Preparation and in vivo evaluation of oral films containing benazepril

Abstract

Mouth dissolving film (MDF) is a better alternate to oral disintegrating tablets due to its novelty, ease of use, and the consequent  patient  compliance.  The  present  investigation highlights  the  formulation  and  evaluation  of  mouth dissolving films of Benazepril. It was prepared by solvent casting method using HPMC and maltodextrin as film forming polymer. The prepared films were subjected for in vitro evaluation tests like thickness, folding endurance, surface pH, morphological properties, moisture content, %Drug content and content uniformity, tensile strength, percent elongation, In  vitro  disintegration time,  in  vitro  dissolution studies and  stability studies. The  in  vitro disintegration time and dissolution time of the optimized formulation (F15) was found to be 9 seconds and 99.45 % within 7 min respectively. FTIR studies showed no drug polymer interaction takes place. From in vivo bioavailability studies, Cmax of the optimized formulation F15 was 105±0.4ng /ml, was significantly higher as compared to pure drug suspension, i.e., 82±0.1ng/ml. Tmax of optimized formulation was decreased significantly when compared with pure drug (1.00±0.2hr, 2.00±0.3hr), AUC0-∞  and AUC0-t  for optimized solid dispersion formulation was significantly higher (p<0.05) as compared to marketed product. These results revealed that fast dissolving films of Benazepril could be formulated for quick onset of action which is required in the efficient management of hypertension.