ABSTRACT:
Background and objectives: Tenofovir disoproxil fumarate is a anti-retroviral agent. It is used in the treatment of HIV-1 infection in adults and pediatric patients of 2 years of age and older. It is also indicated for the treatment of chronic hepatitis-B in adults and pediatric patients 12 years of age and older. The present work is designed to prepare and evaluate mucoadhesive buccal film of Tenofovir disoproxil fumarate as a novel form of fast releasing dosage form. The objective of this study was to develop oral drug delivery system in the form of fast dissolving film which overcomes first pass metabolism and the drug achieve to specific site, for greater therapeutic action. Methods: Buccal films of Tenofovir disoproxil fumarate were prepared by solvent casting method. The prepared films were evaluated for the various evaluation parameters like thickness, surface pH, weight uniformity, content uniformity, folding endurance, swelling index, in vitro drug release study. Results: All the formulations exhibited good results for physicochemical characterizations. In in vitro drug release study, the films exhibited fast release within 5 hours. The formulation F1 (containing HPMC3cps and croscarmellose) showed no irritant effect on buccal mucosa. It was revealed that Superdisintegrants composition had significant influence on drug release. Thus, conclusion can be made that stable dosage form can be developed for Tenofovir disoproxil fumarate for fast release by buccal patches.