Abstract

FORMULATION AND EVALUATION OF DROTAVERINE ORALLY DISINTEGRATING TABLETS

Mahmoud Mahyoob Alburyhi*, Abdalwali Ahmed Saif, Maged Alwan Noman, Tawfeek A. A. Yahya and Mokhtar Abd-hafiz Al-Ghorafi

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Abstract

The pharmaceutical industry widely acknowledges oral drug delivery as the most preferred method for administering medications due to its numerous advantages, including safety, convenience, cost-effectiveness, and high patient compliance. The study aimed to develop Orally disintegrating tablets of Drotaverine hydrochloride, evaluate the effects of superdisintegrants on disintegration time, drug release, and overall efficacy, with the goal of enhancing bioavailability and achieving rapid onset of action. The study involved evaluating the color, odor, and taste of Drotaverine hydrochloride and the formulated tablets. The general appearance, including color, odor, and taste, of the tablets was examined. The physical properties such as diameter, hardness, thickness, and weight variation of the tablets were measured. The wetting time and disintegration time of the tablets were determined. In-vitro dissolution studies were conducted in phosphate buffer and 0.1 N HCl, and the drug release percentages were measured. The organoleptic properties of Drotaverine hydrochloride were found to be pale yellow color, no characteristic odor, and a bitter taste. Eleven formulations were prepared using (Beta-cyclodextrin, Klucel, mannitol, microcrystalline cellulose, aerosil 200, croscarmellose sodium, sodium starch glycolate, stearic acid, magnesium stearate, aspartame, sucralose, menthol and thymol). After evaluation, the results of disintegration time of F10 formulation indicated that the tablets dispersed rapidly in mouth was found to be 8 seconds, while the drug release was found to be 86.7 % within 5 minutes in 0.1 N HCl. The addition of croscarmellose sodium as a superdisintegrant in the formulation enhanced the dissolution rate of Drotaverine, leading to rapid drug release and absorption. It was concluded that F10 is the best formulation of Drotaverine hydrochloride ODTs in order to increase onset of action and bioavailability of drug. The study demonstrates the potential of superdisintegrant methods to improve the dissolution rate of Drotaverine and enhance its therapeutic effects.

Keywords: Drotaverine hydrochloride, Drug delivery system, Orally disintegrating tablets, Formulation.