A multiunit floating drug delivery system of rosiglitazone maleate has been developed by encapsul... more A multiunit floating drug delivery system of rosiglitazone maleate has been developed by encapsulating the drug into Eudragit® RS100 through nonaqueous emulsification/solvent evaporation method. The in vitro performances of microspheres were evaluated by yield (%), particle size analysis, drug entrapment efficiency, in vitro floating behavior, surface topography, drug–polymer compatibility, crystallinity of the drug in the microspheres, and drug release studies. In vitro release was optimized by a {3, 3} simplex lattice mixture design to achieve predetermined target release. The in vivo performance of the optimized formulation was evaluated in streptozotocin-induced diabetic rats. The results showed that floating microspheres could be successfully prepared with good yields (69–75%), high entrapment (78-97%), narrow size distribution, and desired target release with the help of statistical design of experiments from very small number of formulations. In vivo evaluation in albino rats suggested that floating microspheres of rosiglitazone could be a promising approach for better glycemic control.
Yakugaku Zasshi-journal of The Pharmaceutical Society of Japan, 2008
This study investigates the effect of some formulation variables on particulate characteristics o... more This study investigates the effect of some formulation variables on particulate characteristics of poly (DL-lactide-co-glycolide) (PLGA) copolymer nanoparticles by applying 2(3) factorial design and response surface methodology (RSM). Nanoparticles were prepared by solvent displacement technique. Initially, appropriate formulation factors for elaboration of polymeric particles were selected by screening. A 2(3) full factorial design was employed to evaluate the influence of three formulation variables, polymer concentration (X(1)), dispersant concentration (X(2)) and phase volume ratio (X(3)) on the percentage of total particles at submicron range (Y(1)), mean diameter (Y(2)) and specific surface area (Y(3)) as particle characteristics. The results showed that all the three variables had significant influence on mean diameter of particles and amount of particles at submicron range. Simultaneous change of polymer concentration and dispersant concentration had significant effect on specific surface area of particles. Span value as an index of polydispersity indicated uniformity in particle size distribution.
Letrozole (LTZ) incorporated PLGA nanoparticles were prepared by solvent displacement technique a... more Letrozole (LTZ) incorporated PLGA nanoparticles were prepared by solvent displacement technique and characterized by transmission electron microscopy, poly-dispersity index and zeta potential measurement. Radiolabeling of free LTZ and LTZ-loaded PLGA NPs was performed with technetium-99m with high labeling efficiency. The labeled complex showed good in vitro stability as verified by DTPA challenge test. The labeled complexes also showed significant in vivo stability when incubated in rat serum for 24 h. Biodistribution studies of (99m)Tc-labeled complexes were performed after intravenous administration in normal mice and Ehrlich Ascites tumor bearing mice. Compared to free LTZ, LTZ-loaded PLGA NPs exhibited significantly lower uptake by the organs of RES. The tumor concentration of LTZ-loaded PLGA NPs was 4.65 times higher than that of free LTZ at 4 h post-injection. This study indicates the capability of PLGA nanopartcles in enhancing the tumor uptake of letrozole.
Journal of Liquid Chromatography & Related Technologies, 2008
... RSC Journals. Drug dissolution studies and determination of rosiglitazone maleate in tablets ... more ... RSC Journals. Drug dissolution studies and determination of rosiglitazone maleate in tablets and polymeric microspheres by a rapid, validated RP-HPLC method. MM Kamila, N. Mondal, L. Ghosh and BK Gupta J. Liq. Chromatogr. Relat. ...
Simple, sensitive and accurate UV-spectrophotometric methods have been developed for the determin... more Simple, sensitive and accurate UV-spectrophotometric methods have been developed for the determination of an anti-HIV drug, Tenofovir Disoproxil fumarate (TDF), in raw material and in tablets. The drug shows maximum absorbance at 259 nm in selected four different media namely gastric fluid simulated (HCl) pH 1.5, vaginal fluid simulated (VFS) pH 4.2, phosphate buffer (PB) pH 6.8 and double distilled water. Beer's law is obeyed in the concentration range of 5-45 µg/mL of drug. The limits of detection and limits of quantification are found to be 1.37 and 4.17 µg/ml in gastric fluid simulated, 1.27 and 3.85 µg/ml in vaginal fluid simulated, 1.22 and 3.71 µg/ml in phosphate buffer and 1.30 and 3.95 in double distilled water respectively. The methods have been successfully applied for the determination of TDF in tablets and bulk drugs. Results are validated statistically as per ICH guidelines. It is found that the excipients present in the commercial formulation do not interfere with the methods and hence the UV-method permits a rapid and economical quantification of drug in bulk and in tablet dosage form.
A multiunit floating drug delivery system of rosiglitazone maleate has been developed by encapsul... more A multiunit floating drug delivery system of rosiglitazone maleate has been developed by encapsulating the drug into Eudragit® RS100 through nonaqueous emulsification/solvent evaporation method. The in vitro performances of microspheres were evaluated by yield (%), particle size analysis, drug entrapment efficiency, in vitro floating behavior, surface topography, drug–polymer compatibility, crystallinity of the drug in the microspheres, and drug release studies. In vitro release was optimized by a {3, 3} simplex lattice mixture design to achieve predetermined target release. The in vivo performance of the optimized formulation was evaluated in streptozotocin-induced diabetic rats. The results showed that floating microspheres could be successfully prepared with good yields (69–75%), high entrapment (78-97%), narrow size distribution, and desired target release with the help of statistical design of experiments from very small number of formulations. In vivo evaluation in albino rats suggested that floating microspheres of rosiglitazone could be a promising approach for better glycemic control.
Yakugaku Zasshi-journal of The Pharmaceutical Society of Japan, 2008
This study investigates the effect of some formulation variables on particulate characteristics o... more This study investigates the effect of some formulation variables on particulate characteristics of poly (DL-lactide-co-glycolide) (PLGA) copolymer nanoparticles by applying 2(3) factorial design and response surface methodology (RSM). Nanoparticles were prepared by solvent displacement technique. Initially, appropriate formulation factors for elaboration of polymeric particles were selected by screening. A 2(3) full factorial design was employed to evaluate the influence of three formulation variables, polymer concentration (X(1)), dispersant concentration (X(2)) and phase volume ratio (X(3)) on the percentage of total particles at submicron range (Y(1)), mean diameter (Y(2)) and specific surface area (Y(3)) as particle characteristics. The results showed that all the three variables had significant influence on mean diameter of particles and amount of particles at submicron range. Simultaneous change of polymer concentration and dispersant concentration had significant effect on specific surface area of particles. Span value as an index of polydispersity indicated uniformity in particle size distribution.
Letrozole (LTZ) incorporated PLGA nanoparticles were prepared by solvent displacement technique a... more Letrozole (LTZ) incorporated PLGA nanoparticles were prepared by solvent displacement technique and characterized by transmission electron microscopy, poly-dispersity index and zeta potential measurement. Radiolabeling of free LTZ and LTZ-loaded PLGA NPs was performed with technetium-99m with high labeling efficiency. The labeled complex showed good in vitro stability as verified by DTPA challenge test. The labeled complexes also showed significant in vivo stability when incubated in rat serum for 24 h. Biodistribution studies of (99m)Tc-labeled complexes were performed after intravenous administration in normal mice and Ehrlich Ascites tumor bearing mice. Compared to free LTZ, LTZ-loaded PLGA NPs exhibited significantly lower uptake by the organs of RES. The tumor concentration of LTZ-loaded PLGA NPs was 4.65 times higher than that of free LTZ at 4 h post-injection. This study indicates the capability of PLGA nanopartcles in enhancing the tumor uptake of letrozole.
Journal of Liquid Chromatography & Related Technologies, 2008
... RSC Journals. Drug dissolution studies and determination of rosiglitazone maleate in tablets ... more ... RSC Journals. Drug dissolution studies and determination of rosiglitazone maleate in tablets and polymeric microspheres by a rapid, validated RP-HPLC method. MM Kamila, N. Mondal, L. Ghosh and BK Gupta J. Liq. Chromatogr. Relat. ...
Simple, sensitive and accurate UV-spectrophotometric methods have been developed for the determin... more Simple, sensitive and accurate UV-spectrophotometric methods have been developed for the determination of an anti-HIV drug, Tenofovir Disoproxil fumarate (TDF), in raw material and in tablets. The drug shows maximum absorbance at 259 nm in selected four different media namely gastric fluid simulated (HCl) pH 1.5, vaginal fluid simulated (VFS) pH 4.2, phosphate buffer (PB) pH 6.8 and double distilled water. Beer's law is obeyed in the concentration range of 5-45 µg/mL of drug. The limits of detection and limits of quantification are found to be 1.37 and 4.17 µg/ml in gastric fluid simulated, 1.27 and 3.85 µg/ml in vaginal fluid simulated, 1.22 and 3.71 µg/ml in phosphate buffer and 1.30 and 3.95 in double distilled water respectively. The methods have been successfully applied for the determination of TDF in tablets and bulk drugs. Results are validated statistically as per ICH guidelines. It is found that the excipients present in the commercial formulation do not interfere with the methods and hence the UV-method permits a rapid and economical quantification of drug in bulk and in tablet dosage form.
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