Abstract

FORMULATION, EVALUATION AND TASTE MASKING OF FAST DISSOLVING FILM OF THE TAPENTADOL

M. Rahil G.Bhura, Ranveersinh Raolji* and Dr. Sameer K. Shah

ABSTRACT

The present aimed at formulation, evaluation and taste masking of fast dissolving film of Tapentadol to provide quick action and improved patient compliance. Tapentadol is an opioid analgesic drug. Solvent casting method use for preparation of fast dissolving film using HPMCE5 LV as polymer, PEG 400 as a plasticizer, Aspartame as sweetener, Menthol as Flavor, Ethanol (95%) as a solvent and distilled water as a vehicle. Bitter taste evaluated by E-Tongue. A 32 full factorial design applied for optimize Fast dissolving film. The concentration of HPMCE5LV(X1) and concentration of PEG400(X2) were selected as independent variables. The effects of factors were observed on dependent variables % drug release (Y1) and tensile strength (Y2). The prepared films evaluated for various Parmeters. The prepared Tapentadol fast dissolving films were found good quality. The results revealed that concentration of polymer HPMCE5LV and concentration of plasticizer PEG400 affected % drug release and tensile strength. Regression analysis and numerical optimization were performed to identify the best formulation. The optimized batch prepared with HPMCE5 LV 484.59 mg and PEG-400 18.62% was found to be the best formulation.stability studies indicated that there were no changes in evaluation parameters.

Keywords: E-Tongue, Fast dissolving film, Solvent casting, Tapentadol.