Section C.01.015 of the Food and Drug Regulations specifies requirements relating to tablet
disintegration times. These regulations require that all drugs in tablet form, intended to be swallowed whole,
disintegrate in not more than 60 minutes when tested by the official method.
The regulations also prescribe a specific disintegration requirement and test for tablets which are enteric
coated. Subsection (2) specifies conditions where subsection (1) requirements for DO-25 are not required,
i.e., (e) drug demonstrated by an acceptable method to be available to the body, and (f) tablets which are for
example extended release. Refer to C.01.011 and C.01.012.
The Inspectorate has no objection to the use of an alternate disintegration or dissolution method to
demonstrate compliance with the prescribed release requirements provided that the method had been properly
validated. It is understood the DO-25 is not generally used for new drugs.
