Dissolution Highlights from the 2015 AAPS Annual Meeting in Orlando

Fotaki, Nikoletta; Gray, Vivian A.; Krämer, Johannes; Diaz, Dorys Argelia; Flanagan, Talia; Grove, Geoffrey N.

doi:10.14227/dt230216p42

Cited by 2 publications

(1 citation statement)

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“…This linkage may be through an in vitro in vivo relationship, in vitro or in vivo correlation, and/or simulations (3). Lack of dissolution data linking the critical quality attributes to bioavailability and bioequivalence in vivo may lead to design spaces that are not acceptable (23).…”

Section: Introductionmentioning

confidence: 99%

Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes

Gray¹

2018

AAPS PharmSciTech

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For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMAs) and critical product properties (CPPs). The dissolution test has been shown repeatedly to have the power to distinguish between significant changes in active pharmaceutical ingredient (API), formulation, and process that relate to the release mechanism of the in vivo performance. Examples will be discussed in the literature where the effects of formulation, drug substance, and manufacturing variables have been measured by dissolution testing. There will be a suggested plan on how to develop and challenge a discriminating method that may be utilized for regulatory purposes. A brief review of other challenges and considerations regarding discriminatory dissolution testing is presented.

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Section: Introductionmentioning

confidence: 99%