-
1
-
-
0034255393
-
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
-
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
-
3
-
-
0038057730
-
Protein hydration
-
Totowa, NJ: Humana
-
Franks F. Protein hydration. In: Franks F, ed. Protein Biotechnology: Isolation, Characterization, and Stabilization. Totowa, NJ: Humana, 1993:437-465.
-
(1993)
Protein Biotechnology: Isolation, Characterization, and Stabilization
, pp. 437-465
-
-
Franks, F.1
Franks, F.2
-
4
-
-
0003220389
-
Freeze-drying of proteins: Process, formulation, and stability
-
Pikal MJ. Freeze-drying of proteins: process, formulation, and stability. In: Cleland JL, Langer R, eds. Formulation and Delivery of Proteins and Peptides. Washington: ACS Symposium Series, 567, 1994:120-133.
-
(1994)
Formulation and Delivery of Proteins and Peptides. Washington: ACS Symposium Series, 567
, pp. 120-133
-
-
Pikal, M.J.1
Cleland, J.L.2
Langer, R.3
-
5
-
-
0028366155
-
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
-
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
-
8
-
-
0003931655
-
-
Totowa, NJ: Humana
-
Franks F, ed. Protein Biotechnology: Isolation, Characterization, and Stabilization. Totowa, NJ: Humana, 1993:592.
-
(1993)
Protein Biotechnology: Isolation, Characterization, and Stabilization
, pp. 592
-
-
Franks, F.1
-
9
-
-
25444466477
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
50
-
-
0026328935
-
Development of a lyophilized formulation of interleukin-2
-
Hora MS, Rana RK, Wilcox CL, Katre NV, Hirtzer P, Wolfe SN, Thomson JW. 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.S.1
Rana, R.K.2
Wilcox, C.L.3
Katre, N.V.4
Hirtzer, P.5
Wolfe, S.N.6
Thomson, J.W.7
-
51
-
-
0026527801
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
68
-
-
0028789630
-
Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation
-
Schwendeman SP, Costantino HR, Gupta RK, Siber GR, Klibanov AM, Langer R. Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation. Proc Natl Acad Sci USA 1995; 92:11234-11238.
-
(1995)
Proc Natl Acad Sci USA
, vol.92
, pp. 11234-11238
-
-
Schwendeman, S.P.1
Costantino, H.R.2
Gupta, R.K.3
Siber, G.R.4
Klibanov, A.M.5
Langer, R.6
-
69
-
-
0032958279
-
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
-
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
-
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
-
73
-
-
2942648819
-
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
-
75
-
-
23844461800
-
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
-
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
-
77
-
-
27744492676
-
The protective effect of lactose on lyophilization of CNK-20402
-
Lee YC, Nelson J, Sueda K, Seibert D, Hsieh WY, Braxton B. The protective effect of lactose on lyophilization of CNK-20402. AAPS-PharmSciTech (epub) 2005; 6:E42-E48.
-
(2005)
Aaps-Pharmscitech (Epub)
, vol.6
, pp. E42-E48
-
-
Lee, Y.C.1
Nelson, J.2
Sueda, K.3
Seibert, D.4
Hsieh, W.Y.5
Braxton, B.6
-
78
-
-
0346846691
-
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
-
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
-
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
-
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
-
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
-
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
-
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
|