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 aimed to evaluate the physicochemical properties of various brands of 500mg Paracetamol tablets sold in pharmacies in Freetown, Sierra Leone, and to assess if they met the testing specifications.This was an experimental study that used Pharmacopoeia Tests (Identification Test II, Friability, Dissolution, Assay, Uniformity of Dosage Unit) and Non-Pharmacopoeia Tests (Visual Examination and Identification Test I) to evaluate the physicochemical features of 15 different Paracetamol brands. The brands were labelled as P001 to P015 to avoid bias, ensure confidentiality and for easier reference.The results showed that three brands P004, P011 and P014 were not registered with the Pharmacy Board of Sierra Leone, and two brands (P002 and P011) did not have manufacturing date labels. All brands met the specification for uniformity of dosage unit, friability test and assay. The percentage assay of the different brands ranged from (P008) 96.17%w/w to (P003) 101.97%w/w. However, two brands (P012 and P014) did not meet the specification of dissolution, with P012 releasing less than 20% of the drug within the specified time.This study revealed that most brands evaluated met the physicochemical test parameters with some variation in the quality of the different brands. Few products were not labelled with their manufacturing dates, not registered with the National Drug Regulatory Authority in Sierra Leone and failed the dissolution test. This highlights the sales of unregistered products of uncertain quality and shelf life in the market. The study emphasises the need for proper labelling of pharmaceutical products, monitoring of registration status, and quality control of paracetamol tablets sold in Freetown to ensure their safety and efficacy for consumers.