Chapter

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics

Volume VI of the series Biotechnology: Pharmaceutical Aspects pp 221-256

The Use of Solubilizing Excipients and Approaches to Generate Toxicology Vehicles for Contemporary Drug Pipelines

  • MARCUS E. BREWSTERAffiliated withChemical and Pharmaceutical Development, Johnson & Johnson, Pharmaceutical Research and Development
  • , CLAIRE MACKIEAffiliated withResearch and Early Development, Johnson & Johnson, Pharmaceutical Research and Development
  • , MARC NOPPEAffiliated withResearch and Early Development, Johnson & Johnson, Pharmaceutical Research and Development
  • , ANN LAMPOAffiliated withPreclinical Development, Johnson & Johnson, Pharmaceutical Research and Development
  • , THORSTEINN LOFTSSONAffiliated withFaculty of Pharmacy, The University of Iceland

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Abstract

The purpose of this chapter is two-fold and includes approaches for identifying potentially problematic drug candidates with regard to formulation, in general, and for the preparation of toxicology vehicles, in particular. In addition, an attempt is made to provide insight as to what oral and parenteral excipients are appropriate for early human testing and, by extension, which of these materials can reasonably be used in GLP toxicology evaluation intended to support these Phase I human assessments. These considerations are becoming more visible in the drug development arena as evidenced by a number of recent symposia and congresses (Liu 2005; Van Gelder, 2006).