Formulation and Quality
2019 PharmSci 360
Oral administration of small molecules has become increasingly difficult due to a majority of new candidates demonstrating poor aqueous solubility. This presentation focuses on the rationale for selecting technologies that enable progression of such compounds, based on compound’s physical properties (e.g. melt and glass-transition temperatures, Log P) and product specifications (e.g. dose, pharmacokinetics, permeability). Predictive modelling and rapid screening best practices will also be discussed along with representative case studies demonstrating the parameters and rationale for choosing particle size reduction, solid dispersion or lipid-based approaches. Science of scale considerations for advancing early formulations through clinic and commercialization will also be covered.
In this presentation, participants will learn about a proven approach for selecting phase-appropriate enabling technology, from compound onboarding to drug intermediate and dosage form manufacture.