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Biowaiver monographs for immediate release solid oral dosage forms: Metoclopramide hydrochloride

✍ Scribed by A.G. Stosik; H.E. Junginger; S. Kopp; K.K. Midha; V.P. Shah; S. Stavchansky; J.B. Dressman; D.M. Barends

Book ID
102401157
Publisher
John Wiley and Sons
Year
2008
Tongue
English
Weight
134 KB
Volume
97
Category
Article
ISSN
0022-3549

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✦ Synopsis

Literature data are reviewed relevant to the decision for a biowaiver of immediate release (IR) solid oral dosage forms containing metoclopramide hydrochloride. In addition, new solubility data, obtained under Biopharmaceutics Classification System (BCS) conditions are presented. Metoclopramide HCl is conservatively assigned to BCS Class III. Taken also into consideration excipient interactions reported in metoclopramide drug products, its pharmacokinetic properties and therapeutic use and therapeutic index, a biowaiver can be recommended when: (a) the test product contains only excipients present also in metoclopramide HCl containing IR solid oral drug products approved in ICH or associated countries, for instance as presented in this paper, (b) in amounts in normal use in IR solid oral dosage forms, and (c) the test product and the comparator both comply with the criteria for very rapidly dissolving.

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