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J Pharm Sci. 2015 Sep;104(9):2664-75. doi: 10.1002/jps.24303. Epub 2014 Dec 24.

Oral Solid Dosage Form Disintegration Testing - The Forgotten Test.

Author information

1
Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, D-55128, Germany.

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.

KEYWORDS:

bioavailability; biopharmaceutics classification system (BCS); dissolution; excipients; formulation; gastrointestinal; in vitro models; intestinal absorption

PMID:
25546430
DOI:
10.1002/jps.24303
[Indexed for MEDLINE]

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