Abstract

The aim of present work was to undertake comparative in vitro quality evaluation of six marketed clotrimazole cream formulations in Ethiopia with respect to physico-chemical properties like viscosity, spreadability, extrudability, pH and drug content. In vitro clotrimazole release from cream formulations was also studied using synthetic cellulose acetate membrane at 37 ºC in a solvent containing methanol and PBS 7.4 in the ratio of 75:25 as receiver medium. The cumulative amounts of the drug released over 12 h (µg mm-2) were analyzed. All clotrimazole cream formulations showed good and smooth homogeneous appearance with white color. The pH of clotrimazole cream formulations ranged from 4-7, which is a physiologically acceptable pH range and in principle devoid of any skin irritation. Clotrimazole content ranged from 90-110%, ensuring the uniformity of the drug content in all formulations. The increase in diameter of clotrimazole cream formulations following the spreadability test was found to range from 4-6 cm. Cream formulation D (Clotri-Denk) exhibited highest viscosity values than other formulations, whereas formulation E (Chinese Clotrimazole BP) showed lowest viscosity value. Cream formulation F (Mycoril) showed better extrudability and spreadability as compared to other formulations. Drug release from all formulations was slow in the first 6 hrs. After the 6th hr, steady drug release continued for formulation D and E. Fast drug release was observed in formulations A (Candid) and B (Candigen), whereas for the formulations C (Canesten), D and E, steady drug release pattern was observed after the 6th hr. It can be concluded that all clotrimazole cream formulations fulfilled the quality criteria of in-house and pharmacopeias specifications. Keywords: In Vitro Evaluation, Clotrimazole, Cream, Spreadability, Extrudability, Ethiopia

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