Rheology Guided Rational Selection of Processing Temperature To Prepare Copovidone-Nifedipine Amorphous Solid Dispersions via Hot Melt Extrusion (HME).
作者： Fengyuan Yang , Yongchao Su , Jingtao Zhang , James DiNunzio , Anthony Leone
DOI: 10.1021/ACS.MOLPHARMACEUT.6B00516
关键词:
摘要: The production of amorphous solid dispersions via hot melt extrusion (HME) relies on elevated temperature and prolonged residence time, which can result in potential degradation decomposition thermally sensitive components. Herein, the rheological properties a physical mixture polymer an active pharmaceutical ingredient (API) were utilized to guide selection appropriate HME processing temperature. In currently studied copovidone–nifedipine system, critical temperature, is substantially lower (∼13 °C) than melting point crystalline API, was captured during ramp examination regarded as at API could molecularly dissolve into polymer. Based identification this point, various prepared by below, at, above (both below (Tm) API). addition, resultant extrudates along with two contro...
acs.org
sci-hub.se 参考文章(55)
Daniel Treffer, Alexander Troiss, Johannes Khinast, A novel tool to standardize rheology testing of molten polymers for pharmaceutical applications. International Journal of Pharmaceutics. ,vol. 495, pp. 474- 481 ,(2015) , 10.1016/J.IJPHARM.2015.09.001
Simerdeep Singh Gupta, Anuprabha Meena, Tapan Parikh, Abu T. M. Serajuddin, Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion, I: Polyvinylpyrrolidone and related polymers Journal of Excipients and Food Chemicals. ,vol. 5, pp. 32- 45 ,(2014)
Daniel Treffer, Patrick Wahl, Daniel Markl, Gerold Koscher, Eva Roblegg, Johannes G. Khinast, Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process Springer, New York, NY. pp. 363- 396 ,(2013) , 10.1007/978-1-4614-8432-5_15
Robert T. Berendt, Diana M. Sperger, Eric J. Munson, Paul K. Isbester, Solid-state NMR spectroscopy in pharmaceutical research and analysis Trends in Analytical Chemistry. ,vol. 25, pp. 977- 984 ,(2006) , 10.1016/J.TRAC.2006.07.006
Chuanbin Wu, James W McGinity, Influence of methylparaben as a solid-state plasticizer on the physicochemical properties of Eudragit RS PO hot-melt extrudates. European Journal of Pharmaceutics and Biopharmaceutics. ,vol. 56, pp. 95- 100 ,(2003) , 10.1016/S0939-6411(03)00035-3
Sheng Qi, Andreas Gryczke, Peter Belton, Duncan Q.M. Craig, Characterisation of solid dispersions of paracetamol and EUDRAGIT E prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis. International Journal of Pharmaceutics. ,vol. 354, pp. 158- 167 ,(2008) , 10.1016/J.IJPHARM.2007.11.048
Tran N. Pham, Simon A. Watson, Andrew J. Edwards, Manisha Chavda, Jacalyn S. Clawson, Mark Strohmeier, Frederick G. Vogt, Analysis of Amorphous Solid Dispersions Using 2D Solid-State NMR and 1H T1 Relaxation Measurements Molecular Pharmaceutics. ,vol. 7, pp. 1667- 1691 ,(2010) , 10.1021/MP100205G
V. S. Grechishkin, R. V. Grechishkina, G. S. Kuprianova, J. N. Latosińska, B. Nogaj, High-resolution NMR studies of nifedipine Applied Magnetic Resonance. ,vol. 17, pp. 113- 118 ,(1999) , 10.1007/BF03162074
Shigehara Onogi, Toshiro Masuda, Keishi Kitagawa, Rheological Properties of Anionic Polystyrenes. I. Dynamic Viscoelasticity of Narrow-Distribution Polystyrenes Macromolecules. ,vol. 3, pp. 109- 116 ,(1970) , 10.1021/MA60014A001
Geert Verreck, Annelies Decorte, Hongbo Li, David Tomasko, Albertina Arien, Jef Peeters, Patrick Rombaut, Guy Van den Mooter, Marcus E. Brewster, The effect of pressurized carbon dioxide as a plasticizer and foaming agent on the hot melt extrusion process and extrudate properties of pharmaceutical polymers Journal of Supercritical Fluids. ,vol. 38, pp. 383- 391 ,(2006) , 10.1016/J.SUPFLU.2005.11.022