Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP)

Lead Research Organisation: University of Strathclyde
Department Name: Inst of Pharmacy and Biomedical Sci

Abstract

The Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP) Centre will create a new international collaboration bringing together a world-leading group of researchers from the UK (University of Strathclyde), Denmark (University of Copenhagen) and Belgium (Ghent University) to deliver a step change in fundamental understanding of amorphous materials in order to apply to real industrial challenges in medicines manufacturing. Amorphous materials are different from the crystalline materials commonly used in medicines and offer substantial opportunities to address challenges in current products including improved processing, stability and overall performance in patients.

The centre's will address key research questions that underpin the selection, production and application of amorphous molecular solids in medicines development and manufacture. Research is split across four work packages, WP1-4:

WP1 will establish a unique Amorphous Pharmaceuticals Database (APDb) as a research platform to share data across the project, inform model development and disseminate data with the wider community. Specific research aims include establishing a predictive Amorphous Stability Index (ASI) for drug molecules and to investigate the solid-state structure of amorphous drugs as well as co-amorphous and drug-polymer systems using techniques including X-ray PDF, modelling and refinement approaches. This work will allow us to better understand how these materials behave and how best to exploit them in manufacturing processes.

WP2 will develop predictive methodologies and tools for right-first-time amorphous pharmaceutical processing via Hot Melt Extrusion (HME), the process of applying heat and pressure to melt a material, and subsequent dose form processing steps including compression and 3D printing. The team will exploit advanced continuous processing and analytical capabilities available across all three partners and through powerful x-rays, to investigate transformations and stability of amorphous materials during key secondary processing steps such as milling, compaction, drying and additive manufacturing.

WP3 will investigate the mechanisms and structural changes of drug release from amorphous dosage forms in biorelevant media, e.g. that simulate stomach and intestinal fluids, to develop models for performance prediction of amorphous solid dosage forms in patients. Drawing on progress in WP1 and 2 the extensive dissolution and analytical capabilities across the international partners will identify drug release mechanisms and physical transformations that occur in systems during use. We will modify composition and structure to achieve control over release.

WP4 will be managed by the project team to strengthen collaboration across the researchers and partners through sharing data, training, best practices and learning. Mobility and knowledge exchange between centres will be promoted through Faculty and Researcher exchanges with face-to-face progress meetings rotating round centres. Regular virtual meetings will be used to agree plans and track progress. Digital tools (MIRO, Electronic Laboratory Notebooks - ELN) and data management plans will ensure ongoing comms across DDMAP and a digital comms plan will ensure timely dissemination of outputs and outcomes with the international academic and industrial communities. Industrial case studies that integrate outputs from WP1-3 will be disseminated and promoted globally through networks, social media and virtual events anticipated to outreach to tens of thousands based on current network reach analytics. These include examples such as an open access database for amorphous materials (APDb) and access to developed amorphous indexing tool.

Publications

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