Introducing the Revolutionary AmorFx™ Toolkit
Characterisation of processed induced structural disorder and its influence on the functionality and performance of active pharmaceutical ingredients (APIs) for Inhaled Drug Delivery
While conventional bulk analytical tools and screening methods, such as amorphous content detection and quantification, may indirectly highlight changes to the physicochemical properties of the API after processing, their influence on interfacial interactions between drug substances, carrier(s) and components of the device, which govern the overall behaviour and performance of a DPI formulation, are not well understood.
In conjuntion with our Strategic Partner Organisation, Nanopharm Ltd, we have developed a suite of proprietary methodologies and solid-state analytical technologies, including CAB™ analysis, to directly characterise the influence of subtle variations in the physico-chemical and physico-mechanical properties of processed APIs with respect to gaining a deeper scientific understanding into the complex interfacial interactions within solid-state and suspension based formulations.
Developed over several years of internal research, these unique tools and methodologies allow us to make informed decisions throughout our client's research and development programs, facilitating protection measures and optimisation controls earlier on in the development process.
Key descriptors:
- Determining the physico-mechanical properties of feed material and its influence on micronisation performance
- Screening post micronised APIs for variations in degree of mechanically induced surface disorder
- Investigating the influence of processing and storage conditions on the force balance of an API within a DPI formulation with direct correlation to performance
- Determine the surface stability of mechanically activated APIs under accelerated and controlled environmental conditions
- Identifying suitable conditioning requirements for relaxation of process induced surface disorder
- Quantification of low levels of amorphous content (< 1 %) and validation of methods to support regulatory requirements
- Investigating the effect of storage conditions and ageing on the surface relaxation of pharmaceutical materials
This new service offering is available to third parties on a fee-for-service basis. If you would like to see how the AmorFx™ Toolkit can help expidite your inhaled drug development, please contact us directly.
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