Pharmaceutical and Biological Evaluation of Brands of Albendazole Tablets on the Ghanaian Market.

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The dissolution characteristics of the various brands of albendazole have long been a problem to manufacturers. Since dissolution affects the bioavailability of drugs, it is important that all steps be taken to solve this problem once and for all. The possible reasons for the problematic dissolution profile of albendazole are differences in manufacturing processes, compression pressures, levels of excipients particularly, binders, diluents, crystal size and structure of albendazole granules used for compression etc. The effect of chewing on the dissolution was also investigated. The effect of the sparing solubilities and erratic dissolution profiles of albendazole was investigated by their activity on the mobility of earth worms (Lumbricus terretis). A simple analytical method was developed for the assay of albendazole using high performance liquid chromatography (HPLC). A solvent system of 200 volumes of water, 800 volumes of methanol with 3ml of sulphuric acid in methanol was used. The chromatographic system was equipped with a 254nm detector and C18 column. The method developed was found to be specific, precise, accurate and linear. The method was also robust, flow rates of 0.5ml/min and 1.0ml/min were recommended. The limit of detection (LOD) and limit of quantification (LOQ) were respectively 24ug/ml and 80ug/ml. The following brands of albendazole were used: zentel, tanzol, alben, wormplex, wormzap, albendaven, expel, nesben, and benzil. Upon investigation, chewing a tablet of albendazole improves drastically its dissolution and efficacy. It is therefore advised that all albendazole tablets be chewed before swallowing. All the brands of albendazole effectively killed the worms after three hours of experimentation. The differences in paralysis time were investigated by chemical assay. The purpose of the chemical assay (via non-aqueous titration and HPLC) was based on the premise that differences in the active ingredient content could contribute to the difference in the paralysis time. Using non-aqueous titration, only sample K was found to contain the appropriate amount of albendazole by virtue of its % active ingredient content. However, using HPLC samples K, B, C, D and A contained the appropriate amount of active ingredient using the British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and the International Pharmacopoeia (IP) as references. The two methods employed revealed the sensitivity, accuracy and reliability of HPLC over non-aqueous titration, in the analysis of albendazole. The differences in the % active ingredient content contributed to the effects of tablets on the paralysis of the worms, hence playing a crucial role. This was demonstrated by the paralysis activities of samples A, B and C over the other brands.
A Thesis Submitted In Partial Fulfilment of the Requirements for the Degree of Master of Science in Pharmaceutical Analysis and Quality Control in the Department f Pharmaceutical Chemistry.