Is Not More Than 15 minutes disintegration time a hard and fast limit for immediate release tablets? does it depend on release mechanics, BCS class of drug, in vivo mimicking? If an immediate release tablet goes beyond 15 minutes disintegration, is it an absolute failure or it can otherwise be justified?
Dr R Srinivasan sorry i think there supposed is to be a link or document attached, to your response, cant see it.
One of the landmark criteria for dissolution is NMT 15 min (other are 30 min, 45 min) might be responsible for disintegration limit as well.
For rapidly dissolving products containing highly soluble drugs throughout the physiological pH range (pH 1.2 to 6.8), dissolution limit is > 85% in 15 min at pH 1.2, 4.0 and 6.8. Means considering dissolution at 15 min could be one of the criteria which can be linked to disintegration. As we aware the step of dissolution i.e. Tablet --> (disintegration) --> Granules --> (disintegration) --> Fine particles --> solubilization.
- Badges
- Science method