Design and Optimization of Mouth Dissolving Sublingual Film of Fixed Dose Combination of Losartan Potassium and Hydrochlorothiazide

Abstract

Objective: The present research aims at formulating a mouth dissolving sublingual film of fixed dose combination of Losartan Potassium and Hydrochlorothiazide that would provide faster onset of action and hence relief from the condition by lowering blood pressure and to reduce the risk of strokes and heart attacks.

Methods: Mouth dissolving films were prepared using a solvent casting technique. A 23 full-factorial design of eight formulations was set up with three independent variables: X1 - polymer 1 HPMC E15 concentration, X2 - polymer 2 HPMC E5 concentration, and X3 - plasticizer PEG 400 concentration. The responses, i.e., dependent variables measured for the study were Y1 disintegration time in seconds, Y2 tensile strength in kg/cm2, Y3 drug release in the percentage of DS, and Y4 drug release in the percentage of PH. All the formulations were evaluated for physicochemical parameters such as clarity, weight, thickness, folding endurance, surface pH, and content.

Results and Conclusion: All the film formulations were found to be transparent, non-tacky, and easily peelable having the satisfactory tensile strength and folding endurance. The concentration of polymer 1 and 2 was found to have a significant effect on disintegration time and drug release of mouth dissolving films. The best film formulation DP1 was found to have a disintegration time of 77.66s and found to release 96.22% of Losartan Potassiumand 95.43% of Hydrochlorothiazidein 21 min.