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.
In this third and final webinar in the series, we will focus on the advanced analysis methods available using an XRPD system. These methods can help with understanding the following aspects of pharmaceutical products:
- Stability of a formulation over time and as a function of temperature and/or relative humidity;
- Distribution of components within pharmaceutical solid dosage forms;
- Influence of different manufacturing methods on the internal and surface structure for solid dosage forms;
- Amorphous content and the structure of amorphous materials, in support of stability studies and detailed product specification.