Development and Optimization of Mouth Dissolving Film of Granisetron using 32 Factorial Design and Response Surface Methodology

Abstract

Granisetron is a highly selective serotonin (5-HT3) receptor blocker which prevents the vomiting reflex induced by serotonin during cancer chemotherapy. The objective of present research work was development and optimization of mouth dissolving film of granisetron hydrochloride. Solvent casting method was used for preparation of mouth dissolving film. Various film forming polymers like PVP K-30, PVA, maltodextrin, HPMC E5 LV and lycoat RS 720 along with and plasticizer like Propylene glycol, Poly ethylene glycol 400 and glycerin were used for selection of suitable polymer plasticizer combination. Film prepared using lycoat RS 720 and PEG-400 was found satisfactory and further factorial design and desirability function was used for optimization. Regression equation and counter plots were executed to dependent variables i.e., tensile strength, % elongation, elastic modulus and % drug release in 1 minutes to independent variables. Results of experimental design revealed that the independent factors lycoat RS 720 and PEG-400 significantly influenced the mechanical properties and % drug release from the film which was ultimately reflected in this formulation of optimized batch. All experimental design formulations were evaluated for weight variation, thickness, drug content, % moisture loss, pH, folding endurance and stability study at 40˚ ± 2˚ C/75 ± 5% RH. From the result of optimized batch it can be concluded that an optimized formulation was stable with suitable packaging and the high % drug release of film in simulated saliva indicate that it can be used for drug delivery system of granisetron hydrochloride having first pass metabolism