Multi-Route DataFactory for Amorphous Solid Dispersions

Building a multi-route CPS to assess and optimise the manufacturability of direct compressed products, from crystalline powder blends to ASDs. This project will be closely linked with S1 and will contribute to S3 and S4 in terms of manufacturability, stability and performance of products manufactured through different routes.

To address drug delivery limitations of solubility and increasingly complex molecular drug moieties, there is greater emphasis upon the use of amorphous solid dispersions (ASD) for oral administration of pharmaceuticals. To generate ASD systems there are a range of process routes to execute the conversion of raw materials into intermediates (the formulations) and final products (the dose form/tablet).

This research aims to characterise the production routes, investigate production route impact upon the solid state of products and identify modelling routes to further qualify and quantify the route driven phenomenon. Experimental and literature analysis will be used to generate the fundamental solid state and thermodynamic data sets to define stability, instability and metastability "route driven outcomes" as well as physical property and performance data for intermediates and products.

Results will be applied to identification of models and contribution towards a digitally supported rationale for process and product design.