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Sci. Pharm. 2017, 85(2), 20; doi:10.3390/scipharm85020020

Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya

1
Department of Pharmaceutical Chemistry, School of Pharmacy, University of Nairobi, P.O. Box 19676, Nairobi 00202, Kenya
2
National Quality Control Laboratory, P.O. Box 29726, Nairobi 00202, Kenya
*
Author to whom correspondence should be addressed.
Academic Editor: Gernot Eller
Received: 19 March 2017 / Revised: 19 April 2017 / Accepted: 19 April 2017 / Published: 26 April 2017
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Abstract

Clarithromycin is a broad-spectrum semi-synthetic macrolide indicated for treatment of pneumonias, Helicobacter pylori, and chlamydial and skin infections. The object of this study was to evaluate the pharmaceutical equivalence of 14 generic clarithromycin products marketed in Nairobi County, Kenya, to the innovator products, using in vitro dissolution profiles and similarity factors (f2). Further, dissolution profiles of four innovator formulations manufactured in different sites were compared. Fourteen clarithromycin tablets/capsules and four suspensions were subjected to assay and comparative dissolution runs at pH 1.2, 4.5 and 6.8, for 60 and 90 min, respectively. All products complied with pharmacopoeial assay specifications. However, significant differences were observed in their dissolution profiles. The non-compliance rates for tablets/capsules were 50% at pH 1.2, 33% at pH 4.5 and 50% at pH 6.8, while none of the four suspensions were compliant. Overall, only four (25%) products complied with the specifications for similarity factor. The results obtained indicate that a significant percentage of generic clarithromycin products are pharmaceutically non-equivalent to the innovator products, and that assay and single-point dissolution tests are insufficient demonstration of equivalence between the generic and innovator products. View Full-Text
Keywords: clarithromycin; comparative dissolution; similarity factor; pharmaceutical equivalence; quality clarithromycin; comparative dissolution; similarity factor; pharmaceutical equivalence; quality
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Manani, R.O.; Abuga, K.O.; Chepkwony, H.K. Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya. Sci. Pharm. 2017, 85, 20.

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