Comparative Quality Control and Stability Assessment of Enteric-Coated Diclofenac Sodium Tablets Marketed in Saudi Arabia | ||
| Bulletin of Pharmaceutical Sciences Assiut University | ||
| Articles in Press, Accepted Manuscript, Available Online from 27 July 2025 | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfsa.2025.394529.2597 | ||
| Authors | ||
| Samiah A Alhabardi* ; Alyah Madawi Almntshari; Gamal Mahrous; Safa Ali Alqhafi; Sarah mohammed alrajeh; Ehab Taha | ||
| Pharmaceutics Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia | ||
| Abstract | ||
| This study evaluates the quality control and stability of non-steroidal anti-inflammatory drugs (NSAIDs), specifically enteric-coated diclofenac sodium tablets available in the Saudi market. The research study aims to compare some enteric-coated diclofenac sodium generic products (Product A, Product B, Product C, Product D) with a reference brand (Voltaren) to evaluate their compliance with pharmaceutical standards. Quality control tests included hardness, friability, weight variation, disintegration, drug release, and drug content uniformity. Furthermore, accelerated stability studies were performed over six months under controlled conditions (40°C ± 2°C and 75% ± 5% relative humidity) to assess changes in physical properties. Results revealed variations in the drug release profiles. While all brands met pharmacopeial standards for initial testing of quality parameters, drug release profile after storage at accelerated stability conditions showed differences, which highlighted the impact of manufacturing techniques on the product's performance, which could be reflected in the product's therapeutic performance. This research underscores the importance of post-marketing surveillance to ensure pharmaceutical products' long-term efficacy and consistency in challenging environmental conditions in Saudi Arabia. | ||
| Keywords | ||
| Diclofenac sodium; enteric-coated tablets; drug release profile | ||
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