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.
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