Preclinical development for suspensions

Abstract

This chapter summarizes the significance of suspension in preclinical development. Majority of the preclinical studies are carried out using suspension. Therefore, it is important to know the physical form change, particle size distribution, ease of manufacturability and physico-chemical stability for the molecules used in preclinical studies. Here, the impact of physicochemical properties and formulation on the oral exposure in vivo and toxicity of drug candidates were reviewed in line with other ADME parameters (absorption, distribution, metabolism and elimination). From drug discovery perspective, the latest development of in vitro and in vivo approaches and the opportunity/limitation to assess the potential risks of drug candidates are summarized. Strategy to apply multiple ADME and formulation tools in lead optimization and candidate selection in drug discovery were also demonstrated. Authors focused more on oral suspension, however, there are a number of other dosage forms where suspension can be applied such as topical, parenteral, and inhalation.