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Volumn , Issue , 2007, Pages 197-218

Rational Choice of Excipients for Use in Lyophilized Formulations

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EID: 85144143558     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9780849379529-12     Document Type: Chapter
Times cited : (24)

References (85)
  • 1
    • 0034255393 scopus 로고    scopus 로고
    • Lyophilization and development of solid protein pharmaceuticals
    • Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 2000; 203:1-60.
    • (2000) Int J Pharm , vol.203 , pp. 1-60
    • Wang, W.1
  • 2
    • 0036371181 scopus 로고    scopus 로고
    • Spray-drying of proteins
    • Lee G. Spray-drying of proteins. Pharm Biotechnol 2002; 13:135-158.
    • (2002) Pharm Biotechnol , vol.13 , pp. 135-158
    • Lee, G.1
  • 5
    • 0028366155 scopus 로고
    • Protein purification process engineering. Freeze-drying: A practical overview
    • Gatlin LA, Nail SL. Protein purification process engineering. Freeze-drying: a practical overview. Bioprocess Technol 1994; 18:317-367.
    • (1994) Bioprocess Technol , vol.18 , pp. 317-367
    • Gatlin, L.A.1    Nail, S.L.2
  • 7
    • 33645170297 scopus 로고    scopus 로고
    • Pharmaceutical Aspects, 2(Lyophilization of Biopharmaceuticals)
    • Excipients for use in lyophilized pharmaceutical peptide, protein, and other bioproducts. Biotechnology
    • Costantino HR. Excipients for use in lyophilized pharmaceutical peptide, protein, and other bioproducts. Biotechnology: Pharmaceutical Aspects, 2(Lyophilization of Biopharmaceuticals). AAPS Press, 2004:139-228.
    • (2004) AAPS Press , pp. 139-228
    • Costantino, H.R.1
  • 9
    • 25444466477 scopus 로고    scopus 로고
    • Thermodynamic and dynamic factors involved in the stability of native protein structure in amorphous solids in relation to levels of hydration
    • Hill JJ, Shalaev EY, Zografi G. Thermodynamic and dynamic factors involved in the stability of native protein structure in amorphous solids in relation to levels of hydration. J Pharm Sci 2005; 94:1636-1667.
    • (2005) J Pharm Sci , vol.94 , pp. 1636-1667
    • Hill, J.J.1    Shalaev, E.Y.2    Zografi, G.3
  • 10
    • 33847115952 scopus 로고    scopus 로고
    • Freeze-drying. Encyclopedia of Pharmaceutical Technology
    • Pikal MJ. Freeze-drying. Encyclopedia of Pharmaceutical Technology. Marcel Dekker, 2002:1299-1326.
    • (2002) Marcel Dekker , pp. 1299-1326
    • Pikal, M.J.1
  • 11
    • 0346136373 scopus 로고    scopus 로고
    • Solid-Liquid state diagrams in pharmaceutical lyophilisation: Crystallisation of solutes
    • Cambridge: The Royal Society of Chemistry
    • Shalaev E, Franks F. Solid-Liquid state diagrams in pharmaceutical lyophilisation: crystallisation of solutes. In: Levine H, ed. Progress in Amorphous Food and Pharmaceutical Systems. Cambridge: The Royal Society of Chemistry, 2002:200-215.
    • (2002) Progress in Amorphous Food and Pharmaceutical Systems , pp. 200-215
    • Shalaev, E.1    Franks, F.2    Levine, H.3
  • 12
    • 0013448890 scopus 로고
    • Solid-liquid state diagram of the water-glycine-sucrose system
    • Shalaev EY, Kanev AN. Solid-liquid state diagram of the water-glycine-sucrose system. Cryobiology 1994; 31:374-382.
    • (1994) Cryobiology , vol.31 , pp. 374-382
    • Shalaev, E.Y.1    Kanev, A.N.2
  • 13
    • 0033558793 scopus 로고    scopus 로고
    • Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization
    • Heller MC, Carpenter JF, Randolph TW. Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization. Arch Biochem Biophys 1999; 363:191-201.
    • (1999) Arch Biochem Biophys , vol.363 , pp. 191-201
    • Heller, M.C.1    Carpenter, J.F.2    Randolph, T.W.3
  • 14
    • 0037407268 scopus 로고    scopus 로고
    • Crystalline to amorphous transition of disodium hydrogen phosphate during primary drying
    • Pyne A, Chatterjee K, Suryanarayanan R. Crystalline to amorphous transition of disodium hydrogen phosphate during primary drying. Pharm Res 2003; 20:802-803.
    • (2003) Pharm Res , vol.20 , pp. 802-803
    • Pyne, A.1    Chatterjee, K.2    Suryanarayanan, R.3
  • 15
    • 0028342799 scopus 로고
    • Physical stability and protein stability of freeze-dried cakes during storage at elevated temperatures
    • Izutsu K, Yoshioka S, Kojima S. Physical stability and protein stability of freeze-dried cakes during storage at elevated temperatures. Pharm Res 1994; 11:995-999.
    • (1994) Pharm Res , vol.11 , pp. 995-999
    • Izutsu, K.1    Yoshioka, S.2    Kojima, S.3
  • 16
    • 0035054119 scopus 로고    scopus 로고
    • Effect of initial buffer composition on pH changes during far-from-equilibrium freezing of sodium phosphate buffer solutions
    • Gomez G, Pikal MJ, Rodriguez-Hornedo N. Effect of initial buffer composition on pH changes during far-from-equilibrium freezing of sodium phosphate buffer solutions. Pharm Res 2001; 18:90-97.
    • (2001) Pharm Res , vol.18 , pp. 90-97
    • Gomez, G.1    Pikal, M.J.2    Rodriguez-Hornedo, N.3
  • 17
    • 16844378947 scopus 로고    scopus 로고
    • Raffinose crystallization during freeze-drying and its impact on recovery of protein activity
    • Chatterjee K, Shalaev EY, Suryanarayanan R. Raffinose crystallization during freeze-drying and its impact on recovery of protein activity. Pharm Res 2005; 22:303-309.
    • (2005) Pharm Res , vol.22 , pp. 303-309
    • Chatterjee, K.1    Shalaev, E.Y.2    Suryanarayanan, R.3
  • 19
    • 0028913711 scopus 로고
    • Hydration and dehydration of crystalline and amorphous forms of raffinose
    • Saleki-Gerhardt A, Stowell JG, Byrn SR, Zografi G. Hydration and dehydration of crystalline and amorphous forms of raffinose. J Pharm Sci 1995; 84:318-323.
    • (1995) J Pharm Sci , vol.84 , pp. 318-323
    • Saleki-Gerhardt, A.1    Stowell, J.G.2    Byrn, S.R.3    Zografi, G.4
  • 20
    • 85144121456 scopus 로고    scopus 로고
    • Compositions In Glassy Phase, Stabilized By a Sugar
    • In: The Patent Cooperation Treaty, ed
    • Franks F, Auffret AD, Aldous BJ. Compositions In Glassy Phase, Stabilized By a Sugar. In: The Patent Cooperation Treaty, ed. International: WO 96/33744; 1996:40.
    • (1996) International: WO 96/33744 , pp. 40
    • Franks, F.1    Auffret, A.D.2    Aldous, B.J.3
  • 21
    • 0002678950 scopus 로고    scopus 로고
    • Changes in the physical state of model mixtures during freezing and drying: Impact on product quality
    • Shalaev EY, Franks F. Changes in the physical state of model mixtures during freezing and drying: impact on product quality. Cryobiology 1996; 33:14-26.
    • (1996) Cryobiology , vol.33 , pp. 14-26
    • Shalaev, E.Y.1    Franks, F.2
  • 22
    • 17744375823 scopus 로고    scopus 로고
    • Partially crystalline systems in lyophi-lization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery
    • Chatterjee K, Shalaev EY, Suryanarayanan R. Partially crystalline systems in lyophi-lization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery. J Pharm Sci 2005; 94:809-820.
    • (2005) J Pharm Sci , vol.94 , pp. 809-820
    • Chatterjee, K.1    Shalaev, E.Y.2    Suryanarayanan, R.3
  • 23
    • 0033637883 scopus 로고    scopus 로고
    • Freeze-concentration separates proteins and polymer excipients into different amorphous phases
    • Izutsu K-I, Kojima S. Freeze-concentration separates proteins and polymer excipients into different amorphous phases. Pharm Res 2000; 17:1316-1322.
    • (2000) Pharm Res , vol.17 , pp. 1316-1322
    • Izutsu, K.-I.1    Kojima, S.2
  • 24
    • 0031952684 scopus 로고    scopus 로고
    • Characterization of frozen aqueous solutions by low temperature X-ray powder diffractometry
    • Cavatur RK, Suryanarayanan R. Characterization of frozen aqueous solutions by low temperature X-ray powder diffractometry. Pharm Res 1998; 15:194-199.
    • (1998) Pharm Res , vol.15 , pp. 194-199
    • Cavatur, R.K.1    Suryanarayanan, R.2
  • 25
    • 27144484848 scopus 로고    scopus 로고
    • Quantification of crystallinity in substantially amorphous materials by synchrotron x-ray powder diffractometry
    • Nunes C, Mahendrasingam A, Suryanarayanan R. Quantification of crystallinity in substantially amorphous materials by synchrotron x-ray powder diffractometry. Pharm Res 2005; 22:1942-1953.
    • (2005) Pharm Res , vol.22 , pp. 1942-1953
    • Nunes, C.1    Mahendrasingam, A.2    Suryanarayanan, R.3
  • 26
    • 33749451068 scopus 로고    scopus 로고
    • Solute crystallization in frozen systems-use of synchrotron radiation to improve sensitivity
    • Varshney DB, Kumar S, Shalaev EY, Kang S-W, Gatlin LA, Suryanarayanan R. Solute crystallization in frozen systems-use of synchrotron radiation to improve sensitivity. Pharm Res 2006; 23(10):2368-2374.
    • (2006) Pharm Res , vol.23 , Issue.10 , pp. 2368-2374
    • Varshney, D.B.1    Kumar, S.2    Shalaev, E.Y.3    Kang, S.-W.4    Gatlin, L.A.5    Suryanarayanan, R.6
  • 27
    • 0018987451 scopus 로고
    • Buffers-pH control within pharmaceutical systems
    • Flynn G. Buffers-pH control within pharmaceutical systems. J Parenteral Drug Assoc 1980; 34:139-162.
    • (1980) J Parenteral Drug Assoc , vol.34 , pp. 139-162
    • Flynn, G.1
  • 28
    • 33745916544 scopus 로고    scopus 로고
    • The impact of buffer on processing and stability of freeze-dried dosage forms, Part 1. Solution freezing behavior
    • Shalaev EY. The impact of buffer on processing and stability of freeze-dried dosage forms, Part 1. Solution freezing behavior. Am Pharm Rev 2005; 8:80-87.
    • (2005) Am Pharm Rev , vol.8 , pp. 80-87
    • Shalaev, E.Y.1
  • 29
    • 0036178469 scopus 로고    scopus 로고
    • Thermophysical properties of pharmaceutically compatible buffers at sub-zero temperatures: Implications for freeze-drying
    • Shalaev E, Johnson-Elton T, Chang L, Pikal MJ. Thermophysical properties of pharmaceutically compatible buffers at sub-zero temperatures: implications for freeze-drying. Pharm Res 2002; 19:195-201.
    • (2002) Pharm Res , vol.19 , pp. 195-201
    • Shalaev, E.1    Johnson-Elton, T.2    Chang, L.3    Pikal, M.J.4
  • 30
    • 0032782487 scopus 로고    scopus 로고
    • Physical state of L-histidine after freeze-drying and longterm storage
    • Osterberg T, Wadsten T. Physical state of L-histidine after freeze-drying and longterm storage. Eur J Pharm Sci 1999; 8:301-308.
    • (1999) Eur J Pharm Sci , vol.8 , pp. 301-308
    • Osterberg, T.1    Wadsten, T.2
  • 31
    • 0019275975 scopus 로고
    • A study of the phase transitions in frozen antibiotic solutions by differential scanning calorimetry
    • Gatlin LA, Deluca P. A study of the phase transitions in frozen antibiotic solutions by differential scanning calorimetry. J Parenteral Drug Assoc 1980; 34:398-408.
    • (1980) J Parenteral Drug Assoc , vol.34 , pp. 398-408
    • Gatlin, L.A.1    Deluca, P.2
  • 32
    • 0031770219 scopus 로고    scopus 로고
    • Characterization of phase transitions during freeze-drying by in situ X-ray powder diffractometry
    • Cavatur RK, Suryanarayanan R. Characterization of phase transitions during freeze-drying by in situ X-ray powder diffractometry. Pharm Dev Technol 1998; 3:579-586.
    • (1998) Pharm Dev Technol , vol.3 , pp. 579-586
    • Cavatur, R.K.1    Suryanarayanan, R.2
  • 33
    • 0032970823 scopus 로고    scopus 로고
    • Existence of a mannitol hydrate during freeze-drying and practical implications
    • Yu L, Milton N, Groleau EG, Mishra DS, Vanisickle RE. Existence of a mannitol hydrate during freeze-drying and practical implications. J Pharm Sci 1999; 88:196-198.
    • (1999) J Pharm Sci , vol.88 , pp. 196-198
    • Yu, L.1    Milton, N.2    Groleau, E.G.3    Mishra, D.S.4    Vanisickle, R.E.5
  • 34
    • 0022743346 scopus 로고
    • The effects of cooling rate on solid phase transitions and associated vial breakage occurring in frozen mannitol solutions
    • Williams NA, Lee Y, Polli GP, Jennings TA. The effects of cooling rate on solid phase transitions and associated vial breakage occurring in frozen mannitol solutions. J. Parenteral Sci Tech 1986; 40:135-141.
    • (1986) J. Parenteral Sci Tech , vol.40 , pp. 135-141
    • Williams, N.A.1    Lee, Y.2    Polli, G.P.3    Jennings, T.A.4
  • 35
    • 0025857180 scopus 로고
    • Vial breakage by frozen mannitol solutions: Correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration
    • Williams NA, Dean T. Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration. J Parenteral Sci Tech 1991; 45:94-100.
    • (1991) J Parenteral Sci Tech , vol.45 , pp. 94-100
    • Williams, N.A.1    Dean, T.2
  • 36
    • 0027256831 scopus 로고
    • Thermal mechanical analysis of frozen solutions of man-nitol and some related stereoisomers: Evidence of expansion during warming and correlation with vial breakage during lyophilization
    • Williams NA, Guglielmo J. Thermal mechanical analysis of frozen solutions of man-nitol and some related stereoisomers: evidence of expansion during warming and correlation with vial breakage during lyophilization. J Parenteral Sci Tech 1993; 47:119-123.
    • (1993) J Parenteral Sci Tech , vol.47 , pp. 119-123
    • Williams, N.A.1    Guglielmo, J.2
  • 37
    • 44049120561 scopus 로고
    • Study of the phase diagram water fraction of the system water-glycine-sucrose by DTA and X-ray diffraction methods
    • Shalaev EY, Malakhov DV, Kanev AN, et al. Study of the phase diagram water fraction of the system water-glycine-sucrose by DTA and X-ray diffraction methods. Thermochim Acta 1992; 196:213-220.
    • (1992) Thermochim Acta , vol.196 , pp. 213-220
    • Shalaev, E.Y.1    Malakhov, D.V.2    Kanev, A.N.3
  • 38
    • 0028824421 scopus 로고
    • Glycine crystallization during freezing: The effects of salt form, pH, and ionic strength
    • Akers MJ, Milton N, Byrn SR, Nail SL. Glycine crystallization during freezing: the effects of salt form, pH, and ionic strength. Pharm Res 1995; 12:1457-1461.
    • (1995) Pharm Res , vol.12 , pp. 1457-1461
    • Akers, M.J.1    Milton, N.2    Byrn, S.R.3    Nail, S.L.4
  • 39
    • 0031657680 scopus 로고    scopus 로고
    • Formulations of sugars with amino acids or mannitol-influence of concentration ratio on the properties of the freeze-concentrate and the lyophilizate
    • Lueckel B, Bodmer D, Helk B, Leuenberger H. Formulations of sugars with amino acids or mannitol-influence of concentration ratio on the properties of the freeze-concentrate and the lyophilizate. Pharm Dev Technol 1998; 3:325-336.
    • (1998) Pharm Dev Technol , vol.3 , pp. 325-336
    • Lueckel, B.1    Bodmer, D.2    Helk, B.3    Leuenberger, H.4
  • 40
    • 0000764360 scopus 로고
    • Solid-liquid phase transitions and amorphous states in ternary sucrose-glycine-water systems
    • Suzuki T, Franks F. Solid-liquid phase transitions and amorphous states in ternary sucrose-glycine-water systems. J Chem Soc Faraday Trans 1993; 89:3283-3299.
    • (1993) J Chem Soc Faraday Trans , vol.89 , pp. 3283-3299
    • Suzuki, T.1    Franks, F.2
  • 41
    • 17744380461 scopus 로고    scopus 로고
    • Partially crystalline systems in lyophi-lization: I. Use of ternary state diagrams to determine extent of crystallization of bulking agent
    • Chatterjee K, Shalaev EY, Suryanarayanan R. Partially crystalline systems in lyophi-lization: I. Use of ternary state diagrams to determine extent of crystallization of bulking agent. J Pharm Sci 2005; 94:798-808.
    • (2005) J Pharm Sci , vol.94 , pp. 798-808
    • Chatterjee, K.1    Shalaev, E.Y.2    Suryanarayanan, R.3
  • 42
    • 0032817957 scopus 로고    scopus 로고
    • Stabilisation and delivery of labile materials by amorphous carbohydrates and their derivatives
    • Hatley RHM, Blair JA. Stabilisation and delivery of labile materials by amorphous carbohydrates and their derivatives. J Mol Catalysis B: Enzymatic 1999; 7:11-19.
    • (1999) J Mol Catalysis B: Enzymatic , vol.7 , pp. 11-19
    • Hatley, R.H.M.1    Blair, J.A.2
  • 43
    • 0036909494 scopus 로고    scopus 로고
    • Effects of sucrose and trehalose on the preservation of the native structure of spray-dried lysozyme
    • Liao YH, Brown MB, Nazir T, Quader A, Martin GP. Effects of sucrose and trehalose on the preservation of the native structure of spray-dried lysozyme. Pharm Res 2002; 19:1847-1853.
    • (2002) Pharm Res , vol.19 , pp. 1847-1853
    • Liao, Y.H.1    Brown, M.B.2    Nazir, T.3    Quader, A.4    Martin, G.P.5
  • 44
    • 0036917920 scopus 로고    scopus 로고
    • Protective mechanism of stabilizing excipients against dehydration in the freeze-drying of proteins
    • Liao YH, Brown MB, Quader A, Martin GP. Protective mechanism of stabilizing excipients against dehydration in the freeze-drying of proteins. Pharm Res 2002; 19:1854-1861.
    • (2002) Pharm Res , vol.19 , pp. 1854-1861
    • Liao, Y.H.1    Brown, M.B.2    Quader, A.3    Martin, G.P.4
  • 45
    • 0033562141 scopus 로고    scopus 로고
    • Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding
    • Allison SD, Chang B, Randolph TW, Carpenter JF. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Arch Biochem Biophys 1999; 365:289-298.
    • (1999) Arch Biochem Biophys , vol.365 , pp. 289-298
    • Allison, S.D.1    Chang, B.2    Randolph, T.W.3    Carpenter, J.F.4
  • 46
    • 0026071674 scopus 로고
    • Moisture-induced aggregation of lyophilized proteins in the solid state
    • Liu WR, Langer R, Klibanov AM. Moisture-induced aggregation of lyophilized proteins in the solid state. Biotechnol Bioeng 1990; 37:177-184.
    • (1990) Biotechnol Bioeng , vol.37 , pp. 177-184
    • Liu, W.R.1    Langer, R.2    Klibanov, A.M.3
  • 47
    • 0029020745 scopus 로고
    • Increased stabilizing effects of amphiphilic excipients on freeze-drying of lactate dehydrogenase (LDH) by dispersion into sugar matrices
    • Izutsu K, Yoshioka S, Kojima S. Increased stabilizing effects of amphiphilic excipients on freeze-drying of lactate dehydrogenase (LDH) by dispersion into sugar matrices. Pharm Res 1995; 12:838-843.
    • (1995) Pharm Res , vol.12 , pp. 838-843
    • Izutsu, K.1    Yoshioka, S.2    Kojima, S.3
  • 48
    • 0026546749 scopus 로고
    • The influence of sucrose, dextran, and hydroxypropyl-beta-cyclodextrin as lyoprotectants for a freeze-dried mouse IgG2a monoclonal antibody (MN12)
    • Ressing ME, Jiskoot W, Talsma H, van Ingen CW, Beuvery EC, Crommelin DJ. The influence of sucrose, dextran, and hydroxypropyl-beta-cyclodextrin as lyoprotectants for a freeze-dried mouse IgG2a monoclonal antibody (MN12). Pharm Res 1992; 9:266-270.
    • (1992) Pharm Res , vol.9 , pp. 266-270
    • Ressing, M.E.1    Jiskoot, W.2    Talsma, H.3    van Ingen, C.W.4    Beuvery, E.C.5    Crommelin, D.J.6
  • 49
    • 0029093065 scopus 로고
    • Aggregation of insulin and its prevention by carbohydrate excipients
    • Katakam M, Banga AK. Aggregation of insulin and its prevention by carbohydrate excipients. PDA J Pharm Sci Technol 1995; 49:160-165.
    • (1995) PDA J Pharm Sci Technol , vol.49 , pp. 160-165
    • Katakam, M.1    Banga, A.K.2
  • 51
    • 0026527801 scopus 로고
    • Lyophilized formulations of recombinant tumor necrosis factor
    • Hora MS, Rana RK, Smith FW. Lyophilized formulations of recombinant tumor necrosis factor. Pharm Res 1992; 9:33-36.
    • (1992) Pharm Res , vol.9 , pp. 33-36
    • Hora, M.S.1    Rana, R.K.2    Smith, F.W.3
  • 52
    • 0027435684 scopus 로고
    • Stabilization of lyophilized porcine pancreatic elas-tase
    • Chang BS, Randall CS, Lee YS. Stabilization of lyophilized porcine pancreatic elas-tase. Pharm Res 1993; 10:1478-1483.
    • (1993) Pharm Res , vol.10 , pp. 1478-1483
    • Chang, B.S.1    Randall, C.S.2    Lee, Y.S.3
  • 53
    • 0032425839 scopus 로고    scopus 로고
    • Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid
    • Kreilgaard L, Frokjaer S, Flink JM, Randolph TW, Carpenter JF. Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Arch Biochem Biophys 1998; 360:121-134.
    • (1998) Arch Biochem Biophys , vol.360 , pp. 121-134
    • Kreilgaard, L.1    Frokjaer, S.2    Flink, J.M.3    Randolph, T.W.4    Carpenter, J.F.5
  • 54
    • 0032969861 scopus 로고    scopus 로고
    • Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid
    • Kreilgaard L, Frokjaer S, Flink JM, Randolph TW, Carpenter JF. Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid. J Pharm Sci 1999; 88:281-290.
    • (1999) J Pharm Sci , vol.88 , pp. 281-290
    • Kreilgaard, L.1    Frokjaer, S.2    Flink, J.M.3    Randolph, T.W.4    Carpenter, J.F.5
  • 55
    • 0030803492 scopus 로고    scopus 로고
    • Thermal stability of inver-tase in reduced-moisture amorphous matrices in relation to glassy state and trehalose crystallization
    • Cardona S, Schebor C, Buera MP, Karel M, Chirife J. Thermal stability of inver-tase in reduced-moisture amorphous matrices in relation to glassy state and trehalose crystallization. J Food Sci 1997; 62:105-112.
    • (1997) J Food Sci , vol.62 , pp. 105-112
    • Cardona, S.1    Schebor, C.2    Buera, M.P.3    Karel, M.4    Chirife, J.5
  • 57
    • 0031664119 scopus 로고    scopus 로고
    • Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage
    • Lueckel B, Helk B, Bodmer D, Leuenberger H. Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage. Pharm Dev Technol 1998; 3:337-346.
    • (1998) Pharm Dev Technol , vol.3 , pp. 337-346
    • Lueckel, B.1    Helk, B.2    Bodmer, D.3    Leuenberger, H.4
  • 58
    • 0031950419 scopus 로고    scopus 로고
    • Solid-state rehydration-induced recovery of bilirubin oxidase activity in lyophilized formulations reduced during freeze-drying
    • Nakai Y, Yoshioka S, Aso Y, Kojima S. Solid-state rehydration-induced recovery of bilirubin oxidase activity in lyophilized formulations reduced during freeze-drying. Chem Pharm Bull (Tokyo) 1998; 46:1031-1033.
    • (1998) Chem Pharm Bull (Tokyo) , vol.46 , pp. 1031-1033
    • Nakai, Y.1    Yoshioka, S.2    Aso, Y.3    Kojima, S.4
  • 59
    • 0345876464 scopus 로고    scopus 로고
    • Phase separation and crystallization of components in frozen solutions: Effect of molecular compatibility between solutes. Therapeutic Protein and Peptide Formulation and Delivery
    • Izutsu K-i, Yoshioka S, Kojima S. Phase separation and crystallization of components in frozen solutions: effect of molecular compatibility between solutes. Therapeutic Protein and Peptide Formulation and Delivery. ACS, 675, 1997:109-118.
    • (1997) ACS , vol.675 , pp. 109-118
    • K-I, I.1    Yoshioka, S.2    Kojima, S.3
  • 60
    • 0030443567 scopus 로고    scopus 로고
    • Surface-induced denaturation of proteins during freezing and its inhibition by surfactants
    • Chang BS, Kendrick BS, Carpenter JF. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants. J Pharm Sci 1996; 85:1325-1330.
    • (1996) J Pharm Sci , vol.85 , pp. 1325-1330
    • Chang, B.S.1    Kendrick, B.S.2    Carpenter, J.F.3
  • 61
    • 26544467249 scopus 로고
    • Detergent stabilization of proteins against surface and freezing denaturation
    • suppl
    • Kendrick B, Chang BS, Carpenter JF. Detergent stabilization of proteins against surface and freezing denaturation. Pharm Res 1995; 12(suppl):S-85.
    • (1995) Pharm Res , Issue.12 , pp. S-85
    • Kendrick, B.1    Chang, B.S.2    Carpenter, J.F.3
  • 62
    • 0027272126 scopus 로고
    • Freeze-thaw studies of a model protein, lactate dehydrogenase, in the presence of cryoprotectants
    • Nema S, Avis KE. Freeze-thaw studies of a model protein, lactate dehydrogenase, in the presence of cryoprotectants. J Parenter Sci Technol 1992; 47:76-83.
    • (1992) J Parenter Sci Technol , vol.47 , pp. 76-83
    • Nema, S.1    Avis, K.E.2
  • 63
    • 0028816796 scopus 로고
    • Stability of protein formulations: Investigation of surfactant effects by a novel EPR spectroscopic technique
    • Bam NB, Randolph TW, Cleland JL. Stability of protein formulations: investigation of surfactant effects by a novel EPR spectroscopic technique. Pharm Res 1995; 12:2-11.
    • (1995) Pharm Res , vol.12 , pp. 2-11
    • Bam, N.B.1    Randolph, T.W.2    Cleland, J.L.3
  • 64
    • 0027542789 scopus 로고
    • Thermal analysis of Poly(Acrylic Acid)/Poly(Oxyethylene) Blends
    • Chu C-H, Berner B. Thermal analysis of Poly(Acrylic Acid)/Poly(Oxyethylene) Blends. J Appl Polymer Sci 1993; 47:1083-1087.
    • (1993) J Appl Polymer Sci , vol.47 , pp. 1083-1087
    • Chu, C.-H.1    Berner, B.2
  • 65
    • 0033047323 scopus 로고    scopus 로고
    • Stability and surface activity of lactate dehydrogenase in spray-dried trehalose
    • Adler M, Lee C. Stability and surface activity of lactate dehydrogenase in spray-dried trehalose. J Pharm Sci 1999; 88:199-208.
    • (1999) J Pharm Sci , vol.88 , pp. 199-208
    • Adler, M.1    Lee, C.2
  • 66
    • 0031976660 scopus 로고    scopus 로고
    • The formulation of recombinant factor IX: Stability, robustness, and convenience
    • Bush L, Webb C, Bartlett L, Burnett B. The formulation of recombinant factor IX: stability, robustness, and convenience. Semin Hematol 1998; 35(2 suppl 2):18-21.
    • (1998) Semin Hematol , vol.35 , pp. 18-21
    • Bush, L.1    Webb, C.2    Bartlett, L.3    Burnett, B.4
  • 67
    • 0029071504 scopus 로고
    • Aggregation of a lyophilized pharmaceutical protein, recombinant human albumin: Effect of moisture and stabilization by excipients
    • Costantino HR, Langer R, Klibanov AM. Aggregation of a lyophilized pharmaceutical protein, recombinant human albumin: effect of moisture and stabilization by excipients. Biotechnology (N Y) 1995; 13:493-496.
    • (1995) Biotechnology (N Y) , vol.13 , pp. 493-496
    • Costantino, H.R.1    Langer, R.2    Klibanov, A.M.3
  • 69
    • 0032958279 scopus 로고    scopus 로고
    • Influence of calcium ions on the structure and stability of recombinant human deoxyribonuclease I in the aqueous and lyophilized states
    • Chen B, Costantino HR, Liu J, Hsu CC, Shire SJ. Influence of calcium ions on the structure and stability of recombinant human deoxyribonuclease I in the aqueous and lyophilized states. J Pharm Sci 1999; 88:477-482.
    • (1999) J Pharm Sci , vol.88 , pp. 477-482
    • Chen, B.1    Costantino, H.R.2    Liu, J.3    Hsu, C.C.4    Shire, S.J.5
  • 70
    • 0026328935 scopus 로고
    • Development of a lyophilized formulation of interleukin-2
    • Hora MA, Rana RK, Wilcox CL, et al. Development of a lyophilized formulation of interleukin-2. Dev Biol Stand 1992; 74:295-303.
    • (1992) Dev Biol Stand , vol.74 , pp. 295-303
    • Hora, M.A.1    Rana, R.K.2    Wilcox, C.L.3
  • 71
    • 0032899267 scopus 로고    scopus 로고
    • Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems
    • Mattern M, Winter G, Kohnert U, Lee G. Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems. Pharm Dev Technol 1999; 4:199-208.
    • (1999) Pharm Dev Technol , vol.4 , pp. 199-208
    • Mattern, M.1    Winter, G.2    Kohnert, U.3    Lee, G.4
  • 72
    • 0036395858 scopus 로고    scopus 로고
    • Stabilization of pharmaceuticals to oxidative degradation
    • Waterman KC, Adami RC, Alsante KM, et al. Stabilization of pharmaceuticals to oxidative degradation. Pharm Dev Technol 2002; 7:1-32.
    • (2002) Pharm Dev Technol , vol.7 , pp. 1-32
    • Waterman, K.C.1    Adami, R.C.2    Alsante, K.M.3
  • 73
    • 2942648819 scopus 로고    scopus 로고
    • Fast dynamics and stabilization of proteins: Binary glasses of trehalose and glycerol
    • Cicerone MT, Soles CL. Fast dynamics and stabilization of proteins: binary glasses of trehalose and glycerol. Biophys J 2004; 86:3836-3845.
    • (2004) Biophys J , vol.86 , pp. 3836-3845
    • Cicerone, M.T.1    Soles, C.L.2
  • 74
    • 2942680966 scopus 로고    scopus 로고
    • Substantially Improved Stability of Biological Agents in Dried Form
    • Cicerone MT, Tellington A, Trost L, Sokolov A. Substantially Improved Stability of Biological Agents in Dried Form. BioProcess Int 2003; 1:2-9.
    • (2003) Bioprocess Int , vol.1 , pp. 2-9
    • Cicerone, M.T.1    Tellington, A.2    Trost, L.3    Sokolov, A.4
  • 75
    • 23844461800 scopus 로고    scopus 로고
    • Effect of sorbitol and residual moisture on the stability of lyophilized antibodies: Implications for the mechanism of protein stabilization in the solid state
    • Chang L, Shepherd D, Sun J, Tang X, Pikal MJ. Effect of sorbitol and residual moisture on the stability of lyophilized antibodies: implications for the mechanism of protein stabilization in the solid state. J Pharm Sci 2005; 94:1445-1455.
    • (2005) J Pharm Sci , vol.94 , pp. 1445-1455
    • Chang, L.1    Shepherd, D.2    Sun, J.3    Tang, X.4    Pikal, M.J.5
  • 76
    • 16444383511 scopus 로고    scopus 로고
    • Effects of acidic N+1 residues on asparagine deamidation rates in solution and in the solid state
    • Li B, Gorman EM, Moore KD, et al. Effects of acidic N+1 residues on asparagine deamidation rates in solution and in the solid state. J Pharm Sci 2005; 94:666-675.
    • (2005) J Pharm Sci , vol.94 , pp. 666-675
    • Li, B.1    Gorman, E.M.2    Moore, K.D.3
  • 78
    • 0346846691 scopus 로고    scopus 로고
    • Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms
    • Chen B, Bautista R, Yu K, Zapata GA, Mulkerrin MG, Chamow SM. Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms. Pharm Res 2003; 20:1952-1960.
    • (2003) Pharm Res , vol.20 , pp. 1952-1960
    • Chen, B.1    Bautista, R.2    Yu, K.3    Zapata, G.A.4    Mulkerrin, M.G.5    Chamow, S.M.6
  • 80
    • 23844447975 scopus 로고    scopus 로고
    • Mechanism of Protein Stabilization by Sugars during freeze-drying and storage: Native structure preservation, specific interaction and/or immobilization in a glassy matrix?
    • Chang L, Shepherd D, Sun J, et al. Mechanism of Protein Stabilization by Sugars during freeze-drying and storage: native structure preservation, specific interaction and/or immobilization in a glassy matrix? J Pharm Sci 2005; 94:1427-1444.
    • (2005) J Pharm Sci , vol.94 , pp. 1427-1444
    • Chang, L.1    Shepherd, D.2    Sun, J.3
  • 81
    • 85030581141 scopus 로고    scopus 로고
    • Molecular mobility and the glass transition in globular lyophilized proteins
    • Abstract T2300
    • Shalaev EY, Chang L, Reddy R, Collins G, Luthra S, Pikal MJ. Molecular mobility and the glass transition in globular lyophilized proteins. AAPS PharmSci 2003; 5(4): Abstract T2300.
    • (2003) AAPS Pharmsci , vol.5 , Issue.4
    • Shalaev, E.Y.1    Chang, L.2    Reddy, R.3    Collins, G.4    Luthra, S.5    Pikal, M.J.6
  • 82
    • 0035991651 scopus 로고    scopus 로고
    • Dynamics of pharmaceutical amorphous solids: The study of enthalpy relaxation by isothermal microcalorimetry
    • Liu J, Rigsbee DR, Stotz C, Pikal MJ. Dynamics of pharmaceutical amorphous solids: the study of enthalpy relaxation by isothermal microcalorimetry. J Pharm Sci 2002; 91:1852-1862.
    • (2002) J Pharm Sci , vol.91 , pp. 1852-1862
    • Liu, J.1    Rigsbee, D.R.2    Stotz, C.3    Pikal, M.J.4
  • 83
    • 85042129038 scopus 로고    scopus 로고
    • Molecular mobility of freeze-dried formulations as determined by NMR relaxation, and its effect on storage stability
    • (Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products)
    • Yoshioka S. Molecular mobility of freeze-dried formulations as determined by NMR relaxation, and its effect on storage stability. In Drugs and the Pharmaceutical Sciences 137 (Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products), 2004:187-212.
    • (2004) In Drugs and the Pharmaceutical Sciences , vol.137 , pp. 187-212
    • Yoshioka, S.1
  • 84
    • 33745925589 scopus 로고    scopus 로고
    • Impact of freeze-drying on ionization of sulfonephthalein probe molecules in trehalose-citrate systems
    • Govindarajan R, Chatterjee K, Gatlin L, Suryanarayanan R, Shalaev EY. Impact of freeze-drying on ionization of sulfonephthalein probe molecules in trehalose-citrate systems. J Pharm Sci 2006; 95:1498-1510.
    • (2006) J Pharm Sci , vol.95 , pp. 1498-1510
    • Govindarajan, R.1    Chatterjee, K.2    Gatlin, L.3    Suryanarayanan, R.4    Shalaev, E.Y.5
  • 85
    • 38349168245 scopus 로고    scopus 로고
    • Correlation between chemical reactivity and the Hammett acidity function in amorphous solids using inversion of sucrose as a model reaction
    • In press
    • Chatterjee K, Shalaev EY, Suryanarayanan R, Govindarajan R. Correlation between chemical reactivity and the Hammett acidity function in amorphous solids using inversion of sucrose as a model reaction, J Pharm Sci 2007. In press.
    • (2007) J Pharm Sci
    • Chatterjee, K.1    Shalaev, E.Y.2    Suryanarayanan, R.3    Govindarajan, R.4


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