Physicochemical quality assessment of various brands of paracetamol tablets sold in Freetown Municipality

Abstract

Paracetamol is a widely used over-the-counter drug for managing fever and pain, but its quality may vary among different brands, especially in low- and middle-income countries, where counterfeit and substandard medicines are prevalent. This study evaluated the physicochemical properties of fifteen brands of 500 mg paracetamol tablets sold in various pharmacies in Freetown, Sierra Leone using identification tests, friability tests, assay, dissolution tests, and mass variation.The results showed that three brands were not registered with the Pharmacy Board of Sierra Leone, and two brands did not meet the requirement for labelling (no manufacturing date). All the brands met the requirement for mass variation, friability tests and assays. The percentage assay of the different brands ranged from 96.17 %w/w to 101.97 %w/w. However, two brands did not meet the specification for dissolution, with P012 releasing about 21.23 % ± 5.76 of the drug within 45min.Most of the paracetamol brands evaluated met the physicochemical test specification. However, two brands failed the dissolution test, two brands did not meet the labelling requirement and three brands were identified as unregistered products with the National Medicines Regulatory Authority in Sierra Leone. This study underscores the necessity of enhancing monitoring and post-market surveillance of pharmaceuticals in Sierra Leone to ensure they comply with regulatory requirements.

Keywords

• Paracetamol
• Physicochemical test
• Pharmacopoeia
• Substandard medicines
• Quality assessment
• Freetown