Biowaiver monographs for immediate release solid oral dosage forms: metoclopramide hydrochloride.

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作   者：

Stosik AG;  Junginger HE;  Kopp S;  Midha KK;  Shah VP;  Stavchansky S;  Dressman JB;  Barends DM; 

作者机构：

HEXAL AG;  Holzkirchen;  Germany.; 

关键词：

剂型;  Metoclopramide Monohydrochloride;  Monohydrate;  Oral;  Dosage Forms;  Solid; 

期刊名称：

Journal of Pharmaceutical Sciences

i s s n：

0022-3549

年卷期：

2008 年 97 卷 9 期

页   码：

3700-3708

页   码：

摘   要：

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.