X-ray powder diffraction (XRPD) characterization of amorphous pharmaceutical materials

Small molecule drug products often face multiple development challenges, common amongst which are those relating to solubility, stability and manufacturability.

The Developability Classification System (DCS) provides useful guidelines for selecting a formulation technology, based on assessment of the drug’s fundamental properties and dose expectations. APIs which fall under Class 1 (good solubility, good permeability) were discovered and delivered to the market early on.

Nowadays, the majority of small molecule drug candidates are poorly soluble and belong to Class 2 (a & b). For these molecules, solid-form screening and new formulation types are required to create competitive pharmaceutical products.

In the search for more soluble or bioavailable forms, different types of drug formulations are being considered, including nanoparticles, amorphous solid dispersions, co-crystals and drug carrier systems. In this webinar, we’ll focus on amorphous formulations and address the following questions:

• Are amorphous compounds which are obtained in different experimental conditions the same?
• Are they free of nano-crystalline material and are they truly amorphous?
• What are the best ways of quantifying low and high amorphous content?
• How we can we use X-ray diffraction to answer these, and more, questions?

• Who should attend?

- Anyone engaged in developing methods for XRPD

- Anyone engaged in producing or setting specifications for pharmaceutical raw materials or intermediates

- Anyone who is developing pharmaceutical formulations

• What will you learn?
  

- To learn about advanced applications of an XRPD system that are important for characterization of amorphous materials 

- Understand how these methods can be applied within pharmaceutical development