Selection of the correct molecule and an understanding of its behavior in-vivo and any potential risks to progression are critical in the development of new medicines. Frequently pharmaceutical scientists are asked to make more decisions earlier in the development process and with less material.
Historically, the measurement of dissolution rate to assess the properties of an Active Pharmaceutical Ingredient (API) has been performed at later stages of development for quality control purposes rather than to select molecules or determine possible performance risks. This approach typically uses large amounts of material and does not provide a fundamental or mechanistic understanding on the behavior of the material or highlight its potential failure modes, and in many cases provide little correlation to changes that could potentially occur in vivo.
GSK will discuss how it uses a suite of tools, including Pion’s range of fiber optic dissolution and UV imaging techniques, to aid the characterization of API’s to improve molecule selection and help identify differences due to changes in various physChem properties.
Key Learning Objectives:
Solubility and dissolution assessment and characterization at different phases of pharmaceutical development.
Novel dissolution methodologies to support molecule and formulation approaches for new chemical entities.
Determination of risk analysis for changing product performance due to the presence of different polymorphic forms, versions or non-robust formulations.
Learn from case studies using UV dissolution data to select, characterize or troubleshoot real molecules currently in research and development, and how this data correlated or supported more traditional pharmaceutical analysis tests such as USP II dissolution.
Who Should Attend:
Pharmaceutical analysts, laboratory technicians and formulation scientists (Industrial Pharmacists), anyone interested in the use of novel dissolution tools to help support molecule and drug product development.
Brought to you by:
Wayne Matthews Principal Investigator R&D, Drug Substance Development, Materials Science UK
Catherine Dold Health & Environment Writer C&EN Media Group