title: 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.
authors.affiliation: Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, D-55128, Germany.
authors.forename: Jozef
authors.initials: J
authors.lastname: Al-Gousous
authors.affiliation: Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, D-55128, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Langguth
mesh_terms: D001702:Biopharmaceutics; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D004304:Dosage Forms; D012995:Solubility
chemical_list: D004304:Dosage Forms
keywords: bioavailability; biopharmaceutics classification system (BCS); dissolution; excipients; formulation; gastrointestinal; in vitro models; intestinal absorption