Biowaiver monographs for immediate release solid oral dosage forms: metronidazole.

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 metronidazole are reviewed. Metronidazole can be assigned to Biopharmaceutics Classification System Class I. Most BE studies that were identified reported the investigated formulations to be bioequivalent, indicating the risk of bioinequivalence to be low. Formulations showing differences in bioavailability showed dissimilarities in in vitro dissolution profiles. Furthermore, metronidazole has a wide therapeutic index. It is concluded that a biowaiver for solid IR formulations is justified, provided: (a) the test product and its comparator are both rapidly dissolving; (b) meet similarity of the dissolution profiles at pH 1.2, 4.5, and 6.8; (c) the test product contains only excipients present in IR drug products approved in International Conference on Harmonisation (ICH) or associated countries in the same dosage form; and (d) if the test product contains sorbitol, sodium laurilsulfate, or propylene glycol, the test product needs to be qualitatively and quantitatively identical to its comparator with respect to these excipients [corrected]..

journal_name

J Pharm Sci

authors

Rediguieri CF,Porta V,G Nunes DS,Nunes TM,Junginger HE,Kopp S,Midha KK,Shah VP,Stavchansky S,Dressman JB,Barends DM

doi

10.1002/jps.22409

subject

Has Abstract

pub_date

2011-05-01 00:00:00

pages

1618-27

issue

5

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)32160-2

journal_volume

100

pub_type

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