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A Survey of the Quality of Generic Clarithromycin Products from 13 Countries

  • Clinical Pharmacology
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Abstract

Objective: This study evaluated the quality of 40 generic clarithromycin products from Latin America and Asia.

Materials and Methodsv: The generic products were examined visually, assayed by high pressure liquid chromatography for clarithromycin content and impurities, tested for dissolution properties, and compared with the innovator product manufactured by Abbott Laboratories.

Results: This survey found that many generic clarithromycin products are not equivalent to the innovator product, falling short of the approved, registered specifications for the innovator product. Overall, 20% (8 of 40) of all generic tablets tested, and 33% (6 of 18) of tablets from Latin America, failed to contain between 95 and 105% of the clarithromycin claimed in the label, thus falling short of the approved registered specification for the innovator product. A total of 70% (28 of 40) of products tested released less drug in 30 minutes than did the innovator tablets, although they still met the dissolution specification requiring that 80% of the drug must dissolve in 30 minutes; one generic product failed to meet the specification. A total of 60% (24 of 40) of the generic products tested exceeded the Abbott Laboratories’ 3% limit for total impurities in bulk drug, and 70% (28 of 40) exceeded the Abbott Laboratories’ 0.8% limit for 6,11 di-O-methyl erythromycin A.

Conclusions: These results suggest that generic tablets are not equivalent to the innovator product, raising concerns that clinical trial results achieved with branded clarithromycin (Abbott Laboratories) should not be extrapolated to generic products.

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Acknowledgements

This work was supported by a grant from Abbott Laboratories.

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Authors and Affiliations

  1. Hartford Hospital and University of Connecticut School of Pharmacy, Institute of International Healthcare Studies, 80 Seymour Street, Hartford, Connecticut, 06102-5037, USA

    C. H. Nightingale

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  1. C. H. Nightingale
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Nightingale, C.H. A Survey of the Quality of Generic Clarithromycin Products from 13 Countries. Clin. Drug Investig. 19, 293–305 (2000). https://doi.org/10.2165/00044011-200019040-00007

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  • DOI: https://doi.org/10.2165/00044011-200019040-00007

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