Pharmaceutical quality of dispersible diclofenac tablets in the Saudi market

Abstract

The fundamental objective in developing any drug delivery approach is to achieve effective and safe therapy. Medications classified as generics are those that contain the same active ingredients and have the same quality as the reference medications. Several generic drugs are available on the market, all at a reasonable cost. In this study, the quality of Three generic brands of diclofenac dispersible tablets available in the Saudi market was assessed, namely: G1 and G2, and G3.

Except for the borderline performance of one generic formulation (G3), all formulations passed in vitro quality tests according to the United States Pharmacopoeia. According to the US Pharmacopoeia, every generic formulation passed in vitro quality tests, except for one generic formulation (G3) that performed inconclusively. All brands showed low weight variation, minimum weight loss in the friability test, and a rapid dispersion time of around 5 s. The chemical potency results demonstrated that all three brands complied with United States Pharmacopeia (USP) specifications, typically falling between 90% and 110% of the labeled amount. G1 and G2 passed the content uniformity test in their first attempt. G3 initially failed the content uniformity test but passed upon retesting with additional samples. G1 and G2 tablets passed the USP Acceptance criteria in stage one, and G3 tablets met the requirements in stage two. G1 showed the highest DE (%78.83), followed by G2 (%72.23), and G3 (%67.50). The G1 dissolution data, which showed the highest dissolution efficiency, were used as the reference product to calculate the similarity factor (f2 (ratio. G1 (Reference) and G2 with an f2 of (58.3) have similar dissolution profiles, however, the dissolution profiles for the two products may be considered similar without f2 calculation since more than 85% of the drug was dissolved within 15 min (SFDA Guidelines for Bioequivalence, Similarity while G3, with an f2 of (47.5) suggest a lack of similarity between the two dissolution profiles. This study highlights the importance of post-marketing evaluations of generic drug performance.