In Vitro Comparative Quality Evaluation of Locally Manufactured and Imported Diclofenac Dispersible Tablets in Sana’a, Yemen
Background: Ensuring the therapeutic equivalence of medications is essential for public health, particularly in markets with diverse drug origins. In Yemen, Diclofenac dispersible tablets are a mainstay for pain management, yet comparative data between locally manufactured and imported brands remains limited.
Objective: This study aimed to evaluate the compliance of locally manufactured and imported Diclofenac dispersible tablets in the Yemeni market with USP physicochemical quality specifications and to determine the statistical significance of any quality deviations between them.
Methods: Four brands of Diclofenac dispersible tablets, two locally manufactured (D1, D3) and two imported (D2, D4), were subjected to standardized USP testing. Evaluations included weight variation, hardness, thickness, friability, dispersion, assay, content uniformity, and dissolution. Statistical analysis was performed using SPSS software (version 27).
Results: All sampled brands demonstrated 100% compliance with USP all physicochemical quality specifications except for hardness. A systemic deviation was observed in tablet hardness, with all brands. Findings revealed no significant difference (p > 0.05) between locally manufactured and imported brands in all tests except for assay. A significant difference was noted in the assay (p = 0.012), with imported brands showing slightly higher mean potency (106.44%) compared to local brands (99.04%), though both remained within the legal 90–110% window.
Conclusion: Locally manufactured Diclofenac dispersible tablets in Sana’a are pharmaceutically equivalent to their imported counterparts. The findings suggest that domestic manufacturers adhere to high-quality standards.
Keywords: Diclofenac, Dispersible, Quality Control, in vitro, HPLC