Biowaiver monographs for immediate‐release solid oral dosage forms: Primaquine phosphate
Identifieur interne : 001421 ( Main/Exploration ); précédent : 001420; suivant : 001422Biowaiver monographs for immediate‐release solid oral dosage forms: Primaquine phosphate
Auteurs : Anita Nair [Allemagne] ; Bertil Abrahamsson [Suède] ; Dirk M. Barends [Pays-Bas] ; D. W. Groot [Pays-Bas] ; Sabine Kopp [Suisse] ; James E. Polli [États-Unis] ; Vinod P. Shah [Pays-Bas] ; Jennifer B. Dressman [Allemagne]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2012-03.
English descriptors
- Teeft :
- Amidon, Antimalarial, Barends, Biopharmaceutics system, Biowaiver, Biowaiver monograph, Biowaiver monographs, Clin, Clin pharmacol, December, Diphosphate, Dissolution, Dissolution tests, Dos, Dosage, Dosage forms, Dressman, Drug administration, Drug products, Drug release, Essential medicines, Excipient, Excipients, Guideline, Human services, Immediate release, Ipca laboratories, Junginger, Kopp, Literature data, Malaria, Midha, Model list, Monograph, Open literature, Oral dosage forms, Ovale, Permeability, Pharm, Pharmaceutical, Pharmaceutical sciences, Pharmacokinetics, Pharmacol, Phosphate, Plasma concentrations, Primaquine, Primaquine diphosphate, Primaquine phosphate, Primaquine phosphate tablets, Radical cure, Shah, Single dose, Solubility, Solubility studies, Standard media, Stavchansky, Thai, Vivax, Vivax malaria, Western countries, World health organization.
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 the antimalarial drug primaquine phosphate as the only active pharmaceutical ingredient (API) are reviewed. On the basis of permeability data and solubility studies, primaquine phosphate was found to be “highly soluble” and “highly permeable” API, thus conforming to Class I of the Biopharmaceutical Classification System (BCS). It has a wide therapeutic index. BCS‐conform dissolution studies showed the products to be rapidly dissolving. No data pertaining to BE or bioinequivalence of IR primaquine phosphate products could be located in open literature. On the basis of the available data, a biowaiver‐procedure‐based approval can be recommended for IR solid oral dosage forms of primaquine phosphate, provided the generic product contains excipients present in products already approved by the International Conference on Harmonisation or associated countries in similar amounts and the test and reference products meet the dissolution criteria for “rapidly dissolving” (>85% drug release in 30 min in standard media at pH 1.2, 4.5, and 6.8; similarity factor (f2) > 50) or “very rapidly dissolving” products (>85% drug release in 15 min in standard media at pH 1.2, 4.5, and 6.8). © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:936–945, 2012
Url:
DOI: 10.1002/jps.23006
Affiliations:
- Allemagne, Pays-Bas, Suisse, Suède, États-Unis
- District de Darmstadt, Hesse (Land), Maryland
- Francfort-sur-le-Main
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On the basis of permeability data and solubility studies, primaquine phosphate was found to be “highly soluble” and “highly permeable” API, thus conforming to Class I of the Biopharmaceutical Classification System (BCS). It has a wide therapeutic index. BCS‐conform dissolution studies showed the products to be rapidly dissolving. No data pertaining to BE or bioinequivalence of IR primaquine phosphate products could be located in open literature. On the basis of the available data, a biowaiver‐procedure‐based approval can be recommended for IR solid oral dosage forms of primaquine phosphate, provided the generic product contains excipients present in products already approved by the International Conference on Harmonisation or associated countries in similar amounts and the test and reference products meet the dissolution criteria for “rapidly dissolving” (>85% drug release in 30 min in standard media at pH 1.2, 4.5, and 6.8; similarity factor (f2) > 50) or “very rapidly dissolving” products (>85% drug release in 15 min in standard media at pH 1.2, 4.5, and 6.8). © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:936–945, 2012</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Pays-Bas</li><li>Suisse</li><li>Suède</li><li>États-Unis</li></country><region><li>District de Darmstadt</li><li>Hesse (Land)</li><li>Maryland</li></region><settlement><li>Francfort-sur-le-Main</li></settlement></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Nair, Anita" sort="Nair, Anita" uniqKey="Nair A" first="Anita" last="Nair">Anita Nair</name></region><name sortKey="Dressman, Jennifer B" sort="Dressman, Jennifer B" uniqKey="Dressman J" first="Jennifer B." last="Dressman">Jennifer B. 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