Comparison of Disintegration Time between Formulation Information from Disintegration Test Methods in the Japanese Pharmacopoeia and an Orally Disintegrating Tablet Testing Device: A Study on Donepezil Orally Disintegrating Tablets

Abstract

The disintegration time of orally disintegrating (OD) tablets varies with their ingredients and preparation procedures. The disintegration time of OD tablets should be examined with an OD tablet tester, whose results are highly correlated with those of sensory evaluation. However, compared with the disintegration tester according to the Japanese Pharmacopoeia, OD tablet testers are available at limited facilities, thus precluding analyses.The present study examined whether OD tablets with appropriate disintegration time can be selected based on the disintegration time determined with the disintegration tester according to the Japanese Pharmacopoeia and formulation information on OD tablets. Thirteen products of orally disintegrating tablets (3 mg) of donepezil hydrochloride were analyzed, demonstrating little difference in the disintegration time of a general tablet preparation containing crospovidone between the disintegration tester according to the Japanese Pharmacopoeia and OD tablet tester. Thus, based on the disintegration time of the disintegration tester according to the Japanese Pharmacopoeia, appropriate OD tablets can be selected using the formulation information.