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 for 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.
The second webinar in the series will consider how an appropriate method for XRPD analysis can be developed and how various sample preparation techniques can influence it.
The final webinar will focus on the advanced analysis methods available using an XRPD system which can help with understanding the distribution of components within pharmaceutical dosage forms and can also provide a means of describing amorphous materials.