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

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

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.

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Acknowledgment

The author would like to express her gratitude to Marie Sjǿberg from AstraZeneca, Pharmaceutical and Analytical R&D, Mölndal, Sweden who had the idea for simplifying the preparation of FaSSIF and FeSSIF for provision of the preparation instructions.

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  1. Institute of Pharmacy, Biopharmacy and Pharmaceutical Technology, Ernst Moritz Arndt University, 17 Friedrich Ludwig Jahn Street, Greifswald, 17489, Germany

    Sandra Klein

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Correspondence to Sandra Klein.

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Klein, S. The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug. AAPS J 12, 397–406 (2010). https://doi.org/10.1208/s12248-010-9203-3

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