Central Composite Design for the Development of Trimetazidine Dihydrochloride-Loaded Fast Dissolving Film

Year 2023, Volume: 48 Issue: 1, 61 - 74, 01.03.2023

Swapnil Chopade , Santosh A. Payghan

https://doi.org/10.55262/fabadeczacilik.1085351

Cited By: 1

Abstract

A fast-dissolving dosage form is an approach used to improve therapeutic efficacy and bioavailability by avoiding the first-pass metabolism of the cargo. Besides, the approach causes rapid cargo absorption from the pre-gastric area which may outcome in the quick inception of action. The trimetazidine dihydrochloride (TDC) is an anti-anginal drug and there is a prerequisite to provide fast onset of action to treat angina. Therefore, the present work was aimed to prepare and evaluate fast-dissolving oral films (FDOF) of TDC to provide fast onset of action. The FDOF is prepared by using the solvent casting method and it was optimized by employing a central composite statistical design. The two independent variables such as HPMC K4M and PEG 400 are the film-forming polymers which are evaluated at three levels. The dependent variables selected as folding endurance, disintegration time, and % drug release. The formulation was prepared and optimized the batch F-4 showed the least disintegration time (19 s) and the highest drug release (98.55±7.90%). Moreover, the ex-vivo mucus permeation study showed better permeation and satisfying physicochemical properties. As per the above results, we conclude that the prepared formulation could be a novel dosage form to improve drug delivery and patient compliance.

Keywords

Anti-anginal, CCD, Ex-vivo permeation, fast dissolving oral film, Solvent casting method, Trimetazidine dihydrochloride.

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