Determination and comparison of the tablet properties of commercially marketed immediate release tablets of diclofenac sodium and paracetamol in South-South Nigeria

Abstract

Background: Substandard tablets lead to poor outcomes in pain management. This study compared tablet properties of innovator and generic diclofenac sodium (50 mg) and paracetamol (500 mg) tablets in South-South Nigeria. Methods: Physicochemical tests (weight uniformity, hardness, friability, disintegration, dissolution, content uniformity) followed pharmacopeial standards. Pharmacokinetic studies used single-dose crossover in 33 healthy volunteers. Plasma analyzed via UV; bioequivalence via 90% CI (80%-125%). ANOVA/t-tests (p? .05). Results: Generics failed content (e.g., Panda 68.00%±5.60%, Emcap 47.79%±6.30% vs. Panadol 83.24%±1.80%). Innovators had superior bioavailability: Olfen Cmax 5.09±0.19 µg/L, AUC 112.00±8.20 mg·h/L vs. generics. 90% CI confirmed bioequivalence for Clofenac-Olfen, all paracetamol. Dissolution: Innovators slower (p< .05). Conclusion: Select generics bioequivalent; enhanced quality controls recommended.