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Sample records for 99mtc-labelled radiopharmaceuticals version

  1. 99MTC-labelled autologous erythrocytes for the study of hepatic haemangiomas - Retrospective analysis

    Full text: Introduction: Haemangioma represents 5-7% of all benign tumours. Most hepatic lesions are easily diagnosed by ultrasound or CT scan, but sometimes differential diagnosis between haemangioma and other lesions is an important problem. Objectives: To evaluate the contribution of 99mTc-labelled autologous erythrocytes imaging for the diagnosis of hepatic haemangiomas. Population and Methods: We have retrospectively analysed, 61 patients (16(26%) males and 45(74%) females, with age> = 53 years) who have been submitted to hepatic study using 99mTc-labelled autologous erythrocytes (99mTc-LAE), between February 1999 and November 2002, for suspicious hepatic haemangioma. The hepatic lesions (diameter>=4,01±3,7cm) were documented by ultrasound and/or CT and/or MRI, none reaching a conclusive diagnosis: 39/61(64%) patients had single lesions, 8/61(13%) had two lesions, 5/61(8%) had three lesions and 9/61(15%) patients had more than 3 lesions. The erythrocytes in vivo labelling was performed with stannous chloride ev administration followed (by 20 minutes) by an 99mTc-Pertechnetate (740 MBq-20 mCi) ev administration. The hepatic images were made 2-3 hours after the administration of the radiopharmaceutical: 3 planar images (anterior, posterior and right lateral projections) and SPET. Results: 99mTc-LAE results were: 29 haemangiomas identified in 28/61(46%) patients, one of them also showing a lesion without elective erythrocytes accumulation; 6/61(10%) patients with lesions without elective erythrocytes accumulation; 27/61(44%) patients without any modification in the erythrocytes distribution parenchymal pattern. Lesion's dimensions (estimated by ultrasound, CT scan or MRI) were: haemangiomas identified by 99mTc-LAE - =5,27±3,3cm, 'cold' lesions in 99mTc-LAE - =2,58±1,47cm and non visualized lesions in 99mTc-LAE - =2,06±1,33cm. The 29 patients with haemangiomas, diagnosed in 99mTc-LAE, had already performed 25 ultrasounds, 20 CT scan, 5 MRI and 1 hepatic biopsy

  2. Radiopharmaceuticals

    The catalogue offers a wide-spread product range which meets the requirements of the international trend of in vivo application of radiopharmaceuticals. It includes: (1) conditions of sale and delivery, (2) delivery schedule for radiopharmaceuticals, (3) technical information, (4) product specifications, and (5) the complete delivery programme

  3. Radiopharmaceuticals

    Today there are an estimated ten million nuclear imaging procedures, performed each year, in just the United States, and the number is still growing. More than 30,000 therapy procedures are performed in the USA each year using radiopharmaceuticals. Moreover, while the numbers continue to grow, so also do the variety of the procedures being employed. A weakness of nuclear medicine is related also to one of its strengths. Unlike other types of imaging where only an instrument and the patient are required (e.g., with ultrasonics); nuclear medicine requires a radiopharmaceutical. At the same time, the variety of radiopharmaceuticals offers the ability to trace one or more particular functions of the human body. This provides nuclear medicine with great variety in detecting specific pathologies. Various nuclear medicine studies are possible because of the localization of radiopharmaceuticals in different organs

  4. Hospitable radiopharmaceuticals

    Two types of hospitalary radiopharmaceutical was given in Nuclear Medicine: the centralized and hospitalary radiopharmaceuticals. The good practice in the use, instrumentation and quality control of radiopharmaceuticals are used in nuclear medicine for diagnostic and therapy diseases

  5. Lung radiopharmaceuticals

    Indication or main clinical use of Lung radiopharmaceuticals is presented and clasification of radiopharmaceuticals as ventilation and perfusion studies. Perfusion radiopharmaceuticals, main controls for administration quality acceptance. Clearence after blood administration and main clinical applications. Ventilation radiopharmaceuticals, gases and aerosols, characteristics of a ideal radioaerosol, techniques of good inhalation procedure, clinical applications. Comparison of several radiopharmaceuticals reflering to retention time as 50% administered dose, percent administered dose at 6 hours post inhalation, blood activity at 30 and 60 minutes post inhalation, initial lung absorbed dose, cumulated activity.Kinetic description of two radiopharmaceuticals, 99mTcDTPA and 99mTc-PYP

  6. 6. Radiopharmaceuticals

    Radionuclides commonly used in medicine are surveyed and their nuclear characteristics are presented. The methods are given of their preparation, most frequent use and detection. The list is given of radiopharmaceuticals included in the Czechoslovak Pharmacopoeia CsL3, ie., sodium chromate(51Cr), sodium iodide(131I), hippuran(131I), sodium phosphate(32P), colloidal gold(198Au), rose bengal sodium salt(131I), and sodium pertechnetate(sup(99m)Tc) injections. Characteristics, chemical preparation, identification tests, packaging, storage, application and dosage are shown for each preparation. Also listed are important unofficial radiopharmaceuticals, their main characteristics and data on their preparation and application. (B.S.)

  7. Radiopharmaceutical assays

    Under the laws in force, radiopharmaceuticals for human use must be among other features, non-pyrogenous and non-toxic. For this reason pyrogenity and toxicity assays are carried out. Pharmacokinetic studies may also be necessary in some cases. Products currently made at the Radiopharmaceutical Center, new products designed for certification and raw materials used to manufacture the above, were tested. A total 342 pyrogenity and toxicity tests, and four pharmacokinetic studies were conducted in 1996. To determine pyrogenity, the temperature animals were measured following intravenous administration of radiopharmaceuticals concerned: sodium pertechnetate, colloidal gold and sodium orthoradiohippurate from current production; pharmaceutic components of several new products, i.e. technetium generator, fibrinogen and microspheres. A total 327 products were tested, 96 percent of which met the requirements. To determine toxicity, the probit method was used, consisting of the administration of radiopharmaceutical doses for seven straight days, and checking for lethal effects. An overall 15 tests were carried out and 80 percent of products tested were found certifiable. Pharmacokinetic tests consisted of tropism on target organs and biodistribution in several organs using the tomographic method. (author)

  8. Medicinal Radiopharmaceutical Chemistry of Metal Radiopharmaceuticals

    Saw, Maung Maung

    2012-06-01

    Metal complexes have been used as medicinal compounds. Metals have advantageous features over organic compounds. Significant applications of metal complexes are in the field of nuclear medicine. Radiopharmaceuticals are drugs containing radioisotopes used for diagnostic and therapeutic purposes. The generalized targeting strategy for molecular imaging probe consists of three essential parts: (i) reporter unit or payload, (ii) carrier, and (iii) targeting system. Medicinal radiopharmaceutical chemistry pays special consideration to radioisotopes, as a reporter unit for diagnostic application or as a payload for therapeutic application. Targeting is achieved by a few approaches but the most common is the bifunctional chelator approach. While designing a radiopharmaceutical, a range of issues needs to be considered including properties of metal radioisotopes, bifunctional chelators, linkers, and targeting molecules. Designing radiopharmaceuticals requires consideration of two key words: "compounds of biological interest" and "fit for intended use." The ultimate goal is the development of new diagnostic methods and treatment. Diagnostic metal radiopharmaceuticals are used for SPECT and PET applications. Technetium chemistry constitutes a major portion of SPECT and gallium chemistry constitutes a major portion of PET. Therapeutic radiopharmaceuticals can be constructed by using alpha-, beta minus-, or Auger electron-emitting radiometals. Special uses of medicinal radiopharmaceuticals include internal radiation therapy, brachytherapy, immunoPET, radioimmunotherapy, and peptide receptor radionuclide imaging and therapy.

  9. 99MTc labeled antimicrobial peptide ubiquicidin (29-41) accumulates less in E-coli infection as compared with staph. aureus infection

    99mTc labeled antimicrobial peptide ubiquicidin, UBI (29-41) in freeze-dried kit was evaluated as bacterial infection seeking agent in Staph. aureus and E-coli induced infections. Methods: 33 rabbits were categorized in three groups. Biodistribution of 99mTc UBI (29-41) was studied in three animals (group I). The uptake of peptide was determined by counting radioactivity in anatomically fitted regions drawn over the liver, kidneys, urinary bladder and whole body and expressed as percent uptake per organ. Experimental thigh muscle infection was induced by injecting 2 x 108 CFU of live Staph. aureus or E- coli bacteria into fight thigh muscle in 20 rabbits (group II). Turpentine oil and formalin killed Staph. aureus were utilized for inducing sterile thigh muscle inflammation in 10 rabbits (group III). On scintigrams, anatomically adjusted regions of interest (ROIs) were drawn over infected/inflamed (target) and non-infected/non-inflamed (non-target) thigh and accumulation of 99mTc-UBI (29-41) at sites of infection/inflammation was expressed as the target to non-target (T/NT) ratio. Results: Biodistribution study of 99mTc-UBI (29-41) revealed rapid removal of tracer from the circulation via the kidneys (10.6 ± 2.1% at 5 minutes and 5.9 ± 0.8% at 60 minutes) with accumulation of major part in urinary bladder within first hour after injection (66.6 ± 7.2%). Significantly higher (p < 0.05) accumulation of 99mTc-UBI (29-41) was seen at sites of Staph. aureus infected subjects (T/NT ratio 2.2 ± 0.5) as compared to E-coli (T/NT ratio 1.7 ± 0.4). Maximum tracer accumulation was observed at 60 minutes post-injection followed by gradual decline. No significant accumulation was noticed in thighs of rabbits injected with either turpentine oil or killed Staph. aureus with markedly lower T/NT ratios (p < 0.05) compared with Staph. aureus and E-coli infected thighs. Conclusion: 99mTc UBI (29-41) freeze-dried kit can be used for differentiating infections with Staph. aureus and E-coli with significantly higher scintigraphic intensity (P< 0.05) as compared to sterile inflammatory sites. Optimum time for infection imaging is 60 minutes post injection. Relatively low (T/NT) ratios were observed in E-coli infections as compared with Staph. aureus group which may be due to low virulence of the former, however there can be other possible reasons including low affinity of this peptide for E-coli microbial membranes. (authors)

  10. Radiopharmaceuticals for nuclear cardiology

    One of the diagnostic technique periodically used in Nuclear Medicine is the angiographic studi e, employee for detect cardiovascular diseases. The radiopharmaceutical more used in the angiographic ones is 99mTc. Between thetopics described in the present work it find: myocardial infarction, radiopharmaceuticals classification for cardiac studies, labelled proceedings, cardiovascular diseases

  11. FDA approved radiopharmaceuticals

    FDA is the abbreviation of American Food and Drug Administration. It s main job is assuring the safety and reliability of the food, cosmetics, medicines, medical devices and radiation emitting products such as microwave oven, the food and medicine for animals. Radiopharmaceuticals are also under its management. The basic information of FDA and FDA approved radiopharmaceuticals are introduced

  12. Radiopharmaceuticals for neurotransmitter imaging

    Oh, Seung Jun [Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2007-04-15

    Neurotransmitter imaging with radiopharmaceuticals plays major role for understanding of neurological and psychiatric disorders such as Parkinson's disease and depression. Radiopharmaceuticals for neurotransmitter imaging can be divided to dopamine transporter imaging radiopharmaceuticals and serotonin transporter imaging radiopharmaceuticals. Many kinds of new dopamine transporter imaging radiopharmaceuticals has a tropane ring and they showed different biological properties according to the substituted functional group on tropane ring. After the first clinical trials with [{sup 123}I] {beta} -CIT, alkyl chain substituent introduced to tropane ring amine to decrease time for imaging acquisition and to increase selectivity. From these results, [{sup 123}I]PE2I, [18F]FE-CNT, [{sup 123}I]FP-CIT and [{sup 18}F]FP-CIT were developed and they showed high uptake on the dopamine transporter rich regions and fast peak uptake equilibrium time within 4 hours after injection. [{sup 11}C]McN 5652 was developed for serotonin transporter imaging but this compound showed slow kinetics and high background radioactivity. To overcome these problems, new diarylsulfide backbone derivatives such as ADAM, ODAM, AFM, and DASB were developed. In these candidates, [{sup 11}C]AFM and [{sup 11}C]DASB showed high binding affinity to serotonin transporter and fast in vivo kinetics. This paper gives an overview of current status on dopamine and serotonin transporter imaging radiopharmaceuticals and the development of new lead compounds as potential radiopharmaceuticals by medicinal chemistry.

  13. Radiopharmaceuticals for cerebral studies

    For obtain good brain scintillation images in nuclear medicine must be used several radiopharmaceuticals. Cerebral studies give a tumors visual image as well as brain anomalities detection and are helpful in the diagnostic diseases . Are described in this work: a cerebrum radiopharmaceuticals classification,labelled compounds proceeding and Tc 99m good properties in for your fast caption, post administration and blood purification for renal way

  14. Radiopharmaceutical drug review process

    To ensure proper radioactive drug use (such as quality, diagnostic improvement, and minimal radioactive exposure), the Food and Drug Administration evaluates new drugs with respect to safety, effectiveness, and accuracy and adequacy of the labeling. The IND or NDA process is used for this purpose. A brief description of the process, including the Chemical Classification System and the therapeutic potential classification, is presented as it applies to radiopharmaceuticals. Also, the status of the IND or NDA review of radiopharmaceuticals is given

  15. Preparation of radiopharmaceutical formulations

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially 153samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs

  16. Undesirable events with radiopharmaceuticals

    Radiopharmaceuticals are used in nuclear medicine for diagnostic and therapeutic purposes. Many adverse reactions and false positive reactions related to radiopharmaceuticals take place every day in hospitals, but most of them are not reported. It is therefore important to understand the definition of each undesirable reaction. Adverse reactions are defined as any noxious or unintended reactions to a drug, which is administered in standard doses through the proper route for the purpose of prophylaxis, diagnosis, or treatment. False positive reactions can be defined as any imaging appearance caused by undue physiological or pathological accumulation of radiopharmaceuticals. Information concerning these undesirable reactions is limited for radiopharmaceuticals. The present study intends to be a source of information that could be accessed by all nuclear medicine staff. A review of the literature from 1957 to January 2009 was carried out using the criteria of a systematic review, established by the Cochrane Collaboration, an international non-profit organization, that provides up-to-date information about the health care. The present study has revealed that radiopharmaceuticals cause adverse reactions. Six cases of adverse reactions with radiopharmaceuticals were found: 2 cases with 18F-fluorodeoxyglucose (FDG) and 4 cases with technetium 99m (99mTc). Among the 4 cases of adverse reactions with 99mTc, one subject who received 99mTc-labeled sestamibi developed anaphylactic reactions. Moreover, a total of 8 cases with false positive reactions were found with FDG. In conclusion, a worldwide effort should be made to report as many cases as possible of adverse events and false positive reactions with radiopharmaceuticals. (author)

  17. Eleventh international symposium on radiopharmaceutical chemistry

    NONE

    1995-12-31

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry.

  18. Eleventh international symposium on radiopharmaceutical chemistry

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry

  19. Cyclotron produced radiopharmaceuticals

    Kopička, K.; Fišer, M.; Hradilek, P.; Hanč, P.; Lebeda, O.

    2003-01-01

    Some of the cyclotron-produced radionuclides may serve as important materials for the production of radiopharmaceuticals. This lecture deals with basic information relating to various aspects of these compounds. In comparison with radionuclides/compounds used for non-medical purposes, radiopharmaceuticals are subject to a broader scale of regulations, both from the safety and efficacy point of view; besides that, there are both radioactive and medical aspects that must be taken into account for any radiopharmaceutical. According to the regulations and in compliance with general rules of work with radioactivity, radiopharmaceuticals should only be prepared/manufactured under special conditions, using special areas and special equipment and applying special procedures (e.g. sterilisation, disinfection, aseptic work). Also, there are special procedures for cleaning and maintenance. Sometimes the requirements for the product safety clash with those for the safety of the personnel; several examples of solutions pertaining to these cases are given in the lecture. Also, the specific role of cyclotron radiopharmaceuticals is discussed.

  20. Therapeutic applications of radiopharmaceuticals

    Whether a radiopharmaceutical has diagnostic or therapeutic application depends on both the isotope and pharmaceutical used. For diagnostic applications, the isotope should undergo only γ-decay, since usually only γ-radiation is detected by nuclear medicine cameras. The half-life should be just long enough to allow the procedure to be performed. In contrast, the isotope needed for therapeutic purposes should have particulate radiation, such as a β-particle (electron), since these are locally absorbed an increase the local radiation dose. γ-Radiation, which penetrates the tissues, produces less radiation dose than do Β-particles. Several references dealing with radioactive decay, particulate interactions, and diagnostic and therapeutic applications of radiopharmaceuticals are available. Radiopharmaceuticals can legally be used only by physicians who are qualified by specific training in the safe handling of radionuclides. The experience and training of these physicians must be approved by the Nuclear Regulatory Commission or Agreement State Agency authorized to license the use of radiopharmaceuticals. A list of all byproduct material and procedures is available in the Code of Federal Regulations. Of the many radiopharmaceuticals available for diagnostic and therapeutic use, only those commonly used are discussed in this chapter

  1. Quality control of radiopharmaceuticals

    Quality assurance was introduced in the pharmaceutical field long before it was used in many other areas, and the term quality control has been used in a much broader sense than merely analytical quality control. The term Good Manufacturing Practice (GMP) has been used to describe the system used for producing safe and effective drugs of a uniform quality. GMP has also been used for the industrial production of radiopharmaceuticals. For the preparation and control of radiopharmaceuticals in hospitals a similar system has been named Good Radiopharmacy Practice (GRP). It contains the same elements as GMP but takes into account the special nature of this group of drugs. Data on the assessment of the quality of radiopharmaceuticals in relation to present standards are reviewed. The general conclusion is that the quality of radiopharmaceuticals appears comparable to that of other drugs. It seems possible to establish the production of radiopharmaceuticals, generators and preparation kits in such a way that analytical control of the final product at the hospital may be limited provided the final preparation work is carried out in accordance with GRP principles. The elements of GRP are reviewed. (author)

  2. Recent advances in radiopharmaceuticals

    Full text: Radiopharmaceuticals in Nuclear Medicine may be divided into diagnostic and therapeutic agents. The diagnostic area is perceived to be mature, while the therapeutic side of nuclear medicine is still evolving. There are over 100 diagnostic radiopharmaceutical products available, the greatest number applied in cardiology followed by oncology and neurology. The greatest success in therapeutic nuclear medicine has been achieved in thyroid cancer, hyperthyroidism and bone pain palliation. Those in the field believe the future of nuclear medicine resides in the growth potential of the emerging therapeutic market, hence much of the recent research has been focussed in the development of therapeutic agents for targeting cancers. Radiopharmaceuticals under development or in clinical trials involve the use of radionuclides such as Y-90, Pd-103, Ir-192, Re-188, I-131, Sm-153, Sn-114, Sr-90, Cu-64 and In-111. Advances in cyclotron and camera technology as well as automation has enhanced and widened the potential use of positron emitting radiopharmaceuticals such as F-18 Fluorodeoxyglucose (FDG). However the relationship between FDG uptake and glucose consumption in normal and diseased tissue is still to be defined. Many challenges remain for the nuclear medicine community to apply new knowledge of human biochemistry in the development of new radiopharmaceuticals. A better understanding of effects of radiation and its role in the design of therapeutic agents is undoubtedly pivotal for advancing therapeutic Nuclear Medicine into the future

  3. Radiopharmaceuticals in oncology

    Radiopharmaceuticals are generally made of an artificial radionuclide chemically bound to a molecule showing an affinity for a particular type of cells. In oncology, the radionuclide emits either photons for scintigraphic imaging, either beta or alpha particles for metabolic radiotherapy. The development of new radiopharmaceuticals is mostly hampered by the modifications of conformation and hence, of biological behavior, of the original molecule induced by its radiolabelling. The use of positron emitters can be a solution to this difficulty, but their short half-life generates serious management limitations. Radiopharmaceutical used in oncology are targeted toward the cellular and tissular tumorous abnormalities. They belong to different categories: membrane agents, metabolic substrates (such as fluorodeoxyglucose), receptors ligands, antibodies and other agents under development such as hypoxia, apoptosis and genes markers. (authors)

  4. Radiopharmaceutical information and consultation services

    In this chapter, the authors, focus the discussion on: 1. The nature, scope, and depth of typical ''drug'' or ''radiopharmaceutical'' information questions that arise in nuclear medicine facilities and; 2. Possible approaches for handling and/or processing ''radiopharmaceutical'' information questions for nuclear medicine, along with exploration of the feasibility of establishing a radiopharmaceutical information center

  5. Melanin-binding radiopharmaceuticals

    The scope of this paper is limited to an analysis of the factors that are important to the relationship of radiopharmaceuticals to melanin. While the authors do not attempt to deal with differences between melanin-binding vs. melanoma-binding, a notable variance is assumed

  6. Audits of radiopharmaceutical formulations.

    Castronovo, F P

    1992-03-01

    A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team. PMID:1598931

  7. Pain palliative Radiopharmaceuticals

    A pain relieving agents based on β emitters mainly and in some cases a complex preparation are being given for bone metastasis in relation with breast,prostate and lung carcinoma with good performance in clinical practice.Several radionuclides and radiopharmaceuticals are mentioned giving strength to those newly proposed, 153Sm and 186Re.Bibliography

  8. Audits of radiopharmaceutical formulations

    A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team

  9. Melanin-binding radiopharmaceuticals

    Packer, S; Fairchild, R G; Watts, K P; Greenberg, D; Hannon, S J

    1980-01-01

    The scope of this paper is limited to an analysis of the factors that are important to the relationship of radiopharmaceuticals to melanin. While the authors do not attempt to deal with differences between melanin-binding vs. melanoma-binding, a notable variance is assumed. (PSB)

  10. Cyclotron produced radiopharmaceuticals

    Kopička, Karel; Fišer, Miroslav; Hradilek, Pavel; Hanč, Petr; Lebeda, Ondřej

    2003-01-01

    Roč. 53, č. 2 (2003), s. A763-A768. ISSN 0011-4626 R&D Projects: GA AV ČR KSK4055109 Keywords : cyclotron * radionuclides * radiopharmaceuticals Subject RIV: CH - Nuclear ; Quantum Chemistry Impact factor: 0.263, year: 2003

  11. The development of cyclotron radiopharmaceuticals

    The purpose of this project is to develop the radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with 12'3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism

  12. The development of cyclotron radiopharmaceuticals

    Yang, Seung Dae; Chun, K. W.; Suh, Y. S.; Lee, J. D.; Ahn, S. H. and others

    1999-03-01

    The purpose of this project is to developthe radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with {sup 12}'3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism.

  13. Radioisotopes and radiopharmaceuticals catalogue

    The Chilean Nuclear Energy Commission (CCHEN) presents its radioisotopes and radiopharmaceuticals 2002 catalogue. In it we found physical characteristics of 9 different reactor produced radioisotopes ( Tc-99m, I-131, Sm-153, Ir-192, P-32, Na-24, K-42, Cu-64, Rb-86 ), 7 radiopharmaceuticals ( MDP, DTPA, DMSA, Disida, Phitate, S-Coloid, Red Blood Cells In-Vivo, Red Blood Cells In-Vitro) and 4 labelled compounds ( DMSA-Tc99m, DTPA-Tc99m, MIBG-I131, EDTMP-Sm153 ). In the near future the number of items will be increased with new reactor and cyclotron products. Our production system will be certified by ISO 9000 on March 2003. CCHEN is interested in being a national and an international supplier of these products (RS)

  14. Good radiopharmaceuticals practices

    A careful security must be used in the nuclear medicine laboratory concerning to the proceedings, preparation and dispensation of radiopharmaceuticals. Each control laboratory must look after the radiation protection patients,workers and people in general. Between another routinary activities in the present work it find : equipment prearrangement,installations,handling and support of electronic instruments,proceedings,methodology, results and interpretation of analysis , as well as registry maintenance

  15. Radiopharmaceuticals for diagnosis

    During this grant period 1 January 1988--31 December 1990, we have successfully developed a number of new approaches to fluorine-18 labeled compounds, prepared several new radiotracers for both animal studies and eventual clinical trials, and explored the utility of a high-quality industrial robot in radiopharmaceutical applications. The progress during the last grant period is summarized briefly in the following sections. Publications arising from this research are listed below and can be found in Appendix I. 1 fig

  16. Pharmacovigilance in radiopharmaceuticals

    Kumar, Rishi; Kalaiselvan, Vivekanandan; Kumar, Rakesh; Verma, Ravendra; Singh, Gyanendra Nath

    2016-01-01

    Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some adverse reactions to the patients. The objective of presenting this article is to introduce the system of adverse drug reaction reporting to the nuclear medicine fraternity who are dealing with RPs. PMID:27095855

  17. Radiopharmaceuticals for diagnosis

    Kuhl, D.E.

    1990-06-01

    During this grant period 1 January 1988--31 December 1990, we have successfully developed a number of new approaches to fluorine-18 labeled compounds, prepared several new radiotracers for both animal studies and eventual clinical trials, and explored the utility of a high-quality industrial robot in radiopharmaceutical applications. The progress during the last grant period is summarized briefly in the following sections. Publications arising from this research are listed below and can be found in Appendix I. 1 fig.

  18. Safety and efficacy of radiopharmaceuticals

    New radiopharmaceuticals are essential for further developments to take place in nuclear medicine. This book provides a systematic review of the phases involved in bringing a new radiopharmaceutical product from its conception into routine use. Scientists from the radiopharmaceutical industry, hospital pharmacies and the health authorities have contributed to this work. It includes all aspects from the design, chemical description, animal testing and radiation dosimetry to clinical trials and post marketing surveillance of adverse reactions and drug defects. The handling of radiopharmaceuticals in hospitals and the design of laboratory facilities ideal for the protection of personnel against radiation and protection of the product against environmental contamination are also covered. The quality control of radiopharmaceuticals prepared in the hospital is considered, taking into account the points of view held by industry, the hospitals themselves and the regulatory health agencies. This book provides a reference source for scientists involved in the development and testing of new radiopharmaceuticals. (orig.)

  19. Radiopharmaceuticals in cardiovascular diseases

    The high incidence of cardiovascular disorders and the attendant morbidity and mortality have encouraged the development of new radiopharmaceuticals for the diagnosis and localisation of coronary diseases. Myocardial perfusion imaging is an invaluable tool for the demonstration of transient ischemia and infarction in heart and identification of viable and non-viable myocardial tissue. Thallium chloride (Tl-201) is the agent currently in wide use but its drawbacks have been well recognised. Hence tremendous amount of research work has been carried out to develop a suitable Tc-99m radiopharmaceutical for this purpose which has resulted in the introduction of two Tc-99m labelled radiopharmaceuticals HEXAMIBI and BATO. These are being tried as myocardial imaging agents these days and the choice amongst these depends on concrete clinical situation. The experimental work involving the synthesis of ligand MIBI, formulation into freeze dried KIT form, quality control procedure, biodistribution studies and finally clinical evaluation of locally produced KIT in human volunteers has now been reported here. Our KIT has been produced for the first time in Pakistan and has been tried on forty five patients in Nuclear Medical Centre, AFIP (Rawalpindi). The results obtained are comparable to those of Ti-201 with a slightly higher liver background in case of MIBI but because of the easy availability MIBI has become agent of choice for myocardial perfusion studies. (author)

  20. Supply of radiopharmaceuticals in Japan

    Detailed statistics of the application of radiopharmaceuticals in nuclear medicine in Japan are summarized. They are the amount of supply in terms of monetary value and radioactivity, categorized usages of in vivo and in vitro, number of facilities using the radiopharmaceuticals for the time span of 5 years (1998-2002). Obvious tendency of decrease for in vitro use can be seen while the total amount of radiopharmaceuticals is almost unchanged. (author)

  1. Cyclotrons and positron emitting radiopharmaceuticals

    Wolf, A.P.; Fowler, J.S.

    1984-01-01

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs. (ACR)

  2. Placental transfer of selected radiopharmaceuticals

    This paper reviews animal experiments carried out to determine the transfer of radiopharmaceuticals from mother to fetus. Animal data are compared to any human data available. The radiopharmaceuticals included in the discussion are Tc-99m pertechnetate, Tc-99m DTPA, Ga-67 citrate and Tl-201 chloride. (6 tab., 5 refs.)

  3. Cyclotrons and positron emitting radiopharmaceuticals

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs

  4. Radiopharmaceuticals - current state and trends

    The current state as well as the tendencies of modern radiopharmaceutical development and application is reviewed. After an evaluation of the fundamental preconditions of decay characteristics and pharmaceutical properties the problems concerning sup(99m)Tc-radiopharmaceuticals, metabolizable compounds and the use of specific biological interactions are discussed. (author)

  5. Molecularly targeted therapeutic radiopharmaceuticals

    Full text: It is generally agreed that current focus of nuclear medicine development should be on molecular imaging and therapy. Though, the widespread use of the terminology 'molecular imaging' is quite recent, nuclear medicine has used molecular imaging techniques for more than 20 years ago. A variety of radiopharmaceuticals have been introduced for the internal therapy of malignant and inflammatory lesions in nuclear medicine. In the field of bio/medical imaging, nuclear medicine is one of the disciplines which has the privilege of organized and well developed chemistry/ pharmacy section; radio-chemistry/radiopharmacy. Fundamental principles have been developed more than 40 years ago and advanced research is going well into postgenomic era. The genomic revolution and dramatically increased insight in the molecular mechanisms underlying pathology have led to paradigm shift in drug development. Likewise does in the nuclear medicine. Here, the author will present current clinical and pre-clinical therapeutic radiopharmaceuticals based on molecular targets such as membrane-bound receptors, enzymes, nucleic acids, sodium iodide symporter, etc, in correlation with fundamentals of radiopharmacy. (author)

  6. Radiopharmaceuticals: therapeutic applications

    Radiopharmaceuticals are chemical compounds incorporating appropriate radionuclides, which are rendered suitable for human administration. It is the artificial production of radionuclide that laid the foundation of nuclear medicine. The basic principle in designing radiolabeled compounds for therapy is to achieve a high concentration of radioactivity in the target tissue which would be capable of delivering a desirable radiation dose with minimal exposure to the critical organ (usually bone marrow). With the availability of artificially produced radionuclides, therapeutic applications were initiated. Iodine-131 for the treatment of thyroid disorders has remained the most important one. Recent advances over the past 10 years are quite dramatic. There are three important areas where considerable research work is in progress. Intraarticular administration radiocolloids appear to be valuable for the management of synovitis in patients with rheumatoid arthritis. Palliative treatment of bone metastases and total-body bone marrow irradiation seem to be feasible with bone-seeking radiopharmaceuticals. Design and development of radiolabeled compounds for targeted delivery is important, such as (a) monoclonal antibodies for specific antigens, (b) peptides for specific receptors and (c) conjugated drugs for specific tumours. Radionuclide therapy is still in its infancy and present research activities reflect future potentials. (author). 76 refs., 4 figs., 2 tabs

  7. Unconventional Nuclides for Radiopharmaceuticals

    Holland, Jason P.; Williamson, Matthew J.; Lewis, Jason S.

    2016-01-01

    Rapid and widespread growth in the use of nuclear medicine for both diagnosis and therapy of disease has been the driving force behind burgeoning research interests in the design of novel radiopharmaceuticals. Until recently, the majority of clinical and basic science research has focused on the development of 11C-, 13N-, 15O-, and 18F-radiopharmaceuticals for use with positron emission tomography (PET) and 99mTc-labeled agents for use with single-photon emission computed tomography (SPECT). With the increased availability of small, low-energy cyclotrons and improvements in both cyclotron targetry and purification chemistries, the use of “nonstandard” radionuclides is becoming more prevalent. This brief review describes the physical characteristics of 60 radionuclides, including β+, β−, γ-ray, and α-particle emitters, which have the potential for use in the design and synthesis of the next generation of diagnostic and/or radiotherapeutic drugs. As the decay processes of many of the radionuclides described herein involve emission of high-energy γ-rays, relevant shielding and radiation safety issues are also considered. In particular, the properties and safety considerations associated with the increasingly prevalent PET nuclides 64Cu, 68Ga, 86Y, 89Zr, and 124I are discussed. PMID:20128994

  8. Melanin binding radiopharmaceuticals

    We have determined the biodistribution an uptake by the Greene melanoma in the Syrian golden hamster with 21 radiopharmaceuticals. Maximum % uptake and the time at which this occurred are listed. It is essential to know maximum tumor to background ration and the time after injection that this occurs to determine suitability for tumor scanning. The importance of species variation deserves mention. Detection of eye melanoma in humans was quite variable whereas in hamsters it was quite easy to obtain a positive scan with a single pinhole. We then looked at brain uptake in man and found it (the brain scan) to be significant. In addition, we found a high uptake by the lung, something not found in hamsters but not entirely unsuspected of a amine, such as 123I-4,3DMQ. Finally, our clinical experience has shown us some of the vagaries of melanoma-seeking radiopharmaceuticals. This reflects the complexity of melanin and melanin-binding and points out the necessity for a more detailed analysis of the mechanisms involved in melanin binding radionuclides

  9. Development of new radiopharmaceuticals

    The possibilities to design and prepare better and more organ-specific radiopharmaceuticals for diagnostic nuclear medicine has increased dramatically in the recent past with a deeper understanding of the relationships between chemical structure and biological activity. Whereas most of the research is performed in well-funded laboratories of industrialized countries, there are several developing countries with adequate resources and expertise as to undertake fruitful research in the field of radiopharmacy. With the aim of promoting advanced research in radiopharmacy by developing new radiodiagnostics agents, in particular, hepatobiliary imaging agents labelled with 99mTc, and to facilitate exchange of information, the IAEA has established in 1983 the present Research Co-ordination Programme (CRP) with a duration of five years. The report includes detailed results obtained by all participants as well as novel preparation procedures for some of the newest and more promising radiopharmaceuticals developed under the auspices of the CRP. The extensive bibliographic reference listing is considered another important information of particular value for scientists in developing countries who do not always have access to updated scientific information sources. Refs, figs and tabs

  10. Organic radiopharmaceuticals: recent advances

    Organic radiopharmaceuticals are considered in light of accelerator and nuclide production requirements, special problems relating to the carrier-free state, including terminology, of the special technology required to prepare and manipulate these compounds and new trends in compound design and synthesis. The emphasis is on medical cyclotrons and the positron-emitting radionuclides, carbon-11, nitrogen-13, oxygen-15, and fluorine-18. New routes to synthetic precursors and organic compounds of high specific activity labeled with carbon-11, fluorine-18, and iodine-123 including monosaccharides, aromatic amines, neuroleptics, fatty acids, steroids, and other classes of compounds are discussed. Some compounds are considered in terms of the development and evaluation of structure-activity relationships and including some newer concepts such as metabolic trapping. 67 references

  11. Instrumentation and radiopharmaceutical validation

    Although the promise of new positron emission tomography (PET) imaging agents is great, the process of bringing these agents to commercialization remains in its infancy. There are no PET products today that have gone through the full clinical and chemistry development process required to gain marketing approval by the US Food and Drug Administration (Fda). The purpose of this paper was to review validation from the perspective of the chemistry, manufacturing and controls (CMC) section of an Fda filing, as well as the validation requirements described in Fda good manufacturing practice (GMP) regulations, guidance documents and general chapters of the US Pharmacopoeia (Usp). The review includes discussion of validation from development to commercial production of PET radiopharmaceuticals with a special emphasis on equipment and instrumentation used in production and testing. The goal is to stimulate a dialog that leads to the standardization of industry practices and regulatory requirements for validation practices in PET.

  12. Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production

    A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe's about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

  13. Radiopharmaceuticals in breast milk

    As assessment has been made of the radiological hazards to an infant following the administration of a radiopharmaceutical to a breast feeding mother. Feeding should be discontinued after administration of most I-131 and I-125 compounds, Ga-67 citrate or Se-78 methionine, and for iodinated compounds where it was possible to resume feeding, a thyroid-blocking agent should be administered. For Tc-99m compounds, pertechnetate had the greatest excretion in milk and interruptions of 12hr and 4hr were considered appropriate for pertechnetate and MAA respectively. Other Tc-99m compounds, Cr-51 EDTA and In-111 leucocytes did not justify an interruption just on the grounds of their associated excretion in milk. The ingestion hazard could be minimized by reducing the administered activity, and in some cases, by the substitution of a radiopharmaceutical with lower breast milk excretion. For Tc-99m lung and brain scans, the absorbed dose due to radiation emitted by the mother (i.e. when cuddling) was less than the ingested dose, but for a Tc-99m bone scan the emitted dose was greater. In all three cases, the emitted dose did not exceed 0 x 5 mGy for the infant in close contact to the mother for one-third of the time. For In-111 leucocytes, the emitted dose was about 2mGy, and it was concluded that close contact should be restricted to feeding times during the first 3 days after injection. 36 references, 2 figures, 5 tables

  14. Biodistribution of radiopharmaceuticals - mathematic models

    Characteristic biodistributions of radiopharmaceuticals were investigated by means of mathematical pharmacokinetics. Beside linear concentration dependent transport processes the existence of chemical equilibria in corresponding compartments producing chemically different transport and permeating species were included. The derived relations have been demonstrated by mathematical organ models comprising the renal excretion, the distribution of an osteotropic radiopharmaceutical between the skelet and the tumour compartment as well as a kidney model. (author)

  15. PET radiopharmaceuticals for neuroreceptor imaging

    2006-01-01

    Routine clinical PET radiopharmaceuticals for the noninvasive imaging of brain receptors, transporters,and enzymes are commonly labeled with positron emitting nuclides such as carbon-11 or fluorine-18. Certain minimal conditions need to be fulfilled for these PET ligands to be used as imaging agents in vivo. Some of these prerequisites are discussed and examples of the most useful clinical PET radiopharmaceuticals that have found application in the central nervous system are reviewed.

  16. Teaching and research in radiopharmaceuticals

    Radiopharmaceuticals comprise a critical element of diagnostic and therapeutic clinical nuclear medicine. As well they contribute to more basic pre-clinical and clinical diagnostic studies such as the evaluation of new drugs and new drug formulations. Their development and utilization is based on the complex interaction of a number of disciplines including medicine, pharmacy, biochemistry, pharmacology, chemistry, physics and engineering. This technically-complex multidisciplinary base has impeded the development of a uniform curriculum of training for basic scientists and professionals who work with radiopharmaceuticals. the range of technical knowledge required is very broad; it ranges from chemical synthesis and radiolabelling, through a maze of biochemistry, pharmacology and now molecular biology, to GMP manufacture, dispensing and clinical consultation concerning use and interpretation of data. Clearly, no single discipline can (nor should) be expected to undertake in-depth training of radiopharmaceutical scientists, but equally clearly, there is need for the development of curricula that will develop specific components of the essential knowledge base. The 'radiopharmaceutical' or 'product' orientation of both teaching and research can be used to provide a focus for academic and professional organizations to develop 'radiopharmacy' curricula that effectively train radiopharmaceutical practitioners for specific roles within the clinical, academic, government and industrial interests of radiopharmaceutical scientists. Currently, there is a plethora of segmented training programs, many of which are inadequately positioned to be of great value to the field or its practitioners. Efforts to re-focus radiopharmacy programs and to build professional recognition for them are bringing about harmonization of performance objectives, and leading to didactic and experiential curricula. The impact and evolution of regulatory processes will demand new and better

  17. Radiopharmaceuticals: State of the art

    The state of the art in radiopharmaceuticals is reflected by the major topics in the papers presented at the last three symposia on radiopharmaceuticals. For some time most papers have been devoted to positron emission topography compounds, followed closely by fluorine 18 and carbon 11 agents. Future progress in nuclear medicine will be determined both by the development of new, specific tracer agents and by improvements in the quality of the imaging devices. Steady progress is being made. (orig.)

  18. Development of radiopharmaceuticals

    Park, Kyung Bae; Kim, J. R.; Shin, B. C.; Kim, Y. M.; Cho, U. K.; Han, K. H.; Chung, Y. J.; Shin, H. Y.; Hong, S. B.

    1997-09-01

    To overcome many problems caused by external radiation therapy, we have developed a new agent for internal radiation therapy, which is administered directly to the lesions and irradiate {beta}-rays resulting in maximized therapeutic effect and minimized radiation damage to normal tissues or organs to nearby. In the same reasons, we have also developed a new radioactive patch for the treatment of skin cancer using {beta}-emitting radionuclide. We prepared for {sup 166}Ho-chitosan complex ({sup 166}Ho-CHICO) which is potential radiopharmaceuticals for the treatment of liver cancer, peritoneal cancer metastasized from stomach cancer, ovarian cancer, and rheumatoid arthritis in knee joints. We carried out various experiments such as evaluation of absorbed dosimetry, studies on absorption, distribution, metabolism, and excretion (ADME) and clinical trials with {sup 166}Ho-CHICO. For commercialization of {sup 166}Ho-CHICO, we evaluated its toxicity, efficacy and safety, and then prepared documents for submission to the Mininstry of Health and Welfare to get license as an investigational new drug. {sup 166}Ho-Patch for skin cancer treatment was prepared by neutron irradiation of pre-made non-radioactive {sup 165}Ho-Patch. We evaluated the efficacy and safety of {sup 166}Ho-Patch in the treatment of skin cancer using an animal model and in clinical cases. (author). 49 refs., 15 tabs., 36 figs.

  19. New blood flow radiopharmaceutical

    Our program for research into the causes of mental disorders such as schizophrenia, manic depressive illness and senile dementia has led us to the development of a new radiopharmaceutical agent, IDNNA (4-iodo-2,5-dimethoxy-N,N-dimethylamphetamine). A series of some 15 different 131I labeled molecules with various substitutions on the amine were synthesized and tested, and the uptake of the 131I labeled conpounds in rats was measured. The dimethyl amine (IDNNA) had the best brain uptake and brain/blood ratio. When injected into a dog and scanned with a whole-body scanner, the uptake in the brain could be clearly seen and quantified. Plasma sampling at the same time showed that the maximum brain/blood ratio of 8.7 occurred at 8 min after injection, and the concentration in brain remained high for at least 15 min. Labeling is achieved by reacting 131ICl and the precursor, 2,5-dimethoxy-N,N-dimethyl amphetamine, in glacial acetic acid; the reaction is complete in less than one minute

  20. Development of radiopharmaceuticals

    To overcome many problems caused by external radiation therapy, we have developed a new agent for internal radiation therapy, which is administered directly to the lesions and irradiate β-rays resulting in maximized therapeutic effect and minimized radiation damage to normal tissues or organs to nearby. In the same reasons, we have also developed a new radioactive patch for the treatment of skin cancer using β-emitting radionuclide. We prepared for 166Ho-chitosan complex (166Ho-CHICO) which is potential radiopharmaceuticals for the treatment of liver cancer, peritoneal cancer metastasized from stomach cancer, ovarian cancer, and rheumatoid arthritis in knee joints. We carried out various experiments such as evaluation of absorbed dosimetry, studies on absorption, distribution, metabolism, and excretion (ADME) and clinical trials with 166Ho-CHICO. For commercialization of 166Ho-CHICO, we evaluated its toxicity, efficacy and safety, and then prepared documents for submission to the Mininstry of Health and Welfare to get license as an investigational new drug. 166Ho-Patch for skin cancer treatment was prepared by neutron irradiation of pre-made non-radioactive 165Ho-Patch. We evaluated the efficacy and safety of 166Ho-Patch in the treatment of skin cancer using an animal model and in clinical cases. (author). 49 refs., 15 tabs., 36 figs

  1. Radiopharmaceuticals targeting melanoma

    Pham, T.Q.; Berghofer, P.; Liu, X.; Greguric, I.; Dikic, B.; Ballantyne, P.; Mattner, F.; Nguyen, V.; Loc' h, C.; Katsifis, A. [Radiopharmaceuticals Research Institute, Australian Nuclear Science and Technology Organisation, Menai, N.S.W., Sydney (Australia)

    2008-02-15

    Melanoma is one of the most aggressive cancers known with a high rate of mortality and increasing global incidence. So, the development of radiopharmaceuticals for either diagnostic or therapeutic purposes could make enormous contributions to melanoma patient health care. We have been studying melanoma tumours through several targeting mechanisms including melanin or specific receptor based radiopharmaceuticals Structure activity studies indicate that the substitution patterns on radioiodinated benzamides significantly influence the uptake mechanism from melanin to sigma-receptor binding. Furthermore, the position of the iodine as well as the presence of key functional groups and substituents has resulted in compounds with varying degrees of activity uptake and retention in tumours. From these results, a novel molecule 2-(2-(4-(4-iodo benzyl)piperazin-1-yl)-2-oxo-ethyl)isoindoline- 1,3-dione (M.E.L.037) was synthesized, labelled with iodine-123 and evaluated for application in melanoma tumour scintigraphy and radiotherapy. The tumour imaging potential of {sup 123}IM.E.L.037 was studied in vivo in C.57 B.L./ 6 J female mice bearing the B.16 F.0. murine melanoma tumour and in BALB/c nude mice bearing the A.375 human amelanotic melanoma tumour by biodistribution, competition studies and by SPECT imaging. {sup 123}I-M.E.L.037 exhibited high and rapid uptake in the B.16 F.0 melanoma tumour at 1 h (13 % I.D./g) increasing with time to reach 25 % I.D./g at 6 h. A significant uptake was also observed in the eyes (2% I.D., at 3-6 h p.i.) of black mice. No uptake was observed in the tumour or in the eyes of nude mice bearing the A.375 tumour. Due to high uptake and long retention in the tumour and rapid body clearance, standardized uptake values(S.U.V.) of {sup 123}I-M.E.L.037 were 30 and 60, at 24 and 48 h p.i.,respectively. SPECT imaging of mice bearing the B.16 melanoma indicated the radioactivity was predominately located in the tumour followed by the eyes, while no

  2. Radiopharmaceuticals for hepatobiliary imaging

    Chervu, L.R.; Nunn, A.D.; Loberg, M.D.

    1982-01-01

    Tests for liver function have by and large centered around clinical laboratory diagnostic procedures for a number of years. Besides these, radiographic imaging procedures, including oral cholecystography and intravenous cholangiography, serve a very useful purpose, but several of them are invasive and involve a certain degree of risk from the administered contrast media as well as discomfort to the patient. The cholescintigraphic procedures, though noninvasive, have not played a significant role in the evaluation of hepatobiliary disorders prior to the introduction of the currently available /sup 99m/Tc-labeled IDAs. These new hepatobiliary agents offer many advantages over the previously utilized radiopharmaceuticals (/sup 131/I-rose bengal in particular) in terms of the high degree of specificity for localization in the gallbladder with rapid extraction rates by the polygonal cells of the liver and very low excretion via the GU tract. A detailed understanding of the structure distribution relationship of the various groups in the complex enable the design of agents with an improvement in hepatobiliary specificity and other desirable characteristics. In many clinical situations, even in patients with high bilirubin levels, the /sup 99m/Tc-labeled IDAs offer far superior clinical information over the alternative diagnostic imaging modalities. Further, the absorbed radiation dose imparted to the critical organs is far lower than with the older agents. Thus, the introduction of the cholescintigraphic procedures with the /sup 99m/Tc-labeled IDAs have ushered in a new phase in the diagnostic workup of patients with impaired hepatocellular function and other biliary disorders.

  3. Comparative evaluation of therapeutic radiopharmaceuticals

    Radionuclide therapy employing unsealed radiotherapeutic agents has emerged as an important tool for cancer management. The development of therapeutic radiopharmaceuticals based on different types of carrier molecule and a variety of radioisotopes is being actively pursued worldwide. There have been many significant advances in this field, and many of the technical problems involved in labelling biomolecules with a variety of radionuclides have been solved. However, the assessment of the relative effectiveness of different radiopharmaceuticals for cancer therapy is a difficult task owing to the large number of variables that must be considered, some related to the biological carrier and others to the radioisotope. Comparing the therapeutic efficacy in patients is not feasible in most cases for ethical and regulatory reasons. Hence, it is important to develop laboratory methods that can be used for reliable and efficient comparative evaluation of promising therapeutic radiopharmaceuticals. The IAEA has organized several coordinated research projects (CRPs) in the field of radiopharmaceuticals that have helped Member States to acquire technologies for the production of useful radiopharmaceuticals. In one such CRP on techniques for labelling biomolecules for targeted therapy, conducted from 1998 to 2001, the participants developed several protocols and standard operating procedures for labelling peptides and antibodies with therapeutic radioisotopes. During the course of the CRP, it was recognized that successful development of therapeutic radiopharmaceuticals will require in vitro biological assays as well as appropriate tumour models for carrying out biodistribution studies of the products in order to collect data for preclinical studies. Two meetings, held in 1999 and 2001, recommended the organization of a CRP for the development of laboratory methods for comparative evaluation of therapeutic radiopharmaceuticals. Fifteen countries - Brazil, Cuba, the Czech

  4. R and D of radiopharmaceuticals at SINR

    The current status and market trend of the radiopharmaceuticals are discussed in detail. The establishment of the Shanghai Joint R/D Center of Radiopharmaceuticals, under the Chinese Academy of Sciences and the State Administration of Pharmaceuticals of China, will greatly promote the research, development and industrialization of the cyclotron-based radiopharmaceuticals for the SPECT and PET applications

  5. Radiochemical stability of radiopharmaceutical preparations

    Martins, Patricia de A.; Silva, Jose L. da; Ramos, Marcelo P.S.; Oliveira, Ideli M. de; Felgueiras, Carlos F.; Herrerias, Rosana; Zapparoli Junior, Carlos L.; Mengatti, Jair; Fukumori, Neuza T.O.; Matsuda, Margareth M.N. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-07-01

    The 'in vitro' stability studies of the radiopharmaceutical preparations are an essential requirement for routine practice in nuclear medicine and are an important parameter for evaluating the quality, safety and efficacy required for the sanitary registration of pharmaceutical products. Several countries have published guidelines for the evaluation of pharmaceutical stability. In Brazil, the stability studies should be conducted according to the Guide for Conducting Stability Studies published in the Resolution-RE n. 1, of 29th July 2005. There are also for radiopharmaceutical products, two specific resolutions: RDC-63 regulates the Good Manufacturing Practices for Radiopharmaceuticals and RDC-64 provides the Registration of Radiopharmaceuticals, both published on the 18th December 2009. The radiopharmaceutical stability is defined as the time during which the radioisotope can be safely used for the intended purpose. The radiochemical stability can be affected by a variety of factors, including storage temperature, amount of radioactivity, radioactive concentration, presence or absence of antioxidants or other stabilizing agents. The radiochemical stability studies must be established under controlled conditions determined by the effective use of the product. The aim of this work was to evaluate the radiochemical stability of labeled molecules with {sup 131}I, {sup 123}I, {sup 153}Sm, {sup 18}F, {sup 51}Cr, {sup 177}Lu and {sup 111}In as well as {sup 67}Ga and {sup 201}Tl radiopharmaceuticals. Radiochemical purity was evaluated after production and in the validity period, with the maximum activity and in the recommended storage conditions. The analyses were carried out by thin-layer silica gel plate, paper chromatography and gel chromatography. The experimental results showed to be in accordance with the specified limits for all the analysed products. (author)

  6. Molecular modelling and radiopharmaceutical design

    Aim: Among several headings for radiopharmaceuticals (RPs) design, molecular modelling (MM) could be used for the prediction of ligands and metal-complexes structures. Using MM it is also possible to simulate molecular interactions between predicted structures and specific biomolecules. Bisphosphonates (BPs) are ligands that are able to coordinate radioactive metals, such as 153Sm, 166Ho, 186Re, etc., but they are all polymeric complexes difficult to characterize. It is reported that the bone uptake does not depend on the nature of metal center, but is primarily driven by the nature of the ligand, as in the case of HEDP-M (M=99mTc, 186Re, 113Sn). So, it would be interesting to estimate the relevant molecular properties of BPs by MM, simulate their interaction with hydroxyapatite (HAP) the main bone component, and then correlate the predicted molecular parameters with experimental data obtained from HAP binding and biodistribution studies of BPs carrying radioactive metals. Materials and Methods: The molecular structures and preferred conformations of BPs differing in the length of the aliphatic chain attached to their substituted amine groups (pami-dronate, olpadronate and ibandronate) were obtained using the second-generation CVFF 950 (version 1.01) force field of Hwang et al. Simulation of the interactions between the studied BPs and HAP were performed using a Cerius-2 system of programs running on a Silicon Graphics O2 workstation. BPs-153Sm complexes were synthesized and characterized by ITLC. Their binding to HAP and in vivo biodistribution studies were carried out as usual described in literature. Results: A direct correlation could be established between in vitro BPs affinity towards HAP and their corresponding energies from the Coulomb interactions involving the N and P atoms of the studied BPs bound to the HAP (0,0,1) surface and the nearest Ca atoms of HAP. The BPs-153Sm showing the highest binding to HAP and skeletal uptake are those which possess the

  7. Prenatal radiation doses from radiopharmaceuticals

    The radiopharmaceutical administration with diagnostic or therapeutic purpose during pregnancy implies a prenatal radiation dose. The dose assessment and the evaluation of the radiological risks become relevant due to the great radiosensitivity of the fetal tissues in development. This paper is a revision of the available data for estimating fetal doses in the cases of the more frequently used radiopharmaceuticals in nuclear medicine, taking into account recent investigation in placental crossover. The more frequent diagnostic and therapeutic procedures were analyzed according to the radiation doses implied. (author)

  8. Radiopharmaceuticals for palliative therapy pain

    Dissemination to bone of various neoplasms is cause of pain with poor response by major analgesics.Indications. Radiopharmaceuticals,description of main characteristics of various β emitter radionuclides.Choose of patients for worm indication of pain palliative therapy with β emitter radiopharmaceuticals is adequate must be careful . Contraindications are recognized.Pre and post treatment controls as clinical examination and complete serology are described.It is essential to subscribe protocols,keep patient well informed,included the physician in charge of the patient as part of the team.Bibliography

  9. Specific GMP guidelines for radiopharmaceutical products

    These guidelines are intended to complement those provided in ''Good manufacturing practices for pharmaceutical products'', as well as the GMP for sterile pharmaceutical products. The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the sources of products and methods of manufacture. Manufacturing procedures within the scope of these guidelines include: preparation of radiopharmaceuticals in hospital radiopharmacies, preparation of radiopharmaceuticals in centralized radiopharmacies, production of radiopharmaceuticals in nuclear centres, institutes or industrial manufacturers, preparation and production of radiopharmaceuticals in Positron Emission Tomography (PET) centres

  10. Preparation of radiopharmaceuticals labeled with metal radionuclides

    Welch, M.J.

    1992-06-01

    We recently developed a useful zinc-62/copper-62 generator and are presently evaluating copper-62 radiopharmaceuticals for clinical studies. While developing these copper-62 radiopharmaceuticals, in collaboration with the University of Missouri Research Reactor, Columbia we have also explored copper-64 radiopharmaceuticals. The PET images we obtained with copper-64 tracers were of such high quality that we have developed and evaluated copper-64 labeled antibodies for PET imaging. The major research activities described herein include: the development and assessment of gallium-68 radiopharmaceuticals; the development and evaluation of a new zinc-62/copper-62 generator and the assessment of copper-62 radiopharmaceuticals; mechanistic studies on proteins labeled with metal radionuclides.

  11. Preparation of radiopharmaceuticals labeled with metal radionuclides

    We recently developed a useful zinc-62/copper-62 generator and are presently evaluating copper-62 radiopharmaceuticals for clinical studies. While developing these copper-62 radiopharmaceuticals, in collaboration with the University of Missouri Research Reactor, Columbia we have also explored copper-64 radiopharmaceuticals. The PET images we obtained with copper-64 tracers were of such high quality that we have developed and evaluated copper-64 labeled antibodies for PET imaging. The major research activities described herein include: the development and assessment of gallium-68 radiopharmaceuticals; the development and evaluation of a new zinc-62/copper-62 generator and the assessment of copper-62 radiopharmaceuticals; mechanistic studies on proteins labeled with metal radionuclides

  12. Radiopharmaceuticals preparation following hygienic rule

    The rules of radiation protection are essential in a service of nuclear medicine. A sensitization to hygiene in hospital in front of the fresh outbreak of nosocomial infections is useful in order to optimize the quality approach. In this context, the preparation of radiopharmaceuticals in the structure of nuclear medicine deserves a specific reflection. (N.C.)

  13. Lymphoscintigraphy: radiopharmaceutical selection and methods

    Kramer, E.L. (Memorial Sloan-Kettering Cancer Center, New York, NY (USA))

    1990-01-01

    The range of radiopharmaceuticals available for lymphoscintigraphy including radiocolloids, radiolabeled macromolecules and monoclonal antibodies are briefly discussed. The techniques used for tumour staging in internal mammary lymphoscintigraphy, iliopelvic lymphoscintigraphy, peripheral lymphoscintigraphy, localization of 'at risk' lymph nodes and lymphedema are also reviewed. (UK).

  14. Current directions in radiopharmaceutical research

    Much of current radiopharmaceutical research is directed towards the development of receptor-binding tracers which are targeted towards biochemical processes. These may be extra or intracellular in nature and hold promise for an imaging approach to tissue characterisation in-vivo. Many of these products are based on proteins which range in size from large monoclonal antibodies to small neuropeptides and share a radiolabelling chemistry based on the use of bifunctional chelating agents. Although developed initially for use with indium-111, considerations of cost and isotope availability have continued to direct the efforts of many researchers towards the use of technetium-99m. While polypeptide-based radiopharmaceuticals may be useful for imaging peripheral cell-surface receptors, access to sites of interest within the cell, or in the brain, requires the development of small lipophilic molecules with retained ability to interact with intracellular targets. The design and synthesis of these compounds presents a particular challenge to the radiopharmaceutical chemist which is being met through either a pendant or integrated approach to the use of technetium coordination with particular emphasis on technetium (v) cores. Progress continues to be made in the application of targeted radionuclide therapy particularly in the development of radiopharmaceuticals for the treatment of malignant bone disease. methods for labelling antibodies with a great variety of cytotoxic radionuclides have now been refined and their use for radioimmunotherapy in the treatment of haematological malignancies shows great promise. The major medical areas for application of these new radiopharmaceuticals will be in oncology, neurology and inflammation but the increasingly difficult regulatory climate in which drug development and health-care now operate will make it essential for researchers to direct their products toward specific clinical problems as well as biological targets. (author)

  15. Radiopharmaceuticals for diagnosis. Final report

    1994-03-01

    In the period 1969-1986, this project was directed to the evolution of target-specific labeled chemicals useful for nuclear medical imaging, especially radioactive indicators suited to tracing adrenal functions and localizing tumors in the neuroendocrine system. Since 1986, this project research has focused on the chemistry of positron emission tomography (PET) ligands. This project has involved the evaluation of methods for radiochemical syntheses with fluorine-18, as well as the development and preliminary evaluation of new radiopharmaceuticals for positron emission tomography. In the radiochemistry area, the ability to predict fluorine-18 labeling yields for aromatic substitution reactions through the use of carbon-13 NMR analysis was studied. Radiochemical yields can be predicted for some structurally analogous aromatic compounds, but this correlation could not be generally applied to aromatic substrates for this reaction, particularly with changes in ring substituents or leaving groups. Importantly, certain aryl ring substituents, particularly methyl groups, appeared to have a negative effect on fluorination reactions. These observations are important in the future design of syntheses of complicated organic radiopharmaceuticals. In the radiopharmaceutical area, this project has supported the development of a new class of radiopharmaceuticals based on the monoamine vesicular uptake systems. The new radioligands, based on the tetrabenazine structure, offer a new approach to the quantification of monoaminergic neurons in the brain. Preliminary primate imaging studies support further development of these radioligands for PET studies in humans. If successful, such radiopharmaceuticals will find application in studies of the causes and treatment of neurodegenerative disorders such as Parkinson`s disease.

  16. Radiopharmaceutical: options to marketing authorization

    In France, since the law 92-1279 (December 1992) the tracer used in nuclear medicine are considered as medicines, and all the regulations applicable to general medicines have to be followed for radiopharmaceuticals. The best situation in order to use radiopharmaceutical in nuclear medicine center is to use a tracer with a marketing authorization. However due to the very high cost to obtain this authorization, many tracers validated by scientific community will never been sold by pharmaceutical companies. However in respect with legal rules, it is possible to prepare these tracers in the hospital radiopharmacy, under the responsibility of the radio-pharmacist. We discuss here these different possibilities (magistral preparation...) and the conditions for these preparations. (author)

  17. Radiopharmaceutical transport system in France

    Radiopharmaceuticals are transported in type A package, activities are low and distributed among more than 200 000 packages sent throughout France. Impact of ICRP recommendations and of French regulations on packaging, storage, handling and transport is underlined. Road, rail or air transport are determined by geographical consideration and importance of each means of transport concerning quantities or mileage are easily deduced. Risks for normal conditions are evaluated. Accidents or incidents are rare and statistic analysis non-significant. 7 refs

  18. Radiation dose estimates for radiopharmaceuticals

    Tables of radiation dose estimates based on the Cristy-Eckerman adult male phantom are provided for a number of radiopharmaceuticals commonly used in nuclear medicine. Radiation dose estimates are listed for all major source organs, and several other organs of interest. The dose estimates were calculated using the MIRD Technique as implemented in the MIRDOSE3 computer code, developed by the Oak Ridge Institute for Science and Education, Radiation Internal Dose Information Center. In this code, residence times for source organs are used with decay data from the MIRD Radionuclide Data and Decay Schemes to produce estimates of radiation dose to organs of standardized phantoms representing individuals of different ages. The adult male phantom of the Cristy-Eckerman phantom series is different from the MIRD 5, or Reference Man phantom in several aspects, the most important of which is the difference in the masses and absorbed fractions for the active (red) marrow. The absorbed fractions for flow energy photons striking the marrow are also different. Other minor differences exist, but are not likely to significantly affect dose estimates calculated with the two phantoms. Assumptions which support each of the dose estimates appears at the bottom of the table of estimates for a given radiopharmaceutical. In most cases, the model kinetics or organ residence times are explicitly given. The results presented here can easily be extended to include other radiopharmaceuticals or phantoms

  19. Development of radiopharmaceutical for radiosinovectomy

    Radiopharmaceuticals prepared with different radionuclides have been used in diagnostic and therapeutic procedures in Nuclear Medicine. The interest in radionuclidic therapy has been increased in last years, with the introduction of new radiopharmaceuticals applied in the destruction of specific cells or to prevent its undesired proliferation. Radiosinovectomy (RSV) is a therapeutic modality that uses radiopharmaceuticals administered in the intra-articular cavity and represents an alternative to the treatment of different arthropaties and, in particular, the arthropaties derived from rheumatoid arthritis and haemophilic. The objective of the present work was to study the labeling of compounds with 90Y and 177Lu in order to improve the production conditions and quality control procedures, study the stability of the labeled compounds and preliminary biodistribution studies of the radiopharmaceuticals with potential for RSV applications. The study of the production of 90Y citrate colloid (90Y-Cit) was based in a labeling procedure using 90Y Cl3 solution (37 - 54 MBq) that was previously dried, followed by the addition of yttrium nitrate and sodium citrate in p H 7 at 37 deg C for 30 minutes. The production of hydroxyapatite (HA) labeled with 90Y was based in a labeling procedure using mono hydrated citric acid, yttrium nitrate and 90Y Cl3 solution (37 - 370 MBq). The reaction mixture was incubated for 30 minutes at room temperature and the HA was introduced in aqueous medium and the reaction proceed for 30 minutes under strong stirring. 177Lu-HA was produced using 177Lu Cl3 solution (296 MBq), in presence of lutetium oxide in NaCl medium, p H 7, under continuous stirring for 30 minutes at room temperature. Several reaction parameters were studied for the three radiopharmaceuticals. Labeling yield was determined after particles were centrifuged and washed with NaCl 0,9%. Radiochemical purity was determined by ascending chromatography using different chromatographic

  20. Preparation and control of radiopharmaceuticals in hospitals

    This guidebook covers the work commonly organized as part of the work in the hospital. It does not cover the manufacture of radiopharmaceuticals on an industrial scale. The work is characterized by the small scale on which manufacture and preparation of radiopharmaceuticals take place

  1. Radiopharmaceuticals based on antibodies and peptides

    The past two decades have seen a great stride in the development of new diagnostic and therapeutic radiopharmaceuticals due to the discovery and availability of a number of specific carrier molecules and the application of synthetic organic chemistry to modify these carrier molecules to accommodate the radionuclide of interest. Radiopharmaceuticals based on antibodies and peptides are discussed

  2. Quality control in 99m technetium radiopharmaceuticals

    This work means about the quality control in Tc radiopharmaceuticals preparation at hospitalary levels. Several steps must be used in a Nuclear Medicine Laboratory, such as proceeding,radiopharmaceuticals kits preparation, and dispensation materials,glasses,stopper,physical aspects,identification,ph control,storage,and reactif kits

  3. Radiopharmaceuticals. 40 years is nothing

    The nuclear medicine is today a medical speciality recognized and practised in the whole world. The birth was in the middle of the 20th century in the use of molecules or drugs marked with a radionuclide (radiopharmaceutical), for the diagnostic studies in vivo or in vitro, to obtain a therapeutic effect. Early in the decade of 70, its development and evolution was accentuated thanks to electronics, the contribution of new instruments for detection of diagnosis by images (gamma camera) and to the emergence of new radionuclide (in particular, 99mTc). (author)

  4. Clean room installations in a radiopharmaceutical facility

    The standards of radiopharmaceuticals on the facility, working environment and preparation control strategy are yet to be generated. In general, radiopharmaceuticals have short half-lives and emit gamma radiation. Due to its unique characteristics, its preparation has to be made in the fume hood and hot cell to avoid radiation exposure to workers. Considering radiation protection, the working environment has to be maintained under negative pressure so that dispersion of radiopharmaceuticals should be avoided. On the contrary, a positively pressurized working environment gives clean atmosphere and prevents contamination with harmful microorganisms during preparation. Hence, it is required to harmonize for mentioned contradictory conditions in preparation of radiopharmaceuticals for the safety of workers and its quality assurance as well. Therefore, it is reasonable that good manufacturing practice for radiopharmaceutical production facility should be constituted according to the standards for production of biological agents accompanied with a radiation shielding

  5. Biochemical considerations in the design of radiopharmaceuticals

    The goal of radiopharmaceutical chemistry is to design and develop radiotracers targeted to an organ or function whose activity kinetics in tissue can be detected externally by a gamma or a positron device. Radiopharmaceuticals are divided into the general categories of specific and non-specific agents. The specific radiopharmaceuticals are the tracers that follow a biochemical pathway or are involved in a particular interaction, for example metabolic substrates, drugs or analogs, and antibodies. This paper will focus on trends in the design of specific agents. The best radionuclides for the development of specific tracers are the positron emitting nuclides: carbon-11, nitrogen-13, oxygen-15 and fluorine-18. First the design of radiopharmaceuticals are considered in general (labeling strategies, stereochemical effects, specific activity). Next, a brief summary of the use of several radiopharmaceuticals is presented on the basis of their biochemical rationale. (orig./G.J.P.)

  6. Production of radiopharmaceuticals by cyclotrons

    Companies specialized in the development and installation of accelerator-based systems dedicated to the medical applications brought on the market cyclotrons well fitted to the requests of the industrial community or universities and so covering every segment of the market. These machines are fully automatic, and need reduced maintenance; they are highly specialized for defined tasks. They can produce high beam intensity and realize dual beam irradiation. Also the prices are reducing considerably. The targets and the automatic system follow the same trend. Unfortunately, the flexibility of these devices for new area of research and development has been dramatically reduced. The growing number of PET cameras has increased the popularity of PET tracers used for nuclear imaging. Consequently, there is a growing demand for these radiopharmaceuticals compounds labeled with short-lived radioisotopes for clinical applications. From a research and development tool in the eighties, PET has now grown up to a clinical tool. Moreover, depending of the social welfare, reimbursement of some PET examinations is granted, which accelerates the trend for an extended use of PET tracers. Regulatory affairs try to establish and standardize the control on these radiopharmaceutical compounds produced in a growing number of local radio pharmacies owning a baby cyclotron. On the other hand, the attention of equipment suppliers was brought in the setting up of a total quality control follow up. These efforts were successively achieved by getting for instance the ISO 9001 certificate

  7. Fourth international radiopharmaceutical dosimetry symposium

    The focus of the Fourth International Radiopharmaceutical Dosimetry Symposium was to explore the impact of current developments in nuclear medicine on absorbed dose calculations. This book contains the proceedings of the meeting including the edited discussion that followed the presentations. Topics that were addressed included the dosimetry associated with radiolabeled monoclonal antibodies and blood elements, ultrashort-lived radionuclides, and positron emitters. Some specific areas of discussion were variations in absorbed dose as a result of alterations in the kinetics, the influence of radioactive contaminants on dose, dose in children and in the fetus, available instrumentation and techniques for collecting the kinetic data needed for dose calculation, dosimetry requirements for the review and approval of new radiopharmaceuticals, and a comparison of the effect on the thyroid of internal versus external irradiation. New models for the urinary blader, skeleton including the active marrow, and the blood were presented. Several papers dealt with the validity of traditional ''average-organ'' dose estimates to express the dose from particulate radiation that has a short range in tissue. These problems are particularly important in the use of monoclonal antibodies and agents used to measure intracellular functions. These proceedings have been published to provide a resource volume for anyone interested in the calculation of absorbed radiation dose

  8. Radiopharmaceuticals production activities in Egypt

    Applications of radiopharmaceuticals and labelled compounds in the field of nuclear medicine in Egypt have increased so rapidly in the last few years. At present, a large number of hospitals are utilizing these radioisotopic techniques for both diagnosis and treatment. The following production activities are taking place in the Egyptian Radioisotope Production laboratories. By utilizing the research reactor a large number of radioisotopes which find wide applications in nuclear medicine were produced, such as iodine-131, phosphorus-32, sodium-24, potassium-42 and molybdenum-99 / technetium-99m generators. Gallium-67, indium-111 and iodine-123 will be produced locally after installation of the cyclotron at the end of 1998. A large number of Tc-99m based kits for diagnostic medical applications have been produced. Also, many radiopharmaceuticals labelled with iodine-131 were produced. The radioisotope production laboratory is able to supply many hospitals with the radioimmunoassay kits of the thyroid related hormones (T4, T3 and TSH). Research and development activities are taking place in the field of monoclonal antibodies and tumor markers with special consideration of AFP, CEA, PSA and βhCG. (author)

  9. Radiopharmaceuticals drug interactions: a critical review

    Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance) or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here, we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions. (author)

  10. Uncertainty sources in radiopharmaceuticals clinical studies

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  11. Dosimetry for radiopharmaceuticals (invited paper)

    Developments in internal dosimetry for radiopharmaceuticals are summarised, with special reference to work carried out within the International Commission on Radiological Protection (ICRP). Differences and similarities with internal dosimetry for occupationally exposed workers and for members of the public are identified. What is unique for radiopharmaceuticals is their special biokinetics. The products are designed to get high uptake in certain organs and tissues. When a new compound is introduced there are few long-term retention data for humans available. Therefore efforts have continuously to be made to investigate the biokinetics and dosimetry of new products as well as older products, for which the dosimetry is uncertain, e.g. pure β-emitters. Serial, quantitative gamma camera images of patients will continue to be the base for biokinetic information together with analysis of urine samples. The observed time-activity curves are described using exponential functions with specified fractional activities and half-times. The physical calculations are based on the MIRD formalism. For more detailed dosimetry, CT, MR and ultrasound can be used to localise organs and to determine their volumes. Such measurements are also needed for the construction of realistic phantoms (mathematically describable phantoms, 'voxel' phantoms and anthropomorphic phantoms) which are the geometrical base for dose calculations. Variations in anatomy and biokinetics between individuals due to age, gender and disease have to be given greater consideration in the future. Information on the distribution of a radionuclide within organs and tissues is of importance for its therapeutic use as is the intracellular localisation of low energy electron emitters both in therapy and diagnosis. (author)

  12. Radioisotopes and radiopharmaceuticals in nuclear cardiology

    Nuclear medicine studies of the heart represent one of the fastest growing areas of research and clinical interest. Some years ago, nuclear medicine cardiac studies were limited to the evaluations of myocardial infraction. Developments in radiopharmaceuticals chemistry and instrumentation have made possible advances in cardiovascular nuclear medicine. Techniques and Radiopharmaceuticals no exist for the imaging of viable myocardium and the determination of myocardial tissue metabolism, as well as radionuclide angiography to obtain quantitative information of cardiac output, mean transit times, cardiac volumes, and ejection fractions. This paper will firstly describe that anatomy and physiology of the heart as to relate to the radiopharmaceuticals which will be discussed, and will secondly explore various radiopharmaceuticals which have been used for various purposes in cardiac imaging, than will explore radioisotopes which have been proposed for myocardial treatment

  13. Report of the Task Force on radiopharmaceuticals

    The procedures for evaluation of IND and NDA applications were reviewed by FDA and the state members of the Task Force believe that there is significant progress being made toward expeditious handling of these items. Progress toward publication of the final rule on radiopharmaceuticals has reduced the need for state regulatory activity in investigational aspects of radiopharmaceutical research to the point that the original concept for the training is no longer valid

  14. Rational development of radiopharmaceuticals for HIV-1

    The global battle against HIV-1 would benefit from a sensitive and specific radiopharmaceutical to localize HIV-infected cells. Ideally, this probe would be able to identify latently infected host cells containing replication competent HIV sequences. Clinical and research applications would include assessment of reservoirs, informing clinical management by facilitating assessment of burden of infection in different compartments, monitoring disease progression and monitoring response to therapy. A “rational” development approach could facilitate efficient identification of an appropriate targeted radiopharmaceutical. Rational development starts with understanding characteristics of the disease that can be effectively targeted and then engineering radiopharmaceuticals to hone in on an appropriate target, which in the case of HIV-1 (HIV) might be an HIV-specific product on or in the host cell, a differentially expressed gene product, an integrated DNA sequence specific enzymatic activity, part of the inflammatory response, or a combination of these. This is different from the current approach that starts with a radiopharmaceutical for a target associated with a disease, mostly from autopsy studies, without a strong rationale for the potential to impact patient care. At present, no targeted therapies are available for HIV latency, although a number of approaches are under study. Here we discuss requirements for a radiopharmaceutical useful in strategies targeting persistently infected cells. The radiopharmaceutical for HIV should be developed based on HIV biology, studied in an animal model and then in humans, and ultimately used in clinical and research settings

  15. Radiopharmaceuticals for diagnosis of inflammation

    Inflammations represent mediator-induced reactions of the hematopoetic-immunologic cell system resulting from exogenous or endogenous stimuli. On cellular level, an increased expression of inflammatory genes is followed by the release of several mediators. As inflammatory response vascular permeability increases and interstitial oedema develops. Additionally, white blood cells emigrate and several transduction cascades are activated. Radiopharmaceuticals for inflammation scintigraphy should specifically reflect one or several aspects of inflammation pathophysiology on molecular level. A group of elder tracers for this purpose comprised substances that are accumulated due to the permeability of physiological barriers. However, their property to accumulate in all processes with increased vascular permeability results in a comparably low specificity of these methods. In-vitro-labelled granulocytes were the method of choice for scintigraphic imaging of inflammation for years. Investigations with 111In-labelled granulocytes are still frequently considered as the gold standard to detect inflammation by scintigraphy. The use of antibodies or antibody fragments directed against leucocytes allowed in vivo labelling and substituted more complex techniques of in vitro labelling despite of several disadvantages. Due to the superior imaging quality of positron emission tomography, [18F]FDG-labelled leucocytes might result in a renaissance of in vitro methods. In cases of cerebral inflammation, activated microglia was visualised by its increased expression of benzodiazepin receptors. An interesting approach to differentiate between infection and sterile inflammation could be the use of bacterial gyrase inhibitors labelled with radioactive compounds. At present, specificity of this method is still controversially discussed. In search of substances to visualise inflammatory transduction cascades selectively, several chemotactic and chemokinetic cytokines, metabolites of the

  16. Radiopharmaceutical development and clinical needs

    The use of radionuclides for medical applications has continued to grow at a very rapid pace. The use of radiotracers for nuclear medicine imaging and for radiotherapy of cancer as well as certain benign disorders is firmly established as an important clinical modality. Over the past ten years, nuclear medicine has experienced an evolution towards functional studies and novel therapeutic approaches. New radionuclides are required for these applications. In the developmental stages, each new isotope has to go through a phase of careful scrutiny and evaluation, and practical concerns related to the cost of production and availability must be addressed. The development of 18 F-labeled radiopharmaceuticals has opened a completely new area of investigation. Research on bioconjugates (this term includes radiolabeled antibodies, peptides, receptor-specific and other bioactive molecules) has experienced rapid growth because of the promise of a number of these ''bioactive molecules'' to serve as selective carriers of radionuclides for tumor-associated and other specific antigens/receptors ''in vivo''. The new concept of nuclear medicine, particularly when applied to the field of oncology is directed towards the physiological mechanisms and the study of molecular disfunctions. The search for new radiopharmaceuticals thus aims at studying tumors at a tissue and molecular level. Examples of this new approach are scans utilizing the following substances: -guanethidine and noradrenaline analogues such as meta-iodo-benzyl-guanidine labeled with iodine-131 or iodine-123 aimed at targeting neuroendocrine cells and their secretory granules; -various monoclonal antibodies directed at different tumor types, both for diagnostic and therapeutic purposes. Radioimmunotherapy is considered particularly suited for treatment of tumors not easily amenable to surgery and for the treatment of small disseminated lesions; -somatostatin analogs tagged with indium-111 or more recently with Yttrium

  17. Technetium radiopharmaceuticals. Fundamentals, synthesis, structure, and development

    Technetium-99m radiopharmaceuticals are increasingly finding application in nuclear medicine for scintigraphic and emission tomographic imaging, morphologic description and functional testing of organs. Over 80% of the radiopharmaceuticals currently clinically used are labeled with the short-lived, metastable nuclide 99mTc, whose nuclear properties are almost optimal with regard to a low radiation exposure of the patient and an effective detection of the emitted γ quanta. 99mTcO4- can be easily prepared without the use of accelerator systems through generator columns. Most of the 99mTc radiopharmaceuticals are complexes which are synthesized by reduction of 99mTcO4- in the presence of suitable ligands. To achieve a high organ specificity, some understanding of the relationship between the structure of the diagnostic agent and its organ distribution is necessary. Structure analyses can be carried out on analogous compounds of the long-lived nuclide technetium-99g; these compounds are obtainable in weighable quantities. The development of new 99mTc radiopharmaceuticals is a challenge to coordination chemists. The syntheses, molecular structures, and applications of the most important 99mTc radiopharmaceuticals will be described in this review, and current directions and tendencies of the development will be shown. (orig.)

  18. Function test of radiopharmaceutical freeze dryer

    Freeze Dryer is the main tool for radiopharmaceutical production process such as drying of radiopharmaceutical kits. To increase research and development activity of radiopharmaceutical product needs new freeze dryer type of 7948030 Freezone-Stoppering Tray Dryer to obtain high quality radiopharmaceutical dry kit. The aim of this research is ensuring freeze dryer machine can be operated well and fulfilling quality assurance programme. The working principle of freeze dryer is freeze drying process. Liquid material that originally frozen then dried with a heating process at low temperature in the vacuum freeze dryer chamber and will result phorous lyophilized product. Therefore, there are some parameters on freeze dryer operation, such as temperature, pressure, and time. They will effect on quality of radiopharmaceutical kit products. This research try for dry DTPA kit with manual or auto method for ± 31 hours following the procedure of drying DTPA kit. The results showed that freeze dryer can function properly in accordance with the specifications that with manual methods, freezing process reached -40°C and -34 °C in the auto, the drying process at 15°C and 0.050 mbar on each method, and obtain dry product of DTPA kit powder (lyophilized). (author)

  19. Quality controls of radiopharmaceuticals used in nuclear medicine

    Chromatographic quality controls for Tc-99m; In-113m; I-131; Tl-201 and Ga-67 radiopharmaceuticals are described. Moreover, a chromatographic system which allows to separate different radiopharmaceuticals from In-113m is pointed out. (author)

  20. Certification of GMP is imperative necessity on radiopharmaceutical manufacturers

    The general circumstances on the conception, quality of GMP and Chinese GMP for radiopharmaceutical manufacturers are introduced briefly. It explains that certification of GMP is imperative necessity on radiopharmaceutical manufacturers

  1. Radiopharmaceutical development of radiolabelled peptides

    Fani, Melpomeni; Maecke, Helmut R. [University Hospital Freiburg, Department of Nuclear Medicine, Freiburg (Germany)

    2012-02-15

    Receptor targeting with radiolabelled peptides has become very important in nuclear medicine and oncology in the past few years. The overexpression of many peptide receptors in numerous cancers, compared to their relatively low density in physiological organs, represents the molecular basis for in vivo imaging and targeted radionuclide therapy with radiolabelled peptide-based probes. The prototypes are analogs of somatostatin which are routinely used in the clinic. More recent developments include somatostatin analogs with a broader receptor subtype profile or with antagonistic properties. Many other peptide families such as bombesin, cholecystokinin/gastrin, glucagon-like peptide-1 (GLP-1)/exendin, arginine-glycine-aspartic acid (RGD) etc. have been explored during the last few years and quite a number of potential radiolabelled probes have been derived from them. On the other hand, a variety of strategies and optimized protocols for efficient labelling of peptides with clinically relevant radionuclides such as {sup 99m}Tc, M{sup 3+} radiometals ({sup 111}In, {sup 86/90}Y, {sup 177}Lu, {sup 67/68}Ga), {sup 64/67}Cu, {sup 18}F or radioisotopes of iodine have been developed. The labelling approaches include direct labelling, the use of bifunctional chelators or prosthetic groups. The choice of the labelling approach is driven by the nature and the chemical properties of the radionuclide. Additionally, chemical strategies, including modification of the amino acid sequence and introduction of linkers/spacers with different characteristics, have been explored for the improvement of the overall performance of the radiopeptides, e.g. metabolic stability and pharmacokinetics. Herein, we discuss the development of peptides as radiopharmaceuticals starting from the choice of the labelling method and the conditions to the design and optimization of the peptide probe, as well as some recent developments, focusing on a selected list of peptide families, including somatostatin

  2. Experience from a national quality assurance system on radiopharmaceuticals

    A national quality assurance program covering all radiopharmaceuticals used in Denmark was established in 1970. A regulatory system combining official control with a pharmacy service was developed. 15 years experience in the radiopharmaceutical area will be described. This will include a discussion on registration including the evaluation of safety and efficacy and the supply of radiopharmaceuticals. Different ways of surveying the quality of radiopharmaceuticals and results of quality control analysis will be reviewed

  3. Radiopharmaceutical potential of I-131 labelled diazepam

    In this study, diazepam is a derivative of the 1.4 benzodiazepine family that the most widely used drug as anticonvulsant agent has been labeled with I-131, as a new radiopharmaceutical and its radiopharmaceutical potential has been determined. Labeling of diazepam has been performed by iodogen method and optimum labeling conditions have been determined. Optimum reaction conditions are 1 mg for iodogen amount; 1-5 mg for diazepam amount, 15-20 minutes for reaction time and room temperature for reaction temperature. Specific activity of labeled compound was 0,15 Ci/mmol level. N-octanol/water ratio was found 1.9 for 131IDZ (131I labeled diazepam). In vivo experiments have been carried out to determine radiopharmaceutical potentials of labeled compound. Biodistribution studies on rats showed that 131IDZ have accumulated in kidneys, liver, lungs and brain tissues. Scintigraphic results taken with gamma camera on rabbits agree with biodistribution results of rats. (author)

  4. The safe and effective use of radiopharmaceuticals

    In the medical applications of radionuclides, we have to arrange effective radiation protection of patients, staff and general public, maintain high standards of pharmaceutical safety and ensure that the radiopharmaceuticals are effective in use. The influence of the 1976 Council of the European Communities Euratom Directive in producing legislation in the United Kingdom controlling medical work with radioactivity is discussed. Attention is drawn to current studies in the dosimetry of radiopharmaceuticals, and some of the problems that continue to arise in evaluating the dosimetry and possible hazards of isotopes of iodine are discussed. Developments in facilities for preparing radiopharmaceuticals in hospital laboratories are considered and a short report is given of an extensive study of quality control procedures which showed that it was difficult to justify their use as a routine on established products. (Author)

  5. Radiopharmaceutical prescription in nuclear medicine departments

    In France, radiopharmaceutical prescription is often discussed depending to which juridical structure the nuclear medicine department is belonging. According to current regulation, this prescription is an obligation in a department linked to hospital with a pharmacy department inside. But situation remains unclear for independent nuclear medicine departments where physicians are not constrained to prescribe radiopharmaceuticals. However, as radiographers and nurses are only authorized to realize theirs acts in front of a medical prescription, one prescription must be realized. Nowadays, computerized prescription tools have been developed but only for radiopharmaceutical drugs and not for medical acts. In the aim to achieve a safer patient care, the prescription regulation may be applied whatever differences between nuclear medicines departments. (authors)

  6. Use of radiopharmaceuticals for treating bone metastases

    Cancer prevalence is estimated at around 2% of the population and on average between 64-80% of patients with solid tumors develop bone metastases, being breast tumors, lung and prostate those who do more frequency. In this paper an estimate of the prevalence of bone pain from metastases, with reference to the data reported in the literature is presented. the different treatment techniques are summarized for pain management with special emphasis on Radionuclidic therapy, analyzing the different factors to consider for the selection of suitable radiopharmaceutical. cost data and cost-benefit of some radiopharmaceuticals for the purpose to take into account during their selection are provided. It is concluded that although the treatment of metastatic bone disease requires multidisciplinary therapies, Radionuclidic therapy is not sufficiently used, particularly by inadequate perception of risks and costs of radiopharmaceuticals, despite the undeniable support of its efficacy and tolerability. (author)

  7. Radiopharmaceuticals in nuclear medicine: evolution and present status

    A general overview of radiopharmaceuticals and their uses in nuclear medicine is presented. A brief history is outlined followed by the current status of the radiopharmaceuticals employed in the various branches of medicine such as neurology, cardiology, oncology, G.I. system and skeletal system. Important radiopharmaceutical preparations used in radionuclide therapy are described. (author). 58 refs., 1 tab., 2 figs

  8. Synthesis of the radiopharmaceuticals for positron emission tomography

    In this paper is shown a short overview of the biogenic positron radiopharmaceuticals production and a brief summary of some PET preparation synthesis. At the end the overview of some forward-looking positron radionuclides, which can be used for a preparation of the PET radiopharmaceuticals is said. A short review of diagnostic use of PET radiopharmaceuticals is presented (authors)

  9. Radiopharmaceuticals. Pharmaceutical products at service of nuclear medicine

    In this paper, three categories od radiopharmaceuticals are considered: ready to use, radionuclide generators and inactive kits for labelling with Tc-99m. Manufacturing methods of nuclides used for the preparation of radiopharmaceuticals are mentioned, as well as the clinical application of some radiopharmaceuticals widely used on the market

  10. Regulatory control of radiopharmaceuticals in Tanzania

    Full text: Millions of nuclear medicine procedures are performed each year worldwide and the demand for radioisotopes is increasing rapidly.The use of radiopharmaceuticals in Tanzania like in many other countries has also been increasing in recent years that necessitates the need for close regulatory control. Their applications in the country started in 1980's in the areas of medical diagnosis and therapy and at present only one center provides such services. This paper describes how radiopharmaceuticals are regulated (radiological point of view) from importation, their use and the management of the resulting radioactive waste. The regulatory framework for nuclear safety, radiation protection and security of radioactive materials was established following the national interest in the area of peaceful applications of nuclear technology. The regulations require that any person intending to import, export or transport any apparatus, article, plant, installation or other material or substance which is a source or intended to be used for the purposes of an undertaking involving the emission of radiation, must apply for a license from the regulatory authority.Radiopharmaceuticals are not produced in the country therefore whoever intends to import, possess and use has to obtain an authorization from the regulatory authority. Licensing requirements include the presence of: Qualified personnel to administer radiopharmaceuticals; Quality Assuarance and Quality Control Programs; Radiation protection measures including emergency planning, preparedness and response; Radioactive waste management program; Written laboratory procedures and safety guidelines. With regard to radioactive waste generated, it is a requirement that waste be managed properly for the protection of personnel, general public and the environment. While liquid wastes are diluted and disposed in a normal sewage system after reaching the respective exemption levels, solids and biological materials are

  11. In vitro test for pyrogenes in radiopharmaceuticals

    Procedure and results of determination of pyrogenic substances in radiopharmaceutical preparations by an in vitro method based on the reaction between bacterial endotoxine and Limulus Amebocyte Lysate are presented. The advantage of this method as compared to the test in experimental animals performed so far has also been analyzed and proved by the fact that it enables avoidance of introduction of radioactive materials in experimental animals and of radiation effects on the results obtained in efficiency studies. The in vitro method is a quick one and requires only small quantities of the radiopharmaceutical preparation to be examined. (author)

  12. Radiopharmaceuticals in China. Current status and prospects

    Jia, Hong-Mei; Liu, Bo-Li [Beijing Normal Univ. (China). Key Laboratory of Radiopharmaceuticals

    2014-04-01

    The review provides an overview of the current status of radiopharmaceuticals in China for in vivo clinical use and also describes some important advances in the past three decades. Development of the diagnostic and therapeutic radiopharmaceuticals as well as basic research on radiopharmaceutical chemistry are being introduced. The radiotracers developed in China include: (1) Brain perfusion imaging agents and CNS radiotracers for β-amyloid plaques, σ{sub 1} receptors, and dopamine D{sub 2} or D{sub 4} receptors; (2) {sup 99m}Tc- and {sup 18}F-labeled myocardial perfusion imaging agents; (3) tumor imaging agents including integrin-targeting radiotracer, novel sentinel lymph node imaging agents, hypoxia imaging agents, {sup 99m}Tc-labeled glucose derivatives, σ{sub 2} receptor imaging agents, folate receptor imaging agents, and potential radiotracers for imaging of human telomerase reverse transcriptase expression; (4) Potential infection imaging agents; (5) Potential asialoglycoprotein receptor imaging agents; (6) Other imaging agents. Moreover, some prospects of research and development of radiopharmaceuticals in the near future are discussed. (orig.)

  13. Radiopharmaceutical quality control-Pragmatic approach

    The quality control must be considered in a practical manner. The radiopharmaceuticals are drugs. They must satisfy the quality assurance control. These products are then conform to Pharmacopeia. But sometimes the user must control some data especially radiochemical purity and pH value. On all the administered solutions four controls are compulsory: radionuclide identity, administered radioactivity, organoleptic character and pH

  14. Radiopharmaceuticals in China. Current status and prospects

    The review provides an overview of the current status of radiopharmaceuticals in China for in vivo clinical use and also describes some important advances in the past three decades. Development of the diagnostic and therapeutic radiopharmaceuticals as well as basic research on radiopharmaceutical chemistry are being introduced. The radiotracers developed in China include: (1) Brain perfusion imaging agents and CNS radiotracers for β-amyloid plaques, σ1 receptors, and dopamine D2 or D4 receptors; (2) 99mTc- and 18F-labeled myocardial perfusion imaging agents; (3) tumor imaging agents including integrin-targeting radiotracer, novel sentinel lymph node imaging agents, hypoxia imaging agents, 99mTc-labeled glucose derivatives, σ2 receptor imaging agents, folate receptor imaging agents, and potential radiotracers for imaging of human telomerase reverse transcriptase expression; (4) Potential infection imaging agents; (5) Potential asialoglycoprotein receptor imaging agents; (6) Other imaging agents. Moreover, some prospects of research and development of radiopharmaceuticals in the near future are discussed. (orig.)

  15. Polymers and polymeric micellles for targeting radiopharmaceuticals

    Hrubý, Martin

    Valencia: Centro de Investigación Príncipe Felipe, 2008. s. 8. [International Symposium on Polymer Therapeutics: From Laboratory to Clinical Practice /7./. 26.05.2008-28.05.2008, Valencia] R&D Projects: GA AV ČR IAA400480616 Institutional research plan: CEZ:AV0Z40500505 Keywords : drug delivery * radiopharmaceutical * polymer Subject RIV: CD - Macromolecular Chemistry

  16. Safety and efficacy of radiopharmaceuticals 1987

    In this text aspects of the development of new radiopharmaceuticals are reviewed with particular reference to products of biological origin such as monoclonal antibodies and human cells. Also included in this survey are the legal aspects of the introduction of new pharmaceuticals and good radiopharmacy practice

  17. Quality control of radiopharmaceuticals. Pt. 2

    In this article, activities of the Federal Health Office are reported: a) Dictionary-like compilations of methods for control of radiochemical impurities; b) Development of analytical separation and determination procedures as well as measuring methods for the quantification of impurities; c) Market analysis of commercially available radiopharmaceuticals. (RB)

  18. Design and Development of New Radiopharmaceuticals

    The major factors in the design of a new radiopharmaceutical for radioisotope scintigraphy are the photon energy of the radionuclide, the ability to incorporate the radionuclide insuitable chemical and biological form, the radiation dose to the patient, and the cost of production of the radiopharmaceutical. In this laboratory, the radionuclides, indium-113m and ytterbium-169, and technetium-99m, have been incorporated into a variety of radiopharmaceuticals. These include particles suitable for lung and liver studies, chelates for brain and kidney studies, and ionic forms for blood pool imaging. Studies in experimental animals and man indicate that these agents offer certain advantages over previously available radiopharmaceuticals. By providing larger numbers of photons, they permit more precise temporal and spatial resolution. The longer half-life of the tin-113 parent radionuclide from which indium-113m can be eluted makes indium-113m readily available, even at sites distant from the source of production. The tin-indium generator system need be purchased only every five months rather than weekly as in the case of the widely used molybdenum-technetium system. The ytterbium-radionuclide in the chemical form of a chelate is particularly useful as an inexpensive agent that provides high photon yields for renal and brain imaging. The rapid and complete biological excretion results in low radiation dose while the longer physical half-life greatly extends the shelf-life. (author)

  19. Formation and development in control cause of radiopharmaceuticals of China

    The research and manufacture of radiopharmaceuticals in China were begun in 1961. Following that year, the control cause of radiopharmaceuticals was also begun. Through the endeavour of more than thirty years, the quality standards of radio-pharmaceuticals suitable for our country were formed, the level of quality standard gradually elevated and the drug quality assured reliably. Under the leadership of the Ministry of Public Health, a quality assurance system for radiopharmaceuticals was strengthened and perfected. This system consisted of control agencies of radiopharmaceutical which was authorized by the Ministry of Public Health and of testing departments of manufacturing units. The development of the control cause of radiopharmaceutical has strongly promoted the advances of both radiopharmaceuticals and nuclear medicine

  20. Computational chemistry and metal-based radiopharmaceuticals

    Computer-assisted techniques have found extensive use in the design of organic pharmaceuticals but have not been widely applied on metal complexes, particularly on radiopharmaceuticals. Some examples of computer generated structures of complexes of In, Ga and Tc with N, S, O and P donor ligands are referred. Besides parameters directly related with molecular geometries, molecular properties of the predicted structures, as ionic charges or dipole moments, are considered to be related with biodistribution studies. The structure of a series of oxo neutral Tc-biguanide complexes are predicted by molecular mechanics calculations, and their interactions with water molecules or peptide chains correlated with experimental data of partition coefficients and percentage of human protein binding. The results stress the interest of using molecular modelling to predict molecular properties of metal-based radiopharmaceuticals, which can be successfully correlated with results of in vitro studies. (author)

  1. Detection of sentinel nodes with radiopharmaceuticals

    Yokoyama, Kunihiko; Michigishi, Takatoshi; Kinuya, Seigo; Konishi, Shota; Nakajima, Kenichi; Tonami, Norihisa [Kanazawa Univ. (Japan). School of Medicine

    2000-10-01

    Sentinel lymph nodes have been found to be an indicator of lymph node metastasis in breast cancer. In Japan, the theory and concept of sentinel lymph nodes in breast cancer have begun to be applied to carcinomas of the digestive system. Based on clinical experience in the detection of sentinel lymph nodes with radiopharmaceuticals, differences and similarities between the radiopharmaceuticals, methods, and techniques used to detect sentinel lymph nodes have been assessed in relation to breast cancer and carcinomas of the digestive system (including carcinomas of the esophagus and large intestine). The greatest difference between the methods used for breast and digestive cancers is the site of administration of the radiopharmaceutical. In breast cancer, the radiopharmaceutical is administered into a superficial organ (i.e., the mammary gland), whereas in carcinomas of the digestive system, it is administered into a deep organ (i.e., digestive tract). Another obvious difference is in lymph flow, i.e., the flow of the mammary glands is subcutaneous whereas lymph flow in the digestive tract is submucosal. Two radionuclide diagnostic methods are available to detect sentinel lymph nodes: sentinel lymphoscintigraphy with a gamma camera and a method that involves the use of a gamma probe intraoperatively. Radiopharmaceuticals used to detect sentinel lymph nodes must be smoothly transferred from the site of administration into the lymph, and uptake by the sentinel lymph node must continue for a long time without excessive flowing to lower reaches. The optimal particle size remains a matter of controversy, and no radiopharmaceuticals appropriate for lymphoscintigraphy have ever been approved in Japan. The authors compared the pharmacokinetics of three different radiopharmaceuticals used for sentinel lymphoscintigraphy in breast cancer ({sup 99m}Tc-labeled albumin, {sup 99m}Tc-labeled tin colloid, and {sup 99m}Tc-labeled phytic acid) and founded that the detection rate was

  2. Detection of sentinel nodes with radiopharmaceuticals

    Sentinel lymph nodes have been found to be an indicator of lymph node metastasis in breast cancer. In Japan, the theory and concept of sentinel lymph nodes in breast cancer have begun to be applied to carcinomas of the digestive system. Based on clinical experience in the detection of sentinel lymph nodes with radiopharmaceuticals, differences and similarities between the radiopharmaceuticals, methods, and techniques used to detect sentinel lymph nodes have been assessed in relation to breast cancer and carcinomas of the digestive system (including carcinomas of the esophagus and large intestine). The greatest difference between the methods used for breast and digestive cancers is the site of administration of the radiopharmaceutical. In breast cancer, the radiopharmaceutical is administered into a superficial organ (i.e., the mammary gland), whereas in carcinomas of the digestive system, it is administered into a deep organ (i.e., digestive tract). Another obvious difference is in lymph flow, i.e., the flow of the mammary glands is subcutaneous whereas lymph flow in the digestive tract is submucosal. Two radionuclide diagnostic methods are available to detect sentinel lymph nodes: sentinel lymphoscintigraphy with a gamma camera and a method that involves the use of a gamma probe intraoperatively. Radiopharmaceuticals used to detect sentinel lymph nodes must be smoothly transferred from the site of administration into the lymph, and uptake by the sentinel lymph node must continue for a long time without excessive flowing to lower reaches. The optimal particle size remains a matter of controversy, and no radiopharmaceuticals appropriate for lymphoscintigraphy have ever been approved in Japan. The authors compared the pharmacokinetics of three different radiopharmaceuticals used for sentinel lymphoscintigraphy in breast cancer (99mTc-labeled albumin, 99mTc-labeled tin colloid, and 99mTc-labeled phytic acid) and founded that the detection rate was lowest with phytic

  3. Automated radiopharmaceutical production systems for positron imaging

    This study provides information that will lead towards the widespread availability of systems for routine production of positron emitting isotopes and radiopharmaceuticals in a medical setting. The first part describes the collection, evaluation, and preparation in convenient form of the pertinent physical, engineering, and chemical data related to reaction yields and isotope production. The emphasis is on the production of the four short-lived isotopes C-11, N-13, O-15 and F-18. The second part is an assessment of radiation sources including cyclotrons, linear accelerators, and other more exotic devices. Various aspects of instrumentation including ease of installation, cost, and shielding are included. The third part of the study reviews the preparation of precursors and radiopharmaceuticals by automated chemical systems. 182 refs., 3 figs., 15 tabs

  4. Transport processes of radiopharmaceuticals and -modulators

    Radiotherapy and radiology have been indispensable components in cancer care for many years. The detection limit of small tumor foci as well as the development of radio-resistance and severe side effects towards normal tissues led to the development of strategies to improve radio-diagnostic and -therapeutic approaches by pharmaceuticals. The term 'radiopharmaceutical' has been used for drugs labeled with radioactive tracers for therapy or diagnosis. In addition, drugs have been described to sensitize tumor cells to radiotherapy (radiosensitizers) or to protect normal tissues from detrimental effects of radiation (radioprotectors). The present review summarizes recent concepts on the transport of radiopharmaceuticals, radiosensitizers, and radioprotectors in cells and tissues, e.g. by ATP-binding cassette transporters such as P-glycoprotein. Strengths and weaknesses of current strategies to improve transport-based processes are discussed

  5. A new approach to radiopharmaceutical dose assessment

    Dosimetry for bone-seeking radiopharmaceuticals relies on an accurate measurement of the activity administered, a model for uptake of the pharmaceutical, and calculations of the dose to the target organ. The authors report here a new approach to experimental assessment of the radiation dose to bone using electron paramagnetic resonance (EPR) spectrometry. Ionizing radiations interact with mineralized bone tissue (hydroxyapatite) to produce dose-dependent concentrations of long-lived paramagnetic centers. They have successfully applied the EPR technique to bone tissues of an animal treated with a radiopharmaceutical to demonstrate its sensitivity towards radiation-induced centers in the mineralized tissue. Although the EPR bone dosimetry method is invasive, it does offer the first experimental technique for measuring and mapping the tissue response to the administered radioactivity

  6. Drug interaction with radiopharmaceuticals: a review

    Mario Bernardo-Filho; Sebastião David Santos-Filho; Egberto Gaspar de Moura; Adalgisa Ieda Maiworm; Margarida Maria de Camões Orlando; Maria Expósito Penas; Valbert Nascimento Cardoso; Luciana Camargo Bernardo; Lavínia de Carvalho Brito

    2005-01-01

    Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes) and the quality of the SPECT and PET images. Furthermore, the labeling of some of these r...

  7. Safety and efficacy of radiopharmaceuticals 1987

    This volume contains the full text of reviw papers of which summaries were presented at het Third European Smposium on Radiopharmacy and Radiopharmaceuticals, Elsinore, Dnmark 1. -4. May 1987. Aspects of the development of new radiopharmacuticals are reviewed here with particular reference to products of monoclonal antibodies and human cells. Also included are legal aspects of the introduction of new pharmaceuticals and good radiopharmacy practice. (author.). refs.; tabs

  8. Small Molecule Radiopharmaceuticals – A Review of Current Approaches

    Chaturvedi, Shubhra; Mishra, Anil K.

    2016-01-01

    Radiopharmaceuticals are an integral component of nuclear medicine and are widely applied in diagnostics and therapy. Though widely applied, the development of an “ideal” radiopharmaceutical can be challenging. Issues such as specificity, selectivity, sensitivity, and feasible chemistry challenge the design and synthesis of radiopharmaceuticals. Over time, strategies to address the issues have evolved by making use of new technological advances in the fields of biology and chemistry. This rev...

  9. Pitfalls and Limitations of SPECT, PET, and Therapeutic Radiopharmaceuticals.

    Ballinger, James R

    2015-09-01

    Radiopharmaceuticals are widely accepted to be a very safe class of drugs, with very few adverse reactions and unexpected biodistributions. However, problems can arise because of technical issues in manufacture or reconstitution, patient preparation, or drug administration. This review presents highlights of issues that have arisen in the newer classes of radiopharmaceuticals in the last 20 years and expands the scope of the previous report to include PET and therapeutic radiopharmaceuticals. Variations in the "quality" of the eluate of a (99)Mo/(99m)Tc generator remain a major issue. Several of the newer (99m)Tc tracers require a heating step in preparation that can also lead to unacceptably low radiochemical purity. Radiolytic breakdown can be a problem with all classes of radiopharmaceuticals. Many of the newer radiopharmaceuticals localize by receptor- or transporter-mediated processes and thus can be affected by other drugs, making patient preparation more important than ever. Therapeutic radiopharmaceuticals may require coadministration of radioprotectant regimens, such as the use of lysine-arginine infusions with radiopeptide therapy. Extravasation can have serious consequences with therapeutic radiopharmaceuticals. Adverse reactions to newer radiopharmaceuticals remain rare, though may increase because of coadministration of agents such as contrast media. However, there is known to be underreporting of minor adverse reactions. Knowledge of the pitfalls that can occur with radiopharmaceuticals is important in the interpretation of nuclear medicine images and optimal patient care. PMID:26278857

  10. Use of conventional radiopharmaceuticals in drug development

    Full text: Non beta-plus radiopharmaceuticals are routinely used to monitor therapeutic and toxic effects of drugs but still there is hesitancy in using them in drug development mainly due to the fact that most of them cannot be used to directly assess the target site for which the drug is being developed. However, they can be useful during safety, preclinical and clinical testing of new drugs to measure or monitor the pharmacodynamic effects of the drug on the tissue. Initial toxic effect of the drug can be studied in small and or large animals. Screening of multiorgan toxicity can be done in small animals while chronological studies can be done in large animals where planar or SPECT imaging can be performed. For screening, a lipophilic radioactive tracer such as 125I-HIPDM can be used to study multiorgan toxicity. The percentage uptake in various organs of the drug-treated and control animals are compared to each other and the difference is assumed to reflect the tissue response of the drug. Once such a determination is made, organ-specific radiopharmaceuticals are then used to more accurately determine the toxic effect of the candidate drug as exemplified in the use of In-111 antimyosin antibody to document cardiotoxicity of the anthracyclines (particularly adriamycin). During pre-clinical and clinical testing stages, the non beta-plus radiopharmaceutical can be used to determine the therapeutic efficacy of the candidate drug as exemplified in the use of Ga-67 citrate to monitor chemotherapeutic treatment in cancer patients. The use of non-beta plus radiopharmaceuticals in drug development offers several advantages: a) the procedure is currently being routinely used to monitor therapeutic and toxic effects of drugs; b) it is simple, repeatable and adaptable to a chronological study using the same animal when employing imaging technique; c) it can be done in human thereby avoiding the necessity of extrapolating data from animals to human. To establish the use of

  11. Management and supervision of radiopharmaceuticals in China

    Full text: Nuclear technology has been widely applied in China, in which radiopharmaceuticals is a very important field. Chinese government emphasizes radiation, medical and biological safety of radiopharmaceuticals on human while promoting its application for public health. China has established full government infrastructure and corresponding legal system for safety of radiopharmaceuticals. State Food and Drug Administration (SFDA), China Atomic Energy Authority (CAEA), Ministry of Health (MOH), State Environment Protection Administration (SEPA) and other related departments have made great endeavor to ensure the safety of radiopharmaceuticals in all stages. Main roles and responsibilities. SFDA is main safety regulatory body in this field in China, its responsibilities are, as follows: 1) To draft law and administrative regulations on drug administration and supervise their enforcement. 2) To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation. 3) To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; be responsible for drug reevaluation, review drugs to be withdrawn. 4) To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation. 5) To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law. 6) To regulate radiopharmaceuticals and devices in accordance with law. 7) To draw up and improve qualification system for licensed

  12. Radiopharmaceutical production in Albania and its future

    Full text: Research and developing in the field of preparing and quality control of radiopharmaceuticals have been concentrated and continue to be at the Institute of Nuclear Physics. The Institute has a radiochemical laboratory, that possesses adequate infrastructure for research and developing including the scope of radioisotopes and radiopharmaceuticals. The radiochemical laboratory and the group of radiopharmaceuticals have izeion with our Nuclear Medical Center, but also with many research institutes in the country and abroad. Studies on the field of preparing radiopharmaceuticals in the beginning were focused on developing the adequate methods for labelling and quality controls of radiopharmaceuticals more spread used in the 70s. During this time were developed methods for labelling and quality controls of hippurane, oleic acid and rosse-bengale labelled with 131J, dermatological sources with 32P and have done attempts for preparing 131J and 32P with and carrier free from imported targets. At the beginning of the 70s for diagnostic and therapeutic porpoises of thyroid gland was used 131J as 'nuclear cocktail'. Actually for diagnoses of thyroid used 99mTc, meanwhile for therapy 131J as gelatin capsules prepared in the radiochemical laboratory of Institute of Nuclear Physics. The demand for the technetium kits and the impossibility of importing them on the large quantities that covered needs of nuclear medicine for diagnoses and extents of scope of nuclear medicine were premises for developing the technique of production the cold technetium kits. In the frame of technical izeion with IAEA a laboratory was constructed for these purposes. The laboratory fulfills requirements of GMP and has enough capacity to cover demand of nuclear medicine actually and in the future. Now it is consolidated production of such kits as MDP, DMSA, DTPA, HDPA, Pyrophosphate, Phytate, Heptagluconate, etc and continuing before long with more sensitive and complicate kits such as HMPAO

  13. Radiopharmaceuticals drug interactions: a critical review

    Ralph Santos-Oliveira

    2008-12-01

    Full Text Available Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here,we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions.Os radiofármacos desempenham função crítica na medicina moderna, primariamente para fins diagnósticos, mas também no monitoramento da progressão de doenças assim como na avaliação de respostas ao tratamento. O uso da tecnologia por imagem tem crescido e conseqüentemente as prescrições de medicamentos (radiofármacos em especial com esse propósito. Este fato, aumenta o risco de interações entre medicamentos e radiofármacos. Interações que podem ter um impacto na

  14. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides

    Welch, M.J.

    2012-02-16

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N{sup 4}-methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the

  15. Main principles of good production practices for radiopharmaceuticals

    The demands are summed up placed on personnel (qualification, in-service education, practical training), occupational hygiene and work space for the preparation of radiopharmaceuticals in hospitals, in departments of nuclear medicine. The basic instruments are listed for the preparation and testing of radiopharmaceuticals as are procedures in the preparation, testing and handling. (E.S.)

  16. Factors and pharmaceuticals that affect the radiopharmaceuticals bio distributions

    The pattern of biodistribution of radiopharmaceuticals may be affected by various agents and therapeutical procedures, chemotherapy agents, thyroid hormones, metals, radiotherapy, surgery, anesthetic agents, dialysis other radiopharmaceutical interactions. Recommendations for the detection of altered biodistribution in patients by causes not directly related with the pathology itself was given. pathology itself was given

  17. Study on QSAR of brain radiopharmaceuticals of iodoamphetamines

    According to the Fick's law, it is assumed that brain radiopharmaceuticals can pass through Brain Blood Barrier by simple diffusion process. After investigation of parameters of fourteen iodoamphetamines, a linear relationship among initial brain uptake, partition coefficient, protein binding and molecular weight has been established. This relationship may be useful in designing new brain radiopharmaceuticals and predicting initial brain uptake

  18. Radiopharmaceutical chemistry in Peking University (PKU)

    Wang Xiangyun; Wu Yonghui; Wang Yi; Liu Yuanfang [Department of Technical Physics, Peking University, Beijing (China)

    2000-03-01

    In the past 15 years our research activities covered the following four aspects: (1) Labeling of monoclonal anti-bodies (McAb) with radionuclides. Both direct and indirect labeling methods by using various radionuclides were studied. (2) Designing an synthesis of radiopharmaceuticals used for myocardial imaging. Two types of Tc compounds were intensively studies: BATOs and complexes containing [{sup 99m}Tc{identical_to}N]{sup 2+} and [{sup 99m}Tc=NAr]{sup 3+} core. (3) Synthesis and screening of boron- and gadolinium-containing compounds for use in neutron capture therapy. (4) Investigation of the coordination chemistry of Tc. (author)

  19. Consequences of electroplated targets on radiopharmaceutical preparations

    Finn, R. D.; Tirelli, S.; Sheh, Y.; Knott, A.; Gelbard, A. S.; Larson, S. M.; Dahl, J. R.

    1991-05-01

    The staff of the cyclotron facility at Memorial Sloan-Kettering Cancer Center is involved in a comprehensive radionuclide preparation program which culminates with the formulation of numerous requested short-lived, positron-emitting radiopharmaceutical agents for clinical investigation. Both the produced radionuclide as well as the final radiolabeled compound are subjected to stringent quality control standards including assays for radiochemical and chemical purity. The subtle chemical consequences resulting from the irradiation of a nickel-plated target for 13N production serve to emphasize some of these potential technical difficulties.

  20. Transport of radiopharmaceuticals under enhanced security measures

    Full text: The radiopharmaceutical industry makes million of shipments each year of both finished products and the medical radionuclides used to manufacture these drug products. These shipments are made to an from almost every member state of the IAEA. Since the events of September 11, 2001 member states have taken steps to enhance security of all dangerous goods. These well intentioned steps have often resulted in delays causing significant radioactive decay of these short half-life radionuclides. The IAEA can take a leadership role in the international regulatory community by enhancing security measures without allowing delays of critical radioactive materials shipments. (author)

  1. Radiation exposure through radiopharmaceuticals in routine diagnostics

    So far proof is lacking that nuclear medical examinations have somatic or genetic radiation effects. The radioiodine test is a category apart, on account of its involving a high radiation exposure of the relatively exposed thyroid and because it has already been carried through on many patients. Recommendations for radiation hygiene can therefore only relate to the careful ascertainment of indications (e.g. skeletal scintigraphy in pre-school children), the dosage of the activity to be applied, the choice of the collimator, minimization of the bladder dose and quality controls carried out a.o. on equipment and radiopharmaceuticals. (DG)

  2. Placental transfer of radiopharmaceuticals and dosimetry in pregnancy

    Russell, J.R. [Univ. of Maryland, Baltimore, MD (United States); Stabin, M.G.; Sparks, R.B. [Oak Ridge Inst. for Science and Education, TN (United States)

    1999-01-01

    The calculation of radiation dose estimates to the fetus is often important in nuclear medicine. To obtain the best estimates of radiation dose to the fetus, the best biological and physical models should be employed. In this paper, after identification of radiopharmaceuticals often administered to women of childbearing age, the most recent data available on the placental crossover of these radiopharmaceuticals was used (with standard kinetic models describing the maternal distribution and retention and with the best available physical models) to obtain fetal dose estimates for these radiopharmaceuticals were identified as those most commonly administered to women of childbearing years. The literature yielded information on placental crossover of 15 radiopharmaceuticals, from animal or human data. Radiation dose estimates are presented in early pregnancy and at 3-, 6-, and 9-months gestation for these radiopharmaceuticals, as well as for many others used in nuclear medicine (the latter considering only maternal organ contributions to fetal dose). 46 refs., 1 fig., 5 tabs.

  3. Analysis of biodistribution attributes of radiopharmaceuticals by BioDOT

    An important component of radiopharmaceuticals quality evaluation is determination of biological distribution attributes by animal study. This is subjective, time consuming, and difficult to quantify. A user friendly graphical statistical analysis software (BioDOT) was developed using Visual Basic 6.0 for repeatable, objective evaluate of biological distribution attribute of radiopharmaceuticals in animal. The software measured the organs mass, organs radioactivity, radioactivity decay correction, radioactivity per gram of organs, and calculate radioactivity target to non-target ratios. Radiopharmaceuticals quality assessment by a BioDOT was used to estimate post injected biological distribution, and organs radioactivity and uniformity ratio was calculated. The software quantified percent injected dose of radiopharmaceutical in selected organs of the animal study. Total percent injected dose was quantified and correlated with the standard value of BP Pharmacopoeia. The method objectively measured distribution quality attributes of radiopharmaceuticals and generate full report in pdf format in less than 10 min per study. (author)

  4. Preparation of kits for 99Tcm radiopharmaceuticals

    This publication details preparation under Good Manufacturing Practices (GMP) of thirteen widely used 99Tcm radiopharmaceuticals and their quality assurance practices. The objective of this document is to present to those who intend to launch a kit preparation programme a set of preparation procedures and other relevant information gathered during kit production over a period of more than a decade, to serve as a good starting point. The manuals and monographs included in the document are based on the experience gained in two major centres. The publication of this material is intended to give a typical example, and not the only possible procedure for preparing the kits. Following the essentials of these kit preparation procedures, it is always possible to make alterations to the composition of the kits. The kits described here concern widely used 99Tcm radiopharmaceuticals which do not require a Single Photon Emission Computed Tomography (SPECT) camera. These examples of the ''first generation'' of kits are not very intricate to prepare. Although it is advisable to have only one agent for a given intended use, a few agents for each purpose, e.g. EHDP and MDP for bone imagining, have been included in the document so that the reader can have some flexibility in selecting a particular kit. 24 refs, 2 figs

  5. Preparation of radiopharmaceuticals labeled with gallium and indium

    This project was designed to carry out routine production of Ga-68 labeled radiopharmaceuticals for use, particularly in pulmonary studies; to continue work on the development of Ga-68 labeled radiopharmaceuticals that could be used with positron emission tomography; to evaluate indium-111 and possibly gallium-68 labeled antibodies in animal models; to continue development of new chelates and bifunctional chelates for use as radiopharmaceuticals; and to develop new approaches to the delivery of radiopharmaceuticals to the brain. We have made major advances in all of these areas. In area one, we have shown that gallium-68 radiopharmaceuticals can be produced routinely under robotic control for patient studies. This has resulted in several publications by us and by our collaborators in the Pulmonary Division at Washington University. In the second area, we have continued to study gallium-68 labeled radiopharmaceuticals and have carried out the work to allow gallium-68 labeled macroaggregated albumin to be administered to patients. This was necessary due to the fact that our previous gallium-68 particulate tracer, gallium-68 labeled microspheres could not be prepared due to the fact that the microsphere kit from 3M was removed from the market. In the area of labeled antibodies we have studied indium-111 labeled antibodies in two animal models and compared gallium-68 labeled antibodies with indium and iodine antibodies in one of these models. It appears that gallium-68 labeled antibody fragments may have promise as radiopharmaceuticals

  6. Good Practice for Introducing Radiopharmaceuticals for Clinical Use

    The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times

  7. Breast feeding's interruption following radiopharmaceutical administration to nursing mothers

    The radiopharmaceutical administration to lactating women for therapeutic or diagnostic purpose can achieve a radiological risk to the breast feeding child due to levels of radioactivity in the breast milk. International recommendations regarding safe assumption of nursing mother after radiopharmaceutical administration were analysed. We examined the formula proposed by Rommey et al. to establish objective guidelines in case of the administration of radiopharmaceutical to nursing mothers. The ICRP 54 metabolic model for iodine was modified in order to calculate the suppression breast feeding's period according to the radioactivity measured in the breast milk. (author). 6 refs., 1 fig., 1 tab

  8. Good practice in the production of radiopharmaceuticals

    In the paper the evolution of concepts regarding the quality of the pharmaceutical products is analyzed in the framework of the production of radiopharmaceuticals at CENTIS. The world trends range from the quality control of the fi nal product to the comprehensive concept of quality management. It is concluded from the analysis that CENTIS has an appropriate system of Good Manufacturing Practice as a result of 15 years of systematic, growing and qualified attention to the issue, in correspondence with the world tendencies and the continuous support of CECMED, the Cuban regulatory authority. That is certified by the fact that all the production processes of CENTIS have been licensed and all the CENTIS products in the market have been registered. The existing conditions at CENTIS are favorable to establish and certificate a Quality Management System. (author)

  9. Use of radiopharmaceuticals in Finland in 1997

    The use of radiopharmaceuticals in diagnostics and therapy has been surveyed by STUK - Radiation and Nuclear Safety Authority. In 1997 the number of nuclear medicine examinations was 51,700, and the number of treatments 2,240. In 1994 the number of nuclear medicine examinations had been 50,900, and the number of treatments 2,150. In 1997 the collective effective dose received by patients was 207 manSv, and the mean effective dose received by the population was 0.04 mSv per person. In 1994 the collective effective dose had been 220 manSv. Numbers of nuclear medicine examinations and treatments have not changed much from 1994. The collective effective dose has slightly decreased. The main reason for the reduction is decreased use of the radionuclide 131I. (orig.)

  10. Laboratory methods to evaluate therapeutic radiopharmaceuticals

    The overall aim of this coordinated research project was to develop in vivo and in vitro laboratory methods to evaluate therapeutic radiopharmaceuticals. Towards this end, the laboratory methods used in this study are described in detail. Two peptides - an 8 amino acid minigastrin analogue and octreotate - were labelled with 177Lu. Bombesin was labelled with 99mTc, and its diagnostic utility was proven. For comparison, 99mTc-TOC was used. The cell lines used in this study were AR42J cells, which overexpress somatostatin receptors found in neuroendocrine cancers, and PC3 cells, which overexpress gastric releasing peptide receptors (GRP-r) found in human prostate and breast cancers. The animal model chosen was athymic mice with implanted dorsal tumours of pathologically confirmed cell cancers. The methodology described for labelling, quality control, and in vitro and in vivo assays can be easily used with other radionuclides and other peptides of interest. (author)

  11. Use of radiopharmaceuticals in Finland in 1997

    Korpela, H

    1999-04-01

    The use of radiopharmaceuticals in diagnostics and therapy has been surveyed by STUK - Radiation and Nuclear Safety Authority. In 1997 the number of nuclear medicine examinations was 51,700, and the number of treatments 2,240. In 1994 the number of nuclear medicine examinations had been 50,900, and the number of treatments 2,150. In 1997 the collective effective dose received by patients was 207 manSv, and the mean effective dose received by the population was 0.04 mSv per person. In 1994 the collective effective dose had been 220 manSv. Numbers of nuclear medicine examinations and treatments have not changed much from 1994. The collective effective dose has slightly decreased. The main reason for the reduction is decreased use of the radionuclide {sup 131}I. (orig.) 4 refs.

  12. Labelling and biological evaluation of therapeutic radiopharmaceuticals

    The paper describes research aimed at developing radiolabelled agents using 'bone seeking' molecules and peptides as the target specific moieties. For the study of bone seeking molecules, hydroxyethylene diphosphonate (HEDP) and dimercaptosuccinic acid (DMSA) (V) were labelled with 188Re. For peptide radiolabelling, 99mTc and 111In were used as the diagnostic radioisotopes, and 90Y was used as the therapeutic radioisotope. The labelling yielded agents with high radiochemical purity. The labelled compounds - 188Re- HEDP, 188Re-DMSA(V), 111In-DOTATOC, 99mTc-HYNIC-TATE, 90Y-DOTATOC and 90Y-DOTATATE - were evaluated in mice, rats and healthy beagle dogs. All compounds were also tested in dogs with spontaneous tumours as pathological models. Biodistribution studies showed that the molecules accumulated in their respective target cells. Spontaneous tumours in dogs offered a unique opportunity to investigate the diagnostic utility and therapeutic behaviour of the radiopharmaceuticals. (author)

  13. Manufacture of radiopharmaceuticals-recent advances

    Krieger, J.K.

    1996-12-31

    Trends in radiopharmaceutical manufacturing have been influenced by the demands of the regulatory agencies, the demands of the customers, and the ever-increasing complexity of new products. Process improvements resulting from automation in the production of radionuclides for diagnostic imaging products, {sup 99m}/Tc generators, {sup 67}Ga, and {sup 201}Tl have been introduced to enhance compliance with current good manufacturing practices and to improve worker safety, both by reducing dose in accord with as low as reasonably achievable levels of radiation and by providing an ergonomically sound environment. Tighter process control has resulted in less lot-to-lot variability and ensures reliability of supply. Reduced manufacturing lapse time for {sup 99m}Tc generators minimizes decay and conserves the supply of {sup 99}Mo. Automation has resulted in an even greater degree of remote operation and has led to reductions in dose, improved process control, and faster throughput in the manufacture of radionuclides.

  14. Rationale and radiopharmaceuticals for myocardial imaging

    Static radionuclide imaging procedures are now available for evaluating regional myocardial perfusion and for detecting acute myocardial infarction. Thallium-201, a radiopharmaceutical which possesses many of the characteristics of potassium analogs, at present is receiving the greatest attention as a regional blood flow indicator. Ischemic lesions appear as areas of decreased tracer uptake. Unfortunately, this agent is expensive, is in limited supply and has a photopeak which is low for optimum imaging. Positive infarct images can be obtained with various technetium-99m chelates. Pyrophosphate appears to be the best of the technetium compounds studied to date although the mechanism of uptake of the chelates has not yet been fully elucidated. Therefore, quantitative measurements of infarct size are not justified. As perfusion imaging and infarct imaging provide useful, complementary data, a dual tracer approach to evaluating patients with suspected coronary artery disease and/or myocardial infarction is probably justifiable

  15. Technetium radiopharmaceuticals, current situation and perspectives

    Full text: and is still maintaining this privileged position in most departments, although the situation might change in the coming years. It owes this favourable role to its continuous availability, the convenient half-life of 6.02 h, its low radiation dose to patients and manipulators, the efficient and high resolution detection of this gamma radiation by conventional gamma cameras and the possibility to incorporate it as a transition metal in a wide variety of complexes. Most of the first-generation 99mTc-radiopharmaceuticals are structurally not well characterized (e.g. complexes of 99mTc with diphosphonates, DTPA, soluble and denatured albumin, ...) but they survive on the basis of a proven clinical usefulness. However, due to more stringent requirements with respect to manufacturing methods of labelling kits (GMP) and quality of starting matials, a tendency of discontinuation of some of these preparations has started, especially for products of biological origin or with a limited volume of sale. In the eighties and the nineties, an intensive search for new 99mTc-radiopharmaceuticals based on a rational approach (e.g. cationic complexes for myocardial perfusion agents, neutral lipophilic compounds for brain perfusion tracers, ...) and a steadily growing knowledge of Tc-complexation chemistry has resulted in efficient tracer agents for measurement of kidney function (99mTc-mertiatide), myocardial perfusion (99mTc-sestamibi, 99mTc-tetrofosmin) and brain perfusion (99mTc-exametazime, 99mTc-bicisate). In the case of the heart agents, however, the designed rational approach appeared not the correct starting idea and the successful development of the tracers was more a lucky shot. On the other hand, several similar tracer agents with appropriate characteristics for clinical use did not reach commercial availability (99mTc-ethylene dicysteine, 99mTc-NOET, 99mTc-furifosmin, 99mTc-HL-91) or were discontinued (99mTc-BATOs), mainly for reasons of economics. The intensive

  16. Radiopharmaceutical production for PET: Quality assurance, practice, experiences and issues

    The half-lives of the positron-emitting radioisotopes, carbon-11 (t1/2 = 20.3 min) and fluorine-18 (t1/2 = 109.6 min), preclude lengthy techniques from the routine analysis of radiopharmaceuticals derived for positron emission tomography (PET). Therefore, the assurance of radiopharmaceutical quality, with respect to safety and efficacy, should rely heavily on establishing a well-defined production protocol that delivers a high quality product from materials of specified grade. Also, this protocol should be supported routinely by rapid quality control procedures. Such a combination constitutes good manufacturing practice (GMP) in radiopharmaceutical production for PET. This talk will describe the application of GMP, in a PET centre regularly producing a wide range of 11C- and 18F-radiopharmaceuticals

  17. Pattern of radiopharmaceutical administration to patients between 1982 and 1986

    Analysis of the workload of a nuclear medicine department over the period 1982 to 1986 has shown the prevalence of repeated investigations in individual patients. Records from 23 152 investigations on 17 063 patients indicated that 88.5% received a single administration and only 0.5% received more than four doses of the same radiopharmaceutical. Patterns of usage of a wide range of radiopharmaceuticals are presented and show that the technetium bone imaging agent is the radiopharmaceutical most commonly used for repeated administrations. Analysis of the radiation dose to individual patients arising from radiopharmaceutical administration has shown that only two patients in the survey exceeded 50 mSv per annum and approximately 25% of patients exceeded 5 mSv per annum. (author)

  18. Procedure guideline for thyroid scintigraphy. Version 2

    The version 2 of the procedure guideline for thyroid scintigraphy is an update of the procedure guideline published in 1999. The procedure guideline considers the current amendment of legislative rules (Richtlinie Strahlenschutz in der Medizin 2002). Indication and use of radiopharmaceuticals have to be confirmed by the specialist in nuclear medicine. Activities of 75 MBq technetium-99m, respectively of 10 MBq iodine-123 should not be exceeded without an individual justification. The interpretation of the scintigraphy requires the knowledge of the patients' history, the palpation of the neck, the laboratory parameters, and of the sonography. The interpretation of the technetium-99m uptake requires the knowledge of TSH concentration. (orig.)

  19. Preparation of radiopharmaceutical formulations; Fremstilling av radioaktive farmasoeytiske blandinger

    Simon, J.; Garlich, J.R.; Frank, R.K.; McMillan, K

    1998-03-16

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially {sup 153}samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs.

  20. Radionuclide production and radiopharmaceutical chemistry with BNL cyclotrons

    The Brookhaven National Laboratory (BNL) radiopharmaceutical chemistry program focuses on production and utilization of radionuclides having a half-life of > 2 hr. However, a major portion of the BNL program is devoted to short-lived radionuclides, such as 11C and 18F. Activities encompassed in the program are classified into seven areas: cyclotron parameters, radiochemistry, design and rapid synthesis of radiopharmaceuticals and labeled compounds, radiotracer evaluation in animals, studies in humans, technology transfer, and several other areas

  1. The important and clinical pharmaceutical aspects of radiopharmaceuticals usage

    Janevik-Ivanovska, Emilija; Gjorgieva, Darinka; Smilkov, Katarina

    2013-01-01

    The aim of this paper is to devote the development of new radiopharmaceuticals for nuclear medicine application and methods of quality assurance stressing the pharmaceutical aspects. Preparation, distribution, storage and use of radiopharmaceuticals involves a number of pharmaceuticals and radiation protection problems emphasized by the rapidly increasing use of this type of drug relevant for the patient, for the staff and for the environment. To study the pharmaceutical aspects of rad...

  2. Barriers to achieving commercial success for diagnostic and therapeutic radiopharmaceuticals

    The concluding session of this workshop focused on barriers that might be impeding the successful transition of radiopharmaceuticals from research tools to diagnostics and therapeutics that reach commercial success. Some lessons can be learned by reviewing the technology adoption life cycle as described by Geoffrey A. Moore (Moore, GA. Crossing the chasm. New York: HarperCollins, 2002). Additionally, a review of highly successful radiopharmaceuticals suggests that achieving commercial success may require advocacy by other interested groups

  3. Guidelines for breast feeding following maternal radiopharmaceutical administration

    A brief article examines some guidelines for breast feeding following maternal radiopharmaceutical administration. Eighteen radiopharmaceuticals are separated crudely into three categories according to their physical properties and according to their magnitude and effective half-life of excretion in breast milk, i.e. 1) breast feeding must be discontinued, 2) breast feeding must be interrupted for a short period during which milk should be expressed at normal feeding times and discarded and 3) breast feeding need not be interrupted. (UK)

  4. Application of a Small Molecule Radiopharmaceutical Concept to Improve Kinetics.

    Jeong, Jae Min

    2016-06-01

    Recently, large molecules or nanoparticles are actively studied as radiopharmaceuticals. However, their kinetics is problematic because of a slow penetration through the capillaries and slow distribution to the target. To improve the kinetics, a two-step targeting method can be applied by using small molecules and very rapid copper-free click reaction. Although this method might have limitations such as internalization of the first targeted conjugate, it will provide high target-to-non-target ratio imaging of radiopharmaceuticals. PMID:27275356

  5. Production, control and utilization of radioisotopes including radiopharmaceuticals

    From April 29th to May 5th, 1984 27 participants from 21 developing countries stayed within an IAEA Study Tour ('Production, Control and Utilization of Radioisotopes including Radiopharmaceuticals') in the GDR. In the CINR, Rossendorf the reactor, the cyclotron, the technological centre as well as the animal test laboratory were visited. The participants were made familiar by 10 papers with the development, production and control of radiopharmaceuticals in the CINR, Rossendorf. (author)

  6. Pediatric patients: criteria for radiopharmaceuticals activities in diagnostic procedures

    Recent studies recommend new criteria to determine radiopharmaceuticals activities per diagnostic procedures for children and teenagers. In USA, the criteria are: minimum and maximum activity and activity per body weight. The minimum activity is necessary for assuring the quality image due to the minimum requested statistical counting. The reduction of maximum activities minimizes the probability of detriment of radiation. In the European Union (EU), the Pediatric Dosage Card (PDC) proposes combined parameters: category of radiopharmaceutical, patient body weight and minimum activity per procedure. The PDC classifies the radiopharmaceuticals according to their biodistribution in the most sensitive organs. In Brazil, an investigation evaluated radiopharmaceuticals activities administered to 2,411 pediatric patients in sixteen institutions. The Brazilian mean activities per body weight, minimum and maximum activities used per institutions were compared with similar parameters surveyed in thirteen American hospitals. It was also used the PDC model to calculate the minimum activities per radiopharmaceuticals using recorded Brazilian patients corporal masses. The wider differences between Brazilian and USA installations were noticed for minimum activities by as much as a factor of 2 and 8. For 67Ga Citrate, the ranges of activities per patient corporal mass were by as much as a factor of 2 and 9 than activities used in USA. The range of maximum activities presented fewer differences, varying between 0.5 and 2 times for the radiopharmaceuticals studied. The present work needs the collaboration of the professional staff for discussion of the results, to promote regional surveys and to optimize pediatric patient protocols (author)

  7. Report on the Technical Meeting on Therapeutic Radiopharmaceuticals

    The purpose of the TM was to provide an experts' platform to facilitate exploring the current status and future directions on therapeutic radiopharmaceuticals. The invited talks and presentations in the TM were in the following topics: - Radionuclide Production; - Production and availability of alpha emitters and their radiopharmaceuticals; - Therapeutic radiopharmaceutical chemistry; - Targets and biological evaluation; - Medical physics and dosimetry; - Clinical applications including radioimmunotherapy and clinical needs; - Peptide receptor mediated therapy Panel discussions: - Radionuclide therapy using alpha emitters; - Regulatory challenges with therapeutic radiopharmaceuticals; - International activities in radionuclide therapy. he technical meeting generated a large interest among scientists and physicians working in the field of targeted therapy using radiopharmaceuticals. Participants from both developed and developing MS reported on recent developments on the research work and clinical studies going on in the field and provided their views on the future developments in this field. The unexpected high number of participants and the high number of presentations with exceptional quality underlines the great interest of scientists and professionals in therapeutic applications using radiolabelled drugs / biomolecules. The intensive discussions including panels specified the challenges in the future on developing novel agents and to finally use them for the benefit of patients. The IAEA can play as vital role in streamlining developments and to provide tools to overcome scientific, professional and regulatory challenges in the field of therapeutic radiopharmaceuticals

  8. Calculating patient specific doses in X-ray diagnostics and from radiopharmaceuticals

    The risk associated with exposure to ionising radiation is dependent on the characteristics of the exposed individual. The size and structure of the individual influences the absorbed dose distribution in the organs. Traditional methods used to calculate the patient organ doses are based on standardised calculation phantoms, which neglect the variance of the patient size or even sex. When estimating the radiation dose of an individual patient, patient specific calculation methods must be used. Methods for patient specific dosimetry in the fields of X-ray diagnostics and diagnostic and therapeutic use of radiopharmaceuticals were proposed in this thesis. A computer program, ODS-60, for calculating organ doses from diagnostic X-ray exposures was presented. The calculation is done in a patient specific phantom with depth dose and profile algorithms fitted to Monte Carlo simulation data from a previous study. Improvements to the version reported earlier were introduced, e.g. bone attenuation was implemented. The applicability of the program to determine patient doses from complex X-ray examinations (barium enema examination) was studied. The conversion equations derived for female and male patients as a function of patient weight gave the smallest deviation from the actual patient doses when compared to previous studies. Another computer program, Intdose, was presented for calculation of the dose distribution from radiopharmaceuticals. The calculation is based on convolution of an isotope specific point dose kernel with activity distribution, obtained from single photon emission computed tomography (SPECT) images. Anatomical information is taken from magnetic resonance (MR) or computed tomography (CT) images. According to a phantom study, Intdose agreed within 3 % with measurements. For volunteers administered diagnostic radiopharmaceuticals, the results given by Intdose were found to agree with traditional methods in cases of medium sized patients. For patients

  9. Rhenium radioisotopes for therapeutic radiopharmaceutical development

    Rhenium-186 and rhenium-188 represent two important radioisotopes which are of interest for a variety of therapeutic applications in oncology, nuclear medicine and interventional cardiology. Rhenium-186 is directly produced in a nuclear reactor and the 90 hour half-life allows distribution to distant sites. The relatively low specific activity of rhenium-186 produced in most reactors, however, permits use of phosphonates, but limits use for labelled peptides and antibodies. Rhenium-188 has a much shorter 16.9 hour half-life which makes distribution from direct reactor production difficult. However, rhenium-188 can be obtained carrier-free from a tungsten-188/rhenium-188 generator, which has a long useful shelf-life of several months which is cost-effective, especially for developing regions. In this paper we discuss the issues associated with the production of rhenium-186- and rhenium-188 and the development and use of various radiopharmaceuticals and devices labelled with these radioisotopes for bone pain palliation, endoradiotherapy of tumours by selective catheterization and tumour therapy using radiolabelled peptides and antibodies, radionuclide synovectomy and the new field of vascular radiation therapy. (author)

  10. Development of radiopharmaceuticals and industrial constraints

    The development process of a diagnostic or therapeutic radiopharmaceutical does not really differ from the development of a classical drug. Some specific properties of these nuclear medicine tools mainly linked to the ease to follow their distribution in the human body allow to save a couple of years out of the dozen of years required to bring a drug on the market. Overall development costs can be significantly reduced for the same reason. An industrial who wants to invest in such a business bases its analysis on other criteria that need to evaluate the medical, safety and regulatory environment at the time of drug launching. Competition is obviously a major decision criteria, but in order to evaluate the market potential, other data must be available such as the analysis of the medical landscape, the reimbursement issues, the technology evolution, the investment needs or the development of other imaging modalities, among others. In fact all these parameters concentrate toward a common criteria, the profitability of the project. Nuclear medicine moved from an art and crafts era towards the industrial era and hence plunged from the twentieth to the twenty first century in the economic reality with all its constraints and consequences. (author)

  11. Automation of cells of radiopharmaceuticals production

    The 67Ga is an important radiopharmaceutical used to identify inflammatory processes in chronic illnesses, diagnosis by image of tumors in soft tissues and the possibility to evaluate the result for therapeutic intervention. In the present work a module of 67Ga processing was developed with the objective to reduce the interventions in the hot cell, in order to avoid oxidation caused by metallic materials, and consuming in hoses of the peristaltic pumps, that release residues that blocked the valves used in the process. With materials such as: acrylic, PVC, PEEK e teflon and they are used vacuum as method (way) of fluid transferences instead of peristaltic pump in the majority of the procedures, with this improvements the system can make shorter the lengths of transference hoses, increasing the yield in the process with less interventions for maintenance and time exposure of the workers, guaranteeing the quality and reducing the time of the processing. using a mobile system for displacement of the processing module making in the cleanness and maintenance of the cell that works with radioactive material. Reducing the time of exposure dose of the workers in compliance with RDC-17 of ANVISA, which ruling the Good Manufacturing Practice Procedures. (author)

  12. (Coordinated research of chemotherapeutic agents and radiopharmaceuticals)

    Srivastava, P.C.

    1991-01-14

    The traveler received a United Nations Development Program (UNDP) Award for Distinguished Scientists to visit Indian Research Institutions including Central Drug Research Institute (CDRI), Lucknow, the host institution, in cooperation with the Council of Scientific and Industrial Research (CSIR) of India. At CDRI, the traveler had meetings to discuss progress and future directions of on-going collaborative research work on nucleosides and had the opportunity to initiate new projects with the divisions of pharmacology, biopolymers, and membrane biology. As a part of this program, the traveler also visited Sanjay Gandhi Post Graduate Institute (SGPI) of Medical Sciences, Lucknow; Board of Radiation and Isotope Technology (BRIT) and Bhabha Atomic Research Center (BARC), Bombay; Variable Energy Cyclotron Center (VECC) and Indian Institute of Chemical Biology, Calcutta. He also attended the Indo-American Society of Nuclear Medicine Meeting held in Calcutta. The traveler delivered five seminars describing various aspects of radiopharmaceutical development at the Oak Ridge National Laboratory (ORNL) and discussed the opportunities for exchange visits to ORNL by Indian scientists.

  13. Role of radiopharmaceuticals in detection of osteomyelitis

    Osteomyelitis can present as a significant diagnostic problem in medicine. Knowledge of the presence and extent of infection involving bone is important in determining treatment. In this paper the authors review the role played by radiopharmaceutical techniques in establishing the diagnosis of osteomyelitis. Osteomyelitis has been recognized as one of the most serious complications of emergency surgery to repair severe bone trauma. It is also a complication of surgery for prosthesis placement. In still other instances, osteomyelitis can be of hematogenous origin, without a major wound site. Unlike other infections, it rarely presents with acute symptoms. Osteomyelitis is divided into two categories that are time related: acute, in which clinical signs and symptoms of bone infection have been present for less than 1 month, and chronic, in which symptoms have been present for more than 1 month. The acute type is usually caused by Staphylococcus aureus in children (often secondary to skin infection), whereas in adults it can be secondary to intravenous drug abuse. Predisposing factors such as diabetes mellitus, peripheral vascular disease, and sickle cell disease are important to the outcome of osteomyelitis. One way to determine the microbe causing the infection is direct bone biopsy from the site of suspected osteomyelitis. There is one important limitation for needle biopsy in the diagnosis of osteomyelitis. Biopsies are contraindicated in the small bones of the hands and feet, because of risk of pathologic fracture (and may be relatively contraindicated after diphosphonate therapy and loss of bone mineral)

  14. Drug interaction with radiopharmaceuticals: a review

    Bernardo-Filho, Mario; Santos-Filho, Sebastiao David; Moura, Egberto Gaspar de; Maiworm, Adalgisa Ieda; Bernardo, Luciana Camargo; Brito, Lavinia de Carvalho [Universidade do Estado, Rio de Janeiro, RJ (Brazil). Inst. de Biologia. Dept. de Biofisica e Biometria; Orlando, Margarida Maria de Camoes [Universidade do Estado, Rio de Janeiro, RJ (Brazil). Hospital Universitario Pedro Ernesto. Setor de Medicina Nuclear; Penas, Maria Exposito [Universidade Federal do Rio de Janeiro, RJ (Brazil). Hospital Universitario Clementino Fraga Filho. Setor de Medicina Nuclear; Cardoso, Valbert Nascimento [Minas Gerais Univ., Belo Horizonte, MG (Brazil). Faculdade de Farmacia. Lab. de Radioisotopos

    2005-10-15

    Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes) and the quality of the SPECT and PET images. Furthermore, the labeling of some of these radiobiocomplexes, such as plasma proteins, white blood cells and red blood cells, with 99m T, can also be modified. These factors include drugs (synthetic and natural) and dietary conditions, as well as some medical procedures (invasive or non-invasive), such as radiation therapy, surgical procedures, prostheses, cardioversion, intubation, chemo perfusion, external massage, immunotherapy, blood transfusion and hemodialysis. In conclusion, the knowledge about these factors capable of interfering with the bioavailability of the radiobiocomplexes is worthwhile for secure diagnosis. Moreover, the development of biological models to study these phenomena is highly relevant and desirable.(author)

  15. Drug interaction with radiopharmaceuticals: a review

    Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes) and the quality of the SPECT and PET images. Furthermore, the labeling of some of these radiobiocomplexes, such as plasma proteins, white blood cells and red blood cells, with 99m T, can also be modified. These factors include drugs (synthetic and natural) and dietary conditions, as well as some medical procedures (invasive or non-invasive), such as radiation therapy, surgical procedures, prostheses, cardioversion, intubation, chemo perfusion, external massage, immunotherapy, blood transfusion and hemodialysis. In conclusion, the knowledge about these factors capable of interfering with the bioavailability of the radiobiocomplexes is worthwhile for secure diagnosis. Moreover, the development of biological models to study these phenomena is highly relevant and desirable.(author)

  16. Skin contamination by radiopharmaceuticals and decontamination strategies.

    Bolzinger, M A; Bolot, C; Galy, G; Chabanel, A; Pelletier, J; Briançon, S

    2010-12-15

    The aim of the present study was to evaluate the percutaneous penetration of five common radiopharmaceuticals ((99m)Tc, (67)Ga, (125)I, (111)In and (51)Cr) and to evaluate the effect of decontamination by a detergent solution dedicated to hospital institutions for that purpose. The skin kinetic profiles were established by using the in vitro Franz cell method over 24h. The skin distribution in each skin layer was quantified after 6h exposure time and the efficacy of the detergent solution to remove radionuclides was evaluated also after 6h. The most striking result was the repartition into two classes of kinetic profiles: (125)I and (99m)Tc permeated quickly (∼60% of applied activity after 24h) while the 3 other radionuclides permeated slowly (from ∼2.75% for (67)Ga to ∼10% of applied activity for (111)In). The lag times, i.e. the time necessary to cross the skin varied from 20min for (99m)Tc to 5h for (51)Cr, which accumulated in skin compartments. Skin washings with the detergent solution were particularly efficient for this radionuclide, contrary to the others for which the washing procedure should be applied earlier. The permeation of ions was dependent on their chemical and physical forms and on their salting-in or salting-out effects (coordination state and Hofmeister series). PMID:20888404

  17. The chemistry of 99mTc-labeled radiopharmaceuticals

    The subject of the chemistry of 99mTc-radiopharmaceuticals consists of a collection of bits and pieces of information without a unifying theme. Since the initial impetus to the field of organ imaging was provided by radiochemists, nuclear chemists, and clinician-investigators, using easily prepared 99mTc-compounds from available off-the-shelf ligands, complete chemical characterization was not carried for the 99mTc-radiopharmaceuticals and their metabolites. The influx of coordination, organic, and analytic chemists and their systematic studies clarified some of the structures of these tracers, and promoted the general synthetic methods of a variety of ligands and the corresponding 99mTc-chelates as well as understanding of the nature of their metabolites. Although major developments for organ-imaging radiopharmaceuticals had been made, future studies will result in the simplified methodology of protein-labeling, fine-tuning of the currently available radiopharmaceuticals for higher organ-extraction, and replacement of expensive 123I-labeled tracers with the corresponding 99mTc-tracers. In general, the Tc-complexes are thermodynamically less stable and kinetically more labile than the corresponding Re-complexes. The well established chemistry of Re-compounds, the similarity of Tc-chemistry to that of Re compounds, and structure-activity relationships of a few classes of 99mTc-labeled compounds, may promote the development of new generation of 99mTc-labeled radiopharmaceuticals.69 references

  18. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  19. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    Zanette, Camila; Melero, Laura T.U.H.; Araujo, Elaine B. de; Mengatti, Jair; Silva, Katia S. de S., E-mail: czanette@usp.br [Instituto de Pesquisas Energeticas e Nucleares, (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-07-01

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  20. Experience from a national quality assurance system on radiopharmaceuticals

    Safety, efficacy and uniformity are as important for radiopharmaceuticals as for other drugs. This was recognized in Denmark in the sixties and a national system established during the years 1970-74. During the 15 years of experience in radiopharmaceutical quality control the main developments in Europe have been the establishment of: A real industrial production of radiopharmaceuticals; Radiopharmacy as a professional scientific discipline; A regulatory system for radiopharmaceuticals. The main problems facing us today are: The slow developments of new radiopharmaceuticals; The risk that the period of introduction of EEC regulations in Europe may slow this down further; The need for continuous improvement of radiopharmacy in hospitals (facilities, training of personnel); Further development of the regulatory system taking into account special problems like PET, monoclonal antibodies, cell-labelling, and clinical trials. One of the remedies is international cooperation. We have worked hard on this in Europe, and we now feel we are able to cooperate also with other parts of the world that so far have been more advanced in the field

  1. Results of the quality assurance testing program for radiopharmaceuticals 1982-1983

    The Australian Radiation Laboratory conducts a Radiopharmaceutical Quality Assurance Test Programme in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. The results of testing during 1982 and 1983 are summarised. Overall 144 batches of 27 different types of radiopharmaceutical were tested in 1982-83. Samples failed to meet specification in 17 of the 1150 tests performed. In all, failure to meet full specification was observed in 13 different types of radiopharmaceutical. No single radiopharmaceutical was responsible for more than 2 failures. Labelling errors accounted for 6/17 failures. Most other errors were of a minor nature and were due to the product being slightly outside specified limits. Of the 17 failures, 11 were associated with imported radiopharmaceuticals (86 batches tested) and 6 were associated with locally produced radiopharmaceuticals (58 batches tested). There is thus no significant difference in the failure rate of local and imported radiopharmaceuticals

  2. Present states of radiopharmaceuticals unregistered in Japan

    Described are present states of radiopharmaceuticals (RP) registered abroad but yet unregistered in Japan, together with their clinical and basic findings, essentially aiming at their early introduction in the country. Most of RP registered and to be approved in the nearest future either by Food and Drug Administration (FDA) or European Medicines Agency (EMA) are subjected to this paper. Clinical and basic features of those RP are mainly explained about their development and registration process, clinical outcome, pharmacokinetics and safety items like adverse reactions. Unregistered RP in Japan listed in this paper include total 18 RP: for therapy; 223Ra-radium chloride, 131I-tositumomab, 153Sm-lexidronam pentasodium, 90Y-yttrium chloride: for PET; 13N-ammonia, 18F-florbetapir, -fluorocholine, -fluorodopa, -fluoride, 82Rb-rubidium chloride: and for SPECT; 99mTc-arcitumomab, -sulesomab, -fanolesomab, -besilesomab, -red blood cells, 123I-ioflupane, 111In-pentetreotide, and -capromab pendetide. As well, also listed are those RP registered abroad but not actually marketed: 99mTc-apcitide, -depreotide, -nofetumomab and 111In-satumomab pendetide: and those registered by FDA as medical devices, not as RP, 90Y-microsphere and -glass microsphere, since which are to be given in the body similarly to RP. In development of RP, economical (commercial) problems are pointed out to be a rather globally common task and it is a fact that there are RP registered in Japan alone such as 123I-iofetamine and -iomazenil, of which registration has been either abandoned or not conducted in foreign countries. (T.T.)

  3. Auger Emitting Radiopharmaceuticals for Cancer Therapy

    Falzone, Nadia; Cornelissen, Bart; Vallis, Katherine A.

    Radionuclides that emit Auger electrons have been of particular interest as therapeutic agents. This is primarily due to the short range in tissue, controlled linear paths and high linear energy transfer of these particles. Taking into consideration that ionizations are clustered within several cubic nanometers around the point of decay the possibility of incorporating an Auger emitter in close proximity to the cancer cell DNA has immense therapeutic potential thus making nuclear targeted Auger-electron emitters ideal for precise targeting of cancer cells. Furthermore, many Auger-electron emitters also emit γ-radiation, this property makes Auger emitting radionuclides a very attractive option as therapeutic and diagnostic agents in the molecular imaging and management of tumors. The first requirement for the delivery of Auger emitting nuclides is the definition of suitable tumor-selective delivery vehicles to avoid normal tissue toxicity. One of the main challenges of targeted radionuclide therapy remains in matching the physical and chemical characteristics of the radionuclide and targeting moiety with the clinical character of the tumor. Molecules and molecular targets that have been used in the past can be classified according to the carrier molecule used to deliver the Auger-electron-emitting radionuclide. These include (1) antibodies, (2) peptides, (3) small molecules, (4) oligonucleotides and peptide nucleic acids (PNAs), (5) proteins, and (6) nanoparticles. The efficacy of targeted radionuclide therapy depends greatly on the ability to increase intranuclear incorporation of the radiopharmaceutical without compromising toxicity. Several strategies to achieve this goal have been proposed in literature. The possibility of transferring tumor therapy based on the emission of Auger electrons from experimental models to patients has vast therapeutic potential, and remains a field of intense research.

  4. Knowledge-based automated radiopharmaceutical manufacturing for Positron Emission Tomography

    This article describes the application of basic knowledge engineering principles to the design of automated synthesis equipment for radiopharmaceuticals used in Positron Emission Tomography (PET). Before discussing knowledge programming, an overview of the development of automated radiopharmaceutical synthesis systems for PET will be presented. Since knowledge systems will rely on information obtained from machine transducers, a discussion of the uses of sensory feedback in today's automated systems follows. Next, the operation of these automated systems is contrasted to radiotracer production carried out by chemists, and the rationale for and basic concepts of knowledge-based programming are explained. Finally, a prototype knowledge-based system supporting automated radiopharmaceutical manufacturing of 18FDG at Brookhaven National Laboratory (BNL) is described using 1stClass, a commercially available PC-based expert system shell

  5. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2000

    In 2000 the Rossendorf research centre continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. In this respect the potential for diagnostic application depends on the quality and versatility of radiopharmaceutical chemistry, which is the main discipline in our Institute. Areas in which the Institute was particularly active were the design of new radiotracers, both radiometal-based and natural organic molecules, the elaboration of radiolabelling concepts and procedures and the chemical and pharmacological evaluation of new tracers. This was complemented by more clinically oriented activities in the Positron Emission Tomography Centre Rossendorf. With numerous contributions in the fields of radiopharmaceutical chemistry, tumour agents, tumour diagnosis and brain biochemistry this Annual Report will document the scientific progress made in 2000. (orig.)

  6. Radiopharmaceutical design using novel Re-188 imido complexes

    Several efficient new methods for synthesizing rhenium compounds containing a multiply bonded imido linkage (Re≡N-R) between the metal and organic compounds for radiopharmaceutical applications are reported. The imido linkage is stable and compatible with typical organic functional groups, and offers distinct structural and synthetic advantages over other types of linkages commonly used in radiopharmaceutical design. Syntheses of representative peptide and steroid compounds from hydrazine and phosphinimine imido precursors are described, and the preparation of a 188Re-imido complex is discussed. A promising new 188Re-radiolabeling strategy for directly synthesizing rhenium imido radiopharmaceuticals, targeted for low-capacity receptor sites relevant for cancer therapy and based on solid supported imido precursors, is presented. (orig.)

  7. Quality assurance of radiopharmaceuticals - specifications and test procedures

    The authors report on a Radiopharmaceutical Quality Assurance Test Programme carried out by the Australian Radiation Laboratory in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications given have been adopted by this Laboratory and have no legal status. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods described have been developed at this Laboratory. It should be noted that, unless stated otherwise, specifications listed apply at all times up until product expire

  8. Results of the quality assurance testing program for radiopharmaceuticals, 1994

    The Australian Radiation Laboratory conducts a Radiopharmaceutical Quality Assurance Test Program in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications quoted have been adopted by this Laboratory and have no legal status. It should be noted that unless stated otherwise, the specifications listed apply at all times up to product expiry. Radionuclidic purity has been determined at the calibration time, except for Thallous [201Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Samples for testing were obtained through commercial channels. All technetium-99m cold kits were reconstituted according to the directions in the package insert using Sodium Pertechnetate[99mTc] Injection. Methods used for testing are described in the report ARL/TR093

  9. Molecular target in oncology. Opportunity for radiopharmaceuticals development

    Cancer is a cellular multifactorial disease, regulated by changes in phenotype characteristics, such as adhesion, invasion, migration, and tumorigenesis; genotypic status of commonly altered genes (KRAS and p53); microenvironmental conditions, such pH, oxygen and nutrient supply. All these features provide opportunities for radiopharmaceuticals development, both for diagnostic and therapy. For both applications, radiopharmaceuticals molecules can be divided in small synthetic molecules, small peptides (natural or modified), large molecules such as antibody or nanoparticles. The characteristics of those molecules and use will guide the choice of the radionuclide to be used for labeling it. In the presentation, data from literature and research ongoing in the Faculty of Medicine of the University of São Paulo/Brazil will be used for demonstrate the potential for radiopharmaceuticals development. (author)

  10. Design of GMP compliance radiopharmaceutical production facility in MINT

    In 1985, MINT built the only radiopharmaceutical production facility in Malaysia. The facility was designed based on IAEA (International Atomic Energy Agency) standard guidelines which provide radiation safety to the staff and the surrounding environment from radioactive contamination. Since 1999, BPFK (Biro Pengawalan Farmaseutikal Kebangsaan) has used the guidelines from Pharmaceutical Inspection Convention Scheme (PICS) to meet the requirements of the Good Manufacturing Practice (GMP) for Pharmaceutical Products. In the guidelines, the pharmaceutical production facility shall be designed based on clean room environment. In order to design a radiopharmaceutical production facility, it is important to combine the concept of radiation safety and clean room to ensure that both requirements from GMP and IAEA are met. The design requirement is necessary to set up a complete radiopharmaceutical production facility, which is safe, has high production quality and complies with the Malaysian and International standards. (Author)

  11. Applications of quantitative whole body autoradiographic technique in radiopharmaceutical research

    The routine evaluation of radiopharmaceuticals involves dissecting tissue distribution studies (DTDS) and gamma or positron imaging. DTDS have the following disadvantages: since not all tissues can always be sampled, sites of radiopharmaceutical uptake may be missed and because the procedure involves weighing of dissected tissue samples, the spatial resolution of this method is low and determined by the smallest amount that can be weighed accurately. Gamma camera imaging and positron emission tomography though more comprehensive in evaluating the global distribution of a compound, have relative low spatial resolution. Whole body autoradiography of small animals has a much higher spatial resolution as compared to the above and depicts the global distribution of radiopharmaceuticals. A computer-assisted quantification method of WBARG applied to positron, beta, and gamma emitters will complement the method by producing quantitative values comparable to those obtained by dissection and direct tissue counting, with the advantages of depicting the global distribution at high spatial resolution

  12. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits. Part II

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. Many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration

  13. Technetium-99m radiopharmaceuticals for in vivo diagnostics

    Đokić Divna Đ.

    2005-01-01

    Full Text Available Technetiiim-99m is an ideal radionuclide with optimum decay characteristics. It can be obtained in sterile, pyrogen-free and carrier-free condition, as sodium pertechnetate (Na99mTcO4, from 99Mo/99Tc generator. Because of its six-hour physical half-life and monochromatic 140 keV photons free of -radiation, administration of small amounts of 99mTc solution is possible, without a significant radiation damage to the patient. Technetium eluted from the 99Mo/99mTc generator is in the highest oxidation form (+7. It can be used for diagnostic purposes alone, but it is often used for labeling different organic and inorganic compounds. As it is unreactive, reduction with a chemical reductant, (+1, (+3 and (+5 oxidation are necessary before use. Nowadays almost 80% of radiopharmaceuticals are based on 99mTc. Radiopharmaceuticals. Radiopharmaceuticals are radionuclides or radioactive compounds used in diagnosis and therapy of human diseases. A pharmaceutical is chosen based on its localization in the organ, or its participation in its physiological function. Radiation emitted from a radionuclide is detected by a radiation detector. The ability to incorporate available radionuclides into tracer molecules has been the main goal in developing radiopharmaceuticals. As radionuclides with nuclear characteristics used as either diagnostic or therapeutic radiopharmaceuticals, are predominantly metals, they can be designed as metal essential, whereby biological distribution is determined by coordination compound, or metal tagged, in which case the properties of the carrier molecule (ligand system determine the biological distribution. This paper reviews the development of 99mTc-radiopharmaceuticals. .

  14. Stannous ion determination in99mTc - radiopharmaceutical kits

    Two simple and selective methods for determination of stannous ion in radiopharmaceutical kits are proposed. One of this permits the estimation of stannic ion. The first method used is a potentiometric tiration of Sn+2 in HCl medium using KIO3 solution under nitrogen gas and a redox platinum electrode. The second method consist of a compleximetric tiration of tin (Sn+2 and Sn+4) using EDTA standart solution at pH 5.5-5.6 without use of nitrogen gas. The employed procedures indicates that both the methods can be used for routine quantitative determination of tin in most labeled radiopharmaceuticals. (author)

  15. Recent developments in the field of 123I-radiopharmaceuticals

    Due to its advantageous nuclear physical properties iodine-123 is an excellent label for radiopharmaceuticals very well suited for measurements by γ-cameras and single-photon emission tomography. The development of 123I-radiopharmaceuticals should be based on a clear biochemical concept, reliable labelling procedures and careful pharmacokinetic studies in order to evaluate the physiological behaviour of the radioiodinated compounds being analogues of metabolic substrates. The development of 123I-labelled fatty acids and biogenic amines clearly proved the successful use of 123I for labelling compounds applied in medical diagnosis. (orig.)

  16. The transport of radiopharmaceuticals in the United States

    Among all the various uses of radioactive materials for peaceful purposes, the creation and use of radiopharmaceuticals to diagnose and treat medical ailments has probably brought the greatest benefit to humanity. The use of radionuclides in medicine has mushroomed over the past 20 years, as has the number of nuclides and procedures which are now routinely used in hospitals and clinics around the globe. Parallel to the growth in the use of radiopharmaceuticals has been the growth in shipments of these nuclides and their compounds to the locations where they are used

  17. Kinetic investigations of sup(99m)Tc-labelled radiopharmaceuticals

    Several radiopharmaceuticals (sup(99m)Tc-Fe-ascorbates, sup(99m)Tc-Sn-DTPA, sup(99m)Tc-Sn-ACD-citrate-complex and sup(99m)Tc-Sn-tetracyclin-HAsc-ACD-complex) for renal and tumour scintigraphy were tested in animal experiments. Also tested was sup(99m)Tc-penicillamine for scintigraphic investigations of the gallbladder and the liver. The findings suggest that the different radiopharmaceuticals have different degrees of reliability and exactness, and that some of them should be combined to achieve better diagnostic values. (GSE/AK)

  18. Indigenous capacity building in radiopharmaceuticals: Saudi Arabian experience

    Easy availability of radiopharmaceuticals is a key element in the application of radioisotopes in health care. Furthermore, creating self-sufficiency within the country and the geographical region further enhances this prospect. Manufacture of radiopharmaceutical began at King Faisal Specialist Hospital and Research Centre (KFSH and RC) in 1983 with the installation of the CS-30 (26.4 MeV) cyclotron, with the intention not only to make available the cyclotron products for the country and the geographical region, but also to establish a contemporary research programme. Consequently, a PET scanner was installed at KFSH and RC in 1995. Currently, the centre routinely produces several SPECT and PET radiopharmaceuticals supporting around 40 nuclear medicine facilities within the country and the geographical region. A key motivating and driving force has been the goal of becoming a comprehensive radiopharmaceuticals manufacturing facility and making the country self-sufficient in all its radiopharmaceutical needs. Consequently, 2000 witnessed the introduction of 131I based products for diagnosis as well as for therapy. GMP is the cornerstone of any radiopharmaceuticals manufacturing programme. The KFSH and RC is a perfect example of how this operational and guiding principle has been applied and evolved over the years, culminating in an effective quality management system (ISO 9001:2000) for manufacturing high quality radiopharmaceuticals. The programme building has been 'work in progress'. For efficient functioning, the staff must be well qualified and appropriately trained to achieve the mission of the organization. This has been achieved through selective staffing, followed by extensive on the job training, as well as didactic education, including various IAEA programmes for specific training. The year 2005 marked the beginning of an expansion of the KFSH and RC's programme entailing construction of a new building; provision of a state of the art cyclotron (30 MeV), a

  19. Design of radiopharmaceuticals for monitoring gene transfer therapy

    The development of radiopharmaceuticals for monitoring gene transfer therapy with emission tomography is expected to lead to improved management of cancer by the year 2010. There are now only a few examples and approaches to the design of radiopharmaceuticals for gene transfer therapy. This paper introduces a novel concept for the monitoring of gene therapy. We present the optimisation of the labelling of recombinant human β-NGF ligands for in vitro studies prior to using 123I for SPET and 124I for PET studies. (author)

  20. Radiopharmaceutical Chemistry of Targeted Radiopharmaceutics. Synthesis of 211At-Labeled Radiopharmaceuticals at High Activities for Clinical Use

    Targeted α-particle radiotherapy is an appealing approach to cancer treatment because of the potential for delivering curative doses of radiation to tumor with minimal damage to normal tissue due to a range equivalent to only a few cell diameters. Compared with β-emitters they have significant advantages from a radiobiological perspective. The LET of 211At α-particles is more than 400 times higher than the β-particles emitted by 90Y, in addition the distance between ionizing events is almost the same as that between the two strands of DNA, yielding a high probability of creating non-repairable DNA damage. It gives the ability to kill cancer cells not compromised by hypoxia, dose rate effects or cell cycle position, enhancing their attractiveness for targeted radiotherapy. However, translation of the concept to the clinic has been slow, many obstacles had to be surmounted before clinical studies could be initiated, the first clinical evaluation of a 211At- labeled mAb was made in 2001. This study circumvents many of the challenges to entering clinical studies with 211At. But several problems were encountered in maintaining efficient labeling with escalating radiation dose of alpha-particle likely related to radiolysis. The impact of the radiolysis produced by the α-particle over the labeling chemistry is much higher in comparison with typical β-emitters due to a deposition of energy in the solvent in a highly localized manner two orders of magnitude per unit volume higher than 90Y or 131I. Due to these difficulties a comprehensive basic science study about the radiolytic effects of astatine alpha-particles over the synthesis of 211At-labeled radiopharmaceuticals was carried out. Its main goal was overcoming the problem of the synthesis of 211At-labeled radiopharmaceuticals at the high activities necessaries for therapy and also to extend the shelf life of astatine elutions. Briefly this study held several steps, the first one was to study the role of solvent

  1. Investigation of handling the radiopharmaceuticals in Japan and making of guidance to handle the radiopharmaceuticals

    The Working Group in Japanese Society of Nuclear Medicine Technology conducted the investigation of handing the radiopharmaceuticals in Japan through on/off-line questionnaire to 492 facilities in the period of Nov. 14-Dec. 22, 2009 to know the present state of radiopharmaceutical (RP) handling and to compare the data with past ones. This paper describes the questionnaire results and their analysis, and guidance to handle RP, made by the Group. The questionnaire contains 32 items concerning the system for appointment of examination, personnel's responsible work, notes given at RP administration, incidence of failure and questions to positron emission tomography (PET) facilities. Answers to the questionnaire are obtained from 184 facilities (37.4%). It is found that medical radiation technologists have responsibility in 80% or more of works like RP ordering and receiving, milking, labeling and subdivision of RP solution. The results are not so much changed from the past status (15 years ago) and decreased role of pharmacists is noted in this nuclear medicinal field, which, this paper points out, is a problem revealed by the investigation. The guidance in the title is made based on the investigation for the purpose of safe and appropriate handling of RP by concerned personnel and is to be disclosed in the web of the Society. The guidance contains specifications of the brand and general names of RP, contraindication, effect, notice at administration, pre-treatment, efficacy and general pharmacology/ pharmacokinetics, side effects and other notices; and involves 39 diagnostic agents (7-head, 3-neck, 11-chest, 11-abdomen, and 7-whole body agents labeled by 99mTc, 201Tl, 123I, 111In, 133Xe, 81mKr, 67Ga or 18F) and 4 therapeutic ones (131I, 89Sr or 90Y). (K.T.)

  2. Radiopharmaceuticals for diagnosis and therapy of cancer

    This paper addresses the utilization of three very distinct enzyme systems for imaging in oncology. The first of these is an enzyme encoded by a viral gene that is not present in non-infected mammalian cells. This enzyme is a nucleoside kinase that converts selected unnatural nucleosides to nucleotides in virus-infected or gene-transfected cells, but not in normal cells. The most commonly used viral kinase in gene therapy today is Herpes simplex virus type-1 thymidine kinase (HSV tk). The imaging applications of this gene therapy system are demonstrated using data from a murine tumour gene therapy model, with 123IVFRU as the diagnostic radiopharmaceutical. The second enzyme system is endogenous to mammalian cells, but is found in highest concentrations in tissues of neutral crest derivation. The overall biochemical pathway of interest involves the conversion of tyrosine to either dopamine (neurotransmitter pathway), or to melanin (pigmentation pathway). In this system tyrosinase is the 'branching' enzyme, converting dopa to dopaquinone, thereby averting its conversion to dopamine. With selective agents, the tracer can be trapped in this 'melanin pathway', which is particularly active in melanomas. Data on the development of radioiodinated tyrosinase substrates, based on S-cysteaminyl phenol (SCAP), a highly specific tyrosinase substrate, are presented to illustrate this concept. The final example is that of endogenous enzymes that are virtually ubiquitous in biodistribution. One class of enzymes, the reductases, are particularly active in the liver and their activity is amplified in tissues that are hypoxic. They are important in radiotherapy, where they can be utilized to bioreductively activate compounds that can restore the radiosensitivity of hypoxic cells. The 2-nitroimidazoles are of special interest because they are easily reducible by a number of reductases, a process that is made selective by the reversibility of reduction in the presence of cellular

  3. Drug interaction with radiopharmaceuticals: a review

    Mario Bernardo-Filho

    2005-10-01

    Full Text Available Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes and the quality of the SPECT and PET images. Furthermore, the labeling of some of these radiobiocomplexes, such as plasma proteins, white blood cells and red blood cells, with 99mT, can also be modified. These factors include drugs (synthetic and natural and dietary conditions, as well as some medical procedures (invasive or non-invasive, such as radiation therapy, surgical procedures, prostheses, cardioversion, intubation, chemoperfusion, external massage, immunotherapy, blood transfusion and hemodialysis. In conclusion, the knowledge about these factors capable of interfering with the bioavailability of the radiobiocomplexes is worthwhile for secure diagnosis. Moreover, the development of biological models to study these phenomena is highly relevant and desirable.Imagens clínicas são valiosas em Ciências da Saúde e a análise e a interpretação correta das mesmas auxiliam os profissionais, como médico, fisioterapeuta, terapeuta ocupacional, na tomada de decisões e subseqüentes ações terapêuticas e/ou de reabilitação. Além das doenças outros fatores podem interferir e afetar a biodisponibilidade dos radiofármacos (radiobiocomplexos e a qualidade das imagens (SPECT e PET. Além disso, a marcação de alguns desses radiobiocomplexos com Tc-99m, como proteínas plasmáticas, leucócitos e hemácias, também pode ser modificada. Entre esses fatores, estão drogas (sintéticas e naturais e condições alimentares, assim como alguns procedimentos médicos (invasivos e não invasivos, como a radioterapia, processos cirúrgicos, pr

  4. Drug interaction with radiopharmaceuticals: effect on the labeling of red blood cells with technetium-99m and on the bioavailability of radiopharmaceuticals

    Gomes Maria Luisa; Oliveira Marcia B. Nunes de; Bernardo-Filho Mario

    2002-01-01

    The evidence that natural and synthetic drugs can affect radiolabeling or bioavailability of radiopharmaceuticals in setting of nuclear medicine clinic is already known. However, this drug interaction with radiopharmaceuticals (DIR) is not completely understood. Several authors have described the effect of drugs on the labeling of blood elements with technetium-99m (99mTc) and on the biodistribution of radiopharmaceuticals. When the DIR is known, if desirable or undesirable, the natural conse...

  5. Comparison of national PET radiopharmaceutical regulations

    In the United States (US), the European Union (EU) and Japan, physicians frequently prescribe formulations of drugs for patient care which are not available commercially, and require compounding. In the practice of Nuclear Medicine, Positron Emission Tomography (PET) presents a unique compounding challenge in the production of PET radiopharmaceuticals (RaPh), due to the short radionuclide half-lives [F-18 (110 minutes), C-11 (20 minutes), N-13 (10 minutes) and 0-15 (2 minutes)], and the need to maintain high quality standards for human use ''drugs'', particularly intravenous formulations. As PET has progressed and the utilization of PET increases each country is developing regulations to manage cyclotron radionuclide production, compounding and quality control (QC). Production of PET radionuclides in the US is currently regulated by the Nuclear Regulatory Commission (NRC). These radionuclides are then synthetically incorporated into the final PET RaPh for subsequent patient administration. Since these 'drugs' are usually administered intravenously, the regulations for sterile compounding, or manufacturing, come under Pharmacy Practice, which for the US is the Food and Drug Administration (FDA). On receipt of a physician's order for a PET drug, pharmacists (or chemists) working under the authority and supervision of a physician, or a pharmacist working in a centralized PET Nuclear Pharmacy (licensed by an individual State), can compound the PET drug and dispense it for the patient. In 2005, the US FDA published a proposed rule in the Federal Register on Current Good Manufacturing Practice (CGMP) for PET Drug Products [1]. These regulations are intended to ensure that PET drugs meet the requirements of the FDA Modernization Act (FDAMA) regarding safety, identity, strength, quality, and purity. These regulations will be included in the Code of Federal Regulation. After the rule is published, each site will have 2 years to comply with the new regulations, and to file a

  6. WIPR 2013 - Radiopharmaceuticals: from research to industry - Book of abstracts

    This workshop aims at presenting the latest progress in the field of radioimmunotherapy: radiopharmaceutical production, radiochemistry, radiolabelling, nuclear imaging and clinical applications. The presentations have been divided into 4 sessions: 1) alpha or beta radioimmunotherapy, 2) peptides or antibodies, 3) the benefits from nuclear imaging, and multimodal imaging

  7. Radiopharmaceuticals Pattern of Development and Utilisation in India

    V. K. Iya

    1990-10-01

    Full Text Available The availability of research reactors at an early stage of our Atomic Energy Programme led to developmental efforts in the field of radiopharmaceuticals. Starting with temporary laboratories for this work, a sophisticated and dedicated Radiopharmaceutical Laboratory is now installed at Vashi in New Bombay. The use of several /sup 125/I-labelled compounds like Rose-Bengal, hippuran, etc. for imaging has been replaced over the years by /sup 99m/Tc compounds; the final formulations are prepared at the hospital using generators and cold kits supplied by the Board of Radioisotope Technology. Parallel with the development of short lived generators in radiopharmaceuticals came advances in imaging and instrumentation techniques, the scanners being replaced by sophisticated gamma cameras, with capabilities for tomography and computerisation. About 40 centres in India have the modern instrumentation and equipment needed for carrying out nuclear medicine procedures. Further growth of nuclear medicine centres in the country has, however, been limited by the need to import such advanced high cost instrumentation not currently available from indigenous sources. Regarding in-vitro radiopharmaceuticals, some RIA and IRMA kits and procedures have been developed. These include assay of T/sub 3/, T/sub 4/ and TSH in the thyroid group of hormones. Kits for several other important procedures are still being imported by some large medical centres. There are over a hundred and fifty medical laboratories carrying out RIA procedures.

  8. Production and application of radioisotopes and radiopharmaceuticals - status and prospects

    Given are the main data on the use of radioisotopes and radiopharmaceuticals for nuclear medical applications. Shown are the methods for their routine production including the results obtained in the Laboratory for Radioisotopes (Vinca Institute of Nuclear Sciences). Particular emphasis is devoted to the trends in the development of the agents suitable for specific diagnostic or therapeutic applications. (author)

  9. Quality assurance of radiopharmaceuticals-specifications and test procedures

    This report is a compilation of test methods used and specifications adopted for the Radiopharmaceutical Quality Assurance Test Programme conducted by the Australian Radiation Laboratory. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods have been developed at the ARL

  10. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 1992

    The Institute of Bioinorganic and Radiopharmaceutical Chemistry of the Rossendorf Research Center (FZR) presents its 1992 anual report in order to in form on research activities in the first year of its existence. This volume contains 27 individual reports devoted to various aspects of radiotracers for nuclear medicine. (BBR)

  11. Cyclotron targets and production technologies used for radiopharmaceuticals in NPI

    Fišer, Miroslav; Kopička, Karel; Hradilek, Pavel; Hanč, Petr; Lebeda, Ondřej; Panek, T.; Vognar, M.

    2003-01-01

    Roč. 53, č. 2 (2003), s. A737-A743. ISSN 0011-4626 R&D Projects: GA AV ČR KSK4055109 Keywords : cyclotron * radiopharmaceuticals Subject RIV: CH - Nuclear ; Quantum Chemistry Impact factor: 0.263, year: 2003

  12. Sixth international symposium on radiopharmaceutical chemistry: Abstracts: Final report

    The 113 abstracts are arranged under the following section headings: alkyl spiperone derivatives labeled with fluorine, synthesis of compounds labeled with positron emitters, technetium compounds, positron emitters (target design and synthesis), indium and gallium, halogens, labeled proteins and antibodies, radiopharmaceuticals for brain and SPECT, general, and receptor radioligands

  13. Towards a harmonized radiopharmaceutical regulatory framework in Europe

    Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (R P). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in Good Manufacturing Practice (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of R P. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called Good Radiopharmaceutical Practice (cGRPP) to specifically address this in an attempt to harmonize R P preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/E C again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.

  14. Study of the radiopharmaceutical potential of radioiodinated phenolphtalein

    Uenak, T.; Avcibasi, U.; Yildirim, Y. [Ege Univ., Bornova, Izmir (Turkey). Faculty of Science, Dept. of Chemistry, Div. of Nuclear Chemistry; Duman, Y. [Ege Univ., Bornova, Izmir (Turkey). Faculty of Medicine, Div. of Nuclear Medicine

    2004-07-01

    Starting from this pharmaceutical property of phenolphthalein, in this study we examined the radiopharmaceutical potential of radioiodinated phenolphthalein. Phenolphthalein was radioiodinated with iodine-131 using the iodogen method which was earlier applied at our laboratory for radioiodination of different kinds of chemical compounds having at least one phenyl ring in their structures. (orig.)

  15. Harvard-MIT research program in short-lived radiopharmaceuticals

    Adelstein, S.J.

    1991-01-01

    This report presents research on radiopharmaceuticals. The following topics are discussed: antibody labeling with positron-emitting radionuclides; antibody modification for radioimmune imaging; labeling antibodies; evaluation of technetium acetlyacetonates as potential cerebral blood flow agents; and studies in technetium chemistry. (CBS)

  16. Characteristic of 99mTc-glutathione radiopharmaceutical

    Technetium-99m glutathione labelled compound is a radiopharmaceutical which is used in nuclear medicine for cancer diagnoses by imaging method. The distribution and accumulation of radiopharmaceutical in the body depend on its physicochemical and biological characteristic. Therefore, the determination of its characteristic was carried out in order to assure the successful utilization of this radiopharmaceutical. The radiochemical purity was determined with thin layer chromatography (TLC-SG) using dried acetone and 0.9% of NaCl solution as a mobile phase. The charge of 99mTc-GSH was tested by electrophoresis method and its lipophilicity (P) was obtained by determination of octanol-water partition. The plasma binding protein of this radiopharmaceutical was in-vitro investigated with precipitation method using 5% of trichloro acetic acid solution. Beside that, studies on the effect of 99mTc radioactivity to the stability of 99mTc-GSH and its stability in plasma has been in-vitro carried out. From the experiment it was obtained that 99mTc-GSH has 99.08 ± 0.26% of radiochemical purity; neutral (no charge); the lipophilicity (P) = 0.03 ± 0.002; the plasma binding protein of 30.31 ± 0.04%. Utilization of 99mTc radioactivity concentration up to 21 mCi/2 mL resulted 99mTc-GSH radiopharmaceutical which was remained stable up to 5 hours with ≥ 95% of radiochemical purity. In-vitro stability test of 99mTc-GSH in plasma indicated that in the first hour of storage, the radiochemical purity drastically decreased and until 5 hours of storage, its radiochemical purity did not change significantly, that was about 50%. (author)

  17. Radiopharmaceuticals for single-photon emission computed tomography brain imaging.

    Kung, Hank F; Kung, Mei-Ping; Choi, Seok Rye

    2003-01-01

    In the past 10 years, significant progress on the development of new brain-imaging agents for single-photon emission computed tomography has been made. Most of the new radiopharmaceuticals are designed to bind specific neurotransmitter receptor or transporter sites in the central nervous system. Most of the site-specific brain radiopharmaceuticals are labeled with (123)I. Results from imaging of benzodiazepine (gamma-aminobutyric acid) receptors by [(123)I]iomazenil are useful in identifying epileptic seizure foci and changes of this receptor in psychiatric disorders. Imaging of dopamine D2/D3 receptors ([(123)I]iodobenzamide and [(123)I]epidepride) and transporters [(123)I]CIT (2-beta-carboxymethoxy-3-beta(4-iodophenyl)tropane) and [(123)I]FP-beta-CIT (N-propyl-2-beta-carboxymethoxy-3-beta(4-iodophenyl)-nortropane has proven to be a simple but powerful tool for differential diagnosis of Parkinson's and other neurodegenerative diseases. A (99m)Tc-labeled agent, [(99m)Tc]TRODAT (technetium, 2-[[2-[[[3-(4-chlorophenyl)-8-methyl-8-azabicyclo [3,2,1]oct-2-yl]methyl](2-mercaptoethyl)amino]ethyl]amino] ethanethiolato(3-)]oxo-[1R-(exo-exo)]-), for imaging dopamine transporters in the brain has been successfully applied in the diagnosis of Parkinson's disease. Despite the fact that (123)I radiopharmaceuticals have been widely used in Japan and in Europe, clinical application of (123)I-labeled brain radiopharmaceuticals in the United States is limited because of the difficulties in supplying such agents. Development of (99m)Tc agents will likely extend the application of site-specific brain radiopharmaceuticals for routine applications in aiding the diagnosis and monitoring treatments of various neurologic and psychiatric disorders. PMID:12605353

  18. Radiopharmaceuticals as therapeutic agents in medical care and treatment

    Radiation applications in medical research, care, and treatment today are being used to help millions of patients throughout the world. In recent years, the medical community has seen a renaissance of therapeutic radiation applications, particularly of strontium-89 for metastatic bone pain. Radiopharmaceuticals used as therapeutic agents (frequently known as RPTs) are designed to deliver high doses of radiation to selected malignant sites in target organs or tissues, while minimizing the radiation doses to surrounding healthy cells. Over the past several years, several type of RPTs with special properties, including compounds for labelling monoclonal antibodies, have been used in animal and human clinical trials with promising results. The modern trend in radiopharmaceutical research for oncology is the development of RPTs that may be said to be tumour-seeking and tumour-specific. Among the promising RPTs being reported in the medical literature are rhenium-186 and samarium-153. Both can be produced in research reactors available in many countries. 2 tabs

  19. Freeware for reporting radiation dosimetry following the administration of radiopharmaceuticals

    This work describes the development of a software application for reporting patient radiation dosimetry following radiopharmaceutical administration. The resulting report may be included within the patient's medical records. The application was developed in the Visual Basic programming language. The dosimetric calculations are based on the values given by the International Commission on Radiological Protection (ICRP). The software is available in both Spanish and English and can be downloaded at no cost from (www.radiopharmacy.net). - Highlights: • Freeware for reporting radiation dosimetry of administered radiopharmaceuticals. • Printing of reports that can be included within the patient's medical records. • User-friendly and intuitive interface in both English and Spanish

  20. Production of short-lived radiopharmaceuticals with CV-28 cyclotron

    A variable energy isochronous cyclotron CV-28 at the Physical Department of the Instituto de Engenharia Nuclear in Rio de Janeiro, Brazil, is used for radionuclide production of medical interest. The production methods of 67Ga, 77Br, 111In, 123I, 201Tb and their corresponding radiopharmaceuticals were developed. The radiopharmaceuticals 77Br-bromophenol, 77Br-rose bengal, 123I-hippuric acid, 123I-rose bengal, 111In-EDTA, 111In-DTPA and 111In-citrate were under routine production. Their labelling yields were 96%, 82%, 96%, 82%, 89+-6%, 92+-4% and 100+-25%, respectively. The labelling yield and purity were determined using thin layer and paper chromatography. Bio-distribution studies in experimental animals have shown the good quality of these compounds

  1. A simple liquid detector for radiopharmaceutical processing systems

    Sensing the presence of liquids in tubing and vessels in radiochemical processing equipment provides information important to the remote or automatic control of the production of clinical doses of radiopharmaceuticals. Although modern commercial automated radiopharmaceutical synthesis machines do not usually include liquid presence as a measured process variable, earlier more complex automated synthesis devices did; and the inclusion of such feedback can increase system reliability and simplify trouble-shooting tasks carried out by computer software or human operators. Commercial liquid level detectors are often designed for large-scale industrial processes and are therefore too large or expensive to be useful in many radiochemical hardware systems. An inexpensive miniature optical liquid detector originally by Kramer and Fuchs has been duplicated here for use in monitoring the presence of liquids in teflon tubing (1/16 in. O.D.) in an enriched oxygen-18 water recovery system

  2. Infection imaging with radiopharmaceuticals in the 21st century

    Infection continues to be a major cause of morbidity and mortality worldwide. Nuclear medicine has an important role in aiding the diagnosis of particularly deep-seated infections such as abscesses, osteomyelitis, septic arthritis, endocarditis, and infections of prosthetic devices. Established techniques such as radiolabelled leucocytes are sensitive and specific for inflammation but do not distinguish between infective and non-infective inflammation. The challenge for Nuclear Medicine in infection imaging in the 21st century is to build on the recent trend towards the development of more infection specific radiopharmaceuticals, such as radiolabelled anti-infectives (e.g. 99 m Tc ciprofloxacin). In addition to aiding early diagnosis of infection, through serial imaging these agents might prove very useful in monitoring the response to and determining the optimum duration of anti-infective therapy. This article reviews the current approach to infection imaging with radiopharmaceuticals nd the future direction it might take. (author)

  3. Influence of radioactive contaminants on absorbed dose estimates for radiopharmaceuticals

    Several popular radiopharmaceutical products contain low levels of radioactive contaminants. These contaminants increase the radiation absorbed dose to the patient without any increased benefit and, in some cases, with a decrease in image quality. The importance of a contaminant to the radiation dosimetry picture is a function of 1) the contaminant level, 2) the physical half-life of the contaminant, 3) the organ uptake and the biological half-time of the contaminant in the various body systems, and 4) the decay mode, energy, etc. of the contaminant. The general influence of these parameters is discussed in this paper; families of curves are included that reflect the changing importance of contaminant dosimetry with respect to the primary radionuclide as a function of these variables. Several specific examples are also given of currently used radiopharmaceutical products which can contain radioactive contaminants (I-123, In-111, Tl-201, Ir-191m, Rb-82, Au-195m). 7 references, 8 figures, 4 tables

  4. New technologies for production of radiopharmaceuticals and other medical preparations

    The Radioisotope Centre POLATOM belongs to the group of R and D institutions whose profile of activities comprises, besides applied research work, also manufacturing of a range of products based on implementation of the Centre's own developments. The Centre possesses considerable experience in its area of expertise: forty-six years of manufacturing of various radiation sources and radiopharmaceuticals, performing metrology and analysis of radioactive materials, which makes OBRI a unique R and D unit. The Centre is a chief manufacturer supplier of radiopharmaceuticals for nuclear medicine in Poland, and also an active exporter with a market of several tens countries. The current trends in the Centre activity assume combination of R and D work with practical application of its results for production purposes. The undertaken research topics are studied in co-operation with domestic and foreign scientific institutions. (author)

  5. Radiopharmaceuticals in Nuclear Medicine: Evolution and Role in Dentistry

    Vani, Chappidi; Nagalaxmi, V.; Singh, Anshul; Zardi, Faisal Taiyebali; Lalitha, CH

    2013-01-01

    NUCLEAR MEDICINE is the branch of medicine and medical imaging that uses radiation emitted by a radio-pharmaceutical to provide information about both the structure and function of organ systems within the body thereby aiding in the diagnosis and treatment of a disease. This unparalleled branch of radiology concerns with the diagnostic and therapeutic use of radionuclides. The most striking feature that distinguishes Nuclear Medicine from other Imaging Modalities is that Nuclear Medicine aids...

  6. Radiopharmaceuticals and other compounds labelled with short-lived radionuclides

    Welch, Michael J

    2013-01-01

    Radiopharmaceuticals and Other Compounds Labelled with Short-Lived Radionuclides covers through both review and contributed articles the potential applications and developments in labeling with short-lived radionuclides whose use is restricted to institutions with accelerators. The book discusses the current and potential use of generator-produced radionuclides as well as other short-lived radionuclides, and the problems of quality control of such labeled compounds. The book is useful to nuclear medicine physicians.

  7. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2001

    In 2001 the Forschungszentrum Rossendorf e.V. continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. As illustrated by the large number of contributions in this report, the Institute is predominantly engaged in the coordination chemistry and radiopharmacology of technetium and rhenium. (orig.)

  8. Improving radiopharmaceutical supply chain safety by implementing bar code technology.

    Matanza, David; Hallouard, François; Rioufol, Catherine; Fessi, Hatem; Fraysse, Marc

    2014-11-01

    The aim of this study was to describe and evaluate an approach for improving radiopharmaceutical supply chain safety by implementing bar code technology. We first evaluated the current situation of our radiopharmaceutical supply chain and, by means of the ALARM protocol, analysed two dispensing errors that occurred in our department. Thereafter, we implemented a bar code system to secure selected key stages of the radiopharmaceutical supply chain. Finally, we evaluated the cost of this implementation, from overtime, to overheads, to additional radiation exposure to workers. An analysis of the events that occurred revealed a lack of identification of prepared or dispensed drugs. Moreover, the evaluation of the current radiopharmaceutical supply chain showed that the dispensation and injection steps needed to be further secured. The bar code system was used to reinforce product identification at three selected key stages: at usable stock entry; at preparation-dispensation; and during administration, allowing to check conformity between the labelling of the delivered product (identity and activity) and the prescription. The extra time needed for all these steps had no impact on the number and successful conduct of examinations. The investment cost was reduced (2600 euros for new material and 30 euros a year for additional supplies) because of pre-existing computing equipment. With regard to the radiation exposure to workers there was an insignificant overexposure for hands with this new organization because of the labelling and scanning processes of radiolabelled preparation vials. Implementation of bar code technology is now an essential part of a global securing approach towards optimum patient management. PMID:25144560

  9. Adherence of radiopharmaceuticals and labeled cells to intravenous tubing

    A survey of 67 nuclear medicine departments revealed no agreement on which radiolabeled agents could be injected through intravenous lines (IVs) and which required direct venipuncture. Labeled cells and several common radiopharmaceuticals were tested for adherence to intravenous tubing. Residual activity remaining in the tubing after an adequate flush was less than 1% of the injected dose in each case. Administration of radiolabeled agents through existing IVs is an acceptable alternative to direct venipuncture in many cases

  10. Fabrication of SU-8 microreactors for radiopharmaceutical production

    Zizzari, A; Arima, Valentina; Zacheo, A.; Pascali, Giancarlo; Salvadori, Piero; Perrone, E; Mangiullo, D; Rinaldi, Ross

    2011-01-01

    SU-8 is a very interesting material for the fabrication of lab-on-chip devices applied to organic synthesis because of its resistance to chemicals and solvents. Among the possible application fields of microreactor technology, radiochemistry is emerging because microfluidic apparatuses allow to perform radiosynthesis in a quicker, safer and more reliable way compared to traditional vessel-based approaches. Microreactors for synthesizing [18F]-labelled radiopharmaceuticals require the employme...

  11. Molecular Engineering of Technetium and Rhenium Based Radiopharmaceuticals

    The research was based on the observation that despite the extraordinarily rich coordination chemistry of technetium and rhenium and several notable successes in reagent design, the extensive investigations by numerous research groups on a variety of N2S2 and N3S donor type ligands and on HYNIC have revealed that the chemistries of these ligands with Tc and Re are rather complex, giving rise to considerable difficulties in the development of reliable procedures for the development of radiopharmaceutical reagents

  12. Freeware for reporting radiation dosimetry following the administration of radiopharmaceuticals.

    Gómez Perales, Jesús Luis; García Mendoza, Antonio

    2015-09-01

    This work describes the development of a software application for reporting patient radiation dosimetry following radiopharmaceutical administration. The resulting report may be included within the patient's medical records. The application was developed in the Visual Basic programming language. The dosimetric calculations are based on the values given by the International Commission on Radiological Protection (ICRP). The software is available in both Spanish and English and can be downloaded at no cost from www.radiopharmacy.net. PMID:26092354

  13. Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System

    Alireza Aslani; Graeme Snowdon; Dale Bailey; Geoffrey Schembri; Elizabeth Bailey; Pavlakis Nick; Paul Roach

    2015-01-01

    Objective(s): Peptide Receptor Radionuclide Therapy (PRRT) with yttrium-90 (90Y) and lutetium-177 (177Lu)-labelled SST analogues are now therapy option for patients who have failed to respond to conventional medical therapy. In-house production with automated PRRT synthesis systems have clear advantages over manual methods resulting in increasing use in hospital-based radiopharmacies. We report on our one year experience with an automated radiopharmaceutical synthesis system. Methods: All syn...

  14. Analysis of radiochemical impurities in radiopharmaceuticals. Pt. 1

    In a study of the relevant literatur analytical methods for the determination of radiochemical purity of pharmaceuticals were compiled in form of a dictionary. It contains data on studies of 71 radiopharmaceuticals and a total of 123 analyses. About half of the substances were labelled with I 131. The most frequently used investigation method was thin-layer chromatography (75 analyses), followed by paper chromatography (36 analyses), electrophoresis (10 analyses) and high-pressure liquid chromatography (2 analyses). (orig.)

  15. Bone-seeking radiopharmaceuticals in skeletal malignancy: evolution, not revolution

    Many advanced malignancies are complicated by skeletal metastases, with attendant pain and disability. External beam radiotherapy is still the most effective treatment for isolated lesions. Bone-seeking radiopharmaceuticals were perceived as a means of delivering radiation to multiple lesions simultaneously. A wide variety of radioisotopes have been used in this endeavor, with myelosuppression being the most significant potential adverse effect. Benefits of treatment are modest, including a transient improvement in pain control and perhaps prolongation of the treatment-free period. This is best demonstrated in prostate cancer with lower responses by skeletal metastases from breast and lung cancers. However, the treatment is yet to produce any improvement in patient survival. Experimental approaches to improve treatment efficacy include combination with cytotoxic therapy, and administration earlier in the course of the disease. Bone seeking radiopharmaceuticals have been used in treatment of advanced osteosarcoma in humans and canines and achieved effective palliation. The myelosuppressive effects of these agents have been exploited in patients with multiple myeloma to assist in attaining myeloablation prior to stem cell transplantation. Development of more potent non-radiolabelled bisphosphonates and recognition of their antitumour effect against several tumours has sparked a recrudescence of interest in their use for bone metastases. Set against these developments, the role of bone-seeking radiopharmaceuticals in skeletal metastases may need to be redefined

  16. Export of radiopharmaceuticals and establishment of export base of cyclotron

    Sam young Unit ech has seized an opportunity to advance into the radiopharmaceuticals market through successful transfer of radiopharmaceuticals manufacturing technology and medical cyclotron, an original technology in nuclear medicine that is the core of less developed areas in nuclear-related fields. The company has continued to push for research development and establishment of market base through industry-academia-research center cooperation with an aim to complement relatively less developed domestic technology and market than in advanced countries, and is making efforts to establish export base in the overseas market based on stabilized supply in the domestic market. As for radiopharmaceuticals, the company is exporting Tc-99m generator to Vietnam, Thailand and the Philippines and preparing itself to export manufacture facilities for Tc-99m generator to Syria and Kazakhstan. In addition, it plans to export 13Mev Cyclotron that has been commercialized after being developed in the domestic market to the U. S. The company plans to grow up to play a pivotal role in the domestic RT area by conducting proactive business activities with an aim to revitalize the domestic market and further domestic original technologies and products in the global market

  17. RADIOPHARMACEUTICALS FOR IMAGING OF HYPOXIC TUMORS: A REVIEW

    Chaitanya Prasad Meher

    2012-11-01

    Full Text Available Radiopharmaceuticals are drugs containing a radionuclide and are used routinely in nuclear medicine for the diagnosis and therapy of various diseases. The mechanism of localization of the radiopharmaceutical in different organs provides the clue for designing of the agent meant for a specific organ or pathway. Various agent like F-18, Cu-64/67, I-123, and Tc-99m are used as imaging of hypoxic tumors. Of these, F-18-fluoromisonidazole and I-123-iodoazomycin arabinoside (IAZA have been most widely studied clinically. Non-nitro-containing bioreductive complexes, such as the Cu-60/62/64 thiosemicarbazone ATSM and Tc-99m butylene amineoxime (BnAO or HL91, have also been evaluated. In particular, I-123-IAZA and Cu-60-ATSM have shown correlation with response to radiotherapy in preliminary clinical studies. However, more preclinical studies comparing imaging with validated invasive methods and clinical studies with outcome measures are required. Nuclear medicine is poised to play an important role in optimizing the therapy of patients with hypoxic tumors. The present review is concern with the various radiopharmaceuticals used for imaging of hypoxia.

  18. Results of the quality assurance testing program for radiopharmaceuticals, 1994

    Baldas, J.; Bonnyman, J.; Ivanov, Z.; Lauder, R

    1995-08-01

    The Australian Radiation Laboratory conducts a Radiopharmaceutical Quality Assurance Test Program in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications quoted have been adopted by this Laboratory and have no legal status. It should be noted that unless stated otherwise, the specifications listed apply at all times up to product expiry. Radionuclidic purity has been determined at the calibration time, except for Thallous [{sup 201}Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Samples for testing were obtained through commercial channels. All technetium-99m cold kits were reconstituted according to the directions in the package insert using Sodium Pertechnetate[{sup 99m}Tc] Injection. Methods used for testing are described in the report ARL/TR093 24 tabs.

  19. Recent radiopharmaceutical research at the AAEC Research Establishment

    During the past few years a large part of the radiochemical research carried out at Lucas Heights has been devoted to the synthesis of ligands capable of forming chelate complexes with technetium-99m, as part of a search for tumour-localising radiopharmaceuticals. An account is given of the synthesis and biological evaluation of a range of these compounds and of the investigation of certain biochemical and biological properties affecting the clinical application of both ligands and radiopharmaceuticals. In addition to the search for novel Tc-99m radiopharmaceuticals, major research programs on the development of Tc-99m generating systems have been in progress at Lucas Heights for several years. Work on the AAEC's Mark III Tc-99m technetium generator has been brought to a successful conclusion. A new type of Tc-99m generator, which uses an insoluble zirconium molybdate gel and provides high yields of pertechnetate by a simple elution technique, has also been developed. Studies are in progress on the osmium-iridium generator

  20. Synthesis and formulation of 99m Tc-ECD radiopharmaceutical

    Nuclear medicine is a medical specialty which uses radioactive compounds (radionuclides) for diagnostic and therapeutic purposes. 99m Tc is the more common radionuclide used in many studies in nuclear medicine because its advantages: it has a photopeak of 140 KeV and a half-life of 6 hours; it can be eluted from a Molybdenum 99 generator, so radiopharmaceuticals can be prepared on site. Ethyl cysteine dimer (ECD) labelled with reduced Technetium 99m has been purposed recently as a promising radiopharmaceutical for brain perfusion imaging 99m Tc-ECD is a lipophilic neutral complex which cross the brain blood barrier and show high brain uptake. The objective of this work was synthesize and to design a freeze dried formulation for the instant preparation of 99m Tc-ECD complex useful for brain perfusion imaging. We obtained a freeze dried stable formulation for the preparation of 99m Tc-ECD kit with a radiochemical purity higher than 90 %, which fulfills with the quality control of radiopharmaceuticals. Furthermore, we developed analytic techniques for the determination of the different chemical compounds into the lyophilized kit. (Author)

  1. Unusual or unanticipated alterations in the biodistribution of radiopharmaceuticals as a result of pathologic mechanisms

    This chapter discusses radiopharmaceuticals for the following: central nervous system imaging; thyroid imaging; cardiovascular imaging; lung imaging; gastrointestinal imaging; genitourinary imaging; musculoskeletal imaging

  2. The role of high performance liquid chromatography in radiochemical/radiopharmaceutical synthesis and quality assurance

    The usefulness of HPLC in all areas of radiopharmaceutics has been demonstrated in numerous laboratories, particularly in the development of in-house radiopharmaceuticals for SPECT and PET. HPLC continues to be a powerful tool in preparation and quality assurance (QA) as illustrated in such areas as chemical and radiochemical identification; product separation and isolation; preparative scale purification; and specific activity determination. A review of established HPLC techniques in radiopharmaceutics will be presented. Examples from the literature as well as newer applications will be used in an attempt to assess and define the present-day role of HPLC in the preparation of radiochemicals and radiopharmaceuticals with emphasis on QA

  3. GMP compliant radiosynthesis of11C and18F-labeled PET radiopharmaceuticals with a modular disposable cassette system

    Hessels-Scheper, J.G.; Maarsingh, P.; Kwizera, C.; Zijlma, R.; Maas, B.; De Vries, A.M.T.; Antunes, I.F.; Lub-de Hooge, M.N.; Boersma, H.H.; Dierckx, R.A.J.O.; De Vries, E.F.J.; Luurtsema, G.; Elsinga, P.H.

    2014-01-01

    Background Many nuclear medicine departments have an extensive radiopharmaceutical portfolio. Consequently, these multiple PET radiopharmaceuticals have to be produced with the same synthesis module. An important consideration in GMP-compliant PET production is to avoid potential cross-contamination

  4. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides. Final Report

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N4-methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the oxygen

  5. Biochemical studies of the renal radiopharmaceutical compound dimercaptosuccinate. Pt. 4

    As a crucial step towards understanding the mechanism of localisation of radiopharmaceuticals in specific target organs, the interaction of the radiopharmaceuticals sup(99m)Tc-DMS and 99Tc-DMS with blood serum proteins was studied. The interaction of sup(99m)Tc-DMS radiopharmaceutical was examined from two aspects: total protein binding as well as specificity of binding to certain classes of proteins. After in vitro labelling of human sera with sup(99m)Tc-DMS, the following values of bound radioactivity to total serum proteins were determined: 65%+-3.2% by gel-filtration chromatography; 72%+-4.6% by dialysis; while on the basis of precipitation by perchloric and trichloroacetic acid 72.7%+-6.8% and 71%+-2.3%, respectively. Distribution of sup(99m)Tc-DMS or 99TcDMS among serum proteins was analysed by agarose gel electrophoresis of the sera at pH 8.6 after in vivo and in vitro labelling of human sera with sup(99m)Tc-DMS, while the same analysis was performed with 99Tc-DMS complex after in vitro labelling of human and rat sera as well as after in vivo application to the rats. The results obtained demonstrate that carrier serum proteins investigated by agarose gel electrophoresis were in the migration zone of α2-, α1- and β1-globulins, whereas the radioactivity found in the serum albumin zone was negligible. Interaction of both Tc-DMS complexes with proteins was very similar, and this conclusion was in good correlation with our previously obtained results in investigations concerning the biochemical behaviour of these complexes. (orig.)

  6. Profile of MIBI Liquid Phase Radiopharmaceutical for Myocardial Imaging

    I. Daruwati

    2016-04-01

    Full Text Available The 99mTc-MIBI radiopharmaceutical has been used innuclear medicine in Indonesia for myocardial imaging. BATAN researchers have mastered the technology to manufacture MIBI as a liophylized kit. A reformulation of MIBI radiopharmaceutical has been conducted to improve the stability of the kit especially in the liquid-phase kit. Basically, radiopharmaceuticals in liquid form are not different from the dry kit. However in the manufacturing of liquid-phase kit, lyophilization process was not done. To improve the stability of liquid kit, a reformulation of the components was conducted by using two separate vials (Formulation 2 and the characteristics were compared with the one-vial formulation (Formulation 1.The MIBI Formulation 2 consists of two vials, vial A containing 0.06 mg of SnCl2 2H2O and 2.6 mg Sodium Citrate 2H2O and vial B containing 0.5 mg of [Cu(MIBI4]BF4, 1 mg of cysteine hydrochloride, and 20 mg of mannitol.The purposes of this study wereto determine the stability of two different formulations of MIBI as a liquid-phase kit, to compare theirstability in different storage condition such as in refrigerator and freezer, and to compare the ratio of activities attained between target and nontargetorgans after injection to animal model. As a diagnostic agent, MIBI was reconstituted with Technetium-99m as radionuclide tracer to 99mTc-MIBI labeled compound. The radiochemical purity of 99mTc-MIBI was determined by chromatography method using alumina thin-layer chromatography paper as the stationary phase and ethanol 95% as the mobile phase. The results showed MIBI Formulation 2 has a higher stability than Formulation 1. Formulation 2 also maintaineda 96.68%radiochemical purity under 52-day storage and attainedatarget-to-nontarget activity ratio of 8.22.

  7. Analysis of residual solvents in PET radiopharmaceuticals by GC

    The residual solvents in PET radiopharmaceuticals were analyzed by GC, which were acetonitrile, ethanol, N, N-dimethylethanolamine (DMEA), dimethylsulfoxide (DMSO). The standard curves were established with the AT-624 capillary column at GC, and the sensitivity of acetonitrile and ethanol were 0.004-0.320 g/L and 0.010-0.120 g/L respectively. The residual solvents of acetonitrile, ethanol, DMEA and DMSO in PET radio- pharmaceuticals were analyzed by GC. The linearity were 0.9994, 0.9999, 0.9997, 0.999 6 respectively. The residual of acetonitrile were (0.0313±0.0433), (0.0829±0.0668), (0.0156±0.0059), (0.0254±0.0266) g/L in 18F-FDG, 18F-FLT, 11C-CFT, 11C-PIB respectively. The residual of ethanol was (0.0505±0.00528) g/L in 18F-FDG. The residual of DMSO were (0.0331±0.0180) g/L, (0.0238±0.0100) g/L in 18F-W372 and 11C-DTBZ respectively. The residual of DMEA was (0.0348±0.0022) g/L in 11C-Choline. The survived of organic solvent in PET radiopharmaceuticals can be analyzed with GC directly. The results showed that the QC should be done in PET radiopharmaceuticals purity with semi-HPLC to avoid the high residual. (authors)

  8. Survey of radiopharmaceuticals used for in vivo studies in medical practice in New Zealand

    To obtain up-to-date information on numbers and types of radiopharmaceutical procedures, a survey was undertaken in the last quarter of 1983. In conjunction with this survey dosimetry data for the range of radiopharmaceutical procedures has been reviewed and extended where necessary so that effective dose equivalents could be estimated and mean genetically significant and malignancy significant doses for the population derived

  9. Quality control protocols for radiodiagnosis agents and radiopharmaceuticals

    Based on the compilation of pharmacopoeia methods, literature, manuals and other information developed in our laboratory, protocols have been prepared to carry out quality controls for radiodiagnosis agents (RDA), better known as kits and RDA labelled with Tc99m. Quality control protocols cover physicochemical and biological controls. Physicochemical controls described for RDA include physical characteristics, particle size and number, pH, chemical identification, humidity, tin II; whereas biological controls include sterility, acute toxicity and bacterial endotoxin determination (LAL). Physicochemical controls described for radiopharmaceuticals labelled with Tc99m are pH and radiochemical purity; while biological distribution is described as a biological control

  10. Radio-pharmacy and radio-pharmaceutical drugs

    This document proposes the table of content of a book which aims at presenting the scientific, regulatory and technical bases for the implementation of radio-pharmacy in hospital environment. It addresses fundamental theories and notions of nuclear physics and radioactivity (production of artificial radionuclides, sensors and measurement devices, radiochemistry), radiobiology and radiation protection (biological effects of ionizing radiations, radiation protection, regulation related to the use of radionuclides by health care workers), fields of application of radio-pharmaceutical drugs (diagnosis, therapy, biological researches), and radio-pharmacy management in the hospital (design, installation, organisation and operation)