Abstract

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

Hardik R. Joshi*, Yamini D. Shah, Susmita Rajbongshi and Ahsan Ullah Sajib

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. 32full 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 400 give best results with respect to in vitro disintegration time, Folding endurance and % Drug Release in 1minute which was found 6.50 sec, 138 and 94.58% respectively. Conclusion: It is concluded that sublingual film of Isosorbide dinitrate were successfully formulated by Solvent casting technique. The films contained Pullulan (223mg), PEG-400(19.5%) showed satisfactory results with respect to dissolution data, disintegration time and folding time.

Keywords: Isosorbide dinitrate, sublingual film, antianginal drug.