A mini review of scientific and pharmacopeial requirements for the disintegration test.
Disintegration is a performance test for oral dosage forms that is described in the United States Pharmacopeia (USP), the European Pharmacopeia (EP) and the Japanese Pharmacopeia (JP, chapter 14, 2001). This review lists changes that have been made since the USP 23 and compares them to those in the USP 30, EP 5.3 and JP XIV. The differences between the disintegration test methods in the three pharmacopeias are discussed. Examples are provided where disintegration can be used as a performance test for ensuring the drug release.
Donauer
Nina
N
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alta. T6G 2N8, Canada.
Löbenberg
Raimar
R
D002214:Capsules; D002626:Chemistry, Pharmaceutical / Q000266:history / Q000592:standards*; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D005079:Excipients; D049674:History, 21st Century; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D012995:Solubility; D013607:Tablets
D002214:Capsules; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D005079:Excipients; D013607:Tablets