FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF SUBLINGUAL FILM OF ISOSORBIDE DINITRATE

Abstract

Objective: To formulate and evaluated sublingual film containing an antianginal drug. Experimental work: Sublingual film of Isosorbide dinitrate was formulated using film coating polymer pullulan and inert plasticizer PEG-400 by solving casting method. 3 2 full factorial design was applied to optimize the formulation. The lower concentration of film forming polymer and higher concentration of plasticizer showing best results were selected as independent variables. Disintegration time (Y1) and % drug release at 1 minute (Y2) and folding endurance (Y3) were selected as dependent variables. The prepared films were evaluated for, disintegration time in vitro drug release, folding endurance and mechanical strength and further optimized batch compared with marketed sublingual tablet. Results: Isosorbide dinitrate sublingual film prepared was found to be fulfilling all the film dosage form. The film compared to sublingual tablet concentration of pullulan (X1) and PEG-400 (X2) significantly affected the disintegration time (Y1) and % of drug release at 1 minute(Y2) and folding endurance (Y3). Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F10 prepared with 223 mg, pullulan 19.5%, PEGWorld Journal of Pharmaceutical Research SJIF Impact Factor 7.523 Volume 6, Issue 11, 493-507. Research Article ISSN 2277– 7105 *Corresponding Author Hardik R. Joshi Master of Pharmacy, LM