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NTIS 바로가기Frontiers in chemistry, v.6, 2018년, pp.4 -
Horn, Jacqueline , Friess, Wolfgang
The collapse temperature (Tc) and the glass transition temperature of freeze-concentrated solutions (Tg') as well as the crystallization behavior of excipients are important physicochemical characteristics which guide the cycle development in freeze-drying. The most frequently used methods to determ...
Adams G. D. Ramsay J. R. ( 1996 ). Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-asparaginase . J. Pharm. Sci . 85 , 1301 – 1305 . 10.1021/js960146p 8961143
Akyurt M. Zaki G. Habeebullah B. ( 2002 ). Freezing phenomena in ice-water systems . Energy Convers. Manag . 43 , 1773 – 1789 . 10.1016/S0196-8904(01)00129-7
Arshad M. S. Smith G. Polygalov E. Ermolina I. ( 2014 ). Through-vial impedance spectroscopy of critical events during the freezing stage of the lyophilization cycle: the example of the impact of sucrose on the crystallization of mannitol . Eur. J. Pharm. Biopharm. 87 , 598 – 605 . 10.1016/j.ejpb.2014.05.005 24825125
Beirowski J. Inghelbrecht S. Arien A. Gieseler H. ( 2017 ). Freeze drying of nanosuspensions, 2: the role of the critical formulation temperature on stability of drug nanosuspensions and its practical implication on process design . J. Pharm. Sci . 100 , 4471 – 4481 . 10.1002/jps.22634 21607957
Bosca S. Barresi A. A. Fissore D. ( 2013 ). Fast freeze-drying cycle design and optimization using a PAT based on the measurement of product temperature . Eur. J. Pharm. Biopharm. 85 , 253 – 262 . 10.1016/j.ejpb.2013.04.008 23631849
Bosch T. ( 2014 ). Aggressive Freeze-Drying – a Fast and Suitable Method to Stabilize Biopharmaceuticals . Ludwig-Maximilians Universität München
Cavatur R. K. Vemuri N. M. Pyne A. Chrzan Z. Toledo-Velasquez D. Suryanarayanan R. ( 2002 ). Crystallization behavior of mannitol in frozen aqueous solutions . Pharm. Res. 19 , 894 – 900 . 10.1023/A:1016177404647 12134963
Chatterjee K. Shalaev E. Y. Suryanarayanan R. ( 2005 ). Partially crystalline systems in lyophilization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery . J. Pharm. Sci. 94 , 809 – 820 . 10.1002/jps.20304 15729705
Colandene J. D. Maldonado L. M. Creagh A. T. Vrettos J. S. Goad K. G. Spitznagel T. M. ( 2007 ). Lyophilization cycle development for a high-concentration monoclonal antibody formulation lacking a crystalline bulking agent . J. Pharm. Sci . 96 , 1598 – 1608 . 10.1002/jps.20812 17117409
Coleman N. J. Craig D. Q. M. ( 1996 ). Modulated temperature differential scanning calorimetry: a novel approach to pharmaceutical thermal analysis . Int. J. Pharm. 135 , 13 – 29 . 10.1016/0378-5173(95)04463-9
De Beer T. R. M. Alleso M. Goethals F. Coppens A. Vander Heyden Y. Lopez De Diego H. . ( 2007 ). Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring . Anal. Chem . 79 , 7992 – 8003 . 10.1021/ac070549h 17896825
De Beer T. R. M. Vercruysse P. Burggraeve A. Quinten T. Ouyang J. Zhang X. . ( 2009 ). In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools . J. Pharm. Sci. 98 , 3430 – 3446 . 10.1002/jps.21633 19130604
Depaz R. A. Pansare S. Patel S. M. ( 2016 ). Freeze-drying above the glass transition temperature in amorphous protein formulations while maintaining product quality and improving process efficiency . J. Pharm. Sci . 105 , 40 – 49 . 10.1002/jps.24705 26580140
Evans S. A. Morris K. R. Mackenzie A. P. Lordi N. G. ( 1995 ). Dielectric characterization of thermodynamic first order events in model frozen systems intended for lyophilization . PDA J. Pharm. Sci. Technol . 49 , 2 – 8 . 7757454
Greco K. Mujat M. Galbally-kinney K. L. Hammer D. X. Ferguson R. D. Iftimia N. . ( 2013 ). Accurate prediction of collapse temperature using optical coherence tomography-based freeze-drying microscopy . J. Pharm. Sci . 102 , 1773 – 1785 . 10.1002/jps.23516 23681564
Hawe A. Frieß W. ( 2006 ). Impact of freezing procedure and annealing on the physico-chemical properties and the formation of mannitol hydrate in mannitol-sucrose-NaCl formulations . Eur. J. Pharm. Biopharm . 64 , 316 – 325 . 10.1016/j.ejpb.2006.06.002 16875806
Her L.-M. Nail S. L. ( 1994 ). Measurement of glass transition temperatures of freeze-concentrated solutes by differential scanning calorimetry . Pharm. Res . 11 , 54 – 59 . 10.1023/A:1018989509893 8140056
Izutsu K. Kojima S. ( 2002 ). Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying . J. Pharm. Pharmacol. 54 , 1033 – 1039 . 10.1211/002235702320266172 12195816
Jena S. Horn J. Suryanarayanan R. Friess W. Aksan A. ( 2017 ). Effects of Excipient Interactions on the state of the freeze-concentrate and protein stability . Pharm. Res. 34 , 462 – 478 . 10.1007/s11095-016-2078-y 27981449
Jena S. Suryanarayanan R. Aksan A. ( 2016 ). Mutual influence of mannitol and trehalose on crystallization behavior in frozen solutions . Pharm. Res. 33 , 1413 – 1425 . 10.1007/s11095-016-1883-7 26908047
Jiang G. Akers M. Jain M. Guo J. Distler A. Swift R. . ( 2007 ). Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol . PDA J. Pharm. Sci. Technol. 61 , 441 – 451 . 18410045
Johnson R. E. Kirchhoff C. F. Gaud H. T. ( 2002 ). Mannitol-sucrose mixtures–versatile formulations for protein lyophilization . J. Pharm. Sci. 91 , 914 – 922 . 10.1002/jps.10094 11948529
Kaialy W. Khan U. Mawlud S. ( 2016 ). Influence of mannitol concentration on the physicochemical, mechanical and pharmaceutical properties of lyophilised mannitol . Int. J. Pharm . 510 , 73 – 85 . 10.1016/j.ijpharm.2016.05.052 27242312
Kasper J. C. Wiggenhorn M. Resch M. Friess W. ( 2013 ). Implementation and evaluation of an optical fiber system as novel process monitoring tool during lyophilization . Eur. J. Pharm. Biopharm . 83 , 449 – 459 . 10.1016/j.ejpb.2012.10.009 23159708
Liao X. Krishnamurthy R. Suryanarayanan R. ( 2005 ). Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol-implications in freeze-drying . Pharm. Res . 22 , 1978 – 1985 . 10.1007/s11095-005-7625-x 16132343
Liao X. Krishnamurthy R. Suryanarayanan R. ( 2007 ). Influence of processing conditions on the physical state of mannitol–implications in freeze-drying . Pharm. Res . 24 , 370 – 376 . 10.1007/s11095-006-9158-3 17177113
Meister E. Gieseler H. ( 2009 ). Freeze-dry microscopy of protein/sugar mixtures: drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data . J. Pharm. Sci . 98 , 3072 – 3087 . 10.1002/jps.21586 18823013
Nail S. Tchessalov S. Shalaev E. Ganguly A. Renzi E. Dimarco F. . ( 2017 ). Recommended best practices for process monitoring instrumentation in pharmaceutical freeze drying-−2017 . AAPS PharmSciTech 18 , 2379 – 2393 . 10.1208/s12249-017-0733-1 28205144
Oetjen G. W. Haseley P. ( 2004 ). Freeze-Drying . Weinheim : Wiley-VHC .
Pansare S. K. Patel S. M. ( 2016 ). Practical considerations for determination of glass transition temperature of a maximally freeze concentrated solution . AAPS PharmSciTech 17 , 1 – 15 . 10.1208/s12249-016-0551-x 26860744
Passot S. Fonseca F. Barbouche N. Marin M. Alarcon-Lorca M. Rolland D. . ( 2007 ). Effect of product temperature during primary drying on the long-term stability of lyophilized proteins . Pharm. Dev. Technol . 12 , 543 – 553 . 10.1080/10837450701563459 18161627
Patel K. Munjal B. Bansal A. K. ( 2017 ). Effect of cyclophosphamide on the solid form of mannitol during lyophilization . Eur. J. Pharm. Sci . 101 , 251 – 257 . 10.1016/j.ejps.2017.02.025 28214546
Peters B.-H. Staels L. Rantanen J. Molnár F. De Beer T. Lehto V.-P. . ( 2016 ). Effects of cooling rate in microscale and pilot scale freeze-drying - variations in excipient polymorphs and protein secondary structure . Eur. J. Pharm. Sci . 95 , 72 – 81 . 10.1016/j.ejps.2016.05.020 27221369
Pikal M. J. ( 1990 ). Freeze-drying of proteins. part i: process design . Biopharm 3 , 18 – 23 .
Pisano R. Fissore D. Barresi A. A. Brayard P. Chouvenc P. Woinet B. ( 2013 ). Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol . Pharm. Dev. Technol. 18 , 280 – 295 . 10.3109/10837450.2012.734512 23078169
Pyne A. Surana R. Suryanarayanan R. ( 2002 ). Crystallization of mannitol below Tg' during freeze-drying in binary and ternary aqueous systems . Pharm. Res . 19 , 901 – 908 . 10.1023/A:1016129521485 12134964
Randolph T. W. ( 1997 ). Phase separation of excipients during lyophilization: effects on protein stability . J. Pharm. Sci. 86 , 1198 – 1203 . 10.1021/js970135b 9383725
Shah B. Kakumanu V. K. Bansal A. K. ( 2006 ). Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids . J. Pharm. Sci . 95 , 1641 – 1665 . 10.1002/jps.20644 16802362
Varshney D. B. Kumar S. Shalaev E. Y. Sundaramurthi P. Kang S.-W. Gatlin L. A. . ( 2007 ). Glycine crystallization in frozen and freeze-dried systems: effect of pH and buffer concentration . Pharm. Res . 24 , 593 – 604 . 10.1007/s11095-006-9178-z 17245648
Williams N. A. Dean T. ( 1991 ). Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration . J. Parenter. Sci. Technol. 45 , 94 – 100 . 1904931
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