The pre-clinical stage of drug product development encompasses thorough characterization of promising candidates. At this point, stability assessment of the active pharmaceutical ingredients (APIs) is completed. This provides detailed information about the polymorphic landscape of the API, and indicates conditions (temperature, humidity) at which transitions between different crystalline and amorphous forms take place.
Exploring stability using solid form analysis methods, such as in situ X-ray powder diffraction (in situ XRPD), early in development de-risks the whole process of pharmaceutical development by highlighting stable forms with appropriate solubility and bioavailability. These forms can include salts and cocrystals (known for improving solubility), as well as nanosuspensions and amorphous solid dispersions.
Characterizing these forms often demands going beyond XRPD and applying X-ray scattering techniques such as small angle X-ray scattering (SAXS) and pair distribution function (PDF). These analytical approaches will guide you in understanding your API and help in developing formulation and process routes to manufacture larger quantities of drug substances.
This is the third webinar of the “Solid form analysis” series. Join us as we show you how X-ray methods can enhance pre-clinical pharmaceutical development. You’ll also discover how these methods help secure projects by detecting and characterizing as many API forms as possible.
演讲嘉宾
- Natalia Dadivanyan - Segment Manager for Small Molecule, Malvern Panalytical
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Who should attend?
- Anyone working in early and late development of pharmaceuticals
- Anyone involved in manufacturing drug products
What will you learn?
- Explore a range of X-ray scattering techniques that can provide robust solid form analysis data
- Learn how to apply these techniques during pre-clinical stage of drug product development
- Understand how these methods help de-risk your projects