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QUALITY ASSESSMENT OF BETAMETHASONE TOPICAL PRODUCTS: PERMEATION STUDIES ACROSS STRAT-M® MEMBRANE IN FOCUS

MOHAMMED ALTHUWAINI, ABDUL AHAD, FAHAD I. AL-JENOOBI *

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The present study was designed to evaluate the topical products of betamethasone valerate (BMV) available in the Saudi Arabian market. BMV creams and ointments were evaluated for pH, homogeneity, spreadability, in vitro permeation, drug content, and stability studies. In comparison to reference products, test formulations, creams, and ointments have slightly different spreadability. All the products displayed pH and drug content in an acceptable range. In vitro penetration studies demonstrated that the test cream (BMVC-2) presented the lowest permeation across the Strat-M® membrane. The drug penetration profiles of test ointment products (BMVO-1 and BMVO-2) conformity with the reference ointment. No significant changes in colour, odour, pH, homogeneity, or spreadability were observed during stability testing. In conclusion, all studied test products exhibited similar pH, homogeneity, drug content, and penetration profiles (except BMVC-2), which are comparable to those of the reference products. In light of these results, it is proven that this type of in vitro study may contribute to quality control, post-approval evaluation, and advancing topical products as a whole.