The aim of present research work was at formulation, evaluation and taste masking ofmouth dissolving filmof Phenylephrine Hydrochloride to provide rapid onset of action with improved patientcompliance. Phenylephrine Hydrochloride is a NasalDecongestants and Vasoconstrictor drug. Solventcasting method was adopted for preparation of mouth dissolving film using HPMCE5 LV aspolymer, PEG 400 as a plasticizer, Aspartame as sweetener, Menthol as Flavour, Ethanol (95%) as a solvent and distilled water as a vehicle. Bitter taste of drug was evaluated by electronic tongue. A 32 full factorial design wasapplied systematically to optimize mouth dissolving film. The concentration of HPMCE5 LV (X1)andconcentration of PEG 400 (X2) were selected as independent variables. The effects of these factors were observed on dependent variables % drug release (Y1) and tensile strength (Y2). Theprepared films were evaluated for weight variation, Thickness, Folding endurance,Tensile Strength, Disintegration time, and% Drug release. FT-IR and DSC studies proved no chemical interaction betweendrug and Excipients. The prepared Phenylephrine Hydrochloridemouth dissolving films werefound to be of good quality fulfilling all the requirements for films. The resultsrevealed that concentration of polymer HPMCE5 LV and concentration of plasticizer PEG 400significantly affected % drug release and tensile strength. Dependentvariableswere increased with increase in the amount of HPMCE5 LV(X1) andconcentration of PEG 400 (X2). Regression analysis and numerical optimization wereperformed to identify the best formulation. The optimized formulation F10 preparedwith HPMCE5 LV 484.59 mg and PEG-400 18.62% (% of polymer) was found to be the bestformulation with 94.98% drug release and 1.66 N/cm2tensile strength. Acceleratedstability studies on the promising formulations indicatedthat there were no significant changes in evaluation parameters. Thus, the mouth dissolving film of Phenylephrine Hydrochloride was successfully formulated by solvent casting technique with immediate onset ofaction & improved patient compliance.
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