Evolution of Choice of Solubility and Dissolution Media After Two Decades of Biopharmaceutical Classification System

The AAPS Journal
Nadia Bou-ChacraRaimar Löbenberg

Abstract

The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development. Over the years, physiologically adapted media and buffers were introduced with the intention to better predict the in vivo solubility and dissolution of drug substances. Water, buffer solutions, compendial media, micellar solubilization media, and biorelevant media are reviewed. At this time point, there is no universal medium available which can be used to predict every drug substance's solubility or a drug product's in vivo dissolution behavior. However, there have been many improvements and additions made to media to optimize their in vivo predictability; for example, the current phosphate concentrations in buffers seem to be too high to correlate with the carbonate buffer concentrations in v...Continue Reading

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Citations

Jul 3, 2019·AAPS PharmSciTech·Juliet Obianuju NjokuRaimar Löbenberg
Jul 1, 2020·Therapeutic Innovation & Regulatory Science·Claudia Miranda-Pérez de AlejoMiguel Ángel Cabrera-Pérez
Jun 14, 2019·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Daniela Amaral SilvaRaimar Löbenberg
Jul 11, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Daniela Amaral SilvaRaimar Löbenberg
Mar 9, 2019·Molecular Pharmaceutics·Claire DunnGavin W Halbert
Aug 15, 2021·Advanced Drug Delivery Reviews·Connor O'FarrellHannah Batchelor
Aug 23, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Qamar AbuhassanGavin W Halbert

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