FORMULATION OF TRANSDERMAL PATCH BY FACTORIAL DESIGN IN MANAGEMENT OF HYPERTENSION: IN VITRO, EX VIVO AND IN VIVO SKIN IRRITATION EVALUATION

Abstract

An attempt was made to formulate and evaluate the trandolapril transdermal drug delivery system. The matrix type films were prepared by 3² factorial design using solvent casting technique with polymers like Eudragit RL 100 and HPMC K15M. Di-butyl phthalate and DMSO were used as plasticizer and penetration enhancer. The prepared films were evaluated for physicochemical characteristics. The drug excepient Compatibility was determined by Fourier transform infrared spectroscopy and Differential scanning calorimetry. In vitro permeation studies were performed using Franz diffusion cell. Ex vivo studies were performed using skin of albino rats. The results revealed that there is no interaction between drug and selected polymers. Drug content varied from 96.43 ± 0.38 - 99.08 ± 0.8%. Moisture content and moisture uptake were increased for the patches containing higher amount of HPMC due to its hydrophilic nature. It was found that the formulation release followed first order release kinetics with non-fickian anomalous diffusion of drug release mechanism.