Assessment of In Vitro Dissolution Profiles of Marketed Albendazole Tablets in Nakuru County, Kenya

Abstract

Albendazole, a benzimidazole derivative, is widely used to treat helminth infections. The average prevalence of helminthiasis in Kenya is approximately 12.9%. Albendazole is classified as a BCS II class drug, exhibiting low solubility and high permeability, which can result in erratic bioavailability. In vitro dissolution testing provides valuable information for predicting the bioavailability of a drug, particularly in cases where absorption is limited by the dissolution rate. This study aimed to assess the in vitro dissolution profiles of seven brands of albendazole tablets sold in various pharmacy outlets in Nakuru County, Kenya. The tablets were randomly selected and subjected to standard quality control tests. Content of the drug substance in the tablets was determined by UV spectrophotometry. Disintegration and dissolution tests were performed as described in the USP monograph. All tested brands exhibited assay values within the acceptable range of 90% to 110%, ranging from 95.4% to 103.3%. Four brands complied with the specification for the disintegration test for immediate-release tablets, which require disintegration within 15 minutes. One brand disintegrated in 33 minutes, whereas two did not disintegrate within 60 minutes. Four brands failed to meet the dissolution test specifications, releasing only 0.9%, 1.6%, 7.3%, and 20.8% of the labeled content, respectively, after 30 minutes. Their dissolution profiles were dissimilar to that of the reference brand. These findings indicate the presence of substandard albendazole tablets in the Kenyan market and underscore the need for regular post-marketing surveillance and quality assessments to ensure pharmaceutical equivalence among brands and safeguard patient safety.