Characterization of the physicochemical properties of a new substance goes hand in hand with pre-formulation and formulation tests. Differential Scanning Calorimetry (DSC) is used for the identification of the API or excipient as well as for the determination of their glass transition and/or melting point. If the API exhibits polymorphism, DSC also states the polymorphic modification of the substance. Finally, it gives information about its eutectic purity.
Thermal and oxidative stability are investigated by means of Thermogravimetric Analysis (TGA).
Both methods can be used to check the interactions between a pharmaceutical and different excipients and/or packaging materials, giving first information about their compatibility.
Additionally, NETZSCH offers solutions for continuous and batch mixing, wet and dry micronization and higher-pressure homogenizers (https://www.netzsch-grinding.com/en/pharma-cosmetics).
Regarding process safety, DSC and ARC (Accelerating Rate Calorimetry) instruments, often in combination with the Kinetic Neo and Thermal Simulation software packages, can identify chemical hazards and simulate worst-case-scenarios.
Quality control ensures efficacy, safety and quality of commercialized drugs. It concerns the raw materials (active ingredients and excipients), drug delivery systems as well as primary packaging, e.g., blisters or bottles.
DSC and TGA check if a material didn´t change its properties during production or if there is a risk of changing its properties during storage and transport (water uptake, polymorphic modification, amorphous/crystalline phase, …) – and all that in line with 21 CFR Part 11 (data integrity).
- Increase of solubility
- Freeze drying
- Process induced transformations
- Characterization of the packaging material
- Interactions between APIs or formulations and packaging