Assessment of Dosage Forms In Vitro

Abstract

This chapter presents descriptions of some in vitro tests which can be applied to pharmaceutical products, using some of the background physical chemistry discussed in other chapters. In particular, we will examine the influence of some of the key parameters of pharmaceutical systems, such as particle size, viscosity, adhesion or formulation in general on drug release or performance. It is necessary to appreciate the importance of in vitro testing in formulation development, in batch-to-batch control and in assessing defects in products. In vitro tests might be preferred when there is a good correlation between in vitro and in vivo behaviour, but it should be appreciated that such correlations or indeed physiological verisimilitude are not essential for validity in quality control, where reproducibility of a product is in itself a goal.