Formulation and Evaluation of Mouth Dissolving Films of Amlodipine Besylate by using Natural and Synthetic Polymers

Abstract

The present study was undertaken with an objective of formulating the mouth dissolving films of Amlodipine Besylate to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Various batches of Mouth dissolving Films of Amlodipine besylate were prepared by solvent casting method by using various concentration of gelatin and HPMC E5 with PEG- 400, Sodium starch glycolate, Sodium saccharine, Vanillin and Purified water and evaluated for appearance, weight variation, thickness, folding endurance, drug content, disintegration time and in-vitro drug release. The optimized formulation F4 (1:1 ratio of drug and HPMC E5) exhibited acceptable folding endurance (131±1.00), least disintegration time (26±1.00 seconds), highest drug content (100.01±0.89 %) and highest drug release (99.88±0.12%) in 10 minutes. It can be concluded from the study that the mouth dissolving films of amlodipine besylate, formulation F4 for sublingual administration can be an optimized formulation.