Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate
Autor: | Jennifer B. Dressman, Dhanusha Thambavita, Mehul Mehta, James E. Polli, Bertil Abrahamsson, Vinod P. Shah, Peter Langguth, Uthpali Mannapperuma, Rodrigo Cristofoletti, Alan F. Parr, Lal Jayakody, D.W. Groot, Priyadarshani Galappatthy |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
030106 microbiology Administration Oral Biological Availability Pharmaceutical Science Excipient Pharmacology Bioequivalence 030226 pharmacology & pharmacy Permeability Dosage form Biopharmaceutics Excipients 03 medical and health sciences 0302 clinical medicine medicine Animals Humans Dosage Forms Active ingredient Chemistry Amoxicillin Biopharmaceutics Classification System Bioavailability Solubility Therapeutic Equivalency medicine.drug |
Zdroj: | Journal of Pharmaceutical Sciences. 106:2930-2945 |
ISSN: | 0022-3549 |
Popis: | Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), therapeutic uses, therapeutic index, excipient interactions, as well as dissolution and BE and bioavailability studies were taken into consideration. Solubility and permeability studies indicate that amoxicillin doses up to 875 mg belong to BCS class I, whereas 1000 mg belongs to BCS class II and doses of more than 1000 mg belong to BCS class IV. Considering all aspects, the biowaiver procedure can be recommended for solid oral products of amoxicillin trihydrate immediate-release preparations containing amoxicillin as the single active pharmaceutical ingredient at dose strengths of 875 mg or less, provided (a) only the excipients listed in this monograph are used, and only in their usual amounts, (b) the biowaiver study is performed according to the World Health Organization-, U.S. Food and Drug Administration-, or European Medicines Agency-recommended method using the innovator as the comparator, and (c) results comply with criteria for "very rapidly dissolving" or "similarly rapidly dissolving." Products containing other excipients and those containing more than 875 mg amoxicillin per unit should be subjected to an in vivo BE study. |
Databáze: | OpenAIRE |
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