In developing small molecule drug products pharmaceutical scientists must overcome challenges related to the solubility, stability and manufacturability of the Active Pharmaceutical Ingredients (APIs).
The Developability Classification System (DCS) provides useful guidelines for selecting an appropriate formulation technology, based on an assessment of the drug’s fundamental properties and dose expectations. Nowadays, most small molecule drug candidates exhibit poor solubility and require some type of action to transform them into more soluble and/or bioavailable forms. This results in the need for extensive solid-form screening and new formulation types to create competitive pharmaceutical products.
Solid form characterization techniques, such as X-ray Powder Diffraction (XRPD) and Differential Scanning Calorimetry (DSC) are orthogonal methods for understanding structural and phase behavior of pharmaceuticals. These experiments provide great insights on the properties and stability of a material and their shelf-life profile.
In this webinar we are joined by Netzsch to investigate how the combination of X-ray diffraction and scattering techniques and various thermal analysis methods allow us to thoroughly characterize, explain and predict the behaviour of an API. We will then consider how XRPD and DSC can aid formulation developers with material selection and with understanding the impact of formulation processing operations on product performance.
- Natalia Dadivanyan Ph.D. - Application Specialist XRD Malvern Panalytical
- Dr Gabriele Kaiser - Manager for the Business Field for Pharmacy, Cosmetics, and Food of Netzsch
Who should attend?
- Anyone involved in stability studies
- Anyone engaged in chemical development or support of scale-up activities
- Anyone engaged in polymorph screening activities as part of lead optimization activities
- Anyone who is developing pharmaceutical formulations
What will you learn?
- Expand your knowledge on API characterization
- Learn about stability assessment
- Get insight on shelf-life behavior
- Refresh your knowledge of X-ray diffraction and scattering techniques
- Refresh your knowledge of thermal analysis methods