Our advanced analytical characterisation services and our understanding of how input material physico-chemical and mechanical properties affect product specification, functionality and stability of orally inhaled and nasal drug products was the foundation of our company.
Therefore we have developed a range of novel technologies for characterising critical material attributed of APIs and excipients and control methodologies required for optimising crystals, particles and powders for OINDPs.
These are accessible through our NANOPLEX service offering that include:
- Mechanical properties of primary crystals.
- Particle characterisation (particle size, surface area, morphology, crystalline form).
- Levels of surface structural disorder created upon micronisation.
- Direct measurement of the relative magnitude of interparticulate forces that control formulation structure and functionality.
- Structural and interfacial stability of APIs post-micronisation.
- Powder rheometry measurements of powder formulations.
These tools have enabled us to characterise and address common pharmaceutical processing issues that include:
- API batch-to-batch processing variability
- API changes during scale-up
- API stability post-micronisation
- Fingerprinting and evaluating third-party sourced APIs
- Lagering or conditioning requirements for stabilising APIs
- The ability to predict and optimise microstructure and product functionality
- Control methodologies required to maintain optimum control of surface and interfacial properties of materials.
- Critical material attributes of excipients.