Formulation and Characterization of Mouth Dissolving Films of Amlodipine using Natural Polymer

Abstract

Amlodipine is a BCS class I oral hypertensive drug widely prescribed for the management of severe hypertension. The need of rapid reduction of elevated blood pressure makes designing of drug delivery systems that can release the drug in systemic circulation in very short span of time very significant. In the present study an endeavor was made to formulate mouth dissolving films (MDFs) containing amlodipine using a natural polymer, xanthan gum as the film forming polymer. Solvent casting method was utilized to formulate the MDFs. A 32 factorial approach was used for preparing the films with concentration of polymer and plasticizer as the independent variables. All the formulations demonstrated quick drug release, rapid disintegration and optimal mechanical strength. The formulations were also found to be able to release almost complete drug content within a period of 10 minutes. The maximum amount of drug was released by AF4 (97%) while AF5 released the lowest amount of drug (90%) in the same period. The results of accelerated stability study exhibited that all the batches of prepared films were stable under the storage conditions.