Abstract

FORMULATION AND IN VITRO EVALUATION OF MOUTH DISSOLVING FILMS OF AMLODIPINE BESYLATE"

Sanjay Singh*

ABSTRACT

Mouth dissolving films, a novel drug delivery system, especially designed for pediatric and geriatric patient population where the difficulty of swallowing larger oral dosage forms is eliminated. This study was carried out to formulate mouth dissolving films of Amlodipine Besylate by solvent casting method using HPMC (15cps) as hydrophilic film polymer, PG as plasticizer and SSG as super disintegrant along with other excipients. The films were prepared in such a way that each 2×2 cm2 of the film contains 5 mg of Amlodipine Besylate drug. The preliminary 15 batches were carried out to find out the effect of HPMC, SSG and PG on the films and to determine their optimum concentration ranges. Then, the final 15 optimized batches were carried out by hit and trial which revealed the effect of the concentration of polymer (HPMC, SSG, PEG) on response variable i.e. disintegration time and drug release. The films were evaluated for weight variation, thickness, surface pH, assay %, in vitro disintegration time and % drug released. The formulation F10 was found to be the optimum one considering the percentage drug release of 100.67% at the end of 10 minutes with HPMC concentration of 30% and SSG concentration of 6%. Further, the overall result suggested that the intermediate concentration of HPMC and of SSG and PEG favours less disintegration time and higher % of drug release. Thus, it can be concluded that mouth dissolving films of Amlodipine Besylate can be prepared by solvent casting method and can be used effectively for the quick drop of blood pressure due to enhanced bioavailability.

Keywords: Amlodipine Besylate, mouth dissolving films, HPMC, SSG, PEG, Solvent casting method.