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A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion
Kelly, Adrian L. Halsey, S.A. Bottom, R.A. Korde, Sachin A.
Kelly, Adrian L.
Halsey, S.A.
Bottom, R.A.
Korde, Sachin A.
Publication Date
2015-12-30
End of Embargo
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Rights
© 2015 Elsevier. Reproduced in accordance with the publisher's self-archiving policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Peer-Reviewed
Yes
Open Access status
openAccess
Accepted for publication
2015-07-08
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Department
Awarded
Embargo end date
Additional title
Abstract
A transflectance near infra red (NIR) spectroscopy approach has been used to simultaneously measure drug and plasticiser content of polymer melts with varying opacity during hot melt extrusion. A high temperature reflectance NIR probe was mounted in the extruder die directly opposed to a highly reflective surface. Carbamazepine (CBZ) was used as a model drug, with polyvinyl pyrollidone-vinyl acetate co-polymer (PVP-VA) as a matrix and polyethylene glycol (PEG) as a plasticiser. The opacity of the molten extrudate varied from transparent at low CBZ loading to opaque at high CBZ loading. Particulate amorphous API and voids formed around these particles were found to cause the opacity. The extrusion process was monitored in real time using transflectance NIR; calibration and validation runs were performed using a wide range of drug and plasticiser loadings. Once calibrated, the technique was used to simultaneously track drug and plasticiser content during applied step changes in feedstock material. Rheological and thermal characterisations were used to help understand the morphology of extruded material. The study has shown that it is possible to use a single NIR spectroscopy technique to monitor opaque and transparent melts during HME, and to simultaneously monitor two distinct components within a formulation.
Version
Accepted manuscript
Citation
Kelly AL, Halsey SA, Bottom RA et al (2015) A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion. International Journal of Pharmaceutics. 496(1): 117-123.
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Article