Abstract

DESIGN AND IN-VITRO EVALUATION OF MOUTH DISSOLVING FILM CONTAINING AMLODIPNE BESYLATE

Ganesh.R.Kulkarni*, Dr.Moreshwar.P.Patil

ABSTRACT

The main approach for the formulation of Mouth dissolving films (MDF) of Amlodipine besylate is to enhance the convenience and compliance of elderly and paediatric patients for better therapeutic efficacy. Mouth dissolving film of Amlodipine besylate was formulated by solvent casting method using HPMC E15 as film forming polymer. Propylene glycol was used as plasticizer along with Sodium starch glycolate, Mannitol as superdisintegrant and sweetening agent respectively. Purified water and methanol was taken as solvent. The prepared MDFs batches were evaluated for in vitro dissolution characteristics, in vitro disintegration time and their physicomechanical properties. The compatibility between amlodipine besylate and excipients was confirmed by IR study. All the prepared MDFs showed good mechanical properties like visual appearance, tensile strength, folding endurance, disintegration time, thickness of film, weight of film, and pH of film. Formulation F6 containing 150 mg of HPMC E 15 and 0.2 ml of propylene glycol (PG) showed the highest cumulative % drug release of 94.22% at the end of 10 minutes along with other superior film characteristics.

Keywords: Mouth dissolving film, HPMC E15, Solvent casting, Amlodipine besylate.