API and Excipient Solid-State Testing
Physical processing of active drug substances and excipients can have a significant effect on both bulk and surface properties of powders. This can subsequently lead to problems arising in the physical stability/manufacturability of the active ingredient and ultimately the final dosage formulation.
Therefore, in order to design an optimal formulation with suitable stability and efficacy, a detailed understanding of the physicochemical properties of the active before and after processing is required.
Our experience and range of advanced solid state characterisation technologies are used to compare bulk and surface properties of drug substances, excipients, granules and aggregates, providing you with a detailed physicochemical profile of your molecule and formulation.
Typical studies include:
- Particle morphology, size and shape distribution
- Hygroscopic tendency and thermal stability
- Detection and quantification of amorphous content generation after physcial processing
- Monitoring changes in surface amorphous/polymorphic state
- Solid-state testing of crystal properties, inc. polymorphs/hydrates/salts
- Powder flow, hardness and micro compressibility testing
- Cohesive/adhesive/mechanical properties
- Rapid excipient compatibility
- Amorphous content determination
Please contact us for more information