Optimizing the Formulation of Poorly Water-Soluble Drugs

  • Kevin P. O’Donnell
  • Robert O. WilliamsIII
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 3)


With as high as 60% of drugs in company pipelines exhibiting poor aqueous solubility, the ability to successfully develop a poorly water-soluble drug has become essential. Gaining a detailed understanding of a compound through preformulation studies can be especially challenging for poorly water-soluble drugs limiting their development. Therefore, this chapter focuses on the application of preformulation studies essential in understanding a poorly water-soluble drug, including solubility studies, solid-state characterization of the active ingredient and formulations thereof, and in vitro and in vivo testing of the lead formulations.


Differential Scanning Calorimetry Solid Dispersion Physical Mixture Attenuate Total Reflectance Dissolution Medium 
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Copyright information

© American Association of Pharmaceutical Scientists 2012

Authors and Affiliations

  1. 1.Division of Pharmaceutics, College of PharmacyThe University of Texas at AustinAustinUSA

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