Review Article Theme: Role of Dissolution in QbD and Drug Product Life Cycle

The AAPS Journal

, Volume 12, Issue 3, pp 397-406

First online:

The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug

  • Sandra KleinAffiliated withInstitute of Pharmacy, Biopharmacy and Pharmaceutical Technology, Ernst Moritz Arndt University Email author 

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Simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. To reduce the size and number of human studies required to identify a drug product with appropriate performance in both the fed and fasted states, it is advantageous to be able to pre-screen formulations in vitro. The choice of appropriate media for such in vitro tests is crucial to their ability to correctly forecast the food effect in pharmacokinetic studies. The present paper gives an overview of the development and composition of biorelevant dissolution media that can be used for the in vitro simulation of different dosing conditions (fasted and fed states). In addition, the application of these media to predicting food effects is described in several case examples.

Key words

BA biorelevant media dissolution fasted state fed state food effects