Polymorph screening in pharmaceutical development

Identifying crystal form is an ongoing challenge in the pharmaceutical industry. Process and storage conditions can result in polymorphic conversions which turn a stable, efficacious form of a drug substance into an unwanted structural analogue. Presence of an undesired polymorph may even cause an adverse effect to the patient. Hence, it is of great importance to be able to identify and quantify multiple polymorphic forms within a formulation.

In this webinar, we will introduce two complementary techniques that make polymorph screening not only possible, but also easy to conduct.

The first analytical approach is Morphologically-Directed Raman Spectroscopy (MDRS), which combines automated image analysis with Raman spectroscopy, and provides chemical identification of individual particles, alongside their detailed size and shape information. Correlations between morphological and spectroscopic results can be investigated to determine whether morphologically-similar groups of particles share similar spectra, saving analytical time and effort.

The second one is X-Ray Powder Diffraction (XRPD), which provides information on the crystal structure of the materials and not only differentiates between various crystalline polymorphs, but also indicates the presence of amorphous forms. Polymorph identification can be extended with precise quantification of the different forms present, as well as other formulation ingredients.

Case studies will be presented, showing the use of MDRS and XRD to investigate the relationship between polymorphs and their morphological properties, as well as quantifying the relative amounts of polymorphs in complex formulations.