ObjectiveThis study evaluated the quality of 40 generic clarithromycin products from Latin America and Asia.Materials and MethodsThe 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.ResultsThis 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 Laboratoriesrsquo; 3 limit for total impurities in bulk drug, and 70 (28 of 40) exceeded the Abbott Laboratoriesrsquo; 0.8 limit for 6,11 di-O-methyl erythromycin A.ConclusionsThese 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.
展开▼
