QUALITY ASSESSMENT OF SOME BRANDS OF CLARITHROMYCIN TABLETS SOLD IN AMASSOMA, BAYELSA STATE, NIGERIA.

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J. ORAELUNO, F. IGWE, J. OBASI, E. BAMIGBOLA, E. VAIKOSEN, B. JOSEPH

Abstract: Clarithromycin, an antibiotic widely used for the treatment of common infectious disease in Nigeria, is manufactured by different pharmaceutical companies and available in numerous brands. Fake, counterfeit and substandard pharmaceutical products are common phenomenon in most developing countries, yet adequate effort to monitor the quality of drugs and medicaments are not sufficient. This study was aimed at evaluating the quality of five brands of clarithromycin tablets sold in Amassoma, Bayelsa State, Nigeria. The brands were procured from pharmacy shops and analyzed for in-vitro pharmacopoeia and non-pharmacopoeia tests including weight variation, thickness, diameter, crushing strength, friability, disintegration time, drug content and dissolution profile. All the brands tested showed slight variation in weight and size not exceeding 5% of their mean value. Also their crushing strength was between 8.67 – 10.92kg/f which is considered acceptable for film coated tablets. Friability test results ranged from 0.01 to 0.10% and disintegration time was less that 30 minutes. The brands tested contained 92.22 – 96.04% of the label drug content and showed slight difference in their dissolution profiles as they all released more than 90% of the active pharmaceutical ingredient within 30 minutes. The results showed all the examined brands met standard pharmacopoeia specifications for film coated tablets.

Clarithromycin, In-vitro properties, Pharmacopoeia, Generics