-
1
-
-
18744408458
-
A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth
-
Liu J, Viverette T, Virgin M, Anderson M, Paresh D. A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth. Pharm Dev Technol. 2005;10:261-272.
-
(2005)
Pharm Dev Technol
, vol.10
, pp. 261-272
-
-
Liu, J.1
Viverette, T.2
Virgin, M.3
Anderson, M.4
Paresh, D.5
-
2
-
-
0034938921
-
Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg' in pharmaceutical lyophilization
-
Searles JA, Carpenter JF, Randolph TW. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg' in pharmaceutical lyophilization. J Pharm Sci. 2001;90:872-887.
-
(2001)
J Pharm Sci
, vol.90
, pp. 872-887
-
-
Searles, J.A.1
Carpenter, J.F.2
Randolph, T.W.3
-
3
-
-
1342322942
-
Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: The impact of annealing on dry layer resistance to mass transfer and cake structure
-
Lu X, Pikal M. Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: the impact of annealing on dry layer resistance to mass transfer and cake structure. Pharm Dev Technol. 2004;9:85-95.
-
(2004)
Pharm Dev Technol
, vol.9
, pp. 85-95
-
-
Lu, X.1
Pikal, M.2
-
4
-
-
0034029664
-
The influence of lyophilization on the polymorphic behavior of mannitol
-
Cannon A, Trappler E. The influence of lyophilization on the polymorphic behavior of mannitol. PDA J Pharm Sci Technol. 2000;54:13-22.
-
(2000)
PDA J Pharm Sci Technol
, vol.54
, pp. 13-22
-
-
Cannon, A.1
Trappler, E.2
-
5
-
-
12444308939
-
Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride
-
Telang C, Yu L, Suryanararyanan R. Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride. Pharm Res. 2003;20:660-667.
-
(2003)
Pharm Res
, vol.20
, pp. 660-667
-
-
Telang, C.1
Yu, L.2
Suryanararyanan, R.3
-
6
-
-
0036209466
-
Effect of salts on the properties of aqueous sugar systems, in relation to biomaterial stabilization, I: Water sorption behavior and ice crystallization/melting
-
Mazzobre MF, Longinotti MP, Corti HR, Buera MP. Effect of salts on the properties of aqueous sugar systems, in relation to biomaterial stabilization, I: water sorption behavior and ice crystallization/melting. Cryobiology. 2001;43:199-210.
-
(2001)
Cryobiology
, vol.43
, pp. 199-210
-
-
Mazzobre, M.F.1
Longinotti, M.P.2
Corti, H.R.3
Buera, M.P.4
-
7
-
-
0029040644
-
Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes
-
Her LM, Deras M, Nail SL. Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes. Pharm Res. 1995;12:768-772.
-
(1995)
Pharm Res
, vol.12
, pp. 768-772
-
-
Her, L.M.1
Deras, M.2
Nail, S.L.3
-
8
-
-
0028824421
-
Glycine crystallization during freezing: The effect of salt form, pH, and ionic strength
-
Akers MJ, Milton N, Byrn SR, Nail SL. Glycine crystallization during freezing: the effect 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
-
9
-
-
33751124679
-
Crystalline and amorphous phases in the ternary system water-sucrose-sodium chloride
-
Shalaev EY, Franks F, Echlin P. Crystalline and amorphous phases in the ternary system water-sucrose-sodium chloride. J Phys Chem. 1996;100:1144-1152.
-
(1996)
J Phys Chem
, vol.100
, pp. 1144-1152
-
-
Shalaev, E.Y.1
Franks, F.2
Echlin, P.3
-
10
-
-
0000167612
-
Phase behavior of the system trehalose-NaCl-water
-
Nicolajsen H, Hvidt A. Phase behavior of the system trehalose-NaCl-water. Cryobiology. 1994;31:199-205.
-
(1994)
Cryobiology
, vol.31
, pp. 199-205
-
-
Nicolajsen, H.1
Hvidt, A.2
-
11
-
-
33845741935
-
Cetus Corporation, assignee. Stable formulations for lipophilic IL-2 proteins
-
inventors. US patent 4 992 271. February 12
-
Hanish WH, Fernandes PM, Taforo T, inventors. Cetus Corporation, assignee. Stable formulations for lipophilic IL-2 proteins. US patent 4 992 271. February 12, 1991.
-
(1991)
-
-
Hanish, W.H.1
Fernandes, P.M.2
Taforo, T.3
-
12
-
-
0025793265
-
The effects of formulation variables on the stability of freeze-dried human growth hormone
-
Pikal MJ, Dellerman KM, Roy ML, Riggin RM. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm Res. 1991;8:427-436.
-
(1991)
Pharm Res
, vol.8
, pp. 427-436
-
-
Pikal, M.J.1
Dellerman, K.M.2
Roy, M.L.3
Riggin, R.M.4
-
13
-
-
0031828085
-
The physical state of mannitol after freeze-drying: Effect of mannitol concentration, freezing rate and a non-crystallizing cosolute
-
Kim A, Akers M, Nail S. The physical state of mannitol after freeze-drying: effect of mannitol concentration, freezing rate and a non-crystallizing cosolute. J Pharm Sci. 1998;87:931-935.
-
(1998)
J Pharm Sci
, vol.87
, pp. 931-935
-
-
Kim, A.1
Akers, M.2
Nail, S.3
-
14
-
-
0031657680
-
Formulations of sugars with amino acids or mannitol - Influence of concentration ratio on 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 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
-
15
-
-
27144435461
-
Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol - Implications in freeze-drying
-
Liao X, Krishnamurthy R, Suryanarayanan R. Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol - implications in freeze-drying. Pharm Res. 2005;22:1978-1985.
-
(2005)
Pharm Res
, vol.22
, pp. 1978-1985
-
-
Liao, X.1
Krishnamurthy, R.2
Suryanarayanan, R.3
-
17
-
-
0026350187
-
Effect of formulation and freeze-drying on the long-term stability of rDNA-derived cytokines
-
Dawson PJ. Effect of formulation and freeze-drying on the long-term stability of rDNA-derived cytokines. Dev Biol Stand. 1992;74:273-284.
-
(1992)
Dev Biol Stand
, vol.74
, pp. 273-284
-
-
Dawson, P.J.1
-
18
-
-
33845743312
-
-
Food and Drug Administration. Rockville, MD: April 1, 80. Title 21
-
Food and Drug Administration. Code of Federal Regulations: Albumin (Human). vol. 7. Rockville, MD: April 1, 2006:640.80. Title 21.
-
(2006)
Code of Federal Regulations: Albumin (Human)
, vol.7
, pp. 640
-
-
-
19
-
-
2642625324
-
Chemical, clinical, and immunological studies and the products of human plasma fractionation, XXVI: The properties of human serum albumin at low salt content
-
Scatchard G, Jr, Strong LE, Jr, Hughes WL, Jr, Ashworth JN, Sparrow AH. Chemical, clinical, and immunological studies and the products of human plasma fractionation, XXVI: the properties of human serum albumin at low salt content. J Clin Invest. 1945;24:671-679.
-
(1945)
J Clin Invest
, vol.24
, pp. 671-679
-
-
Scatchard Jr., G.1
Strong Jr., L.E.2
Hughes Jr., W.L.3
Ashworth, J.N.4
Sparrow, A.H.5
-
21
-
-
0034660413
-
Stabilizing effects of caprylate and acetyltryptophanate on heat-induced aggregation of bovine serum albumin
-
Arakawa T, Kita Y. Stabilizing effects of caprylate and acetyltryptophanate on heat-induced aggregation of bovine serum albumin. Biochim Biophys Acta. 2000;1479:32-36.
-
(2000)
Biochim Biophys Acta
, vol.1479
, pp. 32-36
-
-
Arakawa, T.1
Kita, Y.2
-
22
-
-
0032431597
-
Effect of selected substances on heat-induced aggregation of albumin, IgG, and lysozyme
-
Saso L, Valentini G, Grippa E, Leone MG, Silvestrini B. Effect of selected substances on heat-induced aggregation of albumin, IgG, and lysozyme. Res Commun Chem Pathol Pharmacol. 1998;102:15-28.
-
(1998)
Res Commun Chem Pathol Pharmacol
, vol.102
, pp. 15-28
-
-
Saso, L.1
Valentini, G.2
Grippa, E.3
Leone, M.G.4
Silvestrini, B.5
-
23
-
-
33646877875
-
Physico-chemical lyophilization behavior of mannitol, human serum albumin formulations
-
Hawe A, Frieß W. Physico-chemical lyophilization behavior of mannitol, human serum albumin formulations. Eur J Pharm Sci. 2006; 28:224-232.
-
(2006)
Eur J Pharm Sci
, vol.28
, pp. 224-232
-
-
Hawe, A.1
Frieß, W.2
-
24
-
-
0035897584
-
Amorphous pharmaceutical solids: Preparation, characterization and stabilization
-
Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Del Rev. 2001,48:27-42.
-
(2001)
Adv Drug Del Rev
, vol.48
, pp. 27-42
-
-
Yu, L.1
-
25
-
-
0036294121
-
Crystallization behavior of mannitol in frozen aqueous solutions
-
Cavatur R, Vemuri N, Pyne A, Chrzan Z, Toledo-Velasquez D, Suryanararyanan R. Crystallization behavior of mannitol in frozen aqueous solutions. Pharm Res. 2002;19:894-900.
-
(2002)
Pharm Res
, vol.19
, pp. 894-900
-
-
Cavatur, R.1
Vemuri, N.2
Pyne, A.3
Chrzan, Z.4
Toledo-Velasquez, D.5
Suryanararyanan, R.6
-
26
-
-
0029941173
-
Freeze-drying: In situ observations using cryoenvironmental scanning electron microscopy and differential scanning calorimetry
-
Meredith P, Donald A, Payne R. Freeze-drying: in situ observations using cryoenvironmental scanning electron microscopy and differential scanning calorimetry. J Pharm Sci. 1996;85:631-637.
-
(1996)
J Pharm Sci
, vol.85
, pp. 631-637
-
-
Meredith, P.1
Donald, A.2
Payne, R.3
-
27
-
-
0019275975
-
A study of the phase transitions in frozen antibiotic solutions by differential scanning calorimetry
-
Gatlin L, Deluca PP. A study of the phase transitions in frozen antibiotic solutions by differential scanning calorimetry. J Parenter Drug Assoc. 1980;34:398-408.
-
(1980)
J Parenter Drug Assoc
, vol.34
, pp. 398-408
-
-
Gatlin, L.1
Deluca, P.P.2
-
28
-
-
0035994868
-
Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying
-
Izutsu K, Kojima S. Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying. J Pharm Pharmacol. 2002; 54:1033-1039.
-
(2002)
J Pharm Pharmacol
, vol.54
, pp. 1033-1039
-
-
Izutsu, K.1
Kojima, S.2
-
29
-
-
37049075919
-
Structural glass transition and thermophysical processes in amorphous carbohydrates and their supersaturated solutions
-
Shalaev EY, Franks F. Structural glass transition and thermophysical processes in amorphous carbohydrates and their supersaturated solutions. J Chem Soc, Faraday Trans. 1995;91:1511-1517.
-
(1995)
J Chem Soc, Faraday Trans
, vol.91
, pp. 1511-1517
-
-
Shalaev, E.Y.1
Franks, F.2
-
30
-
-
0033025189
-
The relevance of the amorphous state to pharmaceutical dosage forms: Glassy drugs and freeze-dried systems
-
Craig DQM, Royall PG, Kett VL, Hopton ML. The relevance of the amorphous state to pharmaceutical dosage forms: glassy drugs and freeze-dried systems. Int J Pharm. 1999;179:179-207.
-
(1999)
Int J Pharm
, vol.179
, pp. 179-207
-
-
Craig, D.Q.M.1
Royall, P.G.2
Kett, V.L.3
Hopton, M.L.4
-
31
-
-
0001498936
-
Solid aqueous solution
-
Franks F. Solid aqueous solution. Pure Appl Chem. 1993;65: 2527-2537.
-
(1993)
Pure Appl Chem
, vol.65
, pp. 2527-2537
-
-
Franks, F.1
-
32
-
-
0001904754
-
Freeze-drying of proteins, part I: Process design
-
Pikal MJ. Freeze-drying of proteins, part I: process design. BioPharm. 1990;3:17-27.
-
(1990)
BioPharm
, vol.3
, pp. 17-27
-
-
Pikal, M.J.1
-
33
-
-
0001904754
-
Freeze-drying of proteins, part II: Formulation selection
-
Pikal MJ. Freeze-drying of proteins, part II: formulation selection. BioPharm. 1990;3:26-30.
-
(1990)
BioPharm
, vol.3
, pp. 26-30
-
-
Pikal, M.J.1
-
34
-
-
0001246021
-
Thermal analysis of proteins of pharmaceutical interest
-
Chen T, Oakley DM. Thermal analysis of proteins of pharmaceutical interest. Thermochim Acta. 1995;248:229-244.
-
(1995)
Thermochim Acta
, vol.248
, pp. 229-244
-
-
Chen, T.1
Oakley, D.M.2
-
36
-
-
0025006471
-
The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase
-
Pikal MJ, Shah S. The collapse temperature in freeze drying: dependence on measurement methodology and rate of water removal from the glassy phase. Int J Pharm. 1990;62:165-186.
-
(1990)
Int J Pharm
, vol.62
, pp. 165-186
-
-
Pikal, M.J.1
Shah, S.2
-
37
-
-
0038246787
-
The relationship between the TMDSC curve of frozen sucrose solutions and collapse during freeze-drying
-
Knopp SA, Chongprasert S, Nail SL. The relationship between the TMDSC curve of frozen sucrose solutions and collapse during freeze-drying. J Therm Anal Calorim. 1998;54: 659-672.
-
(1998)
J Therm Anal Calorim
, vol.54
, pp. 659-672
-
-
Knopp, S.A.1
Chongprasert, S.2
Nail, S.L.3
-
38
-
-
0031952684
-
Characterization of frozen aqueous solutions by low temperature X-ray powder diffractometry
-
Cavatur R, 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.1
Suryanarayanan, R.2
-
39
-
-
0032970823
-
Existence of a mannitol hydrate during freeze-drying and practical implications
-
Yu L, Milton N, Groleau E, Mishra D, Vansickle R. 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.3
Mishra, D.4
Vansickle, R.5
-
40
-
-
0344603644
-
Significance of controlling crystallization mechanisms and kinetics in pharmaceutical systems
-
Rodríguez-Hornedo N, Murphy D. Significance of controlling crystallization mechanisms and kinetics in pharmaceutical systems. J Pharm Sci. 1999;88:651-660.
-
(1999)
J Pharm Sci
, vol.88
, pp. 651-660
-
-
Rodríguez-Hornedo, N.1
Murphy, D.2
|