Background: Vulvovaginal candidiasis is a communal problem in virtually all the women which is caused by Candida albicans. Objective: Aim of the present study was to prepare and characterize vaginal suppositories of fluconazole for the treatment of vulvovaginal candidiasis. Methods: Fluconazole suppositories were prepared using water soluble and fatty bases. Bases and their proportions used were selected in such a way that they have flexibility in storage conditions unlike conventional suppositories. Suppositories were prepared and examined for physical characteristics and in vitro release studies. Results: Present study showed ultimate results with respect to the physical characteristics of suppositories and in vitro drug release studies. In vitro drug release from the prepared suppositories was in the following order FVS 3 (100.00 ± 3.7% in 1.0 h) > FVS 1 (86.29 ± 4.9% in 12.0 h) > FVS 2 (80.47 ± 2.4% in 12.0 h) > FVS 5 (22.51 ± 0.42% in 24.0 h) > FVS 4 (18.09 ± 1.31% in 24.0 h). These drug release results are supported by the disintegration time of suppositories. Lesser the disintegration time faster the drug release. Conclusion: Study concludes that it may be fruitful to explore the in vivo activities of suppositories prepared with the combination of agar and HPMC as it showed around 80% drug release over 12.0 h. Represented combination may also be more effective for the treatment of vulvovaginal candidiasis.
The aim of this study was to prepare mini tablets to be filled into a capsule that is designed to float on the gastric contents based on gas formation technique. The drug-containing core mini-tablets were prepared by wet granulation method followed by a coating of the core units with seal coating, an effervescent layer and a gas-entrapping polymeric membrane (Eudragit RS30D, RL30D). Dipyridamole, which is predominantly absorbed in the upper part of GI tract and unabsorbed/insoluble at the lower intestine, was used as a model drug. The effect of the preparative parameters like amount of the effervescent agent layered onto the seal coated units, type and coating level of the gas-entrapping polymeric membrane, floating ability and drug release properties of the multiple-unit FDDS were evaluated. The formulations were evaluated for pharmacopoeial quality control tests. Physical parameters were found to be within the acceptable limits. The system using Eudragit® RL30D as a gas-entrapping polymeric membrane exhibited floating properties. The time to float decreased as amount of the effervescent agent increased and coating level of gas-entrapping polymeric membrane decreased. The optimum system exhibited complete floating within 3 minutes and maintained that buoyancy over a period of 8 hours. The drug release was sustained and linear with the square root of time. Increasing the coating level of the gas-entrapping polymeric membrane decreased drug release. Both the rapid-floating and sustained-release properties were achieved in the multiple-unit floating delivery system developed in this study. The in vivo gastric residence time was examined by radiograms and it was found that the units remained in the stomach for about 6 hours. The analysis of the dissolution data after storage at 40°C and 75% RH for 6 months showed no significant change indicating good stability.
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