ABSTRACT

Once a drug substance has been profiled, and a sufficient body of information acquired regarding its range of physical and chemical properties, the next stage in development is to acquire the scope of information necessary for the development of a stable and robust formulation. The nature of the formulation to be developed is obviously essential to the decision process, and in the present work the focus will be on solid dosage forms (i.e., tablets and capsules). Individual aspects of this work will be developed at greater length in succeeding chapters, but here the later stage of preformulation will be given an overview with the aim of setting up a rational design for the conduct of this work.