Browsing by Author "Habtamu Bulbula"

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    Comparative in Vitro Availability of Some Locally Manufactured and Imported Bcs Class II Drug Products Against their Innovator/Counter Reference Products
    (Addis Ababa University, 2024-05-05) Habtamu Bulbula; Tsige Gebre
    According to the Biopharmaceutical classification system (BCS), active pharmaceutical ingredients (APIs) are classified into four (BCS Class I-IV) based on aqueous solubility and intestinal permeability. BCS Class II drug products are medicines which have low solubility in body fluids and high permeability through membranes and they are among the drug products that require documented evidence of bioequivalence study. In addition to the solubility problems, there may be differences between generic and innovator products in terms of the type, source, and quantity of ingredients, manufacturing methods and processes, and machineries used in the production, and these factors can bring major differences in dissolution and bioavailability. The objective of this study is therefore to compare in vitro availability of four types of locally manufactured and imported BCS Class II drug products namely two types of macrolide antibiotics, Azithromycin (AZM) 500mg and clarithromycin (CLM) 500mg tablets, atorvastatin (ATO) 40mg tablets (anti-hyperlipidemia) and glibenclamide (GLB) 5mg tablets (oral hypoglycaemic agent) against their innovator/counter comparator products. A total of 21 selected drug products and their comparator counter products were collected from different drug retail outlets in Addis Ababa. For each drug product, quality control parameters such as thickness, and diameter, were determined in house pre-determined standards (Manufacturer’s specifications), and the hardness, weight variation, friability and disintegration time were determined according to USP monograph using appropriate analytical equipment. The assay and dissolution profile of each drug product were also determined as per their respective procedures in the official monograph using high-performance liquid chromatogram (HPLC) and UV/Vis spectrophotometer. All quality control parameters were assessed by a one-way analysis of variance (ANOVA). Statistically, a significant difference was considered when