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Sample records for multi-particulate calcium-pectinate ca-pectinate

  1. Calcium Pectinate Beads Formation: Shape and Size Analysis

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    Boon-Beng Lee

    2014-04-01

    Full Text Available The aim of this study was to investigate the inter-relationship between process variables and the size and shape of pectin solution droplets upon detachment from a dripping tip as well as Ca-pectinate beads formed after gelation via image analysis. The sphericity factor (SF of the droplets was generally smaller than 0.05. There was no specific trend between the SF of the droplets and the pectin concentration or the dripping tip radius. The SF the beads formed from high-concentration pectin solutions and a small dripping tip was smaller than 0.05. The results show that the Reynolds number and Ohnesorge number of the droplets fall within the operating region for forming spherical beads in the shape diagram, with the exception to the lower boundary. The lower boundary of the operating region has to be revised to Oh = 2.3. This is because the critical viscosity for Ca-pectinate bead formation is higher than that of Ca-alginate beads. On the other hand, the radius of the droplets and beads increased as the dripping tip radius increased. The bead radius can easily be predicted by Tate’s law equation.

  2. Wax-incorporated emulsion gel beads of calcium pectinate for intragastric floating drug delivery.

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    Sriamornsak, Pornsak; Asavapichayont, Panida; Nunthanid, Jurairat; Luangtana-Anan, Manee; Limmatvapirat, Sontaya; Piriyaprasarth, Suchada

    2008-01-01

    The purpose of this study was to prepare wax-incorporated pectin-based emulsion gel beads using a modified emulsion-gelation method. The waxes in pectin-olive oil mixtures containing a model drug, metronidazole, were hot-melted, homogenized and then extruded into calcium chloride solution. The beads formed were separated, washed with distilled water and dried for 12 h. The influence of various types and amounts of wax on floating and drug release behavior of emulsion gel beads of calcium pectinate was investigated. The drug-loaded gel beads were found to float on simulated gastric fluid if the sufficient amount of oil was used. Incorporation of wax into the emulsion gel beads affected the drug release. Water-soluble wax (i.e. polyethylene glycol) increased the drug release while other water-insoluble waxes (i.e. glyceryl monostearate, stearyl alcohol, carnauba wax, spermaceti wax and white wax) significantly retarded the drug release. Different waxes had a slight effect on the drug release. However, the increased amount of incorporated wax in the formulations significantly sustained the drug release while the beads remained floating. The results suggest that wax-incorporated emulsion gel beads could be used as a carrier for intragastric floating drug delivery.

  3. Synthesis, characterization, and in vitro release of diclofenac sodium from hybrid nanostructured magnetite–calcium pectinate

    International Nuclear Information System (INIS)

    Dutta, Raj Kumar; Sahu, Saurabh; Reddy, V. R.

    2012-01-01

    A stable spherical nanostructured calcium pectinate loaded with diclofenac sodium (DS) and functionalized by superparamagnetic iron oxide nanoparticles, referred as MCPDS, was developed as a potential magnetically targeted drug delivery system. The sizes of the MCPDS were in the range of 100–200 nm in dried condition, confirmed by scanning electron microscopy and transmission electron microscopy. In the aqueous medium, the sizes of MCPDS were in the range 300 ± 50 nm, measured by dynamic light scattering technique. The X-ray diffraction and 57 Fe Mössbauer spectroscopy confirmed magnetite phase in MCPDS. The magnetic property of the MCPDS nanostructures was confirmed from high saturation magnetization (44.05 emu/g), measured using a vibrating sample magnetometer. The superparamagnetic property of MCPDS was characterized by superconducting quantum unit interference device magnetometry and corroborated by Mössbauer spectroscopy. The loading efficiency of DS in MCPDS was measured by UV–Vis spectrophotometry and corroborated by thermal analysis. The in vitro release of the drug from MCPDS in simulated gastrointestinal fluids and in phosphate buffer solution was found to be pH sensitive and exhibited sustained release property. The cumulative drug release agreed well with that of swelling controlled diffusion mechanism, given by the Korsemeyer Peppas model.

  4. Synthesis, characterization, and in vitro release of diclofenac sodium from hybrid nanostructured magnetite-calcium pectinate

    Energy Technology Data Exchange (ETDEWEB)

    Dutta, Raj Kumar, E-mail: duttafcy@iitr.ernet.in; Sahu, Saurabh, E-mail: saurabhsahu12@gmail.com [Indian Institute of Technology Roorkee, Analytical Chemistry Laboratory, Department of Chemistry (India); Reddy, V. R., E-mail: vrreddy@csr.res.in [UGC-DAE Consortium for Scientific Research (India)

    2012-08-15

    A stable spherical nanostructured calcium pectinate loaded with diclofenac sodium (DS) and functionalized by superparamagnetic iron oxide nanoparticles, referred as MCPDS, was developed as a potential magnetically targeted drug delivery system. The sizes of the MCPDS were in the range of 100-200 nm in dried condition, confirmed by scanning electron microscopy and transmission electron microscopy. In the aqueous medium, the sizes of MCPDS were in the range 300 {+-} 50 nm, measured by dynamic light scattering technique. The X-ray diffraction and {sup 57}Fe Moessbauer spectroscopy confirmed magnetite phase in MCPDS. The magnetic property of the MCPDS nanostructures was confirmed from high saturation magnetization (44.05 emu/g), measured using a vibrating sample magnetometer. The superparamagnetic property of MCPDS was characterized by superconducting quantum unit interference device magnetometry and corroborated by Moessbauer spectroscopy. The loading efficiency of DS in MCPDS was measured by UV-Vis spectrophotometry and corroborated by thermal analysis. The in vitro release of the drug from MCPDS in simulated gastrointestinal fluids and in phosphate buffer solution was found to be pH sensitive and exhibited sustained release property. The cumulative drug release agreed well with that of swelling controlled diffusion mechanism, given by the Korsemeyer Peppas model.

  5. Synthesis, characterization, and in vitro release of diclofenac sodium from hybrid nanostructured magnetite-calcium pectinate

    Science.gov (United States)

    Dutta, Raj Kumar; Sahu, Saurabh; Reddy, V. R.

    2012-08-01

    A stable spherical nanostructured calcium pectinate loaded with diclofenac sodium (DS) and functionalized by superparamagnetic iron oxide nanoparticles, referred as MCPDS, was developed as a potential magnetically targeted drug delivery system. The sizes of the MCPDS were in the range of 100-200 nm in dried condition, confirmed by scanning electron microscopy and transmission electron microscopy. In the aqueous medium, the sizes of MCPDS were in the range 300 ± 50 nm, measured by dynamic light scattering technique. The X-ray diffraction and 57Fe Mössbauer spectroscopy confirmed magnetite phase in MCPDS. The magnetic property of the MCPDS nanostructures was confirmed from high saturation magnetization (44.05 emu/g), measured using a vibrating sample magnetometer. The superparamagnetic property of MCPDS was characterized by superconducting quantum unit interference device magnetometry and corroborated by Mössbauer spectroscopy. The loading efficiency of DS in MCPDS was measured by UV-Vis spectrophotometry and corroborated by thermal analysis. The in vitro release of the drug from MCPDS in simulated gastrointestinal fluids and in phosphate buffer solution was found to be pH sensitive and exhibited sustained release property. The cumulative drug release agreed well with that of swelling controlled diffusion mechanism, given by the Korsemeyer Peppas model.

  6. An oral multi-particulate, modified release, hydrocortisone replacement therapy that provides physiological cortisol exposure

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    Huatan, Hiep; Merke, Deborah; Arlt, Wiebke; Ross, Richard J.

    2013-01-01

    Objective It is not possible with current hydrocortisone replacement to mimic the diurnal cortisol profile in patients with adrenal insufficiency. Previous attempts with modified release technology were unsuccessful. Our objective was to develop hydrocortisone formulations that recreate the diurnal cortisol profile using multi-particulate technology. Design and Measurements Screening by in-vitro dissolution profiles, pharmacokinetic testing in dexamethasone suppressed dogs and humans, and comparison to a reference population. Setting Field laboratories and clinical research facility. Results Formulations were generated using an enteric (delayed-release) design configuration with an extended (sustained-release) dissolution profile. In-vitro dissolution confirmed delayed and sustained hydrocortisone release. However, in dogs and humans, sustained release resulted in reduced bioavailability. A formulation, DIURF-006, was developed that maintained delayed release but omitted the sustained release functionality. Pharmacokinetic characterisation of DIURF-006 showed that, despite absence of a sustained release component, absorption was sufficiently sustained to deliver extended hydrocortisone absorption. In dexamethasone-suppressed volunteers (n=16) receiving a twice daily ‘toothbrush’ regimen (20mg at 23:00h and 10mg at 07:00h), DIURF-006 gave a similar cortisol profile to physiological cortisol levels: DIURF-006 vs physiological, Geomean AUC 5610 vs 4706 hr*nmol/l, Geomean Cmax 665 vs 594 nmol/l and Median Tmax 8.5h vs clock time 08:12 hours for peak cortisol. The relative bioavailability of DIURF-006 vs hydrocortisone was 89% and cortisol levels increased linearly with doses between 5 and 30mg. Conclusion A multi-particulate oral hydrocortisone formulation with only an enteric coat provides delayed and sustained absorption and when given in a ‘toothbrush’ regimen provides physiological cortisol exposure. PMID:23980724

  7. Blends of jackfruit seed starch-pectin in the development of mucoadhesive beads containing metformin HCl.

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    Nayak, Amit Kumar; Pal, Dilipkumar

    2013-11-01

    In this work, calcium pectinate-jackfruit (Artocarpus heterophyllus Lam.) seed starch (JFSS) mucoadhesive beads containing metformin HCl were developed through ionotropic-gelation. Effects of pectin and JFSS amounts on drug encapsulation efficiency (DEE), and cumulative drug release after 10 h (R10 h) were optimized using 3(2) factorial design. The optimized calcium pectinate-JFSS beads containing metformin HCl showed DEE of 94.11 ± 3.92%, R10 h of 48.88 ± 2.02%, and mean diameter of 2.06 ± 0.20 mm. The in vitro drug release from these beads was followed controlled-release (zero-order) pattern with super case-II transport mechanism. The beads were also characterized by SEM and FTIR. The pH of test mediums was found critical for swelling and mucoadhesion of these beads. The optimized calcium pectinate-JFSS beads also exhibited good mucoadhesivity and significant hypoglycemic effect in alloxan-induced diabetic rats over prolonged period after oral administration. Copyright © 2013 Elsevier B.V. All rights reserved.

  8. Enteric coated HPMC capsules plugged with 5-FU loaded microsponges: a potential approach for treatment of colon cancer

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    Ankita Gupta

    2015-09-01

    Full Text Available The work was aimed at developing novel enteric coated HPMC capsules (ECHC plugged with 5 Florouracil (5-FU loaded Microsponges in combination with calcium pectinate beads. Modified quasi-emulsion solvent diffusion method was used to formulate microsponges based on 32 factorial design and the effects of independent variables (volume of organic solvent and Eudragit RS100 content on the dependent variables (Particle size, %EE & % CDR were determined. The optimized microsponges (F4 were characterized by SEM, PXRD, TGA and were plugged along with calcium pectinate beads in HPMC capsules and the HPMC capsules were further coated with enteric polymer Eudragit L 100 (Ed-L100 and/ or Eudrgit S 100 (Ed-S 100 in different proportions. In vitro release study of ECHC was performed in various release media sequentially SGF for 2 h, followed by SIF for the next 6 h and then in SCF (in the presence and absence of pectinase enzyme for further 16 h. Drug release was retarded on coating with EdS-100 in comparison to blend of EdS-100: EdL-100 coating. The percentage of 5-FU released at the end of 24 h from ECHC 3 was 97.83 ± 0.12% in the presence of pectinase whereas in control study it was 40.08 ± 0.02% drug. The optimized formulation was subjected to in vivo Roentgenographic studies in New Zealand white rabbits to analyze the in vivo behavior of the developed colon targeted capsules. Pharmacokinetic studies in New Zealand white rabbits were conducted to determine the extent of systemic exposure provided by the developed formulation in comparison to 5-FU aqueous solutions. Thus, enteric coated HPMC capsules plugged with 5-FU loaded microsponges and calcium pectinate beads proved to be promising dosage form for colon targeted drug delivery to treat colorectal cancer.

  9. Non-invasive MRI detection of individual pellets in the human stomach.

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    Knörgen, Manfred; Spielmann, Rolf Peter; Abdalla, Ahmed; Metz, Hendrik; Mäder, Karsten

    2010-01-01

    MRI is a powerful and non-invasive method to follow the fate of oral drug delivery systems in humans. Until now, most MRI studies focused on monolithic dosage forms (tablets and capsules). Small-sized multi-particulate drug delivery systems are very difficult to detect due to the poor differentiation between the delivery system and the food. A new approach was developed to overcome the described difficulties and permit the selective imaging of small multi-particulate dosage forms within the stomach. We took advantage of the different sensitivities to susceptibility artefacts of T(2)-weighted spin-echo sequences and T(2)-weighted gradient echo pulse sequences. Using a combination of both methods within a breath hold followed by a specific mathematical image analysis involving co-registration, motion correction, voxel-by-voxel comparison of the maps from different pulse sequences and graphic 2D-/3D-presentation, we were able to obtain pictures with a high sensitivity due to susceptibility effects caused by a 1% magnetite load. By means of the new imaging sequence, single pellets as small as 1mm can be detected with high selectivity within surrounding heterogeneous food in the human stomach. The developed method greatly expands the use of MRI to study the fate of oral multi-particulate drug delivery systems and their food dependency in men. Copyright 2009 Elsevier B.V. All rights reserved.

  10. An industrial perspective on the design and development of medicines for older patients.

    Science.gov (United States)

    Page, Sharon; Coupe, Alastair; Barrett, Andrew

    2016-10-30

    An increasing elderly population is leading to a change in the global demographics. This presents a new challenge to society and the pharmaceutical industry. This demographic shift is providing an opportunity for the pharmaceutical industry to meet the specific needs of the changing patient population. One issue that has been identified is defining what is meant by "an older patient", since this definition cannot be simply limited to chronological age. The fundamental purpose of the design and development process is to create a product that can be used by the patient group in a safe and efficacious manner. In the pharmaceutical industry ICH Q8 is used to guide the design and development of medicines. The process leads to the definition of the Quality Target Product Profile (QTPP) for a specific drug product and patient population. One can imagine a product with various presentations described in the QTPP which suit paediatrics, adults and older patients. It is recognised that designing medicines for smaller population groups will result in multiple presentations that could lead to smaller manufacturing batch sizes. In the short to medium term; dose flexibility, easy-to-swallow formulations, and easier access packaging are all factors under consideration. Dose flexibility could be achieved with various dosage forms such as oral liquids, mini-tablets, or multi-particulates. Whilst patient dosage preferences are beginning to be understood, further investigation is needed to balance the needs of the patient, care giver, prescriber, and payer. There also remain a number of challenges with the engineering solutions and delivery device for mini-tablets and multi-particulates (aside from filled capsules) to accurately and robustly deliver the dose, and issues with handling the device and the packaging for an older patient. It is also recognised that there are numerous challenges, not least of which is the definition of the older patient and a generic QTPP for an older

  11. Nanospherical inorganic α-Fe core-organic shell necklaces for the removal of arsenic(V) and chromium(VI) from aqueous solution

    Science.gov (United States)

    Azzam, Ahmed M.; Shenashen, Mohamed A.; Selim, Mahmoud M.; Yamaguchi, Hitoshi; El-Sewify, Islam M.; Kawada, Satoshi; Alhamid, Abdulaziz A.; El-Safty, Sherif A.

    2017-10-01

    Mesoporous nanospherical necklaces (NSN) of inorganic α-Fe core-organic shell and ethylenediaminetetraacetic acid (EDTA) were fabricated. The necklaces were 1 μm in length and 50 nm in thickness, with massive nanospherical particles connecting and overlapping in a neat micro-/nano-necklace archery cage for capturing/trapping of As(V) and Cr(VI) species from water sources. The α-Fe core and the dressing shell of EDTA provided numerous active sites for adsorption, which led to 100% adsorption uptake of these toxic ions. The adsorption isotherms revealed that NSN adsorbent with mesoporous caves and organic-decorated surfaces was promising and effective for the spontaneous and endothermic removal of both ions from contaminated water. The NSN structure exhibited long-term stability. The adsorption efficiency and uptake of the deleterious arsenic and chromium species were achieved after multi-particulate processing of reuse cycles. The pH-dependent removal of As(V) and Cr(VI) species is an emerging topic in selective adsorption assays among competitive ions. Furthermore, the ion-selective conditions at pH 5 for As(V) and pH 7 for Cr(VI) significantly affected the adsorption capacity and affinity of 306.7 and 406.5 mg g-1 into NSN cages, respectively. The obtained results could be used as a basis to provide effective and low-cost products for the purification of wastewater resources from toxic metals.

  12. Oral controlled release drug delivery system and Characterization of oral tablets; A review

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    Muhammad Zaman

    2016-01-01

    Full Text Available Oral route of drug administration is considered as the safest and easiest route of drug administration. Control release drug delivery system is the emerging trend in the pharmaceuticals and the oral route is most suitable for such kind of drug delivery system. Oral route is more convenient for It all age group including both pediatric and geriatrics. There are various systems which are adopted to deliver drug in a controlled manner to different target sites through oral route. It includes diffusion controlled drug delivery systems; dissolution controlled drug delivery systems, osmotically controlled drug delivery systems, ion-exchange controlled drug delivery systems, hydrodynamically balanced systems, multi-Particulate drug delivery systems and microencapsulated drug delivery system. The systems are formulated using different natural, semi-synthetic and synthetic polymers. The purpose of the review is to provide information about the orally controlled drug delivery system, polymers which are used to formulate these systems and characterizations of one of the most convenient dosage form which is the tablets. 

  13. PELLETS AND PELLETIZATION: EMERGING TRENDS IN THE PHARMA INDUSTRY.

    Science.gov (United States)

    Zaman, Muhammad; Saeed-Ul-Hassan, Syed; Sarfraz, Rai Muhammad; Batool, Nighat; Qureshi, Muhammad Junaid; Akram, Muhammad Abdullah; Munir, Saiqa; Danish, Zeeshan

    2016-11-01

    The present time is considered as an era of advancements in drug delivery systems. Different novel approaches are under investigation that range from uniparticulate to multi particulate system, macro to micro and nano particulate systems. Pelletization is one of the novel drug delivery technique that provides an effective way to deliver the drug in modified pattern. It is advantageous in providing site specific delivery of the drug. Drugs with unpleasant taste, poor bioavailability and short biological half-life can be delivered efficiently through pellets. Their reduced size makes them more valuable as compared to the conventional drug deliv- ery system. Different techniques are used to fabricate the pellets such as extrusion and spheronization, hot melt extrusion, powder layering, suspension or solution layering, freeze pelletization and pelletization by direct compression method. Various natural polymers including xanthan gum, guar gum, tragacanth and gum acacia, semisynthetic polymers like cellulose derivatives, synthetic polymers like derivatives of acrylamides, can be used in pellets formulation. Information provided in this review is collected from various national and intemational research articles, review articles and literature available in the books. The purpose of the current review is to discuss pellets, their characterizations, different techniques of pelletization and the polymers with potential of being suitable for pellets formulation.

  14. Feasibility of mini-tablets as a flexible drug delivery tool.

    Science.gov (United States)

    Mitra, Biplob; Chang, Jessica; Wu, Sy-Juen; Wolfe, Chad N; Ternik, Robert L; Gunter, Thomas Z; Victor, Michael C

    2017-06-15

    Mini-tablets have potential applications as a flexible drug delivery tool in addition to their generally perceived use as multi-particulates. That is, mini-tablets could provide flexibility in dose finding studies and/or allow for combination therapies in the clinic. Moreover, mini-tablets with well controlled quality attributes could be a prudent choice for administering solid dosage forms as a single unit or composite of multiple mini-tablets in patient populations with swallowing difficulties (e.g., pediatric and geriatric populations). This work demonstrated drug substance particle size and concentration ranges that achieve acceptable mini-tablet quality attributes for use as a single or composite dosage unit. Immediate release and orally disintegrating mini-tablet formulations with 30μm to 350μm (particle size d 90 ) acetaminophen and Compap™ L (90% acetaminophen) at concentrations equivalent to 6.7% and 26.7% acetaminophen were evaluated. Mini-tablets achieved acceptable weight variability, tensile strength, friability, and disintegration time at a reasonable solid fraction for each formulation. The content uniformity was acceptable for mini-tablets of 6.7% formulations with ≤170μm drug substance, mini-tablets of all 26.7% formulations, and composite dosage units containing five or more mini-tablets of any formulation. Results supported the manufacturing feasibility of quality mini-tablets, and their applicability as a flexible drug delivery tool. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Responses of Pseudokirchneriella subcapitata and algal assembly to photocatalytic titanium dioxide nanoparticles

    Science.gov (United States)

    Metzler, David M.

    varied with algal age and TiO 2 concentration. Finally, the effect of light intensity was examined for both visible and UV wavelengths. The greatest effect was for 1000 mg/L of TiO2 under varying light. Peak maximums occurred for chlorophyll a and lipid peroxidation. Peak minimums occurred for population. Varying UV light intensity resulted in decreased population for 100 and 1000 mg/L of TiO2. Additionally, chlorophyll a reached a maximum at 17 and 5 x the control values under 66% UV light for 100 and 1000 mg/L of TiO 2, respectively. The effect of copper and phenol to P. subcapitata was examined in the presence of TiO2. Copper in the presence of TiO 2 increased both chlorophyll a and lipid peroxidation greater than in the presence of TiO2 alone. Optimum conditions were observed for both endpoints. When algae were exposed to Cu and TiO2 the compounds acted independently of each other, having an additive effect on population. The TiO2 acted as a protective barrier against phenol toxicity at low phenol concentrations. At high phenol concentrations the toxicity of both phenol and TiO2 increased. Both compounds acted to disrupt the cell wall stability as seen with microscopy imaging. This was presumed to be through destruction of the Ca-pectinate within the cell wall, as indicated by increased soluble Ca correlated with phenol concentrations. The effect of TiO2 on cell barriers and natural algal assemblage was investigated. SEM images reveal that algae exposed to TiO2 have DNA external to the cell. Under hypotonic stress the loss of electrolytes was less controlled when the total number of nanoparticles was 1010 in the sample, at d1 less than 46 nm. At d1 greater than 46 nm no effect on electrolyte regulation was noted. Natural algal assemblages exposed to TiO2 varied there fatty acid (FA) content. This could be due to selective growth resistant reactive oxygen species (ROS) organisms or the percentages of certain FAs were decreased because of sensitivity to ROS. (Abstract

  16. Vaginal distribution and retention of a multiparticulate drug delivery system, assessed by gamma scintigraphy and magnetic resonance imaging.

    Science.gov (United States)

    Mehta, Samata; Verstraelen, Hans; Peremans, Kathelijne; Villeirs, Geert; Vermeire, Simon; De Vos, Filip; Mehuys, Els; Remon, Jean Paul; Vervaet, Chris

    2012-04-15

    For any new vaginal dosage form, the distribution and retention in the vagina has to be assessed by in vivo evaluation. We evaluated the vaginal distribution and retention of starch-based pellets in sheep as live animal model by gamma scintigraphy (using Indium-111 DTPA as radiolabel) and in women via magnetic resonance imaging (MRI, using a gadolinium chelate as contrast agent). A conventional cream formulation was used as reference in both studies. Cream and pellets were administered to sheep (n=6) in a two period-two treatment study and to healthy female volunteers (n=6) via a randomized crossover trial. Pellets (filled into hard gelatin capsule) and cetomacrogol cream, both labeled with Indium-111 DTPA (for gamma scintigraphy) or with gadolinium chelate (for MRI) were evaluated for their intravaginal distribution and retention over a 24h period. Spreading in the vagina was assessed based on the part of the vagina covered with formulation (expressed in relation to the total vaginal length). Vaginal retention of the formulation was quantified based on the radioactivity remaining in the vaginal area (sheep study), or qualitatively evaluated (women study). Both trials indicated a rapid distribution of the cream within the vagina as complete coverage of the vaginal mucosa was seen 1h after dose administration. Clearance of the cream was rapid: about 10% activity remained in the vaginal area of the sheep 12h post-administration, while after 8h only a thin layer of cream was detected on the vaginal mucosa of women. After disintegration of the hard gelatin capsule, the pellet formulation gradually distributed over the entire vaginal mucosa. Residence time of the pellets in the vagina was longer compared to the semi-solid formulation: after 24h 23 ± 7% radioactivity was detected in the vaginal area of the sheep, while in women the pellet formulation was still detected throughout the vagina. A multi-particulate system containing starch-based pellets was identified as a