Introduction: Recently, there has been a significant focus on developing extended-release tablets that regulate drug release at a predetermined rate to maintain optimal therapeutic plasma concentrations. Extended-release formulations offer several clinical advantages, including reducing the frequency of drug administration, minimizing fluctuations in plasma drug concentrations, decreasing adverse effects, and improving therapeutic outcomes.
According to Mongolia’s national pharmaceutical policy, it is essential to conduct quality assurance and safety monitoring studies on imported substitute products included in the national essential medicines list. The policy also mandates the quality control of pharmaceuticals in internationally accredited laboratories compliant with MNS ISO/ IEC 17025:2018 standards. Methods: The quality control parameters of Diclofenac Sodium Retard 100 mg tablets from three different manufacturers were evaluated by the methodologies outlined in the United States Pharmacopeia USP32 and USP44. The study assessed physical appearance, average weight, weight variation, friability, dissolution, and quantitative drug content determination. Results: The average weight and weight variation of Diclofenac Sodium Retard 100 mg tablets from three different manufacturers were as follows: Tablet A: (+3.60%, -2.84%), Tablet B: (+1.53%,-1.86%), Tablet C: (+2.53%,-1.96%). The friability and mechanical strength tests determined that all three tablets exhibited 99.9% friability resistance. The quantitative determination of Diclofenac Sodium content per tablet was: Tablet A: 0.098 g, Tablet B: 0.105 g, Tablet C: 0.104 g. Microbiological purity analysis showed that in all three tablets (A, B, and C), The total aerobic bacterial count was <101 CFU. The total mold and yeast count was <101 CFU and Escherichia coli was not detected. Dissolution test results showed the following percentage of drug released at different time points: Tablet A: 60 min: 16.1%, 120 min: 24.7%, 240 min: 39.6%, 360 min: 52.3%, 600 min: 73.6%. Tablet B: 60 min: 18.4%, 120 min: 26.1%, 240 min: 39.1%, 360 min: 55.8%, 600 min: 75.2%. Tablet C: 60 min: 18.6%, 120 min: 31.4%, 240 min: 52.9%, 360 min: 65.9%, 600 min: 77.0%. These results demonstrate that all tested tablets met the dissolution requirements of USP 44, 2021. Conclusion The findings indicate that the three manufacturers’ Diclofenac Sodium Retard 100 mg tablets comply with the quality standards set by the United States Pharmacopeia (USP 32 and USP 44) and Mongolian Pharmacopoeia 2011.