1: J Pharm Sci. 2005 Jul;94(7):1389-95. 

Biowaiver monographs for immediate release solid oral dosage forms based on
biopharmaceutics classification system (BCS) literature data: chloroquine
phosphate, chloroquine sulfate, and chloroquine hydrochloride.

Verbeeck RK, Junginger HE, Midha KK, Shah VP, Barends DM.

Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa.

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. (c) 2005 Wiley-Liss, Inc.

PMID: 15920763 [PubMed - indexed for MEDLINE]