App B – Technical Updates

Strand 1: continuous drug substance filtration

  • Lab scale CFD20 prototype V1 built by AWL, user feedback from initial evaluation at AZ indicated areas for system improvement resulting in prototype V2
  • Prototype V2 will be evaluated at CMAC Q3 2016 via a design of experiments using paracetamol as a model compound which will explore interaction between variable DS particle properties and filtration parameters and impact on filtration efficiency and resultant DS particle attributes
  • Process data from the CFD20 is collected using PharmaMV software from Perceptive
  • PSE have predictive models for filtration, further model development specific to the AWL design will continue Q3/4 2016 and testing/validation of the model with experimental data will be carried out
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Strand 2 : continuous direct compression

  • CDC50 continuous direct compression test rig is set up at GEA, PharmaMV for process data capture installed by Perceptive
  • A detailed design of experiments on the compact feeder has been completed by GEA, material and data analysis is ongoing at AZ, GSK and Perceptive.
  • Formulation optimisation (compaction simulator work) has been completed at GSK, the composition for a model formulation (paracetamol 10% drug load) has been established to be able to explore the interaction between variable DS particle properties and feeding/blending parameters on product quality attributes
  • Further feeding/blending/compression trials based on formulation variants identified above due in Q3-Q4 2016
  • Empirical models for feeding, blending & compression exist (PSE), further work in 2016 to test and validate those models using experimental data being generated
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Strand 3 : hot melt extrusion

  • 16mm twin screw extruder with Raman PAT probe at the die is set up at CMAC, fully PharmaMV ready with remote access for Perceptive
  • Initial extrusion work on excipients designed for HME is in progress (Affinisol, Plasdone) to establish operating windows for process parameters. Preliminary paracetamol loaded polymer runs carried out, analytics ongoing at AZ/CMAC.
  • Full design of experiments to commence Q3 2016 to explore the interaction between variable DS particle properties and process parameters on extrudate quality attributes
  • The possibility of producing 3D printer ready strands from HME or directly linking the extruder to a 3D printer or injection moulder is being explored to establish a fully continuous process for dose form manufacture
  • Modelling work ongoing at PSE, currently a single phase system, refinement continuing based on equipment set up and material properties
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As AppB partners, Cogent and Britest are leading training activities across all strands of the REMEDIES project focussed on two elements:

  • Compiling evidence for the duration of the REMEDIES project of training and up-skilling activities ongoing across partner organisations arising from project delivery in each work stream
  • Assimilating a prioritised list of legacy training that would be required to ensure that the output of the REMEDIES project continues to build UK pharma manufacturing and supply chain capability in the future