Supercritical fluid micronization techniques for gastroresistant insulin formulations

© 2015 Published by Elsevier B.V. The application of three supercritical processes to the micronization of gastroresistant insulin formulations is presented. As pharmaceutical applications of the supercritical anti-solvent micronization processes are becoming established at the bench scale, it is ti...

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Main Authors: Tandya, A., Zhuang, H., Mammucari, R., Foster, Neil
Format: Journal Article
Published: Elsevier BV 2016
Online Access:http://hdl.handle.net/20.500.11937/55560
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author Tandya, A.
Zhuang, H.
Mammucari, R.
Foster, Neil
author_facet Tandya, A.
Zhuang, H.
Mammucari, R.
Foster, Neil
author_sort Tandya, A.
building Curtin Institutional Repository
collection Online Access
description © 2015 Published by Elsevier B.V. The application of three supercritical processes to the micronization of gastroresistant insulin formulations is presented. As pharmaceutical applications of the supercritical anti-solvent micronization processes are becoming established at the bench scale, it is timely that they are compared in terms of product characteristics and scalability aspects. The formulation of insulin with the gastroresistant coating hydroxypropyl methyl cellulose phthalate was conducted by the Gas Anti-Solvent (GAS), the Aerosol Solvent Extraction System (ASES) and the Atomized Rapid Injection for Solvent Extraction (ARISE) processes and results have been compared in terms of insulin content of the microparticles, product morphology and recovery. The insulin content in products was in the range of 9-47%. The particles produced by the GAS process were flake-like in the 1-2 µm range with bi-modal distribution, while particles produced by the ASES and ARISE processes were spherical in the 100-300 nm particle size range with unimodal size distribution. Compared to GAS and ASES, the ARISE process produced the highest recoveries and insulin loadings: 77% and 47%, respectively. Particle characteristics, process recoveries and operational aspects indicate that ARISE should be the process of choice for scale-up.
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spelling curtin-20.500.11937-555602017-09-13T16:11:01Z Supercritical fluid micronization techniques for gastroresistant insulin formulations Tandya, A. Zhuang, H. Mammucari, R. Foster, Neil © 2015 Published by Elsevier B.V. The application of three supercritical processes to the micronization of gastroresistant insulin formulations is presented. As pharmaceutical applications of the supercritical anti-solvent micronization processes are becoming established at the bench scale, it is timely that they are compared in terms of product characteristics and scalability aspects. The formulation of insulin with the gastroresistant coating hydroxypropyl methyl cellulose phthalate was conducted by the Gas Anti-Solvent (GAS), the Aerosol Solvent Extraction System (ASES) and the Atomized Rapid Injection for Solvent Extraction (ARISE) processes and results have been compared in terms of insulin content of the microparticles, product morphology and recovery. The insulin content in products was in the range of 9-47%. The particles produced by the GAS process were flake-like in the 1-2 µm range with bi-modal distribution, while particles produced by the ASES and ARISE processes were spherical in the 100-300 nm particle size range with unimodal size distribution. Compared to GAS and ASES, the ARISE process produced the highest recoveries and insulin loadings: 77% and 47%, respectively. Particle characteristics, process recoveries and operational aspects indicate that ARISE should be the process of choice for scale-up. 2016 Journal Article http://hdl.handle.net/20.500.11937/55560 10.1016/j.supflu.2015.08.009 Elsevier BV restricted
spellingShingle Tandya, A.
Zhuang, H.
Mammucari, R.
Foster, Neil
Supercritical fluid micronization techniques for gastroresistant insulin formulations
title Supercritical fluid micronization techniques for gastroresistant insulin formulations
title_full Supercritical fluid micronization techniques for gastroresistant insulin formulations
title_fullStr Supercritical fluid micronization techniques for gastroresistant insulin formulations
title_full_unstemmed Supercritical fluid micronization techniques for gastroresistant insulin formulations
title_short Supercritical fluid micronization techniques for gastroresistant insulin formulations
title_sort supercritical fluid micronization techniques for gastroresistant insulin formulations
url http://hdl.handle.net/20.500.11937/55560