Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride.
J Pharm Sci
; 94(7): 1389-95, 2005 Jul.
Article
en En
| MEDLINE
| ID: mdl-15920763
ABSTRACT
Literature data on the properties of chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride related to the Biopharmaceutics Classification System (BCS) are reviewed. The available information indicates that these chloroquine salts can be classified as highly soluble and highly permeable, i.e., BCS class I. The qualitative composition of immediate release (IR) tablets containing these Active Pharmaceutical Ingredients (APIs) with a Marketing Authorization (MA) in Belgium (BE), Germany (DE), Finland (FI), and The Netherlands (NL) is provided. In view of these MA's and the critical therapeutic indication of chloroquine, it is assumed that the registration authorities had evidence that these formulations are bioequivalent to the innovator. It is concluded that IR tablets formulated with these excipients are candidates for a biowaiver.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Biofarmacia
/
Cloroquina
/
Antimaláricos
Tipo de estudio:
Etiology_studies
/
Qualitative_research
Límite:
Humans
Idioma:
En
Revista:
J Pharm Sci
Año:
2005
Tipo del documento:
Article
País de afiliación:
Sudáfrica