Design and Evaluation of Sustained Release of Ornidazole by Dental Inserts

Abstract

Aim & Background: Ornidazole an antimicrobial drug used to treat certain types of vaginal, urinary tract, and interstitial infections. The objective of this study is to formulate and evaluate the dental inserts by using drug candidate to sustained release of drug to improve patient compliance, reduce dosing frequency, better therapeutic efficacy and fewer side effects, reduce the risk of dose dumping as well as also to avoid the first-pass metabolism. Materials & Method: The dental inserts were prepared using various polymers and in combination with the different ratios of polymers. The evaluation parameters like thickness, drug content, content uniformity, moisture reuptake, weight variation, swelling studies, and erosion studies of the optimized inserts were studied. The in-vivo studies were conducted for determining the reduction of pocket depth in human volunteers. Results: The system containing ethylcellulose and hydroxyl methyl propyl cellulose K100M (4:1) formulation F6 was optimized because drug release was sustained up to 120 hrs with respect to other formulations. Optimized formulation follows first-order kinetics and Peppas release kinetics via fickian diffusion. There was no swelling, itching, irritation and the reduction of pocket depth was absorbed in in-vivo studies. Conclusion: The study concluded that dental inserts can extend the release of Ornidazole for many hours also enhanced bioavailability, further it also helps in avoiding the first-pass effect. The observations of in vivo studies were, there was no itching, irritation, swelling, and reduction in pocket depth was observed.