Oral Solid Dosage Form Disintegration Testing - The Forgotten Test.

Abstract:

:Since its inception in the 1930s, disintegration testing has become an important quality control (QC) test in pharmaceutical industry, and disintegration test procedures for various dosage forms have been described by the different pharmacopoeias, with harmonization among them still not quite complete. However, because of the fact that complete disintegration does not necessarily imply complete dissolution, much more research has been focused on dissolution rather than on disintegration testing. Nevertheless, owing to its simplicity, disintegration testing seems to be an attractive replacement to dissolution testing as recognized by the International Conference on Harmonization guidelines, in some cases. Therefore, with proper research being carried out to overcome the associated challenges, the full potential of disintegration testing could be tapped saving considerable efforts allocated to QC testing and quality assurance.

journal_name

J Pharm Sci

authors

Al-Gousous J,Langguth P

doi

10.1002/jps.24303

subject

Has Abstract

pub_date

2015-09-01 00:00:00

pages

2664-75

issue

9

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)30051-X

journal_volume

104

pub_type

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