Physicochemical assessment of the quality of Albendazole tablets on the Ugandan market

Abstract

Albendazole tablets are listed by World Health Organization as essential medicines effective for treatment for parasitic worm infections and are indeed widely used in many public deworming campaigns in Uganda. “Albendazole tablets being a high-volume consumption product coupled with the fact that they cure illnesses often referred to as those of the poor make them have a very high risk of being counterfeited. Despite this highly associated risk, there is no comprehensive assessment and documentation available on the quality of Albendazole tablets on the Ugandan market. In this study, both qualitative and quantitative assessments were performed to evaluate the quality of different brands of Albendazole tablets sold in wholesale pharmacies in Kampala, Uganda. A visual inspection checklist was used for the assessment of the physical attributes and packaging requirements. Ultraviolet-visible spectroscopy (UVS) and High-Performance Liquid Chromatography (HPLC) were used for confirmation of the presence and amount of the Active Pharmaceutical Ingredient (API).” A total of 40 batches of Albendazole tablets from 10 different brands were collected and evaluated. All brands of Albendazole tablets, except one, had acceptable physical characteristics. All the 10 brands (40 batches) passed the assay test, with average assay values ranging from 95.9 % (383.6 mg/mg) (to 99.5 % (398 mg/mg). Eight (20 %) batches failed the disintegration test. Three brands (30 %) of 10 brands failed the dissolution test with percentage dissolution values ranging from 0.0 % (0 mg/mg to 79 % (316 mg/mg). The most significant revelation of this study was the batches of Albendazole chewable tablets that did not completely dissolve as demonstrated by dissolution values ranging from 0% to 1%. In conclusion, the Ugandan market had Albendazole tablets of both good and bad quality in circulation. This calls for regulatory enforcement to ensure that all these products that did not meet the specifications are recalled from the market and the manufacturers cautioned.