title: A survey of the quality of generic clarithromycin products manufactured in Slovenia and Israel.
abstract: This study evaluated the quality of 11 generic clarithromycin products obtained in Poland, Slovakia, Slovenia, or Israel and manufactured in Slovenia or Israel. 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. Fifty-five percent of generic products fell short of the specifications for the innovator product. Ten percent of the generic products did not contain the amount of clarithromycin claimed in the label; 18% released less drug than did the branded tablets in the standard dissolution assay. In light of these results, it is not possible to conclude that all generic tablets are of the same quality as the innovator product; clinical trial results achieved with branded clarithromycin should not be extrapolated to generic products.
authors.affiliation: Institute of International Health Care Studies, Hartford Hospital, University of Connecticut School of Pharmacy, USA.
authors.forename: C H
authors.initials: CH
authors.lastname: Nightingale
mesh_terms: D000900:Anti-Bacterial Agents / Q000592:standards*; D017291:Clarithromycin / Q000592:standards*; D004340:Drug Contamination; D004345:Drug Industry / Q000592:standards*; D016568:Drugs, Generic / Q000592:standards*; D007557:Israel; D011786:Quality Control; D017524:Slovenia; D012995:Solubility; D013607:Tablets
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D013607:Tablets; D017291:Clarithromycin