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.
Similar content being viewed by others
References
Langtry HD, Brogden RN. Clarithromycin. A review of its efficacy in the treatment of respiratory tract infections in immunocompetent patients.Drugs. 1997;53:973–1004.
Peters DH, Clissold SJ. Clarithromycin. A review of its antimicrobial activity, pharmacokinetic properties and therapeutic potential.Drugs. 1992;44:117–164.
Bogossian M. Use of clarithromycin for respiratory infections in general practice.Rev Bras Med. 1995;52:500–509.
Farhat CK. Use of clarithromycin in respiratory infections in pediatrics.Mod Pediatr. 1995;31:1–8.
Endo LH. The use of clarithromycin in respiratory infections in general practice.Otorrinolaringologia. 1995;2:1–8.
Nightingale CH. A survey of the quality of generic clarithromycin products from 13 countries.Clin Drug Invest. 2000;19(4):293–305.
Morgan DK, Brown DM, Rotsch TD, et al. A reversed-phase high-performance liquid chromatographic method for the determination and identification of clarithromycin as the drug substance and in various dosage forms.J Pharm Biomed Anal. 1991;9:261–269.
Morgan DK, Cugier P, Marello B, et al. Impurity profiling of clarithromycin using high-performance liquid chromatography with ultraviolet detection.J Chromatogr. 1990;502:351–358.
Ishii K, Katayama Y, Itai S, et al. In vitro dissolution tests corresponding to the in vivo dissolution of clarithromycin tablets in the stomach and intestine.Chem Pharm Bull. 1995;43:1943–1948.
Pharmacopeia of the United States of America. 23rd ed. Rockville, Md: US Pharmacopeial Convention; 1999.
Brittain HG, ed.Analytical Profiles of Drug Substances, XXIV. New York: Academic Press; 1996.
CPMP/ICH/282/95 Step 4, Consensus Guideline, 6 November 1996.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Nightingale, C.H. A survey of the quality of generic clarithromycin products manufactured in Slovenia and Israel. Adv Therapy 17, 167–178 (2000). https://doi.org/10.1007/BF02853159
Issue Date:
DOI: https://doi.org/10.1007/BF02853159