Biopharmaceutics candidate drug selection

Ungell, A.-L., Abrahamsson, B., Biopharmaceutical support in candidate drug selection, in Pharmaceutical Preformulation and Formulation. A Practical Guide from Candidate Drug Selection to Commercial Dosage Formulation. Gibson, M. (ed.), Interpharm Press, 2001. 

Pharmaceutical Preformulation and Formulation A Practical Guide from Candidate Drug Selection to Commercial Formulation covers a wider subject area than just preformulation. Topics include biopharmaceutics, drug delivery, formulation and process development aspects of product development. The book also describes a logical and structured approach to the product development process, recommending at what stages appropriate preformulation, biopharmaceutics and formulation work is best undertaken. 

Chapter 4 describes the importance of drug delivery and biopharmaceutical factors in the candidate drug selection phase. Consideration is given to the intended route of administration and what predictions can be made and useful information gained from biopharmaceutical assessment of the candidate drug. 

The biopharmaceutical information gathered in the candidate drug selection process regarding the characteristics of the drug molecule (e.g., dissolution, solubility, stability in fluids at the site of administration, enzymatic stability, membrane transport and bioavailability) is also very useful as input to the subsequent formulation development. This information is important, for example,... 

The present chapter focuses on aspects of drug solubility/dissolution of specific relevance for biopharmaceutical support in candidate drug selection and preformulation. These aspects include solubility in candidate drug screening, physiological aspects of test media, solubility of amphiphilic drugs and substance characterisation prior to solubility/dissolution tests. 

This chapter is strongly focussed on oral drug delivery. The relevant principles and methods involved in biopharmaceutical characterisation of a drug molecule, mainly applied in the preformulation phase, are described in Chapter 4, Biopharmaceutical Support in Candidate Drug Selection . 

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