Studying Formulation and Physicochemical Characterization of Buccal Mucoadhesive Films Containing Alfuzosin Hydrochloride

Purpose: The physiology of mouth enabled so many drugs to delivery through oral route. Oral mucosal drug delivery is another option and promising technique for drug delivery which offers a number of advantages The purpose of this study was to prevent first pass metabolism and increase bioavailability of a drug molecule alfuzosin hydrochloride by embedding in a sustained release buccal film over a period of 8 hours.

Materials and Methods: In the present study sustained release formulation of buccoadhesive films of alfuzosin hydrochloride were developed using polymers HPMC, K100M, sodium alginate, chitosan and the prepared buccoadhesive films were systematically evaluated for in vitro performances. The films were provided with a backing layer of Eudragit RS100 so as to get an unidirectional release pattern. The films were evaluated for their physical characteristics like weight, thickness, content uniformity, folding endurance, bioadhesive strength, surface pH, in vitro drug release, ex vivo buccal permeation studies.

Results: The films, prepared by the solvent casting method, were smooth and elegant in appearance; uniform in thickness, weight, and drug content; and showed good folding endurance. The mechanical properties reveal that the formulations were found to be strong but not brittle. The in vitro release data were fit to different equations and kinetic models viz. zero order, first order, higuchi’s plot and peppas plot. The best mucoadhesive performance and matrix controlled release was exhibited by the formulation A7 (2% HPMC K100 M and 2% chitosan). The correlation coefficient value (r) indicates, the kinetic of drug release was zero order. Stability study of optimized films was done and it was found that both drug and buccal films were stable.

Conclusion: It can be concluded that the present buccal formulation can be an ideal system to improve the bioavailability of the drug by avoiding hepatic first-pass metabolism. The optimized buccoadhesive films of alfuzosin hydrochloride with the combination of HPMC and chitosan can meet the ideal requirements for oral buccoadhesive film and a therapeutically effective amount of alfuzosin hydrochloride can be delivered via sustained release manner.