Date recorded: June 09 2020

Duration: 45 minutes 49 seconds

Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are crucial. 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 conformation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous form of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal.

This webinar series will consider the guidance available regarding polymorph and crystallinity analysis for pharmaceutical products and how appropriate methods can be developed using the technique of X-Ray Powder Diffraction (XRPD).

In this first presentation we will discuss why a polymorph specification may be required. We’ll review the guidance provided in ICH Q6A, which recommends that formulation developers consider how product bioavailability, uniformity, stability and processability may be impacted by structural changes. We will then consider how XRPD can aid formulation developers in material selection and in understanding the impact of formulation processing operations on product performance.

Join our series of Pharma oral solid dose drugs analysis

- Webinar 1: Polymorphic and crystallinity screening of your APIs and more in your oral solid dose drugs using X-ray diffraction
- Webinar 2: Advanced polymorphic screening using in-situ measurements. More info 
- Webinar 3: Introduction to powder X-ray diffraction. More info
- Webinar 4: Checking the stability, efficacy and performance of your APIs with particle size analysis using laser diffraction. More info

Table of contents
1. Why solid form analysis
2. Quality by Design
3. What can be considered CMA
4. Solutions for solid form analysis
5. Crystallization monitoring
6. Online monitoring benefits
7. In-situ studies
8. Polymorph case study
9. Summary
10. Q & A