What is the difference between disintegration and dissolution

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Dissolution ensures active moiety API is released and dissolved in the Dissolution media and forms a solution from the tablets mass and only then it can get into the systemic circulation in our body. Thus making it bioavailable. By correlating disintegration times in the dissolution vessel with the dissolution rate at selected sampling times it is demonstrated that the disintegration into primary particles is the rate limiting step for the dissolution process.

A direct correlation of disintegration times in the disintegration tester with dissolution rate at a selected sampling time is established supporting a relationship between dissolution and disintegration testing for this type of formulation. Additionally, it could also be shown that the disintegration test method exhibits at least a similar discriminatory power compared to the proposed dissolution method.

Based on a statistical approach and data from a bioavailability study, a clinical relevant specification for the disintegration time was established.