Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 104, Issue 9, Pages 2664-2675Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.24303
Keywords
bioavailability; biopharmaceutics classification system (BCS); dissolution; excipients; formulation; gastrointestinal; in vitro models; intestinal absorption
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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. (c) 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:2664-2675, 2015
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