Dissolution or Disintegration - Substitution of Dissolution by Disintegration Testing for a Fixed Dose Combination Product.

Dissolution or Disintegration - Substitution of Dissolution by Disintegration Testing for a Fixed Dose Combination Product. Drug Dev Ind Pharm. 2018 Sep 19;:1-24 Authors: Grube A, Gerlitzki C, Brendel M Abstract According to ICH guideline Q6A, dissolution testing can be replaced by disintegration testing if it can be shown that the active pharmaceutical ingredient (API) is highly soluble and the formulation is rapidly releasing. In addition, a relationship between dissolution and disintegration has to be established. For a fixed-dose combination tablet of empagliflozin and linagliptin this relationship was established by applying two different approaches. In the first approach, the extent to which the disintegration process of the film-coated tablets contributes to the release of the active ingredients was investigated. In the second approach, the mean disintegration times in a disintegration tester were correlated with the mean dissolution rates at a selected sampling time point. By correlating disintegration times in the dissolution vessel with the dissolution rate at selected sampling times it is demonstrated that 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 ...
Source: Drug Development and Industrial Pharmacy - Category: Drugs & Pharmacology Tags: Drug Dev Ind Pharm Source Type: research