Quality evaluation of near-expiry locally manufactured paracetamol tablets from rural health centers in Punjab, Pakistan

Abstract

This study evaluated the pharmaceutical quality of near-expiry locally manufactured paracetamol 500 mg tablets collected from rural health centers in Punjab, Pakistan. Five commercial brands were assessed for key quality parameters, including physical characteristics, mechanical strength, disintegration, dissolution, and active pharmaceutical ingredient (API) content, in accordance with United States Pharmacopeia (USP) and British Pharmacopoeia (BP) standards. Weight variation, hardness, friability, disintegration, dissolution, and assay tests were performed using standard pharmacopeial methods. All brands complied with pharmacopeial limits for weight variation (616.0±38.2 mg), hardness (5.04±0.89 kg/cm²) and disintegration time (185-876 s). Friability remained within acceptable limits (< 1.0 %) for all brands except brand D (1.141±0.05%), which exceeded the specified limit. Dissolution testing showed that 4 brands released more than 80 % of the drug within 30 mins, whereas Brand D exhibited slightly lower drug release (79.38±1.12%). API assay results (95.90-99.89%) confirmed acceptable chemical stability across all formulations. Overall, the majority of near-expiry paracetamol tablets retained acceptable physicochemical quality, with only minor deviations observed in one brand, supporting their potential use in emergency and resource-limited settings.

J. Bangladesh Acad. Sci. 50(1); 99-106: March 2026