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Cracking the code for continuous processing and personalised medicine

Summary of the Impact:

Personalised medicine is the next great global challenge for the pharmaceutical industry. The vision of the pharmacy of the future is one in which  pharmacies employ disruptive technologies to enable on-demand manufacture of drugs designed to individual needs. For example, multiple medications may be prescribed that treat a patient’s exact age-profile and medical history. These medications could then be 3D printed into one tablet, on-demand at the patient’s local drug supplier.

Multiple medications may be prescribed that treat a patient’s exact age-profile and medical history

Central to this vision is the concept of continuous processing. Currently, active pharmaceutical ingredients (APIs) are manufactured in large batches at distinctly separate times. Continuous processing replaces this large-batch process with the manufacture of lower volumes but at a constant rate. This process enables the continuous flow of product, reduces inventories, and has less batch-to-batch variation, giving higher process control and higher quality.

Researchers led by Prof Gavin Walker at the Bernal Institute, University of Limerick (UL), are generating the chemical engineering solutions for the challenges of personalised medicine. This highly cited research is changing how we train chemical engineers, impacting industry competitiveness, and attracting R&D investment into Ireland.

References to the research

Investigation of polymorphic transitions of piracetam induced during wet granulation
Potter, C.B., Kollamaram, G., Zeglinski, J., Whitaker, D.A., Croker, D.M., Walker, G.M.
https://doi.org/10.1016/j.ejpb.2017.05.012
Design of spray dried ternary solid dispersions comprising itraconazole, soluplus and HPMCP: Effect of constituent compositions
Davis, M.T., Potter, C.B., Mohammadpour, M., Albadarin, A.B., Walker, G.M.
https://doi.org/10.1016/j.ijpharm.2017.01.043
Nucleation and growth in fluidised hot melt granulation
Zhai, H., Li, S., Andrews, G., Jones, D., Bell, S., Walker, G.
https://doi.org/10.1016/j.powtec.2008.04.021
Development of stability enhanced ternary solid dispersions via combinations of HPMCP and Soluplus® processed by hot melt extrusion
Albadarin, A.B., Potter, C.B., Davis, M.T.,
Iqbal, J., Korde, S., Pagire, S., Paradkar, A.,
Walker, G.
https://doi.org/10.1016/j.ijpharm.2017.09.035
Studies into the effect of temperature on the impact of model particles in co-melt granulation
Grau-Bove, J., Mangwandi, C., Walker, G., Ring, D., Cronin, K.
https://doi.org/10.1016/j.powtec.2016.02.041
Effect of poly ethylene glycol on the mechanical and thermal properties of bioactive poly(ε-caprolactone) melt extrudates for pharmaceutical applications
Douglas, P., Albadarin, A.B., Sajjia, M., Mangwandi, C., Kuhs, M., Collins, M.N., Walker, G.M.
https://doi.org/10.1016/j.ijpharm.2016.01.036
Bioactive PCL matrices with a range of structural & rheological properties
Douglas, P., Kuhs, M., Sajjia, M., Khraisheh, M., Walker, G., Collins, M.N., Albadarin, A.B.
https://doi.org/10.1016/j.reactfunctpolym.2016.02.004
ANN Analysis of a Roller Compaction Process in the Pharmaceutical Industry
Sajjia, M., Shirazian, S., Kelly, C.B., Albadarin, A.B., Walker, G.
https://doi.org/10.1002/ceat.201600229
Artificial neural network modelling of continuous wet granulation using a twin-screw extruder
Shirazian, S., Kuhs, M., Darwish, S., Croker, D., Walker, G.M.
https://doi.org/10.1016/j.ijpharm.2017.02.009
Predicting optimal wet granulation parameters for extrusion-spheronisation of pharmaceutical pellets using a mixer torque rheometer
Kuhs, M., Moore, J., Kollamaram, G., Walker, G., Croker, D.
https://doi.org/10.1016/j.ijpharm.2016.11.057
Characterisation of fluidised bed granulation processes using in-situ Raman spectroscopy
Walker, G.M., Bell, S.E.J., Greene, K., Jones, D.S., Andrews, G.P.
https://doi.org/10.1016/j.ces.2008.09.011
Fluidised bed characterisation using Raman spectroscopy: Applications to pharmaceutical processing
Walker, G., Bell, S.E.J., Vann, M., Jones, D.S., Andrews, G.
https://doi.org/10.1016/j.ces.2007.04.017
Statistical analysis of industrial-scale roller compactor ‘Freund TF-MINI model’
Sajjia, M., Albadarin, A.B., Walker, G.
https://doi.org/10.1016/j.ijpharm.2016.09.052
Regime-separated approach for population balance modelling of continuous wet granulation of pharmaceutical formulations
Shirazian, S., Darwish, S., Kuhs, M., Croker, D.M., Walker, G.M.
https://doi.org/10.1016/j.powtec.2017.11.047
Mechanistic modelling of industrialscale roller compactor ‘Freund TF-MINI model’
Sajjia, M., Shirazian, S., Egan, D., Iqbal, J., Albadarin, A.B., Southern, M., Walker, G.
https://doi.org/10.1016/j.compchemeng.2017.04.018
Organic synthesis by Twin Screw Extrusion (TSE): Continuous, scalable and solvent-free
Crawford, D.E., Miskimmin, C.K.G., Albadarin, A.B., Walker, G., James, S.L.
https://doi.org/10.1039/C6GC03413F
Amorphous solid dispersions of BCS class II drugs: A rational approach to solvent and polymer selection
Davis, M.T., Egan, D.P., Kuhs, M., Albadarin, A.B., Griffin, C.S., Collins, J.A., Walker, G.M.
https://doi.org/10.1016/j.cherd.2016.04.008
Inkjet printing of paracetamol and indomethacin using electromagnetic technology: Rheological compatibility and polymorphic selectivity
Kollamaram, G., Hopkins, S.C., Glowacki, B.A., Croker, D.M., Walker, G.M.
https://doi.org/10.1016/j.ejps.2018.01.036
Spray drying ternary amorphous solid dispersions of ibuprofen – An investigation into critical formulation and processing parameters
Ziaee, A., Albadarin, A.B., Padrela, L., Faucher, A., O’Reilly, E., Walker, G.
https://doi.org/10.1016/j.ejpb.2017.08.005
Electrospun API-loaded mixed matrix membranes for controlled release
Castro-Dominguez, B., Moroney, K., Schaller, B., O’Connor, S., Cloonan, A., Vo, T.T.N., Walker, G., O’Reilly, E.J.
https://doi.org/10.1039/C7RA08600H
A method of processing active pharmaceutical ingredients and apparatus for use in such methods
Albadarin, A.B., Zeglinski, J., Walker, G.
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2019145401
Effect of lignin on the release rate of acetylsalicylic acid tablets
Pishnamazi, M., Iqbal, J., Shirazian, S., Walker, G.M., Collins, M.N.
http://doi.org/10.1016/j.ijbiomac.2018.11.136
Developing ANN-Kriging hybrid model based on process parameters for prediction of mean residence time distribution in twin-screw wet granulation
Ismail, H.Y., Singh, M., Darwish, S., Kuhs, M., Shirazian, S., Croker, D.M., Khraisheh, M., Albadarin, A.B., Walker, G.M.
https://doi.org/10.1016/j.powtec.2018.11.060
Aminopropyl functionalized mesoporous silica SBA-15 as drug carrier for cefazolin: adsorption profiles, release studies, and mineralization potential
Szewczyk, A., Prokopowicz, M., Sawicki, W., Majda, D., Walker, G.
https://doi.org/10.1016/j.micromeso.2018.07.046
Spray drying of pharmaceuticals and biopharmaceuticals: Critical parameters and experimental process optimization approaches
Ziaee, A., Albadarin, A.B., Padrela, L., Femmer, T., O’Reilly, E., Walker, G.
https://doi.org/10.1016/j.ejps.2018.10.026
Microcrystalline cellulose, lactose and lignin blends: Process mapping of dry granulation via roll compaction
Pishnamazi, M., Casilagan, S., Clancy, C., Shirazian, S., Iqbal, J., Egan, D., Edlin, C., Croker, D.M., Walker, G.M., Collins, M.N.
https://doi.org/10.1016/j.powtec.2018.07.003
Invention Disclosure: Continuous drying of active pharmaceutical ingredients in twin screw extruder, UL Invention Disclosure
J Zeglinski, AB Albadarin, G Walker, B Wood
Invention Disclosure: Continuous wet granulation-coupled in situ drying in twin screw granulator for pharmaceutical production
AB Albadarin, J Zeglinski, G Walker
A method of processing active pharmaceutical ingredients and apparatus for use in such methods
AB Albadarin, J Zeglinski, G Walker
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2019145401

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