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The “GI dissolution” method: a low volume, in vitro apparatus for assessing the dissolution/precipitation behaviour of an active pharmaceutical ingredient under biorelevant conditions
Tom Gravestock,Karl Box,John Comer,Elizabeth Frake,Sam Judge,Rebeca Ruiz
Analytical Methods Pub Date : 01/24/2011 00:00:00 , DOI:10.1039/C0AY00434K
Abstract

This paper describes a low volume, in vitro apparatus for investigating the dissolution and precipitation behaviour of active pharmaceutical ingredients (APIs) under a wide range of experimental conditions and dissolution media. The apparatus has automated and dynamic pH control, allowing the simulated passage of drugs through the gastrointestinal tract (GIT). Experiments can be performed in the presence of biorelevant media and excipients, providing information related to the predicted behaviour of APIs under physiological conditions. The technique is described in detail and results are presented for a number of neutral, basic, acidic and ampholytic drug compounds.

Graphical abstract: The “GI dissolution” method: a low volume, in vitro apparatus for assessing the dissolution/precipitation behaviour of an active pharmaceutical ingredient under biorelevant conditions
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