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Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing.
Eur J Pharm Biopharm 2015; 96:106-16EJ

Abstract

The aim of the work reported herein was to implement process analytical technology (PAT) tools during hot melt extrusion (HME) in order to obtain a better understanding of the relationship between HME processing parameters and the extruded formulations. For the first time two in-line NIR probes (transmission and reflectance) have been coupled with HME to monitor the extrusion of the water insoluble drug indomethacin (IND) in the presence of Soluplus (SOL) or Kollidon VA64 hydrophilic polymers. In-line extrusion monitoring of sheets, produced via a specially designed die, was conducted at various drug/polymer ratios and processing parameters. Characterisation of the extruded transparent sheets was also undertaken by using DSC, XRPD and Raman mapping. Analysis of the experimental findings revealed the production of molecular solutions where IND is homogeneously blended (ascertained by Raman mapping) in the polymer matrices, as it acts as a plasticizer for both hydrophilic polymers. PCA analysis of the recorded NIR signals showed that the screw speed used in HME affects the recorded spectra but not the homogeneity of the embedded drug in the polymer sheets. The IND/VA64 and IND/SOL extruded sheets displayed rapid dissolution rates with 80% and 30% of the IND being released, respectively within the first 20min.

Authors+Show Affiliations

Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.ThermoFisher Scientific, Stafford House, Boundary Way, Hemel Hempstead HP2 7GE, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK.Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent ME4 4TB, UK. Electronic address: D.Douroumis@gre.ac.uk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26209124

Citation

Islam, Muhammad T., et al. "Implementation of Transmission NIR as a PAT Tool for Monitoring Drug Transformation During HME Processing." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 96, 2015, pp. 106-16.
Islam MT, Scoutaris N, Maniruzzaman M, et al. Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing. Eur J Pharm Biopharm. 2015;96:106-16.
Islam, M. T., Scoutaris, N., Maniruzzaman, M., Moradiya, H. G., Halsey, S. A., Bradley, M. S., ... Douroumis, D. (2015). Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 96, pp. 106-16. doi:10.1016/j.ejpb.2015.06.021.
Islam MT, et al. Implementation of Transmission NIR as a PAT Tool for Monitoring Drug Transformation During HME Processing. Eur J Pharm Biopharm. 2015;96:106-16. PubMed PMID: 26209124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing. AU - Islam,Muhammad T, AU - Scoutaris,Nikolaos, AU - Maniruzzaman,Mohammed, AU - Moradiya,Hiren G, AU - Halsey,Sheelagh A, AU - Bradley,Michael S A, AU - Chowdhry,Babur Z, AU - Snowden,Martin J, AU - Douroumis,Dennis, Y1 - 2015/07/21/ PY - 2015/02/21/received PY - 2015/06/11/revised PY - 2015/06/16/accepted PY - 2015/7/26/entrez PY - 2015/7/26/pubmed PY - 2016/9/13/medline KW - Hot-melt extrusion KW - In-line monitoring KW - Indomethacin KW - Molecular solutions KW - Near infrared spectroscopy KW - Process analytical technology KW - Raman mapping KW - Reflectance KW - Transmission SP - 106 EP - 16 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 96 N2 - The aim of the work reported herein was to implement process analytical technology (PAT) tools during hot melt extrusion (HME) in order to obtain a better understanding of the relationship between HME processing parameters and the extruded formulations. For the first time two in-line NIR probes (transmission and reflectance) have been coupled with HME to monitor the extrusion of the water insoluble drug indomethacin (IND) in the presence of Soluplus (SOL) or Kollidon VA64 hydrophilic polymers. In-line extrusion monitoring of sheets, produced via a specially designed die, was conducted at various drug/polymer ratios and processing parameters. Characterisation of the extruded transparent sheets was also undertaken by using DSC, XRPD and Raman mapping. Analysis of the experimental findings revealed the production of molecular solutions where IND is homogeneously blended (ascertained by Raman mapping) in the polymer matrices, as it acts as a plasticizer for both hydrophilic polymers. PCA analysis of the recorded NIR signals showed that the screw speed used in HME affects the recorded spectra but not the homogeneity of the embedded drug in the polymer sheets. The IND/VA64 and IND/SOL extruded sheets displayed rapid dissolution rates with 80% and 30% of the IND being released, respectively within the first 20min. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/26209124/Implementation_of_transmission_NIR_as_a_PAT_tool_for_monitoring_drug_transformation_during_HME_processing_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(15)00281-7 DB - PRIME DP - Unbound Medicine ER -