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Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies. A project of the International Pharmaceutical Federation FIP, Groupe BCS, http://www.fip.org/bcs .

Authors :
College of Pharmacy, University of Michigan, Ann Arbor, Michigan
Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany
Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
World Health Organization, Geneva, Switzerland
University of Saskatchewan, Saskatoon, Saskatchewan, Canada
International Pharmaceutical Federation FIP, Den Haag, The Netherlands
Division of Pharmaceutics, College of Pharmacy, University of Texas at Austin, Austin, Texas
RIVM???National Institute for Public Health and the Environment, Bilthoven, The Netherlands ; RIVM???National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: +31-30-2744209; Fax: +31-30-2744462
Becker, C.
Dressman, J. B.
Amidon, G. L.
Junginger, H. E.
Kopp, S.
Midha, K. K.
Shah, V. P.
Stavchansky, S.
Barends, D. M.
College of Pharmacy, University of Michigan, Ann Arbor, Michigan
Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany
Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
World Health Organization, Geneva, Switzerland
University of Saskatchewan, Saskatoon, Saskatchewan, Canada
International Pharmaceutical Federation FIP, Den Haag, The Netherlands
Division of Pharmaceutics, College of Pharmacy, University of Texas at Austin, Austin, Texas
RIVM???National Institute for Public Health and the Environment, Bilthoven, The Netherlands ; RIVM???National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: +31-30-2744209; Fax: +31-30-2744462
Becker, C.
Dressman, J. B.
Amidon, G. L.
Junginger, H. E.
Kopp, S.
Midha, K. K.
Shah, V. P.
Stavchansky, S.
Barends, D. M.
Publication Year :
2008

Abstract

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Biopharmaceutics Classification System (BCS) Class III drug with permeability properties approaching the border between BCS Class I and III. BE problems of ethambutol formulations containing different excipients and different dosages forms have not been reported and hence the risk of bio in equivalence caused by excipients is low. Ethambutol has a narrow therapeutic index related to ocular toxicity. However, as long as the prescribers' information of the test product stipulates the need for regular monitoring of ocular toxicity, the additional patient risk is deemed acceptable. It is concluded that a biowaiver can be recommended for IR solid oral dosage forms provided that the test product (a) contains only excipients present in ethambutol IR solid oral drug products approved in ICH or associated countries, for instance as presented in this paper, (b) complies with the criteria for ???very rapidly dissolving??? and (c) has a prescribers' information indicating the need for testing the patient's vision prior to initiating ethambutol therapy and regularly during therapy. ?? 2007 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:1350???1360, 2008

Details

Database :
OAIster
Publication Type :
Electronic Resource
Accession number :
edsoai.ocn894385617
Document Type :
Electronic Resource