Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.

Abstract:

:Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs.

journal_name

J Pharm Sci

authors

Kortejärvi H,Shawahna R,Koski A,Malkki J,Ojala K,Yliperttula M

doi

10.1002/jps.21879

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

621-5

issue

2

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)30416-6

journal_volume

99

pub_type

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