16. Effect of DHA and CoenzymeQ10 Against Aβ- and Zinc-Induced Mitochondrial Dysfunction in Human Neuronal Cells

    Directory of Open Access Journals (Sweden)

    Nadia Sadli

    2013-07-01

    Full Text Available Background: Beta-amyloid (Aβ protein is a key factor in the pathogenesis of Alzheimer's disease (AD and it has been reported that mitochondria is involved in the biochemical pathway by which Aβ can lead to neuronal dysfunction. Coenzyme Q10 (CoQ10 is an essential cofactor involved in the mitochondrial electron transport chain and has been suggested as a potential therapeutic agent in AD. Zinc toxicity also affects cellular energy production by decreasing oxygen consumption rate (OCR and ATP turnover in human neuronal cells, which can be restored by the neuroprotective effect of docosahexaenoic acid (DHA. Method: In the present study, using Seahorse XF-24 Metabolic Flux Analysis we investigated the effect of DHA and CoQ10 alone and in combination against Aβ- and zinc-mediated changes in the mitochondrial function of M17 neuroblastoma cell line. Results: Here, we observed that DHA is specifically neuroprotective against zinc-triggered mitochondrial dysfunction, but does not directly affect Aβ neurotoxicity. CoQ10 has shown to be protective against both Aβ- and zinc-induced alterations in mitochondrial function. Conclusion: Our results indicate that DHA and CoQ10 may be useful for the prevention, treatment and management of neurodegenerative diseases such as AD.

  17. Product Quality Review in Pharmaceutical Manufacturers%药品生产企业产品质量回顾分析的研究

    Institute of Scientific and Technical Information of China (English)

    丁越; 梁毅

    2011-01-01

    介绍了产品质量回顾分析,将其与欧盟GMP、ICHQ7A中的内容进行了对比,并介绍了质量回顾分析的编写方法。%This article introduced product quality review in pharmaceutical manufacturers,compared the content in GMP with it in Good Manufacturing Practice for Active Pharmaceutical Ingredients and in EU GMP.The method of writing product quality review was also included.

  18. Chemometrical aspects of quality in pharmaceutical technology : the application of robustness criteria and multi criteria decision making in optimization procedures for pharmaceutical formulations

    NARCIS (Netherlands)

    Boer, Jan Hendrik de

    1992-01-01

    In pharmaceutical technology one is often engaged with the design and analysis of formulations. A formulation of a solid dosage form is normally a mixture of components. This formulation usually consists of a number of components with fixed concentrations like the the medicinal substance(s) (drug),

  19. ADCK3, an Ancestral Kinase, Is Mutated in a Form of Recessive Ataxia Associated with Coenzyme Q10 Deficiency

    Science.gov (United States)

    Lagier-Tourenne, Clotilde; Tazir, Meriem; López, Luis Carlos; Quinzii, Catarina M.; Assoum, Mirna; Drouot, Nathalie; Busso, Cleverson; Makri, Samira; Ali-Pacha, Lamia; Benhassine, Traki; Anheim, Mathieu; Lynch, David R.; Thibault, Christelle; Plewniak, Frédéric; Bianchetti, Laurent; Tranchant, Christine; Poch, Olivier; DiMauro, Salvatore; Mandel, Jean-Louis; Barros, Mario H.; Hirano, Michio; Koenig, Michel

    2008-01-01

    Muscle coenzyme Q10 (CoQ10 or ubiquinone) deficiency has been identified in more than 20 patients with presumed autosomal-recessive ataxia. However, mutations in genes required for CoQ10 biosynthetic pathway have been identified only in patients with infantile-onset multisystemic diseases or isolated nephropathy. Our SNP-based genome-wide scan in a large consanguineous family revealed a locus for autosomal-recessive ataxia at chromosome 1q41. The causative mutation is a homozygous splice-site mutation in the aarF-domain-containing kinase 3 gene (ADCK3). Five additional mutations in ADCK3 were found in three patients with sporadic ataxia, including one known to have CoQ10 deficiency in muscle. All of the patients have childhood-onset cerebellar ataxia with slow progression, and three of six have mildly elevated lactate levels. ADCK3 is a mitochondrial protein homologous to the yeast COQ8 and the bacterial UbiB proteins, which are required for CoQ biosynthesis. Three out of four patients tested showed a low endogenous pool of CoQ10 in their fibroblasts or lymphoblasts, and two out of three patients showed impaired ubiquinone synthesis, strongly suggesting that ADCK3 is also involved in CoQ10 biosynthesis. The deleterious nature of the three identified missense changes was confirmed by the introduction of them at the corresponding positions of the yeast COQ8 gene. Finally, a phylogenetic analysis shows that ADCK3 belongs to the family of atypical kinases, which includes phosphoinositide and choline kinases, suggesting that ADCK3 plays an indirect regulatory role in ubiquinone biosynthesis possibly as part of a feedback loop that regulates ATP production. PMID:18319074

  20. Effect of coenzyme Q10 alone and its combination with metformin on streptozotocin-nicotinamide-induced diabetic nephropathy in rats

    Directory of Open Access Journals (Sweden)

    Rajesh A Maheshwari

    2014-01-01

    Full Text Available Objectives: This study was aimed to investigate the therapeutic potential of coenzyme Q10 and its combination with metformin on streptozotocin (STZ-nicotinamide-induced diabetic nephropathy (DN. Materials and Methods: Type 2 diabetes in rats was induced with STZ-nicotinamide. The diabetic rats were treated with coenzyme Q10 (10 mg/kg, p.o. alone or coenzyme Q10 + metformin. Various parameters of renal function tests such as serum creatinine, urea, uric acid, and markers of oxidative stress such as renal malondialdehyde (MDA level, superoxide dismutase (SOD, and catalase (CAT activities were measured. Tumor necrosis factor-α (TNF-α, myeloperoxidase (MPO activity, transforming growth factor-β (TGF-β, and nitrite content were estimated in renal tissues. All treated animal were subjected to histopathological changes of kidney. Result: Diabetic rats showed a significant reduction in renal function, which was reflected with an increase in serum urea, serum creatinine, uric acid. In addition, STZ-nicotinamide caused renal tubular damage with a higher MDA level, depletion of SOD and CAT activity and glutathione (GSH level. Moreover, TNF-α, MPO activity, TGF-β, and nitrite content were significantly increased in diabetic rats, while treatment with coenzyme Q10 or metformin or their combination ameliorate STZ-nicotinamide induced renal damage due to improvement in renal function, oxidative stress, suppression of TNF-α, MPO activity, TGF-β and nitrite content along with histopathological changes. Conclusions: This finding suggests that the treatment with coenzyme Q10 or metformin showed significant renoprotective effect against STZ-nicotinamide-induced DN. However, concomitant administration of both showed a better renoprotective effect than coenzyme Q10 or metformin alone treatment.

  1. Coenzyme Q10 remarkably improves the bio-energetic function of rat liver mitochondria treated with statins.

    Science.gov (United States)

    Mohammadi-Bardbori, Afshin; Najibi, Asma; Amirzadegan, Najmeh; Gharibi, Raziyeh; Dashti, Ayat; Omidi, Mahmoud; Saeedi, Arastoo; Ghafarian-Bahreman, Ali; Niknahad, Hossein

    2015-09-05

    CoQ10 shares a biosynthetic pathway with cholesterol therefore it can be a potential target of the widely available lipid-lowering agents such as statins. Statins are the most widely prescribed cholesterol-lowering drugs with the ability to inhibit HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase. Preclinical and clinical safety data have shown that statins do not cause serious adverse effects in humans. However, their long-term administration is associated with a variety of myopatic complaints. The aim of this study was to investigate whether CoQ10 supplementation of animals under high fat diet (HFD) treated with statins is able to bypass the mitochondrial metabolic defects or not? Animals were divided into 7 groups and fed with either regular (RD) or HFD during experiments. The first group considered as regular control and fed with a RD. Groups 2-7 including HFD control, CoQ10 (10mg/kg), simvastatin (30mg/kg), atorvastatin (30mg/kg), simvastatin+CoQ10 or atorvastatin+CoQ10 treated orally for 30 days and fed with HFD. At the end of treatments, the animals were killed and blood samples were collected for biochemical examinations. The rat liver mitochondria were isolated and several mitochondrial indices including succinate dehydrogenase activity (SDA), ATP levels, mitochondrial membrane potential (MMP) and mitochondrial permeability transition pore (MPP) were determined. We found that triglyceride (Tg), cholesterol (Chol) and low-density lipoprotein (LDL) were augmented with HFD compared to RD and treatment with statins remarkably lowered the Tg, Chol and LDL levels. Mitochondrial parameters including, SDA, ATP levels, MMP and MPP were reduced with statin treatment and improved by co-administration with CoQ10.

  2. Thermal sensitivity analysis data utilizing Q10 scanning, Boltzmann slope factor and the change of molar heat capacity.

    Science.gov (United States)

    Kang, KyeongJin

    2016-03-01

    As a further elaboration of the recently devised Q10 scanning analysis ("Exceptionally high thermal sensitivity of rattlesnake TRPA1 correlates with peak current amplitude" [1]), the interval between current data points at two temperatures was shortened and the resulting parameters representing thermal sensitivities such as peak Q10s and temperature points of major thermosensitivity events are presented for two TRPA1 orthologues from rattlesnakes and boas. In addition, the slope factors from Boltzmann fitting and the change of molar heat capacity of temperature-evoked currents were evaluated and compared as alternative ways of thermal sensitivity appraisal of TRPA1 orthologues.

  3. Treatment of cyclic vomiting syndrome with co-enzyme Q10 and amitriptyline, a retrospective study

    Directory of Open Access Journals (Sweden)

    Preston Amy

    2010-01-01

    Full Text Available Abstract Background Cyclic vomiting syndrome (CVS, which is defined by recurrent stereotypical episodes of nausea and vomiting, is a relatively-common disabling condition that is associated with migraine headache and mitochondrial dysfunction. Co-enzyme Q10 (Co-Q is a nutritional supplement that has demonstrated efficacy in pediatric and adult migraine. It is increasingly used in CVS despite the complete lack of studies to demonstrate its value in treatment Methods Using an Internet-based survey filled out by subjects with CVS or their parents, the efficacy, tolerability and subject satisfaction in CVS prophylaxis were queried. Subjects taking Co-Q (22 subjects were compared against those taking amitriptyline (162 subjects, which is the general standard-of-care. Results Subjects/parents reported similar levels of efficacy for a variety of episode parameters (frequency, duration, number of emesis, nausea severity. There was a 50% reduction in at least one of those four parameters in 72% of subjects treated with amitriptyline and 68% of subjects treated Co-Q. However, while no side effects were reported on Co-Q, 50% of subjects on amitriptyline reported side effects (P = 5 × 10-7, resulting in 21% discontinuing treatment (P = 0.007. Subjects/parents considered the benefits to outweigh the risks of treatment in 47% of cases on amitriptyline and 77% of cases on Co-Q (P = 0.008. Conclusion Our data suggest that the natural food supplement Co-Q is potentially efficacious and tolerable in the treatment of CVS, and should be considered as an option in CVS prophylaxis. Our data would likely be helpful in the design of a double-blind clinical trial.

  4. 添加番茄红素、DHA、辅酶Q10的老年“护心”液态奶的研制%Study on the Elderly Milk by Using Lycopene, DHA and Coenzyme Q10

    Institute of Scientific and Technical Information of China (English)

    郭奇慧

    2015-01-01

    采用番茄红素、DHA、辅酶Q10等原辅料,制成老年“护心”液态奶,达到预防老年心脑血管疾病的特殊生理功效。通过单因素试验对不同影响因素进行了考察,运用正交试验找出最优液态奶配方,结果表明,最佳配方为:番茄红素添加量为6.5mg/kg,DHA添加量为300mg/kg,辅酶Q10添加量为110mg/kg。%By using lycopene, DHA and coenzyme Q10, a type of elderly milk is made to possess special efifciency such as heart disease and so on. We studied the different inlfuencing factors during the process through single factor tests, then the orthogonal experiments were used to ifnd the most suitable formula. The results indicated the optimal formula were: lycopene: 6.5mg/kg, DHA: 300mg/kg and coenzyme Q10:110mg/kg.

  5. Distributor– Retailer Interface in Pharmaceutical Supply Chain: Service Quality Measurement Scale

    Science.gov (United States)

    Mehralian, Gholamhossein; Babapour, Jafar; peiravian, farzad

    2016-01-01

    In the current competitive market, service quality management is the key to the survival and success of businesses. SERVQUAL is a popular service quality measurement scale (SQMS) that has served as a basis for subsequent research on service quality; it has been used for testing different aspects of service quality in a market. The purpose of our study is, therefore, to develop a service quality measurement scale (SQMS) for the distributor–retailer interface of Pharm supply chains (PSC) in Iran. A survey was performed to collect data from pharmacies located in Tehran. A valid and reliable questionnaire delivered to pharmacies, and 400 pharmacies were intended to participate in our survey. Confirmatory factor analysis (CFA) was used to develop an SQMS in this study. Sufficient sampling was undertaken to do CFA. Consistent with other service quality studies, this Res developed an SQMS with five dimensions and 20 items for PSC, and contributes to mangers to regularly measure service quality. This is an initial study to develop a framework for measuring service quality in Iranian PCS. The framework can be used effectively to achieve competitive advantage at the distributor–retailer interface. PMID:28243297

  6. Distributor- Retailer Interface in Pharmaceutical Supply Chain: Service Quality Measurement Scale.

    Science.gov (United States)

    Mehralian, Gholamhossein; Babapour, Jafar; Peiravian, Farzad

    2016-01-01

    In the current competitive market, service quality management is the key to the survival and success of businesses. SERVQUAL is a popular service quality measurement scale (SQMS) that has served as a basis for subsequent research on service quality; it has been used for testing different aspects of service quality in a market. The purpose of our study is, therefore, to develop a service quality measurement scale (SQMS) for the distributor-retailer interface of Pharm supply chains (PSC) in Iran. A survey was performed to collect data from pharmacies located in Tehran. A valid and reliable questionnaire delivered to pharmacies, and 400 pharmacies were intended to participate in our survey. Confirmatory factor analysis (CFA) was used to develop an SQMS in this study. Sufficient sampling was undertaken to do CFA. Consistent with other service quality studies, this Res developed an SQMS with five dimensions and 20 items for PSC, and contributes to mangers to regularly measure service quality. This is an initial study to develop a framework for measuring service quality in Iranian PCS. The framework can be used effectively to achieve competitive advantage at the distributor-retailer interface.

  7. 辅酶Q10与维生素E配伍的食用安全性探讨%The Edible Safety of Combined Use of Coenzyme Q10 and Vitamin E

    Institute of Scientific and Technical Information of China (English)

    李羽; 梁艺英; 冯晓文

    2012-01-01

    The stability and toxicity of the combined use of natural vitamin E and coenzyme Qi0 were investigated to confirm the safety of the use of the mixture of Coenzyme Qioand Vitamin E as a health food ingredient. Five different formulations containing natural vitamin E soft capsules and coenzyme Qio was analyzed by high-performance liquid chromatography and their toxicological safety was assessed. Results showed that, in various formulations, no significant changes were found in contents of coenzyme Qlo and a-tocopherol. No new peak was found when extending the detection time to 3 times of the retention time. The presence of excipients did not show any impact on its stability. No reaction of Coenzyme Qio and natural vitamin E was found in a 24-month period. Toxicological evaluation showed that the combination of natural vitamin E and coenzyme Q10 can be applied safely in food production.%考察辅酶Q10和天然维生素E在不同配方组成下的稳定性,并进行安全毒理学评价实验研究,说明辅酶Q10与维生素E配伍作为保健食品原料的食用安全性.采用高效液相色谱法,对经过加速破坏试验的五个不同配方的辅酶Q10天然维生素E软胶囊进行含量分析和安全性毒理学评价.在各个不同的配方中,未见辅酶Q10和小生育酚的量发生明显变化,含量测定结果均在测定的误差范围内,并且在保留时间的3倍延长时间内未发现有新的色谱峰产生,且辅料的存在亦未对其稳定性产生任何的影响.辅酶Q10与天然维生素E在24个月的有效期内长期混合不会发生化学反应.安全性毒理学评价实验结果表明辅酶Q10与天然维生素E配伍使用具有食用安全性.

  8. Quality by design approach of a pharmaceutical gel manufacturing process, part 1: determination of the design space.

    Science.gov (United States)

    Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalá, Manel

    2011-10-01

    This work was conducted in the framework of a quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles (QTPPs) from historical values for previously manufactured batches, as well as the critical quality attributes for the process (viscosity and pH), which were used to construct a D-optimal experimental design. The experimental design comprised 13 gel batches, three of which were replicates at the domain center intended to assess the reproducibility of the target process. The viscosity and pH models established exhibited very high linearity and negligible lack of fit (LOF). Thus, R(2) was 0.996 for viscosity and 0.975 for pH, and LOF was 0.53 for the former parameter and 0.84 for the latter. The process proved reproducible at the domain center. Water content and temperature were the most influential factors for viscosity, and water content and acid neutralized fraction were the most influential factors for pH. A desirability function was used to find the best compromise to optimize the QTPPs. The body of information was used to identify and define the design space for the process. A model capable of combining the two response variables into a single one was constructed to facilitate monitoring of the process.

  9. Quality Culture Survey Report.

    Science.gov (United States)

    Patel, Pritesh; Baker, Denyse; Burdick, Rick; Chen, Cylia; Hill, Jonathon; Holland, Morgan; Sawant, Anil

    2015-01-01

    The Parenteral Drug Association conducted an anonymous global survey of quality culture in the pharmaceutical industry to determine whether there is a relationship between certain quality behaviors and certain quality attributes, and whether these quality attributes could be used as surrogates (or proxy variables) to assess quality culture. Other studies have shown that an unhealthy quality culture is a root cause of many quality or compliance issues seen by sites and organizations. Statistical analysis of survey data suggests that certain attributes are driving good behaviors, and the demographic data suggests that this relationship holds irrespective of the geographic location of the site. Executive survey respondents had a more optimistic view of the current state of quality culture than survey respondents at large, with cross-functional vision showing the biggest gap (P-value = 0.07, F-Test). The top five quality attributes that can serve as surrogates for quality culture were (1) Management communication that quality is everyone's responsibility, (2) Site has formal quality improvement objectives and targets, (3) Clear performance criteria for feedback and coaching, (4) Quality topics included in at least half of all-hands meetings, and (5) Collecting error prevention metrics. These identified mature quality attributes are related to management responsibility, and continual improvement of the pharmaceutical quality system sections of ICH Q10, and therefore may be amenable to be incorporated in audit programs or in regulatory inspections. Additional research and discussion is required to build a coherent approach, which the pharmaceutical industry and regulators can adopt. © PDA, Inc. 2015.

  10. Validation Study and Quality Assurance of Pharmaceutical Water, Waterborne Microorganisms and Endotoxins.

    Science.gov (United States)

    Shintani, Hideharu

    2016-01-01

     Water for injection (WFI) and purified water are the most widely used and stringently regulated raw material in pharmaceutical manufacturing. WFI is utilized for a parenteral drug product. Water system is monitored at frequent and routine frequency for demonstrating the overall system control and stability of performance. The critical ports demonstrating systemic control should be monitored more frequently. For reducing the overall risk of microbial contamination or microbial build-up, it is important to develop appropriate alert and action levels. The assignment of alert and action levels should be performance-based, derived from the historic data and well below water specifications. These levels and overall excursion rates should be assessed annually. An action level should not be established at a level equivalent to the specification. Consecutive or multiple alert level excursions and each action level excursion should be comprehensively investigated with appropriate corrective and preventive action. It is important to analyze the efficacy of the corrective and preventive action to reduce the overall excursion rates.

  11. Water-Quality Data for Pharmaceuticals and Other Organic Wastewater Contaminants in Ground Water and in Untreated Drinking Water Sources in the United States, 2000-01

    Science.gov (United States)

    Barnes, Kimberlee K.; Kolpin, Dana W.; Focazio, Michael J.; Furlong, Edward T.; Meyer, Michael T.; Zaugg, Steven D.; Haack, Sheridan K.; Barber, Larry B.; Thurman, E. Michael

    2008-01-01

    This report presents water-quality data from two nationwide studies on the occurrence and distribution of organic wastewater contaminants. These data are part of the continuing effort of the U.S. Geological Survey Toxic Substances Hydrology Program to collect baseline information on the environmental occurrence of pharmaceuticals and other organic wastewater contaminants.

  12. Lithium carbonate and coenzyme Q10 reduce cell death in a cell model of Machado-Joseph disease

    Directory of Open Access Journals (Sweden)

    C.M. Lopes-Ramos

    Full Text Available Machado-Joseph disease (MJD or spinocerebellar ataxia type 3 (SCA3 is an autosomal dominant neurodegenerative disorder caused by expansion of the polyglutamine domain of the ataxin-3 (ATX3 protein. MJD/SCA3 is the most frequent autosomal dominant ataxia in many countries. The mechanism underlying MJD/SCA3 is thought to be mainly related to protein misfolding and aggregation leading to neuronal dysfunction followed by cell death. Currently, there are no effective treatments for patients with MJD/SCA3. Here, we report on the potential use of lithium carbonate and coenzyme Q10 to reduce cell death caused by the expanded ATX3 in cell culture. Cell viability and apoptosis were evaluated by MTT assay and by flow cytometry after staining with annexin V-FITC/propidium iodide. Treatment with lithium carbonate and coenzyme Q10 led to a significant increase in viability of cells expressing expanded ATX3 (Q84. In addition, we found that the increase in cell viability resulted from a significant reduction in the proportion of apoptotic cells. Furthermore, there was a significant change in the expanded ATX3 monomer/aggregate ratio after lithium carbonate and coenzyme Q10 treatment, with an increase in the monomer fraction and decrease in aggregates. The safety and tolerance of both drugs are well established; thus, our results indicate that lithium carbonate and coenzyme Q10 are good candidates for further in vivo therapeutic trials.

  13. Amelioratory effect of coenzyme Q10 on potential human carcinogen Microcystin-LR induced toxicity in mice.

    Science.gov (United States)

    Lone, Yaqoob; Bhide, Mangla; Koiri, Raj Kumar

    2017-04-01

    Microcystins are a group of cyclic heptapeptide toxins produced by cyanobacteria. More than 100 microcystin analogues have been detected, among which microcystin-LR is the most abundant and toxic variant. Present study was designed to reveal whether potential human carcinogen microcystin-LR could imbalance the glycolytic-oxidative-nitrosative status of heart, kidney and spleen of mice and also to explore the amelioratory effect of coenzyme Q10 on microcystin-LR induced toxicity. Microcystin-LR was administered at a dose of 10 μg/kg bw/day, ip for 14 days in male mice. In microcystin-LR treated mice as compared to control, significant increase in the level of lipid peroxidation, hydrogen peroxide, lactate dehydrogenase, nitric oxide with a concomitant decrease in the level of glutathione was observed, suggesting microcystin-LR induced toxicity via induction of oxidative-nitrosative-glycolytic pathway. Although several studies have evaluated numerous antioxidants but still there is no effective chemoprotectant against microcystin-LR induced toxicity. When microcystin-LR treated mice were co-administered coenzyme Q10 (10 mg/kg bw/day, im) for 14 days, it was observed that coenzyme Q10 ameliorates microcystin-LR induced toxicity via modulation of glycolytic-oxidative-nitrosative stress pathway. Thus, the results suggest that coenzyme Q10 has a potential to be developed as preventive agent against microcystin-LR induced toxicity.

  14. Carcass Traits and Immune Response of Broiler Chickens Fed Dietary L-Carnitine, Coenzyme Q10 and Ractopamine

    Directory of Open Access Journals (Sweden)

    H Asadi

    Full Text Available ABSTRACT This study was conducted to evaluate the effects of coenzyme Q10, L-carnitine and ractopamine supplementation, alone and in combinations, on carcass traits and immune response of broiler chickens. Five hundred and twelve one-day-old Ross 308 male broiler chickens were randomly allocated into eight treatments with four replicates each. A 2×2×2 factorial arrangement was applied, with two levels of coenzyme Q10 (0 and 40 mg/kg, two levels of L-carnitine (0 and 200 mg/kg and two levels of ractopamine (0 and 10 mg/kg. The birds were reared until day 42 of age under standard conditions. Blood samples were collected at the end of grower and finisher periods from the wing vein. Four birds per group were sacrificed at day 42 of age. Except for carcass yield, other carcass traits were not significantly affected (p>0.05 by different levels of coenzyme Q10, L-carnitine, or ractopamine. Immune response parameters were significantly (p<0.05 different between the treatments. The lowest antibody titers against Newcastle disease virus and relative spleen weight were observed in control group. The results of this study suggest that addition of coenzyme Q10 and L-carnitine to broiler diets has benefit effect on immune response of broiler chickens.

  15. Addition of omega-3 fatty acid and coenzyme Q10 to statin therapy in patients with combined dyslipidemia.

    Science.gov (United States)

    Tóth, Štefan; Šajty, Matej; Pekárová, Tímea; Mughees, Adil; Štefanič, Peter; Katz, Matan; Spišáková, Katarína; Pella, Jozef; Pella, Daniel

    2017-07-26

    Statins represent a group of drugs that are currently indicated in the primary and secondary prevention of cardiovascular events. Their administration can be associated with side effects and the insufficient reduction of triacylglyceride (TAG) levels. This study aimed to assess the effect of the triple combination of statins with omega-3 fatty acids and coenzyme Q10 (CoQ10) on parameters associated with atherogenesis and statin side effects. In this pilot randomized double-blind trial, 105 subjects who met the criteria of combined dislipidemia and elevated TAG levels were randomly divided into three groups. In the control group, unaltered statin therapy was indicated. In the second and third groups, omega-3 PUFA 2.52 g/day (Zennix fa Pleuran) and omega-3 PUFA 2.52 g+CoQ10 200 mg/day (Pharma Nord ApS) were added, res//. At the end of the 3-month period (±1 week), all patients were evaluated. Significant reduction of hepatic enzymes activity, systolic blood preasure, inflammatory markers and TAG levels were detected in both groups in comparison to the control group. Activity of SOD and GPx increased significantly after additive therapy. Coenzyme Q10 addition significantly reduced most of the abovementioned parameters (systolic blood preasure, total cholesterol, LDL, hsCRP, IL-6, SOD) in comparison with the statin+omega-3 PUFA group. The intensity of statin adverse effects were significantly reduced in the group with the addition of CoQ10. The results of this pilot study suggest the possible beneficial effects of triple combination on the lipid and non-lipid parameters related to atherogenesis and side effects of statin treatment.

  16. Increased oxidative stress and coenzyme Q10 deficiency in juvenile fibromyalgia: amelioration of hypercholesterolemia and fatigue by ubiquinol-10 supplementation.

    Science.gov (United States)

    Miyamae, Takako; Seki, Manabu; Naga, Tomoko; Uchino, Shinya; Asazuma, Haruki; Yoshida, Takuma; Iizuka, Yuki; Kikuchi, Masako; Imagawa, Tomoyuki; Natsumeda, Yutaka; Yokota, Shumpei; Yamamoto, Yorihiro

    2013-01-01

    Fibromyalgia (FM) is characterized by generalized pain and chronic fatigue of unknown etiology. To evaluate the role of oxidative stress in this disorder, we measured plasma levels of ubiquinone-10, ubiquinol-10, free cholesterol (FC), cholesterol esters (CE), and free fatty acids (FFA) in patients with juvenile FM (n=10) and in healthy control subjects (n=67). Levels of FC and CE were significantly increased in juvenile FM as compared with controls, suggesting the presence of hypercholesterolemia in this disease. However, plasma level of ubiquinol-10 was significantly decreased and the ratio of ubiquinone-10 to total coenzyme Q10 (%CoQ10) was significantly increased in juvenile FM relative to healthy controls, suggesting that FM is associated with coenzyme Q10 deficiency and increased oxidative stress. Moreover, plasma level of FFA was significantly higher and the content of polyunsaturated fatty acids (PUFA) in total FFA was significantly lower in FM than in controls, suggesting increased tissue oxidative damage in juvenile FM. Interestingly, the content of monoenoic acids, such as oleic and palmitoleic acids, was significantly increased in FM relative to controls, probably to compensate for the loss of PUFA. Next, we examined the effect of ubiquinol-10 supplementation (100 mg/day for 12 weeks) in FM patients. This resulted in an increase in coenzyme Q10 levels and a decrease in %CoQ10. No changes were observed in FFA levels or their composition. However, plasma levels of FC and CE significantly decreased and the ratio of FC to CE also significantly decreased, suggesting that ubiquinol-10 supplementation improved cholesterol metabolism. Ubiquinol-10 supplementation also improved chronic fatigue scores as measured by the Chalder Fatigue Scale.

  17. Protective Effects of Coenzyme Q10 Against Hydrogen Peroxide-Induced Oxidative Stress in PC12 Cell: The Role of Nrf2 and Antioxidant Enzymes.

    Science.gov (United States)

    Li, Li; Du, Jikun; Lian, Yaru; Zhang, Yun; Li, Xingren; Liu, Ying; Zou, Liyi; Wu, Tie

    2016-01-01

    Oxidative stress is a major component of harmful cascades activated in neurodegenerative disorders. Coenzyme Q10 (CoQ10), an essential component in the mitochondrial respiratory chain, has recently gained attention for its potential role in the treatment of neurodegenerative disease. Here, we investigated the possible protective effects of CoQ10 on H2O2-induced neurotoxicity in PC12 cells and the underlying mechanism. CoQ10 showed high free radical-scavenging activity as measured by a DPPH and TEAC. Pre-treatment of cells with CoQ10 diminished intracellular generation of ROS in response to H2O2. H2O2 decreased viability of PC12 cells which was reversed by pretreatment with CoQ10 according to MTT assay. H2O2-induced lipid peroxidation was attenuated by CoQ10 as shown by inhibition of MDA formation. Furthermore, pre-incubation of the cells with CoQ10 also restored the activity of cellular antioxidant enzymes which had been altered by H2O2. Moreover, CoQ10 induced Nrf2 nuclear translocation, the upstream of antioxidant enzymes. These findings suggest CoQ10 augments cellular antioxidant defense capacity through both intrinsic free radical-scavenging activity and activation of Nrf2 and subsequently antioxidant enzymes induction, thereby protecting the PC12 cells from H2O2-induced oxidative cytotoxicity.

  18. Competition in the pharmaceutical industry: how do quality differences shape advertising strategies?

    Science.gov (United States)

    de Frutos, Maria-Angeles; Ornaghi, Carmine; Siotis, Georges

    2013-01-01

    We present a Hotelling model of price and advertising competition between prescription drugs that differ in quality/side effects. Promotional effort results in the endogenous formation of two consumer groups: brand loyal and non-brand loyal ones. We show that advertising intensities are strategic substitutes, with the better quality drugs being the ones that are most advertised. This positive association stems from the higher rents that firms can extract from consumers whose brand loyalty is endogenously determined by promotional effort. The model's main results on advertising and pricing strategies are taken to the data. The latter consists of product level data on prices and quantities, product level advertising data, as well as the qualitative information on drug quality contained in the Orange Book compiled by the Food and Drug Administration (FDA). The empirical results provide strong support to the model's predictions.

  19. 碱皂化法提取麸皮中辅酶Q10的工艺研究%Extraction of Wheat Bran in the Alkaline Saponification of Coenzyme Q 10

    Institute of Scientific and Technical Information of China (English)

    王丽霞; 何扩; 史忠林

    2014-01-01

    In this experiment, the author extracted and separated coenzyme Q10from wheat skin using the method of alkaline saponification,and determined by UV.The results showed that the best conditions for alkali saponification:pH 11, ratio of material to liquor 1∶12(g/mL), reflux temperature 90℃, saponification time of 90 min.%以麸皮为原料,利用碱皂化法提取辅酶Q 10,紫外分光光度法测定含量。试验结果表明:最佳碱皂化处理条件为:pH为11,料液比1∶12(g/mL),皂化温度为90℃,皂化时间为90 min。

  20. An improvement of separation and response applying post-column compensation and one-step acetone protein precipitation for the determination of coenzyme Q10 in rat plasma by SFC-MS/MS.

    Science.gov (United States)

    Yang, Rujie; Li, Yingchao; Liu, Cuiru; Xu, Youjun; Zhao, Longshan; Zhang, Tianhong

    2016-09-15

    Coenzyme Q10 (CoQ10) solid dispersion was prepared to improve its oral bioavailability due to the poor solubility of CoQ10. To evaluate the pharmacokinetic behaviors of CoQ10 solid dispersion, a simple, rapid, sensitive and environment friendly method for the determination of CoQ10 in rat plasma was developed. In this study, samples were prepared by one-step protein precipitation with acetone and then the supercritical fluid chromatography-electrospray ionization tandem mass spectrometry (SFC-ESI-MS/MS) method was used. The separation was achieved by an ACQUITY UPC(2)™ BEH 2-EP column (100mm×3mm, 1.7μm) maintained at 35°C, using carbon dioxide (≥99.99%) and methanol (85:15, v/v) as the mobile phase at a flow rate of 1.0ml/min. To improve the response and sensitivity, the compensation solvent of methanol with 2mM ammonium acetate at a flow rate of 0.2ml/min was used and the total analysis time was only 1.5min for each sample. The detection was carried out on a tandem mass spectrometer with electrospray ionization (ESI) source and the mass transition ion pair was m/z 881.0→197.0 and 285.1→193.0 for CoQ10 and diazepam, internal standard (IS), respectively. Calibration curve was linear over the concentration range of 2.00-500.00ng/ml (r(2)≥0.998) with a lower limit of quantification of 2.00ng/ml. The intra- and inter-day accuracy and precision were below 15% for all quality control samples. The proposed method was rapid, accurate and reproducible, which was suitable to compare the pharmacokinetic behaviors in rats after a single oral dose of 100mg/kg CoQ10 solid dispersion or tablets.

  1. Treatment of CoQ(10 deficient fibroblasts with ubiquinone, CoQ analogs, and vitamin C: time- and compound-dependent effects.

    Directory of Open Access Journals (Sweden)

    Luis C López

    Full Text Available BACKGROUND: Coenzyme Q(10 (CoQ(10 and its analogs are used therapeutically by virtue of their functions as electron carriers, antioxidant compounds, or both. However, published studies suggest that different ubiquinone analogs may produce divergent effects on oxidative phosphorylation and oxidative stress. METHODOLOGY/PRINCIPAL FINDINGS: To test these concepts, we have evaluated the effects of CoQ(10, coenzyme Q(2 (CoQ(2, idebenone, and vitamin C on bioenergetics and oxidative stress in human skin fibroblasts with primary CoQ(10 deficiency. A final concentration of 5 microM of each compound was chosen to approximate the plasma concentration of CoQ(10 of patients treated with oral ubiquinone. CoQ(10 supplementation for one week but not for 24 hours doubled ATP levels and ATP/ADP ratio in CoQ(10 deficient fibroblasts therein normalizing the bioenergetics status of the cells. Other compounds did not affect cellular bioenergetics. In COQ2 mutant fibroblasts, increased superoxide anion production and oxidative stress-induced cell death were normalized by all supplements. CONCLUSIONS/SIGNIFICANCE: THESE RESULTS INDICATE THAT: 1 pharmacokinetics of CoQ(10 in reaching the mitochondrial respiratory chain is delayed; 2 short-tail ubiquinone analogs cannot replace CoQ(10 in the mitochondrial respiratory chain under conditions of CoQ(10 deficiency; and 3 oxidative stress and cell death can be counteracted by administration of lipophilic or hydrophilic antioxidants. The results of our in vitro experiments suggest that primary CoQ(10 deficiencies should be treated with CoQ(10 supplementation but not with short-tail ubiquinone analogs, such as idebenone or CoQ(2. Complementary administration of antioxidants with high bioavailability should be considered if oxidative stress is present.

  2. [Quality analysis of Guizhi Fuling capsule before and after application of in-process quality control in pharmaceutical production].

    Science.gov (United States)

    Li, Jia-chun; Wang, Jin-ling; Wu, Jing-ling; Huang, Wen-zhe; Wang, Zhen-zhong; Xiao, Wei

    2015-03-01

    The effects of application of in-process quality control in Guizhi Fuling capsule production were evaluated by 192 batches data analysis. Using a statistical analysis method, each batch of data were to be counted to research for the difference between 96 samples adopting the technologies of in-process control or not. According to quality standards of Guizhi Fuling capsule, all measurements of the 192 batches of the drugs before and after the application of process control technology were analyzed, and they were within the rules. There was a significant difference between adopting the technologies of process control or not. Application of in-process control technology can improve the uniformity of lot-to-lot for Guizhi Fuling capsule.

  3. Determination of Coenzyme Q10 Content in Raw Materials and Dietary Supplements by High-Performance Liquid Chromatography-UV: Collaborative Study

    Science.gov (United States)

    Lunetta, Steven; Roman, Mark

    2008-01-01

    An international collaborative study was conducted of a high-performance liquid chromatographic (HPLC)-UV method for the determination of coenzyme Q10 (CoQ10, ubidecarenone) in raw materials and dietary supplements. Ten collaborating laboratories determined the total CoQ10 content in 8 blind duplicate samples. Sample materials included CoQ10 raw material and 4 finished product dietary supplements representing softgels, hardshell gelatin capsules, and chewable wafers. In addition, collaborating laboratories received a negative control and negative control spiked with CoQ10 at low and high levels to determine recovery. Materials were extracted with an acetonitrile–tetrahydrofuran–water mixture. Ferric chloride was added to the test solutions to ensure all CoQ10 was in the oxidized form. The HPLC analyses were performed on a C18 column using UV detection at 275 nm. Repeatability relative standard deviations (RSDr) ranged from 0.94 to 5.05%. Reproducibility relative standard deviations (RSDR) ranged from 3.08 to 17.1%, with HorRat values ranging from 1.26 to 5.17. Recoveries ranged from 74.0 to 115%. Based on these results, the method is recommended for Official First Action for determination of CoQ10 in raw materials and dietary supplement finished products containing CoQ10 at a concentration of >100 mg CoQ10/g test material. PMID:18727527

  4. The location of coenzyme Q10 in phospholipid membranes made of POPE: a small-angle synchrotron X-ray diffraction study.

    Science.gov (United States)

    Wollstein, Christoph; Winterhalter, Mathias; Funari, Sérgio S

    2015-07-01

    The location of coenzyme Q10 (Q10) inside the inner mitochondrial membrane is a topic of research aiming at a deeper understanding of the function of the mitochondrial respiratory chain. We investigated the location of Q10 inside model membranes made of 1-palmitoyl-2-oleoyl-phosphatidylethanolamine by means of small-angle synchrotron X-ray diffraction. Q10, which stands for ubiquinone-10 (UQ) or ubihydroquinone-10 (UH), did not remarkably influence the main phase transition temperature, but significantly decreased the lamellar-inverse hexagonal phase transition temperature (T(h)). The effect of UH on T(h) was stronger than the effect of UQ and the effect of liquid Q10 on T(h) was stronger than the effect of crystalline Q10. In the presence of Q10, the lattice parameters of the lamellar phases remained unchanged, whereas the H II lattice parameter was clearly influenced: While UQ had an increasing effect, UH had a decreasing effect. Furthermore, Q10 prevented the formation of cubic phases. The results give new evidence that the headgroup of Q10 is distant from the center of the membrane, which might be important for the function of the mitochondrial respiratory chain.

  5. Coenzyme Q10 effect in prevention of atrial fibrillation after Coronary Artery Bypass Graft: double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Jalal Moludi

    2015-05-01

    Results: Thirty-eight women and forty-two men with a mean age of 58.37±7.98 years were enrolled in the study in two CoQ10 and placebo groups (each consisting of 40 patients. The incidence of postoperative AF was 45% in the control group to 20% in the intervention group decreased after supplementation (P=0.030. ICU stay and length of in-hospital stay did not significant. The incidence of arrhythmias ventricular tachycardia (VT and VF in this period was not significant (P=0.865. Conclusion: Q10 supplements have low side effects. Due to the reduction in the incidence of AF in patients after, CABG, these supplements can be recommended for the prevention of AF.

  6. Calidad en los Servicios Farmacéuticos Hospitalarios Quality of the pharmaceutical service at hospital

    Directory of Open Access Journals (Sweden)

    María de las Mercedes Cuba Venereo

    2008-12-01

    Full Text Available La calidad es un concepto clave hoy día para los servicios sanitarios. Ella es considerada una variable esencial por la mayoría de las organizaciones. No es posible hablar de buena gestión en un centro o servicio sanitario, si no se incorpora un sistema de mejora continua de la calidad, ya que hay suficiente evidencia para afirmar que dichos programas son un instrumento para elevar la eficiencia clínica y económica. Esto ha provocado una larga carrera hacia la acreditación y evaluación externa por entidades que puedan dar fe del nivel de calidad alcanzado por la organización. Es por ello que lograr un sistema de acreditación de farmacias hospitalarias, con fines no solo evaluativos sino de crecimiento y desarrollo, sería una respuesta a esta necesidad. Cabe señalar la importancia de que dicho programa se ajuste a la realidad existente en Cuba y se pueda adaptar dinámicamente a las diferentes situaciones que se presentarán.Quality is a key concept for health services today and considered as a fundamental variable for most of the organizations. It is impossible to speak about good management in a health care service or center if a permanent quality improvement system is not involved since enough evidence indicates that such programs are tools for higher clinical and economic efficiency. The aforementioned has brought about a long run for accreditation and external evaluation by agencies that are able to endorse the quality level attained by the organization in question. This is why implementing an accreditation system for hospital pharmacies, not only for evaluation but for growth and development, would be an appropriate response to this requirement. There should be pointed out the importance of adapting this program to the existing realities of Cuba and of adjusting it in a dynamic way to the many situations that may come up.

  7. [Generic drugs: we must cut pharmaceutical spending but undertaking drug quality].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2012-02-01

    The World Health Organization and all drug regulatory agencies (DRA) support the commercialization of generic medicines because they control costs and are irreplaceable therapeutic options in countries lacking the innovator product. Generic drugs are widely considered to be cost-efficient substitutes for brand-name medications. They make up about 20% of the total number of prescriptions in Spain, a figure that is still far from the use of generic drugs in USA and other European countries. Despite economical interest in this issue, in this article we review the interest of generic drugs from a pharmacological and clinical perspective that must undertake drug quality to ensure drug efficacy and safety of the patients. A generic drug (generic drugs, short: generics) is defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use". Both the reference drug and the generic drug have to demonstrate previously they are therapeutically equivalent. With the exception of parenteral drugs, two products have demonstrated to be therapeutically equivalent if after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from bioequivalence studies in terms of comparison of appropriate pharmacokinetic parameters and bioavailability. Parenteral formulations, however, are not required to demonstrate therapeutic equivalence because it may be considered self-evident. Such assumptions have never been challenged, but there are reasons to do so for parenteral antimicrobials. It is interesting to highlight that although brand-name drugs and generic drugs are both approved by DRA and may be interchangeable with respect to their clinical effects, they can differ substantially in their appearance. Consumers of brand-name medications receive identical-appearing batches of pills with

  8. 药品招标采购活动中相关质量术语解读%Interpretation of the Quality Related Terminology in Pharmaceutical Bidding Activities

    Institute of Scientific and Technical Information of China (English)

    王爱杰; 付加雷

    2013-01-01

    Objective: To conduct a monographic study and analysis on the issues of varied interpretations of the related terminology of drug quality in the pharmaceutical bidding schemes of various provinces and cities . Methods:The drug-related quality terminology used in each provincial pharmaceutical bidding scheme was summarized and ana-lyzed . Results:The new interpretations of the quality terms were worked out with more scientific explanations and sug-gestions as well . Conclusion: The standardization and unification of quality related terminology are not only conducive to the country ’ s pharmaceutical bidding activities , but also benefit to the level classification of pharmaceutical quality .%目的:针对目前各省市药品招标采购方案中药品相关的质量术语的解释存在不同的问题,进行专题研究和分析。方法:对各省药品招标采购方案中药品相关的质量术语进行总结、归纳与分析。结果:对各术语进行了新的解读,并给出了更为科学的解释和建议。结论:各个质量术语的规范与统一,不仅有利于全国的药品招标采购活动,更有利于药品的质量层次划分。

  9. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    Science.gov (United States)

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  10. A new definition of pharmaceutical quality: assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance.

    Science.gov (United States)

    Short, Steven M; Cogdill, Robert P; D'Amico, Frank; Drennen, James K; Anderson, Carl A

    2010-12-01

    The absence of a unanimous, industry-specific definition of quality is, to a certain degree, impeding the progress of ongoing efforts to "modernize" the pharmaceutical industry. This work was predicated on requests by Dr. Woodcock (FDA) to re-define pharmaceutical quality in terms of risk by linking production characteristics to clinical attributes. A risk simulation platform that integrates population statistics, drug delivery system characteristics, dosing guidelines, patient compliance estimates, production metrics, and pharmacokinetic, pharmacodynamic, and in vitro-in vivo correlation models to investigate the impact of manufacturing variability on clinical performance of a model extended-release theophylline solid oral dosage system was developed. Manufacturing was characterized by inter- and intra-batch content uniformity and dissolution variability metrics, while clinical performance was described by a probabilistic pharmacodynamic model that expressed the probability of inefficacy and toxicity as a function of plasma concentrations. Least-squares regression revealed that both patient compliance variables, percent of doses taken and dosing time variability, significantly impacted efficacy and toxicity. Additionally, intra-batch content uniformity variability elicited a significant change in risk scores for the two adverse events and, therefore, was identified as a critical quality attribute. The proposed methodology demonstrates that pharmaceutical quality can be recast to explicitly reflect clinical performance.

  11. Pharmaceutical policy in China.

    Science.gov (United States)

    Sun, Qiang; Santoro, Michael A; Meng, Qingyue; Liu, Caitlin; Eggleston, Karen

    2008-01-01

    Contradictory goals plague China's pharmaceutical policy. The government wants to develop the domestic pharmaceutical industry and has used drug pricing to cross-subsidize public hospitals. Yet the government also aims to control drug spending through price caps and profit-margin regulations to guarantee access even for poor patients. The resulting system has distorted market incentives, increased consumers' costs, and financially rewarded inappropriate prescribing, thus undermining public health. Pharmaceuticals account for about half of total health spending in China, representing 43 percent of spending per inpatient episode and 51 percent of spending per outpatient visit. Yet some essential medicines are unavailable or of questionable quality.

  12. Using the Q10 model to simulate E. coli survival in cowpats on grazing lands

    Science.gov (United States)

    Microbiological quality of surface waters can be affected by microbial load in runoff from grazing lands. This effect, with other factors, depends on the survival of microorganisms in animal waste deposited on pastures. Since temperature is a leading environmental parameter affec...

  13. Using the Q10 model to simulate the E. coli survival in cowpats on grazing lands

    Science.gov (United States)

    Microbiological quality of surface water sources can be affected by microbial load in runoff from grazing lands. This effect depends, among other factors, on survival of microorganisms in animal waste deposited at pastures. Temperature is one of leading environmental parameters affecting the surviva...

  14. Coenzyme Q10 Inhibits the Aging of Mesenchymal Stem Cells Induced by D-Galactose through Akt/mTOR Signaling

    Directory of Open Access Journals (Sweden)

    Dayong Zhang

    2015-01-01

    Full Text Available Increasing evidences indicate that reactive oxygen species are the main factor promoting stem cell aging. Recent studies have demonstrated that coenzyme Q10 (CoQ10 plays a positive role in organ and cellular aging. However, the potential for CoQ10 to protect stem cell aging has not been fully evaluated, and the mechanisms of cell senescence inhibited by CoQ10 are still poorly understood. Our previous study had indicated that D-galactose (D-gal can remarkably induce mesenchymal stem cell (MSC aging through promoting intracellular ROS generation. In this study, we showed that CoQ10 could significantly inhibit MSC aging induced by D-gal. Moreover, in the CoQ10 group, the expression of p-Akt and p-mTOR was clearly reduced compared with that in the D-gal group. However, after Akt activating by CA-Akt plasmid, the senescence-cell number in the CoQ10 group was significantly higher than that in the control group. These results indicated that CoQ10 could inhibit D-gal-induced MSC aging through the Akt/mTOR signaling.

  15. The effect of dietary intake of coenzyme Q10 on skin parameters and condition: Results of a randomised, placebo-controlled, double-blind study.

    Science.gov (United States)

    Žmitek, Katja; Pogačnik, Tina; Mervic, Liljana; Žmitek, Janko; Pravst, Igor

    2017-01-02

    Coenzyme Q10 (CoQ10) is a natural constituent of foods and is also often used in both functional foods and supplements. In addition, it is a common ingredient of cosmetics where it is believed to reduce the signs of skin ageing. However, the existing data about the effect of dietary intake of CoQ10 on skin parameters and condition are scarce. To gain an insight into this issue, we conducted a double-blind, placebo-controlled experiment with 33 healthy subjects. Our objective was to investigate the effects of 12 weeks of daily supplementation with 50 and 150 mg of CoQ10 on skin parameters and condition. Study was conducted with a water-soluble form of CoQ10 with superior bioavailability (Q10Vital(®) ). While the results of some previous in vitro studies showed possible protection in UVB response, we did not observe significant changes in the minimal erythema dose (MED). On the other hand, the intake of CoQ10 limited seasonal deterioration of viscoelasticity and reduced some visible signs of ageing. We determined significantly reduced wrinkles and microrelief lines, and improved skin smoothness. Supplementation with CoQ10 did not significantly affect skin hydration and dermis thickness. © 2016 BioFactors, 43(1):132-140, 2017.

  16. Combination of coenzyme Q10 with methotrexate suppresses Freund's complete adjuvant-induced synovial inflammation with reduced hepatotoxicity in rats: Effect on oxidative stress and inflammation.

    Science.gov (United States)

    Tawfik, Mona K

    2015-01-01

    Methotrexate (MTX) is a cornerstone disease modifying anti-rheumatic drug. One of its major drawbacks is hepatotoxicity, resulting in poor compliance of therapy. Coenzyme Q10 (CoQ10) is an antioxidant and anti-inflammatory compound, possessing both anti-arthritic and hepatoprotective potential. The present study was carried out to evaluate the effect of CoQ10 (10mg/kg) alone and in combination with MTX (2mg/kg) on the progression of adjuvant-induced arthritis in rats, and to elucidate the potential properties of CoQ10 in ameliorating MTX-induced liver damage in rats. Rats were assigned to; normal, arthritic, MTX treated, CoQ10 treated or a combination of MTX and CoQ10. CoQ10 administration potentiated the antiarthritic effect of MTX. Moreover, the combination therapy was effective in attenuating the severity of MTX-induced liver damage displayed by the improvement in hepatospecific serum markers and confirmed by the histo-pathological evaluation. Additionally, it attenuated the hepatic oxidative stress and the intensity of inflammatory mediators associated with MTX administration as evident by the regulation of oxidant/anti-oxidant balance and the inhibitory effects on TNF-α and IL-6 levels. These results revealed that CoQ10 can serve as a useful adjuvant and promote the safe use of MTX in the management of arthritis, not only by potentiating the antiarthritic effect of MTX, but also by alleviating MTX-induced hepatocellular injury.

  17. Effects of Oral, Vaginal, and Transdermal Hormonal Contraception on Serum Levels of Coenzyme Q10, Vitamin E, and Total Antioxidant Activity

    Directory of Open Access Journals (Sweden)

    Prabhudas R. Palan

    2010-01-01

    coenzyme Q10 levels compared with normal subjects. Serum TAOC levels were significantly lower (P<.05 among the contraceptive user groups. Alterations in coenzyme Q10 and α-tocopherol induced by hormonal contraception and the potential effect(s of exogenous ovarian hormones should be taken into consideration in future antioxidant research.

  18. 31 CFR 30.10 - Q-10: What actions are necessary for a TARP recipient to comply with section 111(b)(3)(D) of EESA...

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Q-10: What actions are necessary for....10 Section 30.10 Money and Finance: Treasury Office of the Secretary of the Treasury TARP STANDARDS FOR COMPENSATION AND CORPORATE GOVERNANCE § 30.10 Q-10: What actions are necessary for a TARP...

  19. 土壤异养呼吸温度敏感性(Q10)的影响因子

    Institute of Scientific and Technical Information of China (English)

    盛浩; 杨玉盛; 陈光水; 高人; 曾宏达; 杜紫贤; 张静

    2006-01-01

    首先对国内外土壤异养呼吸Q10的研究成果进行了全面的综合述评.影响土壤异养呼吸Q10的因子主要包括环境因子(主要是温度和湿度)、呼吸底物和土壤生物等.较多的研究表明土壤异养呼吸的Q10在低温时较高,高温时较低,但Q10也可随温度升高而增加,或随温度变化而保持稳定;通常土壤异养呼吸的Q10与土壤水分成正相关,但极端水分条件下(干旱胁迫或渍水)Q10较低;有限的研究表明呼吸底物和土壤生物对土壤异养呼吸Q10的影响还具有很大的不确定性;调控土壤异养呼吸Q10的机理目前还不清楚.然后从温度、水分、呼吸底物、土壤微生物对土壤异养呼吸Q10的影响等方面对影响土壤异养呼吸温度敏感性的原因进行了深入的探讨,并提出未来应重点开展的研究:(1)加强不同尺度土壤异养呼吸Q10的影响因子及调控机理研究;(2)扩大土壤异养呼吸Q10的野外研究;(3)扩大热带、亚热带土壤异养呼吸Q10的研究;(4)深入探讨呼吸底物有效性和土壤生物对土壤异养呼吸Q10的影响;(5)加强其他因子对土壤异养呼吸Q10影响的研究.

  20. Application of Risk Quality Management in Pharmaceutical Engineering Desin%质量风险管理在医药工程设计中的应用

    Institute of Scientific and Technical Information of China (English)

    丁之洁

    2014-01-01

    Quality risk management is one important part in quality management system, and it is the process to assess, control, communicate and verify quality risks existed in whole life of products. The methods of quality risk management and its application in pharmaceutical engineering design shall meet the requirements in pharmaceutical production quality management code. In this article, some examples were used to explain the application of methods in quality risk management for aseptic injection products.%质量风险管理是质量管理体系的一个重要组成部分,是一个贯穿于产品生命周期的对其质量风险进行评估、控制、沟通和审核的系统化过程。质量风险管理的方法及在医药工程设计中的应用以满足药品生产质量管理规范的要求,举例说明在无菌制剂的设计中质量风险管理的应用方法。

  1. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

    Science.gov (United States)

    Mintzes, Barbara; Lexchin, Joel; Sutherland, Jason M; Beaulieu, Marie-Dominique; Wilkes, Michael S; Durrieu, Geneviève; Reynolds, Ellen

    2013-10-01

    The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards. This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was "minimally adequate safety information" (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications). Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. "Minimally adequate safety information" did not differ: 1.7 % of promotions; range 0.9-3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver: 61 % vs. 34 %, OR = 4.0; 95 % CI 2.8-5.6, or Sacramento (39 %), OR = 2.4; 95 % CI 1.7-3.6. Serious adverse events were rarely mentioned (5-6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) "black box" warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time. "Minimally adequate safety information" did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about

  2. Co-enzyme Q10 and acetyl salicylic acid enhance Hsp70 expression in primary chicken myocardial cells to protect the cells during heat stress.

    Science.gov (United States)

    Xu, Jiao; Tang, Shu; Yin, Bin; Sun, Jiarui; Song, Erbao; Bao, Endong

    2017-05-11

    We investigated the effects of co-enzyme Q10 (Q10) and acetyl salicylic acid (ASA) on expression of Hsp70 in the protection of primary chicken myocardial cells during heat stress. Western blot analysis showed that Q10 and ASA accelerated the induction of Hsp70 when chicken myocardial cells were exposed to hyperthermia. In the absence of heat stress, however, neither Q10 nor ASA are able to upregulate Hsp70 expression. Analysis of enzymes that respond to cellular damage and pathological examination revealed that ectopic expression of ASA and Q10 alleviate cellular damage during heat stress. Quantification of heat shock factors (HSF) indicated that treatment of ASA increased the expression of HSF-1 and HSF-3 during heat stress. Treatment with Q10 resulted in the elevation of HSF-1 expression. Expression of HSF-2 and HSF-4 was not affected by ASA or Q10. Subcellular distribution analysis of HSF-1 and HSF-3 showed that in response to heat stress ASA promoted nuclear translocation of HSF-1 and HSF-3, while Q10 promoted only HSF-1 nuclear translocation. Chromatin immunoprecipitation (ChIP) analysis indicated that HSF-1 occupies the Hsp70 promoter in chicken primary myocardial cells during heat stress and under normal conditions, while HSF-3 occupies the Hsp70 promoter only during heat stress. Real-time PCR analysis revealed that ASA induces HSF-1 and HSF-3 binding to Hsp70 HSE, while Q10 only induces HSF1 binding to Hsp70 HSE, in agreement with the impact of HSF1 and HSF3 silencing on Hsp70 expression. These data demonstrate that ASA and Q10 both induce the expression of Hsp70 to protect chicken primary myocardial cells during heat stress, but through distinct pathways.

  3. CoQ10-containing eye drops prevent UVB-induced cornea cell damage and increase cornea wound healing by preserving mitochondrial function.

    Science.gov (United States)

    Mencucci, Rita; Favuzza, Eleonora; Boccalini, Carlotta; Lapucci, Andrea; Felici, Roberta; Resta, Francesco; Chiarugi, Alberto; Cavone, Leonardo

    2014-10-09

    We evaluated the potential protective effects of Coenzyme Q10 (CoQ10) on human corneal cells and rabbit eyes after ultraviolet B (UVB) exposure and a model of wound healing in rabbit eyes after corneal epithelium removal. Human corneal epithelium cells (HCE) were exposed to a source of UVB radiation (312 nM) in the presence of different CoQ10 concentrations or vehicle. The mitochondrial function and cell survival were evaluated by means of 3-(4,5-dimethylthiazole-2-yl)2,5-diphenyl-tetrazolium (MTT) reduction and lactic dehydrogenase (LDH) release. Furthermore, quantitation of oxygen consumption and mitochondrial membrane potential were conducted. In vivo rabbit models were adopted to evaluate the effect of CoQ10 on UVB-induced conjunctival vessel hyperemia and corneal recovery after ethanol induced corneal lesion. In UVB-exposed HCE cells, CoQ10 addition led to an increased survival rate and mitochondrial function. Furthermore, oxygen consumption was maintained at control levels and adenosine triphosphate (ATP) decline was completely prevented in the CoQ10-treated cells. Interestingly, in an in vivo model, CoQ10 was able dose-dependently to reduce UVB-induced vessel hyperemia. Finally, in a model of corneal epithelium removal, 12 hours from surgery, animals treated with CoQ10 showed a reduction of damaged area in respect to vehicle controls, which lasted until 48 hours. We demonstrated that CoQ10 reduces corneal damages after UVB exposure in vivo and in vitro by preserving mitochondrial function. Also, for the first time to our knowledge we showed that the administration of CoQ10 after corneal epithelium removal promotes corneal wound healing. Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.

  4. Recovery of the Frank-Starling mechanism by coenzyme Q10 in patients with load-induced contractility depression.

    Science.gov (United States)

    Oda, T

    1993-01-01

    Load-induced contractility depression, in which supernormal left ventricular ejection fraction and contractility at rest decrease by added afterload, is most often found in children with mitral valve prolapse who have symptoms. Patients have high ventricular end-diastolic pressure at rest, which is further increased by afterload challenge. The Frank-Starling mechanism may be maximally mobilized with high preload even at rest to compensate for the intrinsically depressed inotropic state. Therefore, preload reserve may be easily exhausted due to afterload addition. We aimed to determine left ventricular end-diastolic fiber length, stroke work, and contractility before and during handgrip by echocardiograms to obtain evidence for the Frank-Starling mechanism in patients and controls, including patients treated with coenzyme Q10. The subjects were divided into four groups, each consisting of 30 children aged 6-16 years: group 1, normals; group 2, patients; group 3, the same patients as in group 2 after coenzyme Q10 therapy; and group 4, patients with asymptomatic mitral valve prolapse. Baseline values and percentage increases in systolic blood pressure, heart rate, and left ventricular wall stress showed no differences among the groups. Only in group 2 were the percentage increase in ejection fraction, fiber shortening velocity, contractility, and end-diastolic dimension strongly negative, despite supernormal baseline levels. In other groups, these were significantly positive, without intergroup differences. We conclude that in the heart with load-induced contractility depression, the Frank-Starling mechanism deviates from normal. The normal Frank-Starling mechanism was recovered due to coenzyme Q10, which may improve disturbed bioenergetic function at the molecular level.

  5. Automated statistical experimental design approach for rapid separation of coenzyme Q10 and identification of its biotechnological process related impurities using UHPLC and UHPLC-APCI-MS.

    Science.gov (United States)

    Talluri, Murali V N Kumar; Kalariya, Pradipbhai D; Dharavath, Shireesha; Shaikh, Naeem; Garg, Prabha; Ramisetti, Nageswara Rao; Ragampeta, Srinivas

    2016-09-01

    A novel ultra high performance liquid chromatography method development strategy was ameliorated by applying quality by design approach. The developed systematic approach was divided into five steps (i) Analytical Target Profile, (ii) Critical Quality Attributes, (iii) Risk Assessments of Critical parameters using design of experiments (screening and optimization phases), (iv) Generation of design space, and (v) Process Capability Analysis (Cp) for robustness study using Monte Carlo simulation. The complete quality-by-design-based method development was made automated and expedited by employing sub-2 μm particles column with an ultra high performance liquid chromatography system. Successful chromatographic separation of the Coenzyme Q10 from its biotechnological process related impurities was achieved on a Waters Acquity phenyl hexyl (100 mm × 2.1 mm, 1.7 μm) column with gradient elution of 10 mM ammonium acetate buffer (pH 4.0) and a mixture of acetonitrile/2-propanol (1:1) as the mobile phase. Through this study, fast and organized method development workflow was developed and robustness of the method was also demonstrated. The method was validated for specificity, linearity, accuracy, precision, and robustness in compliance to the International Conference on Harmonization, Q2 (R1) guidelines. The impurities were identified by atmospheric pressure chemical ionization-mass spectrometry technique. Further, the in silico toxicity of impurities was analyzed using TOPKAT and DEREK software.

  6. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

    Directory of Open Access Journals (Sweden)

    Ramalingam Peraman

    2015-01-01

    Full Text Available Very recently, Food and Drug Administration (FDA has approved a few new drug applications (NDA with regulatory flexibility for quality by design (QbD based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design. It allows the analytical method for movement within method operable design region (MODR. Unlike current methods, analytical method developed using analytical quality by design (AQbD approach reduces the number of out-of-trend (OOT results and out-of-specification (OOS results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10. Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT.

  7. Analytical quality by design: a tool for regulatory flexibility and robust analytics.

    Science.gov (United States)

    Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

    2015-01-01

    Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

  8. Assessment of Household Disposal of Pharmaceuticals in Lebanon: Management Options to Protect Water Quality and Public Health

    Science.gov (United States)

    Massoud, May A.; Chami, Ghida; Al-Hindi, Mahmoud; Alameddine, Ibrahim

    2016-05-01

    Pharmaceuticals comprise an extensive group of compounds whose release into the environment has potential adverse impacts on human health and aquatic ecosystems. In many developing countries the extent of the problem and the occurrence of pharmaceuticals in water bodies are generally unknown. While thousands of tons of pharmaceutical substances are used annually, little information is known about their final fate after their intended use. This paper focuses on better understanding the management of human-use pharmaceutical wastes generated at the residential level within the Administrative Beirut Area. A survey encompassing 300 households was conducted. Results revealed that the majority of respondents were found to dispose of their unwanted medications, mainly through the domestic solid waste stream. Willingness to participate in a future collection program was found to be a function of age, medical expenditure, and the respondents' views towards awareness and the importance of establishing a collection system for pharmaceutical wastes. Respondents who stated a willingness to participate in a collection program and/or those who believed in the need for awareness programs on the dangers of improper medical waste disposal tended to favor more collection programs managed by the government as compared to a program run by pharmacies or to the act of re-gifting medication to people in need. Ultimately, collaboration and coordination between concerned stakeholders are essential for developing a successful national collection plan.

  9. Coenzyme Q10 enhances the anticonvulsant effect of phenytoin in pilocarpine-induced seizures in rats and ameliorates phenytoin-induced cognitive impairment and oxidative stress.

    Science.gov (United States)

    Tawfik, Mona K

    2011-12-01

    Conventional antiepileptic drugs fail to adequately control seizures and predispose to cognitive impairment and oxidative stress with chronic usage in a significant proportion of patients with epilepsy. Coenzyme Q10 (CoQ10), an antioxidant compound, exhibits a wide range of therapeutic effects that are attributed to its potent antioxidant capacity. To evaluate the neuroprotective effects of CoQ10 in rats against the observed oxidative stress during seizures induced by pilocarpine, and to study its interactions with the conventional antiepileptic drug phenytoin, two experiments were performed. Experiment 1 was conducted to test the effect of phenytoin, CoQ10, or both on seizure severity and oxidative markers in the pilocarpine model of epilepsy. Experiment 2 was conducted to test the effect of 2 weeks of chronic treatment with phenytoin, CoQ10, or both on oxidative markers and behavioral tests in rats. Overall, CoQ10 reduced the severity of pilocarpine-induced seizures and the severity of oxidative stress. Moreover, it potentiated the antiepileptic effects afforded by phenytoin treatment, with the potential safety and efficacy in ameliorating oxidative stress and cognitive impairment caused by chronic phenytoin therapy. Our findings strongly suggest that CoQ10 can be considered a safe and effective adjuvant to phenytoin therapy in epilepsy both to ameliorate seizure severity and to protect against seizure-induced oxidative damage by reducing the cognitive impairment and oxidative stress associated with chronic use of phenytoin.

  10. An Improvement of Oxidative Stress in Diabetic Rats by Ubiquinone-10 and Ubiquinol-10 and Bioavailability after Short- and Long-Term Coenzyme Q10 Supplementation.

    Science.gov (United States)

    Prangthip, Pattaneeya; Kettawan, Aikkarach; Posuwan, Juthathip; Okuno, Masaaki; Okamoto, Tadashi

    2016-11-01

    This study explored effects of ubiquinol-10 and ubiquinone-10, two different forms of coenzyme Q10, in diabetic rats. Oxidative stress is characterized by the depletion of antioxidant defenses and overproduction of free radicals that might contribute to, and even accelerate, the development of diabetes mellitus (DM) complications. Coenzyme Q10 was administered orally to diabetic rats and oxidative stress markers were then assessed. Bioavailability in normal rats was additionally assessed in various tissues and subcellular fractions after short-term and long-term coenzyme Q10 supplementation. Elevated nonfasting blood glucose and blood pressure in diabetic rats were decreased by ubiquinone-10. Both ubiquinol-10 and ubiquinone-10 ameliorated oxidative stress, based on assays for reactive oxygen metabolites and malondialdehyde. Coenzyme Q10 levels increased with both treatments and liver nicotinamide adenine dinucleotide phosphate (NADPH) coenzyme Q reductase with ubiquinone-10. Ubiquinol-10 was better absorbed in the liver and pancreas than ubiquinone-10, though both were similarly effective. In bioavailability study, a longer period of coenzyme Q10 supplementation did not lead to its accumulation in tissues or organelles. Both forms of coenzyme Q10 reduced oxidative stress in diabetic rats. Long-term supplementation of coenzyme Q10 appeared to be safe.

  11. Determination of coenzyme Q10, coenzyme Q9, and melatonin contents in virgin argan oils: comparison with other edible vegetable oils.

    Science.gov (United States)

    Venegas, Carmen; Cabrera-Vique, Carmen; García-Corzo, Laura; Escames, Germaine; Acuña-Castroviejo, Darío; López, Luis Carlos

    2011-11-23

    Virgin argan oil possesses high antioxidant capacity (AC), which may be partially explained by its high content in antioxidant molecules such as polyphenols and tocopherols. However, the content in other antioxidant molecules, for example, coenzyme Q10 (CoQ(10)), coenzyme Q9 (CoQ(9)), and melatonin (Mel), which have been identified in other edible vegetable oils, have not been evaluated in virgin argan oil. Consequently, it was decided to evaluate the contents of CoQ(10), CoQ(9), and Mel in virgin argan oils and compare the results to those obtained in extra virgin olive oils and some varieties of seed oils. By the use of sensitive HPLC-EC/F methods, the results showed that virgin argan oil is a rich source of CoQ(10) and Mel, but no CoQ(9) was detected. Extra virgin olive oil showed higher levels of CoQ(10) and lower levels of Mel than virgin argan oil. Between the seed oil samples, only virgin soybean oil showed higher CoQ(10) and Mel levels than virgin argan oil. The results may be relevant for the contribution of CoQ(10) and Mel to the biological activities of virgin argan oil.

  12. The suppressive effect of dietary coenzyme Q10 on mitochondrial reactive oxygen species production and oxidative stress in chickens exposed to heat stress.

    Science.gov (United States)

    Kikusato, Motoi; Nakamura, Kasumi; Mikami, Yukiko; Mujahid, Ahmad; Toyomizu, Masaaki

    2016-10-01

    This study was conducted to determine if dietary supplementation with coenzyme Q10 (CoQ10 ), which can act as a potent antioxidant and is an obligatory cofactor of mitochondrial uncoupling protein, suppresses the heat stress (HS)-induced overproduction of mitochondrial reactive oxygen species (ROS) and oxidative damage in the skeletal muscle of birds. The carbonyl protein content of skeletal muscle was significantly higher in birds exposed to HS treatment (34°C, 12 h) than in thermoneutral birds (25°C). This increase was suppressed by CoQ10 supplementation (40 mg/kg diet). Succinate-supported mitochondrial ROS production was increased by HS treatment, and this increase was also suppressed by CoQ10 supplementation. In contrast, CoQ10 supplementation did not affect the HS-induced decrease in mitochondrial proton leak. The mitochondrial membrane potential (ΔΨ), to which HS-induced ROS production was previously shown to be sensitive, tended to be increased by HS treatment, but this rise in ΔΨ was not affected by CoQ10 supplementation. Taken together, these results suggest that dietary CoQ10 supplementation attenuates HS-induced oxidative damage to skeletal muscle, by preventing the overproduction of succinate-supported mitochondrial ROS in a manner that is independent of ΔΨ. © 2015 Japanese Society of Animal Science. © 2015 Japanese Society of Animal Science.

  13. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial.

    Science.gov (United States)

    Nadjarzadeh, A; Shidfar, F; Amirjannati, N; Vafa, M R; Motevalian, S A; Gohari, M R; Nazeri Kakhki, S A; Akhondi, M M; Sadeghi, M R

    2014-03-01

    Low seminal plasma concentrations of coenzyme Q10 (CoQ10) have been correlated with impaired sperm parameters, but the exact mechanism remains of dominating interest. This randomised, placebo-controlled study examined the effect of CoQ10 on catalase, superoxide dismutase (SOD) and F2 -isoprostanes in seminal plasma in infertile men and their relation with CoQ10 concentration. Sixty infertile men with idiopathic oligoasthenoteratozoospermia (OAT) were randomised to receive 200 mg d(-1) of CoQ10 or placebo for 3 months. 47 persons of them completed the study. Semen analysis, anthropometric measurements, diet and physical activity assessment were performed for subjects before and after treatment. Independent and paired t-test, chi-square test and ancova were compared outcomes of supplementation between two groups. CoQ10 levels increased from 44.74 ± 36.47 to 68.17 ± 42.41 ng ml(-1) following supplementation in CoQ10 (P concentration and normal sperm morphology (P = 0.037), catalase (P = 0.041) and SOD (P enzymes activity.

  14. Influence of nanostructured lipid carriers (NLC) on the physical properties of the Cutanova Nanorepair Q10 cream and the in vivo skin hydration effect.

    Science.gov (United States)

    Pardeike, Jana; Schwabe, Kay; Müller, Rainer H

    2010-08-30

    Cutanvoa Nanorepair Q10 cream, the first NLC containing cosmetical product introduced to the market in October 2005, was compared to an identical o/w cream without NLC with regards to particle size, melting behaviour, rheological properties and the in vivo effect on skin hydration. The consistency, the spreadability on the skin and the subjective feeling of increase in skin hydration were evaluated using a standardized questionnaire, and compared to hydration data measured. Furthermore, it was shown by epicutaneous patch test that Cutanova Nanorepair Q10 cream has no irritating effects on the skin. By laser diffraction (LD) and differential scanning calorimetry (DSC) measurements it could be shown that NLC are physically stable in Cutanova Nanorepair Q10 cream. After 7 days application of Cutanova Nanorepair Q10 cream and NLC negative control cream an increase in skin hydration could be objectively confirmed by measurements in vivo. From day 28 on the skin hydration measured in the test areas of Cutanova Nanorepair Q10 cream was significantly higher than the skin hydration in the test areas of the NLC negative control cream (p=0.05). The subjective feeling of increase in skin hydration was also rated from the volunteers as superior for Cutanova Nanorepair Q10 cream. The rheological properties of Cutanova Nanorepair Q10 cream contributed to a better subjective impression of consistency and spreadability on the skin than found for NLC negative control cream.

  15. 微生物发酵法生产辅酶Q10提取方法研究进展

    Institute of Scientific and Technical Information of China (English)

    宋亚琼; 高盼盼; 吕乐

    2009-01-01

    辅酶Q10作为多功能生化药物在临床上应用越来越广泛。微生物发酵法生产辅酶Q10,其产物活性好,并可通过规模放大提高生产能力,本文简要介绍了近年来利用微生物发酵法生产辅酶Q10被广泛应用的几种提取方法。

  16. Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Boltić Zorana

    2016-01-01

    Full Text Available The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije, br. TR 34009

  17. Characteristics of the temperature coefficlent,Q10,for the respiration of non-photosynthetic organs and soils of forest ecosystems

    Institute of Scientific and Technical Information of China (English)

    Wang Wenjie; Wang Huimei; Zu Yuangang; Li Xueying; Koike Takayoshi

    2006-01-01

    The temperature coefficient,Q10 (fractional change in rate with a 10℃ increase in temperature)describes the temperature sensitivity of soils,roots,and stems,as well as their possible performance in global warming processes.It is also a necessary parameter for the estimation of total CO2 effiux from each element.A number of studies have focused on Q10 values to date;however,their conclusions are not universal and do not always agree.A review of these reported Qi0 values therefore becomes necessary and important for a global understanding of the temperature sensitivity of different forest types and elements.The alms of our present paper are,first,to find the frequency distribution pattern of soils,roots,and stems (branches) and compare their temperature sensitivity;then,to find the Q10 differences between conifer and deciduous tree species and the effect of methodology on Q10 values;finally we want to give a perspective on future Q10-related studies.We found that most Q10 values of each element were concentrated in a relatively narrow range despite a total data distribution over quite a wide range.For soil respiration,the median Ql0 value was 2.74 and the center of the frequency distribution was between 2.0 and 2.5 with a percentage of 23%.Most of the data (>80%) were within the range from 1.0 to 4.0.The median Q10 value for root respiration was 2.40 and the center of the frequency distribution was from 2.5 to 3.0 with a percentage of 33%.Most of the results (>80%) ranged from 1.0 to 3.0.For stem respiration,the median Q10 value was 1.91 and the frequency distribution was concentrated between 1.5 and 2.0.Over 90% of the data ranged from 1.0 to 3.0.Obvious differences in Q10 value were found between different elements,stem < root < soil including root < soil excluding root.The differences between woody organisms of stems,roots,and soils excluding roots were statistically significant (p<0.05),indicating that heterotrophic respiration from microorganism

  18. Screening of High Productivity CoQ10 Strain and Optimization of Fermentation Conditions for CoQ10 Production with Rhizobium radiobacter%辅酶Q10高产菌Rhizobium radiobacter的选育及发酵条件优化

    Institute of Scientific and Technical Information of China (English)

    潘春梅; 堵国成; 陈坚

    2004-01-01

    以放射型根瘤菌(Rhizobium radiobacter)WSH2601为出发菌株,经紫外线和亚硝基胍复合诱变,获得遗传稳定性好的抗放线菌素D突变株WSH-F06. 在摇瓶中考察了碳、氮源等营养条件以及接种量、装液量和初始pH等环境条件对突变株WSH-F06细胞生长和积累辅酶Q10的影响. 通过诱变和优化发酵条件,突变株WSH-F06的辅酶Q10产量和胞内含量分别达到34 mg/L和2.4 mg/g,比出发菌株在同样条件下提高了16%.

  19. Coenzyme Q10 prevented full blown splenomegaly and decreased melarsoprol-induced reactive encephalopathy in mice infected with Trypanosoma brucei rhodesiense

    Directory of Open Access Journals (Sweden)

    James Nyabuga Nyariki

    2015-03-01

    Full Text Available Objective: To establish the modulatory effects of coenzyme Q10 on experimental trypanosome infections in mice and evaluate the risk of occurrence and severity of melarsoprol-induced post treatment reactive encephalopathy (PTRE. Methods: Female Swiss white mice were orally administered with 200 mg/kg of coenzyme Q10 after which they were intraperitoneally inoculated with Trypanasoma brucei rhodesiense (T. b. rhodesiense. The resultant infection was allowed to develop and simulate all phases of human African trypanosomiasis and PTRE. Parasitaemia development, packed cell volume, haematological and pathological changes were determined. Results: A histological study in the brain tissue of T. b. rhodesiense infected mice demonstrated neuroinflammatory pathology which was highly amplified in the PTRE-induced groups. A prominent reduction in the severity of the neuroinflammatory response was detected when coenzyme-Q10 was administered. Furthermore, the mean tissue weight of spleen to body ratio in coenzyme Q10 supplemented group was significantly (P<0.05 different compared to un-supplemented groups, and clearly indicated that coenzyme Q10 prevented full blown splenomegaly pathogenesis by T. b. rhodesiense. A significant (P<0.05 increase in hemoglobin levels and red blood cells was observed in coenzyme Q10 mice compared to those infected and un-supplemented with coenzyme Q10. Conclusions: The capacity of coenzyme Q10 to alter the pathogenesis of T. b. rhodesiense infection in mice and following treatment with melarsoprol, may find application by rendering humans and animals less susceptible to deleterious effects of trypanosome infection such as splenomegaly and melarsoprol-induced PTRE and neurotoxicity.

  20. Comparative evaluation of co-enzyme Q10 and Melaleuca alternifolia as antioxidant gels in treatment of chronic periodontitis: A clinical study

    OpenAIRE

    Chetan Purushottam Raut; Kunal S Sethi

    2016-01-01

    Background: Conventional nonsurgical periodontal therapy has been proven to be an effective treatment for patients with chronic periodontitis. Coenzyme Q10 and tea tree oil (TTO) are known to have potential therapeutic benefits in chronic periodontitis. Aims: The aim of the study is to compare the efficacy of Coenzyme Q10 (Perio Q® ) and tea tree oil (Melaleuca alternifolia) gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Materials and Methods: Patient...

  1. Simple and fast HPLC method for simultaneous determination of retinol, tocopherols, coenzyme Q(10) and carotenoids in complex samples.

    Science.gov (United States)

    Gleize, Béatrice; Steib, Marlène; André, Marc; Reboul, Emmanuelle

    2012-10-15

    The effects of fat-soluble vitamins (such as vitamins A and E) and lipid microconstituents (such as carotenoids) on human health are now well established. However, high-performance liquid chromatography (HPLC) methods able to detect these molecules in simultaneous runs are often difficult to set up. We report here a 35-min reversed-phase HPLC method using a single C30 column kept at 35°C with a gradient system of methanol, methyl-tert-butyl ether and water at a flow-rate of 1 mL/min. This method resolves 11 carotenoids, retinol, α- and γ-tocopherol from complex matrixes such as food samples, human plasma and human adipose tissue within 35 min. The method is also able to separate coenzyme Q(10). The intra-day and inter-day coefficients of variation are suitable for routine clinical and scientific applications for the determination of lipid micronutrients from various sample types.

  2. Beneficial effects of co-enzyme Q10 and rosiglitazone in fructose-induced metabolic syndrome in rats

    Directory of Open Access Journals (Sweden)

    Suzan M. Mansour

    2013-06-01

    Full Text Available Increased fructose consumption is strongly associated with metabolic syndrome (MS. This study was performed to elucidate the role of co-enzyme Q10 (CoQ and/or rosiglitazone (Rosi in fructose induced MS. Four groups of rats (n = 8–10 were fed on fructose-enriched diet (FED for 16 weeks. One served as FED-control while the remaining groups were treated with CoQ (10 mg/kg/day, Rosi (4 mg/kg/day or their combination during the last 6 weeks. Another group was fed on normal laboratory chow (normal control. At the end of the experiment, blood samples were collected for estimation of markers related to MS. In addition, histological examination of liver, kidney and pancreas samples was done. Induction of the MS was associated with increased body weight gain (34% coupled with elevated levels of blood glucose (48%, insulin (86%, insulin resistance (270%, uric acid (69%, urea (155%, creatinine (129% and blood lipids with different degrees. Fructose-induced MS also reduced plasma catalase (62% and glutathione peroxidase (89% activities parallel to increased serum leptin and tumor necrosis factor-alpha (TNF-α levels. These changes were coupled by marked histological changes in the examined tissues. Treatment with CoQ or Rosi attenuated most of MS-induced changes. Besides, the combination of both agents further reduced blood glucose, total cholesterol, triglycerides and urea levels, as well as, normalized serum levels of leptin and TNF-α. In addition, combined therapy of both agents elevated HDL-cholesterol level and glutathione peroxidase activity. In conclusion, the present study proves the benefits of co-supplementation of CoQ and Rosi in a fructose-induced model of insulin resistance.

  3. Protoplast fusion technology for improved production of coenzyme Q10 using Paracoccus denitrificans ATCC 19367 mutant strains

    Directory of Open Access Journals (Sweden)

    Pradipta Tokdar

    2014-01-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 Induced mutants generated from Paracoccus denitrificans ATCC 19367 having antibiotic resistant markers, were used as parent strains to carry out protoplast fusion. The generated fusants were screened using standardized protocol for CoQ10 production. Among the generated fusants, one fusant namely PF-P1 showed 1.73 folds enhancements in specific CoQ10 content than wild type strain. Fusant PF-P1 was characterized by biochemical and molecular approaches where it showed differences than wild type strain. The fusant was further identified by 16S rRNA gene sequence analysis that showed eight nucleotide base pair mutation on conserved region and 99% homology with Paracoccus denitrificans strains. /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;}

  4. Age-Related Loss in Bone Mineral Density of Rats Fed Lifelong on a Fish Oil-Based Diet Is Avoided by Coenzyme Q10 Addition

    Science.gov (United States)

    Varela-López, Alfonso; Ochoa, Julio J.; Llamas-Elvira, José M.; López-Frías, Magdalena; Planells, Elena; Ramirez-Tortosa, MCarmen; Ramirez-Tortosa, Cesar L.; Giampieri, Francesca; Battino, Maurizio; Quiles, José L.

    2017-01-01

    During aging, bone mass declines increasing osteoporosis and fracture risks. Oxidative stress has been related to this bone loss, making dietary compounds with antioxidant properties a promising weapon. Male Wistar rats were maintained for 6 or 24 months on diets with fish oil as unique fat source, supplemented or not with coenzyme Q10 (CoQ10), to evaluate the potential of adding this molecule to the n-3 polyunsaturated fatty acid (n-3 PUFA)-based diet for bone mineral density (BMD) preservation. BMD was evaluated in the femur. Serum osteocalcin, osteopontin, receptor activator of nuclear factor-κB ligand, ostroprotegerin, parathyroid hormone, urinary F2-isoprostanes, and lymphocytes DNA strand breaks were also measured. BMD was lower in aged rats fed a diet without CoQ10 respect than their younger counterparts, whereas older animals receiving CoQ10 showed the highest BMD. F2-isoprostanes and DNA strand breaks showed that oxidative stress was higher during aging. Supplementation with CoQ10 prevented oxidative damage to lipid and DNA, in young and old animals, respectively. Reduced oxidative stress associated to CoQ10 supplementation of this n-3 PUFA-rich diet might explain the higher BMD found in aged rats in this group of animals. PMID:28241421

  5. Age-Related Loss in Bone Mineral Density of Rats Fed Lifelong on a Fish Oil-Based Diet Is Avoided by Coenzyme Q10 Addition

    Directory of Open Access Journals (Sweden)

    Alfonso Varela-López

    2017-02-01

    Full Text Available During aging, bone mass declines increasing osteoporosis and fracture risks. Oxidative stress has been related to this bone loss, making dietary compounds with antioxidant properties a promising weapon. Male Wistar rats were maintained for 6 or 24 months on diets with fish oil as unique fat source, supplemented or not with coenzyme Q10 (CoQ10, to evaluate the potential of adding this molecule to the n-3 polyunsaturated fatty acid (n-3 PUFA-based diet for bone mineral density (BMD preservation. BMD was evaluated in the femur. Serum osteocalcin, osteopontin, receptor activator of nuclear factor-κB ligand, ostroprotegerin, parathyroid hormone, urinary F2-isoprostanes, and lymphocytes DNA strand breaks were also measured. BMD was lower in aged rats fed a diet without CoQ10 respect than their younger counterparts, whereas older animals receiving CoQ10 showed the highest BMD. F2-isoprostanes and DNA strand breaks showed that oxidative stress was higher during aging. Supplementation with CoQ10 prevented oxidative damage to lipid and DNA, in young and old animals, respectively. Reduced oxidative stress associated to CoQ10 supplementation of this n-3 PUFA-rich diet might explain the higher BMD found in aged rats in this group of animals.

  6. The reduced form of coenzyme Q10 mediates distinct effects on cholesterol metabolism at the transcriptional and metabolite level in SAMP1 mice.

    Science.gov (United States)

    Schmelzer, Constance; Okun, Jürgen G; Haas, Dorothea; Higuchi, Keiichi; Sawashita, Jinko; Mori, Masayuki; Döring, Frank

    2010-11-01

    Studies in humans and mice indicate a role for coenzyme Q(10) (CoQ(10)) in gene expression. To analyze this function in relation to metabolism, SAMP1 mice were supplemented with the reduced (ubiquinol) or oxidized (ubiquinone) form of CoQ(10) (500 mg/kg BW/d) for 14 months. Microarray analyses in liver tissues of SAMP1 mice identified 946 genes as differentially expressed between ubiquinol-treated and control animals (≥1.5-fold, P < 0.05). Text mining analyses revealed for a part of the ubiquinol-regulated genes, a functional connection in PPARα and LXR/RXR signalling pathways. Because these pathways are involved in cholesterol homeostasis, relevant metabolites were determined by gas chromatography/mass spectrometry (GC/MS). We found a significant increase of desmosterol (2.0-fold, P < 0.001) in the liver of ubiquinol-supplemented SAMP1 mice when related to control animals. In agreement, cholesterol concentrations were also distinctly increased (1.3-fold, P = 0.057). The Q(10)H(2)-induced PPARα and LXR/RXR gene expression signatures and effects on cholesterol metabolism were not apparent for the oxidized form of CoQ(10). In conclusion, the reduced form of CoQ(10) mediates distinct effects on cholesterol metabolism at the transcriptional and metabolite level in SAMP1 mice.

  7. The Protective Effects of Alpha-Lipoic Acid and Coenzyme Q10 Combination on Ovarian Ischemia-Reperfusion Injury: An Experimental Study

    Directory of Open Access Journals (Sweden)

    Ahmet Ali Tuncer

    2016-01-01

    Full Text Available Objective. This study aims to evaluate whether alpha-lipoic acid and/or coenzyme Q10 can protect the prepubertal ovarian tissue from ischemia-reperfusion injury in an experimental rat model of ovarian torsion. Materials and Methods. Forty-two female preadolescent Wistar-Albino rats were divided into 6 equal groups randomly. The sham group had laparotomy without torsion; the other groups had torsion/detorsion procedure. After undergoing torsion, group 2 received saline, group 3 received olive oil, group 4 received alpha-lipoic acid, group 5 received coenzyme Q10, and group 6 received both alpha-lipoic acid and coenzyme Q10 orally. The oxidant-antioxidant statuses of these groups were compared using biochemical measurement of oxidized/reduced glutathione, glutathione peroxidase and malondialdehyde, pathological evaluation of damage and apoptosis within the ovarian tissue, and immunohistochemical assessment of nitric oxide synthase. Results. The left ovaries of the alpha-lipoic acid + coenzyme Q10 group had significantly lower apoptosis scores and significantly higher nitric oxide synthase content than the left ovaries of the control groups. The alpha-lipoic acid + coenzyme Q10 group had significantly higher glutathione peroxidase levels and serum malondialdehyde concentrations than the sham group. Conclusions. The combination of alpha-lipoic acid and coenzyme Q10 has beneficial effects on oxidative stress induced by ischemia-reperfusion injury related to ovarian torsion.

  8. 辅酶Q10脂质体在小鼠体内药物动力学和组织分布

    Institute of Scientific and Technical Information of China (English)

    李喆; 邓英杰; 杨静文; 李宝齐; 张修宇; 雷国峰

    2006-01-01

    目的考察辅酶Q10脂质体静脉给药后在小鼠体内的药代动力学和组织分布。方法采用乙醇注入法制备辅酶Q10脂质体,静脉注射给药后,HPLC法测定小鼠血浆和组织中辅酶Q10浓度变化。结果辅酶Q10脂质体的t1/2和AUC均为溶液剂的1.54倍,辅酶Q10脂质体在心、脾、肺中分布增加,尤以心中增加明显。结论辅酶Q10脂质体延缓了药物释放,提高了生物利用度,增强了靶向性作用。

  9. Prophylactic role of coenzyme Q10 and Cynara scolymus L on doxorubicin-induced toxicity in rats: Biochemical and immunohistochemical study

    Directory of Open Access Journals (Sweden)

    Hesham N Mustafa

    2015-01-01

    Full Text Available Objective: The study aims to evaluate the protective effects of coenzyme Q10 (CoQ10 and Cynara scolymus L (CS on doxorubicin (dox-induced toxicity. Materials and Methods: Sixty male rats were divided into six groups. Group 1 as a control. Group 2 received dox (10 mg/kg intraperitoneally. Group 3 received CoQ10 (200 mg/kg. Group 4 received CS (500 mg/kg. Group 5 received CoQ10 (200 mg/kg and dox (10 mg/kg. Group 6 received CS (500 mg/kg and dox (10 mg/kg. The rats were then evaluated biochemically and immunohistochemically. Results: Dox produced a significant deterioration of hepatic and renal functional parameters. Moreover, an upsurge of oxidative stress and nitrosative stress markers. The expression of alpha-smooth muscle actin (α-SMA was increased and proliferating cell nuclear antigen (PCNA expression was decreased. Administration of CoQ10 and CS resulted in a significant improvement of hepatic and renal functional parameters, and an improvement of both α-SMA and PCNA. Conclusion: It is concluded that pretreatment with CoQ10 and CS is associated with up-regulation of favorable protective enzymes and down-regulation of oxidative stress. That can be advised as a supplement to dox-treated patients.

  10. Pharmaceutical Frenzy

    Institute of Scientific and Technical Information of China (English)

    LAN XINZHEN

    2010-01-01

    @@ When shares of Shanghai Pharmaceutical(Group)Co.Ltd.(Shanghai Pharma)resumed normal transactions on March9,2010,the biggest listed pharmaceutical company on China's stock market was born.By the time the closing bell rang at the end of the trading day,the market value of Shanghai Pharma had reached 32.28 billion yuan($4.73 billion).

  11. Treatment with zinc, d-aspartate, and coenzyme Q10 protects bull sperm against damage and improves their ability to support embryo development.

    Science.gov (United States)

    Gualtieri, R; Barbato, V; Fiorentino, I; Braun, S; Rizos, D; Longobardi, S; Talevi, R

    2014-09-01

    Reactive oxygen species (ROS) are physiologically generated during mitochondrial respiration and are involved in several signaling mechanisms. However, under pathological conditions, the concentration of ROS may exceed the antioxidant scavenging systems and subsequently lead to cell damage. High ROS levels have been proven to be detrimental to spermatozoa and furthermore compromise sperm function through lipid peroxidation, protein damage, and DNA strand breakage. Although the oral administration of antioxidants has been demonstrated to improve the semen quality in subfertile men, it is still a matter of debate if it can positively influence fertilization outcome and embryo developmental competence. Studies carried out in suitable animal models could resolve these fundamental questions. Hence, the main aims of the present study were to evaluate: (1) the effects of zinc, d-aspartate, and coenzyme Q10, included in the dietary supplement Genadis (Merck Serono), on bull sperm motility and DNA fragmentation; and (2) whether treated spermatozoa have a superior competence in fertilization and in supporting the development of healthy embryos. Our data indicate that this treatment prevents the loss of sperm motility and the rise in sperm DNA fragmentation over time. Moreover, blastocyst rate was found to be significantly higher in oocytes fertilized by treated spermatozoa, and these blastocysts harbored a significantly lower percentage of apoptotic cells.

  12. Targeting Oxidative Stress, Cytokines and Serotonin Interactions Via Indoleamine 2, 3 Dioxygenase by Coenzyme Q10: Role in Suppressing Depressive Like Behavior in Rats.

    Science.gov (United States)

    Abuelezz, Sally A; Hendawy, Nevien; Magdy, Yosra

    2016-10-11

    Depression is a major health problem in which oxidative stress and inflammation are inextricably connected in its pathophysiology. Coenzyme Q10 (CoQ10) is an important anti-oxidant compound with anti-inflammatory and neuro-protective properties. This study was designed to investigate the hypothesis that CoQ10 by its anti-oxidant and anti-inflammatory potentials can alleviate depressive- like behavior by restoring the balance of the tryptophan catabolites kynurenine/serotonin toward the serotonin pathway by down-regulation of hippocampal indoleamine 2,3-dioxygenase 1 (IDO-1). Depressive-like behavior was induced by chronic unpredictable mild stress (CUMS) protocol including food or water deprivation, cage tilting, reversed light cycle etc. Male Wistar rats were randomly divided into five groups; Control, CUMS, CUMS and CoQ10 (50,100 and 200 mg/kg/day i.p. respectively) groups. CoQ10 effects on different behavioral and biochemical tests were analyzed. CoQ10 showed significant antidepressant efficacy, as evidenced by significantly decreased stress induced changes to forced swimming challenge and open field test, as well as attenuating raised corticosterone level and adrenal glands weight. The anti-oxidant effect of CoQ10 was exhibited by its ability to significantly reduce hippocampal elevated malondialdehyde and 4-hydroxynonenal levels and elevate the reduced glutathione and catalase levels. CoQ10 significantly reduced different pro-inflammatory cytokines levels including interleukin (IL)-1β, IL-2, IL-6 and tumor necrosis factor-α. It suppressed hippocampal IDO-1 and subsequent production of kynurenine and enhanced the hippocampal contents of tryptophan and serotonin. Immunohistochemical analysis revealed that CoQ10 was able to attenuate the elevated microglial CD68 and elevate the astrocyte glial fibrillary acidic protein compared to CUMS group. CoQ10 exhibited antidepressant-like effects on rats exposed to CUMS. This could be attributed to its ability to reduce

  13. An Assay of Bax and Bcl2 Expression in Mice Hippocampus Following Ischemia-Reperfusion Treatment with CoQ10

    Directory of Open Access Journals (Sweden)

    Jalal Hassanshahi

    2013-10-01

    Full Text Available Introduction: Preliminary studies confirmed reduction of cell death following treatment with antioxidants. According to this finding we investigated the relationship between consumption of CoQ10 and expression of bax and bcl2 in hippocampus ischemia that this expression related to cell programmed death.Material and Methods: We studied the protective role of CoQ10 against ischemia-reperfusion. Experimental design includes four groups: intact (N=7, ischemic control (N=7, sham control (N=7 and treatment groups with CoQ10 (N=7. The mice (treatment group treated with CoQ10 as Pre-Treatment for a week. Then, ischemia induced by common carotid artery ligation and following the reduction in inflammation (a week the treatment group post-treated with CoQ10 for a week. Nissl staining applied to counting necrotic cells of hippocampus and the western blotting performed to measurement the bax and bcl2 expression. Tunnel kit was used to quantify apoptotic cell death while to short term memory scale, we apply Y-maze.Results: Cell death was significantly lower when mice treated with CoQ10. Bax expression was significantly high in ischemic group but in treatment group was less and reversely the bcl2 expression in ischemic group was lower than treatment and vehicle groups. The memory test results were consistent with cell death results. Conclusion: Ischemia for 15 minutes induced cell death in hippocampus with more potent effect on CA1. CoQ10 intake significantly reduced cell death and decreased memory loss. with prevent of expression of bax and increase in expression of bcl2.

  14. Supplementation with the reduced form of Coenzyme Q10 decelerates phenotypic characteristics of senescence and induces a peroxisome proliferator-activated receptor-alpha gene expression signature in SAMP1 mice.

    Science.gov (United States)

    Schmelzer, Constance; Kubo, Hiroshi; Mori, Masayuki; Sawashita, Jinko; Kitano, Mitsuaki; Hosoe, Kazunori; Boomgaarden, Inka; Döring, Frank; Higuchi, Keiichi

    2010-06-01

    Our present study reveals significant decelerating effects on senescence processes in middle-aged SAMP1 mice supplemented for 6 or 14 months with the reduced form (Q(10)H(2), 500 mg/kg BW/day) of coenzyme Q(10) (CoQ(10)). To unravel molecular mechanisms of these CoQ(10) effects, a genome-wide transcript profiling in liver, heart, brain and kidney of SAMP1 mice supplemented with the reduced (Q(10)H(2)) or oxidized form of CoQ(10) (Q(10)) was performed. Liver seems to be the main target tissue of CoQ(10) intervention, followed by kidney, heart and brain. Stringent evaluation of the resulting data revealed that Q(10)H(2) has a stronger impact on gene expression than Q(10), primarily due to differences in the bioavailability. Indeed, Q(10)H(2) supplementation was more effective than Q(10) to increase levels of CoQ(10) in the liver of SAMP1 mice. To identify functional and regulatory connections of the "top 50" (p<0.05) Q(10)H(2)-sensitive transcripts in liver, text mining analysis was used. Hereby, we identified Q(10)H(2)-sensitive genes which are regulated by peroxisome proliferator-activated receptor-alpha and are primarily involved in cholesterol synthesis (e.g. HMGCS1, HMGCL and HMGCR), fat assimilation (FABP5), lipoprotein metabolism (PLTP) and inflammation (STAT-1). These data may explain, at least in part, the decelerating effects on degenerative processes observed in Q(10)H(2)-supplemented SAMP1 mice.

  15. LC/MS/MS analysis of α-tocopherol and coenzyme Q10 content in lyophilized royal jelly, beebread and drone homogenate.

    Science.gov (United States)

    Hryniewicka, Marta; Karpinska, Agnieszka; Kijewska, Marta; Turkowicz, Monika Joanna; Karpinska, Joanna

    2016-11-01

    This study shows the results of application liquid chromatography-tandem mass spectrometry (LC/MS/MS) for assay of the content of α-tocopherol and coenzyme Q10 in bee products of animal origin, i.e. royal jelly, beebread and drone homogenate. The biological matrix was removed using extraction with n-hexane. It was found that drone homogenate is a rich source of coenzyme Q10 . It contains only 8 ± 1 µg/g of α-tocopherol and 20 ± 2 µg/g of coenzyme Q10 . The contents of assayed compounds in royal jelly were 16 ± 3 and 8 ± 0.2 µg/g of α-tocopherol and coenzyme Q10 , respectively. Beebread appeared to be the richest of α-tocopherol. Its level was 80 ± 30 µg/g, while the level of coenzyme Q10 was only 11.5 ± 0.3 µg/g. Copyright © 2016 John Wiley & Sons, Ltd.

  16. Coenzyme Q10 prevented full blown splenomegaly and decreased melarsoprol-induced reactive encephalopathy in mice infected with Trypanosoma brucei rhodesiense

    Institute of Scientific and Technical Information of China (English)

    James Nyabuga Nyariki; John Kibuthu Thuita; Grace Kemunto Nyambati; Alfred Orina Isaac

    2014-01-01

    Objective: To establish the modulatory effects of coenzyme Q10 on experimental trypanosome infections in mice and evaluate the risk of occurrence and severity of melarsoprol-induced post treatment reactive encephalopathy (PTRE). Methods: Female Swiss white mice were orally administered with 200 mg/kg of coenzyme Q10 after which they were intraperitoneally inoculated with Trypanasoma brucei rhodesiense (T. b. rhodesiense). The resultant infection was allowed to develop and simulate all phases of human African trypanosomiasis and PTRE. Parasitaemia development, packed cell volume, haematological and pathological changes were determined. Results:A histological study in the brain tissue of T. b. rhodesiense infected mice demonstrated neuroinflammatory pathology which was highly amplified in the PTRE-induced groups. A prominent reduction in the severity of the neuroinflammatory response was detected when coenzyme-Q10 was administered. Furthermore, the mean tissue weight of spleen to body ratio in coenzyme Q10 supplemented group was significantly (P Conclusions: The capacity of coenzyme Q10 to alter the pathogenesis of T. b. rhodesiense infection in mice and following treatment with melarsoprol, may find application by rendering humans and animals less susceptible to deleterious effects of trypanosome infection such as splenomegaly and melarsoprol-induced PTRE and neurotoxicity.

  17. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.

    Science.gov (United States)

    Boussès, Christine; Ferey, Ludivine; Vedrines, Elodie; Gaudin, Karen

    2015-11-10

    An innovative combination of green chemistry and quality by design (QbD) approach is presented through the development of an UHPLC method for the analysis of the main degradation products of dextromethorphan hydrobromide. QbD strategy was integrated to the field of green analytical chemistry to improve method understanding while assuring quality and minimizing environmental impacts, and analyst exposure. This analytical method was thoroughly evaluated by applying risk assessment and multivariate analysis tools. After a scouting phase aimed at selecting a suitable stationary phase and an organic solvent in accordance with green chemistry principles, quality risk assessment tools were applied to determine the critical process parameters (CPPs). The effects of the CPPs on critical quality attributes (CQAs), i.e., resolutions, efficiencies, and solvent consumption were further evaluated by means of a screening design. A response surface methodology was then carried out to model CQAs as function of the selected CPPs and the optimal separation conditions were determined through a desirability analysis. Resulting contour plots enabled to establish the design space (DS) (method operable design region) where all CQAs fulfilled the requirements. An experimental validation of the DS proved that quality within the DS was guaranteed; therefore no more robustness study was required before the validation. Finally, this UHPLC method was validated using the concept of total error and was used to analyze a pharmaceutical drug product. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Blood CoQ10 levels and safety profile after single-dose or chronic administration of PureSorb-Q40: animal and human studies.

    Science.gov (United States)

    Nukui, Kazuki; Yamagishi, Toshihiko; Miyawaki, Hiromi; Kettawan, Aikkarach; Okamoto, Tadashi; Belardinelli, Romualdo; Tiano, Luca; Littarru, Gian Paulo; Sato, Kiyoshi

    2008-01-01

    Coenzyme Q10 (CoQ10) is known to be highly hydrophobic and, as such, insoluble in water: this leads to serious inconvenience when trying to incorporate it in food products. Its absorption is also known to be very limited. PureSorb-Q40 (P40) (Water-soluble type CoQ10 powder, CoQ10 content 40 w/w % was developed in order to improve its use with food products and to enhance its absorption. In the present study the absorption of this novel formulation was compared to a conventional lipid soluble CoQ10 by administering both products to rats and humans. Acute, single-administration studies in rats showed that P40 has a higher absorption, compared to lipid soluble CoQ10, both in prandial and fasting states. Similarly, single administration in humans revealed a higher absorption level for P40, taken in the fasting state or together with meals. In the rat study, no adverse effects were observed with P40 at doses up to 2,000 mg/kg in both sexes. In a double-blind, placebo controlled, comparative study conducted on 46 healthy volunteers and randomly divided into two groups, in the group receiving 900~mg of CoQ10 per day, for 4 consecutive weeks, the average level at two weeks was 8.79 +/- 3.34 microg/mL, similar to the corresponding level after 4 weeks (8.33 +/- 4.04 microg/mL). After 2 weeks of washout, serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. P40 intake did not cause any significant changes in symptoms and clinical laboratory tests as assessed by physical, hematological, blood biochemical or urinalysis. Clinical examinations also did not reveal any abnormalities. The above blood (serum) CoQ10 level at 2 weeks after start of intake was compared with other reported values. The same dose of CoQ10 (900mg/day), when administered by softgel capsules yielded a plasma CoQ10 concentration of 3.6 microg/mL, while P40 levels were 8.79 +/- 3.34 microg/mL. These levels are remarkably high for instance when compared to the corresponding levels obtained, in patients

  19. Successful reversal of propionic acidaemia associated cardiomyopathy: evidence for low myocardial coenzyme Q10 status and secondary mitochondrial dysfunction as an underlying pathophysiological mechanism.

    Science.gov (United States)

    Baruteau, J; Hargreaves, I; Krywawych, S; Chalasani, A; Land, J M; Davison, J E; Kwok, M K; Christov, G; Karimova, A; Ashworth, M; Anderson, G; Prunty, H; Rahman, S; Grünewald, S

    2014-07-01

    Dilated cardiomyopathy is a rare complication in propionic acidaemia (PA). Underlying pathophysiological mechanisms are poorly understood. We present a child of Pakistani consanguineous parents, diagnosed with late-onset PA at 18months of age. He presented a mild phenotype, showed no severe further decompensations, normal growth and psychomotor development on a low protein diet and carnitine supplementation. At 15years, a mildly dilated left ventricle was noticed. At 17years he presented after a 2-3month history of lethargy and weight loss with severe decompensated dilated cardiomyopathy. He was stabilised on inotropic support and continuous haemofiltration; a Berlin Heart biventricular assist device was implanted. He received d,l-hydroxybutyrate 200mg/kg/day, riboflavin and thiamine 200mg/day each and coenzyme Q10 (CoQ10). Myocardial biopsy showed endocardial fibrosis, enlarged mitochondria, with atypical cristae and slightly low respiratory chain (RC) complex IV activity relative to citrate synthase (0.012, reference range 0.014-0.034). Myocardial CoQ10 was markedly decreased (224pmol/mg, reference range 942-2738), with a marginally decreased white blood cell level (34pmol/mg reference range 37-133). The dose of CoQ10 was increased from 1.5 to 25mg/kg/day. Cardiomyopathy slowly improved allowing removal of the external mechanical cardiac support after 67days. We demonstrate for the first time low myocardial CoQ10 in cardiomyopathy in PA, highlighting secondary mitochondrial impairment as a relevant causative mechanism. According to these findings, a high-dose CoQ10 supplementation could be a potential adjuvant therapeutic to be considered in PA-related cardiomyopathy.

  20. The use of coenzyme Q0 as a template in the development of a molecularly imprinted polymer for the selective recognition of coenzyme Q10.

    Science.gov (United States)

    Contin, Mario; Flor, Sabrina; Martinefski, Manuela; Lucangioli, Silvia; Tripodi, Valeria

    2014-01-07

    In this work, a novel molecularly imprinted polymer (MIP) for use as a solid phase extraction sorbent was developed for the determination of coenzyme Q10 (CoQ10) in liver extract. CoQ10 is an essential cofactor in mitochondrial oxidative phosphorylation and a powerful antioxidant agent found in low concentrations in biological samples. This fact and its high hydrophobicity make the analysis of CoQ10 technically challenging. Accordingly, a MIP was synthesised using coenzyme Q0 as the template, methacrylic acid as the functional monomer, acetonitrile as the porogen, ethylene glycol dimethacrylate as the crosslinker and benzoyl peroxide as the initiator. Various parameters affecting the polymer preparation and extraction efficiency were evaluated. Morphological characterisation of the MIP and its proper comparison with C18 as a sorbent in solid phase extraction were performed. The optimal conditions for the molecularly imprinted solid phase extraction (MISPE) consisted of 400 μL of sample mixed with 30 mg of MIP and 600 μL of water to reach the optimum solution loading. The loading was followed by a washing step consisting of 1 mL of a 1-propanol solution (1-propanol:water, 30:70,v/v) and elution with 1 mL of 1-propanol. After clean-up, the CoQ10 in the samples was analysed by high performance liquid chromatography. The extraction recoveries were higher than 73.7% with good precision (3.6-8.3%). The limits of detection and quantification were 2.4 and 7.5 μg g(-1), respectively, and a linear range between 7.5 and 150 μg g(-1) of tissue was achieved. The new MISPE procedure provided a successful clean-up for the determination of CoQ10 in a complex matrix.

  1. Administration of CoQ10 analogue ameliorates dysfunction of the mitochondrial respiratory chain in a mouse model of Angelman syndrome.

    Science.gov (United States)

    Llewellyn, Katrina J; Nalbandian, Angèle; Gomez, Arianna; Wei, Don; Walker, Naomi; Kimonis, Virginia E

    2015-04-01

    Genetic defects in the UBE3A gene, which encodes for the imprinted E6-AP ubiquitin E3 ligase (UBE3A), is responsible for the occurrence of Angelman syndrome (AS), a neurodegenerative disorder which arises in 1 out of every 12,000-20,000 births. Classical symptoms of AS include delayed development, impaired speech, and epileptic seizures with characteristic electroencephalography (EEG) readings. We have previously reported impaired mitochondrial structure and reduced complex III in the hippocampus and cerebellum in the Ube3a(m-/p+) mice. CoQ10 supplementation restores the electron flow to the mitochondrial respiratory chain (MRC) to ultimately increase mitochondrial antioxidant capacity. A number of recent studies with CoQ10 analogues seem promising in providing therapeutic benefit to patients with a variety of disorders. CoQ10 therapy has been reported to be safe and relatively well-tolerated at doses as high as 3000mg/day in patients with disorders of CoQ10 biosynthesis and MRC disorders. Herein, we report administration of idebenone, a potent CoQ10 analogue, to the Ube3a(m-/p+) mouse model corrects motor coordination and anxiety levels, and also improves the expression of complexes III and IV in hippocampus CA1 and CA2 neurons and cerebellum in these Ube3a(m-/p+) mice. However, treatment with idebenone illustrated no beneficial effects in the reduction of oxidative stress. To our knowledge, this is the first study to suggest an improvement in mitochondrial respiratory chain dysfunction via bioenergetics modulation with a CoQ10 analogue. These findings may further elucidate possible cellular and molecular mechanism(s) and ultimately a clinical therapeutic approach/benefit for patients with Angelman syndrome.

  2. [Hospital pharmacist has a rule for best practice use and French hospital activity tariffs. Example of a pharmaceutical quality control for drugs reimbursed in addition of DRGs].

    Science.gov (United States)

    Hedoux, S; Dode, X; Pivot, C; Couray-Targe, S; Aulagner, G

    2012-07-01

    The best practice contract has given a new objective to the hospital pharmacists for the reimbursement in addition to Diagnosis Related Groups' (DRGs) tariffs. We built our pharmaceutical quality control for the administration traceability follow-up regarding the DRGs and the cost of care, for two reasons: the nominal drugs dispensation in link with the prescription made by pharmacist and the important expenditure of these drugs. Our organization depends on the development level of the informatized drugs circuit and minimizes the risk of financial shortfalls or wrong benefits, possible causes of economic penalties for our hospital. On the basis of this follow-up, we highlighted our activity and identified problems of management and drugs circuit organization. The quality of the administration traceability impacts directly on the quality of the medical records and the reimbursements of the expensive drugs. A better knowledge of prescription software is also required for a better quality and security of the medical data used in the medical informatic systems. The drugs management and the personal treatment in and between the care units need to be improved too. We have to continue and improve our organization with the future financial model for ATU drugs and the FIDES project. The health personnel awareness and the development of best informatic tools are also required. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  3. Integrating tristimulus colorimetry into pharmaceutical development for color selection and physical appearance control: a quality-by-design approach.

    Science.gov (United States)

    Hetrick, Evan M; Vannoy, Jeffrey; Montgomery, Laura L; Pack, Brian W

    2013-08-01

    The color of pharmaceutical dosage forms can be an important aspect of product branding and patient compliance with a dosing regimen. During the development of drug products, it is important to understand the stability of not only the active pharmaceutical ingredient but also the color and appearance of the tablet or capsule. Currently, the most common method to ensure color stability is to conduct a visual test throughout a stability study. This visual test is subjective and can be expensive, especially if there is a failure late in development or after marketing approval. This work describes a series of studies using accelerated conditions (i.e., heat, humidity, and light) and logistic regression analyses that have been developed to determine the relative stability ranking of multiple color coatings early in development to provide an increased probability of technical success on long-term stability studies and to avoid coatings whose visual appearance may change over time. Once this relative stability ranking has been established, the stability advantages can be assessed versus any manufacturing/processing liabilities of the selected coating in order to make a data-driven decision around coating selection. This work reviews the basic fundamentals of colorimetry, followed by the description of a consistent experimental approach to correlate a visual rating with an instrumental measurement (e.g., dE(*) from a colorimeter) to remove the subjectivity from the assessment. This approach represents a novel strategy for establishing a probabilized correlation between the quantitative instrumental color measurement and the visual rating of the same color change.

  4. Enhanced antitumor efficacy and counterfeited cardiotoxicity of combinatorial oral therapy using Doxorubicin- and Coenzyme Q10-liquid crystalline nanoparticles in comparison with intravenous Adriamycin

    DEFF Research Database (Denmark)

    Swarnakar, Nitin K; Thanki, Kaushik; Jain, Sanyog

    2014-01-01

    UNLABELLED: Present study focuses on enhancing oral antitumor efficacy and safety of Dox-LCNPs in combination with CoQ10-LCNPs. Drug-loaded-LCNPs were prepared by solvent-diffusion-evaporation method and optimized. Median effect analysis suggested dose-reduction-index of 16.84- and 5.047-fold and...... Q10 and doxorubicin. The nano-conjugates not only provided an enhanced oral treatment option for a tumor model, but prevented cardiotoxicity, a major complication of this drug when delivered via conventional methods....

  5. 辅酶Q10高产菌株的诱变选育%Induced Mutation Breeding and Screening of a Coenzyme QlO-Producing Strain

    Institute of Scientific and Technical Information of China (English)

    曹燕妮; 岳田利; 袁亚红; 高振鹏

    2012-01-01

    以豌豆根瘤菌(Rhizobium leguminosarum 11723)为出发菌株,利用紫外-LiCl和超声波进行诱变,以期获得高产辅酶Q10菌株。结果表明:lg/LLiCl诱变能显著提高菌株的正突变率,超声波诱变会引起细胞壁结构与构成发生改变。通过罗红霉素初筛和摇床复筛,获得辅酶Q10突变株C40-05,胞内辅酶QlO产量为1.198mg/g干菌,比出发菌株(0.389mg/g)提高了208%。菌株经5次传代培养,胞内辅酶Q10产量下降了2.67%,突变株遗传形状稳定,可作为辅酶Q10生产菌株。%Rhizobium leguminosarum 1.1723 was mutagenized by means of LiCl treatment followed by UV irradiation or ultrasonic treatment alone to yield coenzyme Q10-producing strains. The results showed that 1 g/L LiCl could obviously increase the positive mutation rate and that ultrasonic treatment could change cell wall structure of Rhizobium leguminosarum. A mutant C40-05 with high productivity of coenzyme Q10 was obtained through preliminary screening with roxithromycin and secondary screening by means of shake flask cultivation. Its coenzyme Q10 yield was up to 1.198 mg/g, which revealed a 208% increase compared with the original stain. Only 2.67% reduction in coenzyme Q10 yield of the mutant was observed after the fifth passage. Therefore, the obtained mutant is a stable strain that deserves to be studied further.

  6. CoQ10治疗慢性心功能不全:一项随机、双盲、对照研究%Coenzye Q10 for chronic heart failure: a randomized, double-blind, placebo-controlled trial

    Institute of Scientific and Technical Information of China (English)

    姚秀萍; 李华; 高永艳; 董继红

    2012-01-01

    Objective To investigate the efficacy of coenzyme QlO(CoQlO) in patients with chronic cardiac dysfunction. Methods One hundred cases with New York Heart Association (NYHA) Class Ⅱ or Ⅲ heart failure were enrolled in this double-blind, placebo-controlled study. Patients were randomly divided into CoQ10 group (n = 50) and control group (n = 50), and were administrated with 100 mg/day of oral CoQ10 or placebo respectively for 3 months. Results All patients completed the trial. After 3 months of treatment, NYHA class in CoQ10 group showed a significant improvement compared with control group (P = 0.01). There was a significant (P = 0.045) increase of the 6-min walk-test distance in CoQ10 group but no change in control group (P = 0.63). A tendency of increase of left ventricular ejection fraction was observed in CoQIO group (P = 0.059). There was a threefold increase of CoQIO level in CoQ10 group [(0.70 ± 0.06) vs (2.15 ± 0.26) mg/L], but no change was observed in control group. There was a significant decrease in the serum brain natriuretic peptide level in CoQIO group (P = 0.002), but not in control group (P = 0.31). Conclusions This pilot study suggests that CoQIO therapy improves cardiac function in patients with NYHA class Ⅱ or Ⅲ heart failure.%目的 探讨辅酶Q10 (CoQ10)对慢性心功能不全的疗效.方法 本研究为随机、双盲、对照研究.共完成Ⅱ~Ⅲ心功能不全(心功能纽约分级)病例100例,CoQ10组50例,口服CoQ10 100mg,每日一次;对照组50例,口服安慰剂100mg,1次/d;疗程3个月.结果 所有患者均完成试验.经过3个月治疗后,CoQ10组患者心功能纽约心脏病学会分级较对照组明显改善(P=0.01);CoQ10组患者6min步行距离较治疗前明显增加(P=0.045),而对照组患者6min试验步行距离无明显改善(P=0.63);CoQ10组患者左室射血分数较治疗前有增高趋势,但无统计学差异(P=0.059);CoQ10组患者血CoQ10水平较治疗前升高近3倍[(0.70±0.06) vs (2.15±0

  7. Ultrafast Liquid Chromatographic Method Development and its Validation for Quantification of Telaprevir in Pharmaceutical Dosage Form by Using Quality by Design Approach.

    Science.gov (United States)

    Panda, Sagar Suman; Bera, Venkata Varaha Ravi Kumar; Beg, Sarwar; Sahu, Sunil Kumar

    2015-08-01

    Quality by design (QbD) approach thrives to achieve an assured and predicted quality product. A stability-indicating reversed phase ultrafast liquid chromatographic method was developed using the principles of QbD to quantify telaprevir (TEL) in pharmaceutical dosage form. A Box-Behnken experimental design was employed for identifying optimum chromatographic conditions by assessing the method robustness by selecting organic phase composition (%), mobile phase flow rate (mL/min) and pH of the borate buffer as the factors, to study their effect on the responses like retention time, theoretical plate count and tailing factor. Chromatographic separation was achieved on Enable-C18G (250 × 4.6 mm i.d., 5 µm) column using methanol: borate buffer of pH 9.0 (90 : 10, v/v) as mobile phase at a flow rate of 1.2 mL/min and PDA detection at 270 nm. Establishment of calibration curve yielded linearity in the range of 5-70 µg/mL along with values of accuracy and precision within the acceptance limit of mean percent recoveries between 98.9 and 100.7%. Limit of detection and limit of quantitation were found to be 1.60 and 4.75 µg/mL. Analysis of system suitability yielded high degree of method reproducibility and robustness. The developed method showed high specificity for TEL and its degradation products formed during forced degradation conditions. The developed method also demonstrated suitability for routine analysis of TEL in bulk drug and pharmaceutical dosage forms.

  8. Characterizing pharmaceutical, personal care product, and hormone contamination in a karst aquifer of southwestern Illinois, USA, using water quality and stream flow parameters.

    Science.gov (United States)

    Dodgen, L K; Kelly, W R; Panno, S V; Taylor, S J; Armstrong, D L; Wiles, K N; Zhang, Y; Zheng, W

    2017-02-01

    Karst aquifers are drinking water sources for 25% of the global population. However, the unique geology of karst areas facilitates rapid transfer of surficial chemicals to groundwater, potentially contaminating drinking water. Contamination of karst aquifers by nitrate, chloride, and bacteria have been previously observed, but little knowledge is available on the presence of contaminants of emerging concern (CECs), such as pharmaceuticals. Over a 17-month period, 58 water samples were collected from 13 sites in the Salem Plateau, a karst region in southwestern Illinois, United States. Water was analyzed for 12 pharmaceutical and personal care products (PPCPs), 7 natural and synthetic hormones, and 49 typical water quality parameters (e.g., nutrients and bacteria). Hormones were detected in only 23% of samples, with concentrations of 2.2-9.1ng/L. In contrast, PPCPs were quantified in 89% of groundwater samples. The two most commonly detected PPCPs were the antimicrobial triclocarban, in 81% of samples, and the cardiovascular drug gemfibrozil, in 57%. Analytical results were combined with data of local stream flow, weather, and land use to 1) characterize the extent of aquifer contamination by CECs, 2) cluster sites with similar PPCP contamination profiles, and 3) develop models to describe PPCP contamination. Median detection in karst groundwater was 3 PPCPs at a summed concentration of 4.6ng/L. Sites clustered into 3 subsets with unique contamination models. PPCP contamination in Cluster I sites was related to stream height, manganese, boron, and heterotrophic bacteria. Cluster II sites were characterized by groundwater temperature, specific conductivity, sodium, and calcium. Cluster III sites were characterized by dissolved oxygen and barium. Across all sites, no single or small set of water quality factors was significantly predictive of PPCP contamination, although gemfibrozil concentrations were strongly related to the sum of PPCPs in karst groundwater

  9. Quality assurance measures in non-interventional studies: Results of a survey among the members of the Association of Research-Based Pharmaceutical Companies

    Directory of Open Access Journals (Sweden)

    Ruppert, Thorsten

    2008-11-01

    Full Text Available Research into the therapeutic efficacy of a preparation, its safety and tolerability in the human body, as well as its development into a medicinal product is governed by strict legal provisions and regulations such as those stipulated in the German Drug Law (AMG and the German Ordinance for Good Clinical Practice in Trials on Medicinal Products for Human Use (GCP-V. In the post-marketing setting, when drugs are tested under routine conditions and in large numbers of patients, non-interventional studies (NIS, which include Anwendungsbeobachtungen (AWB as the most common form in Germany, have shown to be effective instruments for assessing the safety of a medicinal product and for confirming the results obtained in clinical trials regarding the efficacy of the drug. NIS/AWB studies are not subject to the same strict regulations that govern the development of a medicinal product; in fact they follow recommendations such as those issued by the Federal Higher Authorities and the Expert Committee on Good Epidemiological Practice. Further provisions on NIS/AWB are laid down in the “Codex of the Voluntary Self-regulation for the Pharmaceutical Industry” and the “Common point of view of the Associations of the Pharmaceutical Industry on the assessment of criminality in the collaboration between industry, medical institutions and their staff”. In early 2007, the German Association of Research-Based Pharmaceutical Companies (VFA consolidated the essential elements of these recommendations, supplemented them by new provisions and published the resulting document as „VFA Recommendations for the Improvement of Quality and Transparency of Non-interventional Studies“. Among other initiatives, these recommendations stipulate specific measures for quality assurance in NIS, approximating NIS standards to those applicable to clinical trials. At the same time NIS are being subjected to transparency criteria with regard to the planning, conduct and

  10. CoQ10对DA损伤PC12细胞保护作用的实验研究%Experimental study on the protective effect of CoQ10 on damaged PC12 cells induced by DA

    Institute of Scientific and Technical Information of China (English)

    李熙东; 刘兴; 隋汝波; 赵宝东

    2009-01-01

    目的:探讨辅酶Q10(CoQ10)在以PC12细胞建立的多巴胺神经元损伤细胞模型中的作用.方法:实验于2007年4月~2008年4月在辽宁医学院科技实验中心进行.在体外培养PC12细胞的条件下,加入多巴胺以损伤PC12细胞.同时加入一定浓度的CoQ10,检测细胞的生长活力及培养液MDA含量,比较多巴胺损伤的PC12细胞在加与不加CoQ10时损伤的差异.结果:CoQ10+多巴胺组PC12死亡率及MDA含量较多巴胺组显著降低(P<0.05).结论:CoQ10能减轻多巴胺对PC12细胞的损害.

  11. Pharmaceutical virtue.

    Science.gov (United States)

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  12. Blood serum and seminal plasma selenium, total antioxidant capacity and coenzyme q10 levels in relation to semen parameters in men with idiopathic infertility.

    Science.gov (United States)

    Eroglu, Mustafa; Sahin, Sadik; Durukan, Birol; Ozakpinar, Ozlem Bingol; Erdinc, Nese; Turkgeldi, Lale; Sofuoglu, Kenan; Karateke, Ates

    2014-06-01

    In this case-control study, we aimed to evaluate the serum and seminal plasma levels of Selenium (Se), total antioxidant capacity (TAC), and Coenzyme Q10 (CoQ-10) and determine their relationship with sperm concentration, motility, and morphology in men with idiopathic infertility. A total of 59 subjects were enrolled in the study. Forty four patients were diagnosed with idiopathic male infertility and had abnormal sperm parameters, and 15 subjects had normal sperm parameters with proven fertility. Serum Se, semen Se, and semen TAC levels were significantly different in the fertile and infertile groups (pspermatozoa concentration, motility, and morphology. Additionally, seminal plasma levels of TAC correlated positively with all these sperm parameters. On the other hand, seminal plasma levels of CoQ-10 correlated only with sperm morphology but not with concentration or motility. No relationship was observed between serum levels of TAC or serum levels of CoQ-10 and sperm parameters. In conclusion, serum and seminal plasma Se deficiency may be a prominent determinant of abnormal sperm parameters and idiopathic male infertility. Measurement of serum Se levels may help determine nutritional status and antioxidant capacity in infertile patients, which may help distinguish those patients who will benefit from supplementation therapy.

  13. Recurrent unbalanced whole-arm t(1;10)(q10;p10) in myelodysplastic syndrome: a case report and literature review.

    Science.gov (United States)

    Odish, Omar Ferkad Faraj; Gotoh, Akihiko; Liu, Yi-Chang; Shoji, Nohoko; Kimura, Yukihiko; Kodama, Atsushi; Ohyashiki, Kazuma

    2007-01-15

    We report a patient with myelodysplastic syndrome (refractory anemia) showing the karyotype 46,XY,+1,der(1;10)(q10;p10), resulting in trisomy 1q and monosomy 10q abnormality. This finding suggests that either trisomy of 1q or centromeric connection between chromosomes 1 and 10, rather than the absence of 10q, might be essential toward neoplastic transformation.

  14. Patient beliefs about medicines and quality of life after a clinical medication review and follow-up by a pharmaceutical care plan: A study in elderly polypharmacy patients with a cardiovascular disorder

    NARCIS (Netherlands)

    Geurts, Marlies M.E.; Stewart, Roy E.; Brouwers, Jacobus R.B.J.; de Graeff, Pieter A.; de Gier, Johan J.

    2015-01-01

    Objective: To determine the effect of a clinical medication review, followed up by a pharmaceutical care plan, on the beliefs about medicines and quality of life (QoL) of older patients with polypharmacy and a cardiovascular disorder. Methods: Patients were randomly assigned to an intervention or

  15. Kenyan purple tea anthocyanins and coenzyme-Q10 ameliorate post treatment reactive encephalopathy associated with cerebral human African trypanosomiasis in murine model.

    Science.gov (United States)

    Rashid, Khalid; Wachira, Francis N; Nyariki, James N; Isaac, Alfred O

    2014-04-01

    Human African trypanosomiasis (HAT) is a tropical disease caused by two subspecies of Trypanosoma brucei, the East African variant T. b. rhodesiense and the West African variant T. b. gambiense. Melarsoprol, an organic arsenical, is the only drug used to treat late stage T. b. rhodesiense infection. Unfortunately, this drug induces an extremely severe post treatment reactive encephalopathy (PTRE) in up to 10% of treated patients, half of whom die from this complication. A highly reproducible mouse model was adapted to assess the use of Kenyan purple tea anthocyanins and/or coenzyme-Q10 in blocking the occurrence of PTRE. Female Swiss white mice were inoculated intraperitoneally with approximately 10(4) trypanosome isolate T. b. rhodesiense KETRI 2537 and treated sub-curatively 21days post infection with 5mg/kg diminazene aceturate (DA) daily for 3days to induce severe late CNS infection that closely mirrors PTRE in human subjects. Thereafter mice were monitored for relapse of parasitemia after which they were treated with melarsoprol at a dosage of 3.6mg/kg body weight for 4days and sacrificed 24h post the last dosage to obtain brain samples. Brain sections from mice with PTRE that did not receive any antioxidant treatment showed a more marked presence of inflammatory cells, microglial activation and disruption of the brain parenchyma when compared to PTRE mice supplemented with either coenzyme-Q10, purple tea anthocyanins or a combination of the two. The mice group that was treated with coenzyme-Q10 or purple tea anthocyanins had higher levels of GSH and aconitase-1 in the brain compared to untreated groups, implying a boost in brain antioxidant capacity. Overall, coenzyme-Q10 treatment produced more beneficial effects compared to anthocyanin treatment. These findings demonstrate that therapeutic intervention with coenzyme-Q10 and/or purple tea anthocyanins can be used in an experimental mouse model to ameliorate PTRE associated with cerebral HAT.

  16. Toxicological Impacts of Pharmaceuticals and Personal Care Products on Water Quality: Environmental Fate, Transformation and Health Effects

    Science.gov (United States)

    Rubasinghege, G. R. S.; Rijal, H.; Gurung, R.; Maldonado-Torres, S.; Rogelj, S.; Piyasena, M.

    2016-12-01

    The growing medical and personal needs of the human population have escalated release of pharmaceuticals and personal care products (PPCPs) to the nature. The current work investigated abiotic degradation pathways of selected PPCPs in the presence of major mineral components of soil and the acute health effects of degraded PPCPs. Degradation of selected PPCPs (ibuprofen and clofibric acid) was carried out using custom-built glass reactors in batch studies. The secondary products of PPCPs were analyzed and identified using modified HPLC and LC-MS methods. Results from these studies showed that the extent of degradation depends on the type of the clay or mineral oxide, and solar radiation. In the absence of solar radiation (night time chemistry), the dominant reaction mechanism was observed to be the adsorption of PPCPs on to clay particles where surface functional groups and particle size play a key role. In contrast, under solar radiation, PPCPs break down to several fractions in the presence of clay particles. The decay rates were at least 3-fold higher for irradiated samples compared to that of dark conditions. Acute toxicity of selected PPCPs and their degradation products were tested on three microorganisms: gram-positive soil bacteria, Bacillus megaterium; gram-negative marine bacteria, Pseudoaltermonas atlantica; and algae from the Chlorella genus. Growth inhibition was measured using optical density measurements, MTT viability assay, and flow cytometer. The results suggest that the concentrations of primary compounds, Ibuprofen and Clofibric Acid, found in the environment that ranges from μg/L to ng/L are not sufficient to inhibit growth of either three microorganisms. However, selected organisms showed significant differences in sensitivity to degraded products. Results from current work advance our knowledge and understanding in the fields of environmental toxicology, chemistry in aqueous phases, and geochemistry.

  17. 营养条件和流加发酵对放射型根瘤菌(Rhizobium radiobacter)产辅酶Q10的影响%Effects of Nutrient Conditions and Fed-batch Culture on CoQ10 Production by Rhizobium radiobacter WSH2601

    Institute of Scientific and Technical Information of China (English)

    吴祖芳; 堵国成; 陈坚

    2003-01-01

    利用放射型根瘤菌WSH2601(Rhizobium radiobacter WSH2601)重点考察了葡萄糖、蔗糖、玉米浆和蛋白胨、添加物以及流加发酵对细胞生长和产辅酶Q10的影响,结果表明, 葡萄糖和蔗糖适合于生产辅酶Q10的最佳浓度分别为30 g/L和40 g/L;辅酶Q10发酵时玉米浆和蛋白胨的最适浓度分别为11 g/L和16 g/L;添加蕃茄汁、玉米浆能提高发酵液的生物量,玉米浆、异戊醇、L-甲硫氨基酸等能促进辅酶Q10的积累;与分批发酵相比,在7L罐上流加蔗糖其细胞生物量(DCW)和辅酶Q10积累量增加,若在流加蔗糖的同时流加适当浓度的玉米浆能显著提高辅酶Q10的产量,最大产量达到52.4 mg/L;最大生物量(DCW)和胞内辅酶Q10含量(C/B值)分别达到26.4 g/L和2.38 mg/g-DCW,比不流加的分批发酵分别提高53%和33%,比只流加蔗糖分别提高24%和26%.

  18. Efeito da coenzima Q10 nos danos oxidativos induzidos pela L-tiroxina no músculo sóleo de ratos

    Directory of Open Access Journals (Sweden)

    Fabiana Barreiro de Freitas Silva

    2015-04-01

    Full Text Available INTRODUÇÃO: os músculoesqueléticos são tecidos dinâmicos que podem alterar suas características fenotípicas proporcionando melhor adaptação funcional com estímulos variados. A L-tiroxina é um hormônio produzido pela glândula tireoide e tem sido utilizada como modelo experimental para estimulação de estresse oxidativo no músculo esquelético. A coenzima Q10 é uma provitamina lipossolúvel sintetizada endogenamente e naturalmente encontrada em alimentos como carne vermelha, peixes, cereais, brócolis e espinafre. Apresenta propriedade antioxidante e tem potencial no tratamento de doenças degenerativas e neuromusculares. OBJETIVO: avaliar o efeito protetor da coenzima Q10 no músculo sóleo de ratos frente aos danos oxidativos provocados pela L-tiroxina. MÉTODOS: os ratos foram distribuídos em quatro grupos de seis animais cada: Grupo 1 controle; Grupo 2 coenzima Q10; Grupo 3 L-tiroxina e Grupo 4 coenzima Q10 e L-tiroxina. Após a eutanásia, o sangue dos animais foi colhido e foi analisada a atividade sérica das enzimas creatina quinase CK e aspartato aminotransferase AST. No homogenato do músculo sóleo foram avaliados fatores relacionados ao estresse oxidativo. RESULTADOS: a coenzima Q10 protegeu o músculo sóleo dos danos provocados pela L-tiroxina e favoreceu a manutenção da atividade das enzimas antioxidantes glutationa redutase e glutationa peroxidase, da concentração de glutationa reduzida e oxidada, além de evitar a lipoperoxidação. CONCLUSÃO: os resultados indicam que a coenzima Q10 protege o músculo sóleo de ratos dos danos oxidativos provocados pela L-tiroxina.

  19. Enhancement of muscular performance by a coformulation of propionyl-L-carnitine, coenzyme Q10, nicotinamide, riboflavin and pantothenic acid in the rat.

    Science.gov (United States)

    Vargiu, Romina; Licheri, Donatella; Carcassi, Anna Maria; Naimi, Silvia; Collu, Maria; Littarru, Gian Paolo; Mancinelli, Rino

    2002-06-01

    A coformulation of essential factors, i.e. propionyl-L-carnitine (PLC), coenzyme Q10 (CoQ10), nicotinamide (NAM), riboflavin and pantothenic acid, was administered orally to Wistar rats for 7 weeks and its efficacy was tested through in vivo and in vitro techniques in improving motor functions of striated, cardiac and smooth musculature of the rat. In vivo experiments showed that long-term supplementation significantly improved horizontal locomotor activity by about 19% in male and 26% in female rats. Maximum values of shortening velocity, work and power were significantly increased (PWork was the most affected parameter and it increased by 160% in smooth muscle from treated animals. The present results indicate that supplementation with the combination of the above mentioned substances elicits positive functional changes on motor performance of skeletal, cardiac and smooth muscle of the rat.

  20. The Impact of Global Budgets on Pharmaceutical Spending and Utilization: Early Experience from the Alternative Quality Contract

    Science.gov (United States)

    Afendulis, Christopher C.; Fendrick, A. Mark; Song, Zirui; Landon, Bruce E.; Safran, Dana Gelb; Mechanic, Robert E.; Chernew, Michael E.

    2016-01-01

    In 2009, Blue Cross Blue Shield of Massachusetts implemented a global budget-based payment system, the Alternative Quality Contract (AQC), in which provider groups assumed accountability for spending. We investigate the impact of global budgets on the utilization of prescription drugs and related expenditures. Our analyses indicate no statistically significant evidence that the AQC reduced the use of drugs. Although the impact may change over time, early evidence suggests that it is premature to conclude that global budget systems may reduce access to medications. PMID:25500751

  1. De Novo Trisomy 1q10q23.3 Mosaicism Causes Microcephaly, Severe Developmental Delay, and Facial Dysmorphic Features but No Cardiac Anomalies

    Directory of Open Access Journals (Sweden)

    Shirley Lo-A-Njoe

    2016-01-01

    Full Text Available Proximal duplications of chromosome 1q are rare chromosomal abnormalities. Most patients with this condition present with neurological, urogenital, and congenital heart disease and short life expectancy. Mosaicism for trisomy 1q10q23.3 has only been reported once in the literature. Here we discuss a second case: a girl with a postnatal diagnosis of a de novo pure mosaic trisomy 1q1023.3 who has no urogenital or cardiac anomalies.

  2. Recent Progress of Ubiquinone-10 Production by Microbial Fermentation%微生物发酵生产辅酶Q10的研究进展

    Institute of Scientific and Technical Information of China (English)

    袁静; 魏泓

    2004-01-01

    利用微生物发酵生产辅酶Q10产物活性好,并可通过规模放大提高生产能力,因而颇受国内外学者的关注.文章综述菌种的选择和遗传改造,发酵条件的优化及其分离纯化.

  3. Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy

    Directory of Open Access Journals (Sweden)

    Gustavs Latkovskis

    2016-01-01

    Conclusions: Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60 mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols.

  4. Protective effects of in vitro treatment with zinc, d-aspartate and coenzyme q10 on human sperm motility, lipid peroxidation and DNA fragmentation.

    Science.gov (United States)

    Talevi, Riccardo; Barbato, Vincenza; Fiorentino, Ilaria; Braun, Sabrina; Longobardi, Salvatore; Gualtieri, Roberto

    2013-08-16

    Spermatozoa are extremely vulnerable to oxidative stress caused by the unbalance between concentrations of reactive oxygen species and antioxidant scavenging systems present inside the male reproductive tract. In spite of a large number of clinical studies that claimed the beneficial effects of antioxidant oral administration on sperm physiology and fertility, only a few studies were addressed to evaluate their effects on spermatozoa in vitro. Main aims of the present study were to assess the influence of zinc, D-aspartate and coenzyme Q10, included in the dietary supplement Genadis (Merck Serono), on human sperm motility, DNA fragmentation and lipid peroxidation. Semen samples, obtained from forty-four patients (23-30 years of age) were enrolled in this study, twenty-four were normospermic and twenty patients were oligospermic. Semen samples were analysed for sperm progressive motility and kinetics through computer assisted analysis, DNA fragmentation and lipid peroxidation. Main results showed that in both normo and oligospermic samples, total and progressive sperm motility is maintained by in vitro treatment with zinc, D-aspartate and coenzyme Q10, whereas a significant decrease of these parameters occurs in parallel samples incubated in medium alone. Zinc, D-aspartate and coenzyme Q10 also prevented the decrease of sperm kinetics but such an effect was highly significant only in oligospermic samples. Moreover, they also protected spermatozoa by the increase of DNA fragmentation and lipid peroxidation. Zinc, D-aspartate and coenzyme Q10 exert a direct protective effect on human spermatozoa preventing the decrease of motility and the increase of DNA fragmentation and lipid peroxidation during in vitro culture.

  5. High-fat diet-induced met-hemoglobin formation in rats prone (WOKW) or resistant (DA) to the metabolic syndrome: effect of CoQ10 supplementation.

    Science.gov (United States)

    Orlando, Patrick; Silvestri, Sonia; Brugè, Francesca; Tiano, Luca; Kloting, Ingrid; Falcioni, Giancarlo; Polidori, Carlo

    2014-01-01

    The aim of this study was to evaluate the effects of a high-fat diet (HFD) on oxidative indexes in WistarOttawaKarlsburg W (WOKW) rats used as a model of metabolic syndrome in comparison with Dark Agouti (DA) rats used as a control strain. This syndrome is defined by the occurrence of two or more risk factors including obesity, hypertension, dyslipidemia, and insulin resistance. Forty rats were used in the study and the effect of HFD was evaluated in terms of body weight and both hemoglobin and CoQ oxidative status. Moreover, 16 rats (8 of each strain) were supplemented with 3 mg/100 g b.w. of CoQ10 for 1 month in view of its beneficial properties in cardiovascular disease due to its antioxidant activity in the lipid environment. HFD promoted an increase in body weight, in particular in WOKW males, and in the methemoglobin (met-Hb) index in both strains. Moreover, HFD promoted endogenous CoQ10 oxidation. CoQ10 supplementation was able to efficiently counteract the HFD pro-oxidant effects, preventing met-Hb formation and CoQ oxidation.

  6. Coenzyme Q10 in combination with triple therapy regimens ameliorates oxidative stress and lipid peroxidation in chronic gastritis associated with H. pylori infection.

    Science.gov (United States)

    Rahmani, Asghar; Abangah, Ghobad; Moradkhani, Atefeh; Hafezi Ahmadi, Mohammad Reza; Asadollahi, Khairollah

    2015-08-01

    Chronic gastritis associated with H. pylori infection causes oxidative stress in the stomach. This study aimed to evaluate the therapeutic effects of coenzyme q10 among gastric patients infected by H. pylori. By a clinical trial, chronic gastric patients infected by H. pylori were randomly divided into 2 groups: intervention and placebo. The placebo group received a standard triple therapy regimen, and the intervention group received the triple regimen + coenzyme Q10 (CoQ10). Mean inflammation score; serum levels of 3 serum markers were then compared. A total of 100 participants of whom 67% were female were evaluated. The mean age of participants was 59.4 ± 11.4 years. The mean inflammation score was considerably decreased at the end of the study, in the intervention group. The mean levels of total antioxidant capacity (TAC) and glutathione peroxidase (GPx) at the end of the study were reduced among the triple therapy group (P gastritis.

  7. RISK MANAGEMENT IN PHARMACEUTICALS

    Directory of Open Access Journals (Sweden)

    V. SIVA RAMA KRISHNA

    2014-04-01

    Full Text Available Objective: To review the risk in pharmaceutical industries and the risk management process and tools. There is risk always in anything we do. All the industries on this globe perform actions that involve risks; risk is only dangerous when there is no anticipation to manage it. Risks if assessed and controlled properly will benefit the industries against the fall and makes stronger. Risk should not be assessed as bad, but should assess as an opportunity for making things resilient by proper management. Risk management can benefit industries from disasters either natural or human. The impact of the risk should be assessed in order to plan alternatives and minimize the effect of the impact. Risk in pharmaceutical industry is very high because it involves research, money and health. The impact is severe and the probability of the risk is more often in pharmaceutical industry. A risk management plans and control measures will help the companies to do better at the time of uncertainties and create positive opportunities to turn those risks into benefits which maximize quality. Materials and Methods: The information was collected and compiled from scientific literature present in different databases and articles, books. Results: The risk management process and tools helps to minimize the risk and its effects. Conclusion: The risk management is at the core of any organization. Risk management should be part of organization culture. The risk management is a wise investment if properly processed.

  8. Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity

    Directory of Open Access Journals (Sweden)

    Rakshit Kanubhai Trivedi

    2011-01-01

    Full Text Available A reversed phase ultra performance liquid chromatography (UPLC method was developed and validated for the quantification of aniline in mesalamine delayed-release tablets. The optimization of the experimental condition was carried out considering some important requirements like, detection limit, short run time and reproducibility. In the present study, isocratic reversed-phase UPLC method was developed for determination and separation of aniline from the drug product. The drug and impurity are well separated by using a reversed phase (Reprosil Gold C18-XBD column and mobile phase comprising of buffer pH 6.0 and acetonitrile in the ratio of 90:10 v/v. Other UPLC parameters which were optimised are flow rate, 0.5 mL/min; detection wavelength, 200 nm; column oven temperature, 50 °C and injection volume 7 µL. Stability indicating capability was also established by forced degradation experiments. The method was validated as per ICH guideline. LOQ (limit of quantification concentration (18 ng/mL was found precise with RSD of less than 2%. In essence, the present study provides an improved low detection limit and lower run time for evaluation of pharmaceutical quality of mesalamine delayed-release formulation. Moreover, the developed method was also successfully applied for quantification of aniline in mesalamine delayed-release formulation. The same method can also be used for determination of aniline from drug substances.

  9. There’s More to Science than Research: A Team-Based Role Game to Develop School Students’ Understanding of Science Careers in Pharmaceutical Quality Control

    Directory of Open Access Journals (Sweden)

    Rachael Collins

    2015-08-01

    Full Text Available School students lack information about STEM based careers, a subject that is not sufficiently embedded in the national science curriculum. As a result, students feel they receive insufficient advice to support their choice of subjects at GCSE level and beyond. Students struggle to envisage potential career pathways leading on from studying science at school, and especially for younger students it is difficult to convey typical science-based career pictures in a way that is easily accessible to them. To address this need, we developed an interactive team-based activity which uses role play to help students envisage typical work processes within a science-based career—microbial quality control in a pharmaceutical industrial environment. This activity addresses children’s curiosity about science-based careers, by enabling them to experience typical every day work processes in an industrial environment in a hands-on fashion. Additionally, the activity helps to convey abstract concepts, such as the abundance of microbes in the natural environment, microbial contamination and the importance of hygiene, which link to the science curriculum.

  10. Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (Over The Counter in Surabaya, Indonesia

    Directory of Open Access Journals (Sweden)

    Gardjito Widjoseno

    2010-07-01

    Full Text Available Abstract Background Antimicrobial resistance is an increasing problem in developing countries and antibiotic use is widespread. Our previous surveys in Java, Indonesia, revealed that most antibiotic use was probably unnecessary or ineffective. The aim of this study was to explore a potential connection between resistance and substandard antibiotics sold in the area. Methods A cross-sectional field study using the simulated client method was conducted in Surabaya. Five first-line antibiotics were requested with or without prescription (OTC. A certified laboratory analysed the drug content using validated methods. Possible determinants of substandard quality were explored. Results In total, 104 samples from 75 pharmacies, ten drug stores and 39 roadside stalls (kiosks were obtained. Pharmacy employees filled all OTC requests. Three quarters of kiosks sold antibiotics. Antibiotics were dispensed as single blister strips or repackaged (16% without label. Ninety five percent of samples carried the label of 14 Indonesian manufacturers. The pharmaceutical quality did not meet BP standards for 18% of samples. Deviations (less active ingredient were small. There was no association between low content and type of outlet, sold with or without prescription, registration type, price or packaging. Median retail prices of products carrying the same label varied up to 20 fold. Conclusions Antibiotics were available OTC in all visited pharmacies and sold in the streets of an Indonesian city. Most samples contained an active ingredient. We urge to increase enforcement of existing regulations, including legislation that categorizes antibiotics as prescription-only drugs for all types of medicine outlets, to limit further selection of antimicrobial resistance.

  11. 不同厂家六味地黄丸质量比对分析%Quality comparative analysis of Liuweidihuang pill with different pharmaceutical companies

    Institute of Scientific and Technical Information of China (English)

    白林; 方旬; 任韡

    2011-01-01

    目的:比较四个不同厂家生产的六味地黄丸的质量差异.方法:按照2010年版质量标准,采用HPLC法测定六味地黄丸中丹皮酚和马钱苷的含量,并进行体外溶出度的测定.结果:两个厂家的产品含量不合格;不同厂家生产的六味地黄丸中,丹皮酚和马钱苷的含量及其体外溶出度有显著性差异.结论:为达到临床疗效的一致性,有必要对中成药的原料药材进行严格地质量控制,对制剂工艺进行标准化研究.%Objective: To compare the quality of Liuweidihuang pill produced by different pharmaceutical companies. Methods: According to the Chinese Pharmacopeia (2010th edition), the HPLC method was used for the content determination of paeonol and loganin in Liuweidihuang pill. The standard dissolution test was used to investigate the dissolution in vitro of paeonol and loganin. Results: The assay results showed that samples from two manufactures were unqualified. The content of paeonol and loganin in Liuweidihuang pills from different manufactures differed significantly as well as the dissolution in vitro. Conclusion: In order to obtain the similar clinical effect, it is necessary to control the quality of the Chinese herbs strictly and develop the standardization research about the preparation technology.

  12. Improvement in Flavonoids and Phenolic Acids Production and Pharmaceutical Quality of Sweet Basil (Ocimum basilicum L. by Ultraviolet-B Irradiation

    Directory of Open Access Journals (Sweden)

    Ali Ghasemzadeh

    2016-09-01

    Full Text Available Sweet basil (Ocimum basilicum Linnaeus is aromatic herb that has been utilized in traditional medicine. To improve the phytochemical constituents and pharmaceutical quality of sweet basil leaves, ultraviolet (UV-B irradiation at different intensities (2.30, 3.60, and 4.80 W/m2 and durations (4, 6, 8, and 10-h was applied at the post-harvest stage. Total flavonoid content (TFC and total phenolic content (TPC were measured using spectrophotometric method, and individual flavonoids and phenolic acids were identified using ultra-high performance liquid chromatography. As a key enzyme for the metabolism of flavonoids, chalcone synthase (CHS activity, was measured using a CHS assay. Antioxidant activity and antiproliferative activity of extracts against a breast cancer cell line (MCF-7 were evaluated using 1,1-diphenyl-2-picrylhydrazyl (DPPH assays and MTT (3-(4,5-dimethylthiazol-2-yl-2,5-diphenyltetrazolium bromide assays, respectively. UV-B irradiation at an intensity of 3.60 W/m2 increased TFC approximately 0.85-fold and also increased quercetin (0.41-fold, catechin (0.85-fold, kaempferol (0.65-fold rutin (0.68-fold and luteolin (1.00-fold content. The highest TPC and individual phenolic acid (gallic acid, cinnamic acid and ferulic acid was observed in the 3.60 W/m2 of UV-B treatment. Cinnamic acid and luteolin were not detected in the control plants, production being induced by UV-B irradiation. Production of these secondary metabolites was also significantly influenced by the duration of UV-B irradiation. Irradiation for 8-h led to higher TFC, TPC and individual flavonoids and phenolic acids than for the other durations (4, 8, and 10-h except for cinnamic acid, which was detected at higher concentration when irradiated for 6-h. Irradiation for 10-h significantly decreased the secondary metabolite production in sweet basil leaves. CHS activity was induced by UV-B irradiation and highest activity was observed at 3.60 W/m2 of UV-B irradiation. UV

  13. Improvement in Flavonoids and Phenolic Acids Production and Pharmaceutical Quality of Sweet Basil (Ocimum basilicum L.) by Ultraviolet-B Irradiation.

    Science.gov (United States)

    Ghasemzadeh, Ali; Ashkani, Sadegh; Baghdadi, Ali; Pazoki, Alireza; Jaafar, Hawa Z E; Rahmat, Asmah

    2016-09-09

    Sweet basil (Ocimum basilicum Linnaeus) is aromatic herb that has been utilized in traditional medicine. To improve the phytochemical constituents and pharmaceutical quality of sweet basil leaves, ultraviolet (UV)-B irradiation at different intensities (2.30, 3.60, and 4.80 W/m²) and durations (4, 6, 8, and 10-h) was applied at the post-harvest stage. Total flavonoid content (TFC) and total phenolic content (TPC) were measured using spectrophotometric method, and individual flavonoids and phenolic acids were identified using ultra-high performance liquid chromatography. As a key enzyme for the metabolism of flavonoids, chalcone synthase (CHS) activity, was measured using a CHS assay. Antioxidant activity and antiproliferative activity of extracts against a breast cancer cell line (MCF-7) were evaluated using 1,1-diphenyl-2-picrylhydrazyl (DPPH) assays and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assays, respectively. UV-B irradiation at an intensity of 3.60 W/m² increased TFC approximately 0.85-fold and also increased quercetin (0.41-fold), catechin (0.85-fold), kaempferol (0.65-fold) rutin (0.68-fold) and luteolin (1.00-fold) content. The highest TPC and individual phenolic acid (gallic acid, cinnamic acid and ferulic acid) was observed in the 3.60 W/m² of UV-B treatment. Cinnamic acid and luteolin were not detected in the control plants, production being induced by UV-B irradiation. Production of these secondary metabolites was also significantly influenced by the duration of UV-B irradiation. Irradiation for 8-h led to higher TFC, TPC and individual flavonoids and phenolic acids than for the other durations (4, 8, and 10-h) except for cinnamic acid, which was detected at higher concentration when irradiated for 6-h. Irradiation for 10-h significantly decreased the secondary metabolite production in sweet basil leaves. CHS activity was induced by UV-B irradiation and highest activity was observed at 3.60 W/m² of UV-B irradiation. UV

  14. Pharmaceutical compounds in drinking water

    Directory of Open Access Journals (Sweden)

    Vikas Chander

    2016-06-01

    Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

  15. Drivers of peak sales for pharmaceutical brands

    NARCIS (Netherlands)

    Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.

    2010-01-01

    Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.

  16. Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities.

    Science.gov (United States)

    Orlandini, Serena; Pasquini, Benedetta; Caprini, Claudia; Del Bubba, Massimo; Pinzauti, Sergio; Furlanetto, Sandra

    2015-11-01

    A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets.

  17. 药品质控实验室用水的微生物分析%Microbiological Analysis of Water Used in Laboratory of Quality Control of Pharmaceuticals

    Institute of Scientific and Technical Information of China (English)

    顾珉; 杨美琴; 马仕洪; 顾炳仁

    2015-01-01

    目的:针对目前国内药检所微生物实验室用水的实际情况,探索实验室用水微生物分析的可行方法,提出合理的水微生物污染的质控水平。方法:参考国内外药典对药用水的微生物质控方法,采用培养基方法考察了实验用水在储水期、培养基配制过程中的微生物生长情况和运用96孔酶标板法初步考察了水的污染程度对培养基检测性能的影响。结果:水在储水期、培养基配制过程中的微生物生长迅速,在水的微生物污染程度达到104 cfu/mL 的时候对培养基的检测性能有影响。结论:本研究为微生物实验室水质影响评估和合理利用实验室用水提供了依据。%Objective: In view of the actual situation of the water used in microbiological laboratories in domestic institutes for drug control, feasible methods for microbiological analysis of water for laboratory use were explored and the reasonable standards were put forward for the quality control of water at different microbial contamination levels. Methods: Referring to the methods set forth in domestic and foreign pharmacopoeias for quality control of microorganism in the water for pharmaceutical use, an investigation was conducted, using culture medium method, of the microbial growth in water for laboratory use during the period of water storage and the process of culture medium preparation, and the impact on the detection performance of culture medium by water microbial contamination was detected using 96-well enzyme labeling plate method. Results: During the water storage period and the process of culture medium preparation, microbial growth was fast and the detection performance of culture medium was impacted when microbial contamination level of water reached to 104 cfu/mL. Conclusion: A basis was provided for the assessment of water quality and the reasonable utilization of water for the microbiological laboratories.

  18. Effect of coenzyme Q10 on the expression of interleukin-17 and interleukin-23 in gingival tissue of diabetic rats with periodontitis%辅酶Q10干预糖尿病牙周炎模型大鼠牙龈组织白细胞介素17,23的表达

    Institute of Scientific and Technical Information of China (English)

    徐艳丽; 薛毅; 吴仲寅; 张楠

    2016-01-01

    BACKGROUND:Coenzyme Q10 participates in the electron transport of respiratory chain and possesses antioxidant, anti-apoptotic and anti-inflammatory properties. It has achieved good outcomes in cardiovascular disease, diabetes and cancer. Coenzyme Q10 may also have a certain application value in the fields of diabetes and periodontitis. OBJECTIVE:To observe the effect of coenzyme Q10 on the expression of interleukin-17 and interleukin-23 in gingival tissue of type 2 diabetic rats with periodontitis.METHODS:Forty-eight healthy male Wistar rats were randomly divided into 3 groups: control, periodontitis+ diabetes+physiological saline and periodontitis+diabetes+coenzyme Q10. Rats in the control group were fed with normal diet and water. Rats in the periodontitis+diabetes+physiological saline and periodontitis+diabetes+ coenzyme Q10 groups were subjected to induction of periodontitis using the method of silk ligation and type 2 diabetes by feeding a high-fat and high-sugar diet and intraperitoneal injection of streptozotocin. After successful modeling, rats in the periodontitis+diabetes+coenzyme Q10 group were intragastricaly administered coenzyme Q10 for 8 successive weeks. Rats in the periodontitis+diabetes+physiological saline group were administered equal amount of physiological saline. At the end of 2nd, 4th and 8th weeks after drug administration, four rats were randomly selected and sacrificed. The expression levels of interleukin-17 and interleukin-23 in gingival tissue were detected by immunohistochemistry. RESULTS AND CONCLUSION: At the end of 8th week, interleukin-17- and interleukin-23-positive expression in the periodontitis+diabetes+physiological saline group was significantly higher than that in the periodontitis+ diabetes+coenzyme Q10 group (P < 0.05). Coenzyme Q10 can reduce the expression levels of interleukin-17 and interleukin-23 in gingival tissue of type 2 diabetic rats with periodontitis, and aleviate periodontal tissue inflammation of type 2

  19. Effects of milk and coenzyme Q10 on the interference of acrylonitrile on vascular endothelial functions%牛奶和辅酶Q10对丙烯腈致血管内皮功能紊乱的影响

    Institute of Scientific and Technical Information of China (English)

    郭进; 王卫群; 龚辉

    2011-01-01

    目的 探讨牛奶或辅酶Q10预处理对丙烯腈致大鼠血管内皮功能紊乱的影响.方法 将80只大鼠分为4组:对照组、单纯丙烯腈组、牛奶组、辅酶Q10组.采用灌胃染毒法,对照组仅予玉米油(丙烯腈的溶剂,1 ml/100 g),其他3组予丙烯腈25 mg/kg染毒.牛奶组和辅酶Q10组在染毒前30 min分别给予牛奶、辅酶Q10预处理.染毒12周后检测血清及主动脉组织中诱导型一氧化氮合酶(iNOS)和内皮型一氧化氮合酶(eNOS)的活力.结果 单纯丙烯腈组、牛奶组、辅酶Q10组血清iNOS水平[(42.9±2.5)U/ml、(26.5±4.4)U/ml、(26.7±3.3)U/ml]比对照组[(21.9±1.6)U/ml,P<0.05]升高.主动脉组织中iNOS在单纯丙烯腈组、牛奶组、辅酶Q10组[(0.812±0.008)、(0.773±0.019)、(0.622±0.013)U/mg蛋白]比对照组[(0.540±0.028)U/mg蛋白,P<0.05]高;而辅酶Q10组的主动脉eNOS活力[(0.471±0.011)U/mg蛋白]高于对照组、单纯丙烯腈组和牛奶组[(0.371±0.029)、(0.380±0.016)、(0.425±0.020)U/mg蛋白,P<0.05].结论 牛奶和辅酶Ql0可以缓解丙烯腈致血管内皮功能紊乱作用.%Objective To explore the influences of milk or coenzyme Q10 pretreatment to acrylonitrile on vascular endothelial functions in rats.Methods A total of 80 rats were randomly divided into 4 groups:control group(Con),acrylonitrile exposure group(ACN),milk pretreatment group (M + ACN)and coenzyme Q10 pretreatment group(Q10 + ACN).The experiment was conducted by the method of gavage exposure in rats.Control group was exposed to corn oil;acrylonitrile was administered to other three groups at the doses of 25 mg/kg.The M + ACN and Q10 + ACN groups were pretreated by milk or coenzyme Q10 at 30 minutes before acrylonitrile exposureAfter a 12-week exposure,the activities of inducible nitric oxide synthase(iNOS)and endothelial nitric oxide synthase(eNOS)were measured in serum and aortal tissues.Results As compared with Con group[(21.9 ± 1.6)U/ml],the activity of blood serum i

  20. A t(1;19)(q10;p10) mediates the combined deletions of 1p and 19q and predicts a better prognosis of patients with oligodendroglioma.

    Science.gov (United States)

    Jenkins, Robert B; Blair, Hilary; Ballman, Karla V; Giannini, Caterina; Arusell, Robert M; Law, Mark; Flynn, Heather; Passe, Sandra; Felten, Sara; Brown, Paul D; Shaw, Edward G; Buckner, Jan C

    2006-10-15

    Combined deletion of chromosomes 1p and 19q is associated with improved prognosis and responsiveness to therapy in patients with anaplastic oligodendroglioma. The deletions usually involve whole chromosome arms, suggesting a t(1;19)(q10;p10). Using stem cell medium, we cultured a few tumors. Paraffin-embedded tissue was obtained from 21 Mayo Clinic patients and 98 patients enrolled in 2 North Central Cancer Treatment Group (NCCTG) low-grade glioma trials. Interphase fusion of CEP1 and 19p12 probes detected the t(1;19). 1p/19q deletions were evaluated by fluorescence in situ hybridization. Upon culture, one oligodendroglioma contained an unbalanced 45,XX,t(1;19)(q10;p10). CEP1/19p12 fusion was observed in all metaphases and 74% of interphase nuclei. Among Mayo Clinic oligodendrogliomas, the prevalence of fusion was 81%. Among NCCTG patients, CEP1/19p12 fusion prevalence was 55%, 47%, and 0% among the oligodendrogliomas, mixed oligoastrocytomas, and astrocytomas, respectively. Ninety-one percent of NCCTG gliomas with 1p/19q deletion and 12% without 1p/19q deletion had CEP1/19p12 fusion (P low-grade oligodendroglioma was 9.1 years without fusion and 13.0 years with fusion (P = 0.01). Similar significant median OS differences were observed for patients with combined 1p/19q deletions. The absence of alterations was associated with a significantly shorter OS for patients who received higher doses of radiotherapy. Our results strongly suggest that a t(1;19)(q10;p10) mediates the combined 1p/19q deletion in human gliomas. Like combined 1p/19q deletion, the 1;19 translocation is associated with superior OS and progression-free survival in low-grade glioma patients.

  1. A Direct Comparison of Anti-ulcer Effects of Coenzyme Q10 and Vitamin C on Indomethacin-induced Gastric Ulcer in Rat: A Controlled Experimental Study

    Directory of Open Access Journals (Sweden)

    2013-08-01

    Full Text Available Introduction: Indomethacin increases generation of mitochondrial reactive oxygen species (ROS which have a crucial role in the indomethacin-induced gastric ulcer. Coenzyme Q10 has an antioxidant activity on mitochondria and cell membranes and protects lipids from oxidation and is essential for stabilizing biological membranes. Superoxide dismutase (SOD acts as one of the defense mechanisms against free radicals. When the generation of ROS overwhelms, the antioxidant defense, lipid peroxiation of cell membrane occurs and cause cell damage. Materials and Methods: Male adult Wistar rats were divided into A and B groups. The rats in group A were then further divided into three subgroups of 6 animals each and received one of the following treatments: Animals in the first subgroup received saline. Animals in the second subgroup received saline and indomethacin. Animals in the third subgroup received vitamin C and indomethacin. The rats in group B were also further divided into 3 subgroups of 6 rats each and treated with one of the following treatments: Animals in first subgroup received 1% Tween 80 as vehicle. Animals In second subgroup received 1% Tween 80 and indomethacin. Animals in third subgroup received CoQ10 and indomethacin. Four hours after the last treatment, animals were killed and the stomachs removed were cut and gastric mucosal lesions were examined. Ulcer indexes were determined and SOD activity measured in plasma                                                             Results: Pretreatment with both vitamin C and coenzyme Q10 was associated with attenuation of ulcer index and increased SOD activity compared with animals treated with indomethacin alone (P

  2. Comparative evaluation of co-enzyme Q10 and Melaleuca alternifolia as antioxidant gels in treatment of chronic periodontitis: A clinical study

    Directory of Open Access Journals (Sweden)

    Chetan Purushottam Raut

    2016-01-01

    Full Text Available Background: Conventional nonsurgical periodontal therapy has been proven to be an effective treatment for patients with chronic periodontitis. Coenzyme Q10 and tea tree oil (TTO are known to have potential therapeutic benefits in chronic periodontitis. Aims: The aim of the study is to compare the efficacy of Coenzyme Q10 (Perio Q® and tea tree oil (Melaleuca alternifolia gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Materials and Methods: Patients were divided equally into three groups: Group I (Control group: those receiving placebo gel + SRP, Group II (Test group I: those receiving Perio Q TM gel + SRP, and Group III (Test group II: those receiving tea tree oil gel + SRP. A total of 15 patients with 45 sites were enrolled in the study. Clinical parameters evaluated were plaque index (PI, gingival bleeding index (GI, probing pocket depth (PPD, and clinical attachment level (CAL. Statistical Analysis Used: Paired t-test was applied using SPSS software. Results: Mean PPD reduction for Group I, Group II, and Group III was 0.50 ± 0.2, 2.95 ± 0.20, and 2.09 ± 0.15, respectively. Mean CAL reduction for Group I, Group II, and Group III was 0.45 ± 0.22, 2.33 ± 0.04, and 2.28 ± 0.09, respectively. Changes in mean PI scores for Group I, Group II, and Group III were 0.67 ± 017, 1.00 ± 0.11, and 1.08 ± 0.05 and GBI scores were 0.92 ± 0.29, 1.08 ± 0.13, and 0.88 ± 0.28, respectively. Conclusions: Coenzyme Q10 and tea tree oil gel proved to be effective in the treatment of chronic periodontitis.

  3. VIDA ÚTIL DE LA HUMITA PRECOCIDA, POR MÉTODOS FÍSICO Y QUÍMICO MEDIANTE FACTOR DE ACELERACIÓN Q10

    Directory of Open Access Journals (Sweden)

    Raúl Bienvenido Zambrano Velásquez

    2013-06-01

    Full Text Available El objetivo de la presente investigación fue estimar la vida útil de la humita en función a la temperatura de almacenamiento con la aplicación de conservante (ácido ascórbico y el factor de aceleración Q10. Se estudió el almacenamiento de la humita a 0 y 10°C (A, con dos métodos de aplicación de ácido ascórbico (aplicación directa e inmersión (B. La unidad experimental fue de 100 g. Para el experimento se aplicó un diseño completamente al azar con tres réplicas. Se evaluaron parámetros sensoriales como: sabor, olor, color, textura; químicos: pH, acidez y microbiológicos mohos y levaduras (UFC, vida útil mediante la ecuación de regresión lineal planteada por Labuza y el factor de aceleración Q10. En el análisis sensorial el tratamiento A1B2 presentó los mejores resultados. El número de UFC.g-1 tanto en mohos y levaduras, no superó los límites permitidos por la norma INEN de 50x103 UFC.g-1 (In=10.81 a excepción A2B1. En el pH los tratamientos A1B2 y A1B1 presentaron los mayores promedios cercanos al neutro. Los días de vida útil fueron 5.5, 0.9, 2.61 para los tratamientos A1B1, A1B2 y A2B1 respectivamente; y el valor Q10 que se obtuvo fue de 2.1. El mayor tiempo de vida útil se obtuvo a 0°C con aplicación directa del conservante. El factor Q10 permitió establecer que el cambio de temperatura en 10°C, acelera 2.1 veces las reacciones de deterioro.

  4. Chemistry in the Pharmaceutical Industry

    Science.gov (United States)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  5. A Review on Advanced Treatment of Pharmaceutical Wastewater

    Science.gov (United States)

    Guo, Y.; Qi, P. S.; Liu, Y. Z.

    2017-05-01

    The composition of pharmaceutical wastewater is complex, which is high concentration of organic matter, microbial toxicity, high salt, and difficult to biodegrade. After secondary treatment, there are still trace amounts of suspended solids and dissolved organic matter. To improve the quality of pharmaceutical wastewater effluent, advanced treatment is essential. In this paper, the classification of the pharmaceutical technology was introduced, and the characteristics of pharmaceutical wastewater effluent quality were summarized. The methods of advanced treatment of pharmaceutical wastewater were reviewed afterwards, which included coagulation and sedimentation, flotation, activated carbon adsorption, membrane separation, advanced oxidation processes, membrane separation and biological treatment. Meanwhile, the characteristics of each process were described.

  6. Improvement of Comprehensive Quality and Creative Ability of the Pharmaceutical Students through Undergraduate Tutorial System%以本科生导师制为依托提高学生综合素质

    Institute of Scientific and Technical Information of China (English)

    于新凤; 曲显俊

    2015-01-01

    药学教育的本质是培养高素质的创新型药学人才,为了将药学理论知识的讲授和实践更好的结合,首都医科大学化学生物学与学院以本科生导师制为依托,不断完善导师制培养体系和考核办法,促进了药学生综合素质和创新能力的提高,并对药学生导师制培养出现的问题提出改进建议。%The essence of pharmaceutical education is to cultivate the innovative talents with high quality. In order to put the pharmaceutical theory into practice, School of Chemical Biology and Pharmaceutical Sciences of Capital Medical University established undergraduate tutorial system, which promotes the students'comprehensive quality and creative ability through Improving the tutor system and assessment methods.The problems of undergraduate tutorial system were also raised and suggestions for improvement were put forward.

  7. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  8. Efficiency of emulsifier-free emulsions and emulsions containing rapeseed lecithin as delivery systems for vectorization and release of coenzyme Q10: physico-chemical properties and in vitro evaluation.

    Science.gov (United States)

    Kaci, M; Arab-Tehrany, E; Dostert, G; Desjardins, I; Velot, E; Desobry, S

    2016-11-01

    To improve the encapsulation and release of coenzyme Q10 (CoQ10), emulsifier-free-emulsions were developed with a new emulsification process using high-frequency ultrasound (HFU) at 1.7MHz. Nano-emulsions containing CoQ10 were prepared with or without rapeseed lecithin as an emulsifier. The emulsions prepared with HFU were compared with an emulsion of CoQ10 containing emulsifier prepared with the same emulsification technique as well as with emulsions prepared with low-frequency ultrasound coupled with high-pressure homogenization (LFU+HPH). The physico-chemical properties of the emulsions were determined by average droplet size measurement with nano-droplet tracking analysis, droplet surface charge with ζ potential measurement, surface tension and rheological behaviour. Emulsions made by LFU+HPH with an emulsifier showed lower droplet sizes due to cavitation generated by the HFU process. Surface tension results showed that there was no significant difference between emulsions containing lecithin emulsifier regardless of the preparation process or the inclusion of CoQ10. In vitro biocompatibility tests were performed on human mesenchymal stem cells in order to show the cytotoxicity of various formulations and the efficiency of CoQ10-loaded emulsions. In vitro tests proved that the vectors were not toxic. Furthermore, CoQ10 facilitated a high rate of cell proliferation and metabolic activity especially when in an emulsifier-free formulation. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. The effects of coenzyme Q10 supplementation on cardiometabolic markers in overweight type 2 diabetic patients with stable myocardial infarction: A randomized, double-blind, placebo-controlled trial

    Science.gov (United States)

    Mirhashemi, Seyyed Mehdi; Najafi, Vajiheh; Raygan, Fariba; Asemi, Zatollah

    2016-01-01

    BACKGROUND Limited data are present that have assessed the effects of coenzyme Q10 (CoQ10) intake on cardiometabolic markers in type 2 diabetic patients with coronary heart disease (CHD). This study was done to determine the effects of CoQ10 administration on cardiometabolic markers in overweight diabetic patients with stable myocardial infarction. METHODS This randomized double-blind placebo-controlled clinical trial was done among 60 diabetic patients with CHD aged 45-75 years old. Subjects were randomly allocated into two groups to receive either 100 mg/day CoQ10 supplements (n = 30) or placebo (n = 30) for 8 weeks. RESULTS Compared with the placebo, CoQ10 intake led to a significant reduction in serum interleukin 6 (IL-6) (-1.7 ± 1.6 vs. 0.8 ± 1.7 ng/l, P < 0.001) and protein carbonyl (PCO) levels (-0.2 ± 0.3 vs. 0.1 ± 0.2 nmol/mg protein, P < 0.001). Supplementation with CoQ10 did not affect serum lipoprotein(a), advanced glycation end-products and thiol concentrations compared with the placebo. CONCLUSION Overall, this study indicated that CoQ10 intake after 8 weeks among diabetic patients with the stable CHD had beneficial effects on serum IL-6 and PCO levels, but did not alter other cardiometabolic markers. PMID:28149310

  10. Coenzyme Q10 supplementation rescues renal disease in Pdss2kd/kd mice with mutations in prenyl diphosphate synthase subunit 2.

    Science.gov (United States)

    Saiki, Ryoichi; Lunceford, Adam L; Shi, Yuchen; Marbois, Beth; King, Rhonda; Pachuski, Justin; Kawamukai, Makoto; Gasser, David L; Clarke, Catherine F

    2008-11-01

    Homozygous mice carrying kd (kidney disease) mutations in the gene encoding prenyl diphosphate synthase subunit 2 (Pdss2kd/kd) develop interstitial nephritis and eventually die from end-stage renal disease. The PDSS2 polypeptide in concert with PDSS1 synthesizes the polyisoprenyl tail of coenzyme Q (Q or ubiquinone), a lipid quinone required for mitochondrial respiratory electron transport. We have shown that a deficiency in Q content is evident in Pdss2kd/kd mouse kidney lipid extracts by 40 days of age and thus precedes the onset of proteinuria and kidney disease by several weeks. The presence of the kd (V117M) mutation in PDSS2 does not prevent its association with PDSS1. However, heterologous expression of the kd mutant form of PDSS2 together with PDSS1 in Escherichia coli recapitulates the Q deficiency observed in the Pdss2kd/kd mouse. Dietary supplementation with Q10 provides a dramatic rescue of both proteinuria and interstitial nephritis in the Pdss2kd/kd mutant mice. The results presented suggest that Q may be acting as a potent lipid-soluble antioxidant, rather than by boosting kidney mitochondrial respiration. Such Q10 supplementation may have profound and beneficial effects in treatment of certain forms of focal segmental glomerulosclerosis that mirror the renal disease of the Pdss2kd/kd mouse.

  11. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

    Science.gov (United States)

    1998-04-10

    The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

  12. Effects of Culture Conditions on Rhizobium leguminosarum Cell Growth and CoQ10 Production%发酵条件对豌豆根瘤菌细胞生长和辅酶Q10合成的影响

    Institute of Scientific and Technical Information of China (English)

    王根华; 钱和

    2003-01-01

    以豌豆根瘤菌(Rhizobium leguminosarum)1.172 3为研究对象,对影响细胞生长和辅酶Q10合成的培养条件:温度、pH值、接种量、装液量、收集时间等进行了研究.结果表明:菌株的最适生长条件为pH值5.0,温度30 ℃,接种量体积分数2%,装液量25 mL,培养时间24 h,辅酶Q10的合成量最高.

  13. Changes in phytochemical synthesis, chalcone synthase activity and pharmaceutical qualities of sabah snake grass (Clinacanthus nutans L.) in relation to plant age.

    Science.gov (United States)

    Ghasemzadeh, Ali; Nasiri, Alireza; Jaafar, Hawa Z E; Baghdadi, Ali; Ahmad, Izham

    2014-10-30

    In the current study, changes in secondary metabolite synthesis and the pharmaceutical quality of sabah snake grass leaves and buds were considered in relation to plant age (1 month, 6 months, and 1 year old). The activity of the enzyme chalcone synthase (CHS, EC 2.3.1.74) was measured, as it is a key enzyme for flavonoid production. Significant differences in total flavonoid (TF) production were observed between the three plant growth periods and the different plant parts. The highest contents of TF (6.32 mg/g dry weight [DW]) and total phenolic (TP) (18.21 mg/g DW) were recorded in 6-month-old buds. Among the flavonoids isolated in this study the most important ones based on concentration were from high to low as follows: catechin > quercetin > kaempferol > luteolin. Production of phenolic acids increased from 1 to 6 months, but after 6 months up to 1 year of age, they decreased significantly. The highest contents of caffeic acid (0.307 mg/g DW) and gallic acid (5.96 mg/g DW) were recorded in 1-year and 6-month-old buds, respectively. The lowest and highest activity of CHS was recorded in 1-month and 6-month-old buds with values of 3.6 and 9.5 nkat/mg protein, respectively. These results indicate that the increment in flavonoids and phenolic acids in 6-month-old buds can be attributed to an increase in CHS activity. The highest 1,1-diphenyl-2-picrylhydrazyl (DPPH) activity was observed in the extract of 1-year-old buds followed by 6-month-old buds, with 50% of free radical scavenging (IC50) values of 64.6 and 73.5 µg/mL, respectively. Interestingly, a ferric reducing antioxidant power (FRAP) assay showed a higher activity in 6-month-old buds (488 μM of Fe(II)/g) than in 1-year-old buds (453 μM of Fe(II)/g), in contrast to the DPPH result. Significant correlations (p < 0.05) were observed between CHS enzyme activity and FRAP activity, TF, catechin, and kaempferol content. Extracts of 6-month-old bud exhibited a significant in vitro anticancer activity against

  14. Changes in Phytochemical Synthesis, Chalcone Synthase Activity and Pharmaceutical Qualities of Sabah Snake Grass (Clinacanthus nutans L. in Relation to Plant Age

    Directory of Open Access Journals (Sweden)

    Ali Ghasemzadeh

    2014-10-01

    Full Text Available In the current study, changes in secondary metabolite synthesis and the pharmaceutical quality of sabah snake grass leaves and buds were considered in relation to plant age (1 month, 6 months, and 1 year old. The activity of the enzyme chalcone synthase (CHS, EC 2.3.1.74 was measured, as it is a key enzyme for flavonoid production. Significant differences in total flavonoid (TF production were observed between the three plant growth periods and the different plant parts. The highest contents of TF (6.32 mg/g dry weight [DW] and total phenolic (TP (18.21 mg/g DW were recorded in 6-month-old buds. Among the flavonoids isolated in this study the most important ones based on concentration were from high to low as follows: catechin > quercetin > kaempferol > luteolin. Production of phenolic acids increased from 1 to 6 months, but after 6 months up to 1 year of age, they decreased significantly. The highest contents of caffeic acid (0.307 mg/g DW and gallic acid (5.96 mg/g DW were recorded in 1-year and 6-month-old buds, respectively. The lowest and highest activity of CHS was recorded in 1-month and 6-month-old buds with values of 3.6 and 9.5 nkat/mg protein, respectively. These results indicate that the increment in flavonoids and phenolic acids in 6-month-old buds can be attributed to an increase in CHS activity. The highest 1,1-diphenyl-2-picrylhydrazyl (DPPH activity was observed in the extract of 1-year-old buds followed by 6-month-old buds, with 50% of free radical scavenging (IC50 values of 64.6 and 73.5 µg/mL, respectively. Interestingly, a ferric reducing antioxidant power (FRAP assay showed a higher activity in 6-month-old buds (488 μM of Fe(II/g than in 1-year-old buds (453 μM of Fe(II/g, in contrast to the DPPH result. Significant correlations (p < 0.05 were observed between CHS enzyme activity and FRAP activity, TF, catechin, and kaempferol content. Extracts of 6-month-old bud exhibited a significant in vitro anticancer activity

  15. Analytical techniques in pharmaceutical analysis: A review

    Directory of Open Access Journals (Sweden)

    Masoom Raza Siddiqui

    2017-02-01

    Full Text Available The development of the pharmaceuticals brought a revolution in human health. These pharmaceuticals would serve their intent only if they are free from impurities and are administered in an appropriate amount. To make drugs serve their purpose various chemical and instrumental methods were developed at regular intervals which are involved in the estimation of drugs. These pharmaceuticals may develop impurities at various stages of their development, transportation and storage which makes the pharmaceutical risky to be administered thus they must be detected and quantitated. For this analytical instrumentation and methods play an important role. This review highlights the role of the analytical instrumentation and the analytical methods in assessing the quality of the drugs. The review highlights a variety of analytical techniques such as titrimetric, chromatographic, spectroscopic, electrophoretic, and electrochemical and their corresponding methods that have been applied in the analysis of pharmaceuticals.

  16. Temperature sensitivity (Q10), and dynamics of soil organic matter (SOM) decomposition in permafrost soils with different carbon quality and under experimental warming. R. Bracho1, E.A.G Schuur1, E. Pegoraro1, K.G. Crummer1, S. Natali2, J. Zhou, Y Luo3, J. L. Wu3, M. Tiedje4, K. Konstantinidis5 1Department of Biology, University of Florida, Gainesville, FL. 2Woods Hole Research Center, Falmouth, MA. 3Institute for Environmental Genomics and Department of Botany and Microbiology, University of Oklahoma, Norman, OK, 4Center for Microbial Ecology, Michigan State University, East Lansing, MI; 5Center for Bioinformatics and Computational Genomics and School of Biology, Georgia Institute of Technology, Atlanta, GA

    Science.gov (United States)

    Bracho, R. G.; Schuur, E. A.; Pegoraro, E.; Crummer, K. G.; Natali, S.; Zhou, J.; Wu, L.; Luo, Y.; Tiedje, J. M.; Konstantinidis, K.

    2013-12-01

    Permafrost soils contain approximately1700 Pg of carbon (C), twice the amount of C in the atmosphere. Temperatures in higher latitudes are increasing, inducing permafrost thaw and subsequent microbial decomposition of previously frozen C. This process is one of the most likely positive feedbacks to climate change. Understanding the temperature sensitivity (Q10) and dynamics of SOM decomposition under warming is essential to predict the future state of the earth - climate system. Alaskan tundra soils were exposed to two winter warming (WW) seasons in the field, which warmed the soils by 4°C to 40 cm depth. Soils were obtained from three depths (0 - 15, 15 - 25 and 45 - 55 cm) and differed in initial amounts of labile and recalcitrant C. Soils were incubated in the lab under aerobic conditions, at 15 and 25°C over 365 days. Q10 was estimated at 14, 100 & 280 days of incubation (DOI); C fluxes were measured periodically and dynamics of SOM decomposition (C pool sizes and decay rates) were estimated by fitting a two pool C model to cumulative respired C (Ccum, mgC/ginitialC). After two WW seasons, initial C content tended to decrease through the soil profile and C:N ratio was significantly decreased in the top 15 cm. After one year of incubation, Ccum was twice as high at 25°C as at 15°C and significantly decreased with depth. No significant WW field treatment was detected, although Ccum tended to be lower in warmed soils. Labile C accounted for up to 5% of initial soil C content in the top 15 cm and decreased with depth. Soils exposed to WW had smaller labile C pools, and higher labile C decay rates in the top 25 cm. Q10 significantly decreased with time and depth as labile pool decreased, especially for WW. This decrease with time indicates a lower temperature sensitivity of the most recalcitrant C pool. The deepest WW soil layer, where warming was more pronounced, had significantly lower Q10 compared to control soils at the same depth. After two seasons, the

  17. Effects of Backpacker Use, Pack Stock Trail Use, and Pack Stock Grazing on Water-Quality Indicators, Including Nutrients, E. coli, Hormones, and Pharmaceuticals, in Yosemite National Park, USA.

    Science.gov (United States)

    Forrester, Harrison; Clow, David; Roche, James; Heyvaert, Alan; Battaglin, William

    2017-09-01

    We investigated how visitor-use affects water quality in wilderness in Yosemite National Park. During the summers of 2012-2014, we collected and analyzed surface-water samples for water-quality indicators, including fecal indicator bacteria Escherichia coli, nutrients (nitrogen, phosphorus, carbon), suspended sediment concentration, pharmaceuticals, and hormones. Samples were collected upstream and downstream from different types of visitor use at weekly to biweekly intervals and during summer storms. We conducted a park-wide synoptic sampling campaign during summer 2014, and sampled upstream and downstream from meadows to evaluate the mitigating effect of meadows on water quality. At pack stock stream crossings, Escherichia coli concentrations were greater downstream from crossings than upstream (median downstream increase in Escherichia coli of three colony forming units 100 mL(-1)), with the greatest increases occurring during storms (median downstream increase in Escherichia coli of 32 CFU 100 mL(-1)). At backpacker use sites, hormones, and pharmaceuticals (e.g., insect repellent) were detected at downstream sites, and Escherichia coli concentrations were greater at downstream sites (median downstream increase in Escherichia coli of 1 CFU 100 mL(-1)). Differences in water quality downstream vs. upstream from meadows grazed by pack stock were not detectable for most water-quality indicators, however, Escherichia coli concentrations decreased downstream, suggesting entrapment and die-off of fecal indicator bacteria in meadows. Our results indicate that under current-use levels pack stock trail use and backpacker use are associated with detectable, but relatively minor, effects on water quality, which are most pronounced during storms.

  18. Effects of Backpacker Use, Pack Stock Trail Use, and Pack Stock Grazing on Water-Quality Indicators, Including Nutrients, E. coli, Hormones, and Pharmaceuticals, in Yosemite National Park, USA

    Science.gov (United States)

    Forrester, Harrison; Clow, David; Roche, James; Heyvaert, Alan; Battaglin, William

    2017-09-01

    We investigated how visitor-use affects water quality in wilderness in Yosemite National Park. During the summers of 2012-2014, we collected and analyzed surface-water samples for water-quality indicators, including fecal indicator bacteria Escherichia coli, nutrients (nitrogen, phosphorus, carbon), suspended sediment concentration, pharmaceuticals, and hormones. Samples were collected upstream and downstream from different types of visitor use at weekly to biweekly intervals and during summer storms. We conducted a park-wide synoptic sampling campaign during summer 2014, and sampled upstream and downstream from meadows to evaluate the mitigating effect of meadows on water quality. At pack stock stream crossings, Escherichia coli concentrations were greater downstream from crossings than upstream (median downstream increase in Escherichia coli of three colony forming units 100 mL-1), with the greatest increases occurring during storms (median downstream increase in Escherichia coli of 32 CFU 100 mL-1). At backpacker use sites, hormones, and pharmaceuticals (e.g., insect repellent) were detected at downstream sites, and Escherichia coli concentrations were greater at downstream sites (median downstream increase in Escherichia coli of 1 CFU 100 mL-1). Differences in water quality downstream vs. upstream from meadows grazed by pack stock were not detectable for most water-quality indicators, however, Escherichia coli concentrations decreased downstream, suggesting entrapment and die-off of fecal indicator bacteria in meadows. Our results indicate that under current-use levels pack stock trail use and backpacker use are associated with detectable, but relatively minor, effects on water quality, which are most pronounced during storms.

  19. Effects of backpacker use, pack stock trail use, and pack stock grazing on water-quality indicators, including nutrients, E. coli, hormones, and pharmaceuticals, in Yosemite National Park, USA

    Science.gov (United States)

    Forrester, Harrison; Clow, David W.; Roche, James W.; Heyvaert, Alan C.; Battaglin, William A.

    2017-01-01

    We investigated how visitor-use affects water quality in wilderness in Yosemite National Park. During the summers of 2012–2014, we collected and analyzed surface-water samples for water-quality indicators, including fecal indicator bacteria Escherichia coli, nutrients (nitrogen, phosphorus, carbon), suspended sediment concentration, pharmaceuticals, and hormones. Samples were collected upstream and downstream from different types of visitor use at weekly to biweekly intervals and during summer storms. We conducted a park-wide synoptic sampling campaign during summer 2014, and sampled upstream and downstream from meadows to evaluate the mitigating effect of meadows on water quality. At pack stock stream crossings, Escherichia coli concentrations were greater downstream from crossings than upstream (median downstream increase in Escherichia coli of three colony forming units 100 mL−1), with the greatest increases occurring during storms (median downstream increase in Escherichia coli of 32 CFU 100 mL−1). At backpacker use sites, hormones, and pharmaceuticals (e.g., insect repellent) were detected at downstream sites, and Escherichia coli concentrations were greater at downstream sites (median downstream increase in Escherichia coli of 1 CFU 100 mL−1). Differences in water quality downstream vs. upstream from meadows grazed by pack stock were not detectable for most water-quality indicators, however, Escherichia coli concentrations decreased downstream, suggesting entrapment and die-off of fecal indicator bacteria in meadows. Our results indicate that under current-use levels pack stock trail use and backpacker use are associated with detectable, but relatively minor, effects on water quality, which are most pronounced during storms.

  20. Jordanian pharmaceutical companies: are their marketing efforts paying off?

    Science.gov (United States)

    Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman

    2011-04-01

    The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed.

  1. Economic Drivers of Pharmaceutical Investment Location

    OpenAIRE

    David Lewis; Edward Bramley-Harker; Joshua Farahnik

    2007-01-01

    The article examines the range of economic factors that underlie decision making about the location of investments by research-based pharmaceutical companies. Set in the context of the commercial challenges facing the industry, structured interviews with 34 senior executives in pharmaceutical companies examined hypothetical investment scenarios. Unsurprisingly, both cost and quality factors are important to decision making, but their nature and relative importance depend heavily on the type o...

  2. The effect of water on the solid state characteristics of pharmaceutical excipients: Molecular mechanisms, measurement techniques, and quality aspects of final dosage form.

    Science.gov (United States)

    Szakonyi, Gergely; Zelkó, Romána

    2012-01-01

    In this paper we give an overview about the interaction of water molecules with pharmaceutical excipients. Most of these excipients are amorphous or partially amorphous polymers and their characteristics are very sensitive to the water content. In the course of the manufacturing processes water sorption is possible, therefore in some cases it is important to strictly control the residual moisture content of a dosage form. There are several mechanisms of water sorption, like water is able to bind to polar groups of hygroscopic excipients and could also exist in the capillary system of amorphous excipients. Several techniques are available to characterise the states of water inside the materials and the effects of residual water on polymers. For this purpose water sorption measurements, differential scanning calorimetry and the Fourier-transform infrared spectroscopy are reviewed. The importance of water content and storage conditions of pharmaceuticals on the properties of the final dosage forms are also demonstrated with practical examples.

  3. Novel CoQ10 antidiabetic mechanisms underlie its positive effect: modulation of insulin and adiponectine receptors, Tyrosine kinase, PI3K, glucose transporters, sRAGE and visfatin in insulin resistant/diabetic rats.

    Directory of Open Access Journals (Sweden)

    Mohamed M Amin

    Full Text Available As a nutritional supplement, coenzyme Q10 (CoQ10 was tested previously in several models of diabetes and/or insulin resistance (IR; however, its exact mechanisms have not been profoundly explicated. Hence, the objective of this work is to verify some of the possible mechanisms that underlie its therapeutic efficacy. Moreover, the study aimed to assess the potential modulatory effect of CoQ10 on the antidiabetic action of glimebiride. An insulin resistance/type 2 diabetic model was adopted, in which rats were fed high fat/high fructose diet (HFFD for 6 weeks followed by a single sub-diabetogenic dose of streptozotocin (35 mg/kg, i.p.. At the end of the 7(th week animals were treated with CoQ10 (20 mg/kg, p.o and/or glimebiride (0.5 mg/kg, p.o for 2 weeks. CoQ10 alone opposed the HFFD effect and increased the hepatic/muscular content/activity of tyrosine kinase (TK, phosphatidylinositol kinase (PI3K, and adiponectin receptors. Conversely, it decreased the content/activity of insulin receptor isoforms, myeloperoxidase and glucose transporters (GLUT4; 2. Besides, it lowered significantly the serum levels of glucose, insulin, fructosamine and HOMA index, improved the serum lipid panel and elevated the levels of glutathione, sRAGE and adiponectin. On the other hand, CoQ10 lowered the serum levels of malondialdehyde, visfatin, ALT and AST. Surprisingly, CoQ10 effect surpassed that of glimepiride in almost all the assessed parameters, except for glucose, fructosamine, TK, PI3K, and GLUT4. Combining CoQ10 with glimepiride enhanced the effect of the latter on the aforementioned parameters.These results provided a new insight into the possible mechanisms by which CoQ10 improves insulin sensitivity and adjusts type 2 diabetic disorder. These mechanisms involve modulation of insulin and adiponectin receptors, as well as TK, PI3K, glucose transporters, besides improving lipid profile, redox system, sRAGE, and adipocytokines. The study also points to the

  4. Thermal properties of food and pharmaceutical powders

    Science.gov (United States)

    Abiad, Mohamad Ghassan

    Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.

  5. Patent Quality Evaluation Index:an Case of Chinese Bio-pharmaceutical Industry%专利质量综合评价指数--以我国生物医药行业为例

    Institute of Scientific and Technical Information of China (English)

    吴菲菲; 张广安; 张辉; 黄鲁成

    2014-01-01

    专利质量问题已引起世界各国的广泛关注。利用文献计量方法确定专利质量评价指标和权重,并给出了专利质量评价指数。根据数据的可得性对指标进行删减,利用 OECD 给出的生物技术专利IPC分类号,结合医药特征关键词对专利进行筛选,最终得到全国不同省(区、市)生物医药行业专利质量评价指数。研究结果表明,所确定的专利质量指数是有效的,我国生物医药行业专利质量排名前五位的分别是:北京、上海、台湾、香港和江苏。最后提出提高专利质量的对策建议。%Attentions to patent quality has arisen around the world.This paper determines the patent quality evaluation indi-cators and their weight with the method of bibliometrics.It also puts forward the patent evaluation index.After deletion of indicators according to their accessibility,It filters all patents by using the IPC numbers included in biotechnology given by OECD and reference keywords which can represent the character of pharmaceuticals industry.After that,the paper con-clude the pharmaceuticals industry's patent quality evaluation indices of all provinces (districts or cities).The results show that the patent quality indices are valid.The top five of pharmaceuticals industry's patent quality are Beijing,Shanghai, Taiwan,Hong Kong and Jiangsu.Suggestions to improve the patent quality are proposed in the end of the paper.

  6. Exploration of the Establishment of Quality Evaluation System of Clinical Pharmaceutical Care%临床药学服务质量评价体系的建立探索

    Institute of Scientific and Technical Information of China (English)

    杨男; 胡明; 蒋学华

    2011-01-01

    OBJECTIVE: To provide reference for the quality evaluation of clinical pharmaceutical care in China. METHODS: By literature reviewing method, the definition and characteristics of clinical pharmacy were analyzed from the view of management on the basis of the theories of service quality, medical service quality and performance. The feasibility of quality evaluation methods of relevant theory in quality evaluation and examination of clinical pharmaceutical care were compared to select optimal evaluation method for the establishment of quality evaluation system of clinical pharmaceutical care. RESULTS & CONCLUSIONS: The method of structure-process-result has been chosen as a frame of evaluation, and specific indicators are developed by using SERVQUAL, 360 Degree and AHP. The evaluation system can be used for investigating the implementation of clinical pharmacist system and provides adequate evidence for the implementation of clinical pharmacy in China.%目的:为评价我国临床药学服务质量提供参考.方法:采用文献研究法,基于服务质量理论、医疗服务质量理论和绩效理论,从管理学角度对临床药学的定义、特征进行分析,比较相关理论中各种质量评价方法在临床药学服务质量评价和考核中的适用性,优选适当评价方法构建临床药学服务质量评价体系.结果与结论:临床药学服务质量评价体系可以“结构-过程-结果”法为基本框架,采用层次分析法、SERVQUAL服务质量评价法、360度绩效考核法等方法设计具体指标.该评价体系可用于考察临床药师制实施效果,为在全国推行临床药学工作提供充分证据.

  7. Discussion on the new GMP's content of improving quality management system in pharmaceutical enterprises%新版GMP关于强化药品生产企业质量管理体系的探讨

    Institute of Scientific and Technical Information of China (English)

    杨敏茹; 张荣玉

    2011-01-01

    Objective To introduce the content of quality management in newly revised GMP and to discuss the content of pharmaceutical enterprise's quality management system. Methods The newly revised GMP , such as investigation , induction , building organizations,personnel and relevant trainings in the process of improving pharmaceutical enterprise's quality management system were compared and discussed. Results Some advises put forward to improve the quality management system. Conclusion Only improvement the quality management system could ensure the safcty and effective in the drug production and the use.%目的 介绍新修订GMP中增加的有关质量管理章节内容,对新版GMP中关于强化药品生产企业质量管理体系进行探讨.方法 采用调查、归纳等方法,与新版GMP要求进行对比,阐述制药企业健全质量管理体系的组织、人员及培训要求;针对目前实际,对制药企业在产品质量风险评估、质量回顾分析等方面存在的差距予以剖析.结果 为企业完善质量管理体系提出建议,使新版GMP要求尽快得到实施.结论 完善药品生产质量管理体系,才能保证整个药品生产和使用过程安全有效.

  8. The pharmaceutical quality regulation systems in European Union and its inspirations*%欧盟药品质量规制体系对我国的启示*

    Institute of Scientific and Technical Information of China (English)

    杨菲; 邵蓉

    2013-01-01

      Based on the theory of regulation, the differences in the regulation systems of pharmaceutical quality between China and European Union were analyzed in three parts including the policies , regulations and the agencies and capacity of law enforcement . It is necessary to further clear the legal framework, protect the independence of law enforcement agencies, ensure the symmetry of information with the public and improve the ability of law enforcement so as to enhance the pharmaceutical quality regulation systems in China.%  在规制相关理论的基础上,运用对比研究方法从政策、法规、执法机构和执法能力3个方面分析我国药品质量规制体系与欧盟的差异。完善我国药品质量规制体系需进一步明确相关法律框架,保障执法机构的独立性,保持与公众的信息对称,并提高执法者的综合能力。

  9. A novel 96-microwell-based high-throughput spectrophotometric assay for pharmaceutical quality control of crizotinib, a novel potent drug for the treatment of non-small cell lung cancer

    Directory of Open Access Journals (Sweden)

    Tanveer Ahmed Wani

    2015-06-01

    Full Text Available This study describes the development and validation of a novel 96-microwell-based high throughput spectrophotometric assay for pharmaceutical quality control of crizotinib (CZT, a novel drug for the treatment of non-small cell lung cancer. We examined the reaction between CZT and 1,2-naphthoquinone-4-sulphonate, a chromogenic reagent. A red-colored product showing a maximum absorption peak (λmax at 490 nm was produced in an alkaline medium (pH 9. We examined stoichiometry of the reaction and postulated the reaction mechanism. To our knowledge, this is the first study to describe a color-developing reaction for the proposed assay. The reaction was performed in a 96-microwell plate, and the absorbance of the colored product was measured using an absorbance reader at 490 nm. Under optimized reaction conditions, Beer's law, which shows a correlation between absorbance and CZT concentration, was obeyed in the range of 4-50 µg/well with an appropriate correlation coefficient (0.999. The limits of detection and quantification were 1.73 and 5.23 µg/well, respectively. The assay showed high precision and accuracy. The proposed assay was applied successfully for the determination of CZT in capsules. Thus, the assay proposed in this study is practical and valuable for routine application in pharmaceutical quality control laboratories.

  10. Fuzzy Comprehensive Evaluation Method for the Evaluation of Pharmaceutical GMP Quality System Effectiveness%制药GMP质量体系有效性评价的模糊综合评价方法

    Institute of Scientific and Technical Information of China (English)

    陈霖; 郑建国

    2011-01-01

    提出药品生产质量管理规范(简称GMP)质量体系有效性评价的模糊综合评价方法,并运用该方法对1个制药公司的GMP质量体系的有效性进行实际测评分析。模糊综合评价方法运用模糊数学理论,从质量方针和目标、产品质量的稳定性、质量改进与创新、资源管理4个方面来综合评价制药GMP质量体系运行的有效性,评价结果具有整体性。%A fuzzy comprehensive evaluation system was proposed and it was used to evaluate the effectiveness of the GMP quality system of a pharmaceutical company.The system was established to evaluate the effectiveness of GMP quality system using a fuzzy mathematics theory based on the policy and goal of quality,stability of the product's quality,quality improvement and innovation,and resource management.The evaluation system provided a complete algorithm for the GMP quality system evaluation process.

  11. Biological and Pharmaceutical Nanomaterials

    Science.gov (United States)

    Kumar, Challa S. S. R.

    2006-01-01

    This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

  12. Does brand differentiate pharmaceuticals?

    Science.gov (United States)

    Bednarik, Josef

    2005-12-01

    Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

  13. Ethics and the pharmaceutical industry.

    Science.gov (United States)

    Green, Stephen

    2008-06-01

    Relationships between the pharmaceutical industry and the medical profession enhance the potential for physicians to become involved in conflicts of interest. Whether or not these rise to a level that violates standards of medical ethics depends on the degree to which they detract from the quality of health care and its cost, the objectivity of research, and the profession's integrity. This paper explores those issues from two perspectives--the micro-level of the medical profession and the macro-level of society. Practices and policies that affect varied aspects of the interaction between the pharmaceutical industry and the medical profession--such as education, research and marketing--are discussed. The reader is asked to reflect on the ethics of issues raised; the author offers suggestions for mitigating conflicts of interest and, in turn, the potential for unethical medical care.

  14. Pharmacological Chaperones and Coenzyme Q10 Treatment Improves Mutant β-Glucocerebrosidase Activity and Mitochondrial Function in Neuronopathic Forms of Gaucher Disease.

    Science.gov (United States)

    de la Mata, Mario; Cotán, David; Oropesa-Ávila, Manuel; Garrido-Maraver, Juan; Cordero, Mario D; Villanueva Paz, Marina; Delgado Pavón, Ana; Alcocer-Gómez, Elizabet; de Lavera, Isabel; Ybot-González, Patricia; Paula Zaderenko, Ana; Ortiz Mellet, Carmen; García Fernández, José M; Sánchez-Alcázar, José A

    2015-06-05

    Gaucher disease (GD) is caused by mutations in the GBA1 gene, which encodes lysosomal β-glucocerebrosidase. Homozygosity for the L444P mutation in GBA1 is associated with high risk of neurological manifestations which are not improved by enzyme replacement therapy. Alternatively, pharmacological chaperones (PCs) capable of restoring the correct folding and trafficking of the mutant enzyme represent promising alternative therapies.Here, we report on how the L444P mutation affects mitochondrial function in primary fibroblast derived from GD patients. Mitochondrial dysfunction was associated with reduced mitochondrial membrane potential, increased reactive oxygen species (ROS), mitophagy activation and impaired autophagic flux.Both abnormalities, mitochondrial dysfunction and deficient β-glucocerebrosidase activity, were partially restored by supplementation with coenzyme Q10 (CoQ) or a L-idonojirimycin derivative, N-[N'-(4-adamantan-1-ylcarboxamidobutyl)thiocarbamoyl]-1,6-anhydro-L-idonojirimycin (NAdBT-AIJ), and more markedly by the combination of both treatments. These data suggest that targeting both mitochondria function by CoQ and protein misfolding by PCs can be promising therapies in neurological forms of GD.

  15. Effect of coenzyme Q10 against skin photoageing%辅酶Q1O在抗皮肤光老化中的作用

    Institute of Scientific and Technical Information of China (English)

    黄淳韵; 项蕾红

    2013-01-01

    如同人体其他系统,皮肤的内在老化也是不可避免的.此外,紫外线辐射诱发的氧化应激状态构成了皮肤的光老化,在皮肤老化的外因中起主要作用,抗氧化成了缓解皮肤外在老化的主要环节.辅酶Ql0一直以来主要用于维护心血管系统的健康,基于其抗氧化和抗炎活性,近年来逐渐应用在皮肤的健康领域.%Like other systems of the body,skin inevitably suffers from intrinsic ageing.In addition,ultraviolet radiation-induced oxidative stress plays a determinant role in extrinsic skin ageing.Therefore,counteracting oxidative stress is the key to alleviating extrinsic skin ageing.Coenzyme Q1O has been mainlyused in the improvement of cardiovascular function.Recently,because of its antioxidant and anti-inflammatoryproperties,coenzyme Q10 has been attempted to slow down skin ageing process.

  16. 左卡尼汀(而非辅酶 Q10)提高阿托伐他汀在切除卵巢的老鼠的抗骨质疏松作用%L-Carnitine, but not coenzyme Q10, enhances the anti-osteoporotic effect of atorvastatin in ovariectomized rats

    Institute of Scientific and Technical Information of China (English)

    Hussam A S MURAD

    2016-01-01

    Objective: Statins’ therapy in osteoporosis can aggravate muscle damage. This study was designed to assess which agent,L-carnitine or coenzyme Q10, could enhance the anti-osteoporotic effect of atorvastatin while antagonizing myopathy in ovariectomized rats. Methods: Forty-eight female Sprague Dawley rats were used; forty rats were ovariectomized while eight were sham-operated. Eight weeks post-ovariectomy, rats were divided into ovariectomized-untreated group and four ovariectomized-treated groups (n=8) which received by gavage (mg/(kg·d), for 8 weeks) 17β-estradiol (0.1), atorvastatin (50), atorvastatin (50)+L-carnitine (100), or atorvastatin (50)+coenzyme Q10 (20). At the end of therapy, bone mineral density (BMD), bone mineral content (BMC), and serum levels of bone metabolic markers (BMMs) and creatine kinase (CK) were measured. Femurs were used for studying the breaking strength and histopathological changes. Results: Treatment with atorvastatin+L-carnitine restored BMD, BMC, and bone strength to near normal levels. Estrogen therapy restored BMD and BMC to near normal levels, but failed to increase bone strength. Although atorvastatin and atorvastatin+coenzyme Q10 improved BMD, BMC, and bone strength, they failed to restore levels to normal. Al treatments decreased BMMs and improved histopathological changes maximaly with atorvastatin+L-carnitine which restored levels to near normal. Atorvastatin aggravated the ovariectomy-induced increase in CK level while estrogen, atorvastatin+L-carnitine, and atorvastatin+coenzyme Q10 decreased its level mainly with atorvastatin+L-carnitine which restored the level to near normal. Conclusions: Co-administrationofL-carnitine, but not coenzyme Q10, enhances the anti-osteoporotic effect of atorvastatin while an-tagonizing myopathy in ovariectomized rats. This could be valuable in treatment of osteoporotic patients. However, further confirmatory studies are needed.%目的:他汀类药物在治疗骨质疏松症时会

  17. Deepening the Reform of Higher Pharmaceutical Education for the 21st Century.

    Science.gov (United States)

    Wu, Xiaoming

    2000-01-01

    Development of the pharmaceutical industry in China depends on research and development of new drugs. The development of high-quality education for potential pharmaceutical practitioners is central to the development of this industry in China. (JM)

  18. Pharmaceutical pricing and reimbursement reforms in Greece.

    Science.gov (United States)

    Yfantopoulos, John

    2008-02-01

    Pharmaceutical price regulation in Greece is centralized. The National Drug Organization (EOF) is the main regulatory authority functioning under the auspices of the Ministry of Health and Social Solidarity. In 2004, total pharmaceutical expenditure in Greece reached the level of 2.9 billion euro, of which 77.9% were public expenditure and the remaining 22.1% private. According to Organization for Economic Cooperation and Development (OECD) data the total per-capita expenditure on pharmaceutical care in Greece is among the lowest in Europe, representing 58% of the EU-12 average. In 1998, Greece introduced a reimbursement list, and the lowest reference pricing system among the 15 European Union member states with the purpose of controlling the growth of pharmaceutical expenditure. The measures proved to be ineffective since pharmaceutical expenditure, after a short-term reduction, continued to increase at similar rates to those before the introduction of price control mechanisms. The average annual increase of pharmaceutical expenditure in Greece over the period 1998-2003 was 7.9%, which is among the highest in the OECD countries (average 6.1%). New pharmaceutical legislation, no. 3457, was enacted on May 8th 2006, aiming at greater access to medicines, improvements to citizens' quality of life, effective and efficient utilization of health resources, transparency in public management, protecting public health, and maintaining long-term financial viability of the insurance system. The innovative aspect of the new legislation is the abolition of the positive list and the establishment of a rebate system granting the National Insurance Funds a rebate rate paid by the pharmaceutical companies. The purpose of this paper is twofold. First to assess the effectiveness of the positive list introduced in 1988 in Greece, using simple econometric models. Second to present the recent pharmaceutical reforms aimed at the introduction of a rebate system and establishing

  19. Quality-by-Design (QbD): an integrated process analytical technology (PAT) approach for real-time monitoring and mapping the state of a pharmaceutical coprecipitation process.

    Science.gov (United States)

    Wu, Huiquan; Khan, Mansoor A

    2010-03-01

    In this work, an integrated PAT approach was developed for monitoring a pharmaceutical (naproxen) and a polymer (eudragit) coprecipitation process: real-time in-line near-infrared (NIR) absorbance monitoring, real-time on-line turbidity monitoring, and in situ crystal size monitoring. The data and information obtained through these three monitoring techniques confirmed the observation of the onsets of three distinct stages: incubation, nucleation, and crystal growth. The process trajectory constructed based on results of applying principal component analysis (PCA) to either process NIR spectra data or process turbidity profile, clearly demonstrated that various distinguishable process events, including incubation, nucleation, and crystal growth, could be accurately tracked and differentiated. These findings were further supported by process knowledge and information, such as process design, process sequence, thermodynamic and mass-transfer analysis. Therefore, this work provides a case study that illustrated a rational approach to develop a science-based and knowledge-based process monitoring strategy, which is essential for establishing both a suitable process control strategy and an operational process space for a pharmaceutical unit operation. 2009 Wiley-Liss, Inc. and the American Pharmacists Association

  20. RISK-FACTORS, PATHOGENESIS, AND PHARMACEUTICAL APPROACHES FOR TREATMENT OF STEROID-INDUCED BONE INFARCTION OF FEMORAL HEAD.

    Science.gov (United States)

    Wang, Fei; Wang, Yang; Hu, Ningning; Miao, Xuman

    2016-01-01

    During first year of steroid usage, osteocyte necrosis and blood vessel blockage may occur, which subsequently may produce steroid-induced bone infarction (SIBI) resulting in painful movement of patient. For treatment of SIBI, pharmaceutical strategy is the basic approach. It involves the use of various pharmacologically active compounds including bisphosphonates, hyperbaric oxygen (HBO), coenzyme Q10, erythropoietin, antihyperlipidemics, anticoagulants, antioxidants, and tissue repair protein. Out of these, there is no pharmaceutical agent that may completely treat this disease because many factors are found to be responsible for SIBI development; therefore, there are multiple biomarkers of this disease. This situation argues for need of new therapeutic agents for SIEB1.

  1. Wisdom Pharmaceutical Co., Ltd.

    Institute of Scientific and Technical Information of China (English)

    2003-01-01

    @@ Wisdom Pharmaceutical Co., Ltd. (Wisdom) headquartered in Haimen, Nantong, Jiangsu Province, China, is specialized in providing highly efficient production processes of active pharmaceutical ingredients (API) and intermediates. Currently, Wisdom is in the process of expanding GMP (Good Manufacturing Practice) capabilities, which is expected to be approved by the authorities before the end of September 2003.

  2. RECENT TRENDS IN PACKAGING SYSTEMS FOR PHARMACEUTICAL PRODUCTS

    OpenAIRE

    Renata Dobrucka

    2014-01-01

    Background:  In recent years, pharmaceutical packaging market was one of the fastest growing areas of the packaging industry. At the same time the packaging manufacturers put high demands on quality and safety. Methods: Review of innovations in packaging systems for pharmaceutical products was made including newest information of researches and achievements of recent years. Results and conclusion: Observed in recent years the development of pharmaceutical packaging market expan...

  3. Glycophospholipid Formulation with NADH and CoQ10 Significantly Reduces Intractable Fatigue in Western Blot-Positive ‘Chronic Lyme Disease’ Patients: Preliminary Report

    Directory of Open Access Journals (Sweden)

    Garth L. Nicolson

    2012-03-01

    Full Text Available Background: An open label 8-week preliminary study was conducted in a small number of patients to determine if a combination oral supplement containing a mixture of phosphoglycolipids, coenzyme Q10 and microencapsulated NADH and other nutrients could affect fatigue levels in long-term, Western blot-positive, multi-symptom ‘chronic Lyme disease’ patients (also called ‘post-treatment Lyme disease’ or ‘post Lyme syndrome’ with intractable fatigue. Methods: The subjects in this study were 6 males (mean age = 45.1 ± 12.4 years and 10 females (mean age = 54.6 ± 7.4 years with ‘chronic Lyme disease’ (determined by multiple symptoms and positive Western blot analysis that had been symptomatic with chronic fatigue for an average of 12.7 ± 6.6 years. They had been seen by multiple physicians (13.3 ± 7.6 and had used many other remedies, supplements and drugs (14.4 ± 7.4 without fatigue relief. Fatigue was monitored at 0, 7, 30 and 60 days using a validated instrument, the Piper Fatigue Scale.Results: Patients in this preliminary study responded to the combination test supplement, showing a 26% reduction in overall fatigue by the end of the 8-week trial (p< 0.0003. Analysis of subcategories of fatigue indicated that there were significant improvements in the ability to complete tasks and activities as well as significant improvements in mood and cognitive abilities. Regression analysis of the data indicated that reductions in fatigue were consistent and occurred with a high degree of confidence (R2= 0.998. Functional Foods in Health and Disease 2012, 2(3:35-47 Conclusions: The combination supplement was a safe and effective method to significantly reduce intractable fatigue in long-term patients with Western blot-positive ‘chronic Lyme disease.’

  4. Effects of Combined Treatment with Branched-Chain Amino Acids, Citric Acid, L-Carnitine, Coenzyme Q10, Zinc, and Various Vitamins in Tumor-Bearing Mice.

    Science.gov (United States)

    Awa, Hiroko; Futamura, Akihiko; Higashiguchi, Takashi; Ito, Akihiro; Mori, Naoharu; Murai, Miyo; Ohara, Hiroshi; Chihara, Takeshi; Kaneko, Takaaki

    2017-03-01

    A functional dietary supplement (FDS) containing Coenzyme Q10, branched-chain amino acids and L-carnitine was administered to tumor-bearing mice, investigating its effects on tumor and muscle tissues. Experiment (A): B16 melanoma cells were implanted subcutaneously into the right side of the abdomen of 8- to 9-week-old C57BL/6J mice. The mice were divided into two groups: a FDS group that received oral administration of FDS (n=10), and a control group that received oral administration of glucose (n=10). The moribund condition was used as the endpoint, and median survival time was determined. Experiment (B): On day 21 after tumor implantation, tumors, soleus muscle, gastrocnemius muscle, and suprahyoid muscles were collected. Tumor and muscle weight and other aspects were evaluated in each group: FDS group (n=15) and control group (n=15). The median survival time was comparable (21 d in the FDS group vs. 18 d in the control group, p=0.30). However, cumulative food intake was significantly higher in the FDS group than the control group (p=0.011). Metastasis of melanoma to the lung was observed in the control group but not in the FDS group (p=0.043). The weight of the suprahyoid muscles was significantly higher in the FDS group than in the control group (p=0.0045). The weight of the tumor was significantly lower in the FDS group than in the control group (p=0.013). The results possibly suggest oral administration of FDS in tumor-bearing mice enhances the maintenance of suprahyoid muscles, resulting in an extended feeding period and suppression of tumor growth and metastasis.

  5. Defining pharmaceutical systems strengthening: concepts to enable measurement.

    Science.gov (United States)

    Hafner, Tamara; Walkowiak, Helena; Lee, David; Aboagye-Nyame, Francis

    2017-05-01

    Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their

  6. Pharmaceutical regulation in 15 European countries review.

    Science.gov (United States)

    Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

    2016-10-01

    In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices.

  7. A der(18)t(9;18)(p13;p11) and a der(9;18)(p10;q10) in polycythemia vera associated with a hyperproliferative phenotype in transformation to postpolycythemic myelofibrosis

    DEFF Research Database (Denmark)

    Larsen, Thomas Stauffer; Hasselbalch, Hans Carl; Pallisgaard, Niels

    2007-01-01

    [two with PV, one with PV in transformation to idiopathic myelofibrosis (IMF) and one IMF patient], with the distinct karyotypic abberations der(18) t(9;18) (p13;p11) and der(9;18)(p10;q10). Two patients had hyperproliferative PV and two had "transitional PV" and IMF, respectively. All four patients...

  8. Pharmaceutical Industry Develops Steadily

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ With the development of the economy, the growth of the total population, the growing proportion of older citizens, and the increasing awareness of people's health care,the pharmaceutical market in China has seen a sustained and rapid expansion.

  9. Ethiopian Pharmaceutical Journal: Submissions

    African Journals Online (AJOL)

    Ethiopian Pharmaceutical Journal (EPJ) is a bian-nual Journal, which ... Acknowledgements, References, Illustrations (Tables, Figures and chemistry ... Nomenclature and spelling should conform to the directions given by IUPAC and IUB.

  10. Amorphous pharmaceutical solids.

    Science.gov (United States)

    Vranić, Edina

    2004-07-01

    Amorphous forms are, by definition, non-crystalline materials which possess no long-range order. Their structure can be thought of as being similar to that of a frozen liquid with the thermal fluctuations present in a liquid frozen out, leaving only "static" structural disorder. The amorphous solids have always been an essential part of pharmaceutical research, but the current interest has been raised by two developments: a growing attention to pharmaceutical solids in general, especially polymorphs and solvates and a revived interest in the science of glasses and the glass transition. Amorphous substances may be formed both intentionally and unintentionally during normal pharmaceutical manufacturing operations. The properties of amorphous materials can be exploited to improve the performance of pharmaceutical dosage forms, but these properties can also give rise to unwanted effects that need to be understood and managed in order for the systems to perform as required.

  11. Vendor qualification for pharmaceutical excipients--GMP requirements and approach.

    Science.gov (United States)

    Patel, K T; Chotal, N P

    2010-11-01

    Excipients are, in the large majority of cases, not made specifically for pharmaceutical use. Most pharmaceutical excipient manufacturers supply less than 10% of the total production of that particular material for pharmaceutical use. Excipient product portfolio consists of hundreds of products differing in chemistry, origin and functionality and they are used in many different applications. The days of treating excipients like commodities and buying them without fully qualifying the source and the entire distribution chain have gone by as GMP regulations demands to ensure quality of other materials used in the manufacturing process. The paradigm that exists in some pharmaceutical companies today where excipients are sourced from distributors without knowing the actual manufacturer, manufacturing site and full distribution lifecycle chain to be changed. The present contribution gives an overview about the current moves on GMP requirements for pharmaceutical excipient and approach for qualification of pharmaceutical excipient manufacturers.

  12. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development.

    Science.gov (United States)

    Wu, Huiquan; White, Maury; Khan, Mansoor A

    2011-02-28

    The aim of this work was to develop an integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and design space development. A dynamic co-precipitation process by gradually introducing water to the ternary system of naproxen-Eudragit L100-alcohol was monitored at real-time in situ via Lasentec FBRM and PVM. 3D map of count-time-chord length revealed three distinguishable process stages: incubation, transition, and steady-state. The effects of high risk process variables (slurry temperature, stirring rate, and water addition rate) on both derived co-precipitation process rates and final chord-length-distribution were evaluated systematically using a 3(3) full factorial design. Critical process variables were identified via ANOVA for both transition and steady state. General linear models (GLM) were then used for parameter estimation for each critical variable. Clear trends about effects of each critical variable during transition and steady state were found by GLM and were interpreted using fundamental process principles and Nyvlt's transfer model. Neural network models were able to link process variables with response variables at transition and steady state with R(2) of 0.88-0.98. PVM images evidenced nucleation and crystal growth. Contour plots illustrated design space via critical process variables' ranges. It demonstrated the utility of integrated PAT approach for QbD development. Published by Elsevier B.V.

  13. Electroanalytical Performance of a Carbon Paste Electrode Modified by Coffee Husks for the Quantification of Acetaminophen in Quality Control of Commercialized Pharmaceutical Tablets

    Directory of Open Access Journals (Sweden)

    Serge Foukmeniok Mbokou

    2016-01-01

    Full Text Available Electrochemical determination of acetaminophen (APAP was successfully performed using a carbon paste electrode (CPE modified with coffee husks (CH-CPE. Scanning electron microscopy (SEM and SEM-energy dispersive X-ray spectroscopy (SEM-EDX were, respectively, used for the morphological and elemental characterization of coffee husks prior to their utilization. The electrochemical oxidation of APAP was investigated by cyclic voltammetry (CV, differential pulse voltammetry (DPV, and square wave voltammetry (SWV. SWV technique appeared to be more sensitive since the oxidation current of APAP was twofold higher with the CH-CPE sensor than with the bare CPE, in relation to the increase in the organophilic character of the electrode surface. Furthermore, on CH-CPE, the current response of APAP varied linearly with its concentration in the range of 6.6 μM to 0.5 mM, leading to a detection limit of 0.66 μM (S/N=3. Finally, the proposed CH-CPE sensor was successfully used to determine the amount of APAP in commercialized tablets (Doliprane® 500 and Doliprane 1000, with a recovery rate ranging from 98% to 103%. This novel sensor opens the way for the development of low-cost and reliable devices for the electroanalysis of pharmaceutical formulations in developing countries.

  14. Reduced Cardiovascular Mortality 10 Years after Supplementation with Selenium and Coenzyme Q10 for Four Years: Follow-Up Results of a Prospective Randomized Double-Blind Placebo-Controlled Trial in Elderly Citizens.

    Directory of Open Access Journals (Sweden)

    Urban Alehagen

    Full Text Available Selenium and coenzyme Q10 are important antioxidants in the body. As the intake of selenium is low in Europe, and the endogenous production of coenzyme Q10 decreases as age increases, an intervention trial using selenium and coenzyme Q10 for four years was performed. As previously reported, the intervention was accompanied by reduced cardiovascular mortality. The objective of the present study was to analyze cardiovascular mortality for up to 10 years after intervention, to evaluate if mortality differed in subgroups differentiated by gender, diabetes, ischemic heart disease (IHD, and functional class.Four-hundred forty-three healthy elderly individuals were included from a rural municipality in Sweden. All cardiovascular mortality was registered, and no participant was lost to the follow-up. Based on death certificates and autopsy results mortality was registered.Significantly reduced cardiovascular mortality could be seen in those on selenium and coenzyme Q10 intervention. A multivariate Cox regression analysis demonstrated a reduced cardiovascular mortality risk in the active treatment group (HR: 0.51; 95%CI 0.36-0.74; P = 0.0003. The reduced mortality could be seen to persist during the 10-year period. Subgroup analysis showed positive effects in both genders. An equally positive risk reduction could be seen in those with ischemic heart disease (HR: 0.51; 95%CI 0.27-0.97; P = 0.04, but also in the different functional classes.In a 10-year follow-up of a group of healthy elderly participants given four years of intervention with selenium and coenzyme Q10, significantly reduced cardiovascular mortality was observed. The protective action was not confined to the intervention period, but persisted during the follow-up period. The mechanism explaining the persistency remains to be elucidated. Since this was a small study, the observations should be regarded as hypothesis-generating.

  15. Q10 supplementation effects on cardiac enzyme CK-MB and troponin in patients undergoing coronary artery bypass graft: a randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Moludi, Jalal; Keshavarz, Seyedali; Tabaee, Ali Sadeghpour; Safiri, Saeid; Pakzad, Reza

    2016-01-01

    Coronary artery bypass surgery (CABG) is associated with ischemia-reperfusion injury and tissue damage. CoQ10 as an antioxidant has an important role and may have cardio-protective effects after myocardial dysfunction and CABG. We aimed to evaluate whether CoQ10 has a myocardial cardio protective impact on cardiac biomarkers after CABG. In this double-blind study, 80 patients with coronary artery disease (CAD) who underwent CABG surgery were divided into intervention and control groups and received Q10 supplement or placebo, respectively. The surgical characteristics of the patients in the two groups were similar. The intervention group received 150 mg of Q10 supplement per day for 7 days before the surgery. The control group received placebo capsule. After operation the inter- and intra-group blood levels of CK-MB and troponin, before and after supplementation and 12 hours after the CABG, and postoperative outcomes such as intensive care unit (ICU) stay and hospital stay were compared. In this study, 40 subjects were located in each group. The participation rate was 97.5% and men and women accounted for 52.5% and 47.5% respectively. The mean age of the subjects was 58.17 ± 8.55. The two groups were not significantly different in terms of basic variables. Within-group comparison showed a significant increase in the level of troponin enzymes over time (P MB (P MB (P = 0.384) and troponin (P = 0.115). In the end, no interaction was observed between the intervention and time on CK-MB (P = 0.095) and troponin (P = 0.198) variables. Q10 supplementation 7 days before surgery was not effective in reducing CK-MB and troponin after CABG.

  16. The uncertainty budget in pharmaceutical industry

    DEFF Research Database (Denmark)

    Heydorn, Kaj

    Measurements in a pharmaceutical industry are usually carried out to ascertain the quality of a product or the control of a process; in either case the measurement result serves to demonstrate that the value of the measurand is within specified limits. No method is without bias, and no result...... of their uncertainty, exactly as described in GUM [2]. Pharmaceutical industry has therefore over the last 5 years shown increasing interest in accreditation according to ISO 17025 [3], and today uncertainty budgets are being developed for all so-called critical measurements. The uncertainty of results obtained...

  17. Review: Pharmaceutical policies : effects of financial incentives for prescribers

    NARCIS (Netherlands)

    Sturm, H.; Austvoll-Dahlgren, A.; Aaserud, M.; Oxman, A. D.; Ramsay, C.; Vernby, A.; Koesters, J. P.

    2007-01-01

    Background Pharmaceuticals, while central to medical therapy, pose a significant burden to health care budgets. Therefore regulations to control prescribing costs and improve quality of care are implemented increasingly. These include the use of financial incentives for prescribers, namely increased

  18. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    Science.gov (United States)

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

  19. Comparative standardization study for determination of reserpine in Rauwolfia serpentina homoeopathic mother tinctures manufactured by different pharmaceutical industries using HPTLC as a check for quality control

    Directory of Open Access Journals (Sweden)

    Binit Kumar Dwivedi

    2017-01-01

    Full Text Available Background: Rauwolfia serpentina (L. Benth. ex Kurz (Apocynaceae (Indian snakeroot, popularly known as Sarpagandha (Sanskrit, is used for the treatment of insanity, fever, snake bites, anxiety and in neuropsychiatric conditions. The antihypertensive actions of Reserpine are a result of its ability to deplete catecholamines (amongst other monoamine neurotransmitters from peripheral sympathetic nerve endings which are normally involved in controlling heart rate, force of cardiac contraction and peripheral vascular resistance. Objective: Comparative study of Reserpine content in R. serpentina homoeopathic mother tinctures manufactured by different pharmaceutical industries and in-house mother tinctures applying high-performance thin-layer chromatography investigative techniques to facilitate the use of correct species. Materials and Methods: The authentic samples of roots of R. serpentina were supplied by Centre of Medicinal Plants Research in Homoeopathy, Emerald, Tamil Nadu, India. Authentic plant material was used to prepare the mother tincture (as per Homoeopathic Pharmacopoeia of India. Reserpine (C33H40N2O9,M.P. 360°C, purity >99% w/w by high-performance liquid chromatography [HPLC] was purchased from Sigma-Aldrich as a standard reference. The solvents for the study, namely, ethanol, HPLC water, toluene, ethyl acetate, diethylamine and chloroform were of analytical grade purity (MERCK Ltd.,, used throughout. Results: Five samples of mother tinctures were used for the study, in-house mother tinctures (labelled: D and E of R. serpentina shows a higher amount of Reserpine content than the marketed samples (labelled: A, B and C. Conclusion: It may be concluded that mother tinctures prepared by authentic plants showed the excess amount of Reserpine rather than that of mother tinctures procured from the market.

  20. Ion beam analysis and PD-MS as new analytical tools for quality control of pharmaceuticals: comparative study from fluphenazine in solid dosage forms.

    Science.gov (United States)

    Nsouli, Bilal; Bejjani, Alice; Negra, Serge Della; Gardon, Alain; Thomas, Jean-Paul

    2010-09-01

    In order to evaluate the potential of accelerator based analytical techniques ((particle induced X-ray emission (PIXE), particle induced gamma-ray emission (PIGE), and particle desorption mass spectrometry (PD-MS)) for the analysis of commercial pharmaceutical products in their solid dosage form, the fluphenazine drug has been taken as a representative example. It is demonstrated that PIXE and PIGE are by far the best choice for quantification of the active ingredient (AI) (certification with 7% precision) from the reactions induced on its specific heteroatoms fluorine and sulfur using pellets made from original tablets. Since heteroatoms cannot be present in all types of drugs, the PD-MS technique, which makes easily the distinction between AI(s) and excipients, has been evaluated for the same material. It is shown that the quantification of AI is obtained via the detection of its protonated molecule. However, calibration curves have to be made from the secondary ion yield variations since matrix effects of various nature are characteristics of such mixtures of heterogeneous materials (including deposits from soluble components). From the analysis of solid tablets, (either transformed into pellets and even as received), it is strongly suggested that the physical state of the grains in the mixture is a crucial parameter in the ion emission and accordingly for the calibration curves. As a result of our specific (but not optimized) conditions the resulting precision is <17% with an almost linear range extending from 0.04 to 7.87 mg of AI in a tablet made under the manufacturer conditions (the commercial drug product is labeled at 5 mg).

  1. 21 CFR 26.19 - Information relating to quality aspects.

    Science.gov (United States)

    2010-04-01

    ... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.19...

  2. Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective.

    Science.gov (United States)

    Tucker, Geoffrey; DeSilva, Binodh; Dressman, Jennifer; Ito, Michiho; Kumamoto, Takuya; Mager, Don; Mahler, Hanns-Christian; Maitland-van der Zee, Anke H; Pauletti, Giovanni M; Sasaki, Hitoshi; Shah, Vinod; Tang, Daniel; Ward, Michael

    2016-09-01

    The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery, natural products, formulation design and pharmaceutical technology, pharmacokinetics/pharmacodynamics and systems pharmacology, translational and personalized medicine, biotechnology, analytical sciences and quality control, and regulatory science.

  3. Significant changes in circulating microRNA by dietary supplementation of selenium and coenzyme Q10 in healthy elderly males. A subgroup analysis of a prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens.

    Science.gov (United States)

    Alehagen, Urban; Johansson, Peter; Aaseth, Jan; Alexander, Jan; Wågsäter, Dick

    2017-01-01

    Selenium and coenzyme Q10 is essential for important cellular functions. A low selenium intake is reported from many European countries, and the endogenous coenzyme Q10 production is decreasing in the body with increasing age. Supplementation with selenium and coenzyme Q10 in elderly have shown reduced cardiovascular mortality and reduced levels of markers of inflammation. However, microRNA analyses could give important information on the mechanisms behind the clinical effects of supplementation. Out of the 443 healthy elderly participants that were given supplementation with 200 μg Se/day as organic selenium yeast tablets, and 200 mg/day of coenzyme Q10 capsules, or placebo for 4 years, 25 participants from each group were randomized and evaluated regarding levels of microRNA. Isolation of RNA from plasma samples and quantitative PCR analysis were performed. Volcano- and principal component analyses (PCA)-plots were used to illustrate the differences in microRNA expression between the intervention, and the placebo groups. Serum selenium concentrations were measured before intervention. On average 145 different microRNAs out of 172 were detected per sample. In the PCA plots two clusters could be identified indicating significant difference in microRNA expression between the two groups. The pre-treatment expression of the microRNAs did not differ between active treatment and the placebo groups. When comparing the post-treatment microRNAs in the active and the placebo groups, 70 microRNAs exhibited significant differences in expression, also after adjustment for multiple measurements. For the 20 microRNAs with the greatest difference in expression the difference was up to more than 4 fold and with a P-value that were less than 4.4e-8. Significant differences were found in expression of more than 100 different microRNAs with up to 4 fold differences as a result of the intervention of selenium and coenzyme Q10 combined. The changes in microRNA could be a part of

  4. Fuzzy Comprehensive Evaluation on e-Service Quality of B to C E-commerce in Pharmaceutical Industry%基于模糊理论的B2C医药电子商务服务质量的综合评价

    Institute of Scientific and Technical Information of China (English)

    曾学文; 刘斯敏

    2013-01-01

    The development of B2C E-commerce in Pharmaceutical Industry is depends largely on the quality service of the medical e-commerce businesses, combined with the characteristics of pharmaceutical e-commerce, this paper build on the basis of the B2C pharmaceutical e-commerce service quality evaluation, fuzzy mathematics theory, based on fuzzy comprehensive evaluation method of the theory of fuzzy mathematics B2C pharmaceutical e-commerce service quality.%B2C 医药电子商务的发展很大程度上取决于医药电子商务企业的服务质量,结合医药电子商务的特点,该文构建B2C医药电子商务服务质量的评价指标的基础上,应用模糊数学的相关理论,建立了基于模糊数学理论的B2C医药电子商务服务质量的模糊综合评价方法.

  5. Pharmaceutical characterization of novel tenofovir liposomal formulations for enhanced oral drug delivery: in vitro pharmaceutics and Caco-2 permeability investigations

    OpenAIRE

    Spinks, Crystal; Zidan, Ahmed; Khan, Mansoor; Habib, Muhammad; Faustino,Patrick

    2017-01-01

    Crystal B Spinks,1 Ahmed S Zidan,2,3 Mansoor A Khan,4 Muhammad J Habib,1 Patrick J Faustino2 1Department of Pharmaceutical Sciences, School of Pharmacy, Howard University, Washington, DC, 2Division of Product Quality Research, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA; 3Faculty of Pharmacy, Zagazig University, Zagazig, Egypt; 4Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, College Station, TX, USA Abstract: Tenofovi...

  6. Pharmaceutical supply chain risks: a systematic review.

    Science.gov (United States)

    Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

    2013-12-19

    Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

  7. New pharmaceuticals reduce cost of illness.

    Science.gov (United States)

    Hansen, R W

    1986-06-01

    The cost of illness includes not only the funds required to treat illness, but also the effect on the patient's quality of life. Recent concern about rising health costs have focused on the direct expenditures without noting that the cost of illness in terms of mortality and morbidity has declined significantly. Pharmaceuticals have played a major role in reducing the total cost of illness. Several studies of the cost-effectiveness of past introductions of vaccines and pharmaceuticals reveal large cost savings. Although the focus of most studies has been on major advances, the continuing process of less dramatic therapeutic improvements has significantly trimmed the cost of illness. Cost-benefit studies of new drugs or changes in drug use, while more difficult to perform, make it possible to influence the selection of therapy. Since pharmaceuticals represent less than 10% of total treatment costs, reduction in the cost of pharmaceutical products can only have a minor impact on the total cost of illness. Pharmaceuticals can reduce the cost of illness by providing alternative therapies that reduce direct treatment cost or improve the public health.

  8. Microbial growth in small-volume pharmaceuticals.

    Science.gov (United States)

    Whyte, W; Niven, L; Bell, N D

    1989-01-01

    The ability of aseptically filled pharmaceuticals to support microbial growth was tested on 43 small-volume products (mainly parenterals). These were inoculated with a variety of microorganisms which were known to be associated with contamination of pharmaceutical products. In general, Gram-negative bacteria were found to be much more likely to grow than Gram-positive. It was possible for an inoculum of a few cells to multiply to levels up to 10(7)/mL. The presence of preservatives also influenced the likelihood of growth, 12 out of 19 (63%) of the pharmaceuticals without preservatives supporting growth of one or more microorganisms; only 3 out of 24 (12%) of those with preservatives supported growth. The importance of these observations is discussed with reference to formulation of aseptically filled products, environmental sampling and the quality of cleanroom conditions necessary for production. It is suggested that those pharmaceuticals which are designed to be sterile but not to be terminally sterilized, should be tested before production begins, for their ability to support microbial growth. In this way, the risks involved in aseptically filling can be ascertained. A test is proposed in which "indicator" microorganisms would predict the likelihood of pharmaceutical formulations supporting growth.

  9. [Fourcroy and pharmaceutical journals].

    Science.gov (United States)

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  10. Conceptualizing Pharmaceutical Plants

    DEFF Research Database (Denmark)

    Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel

    2006-01-01

    In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

  11. Rheology in Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania

    2016-01-01

    Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology...... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...

  12. Robustness testing in pharmaceutical freeze-drying: inter-relation of process conditions and product quality attributes studied for a vaccine formulation.

    Science.gov (United States)

    Schneid, Stefan C; Stärtzel, Peter M; Lettner, Patrick; Gieseler, Henning

    2011-01-01

    The recent US Food and Drug Administration (FDA) legislation has introduced the evaluation of the Design Space of critical process parameters in manufacturing processes. In freeze-drying, a "formulation" is expected to be robust when minor deviations of the product temperature do not negatively affect the final product quality attributes. To evaluate "formulation" robustness by investigating the effect of elevated product temperature on product quality using a bacterial vaccine solution. The vaccine solution was characterized by freeze-dry microscopy to determine the critical formulation temperature. A conservative cycle was developed using the SMART™ mode of a Lyostar II freeze dryer. Product temperature was elevated to imitate intermediate and aggressive cycle conditions. The final product was analyzed using X-ray powder diffraction (XRPD), scanning electron microscopy (SEM), Karl Fischer, and modulated differential scanning calorimetry (MDSC), and the life cell count (LCC) during accelerated stability testing. The cakes processed at intermediate and aggressive conditions displayed larger pores with microcollapse of walls and stronger loss in LCC than the conservatively processed product, especially during stability testing. For all process conditions, a loss of the majority of cells was observed during storage. For freeze-drying of life bacterial vaccine solutions, the product temperature profile during primary drying appeared to be inter-related to product quality attributes.

  13. Aquisição de medicamentos no setor público: o binômio qualidade - custo Pharmaceutical procurement by the public sector: the quality/cost relationship

    Directory of Open Access Journals (Sweden)

    Vera Lúcia Luiza

    1999-10-01

    Full Text Available No presente trabalho, os autores abordam, dentro do âmbito da administração de materiais, a aquisição e o aprovisionamento de medicamentos no setor público de saúde, discutindo as duas principais vertentes da questão: qualidade e custo. São relatados os fatores que devem ser considerados pelo comprador quando se avalia o quesito qualidade de medicamentos, em especial a questão dos genéricos, a bioequivalência e a estabilidade das formulações. Por outro lado, o item custo é examinado, assim como as implicações que uma demanda diferenciada e voltada para as inovações tecnológicas tem sobre ele. Por fim, discutem-se alternativas, já empregadas em algumas instituições, apresentando-se sugestões cuja finalidade implica na possibilidade de compra de produtos de qualidade aliada à contenção de custos.The authors discuss procurement and provision of pharmaceutical products from the perspective of supply management in the public health sector, focusing on two main aspects: quality and cost. The article analyzes issues to be considered by buyers when evaluating drug quality, especially formulation stability, bioequivalence, and the role of generics. Also discussed are factors involving costs and cost management in relation to technological innovations and consumer demands. New alternatives and suggestions are examined and presented for procurement of high-quality, cost-effective drug products.

  14. 多策略代谢工程大肠杆菌高效生产辅酶Q10%Multiple Strategies for Metabolic Engineering of Escherichia coli for Efficient Production of Coenzyme

    Institute of Scientific and Technical Information of China (English)

    黄明涛; 王玥; 刘建忠; 毛宗万

    2011-01-01

    Escherichia coli BW25113 was metabolically engineered for CoQ10 production by replacing ispB with ddsA from Gluconobacter suboxydans. Effects of precursor balance and reduced nicotinamide-adenine dinucleotide phosphate (NADPH) availability on CoQ1o production in E. coli were investigated. The knockout of pykFA along with pck overexpression could maintain a balance between glyceraldehyde 3-phosphate and pyruvate, increasing CoQ10 production. Replacement of native NAD-dependent gapA with NADP-dependent gapC from Clostridium acetobutylicum, together with the overexpression of gapC, could increase NADPH availability and then enhanced CoQ10 production. Three effects, overexpressions of various genes in CoQ biosynthesis and central metabolism, different vectors and culture conditions on CoQ1o production in E. coli, were all investigated. The investigation of different vectors indicated that low copy number vector may be more beneficial for CoQ1o production in E. coli. The recombinant E. coli (△ispB::ddsA, △pykFA and △gapA::gapC), harboring the two plasmids encoding pck, dxs,idi and ubiCA genes under the control of PT5 on pQE30, ispA, ddsA from Gluconobacter suboxydans and gapC,from Clostridium acetobutylicum under the control of PBAD on pBAD33, could produce CoQ10 up to 3.24 mg·g-1 dry cell mass simply by changing medium from M9YG to SOB with phosphate salt and initial culture pH from 7.0 to 5.5. The yield is unprecedented and 1.33 times of the highest production so far in E. coli.

  15. In Vitro Effects of the Reduced Form of Coenzyme Q(10) on Secretion Levels of TNF-alpha and Chemokines in Response to LPS in the Human Monocytic Cell Line THP-1.

    Science.gov (United States)

    Schmelzer, Constance; Lorenz, Gerti; Rimbach, Gerald; Döring, Frank

    2009-01-01

    Ubiquinol-10 (QH(2)), the reduced form of Coenzyme Q(10) (CoQ(10)) serves as a potent antioxidant of lipid membranes. Because many antioxidants reveal potent anti-inflammatory effects, the influence of QH(2) on lipopolysaccharide (LPS)-induced pro-inflammatory cytokines and chemokines were determined in the human monocytic cell line THP-1. Stimulation of cells with LPS resulted in a distinct release of Tumour necrosis factor-alpha (TNF-alpha), Macrophage inflammatory protein-1 alpha (MIP-1alpha), Regulated upon activation, normal T cell expressed and secreted (RANTES) and Monocyte chemotattractant protein-1 (MCP-1). The LPS-induced responses were significantly decreased by pre-incubation of cells with QH(2) to 60.27 +/- 9.3% (p = 0.0009), 48.13 +/- 6.93% (p = 0.0007) and 74.36 +/- 7.25% (p = 0.008) for TNF-alpha, MIP-1alpha and RANTES, respectively. In conclusion, our results indicate anti-inflammatory effects of the reduced form of CoQ(10) on various proinflammatory cytokines and chemokines in vitro.

  16. Paraquat induces oxidative stress, neuronal loss in substantia nigra region and Parkinsonism in adult rats: Neuroprotection and amelioration of symptoms by water-soluble formulation of Coenzyme Q10

    Directory of Open Access Journals (Sweden)

    Sridhar TS

    2009-07-01

    Full Text Available Abstract Background Parkinson's disease, for which currently there is no cure, develops as a result of progressive loss of dopamine neurons in the brain; thus, identification of any potential therapeutic intervention for disease management is of a great importance. Results Here we report that prophylactic application of water-soluble formulation of coenzyme Q10 could effectively offset the effects of environmental neurotoxin paraquat, believed to be a contributing factor in the development of familial PD. In this study we utilized a model of paraquat-induced dopaminergic neurodegeneration in adult rats that received three weekly intra-peritoneal injections of the herbicide paraquat. Histological and biochemical analyses of rat brains revealed increased levels of oxidative stress markers and a loss of approximately 65% of dopamine neurons in the substantia nigra region. The paraquat-exposed rats also displayed impaired balancing skills on a slowly rotating drum (rotorod evidenced by their reduced spontaneity in gait performance. In contrast, paraquat exposed rats receiving a water-soluble formulation of coenzyme Q10 in their drinking water prior to and during the paraquat treatment neither developed neurodegeneration nor reduced rotorod performance and were indistinguishable from the control paraquat-untreated rats. Conclusion Our data confirmed that paraquat-induced neurotoxicity represents a convenient rat model of Parkinsonian neurodegeneration suitable for mechanistic and neuroprotective studies. This is the first preclinical evaluation of a water-soluble coenzyme Q10 formulation showing the evidence of prophylactic neuroprotection at clinically relevant doses.

  17. A GC-FID validated method for the quality control of Eucalyptus globulus raw material and its pharmaceutical products, and gc-ms fingerprinting of 12 Eucalyptus species.

    Science.gov (United States)

    Buenoa, Paula Carolina Pires; Junior, Milton Groppo; Bastos, Jairo Kenupp

    2014-12-01

    In this work we have validated a method to standardize and control the quality of Eucalyptus globulus raw material and phytomedicines containing either the essential oil or the fluid extract of this plant in the final formulation. Internal standardization provided a simple, fast, and reproducible GC-FID analytical method that accurately quantified 1,8-cineol in different E. globulus sub-products, such as its essential oil, dried leaves, fluid extract, and syrup. In addition, GC-MS identification of the main compounds ofE. globulus species afforded fingerprints for the qualitative analysis of different Eucalyptus species.

  18. The Effectiveness of Pharmaceutical Marketing

    NARCIS (Netherlands)

    E.R. Kappe

    2011-01-01

    textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to contr

  19. The Effectiveness of Pharmaceutical Marketing

    NARCIS (Netherlands)

    E.R. Kappe

    2011-01-01

    textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to

  20. Free trade in pharmaceuticals.

    Science.gov (United States)

    Outterson, M Kevin

    2004-09-06

    Provisions in the Australia-United States Free Trade Agreement (AUSFTA) may threaten the Australian Pharmaceutical Benefits Scheme (PBS), the "gold standard" of such programs worldwide. If Australia postpones passing of the US Free Trade Agreement Implementation Bill in the Senate, there will be opportunity for broader interests in both the United States and Australia to carefully study the agreement. The provisions of AUSFTA relating to the PBS are supposed to promote transparency, but the pharmaceutical manufacturers themselves (who are demanding transparency) do not reveal the content of their submissions to the Pharmaceutical Benefits Advisory Committee, or disclose all their financial relationships with researchers and policymakers. In AUSFTA, the "public health" language of affordable prescription drugs is missing and is replaced by language supporting "pharmaceutical innovation". Debate as to whether AUSFTA will force significant changes to the PBS, including higher drug prices, is currently under way in Australia. Perhaps the appropriate target of reforms should be the excessive US drug prices, and not the economically efficient Australian drug prices.

  1. Doctors and pharmaceutical industry.

    Science.gov (United States)

    Beran, Roy G

    2009-09-01

    The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

  2. The extended pharmaceutical enterprise.

    Science.gov (United States)

    Cavalla, David

    2003-03-15

    The availability of widespread contractual services led to the birth of the virtual company in the 1990s. As the concept has matured, and the biotechnology sector diversified, interchange of intellectual property in the form of collaborative and license arrangements opens up still further the opportunities for outsourced forms of pharmaceutical R&D.

  3. Cleaner production at pharmaceutical industry: first steps assessment

    Directory of Open Access Journals (Sweden)

    Edilaine Conceição Rezende

    2015-12-01

    Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.

  4. Pharmaceutical Public-Private Partnerships

    DEFF Research Database (Denmark)

    Bagley, Constance; Tvarnø, Christina D.

    2014-01-01

    This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding con...

  5. Nanoparticulate carriers (NPC) for oral pharmaceutics and nutraceutics.

    Science.gov (United States)

    Lopes, C M; Martins-Lopes, P; Souto, E B

    2010-02-01

    The introduction of nanoparticulate carriers (NPC) in the pharmaceutic and nutraceutic fields has changed the definitions of disease management and treatment, diagnosis, as well as the supply food chain in the agri-food sector. NPC composed of synthetic polymers, proteins or polysaccharides gather interesting properties to be used for oral administration of pharmaceutics and nutraceutics. Oral administration remains the most convenient way of delivering drugs (e.g. peptides, proteins and nucleic acids) since these suffer similar metabolic pathways as food supply. Recent advances in biotechnology have produced highly potent new molecules however with low oral bioavailability. A suitable and promising approach to overcome their sensitivity to chemical and enzymatic hydrolysis as well as the poor cellular uptake, would be their entrapment within suitable gastrointestinal (GI) resistant NPC. Increasing attention has been paid to the potential use of NPC for peptides, proteins, antioxidants (carotenoids, omega fatty acids, coenzyme Q10), vitamins, probiotics, for oral administration. This review focuses on the most important materials to produce NPC for oral administration, and the most recent achievements in the production techniques and bioactives successfully delivered by these means.

  6. The pharmaceutical care in asthma - Polish and global perspective.

    Science.gov (United States)

    Swieczkowski, Damian; Poniatowski, Patryk; Merks, Piotr; Jaguszewski, Milosz

    2016-01-01

    The pharmaceutical care is a pharmacist's contribution to the care of individual patients and leads to optimize the use of drugs. The pharmaceutical care may improve adherence, clinical effectiveness of providing therapy and improve the health-related quality of life. The conducted literature review confirmed that pharmaceutical care and advanced pharmaceutical services are clinical effective in asthma. The implementation of pharmaceutical care under Polish conditions is currently insufficient and remains challenging for the future. Herein we should admit, that the polish government has recently put an effort to appoint specially dedicated team establishing a program of reimbursed pharmaceutical care. This move should be considered as a new phase for amendments community pharmacy in Poland. The experience of different health care systems, including for instance United Kingdom, Australia or Canada, might be used in the process of changing Polish perspective. Herein, we have reviewed the literature and highlighted the services creating the program of pharmaceutical care in asthma. This unique work describes the complex nature of optimal pharmaceutical services emphasizing the strong necessity of multidimensional approach in this field.

  7. Effective executive management in the pharmaceutical industry.

    Science.gov (United States)

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

    Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they

  8. Pharmaceutical market in Serbia

    Directory of Open Access Journals (Sweden)

    Veselin Tima Dickov

    2012-02-01

    Full Text Available Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmaceutical product. A special challenge that the subject raises is the existence of controversy generated from two sources. Marketing controversy stems from criticism leveled at the effectiveness and efficiency of marketing activities and the debatable ethical code of conduct. [J Intercult Ethnopharmacol 2012; 1(1.000: 44-51

  9. RECENT TRENDS IN PACKAGING SYSTEMS FOR PHARMACEUTICAL PRODUCTS

    Directory of Open Access Journals (Sweden)

    Renata Dobrucka

    2014-12-01

    Full Text Available Background:  In recent years, pharmaceutical packaging market was one of the fastest growing areas of the packaging industry. At the same time the packaging manufacturers put high demands on quality and safety. Methods: Review of innovations in packaging systems for pharmaceutical products was made including newest information of researches and achievements of recent years. Results and conclusion: Observed in recent years the development of pharmaceutical packaging market expanded due to with the huge technological advances that allow introduction of new packaging. Also, in this study presented intelligent packaging in pharmacy and innovation in child-resistance packaging.

  10. The Pharmaceutical Commons

    OpenAIRE

    Lezaun, Javier; Catherine M Montgomery

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of p...

  11. Analysis of molecular interactions in solid dosage forms; challenge to molecular pharmaceutics.

    Science.gov (United States)

    Yamamoto, Keiji; Limwikrant, Waree; Moribe, Kunikazu

    2011-01-01

    The molecular states of active pharmaceutical ingredients (APIs) in pharmaceutical dosage forms strongly affect the properties and quality of a drug. Various important fundamental physicochemical studies were reviewed from the standpoint of molecular pharmaceutics. Mechanochemical effects were evaluated in mixtures of APIs and pharmaceutical additives. Amorphization, complex formation and nanoparticle formation are observed after grinding process depending on the combination of APIs and pharmaceutical additives. Sealed-heating method and mesoporous materials have been used to investigate drug molecular interactions in dosage forms. Molecular states have been investigated using powder X-ray diffraction, thermal analysis, IR, solid state fluorometry, and NMR.

  12. Trade, TRIPS, and pharmaceuticals.

    Science.gov (United States)

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

  13. Postgraduate Courses in Pharmaceutical Medicine in Italy.

    Science.gov (United States)

    Criscuolo, Domenico

    2017-01-01

    Italy has a significant tradition of excellence in the area of clinical trials (CTRs): important achievements in the clinical development of rifampicin and adriamycin, the two most famous drugs discovered in the research laboratories of two Italian pharmaceutical companies, paved the way to the establishment of a culture of clinical development, mainly in the areas of antimicrobials and oncology. Despite the fact that now the Italian market of pharmaceuticals is largely dominated by multinational companies with headquarters outside Italy, the contribution of Italian studies to the clinical development of new drugs is still significant. Indeed, it largely exceeds the percentage of Italian inhabitants versus the ones living in the remaining EU countries, as Italy has about 12% of EU population, but has a 17% share of the EU CTRs. Education in Pharmaceutical Medicine is now a must for all professionals interested to work either in pharma companies or in contract research organizations: several Italian universities are offering high quality courses, and in the last 10 years, more than 1,200 professionals received a postgraduate education in pharmaceutical medicine. This result places Italy on top of countries concerned about the professional education of people involved in drug development and will represent an asset for a larger involvement of Italian clinical sites in the global process of clinical research.

  14. APPROACHES TO IMPLEMENTATION OF AN INTEGRATED MANAGEMENT SYSTEM IN THE PHARMACEUTICAL INDUSTRY. GALENICAL PHARMACEUTICAL PRODUCTION

    Directory of Open Access Journals (Sweden)

    Ershova Elena Vladimirovna

    2015-10-01

    Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.

  15. A biochemical quality study of a pharmaceutically licenced coagulation active plasma (Octaplas) thawed by the SAHARA-III dry tempering system compared to the regular use of a water bath.

    Science.gov (United States)

    Heger, A; Römisch, J; Svae, T-E

    2008-01-01

    The most common way to thaw frozen coagulation-active plasma products for transfusion is the use of a water bath with good circulation at 30-37 degrees C. The aim of this study was to perform an extensive biochemical characterization of the pharmaceutically licenced solvent/detergent-treated plasma, Octaplas, thawed using the SAHARA-III dry tempering system from the company Sarstedt GmbH, Austria. A regular water bath was used in parallel for comparison. Six batches Octaplas with different blood groups were thawed in a water bath or using the SAHARA-III dry tempering system in parallel. Thawed plasma was investigated on screening tests for blood coagulation, as well as on the activities of important coagulation factors and protease inhibitors. In addition, markers of activated coagulation and fibrinolysis were tested and von Willebrand factor multimeric analysis was performed. There were neither significant differences in the blood coagulation parameters, coagulation factors, protease inhibitors, nor of markers of activated coagulation and fibrinolysis when Octaplas thawed by the two different methods was tested. The von Willebrand factor analyses showed no influence on the overall profile of the multimeric pattern when using the SAHARA-III dry tempering system. Octaplas can be thawed using the SAHARA-III dry tempering system without any negative influences on the demonstrated quality of this product. The SAHARA-III dry tempering system enables standardized thawing and warming procedure. Furthermore, tempering of Octaplas in the emergency unit or operating theatre, where no water baths can be utilized, is safe and can be fully endorsed.

  16. [Pharmaceutical technology and pharmaceutical care in the dispensary].

    Science.gov (United States)

    Remon, J P

    2007-01-01

    In this lecture the science 'Pharmaceutical Technology' was briefly elucidated, but the main part was about the concept of 'Pharmaceutical Care' in the community pharmacy. Pharmaceutical Care aims at ensuring a safe, efficacious, and cost-effective pharmacotherapy. Thus the pharmacist tries--in collaboration with other healthcare professionals --to improve the clinical and humanistic outcomes of the therapy. Moreover, an efficacious and rational drug therapy is cost-saving, for the patient as well as for the health insurer. A pharmacist delivering Pharmaceutical Care not only dispenses medication, but also takes responsibility about the outcome of the drug therapy. Pharmaceutical Care in community pharmacies encompasses the following activities: Advice about prescribed drugs, to ensure that patients take their medication as correct, as safe and as compliant as possible. Advice about self-care: counselling about OTC-medication. Prevention of medication errors, for example drug interactions. Pay attention to prevention of diseases: for example stimulation of vaccination. Collaboration with physicians, especially general practitioners, both aiming at an optimal drug therapy for the patient Pharmaceutical Care in the hospital setting ('Clinical Pharmacy'): clinical pharmacists participate in drawing up, evaluating and following up the pharmacotherapy of every individual patient, in close collaboration with physicians, nurses and other healthcare professionals on the ward. In Belgium Pharmaceutical Care is in the making. Scientific research on this topic is carried out by the Pharmaceutical Care Unit of Ghent University. An overview of their ongoing research projects was given. Finally, the problems encountered with the implementation of Pharmaceutical Care were highlighted.

  17. How Radio Frequency Identification Improves Pharmaceutical Industry: A Comprehensive Review Literature

    Directory of Open Access Journals (Sweden)

    Roxana Sharifian

    2016-05-01

    Full Text Available According to the vital role of pharmaceutical industry in health care system, pharmaceutical supply chain security, standard production and distribution of the pharmaceutical products are of great importance for pharmaceutical companies. Therefore, applying technology, especially Radio Frequency Identification (RFID, is essential to achieve these goals. Moreover, due to the importance of security in production and distribution and also the quality of pharmaceutical products, international pharmaceutical Institutes such as Food and Drug Administration (FDA and huge pharmaceutical companies apply RFID to increase their success and improve their efficiency and effectiveness. The present study explains the concept of RFID, its application and importance in pharmaceutical industry, and its role in struggling against counterfeit medicines in addition to presenting a framework of RFID in struggling against counterfeit medicines. It is discussed that RFID has various applications in pharmaceutical industry such as inventory and property management system, access control and machines’ performances, producing sterile pharmaceutical products, anti-thieving mechanism, preventing medicines’ diversion.Counterfeit medicines and recognition of counterfeit medicines. As a conclusion RFID can be suggested to make the pharmaceutical industry and health system smart. Therefore, it is suggested to establish this technology in pharmaceutical supply chain by the use of Information Technology and create a team of related specialists in order to successful application of this technology and gain the positive related results.

  18. Quality by design approach: application of artificial intelligence techniques of tablets manufactured by direct compression.

    Science.gov (United States)

    Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Ozer, Ozgen; Güneri, Tamer; York, Peter

    2012-12-01

    The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs.

  19. [Chinese medicine industry 4.0:advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

    Science.gov (United States)

    Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

    2016-01-01

    A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

  20. China's Chemical Pharmaceutical Industry Rebounding

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ After reorganization in 2006, China's chemical pharmaceutical industry began to pick up in 2007. According to the China Pharmaceutical Industry Association,China's chemical pharmaceutical industry achieved sales revenues of RMB202.5 billion in the first eight months this year, a growth of 24.6% - 5.6 percentage points faster than January to May this year. The net profit was RMB17.4 billion, an increase of 50.8% over the same period of 2006.

  1. [Adhesive cutaneous pharmaceutical forms].

    Science.gov (United States)

    Gafiţanu, E; Matei, I; Mungiu, O C; Pavelescu, M; Mîndreci, I; Apostol, I; Ionescu, G

    1989-01-01

    The adhesive cutaneous pharmaceutical forms aimed to local action release the drug substance in view of a dermatological, traumatological, antirheumatic, cosmetic action. Two such preparations were obtained and their stability, consistency and pH were determined. The "in vitro" tests of their bioavailability revealed the dynamics of calcium ions release according to the associations of each preparation. The bioavailability determined by evaluating the pharmacological response demonstrated the antiinflammatory action obtained by the association of calcium ions with the components extracted from poplar muds. The therapeutical efficiency of the studied preparations has proved in the treatment of some sport injuries.

  2. [Amorphization in pharmaceutical technology].

    Science.gov (United States)

    Révész, Piroska; Laczkovich, Orsolya; Eros, István

    2004-01-01

    The amorphization of crystalline active ingredients may be necessary because of the polymorphism of the active substance, the poor water-solubility of the drug material, difficult processing in the crystalline form and the taking out of a patent for a new (amorphous) form. This article introduces protocols for amorphization, which use methods traditionally applied in pharmaceutical technology. The protocols involve three possible routes: solvent methods, hot-melt technologies and milling procedures. With this presentation, the authors suggest help for practising experts to find the correct amorphization method.

  3. Bolaamphiphiles: A Pharmaceutical Review

    Directory of Open Access Journals (Sweden)

    Mayur Fariya

    2014-12-01

    Full Text Available The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery.

  4. [Importance of interfacial characteristics in pharmaceutical technology].

    Science.gov (United States)

    Dredán, Judit; Csóka, Gabriella; Marton, Sylvia; Antal, István

    2003-01-01

    Since drug release from the dosage forms has priority to absorption from the gastrointestinal system, physico-chemical characterisation of pharmaceutical systems is essential during the development of an optimal formulation with high efficacy and quality. Interfacial parameters of several pharmaceutical excipients were studied regarding their possible modifying effect on drug release from the dosage form. These inactive ingredients may influence the interfacial phenomena of the drug carrier system, which behaviour determines both the efficacy and the quality of the pharmaceutical preparation In this work authors deal mainly with the two introducing steps of the LADME model influenced by interfacial parameters on them, namely with the liberation of drug from the dosage form and with the characteristics influencing the absorption through biological membranes, respectively. The objective of the present work was to study modifying effects of excipients on drug liberation in connection with their physical and chemical characteristics such as interfacial tension of solid and liquid phases, wetting contact angle of solid phase and--a calculated quantity,--adhesion tension of the solid particles.

  5. Raman spectroscopy in pharmaceutical product design

    DEFF Research Database (Denmark)

    Paudel, Amrit; Raijada, Dhara; Rantanen, Jukka

    2015-01-01

    Almost 100 years after the discovery of the Raman scattering phenomenon, related analytical techniques have emerged as important tools in biomedical sciences. Raman spectroscopy and microscopy are frontier, non-invasive analytical techniques amenable for diverse biomedical areas, ranging from...... molecular-based drug discovery, design of innovative drug delivery systems and quality control of finished products. This review presents concise accounts of various conventional and emerging Raman instrumentations including associated hyphenated tools of pharmaceutical interest. Moreover, relevant...... application cases of Raman spectroscopy in early and late phase pharmaceutical development, process analysis and micro-structural analysis of drug delivery systems are introduced. Finally, potential areas of future advancement and application of Raman spectroscopic techniques are discussed....

  6. 辅酶Q10治疗帕金森病临床效果的Meta分析%Efficacy and Safety of CoenzymeQ1O for Parkinson's Disease: A Meta-analysis

    Institute of Scientific and Technical Information of China (English)

    2016-01-01

    目的 系统评价辅酶Q10治疗帕金森病的安全性及有效性.方法 计算机检索PubMed、EMbase、The Cochrane Library(2015年1期)、CBM、CNKI、VIP和WanFang Data数据库,搜集辅酶Q10治疗帕金森病的相关随机对照试验(RCT),检索时限为建库至2015年8月.由2位研究员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析.结果 最终纳入5个研究,共981例患者,其中辅酶Q10组610例,安慰剂对照组371例.Meta分析结果:①近期疗效方面:辅酶Q10 2 400 mg剂量组治疗前后总UPDRS评分变化[MD=1.09,95%CI (0.94,1.24),P<0.000 01]、UPDRS-Ⅰ评分变化[MD=0.19,95%CI (0.17,0.21),P<0.000 01]、UPDRS-Ⅱ评分变化[MD=0.27,95%CI (0.21,0.32),P<0.000 01]、UPDRS-Ⅲ评分变化[MD=0.65,95%CI (0.54,0.76),P<0.000 01]、Hoehn& Yahr评分变化[MD=0.05,95%CI (0.04,0.06),P<0.000 01]和Schwab英格兰评分变化[MD=-0.87,95%CI(-1.02,-0.72),P<0.000 01]均高于安慰剂组;②长期疗效方面:除辅酶Q101 200mg亚组UPDRS-Ⅱ评分变化高于安慰剂组外,两组差异无统计学意义.③不良反应方面:除辅酶Q10600mg亚组胆固醇升高发生率和1 200 mg亚组腹泻发生率低于安慰剂组[OR=0.03,95%CI (0.00,0.87),P=0.04;OR=0.42,95%CI (0.19,0.91),P=0.03]外,两组间不良反应发生率差异均无统计学意义.结论 现有证据表明,2 400mg剂量辅酶Q10对早期帕金森病患者是安全有效的.受纳入研究数量和质量限制,上述结论尚需开展更多高质量研究予以验证.

  7. The Pharmaceutical Commons

    Science.gov (United States)

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  8. Pharmaceutical Education and the Translation of Pharmaceutical Care into Practice.

    Science.gov (United States)

    Newton, Gail D.

    1991-01-01

    A systematic approach to reform of pharmaceutical education is seen as necessary to link intended outcomes of reform to a progressive and generally accepted mission of professional practice. Cooperation between pharmaceutical education, professional organizations, and regulatory agencies is viewed as necessary and refinement of professional…

  9. A Review on applications of GAMP -5 in Pharmaceutical Industries

    Directory of Open Access Journals (Sweden)

    P. Lalasa

    2013-09-01

    Full Text Available The new Good automated manufacturing practices (GAMP-5 guidelines were released February 2008 at the ISPE(International Society for Pharmaceutical Engineering Manufacturing Excellence Conference in Tampa, Florida. These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. The purpose of the guidelines is to “provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.” There are five key concepts to GAMP 5: • Product and Process Understanding. • Lifecycle approach within QMS. • Scalable Lifecycle Activities. • Science Based Quality Risk Management. • Leveraging Supplier Involvement. Understanding the product and process is critical in determining system requirements and for making science and risk-based decisions to ensure that the system is “fit for use.” In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity.” Defining a lifecycle approach to a computerized system has been expanded from GAMP 4 to include all phases and activities from concept and implementation through operation and retirement. Some applications of GAMP- 5 in Pharmaceutical industries like Monitoring manufacturing, production and storage environments in the pharmaceutical industry, Monitoring the autoclaving process in the pharmaceutical industry, Water purification in the pharmaceutical industry, Freeze drying in the pharmaceutical industry

  10. Bioremediation Kinetics of Pharmaceutical Industrial Effluent

    Directory of Open Access Journals (Sweden)

    M. Šabić

    2015-05-01

    Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental

  11. Pharmaceutical Receivables, the Source of the Pharmaceutical Units Solvency

    Directory of Open Access Journals (Sweden)

    Doina Margaritti

    2016-07-01

    Full Text Available The objective of this work is to analyze the current assets recorded by the pharmaceutical units, namely the role of the pharmaceutical receivables to improve the financial performances carried out by the pharmaceutical entities. The study was carried out through the analysis of the financial statements drawn up by a community pharmaceutical entity from Bucharest. In order to achieve the proposed objective, we analyzed the current assets in their structure, namely the pharmaceutical receivables which are to be recovered by the Bucharest Health Insurance House and the Insurance House OPSNAJ, resulting from the issuance of the compensated drugs prescriptions. Thus, it was determined the total receivables, but also differentiated release programs, how they are created, the term of settlement and the manner in which they have influenced the level of financial performance indicators.

  12. Recent trends and future of pharmaceutical packaging technology

    Directory of Open Access Journals (Sweden)