Why is solid form analysis essential for API development?

Why is solid form analysis so critical for the drug development process? 

Verification of the polymorphic form and crystallinity of your active pharmaceutical ingredient (API) is of vital importance when developing new drug products. The presence of an undesired polymorph could lead to a reduction in therapeutic benefit due to changes in API solubility and may even cause an adverse effect to the patient. Polymorph selection, and confirmation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous form of the API is selected in order to improve solubility, as unexpected crystallization of an insoluble form can be fatal.

Whether it’s applying quality by design (QbD) principles to analytical method development, following appropriate regulatory guidance (ICH Q6A, ICH Q2B and USP<941>), or securing method transfer from preclinical development towards scale-up and manufacturing, we have the tools and expertise that you need for successful method development.

Through a combination of theoretical principles and real-life case studies, we will showcase why X-ray Powder Diffraction (XRPD) is so important and how this technique delivers robust methods that ensure drug products meet target performance profiles.

Our expert in solid form analysis of pharmaceuticals, Dr. Natalia Dadivanyan, Segment Manager for Small Molecule Pharmaceuticals, will share her inside knowledge and show how you can make the impossible possible with help of Malvern Panalytical’s expertise, services and instrumentation.