Design, Optimization and In Vivo Evaluation of Granisetron HCl Mouth Dissolving Films

摘要

ABSTRACT Present work aimed at preparing quick onset of action of Granisetron HCl which is beneficial in emesis, aiding in the enhancement of bioavailability and is very convenient for administration without the problem of swallowing and using water. The films were prepared by using different grades of HPMC E3, E6 and E15, maltodextrin DE6 and other polymers by solvent casting method. They were evaluated for physical characteristics such as thickness, uniformity of weight, folding endurance, drug content, surface pH, percentage elongation and tensile strength and results were found to be satisfactory. The formulations were subjected to disintegration and in-vitro drug release test. The in vitro disintegration time of the optimized formulation F9 was 9 sec and drug release was found to be very fast i.e. 97.8% of within 8 min when compared with innovator product i.e 70.8%. In vivo studies confirmed that their potential as an innovative dosage form to improve the bioavailability and considered to be potentially useful for the treatment of emesis where quick onset of action is desirable. DSC and FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. From the above results, it can be a good alternative to conventional Granisetron Hydrochloride tablets in the treatment of emesis. In vitro and in vivo evaluation of the films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of Granisetron Hydrochloride. Keywords: Granisetron Hydrochloride, fast dissolving oral films, emesis, HPMC, bioavailability studies.