-
3
-
-
0003220389
-
Freeze-drying of proteins: Process formulation and stability
-
Cleland JL, Langer R, editors. Washington, DC: American Chemical Society
-
Pikal MJ. 1994. Freeze-drying of proteins: Process formulation and stability. In: Cleland JL, Langer R, editors. Formulation and delivery of proteins and peptides. Washington, DC: American Chemical Society. pp. 120-133.
-
(1994)
Formulation and Delivery of Proteins and Peptides
, pp. 120-133
-
-
Pikal, M.J.1
-
4
-
-
0003161362
-
Parenteral formulations of proteins and peptides: Stability and stabilizers
-
Wang YCJ, Hanson MA. 1998. Parenteral formulations of proteins and peptides: Stability and stabilizers. J Parenteral Sci Technol 42:S1-S24.
-
(1998)
J Parenteral Sci Technol
, vol.42
-
-
Wang, Y.C.J.1
Hanson, M.A.2
-
5
-
-
0030638567
-
Characteristics and significance of the amorphous state in pharmaceutical systems
-
Hancock BC, Zografi G. 1997. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1-12.
-
(1997)
J Pharm Sci
, vol.86
, pp. 1-12
-
-
Hancock, B.C.1
Zografi, G.2
-
6
-
-
0030770631
-
Rational design of stable lyophilized protein formulations: Some practical advice
-
Carpenter JF, Pikal MJ, Randolph TW. 1997. Rational design of stable lyophilized protein formulations: Some practical advice. Pharm Res 14:969-975.
-
(1997)
Pharm Res
, vol.14
, pp. 969-975
-
-
Carpenter, J.F.1
Pikal, M.J.2
Randolph, T.W.3
-
8
-
-
0001904754
-
Freeze-drying of proteins. Part I: Process design
-
22-24, 26-28
-
Pikal MJ. 1990. Freeze-drying of proteins. Part I: Process design. BioPharm 3:18-20, 22-24, 26-28.
-
(1990)
BioPharm
, vol.3
, pp. 18-20
-
-
Pikal, M.J.1
-
9
-
-
0036371181
-
Spray-drying of proteins
-
Lee G. 2002. Spray-drying of proteins. Pharm Biotechnol 13:135-138.
-
(2002)
Pharm Biotechnol
, vol.13
, pp. 135-138
-
-
Lee, G.1
-
11
-
-
0036784625
-
Spray-freeze drying for protein and powder preparation: Particle characterization and a case study with trypsinogen stability
-
Sonner C, Maa YF, Lee G. 2002. Spray-freeze drying for protein and powder preparation: Particle characterization and a case study with trypsinogen stability. J Pharm Sci 91:2122-2139.
-
(2002)
J Pharm Sci
, vol.91
, pp. 2122-2139
-
-
Sonner, C.1
Maa, Y.F.2
Lee, G.3
-
12
-
-
0033043629
-
Protein inhalation powders: Spray drying vs. spray freeze drying
-
Maa YF. 1999. Protein inhalation powders: Spray drying vs. spray freeze drying. Pharm Res 16:249-254.
-
(1999)
Pharm Res
, vol.16
, pp. 249-254
-
-
Maa, Y.F.1
-
15
-
-
0026703427
-
Chemical stability of insulin. 1. Hydrolytic degradation during storage of pharmaceutical preparations
-
Brange J, Langkjaer L, Havelund S, Volund A. 1992. Chemical stability of insulin. 1. Hydrolytic degradation during storage of pharmaceutical preparations. Pharm Res 9:715-726.
-
(1992)
Pharm Res
, vol.9
, pp. 715-726
-
-
Brange, J.1
Langkjaer, L.2
Havelund, S.3
Volund, A.4
-
16
-
-
0028301459
-
The role of intramolecular nucleophilic catalysis and the effects of self-association on the deamidation of human insulin at low pH
-
Darrington RT, Anderson BD. 1994. The role of intramolecular nucleophilic catalysis and the effects of self-association on the deamidation of human insulin at low pH. Pharm Res 11:784-793.
-
(1994)
Pharm Res
, vol.11
, pp. 784-793
-
-
Darrington, R.T.1
Anderson, B.D.2
-
17
-
-
0028998979
-
Effects of insulin concentration and self-association of its A-21 cyclic anhydride intermediate to desamido insulin and covalent dimer
-
Darrington RT, Anderson BD. 1995. Effects of insulin concentration and self-association of its A-21 cyclic anhydride intermediate to desamido insulin and covalent dimer. Pharm Res 12:1077-1084.
-
(1995)
Pharm Res
, vol.12
, pp. 1077-1084
-
-
Darrington, R.T.1
Anderson, B.D.2
-
18
-
-
0028931574
-
Evidence for a common intermediate in insulin deamidation and covalent dimer formation: Effects of pH and aniline trapping in dilute acidic solution
-
Darrington RT, Anderson BD. 1995. Evidence for a common intermediate in insulin deamidation and covalent dimer formation: Effects of pH and aniline trapping in dilute acidic solution. J Pharm Sci 84: 275-282.
-
(1995)
J Pharm Sci 84
, pp. 275-282
-
-
Darrington, R.T.1
Anderson, B.D.2
-
19
-
-
0026659078
-
Chemical stability of insulin. 2. Formation of high molecular weight transformation products during storage of pharmaceutical preparations
-
Brange J, Havelund S, Hougaard P. 1992. Chemical stability of insulin. 2. Formation of high molecular weight transformation products during storage of pharmaceutical preparations. Pharm Res 9:727-734.
-
(1992)
Pharm Res
, vol.9
, pp. 727-734
-
-
Brange, J.1
Havelund, S.2
Hougaard, P.3
-
20
-
-
0029764145
-
Solid-state stability of human insulin. I. Mechanism and the effect of water on the kinetics of degradation in lyophilizes from pH 2-5 solutions
-
Strickley RG, Anderson BD. 1996. Solid-state stability of human insulin. I. Mechanism and the effect of water on the kinetics of degradation in lyophilizes from pH 2-5 solutions. Pharm Res 13:1142-1153.
-
(1996)
Pharm Res
, vol.13
, pp. 1142-1153
-
-
Strickley, R.G.1
Anderson, B.D.2
-
21
-
-
0030997388
-
Solid-state stability of human insulin. II. Effect of water on reactive intermediate portioning in lyophiles from pH 2-5 solutions: Stabilization against covalent dimer formation
-
Strickley RG, Anderson BD. 1997. Solid-state stability of human insulin. II. Effect of water on reactive intermediate portioning in lyophiles from pH 2-5 solutions: Stabilization against covalent dimer formation. J Pharm Sci 86:645-653.
-
(1997)
J Pharm Sci
, vol.86
, pp. 645-653
-
-
Strickley, R.G.1
Anderson, B.D.2
-
22
-
-
0030831389
-
The stability of insulin in crystalline and amorphous solids: Observation of greater stability for the amorphous form
-
Pikal MJ, Rigsbee RD. 1997. The stability of insulin in crystalline and amorphous solids: Observation of greater stability for the amorphous form. Pharm Res 14:1379-1387.
-
(1997)
Pharm Res
, vol.14
, pp. 1379-1387
-
-
Pikal, M.J.1
Rigsbee, R.D.2
-
23
-
-
0029886378
-
Importance of glass transition temperature in accelerated stability testing of amorphous solids: Case study using lyophilized aspirin formulation
-
Duddu SP, Weller K. 1996. Importance of glass transition temperature in accelerated stability testing of amorphous solids: Case study using lyophilized aspirin formulation. J Pharm Sci 85:345-347.
-
(1996)
J Pharm Sci
, vol.85
, pp. 345-347
-
-
Duddu, S.P.1
Weller, K.2
-
24
-
-
33749478518
-
Coupling between chemical reactivity and structural relaxation in pharmaceutical glasses
-
Shamblin SL, Hancock BC, Pikal MJ. 2006. Coupling between chemical reactivity and structural relaxation in pharmaceutical glasses. Pharm Res, 10:2254-2268.
-
(2006)
Pharm Res
, vol.10
, pp. 2254-2268
-
-
Shamblin, S.L.1
Hancock, B.C.2
Pikal, M.J.3
-
25
-
-
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, Ouellette D, Grant KL, Tang X, Pikal MJ. 2005. 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 94:1427-1444.
-
(2005)
J Pharm Sci
, vol.94
, pp. 1427-1444
-
-
Chang, L.1
Shepherd, D.2
Sun, J.3
Ouellette, D.4
Grant, K.L.5
Tang, X.6
Pikal, M.J.7
-
26
-
-
0033971208
-
Physical characteristics and chemical degradation of amorphous quinapril hydrochloride
-
DOI 10.1002/(SICI)1520-6017(200001)89:1<128::AID-JPS13>3.0.CO;2-Z
-
Guo Y, Byrn SR, Zografi G. 2000. Physical characteristics and chemical degradation of amorphous quinapril hydrochloride. J Pharm Sci 89:128-143. (Pubitemid 30080161)
-
(2000)
Journal of Pharmaceutical Sciences
, vol.89
, Issue.1
, pp. 128-143
-
-
Guo, Y.1
Byrn, S.R.2
Zografi, G.3
-
29
-
-
68649109055
-
Ueber de Elastische Nachwirkung Beider Torsion
-
Kohlrausch F. 1863. Ueber de Elastische Nachwirkung Beider Torsion. Pogg Ann Phys 119:337-368.
-
(1863)
Pogg Ann Phys
, vol.119
, pp. 337-368
-
-
Kohlrausch, F.1
-
30
-
-
0014699523
-
Non-symmetrical dielectric relaxation behavior arising from a simple decay function
-
Williams G, Watts DC. 1970. Non-symmetrical dielectric relaxation behavior arising from a simple decay function. Trans Faraday Soc 66:80-85.
-
(1970)
Trans Faraday Soc
, vol.66
, pp. 80-85
-
-
Williams, G.1
Watts, D.C.2
-
31
-
-
0034950544
-
Usefulness of the Kohlrausch-Williams-Watts stretched exponential function to describe protein aggregation in lyophilized formulations and the temperature dependence near the glass transition temperature
-
Yoshioka S, Aso Y, Kojima S. 2001. Usefulness of the Kohlrausch-Williams- Watts stretched exponential function to describe protein aggregation in lyophilized formulations and the temperature dependence near the glass transition temperature. Pharm Res 18:256-260.
-
(2001)
Pharm Res
, vol.18
, pp. 256-260
-
-
Yoshioka, S.1
Aso, Y.2
Kojima, S.3
-
32
-
-
33751124528
-
Non-exponential relaxations in strong and fragile glass-formers
-
Bohmer R, Ngai KL, Angell CA, Plazek DJ. 1993. Non-exponential relaxations in strong and fragile glass-formers. J Chem Phys 99:4201-4209.
-
(1993)
J Chem Phys
, vol.99
, pp. 4201-4209
-
-
Bohmer, R.1
Ngai, K.L.2
Angell, C.A.3
Plazek, D.J.4
-
33
-
-
20344362926
-
Calorimetric investigation of the structural relaxation of amorphous materials: Evaluating validity of the methodologies
-
Kawakami K, Pikal MJ. 2005. Calorimetric investigation of the structural relaxation of amorphous materials: Evaluating validity of the methodologies. J Pharm Sci 94:948-965.
-
(2005)
J Pharm Sci
, vol.94
, pp. 948-965
-
-
Kawakami, K.1
Pikal, M.J.2
-
34
-
-
0035991651
-
Dynamics of pharmaceutical amorphous solids: The study of enthalpy relaxation by isothermal microcalorimetry
-
DOI 10.1002/jps.10181
-
Liu J, Rigsbee DR, Stotz C, Pikal MJ. 2002. Dynamics of pharmaceutical amorphous solids: The study of enthalpy relaxation by isothermal microcalorimetry. J Pharm Sci 91:1853-1862. (Pubitemid 34810530)
-
(2002)
Journal of Pharmaceutical Sciences
, vol.91
, Issue.8
, pp. 1853-1862
-
-
Liu, J.1
Rigsbee, D.R.2
Stotz, C.3
Pikal, M.J.4
-
35
-
-
33646736394
-
The modified stretched-exponential model for characterization of NMR relaxation in porous media
-
Peyron M, Pierens GK, Lucas AJ, Hall LD, Stewart RC. 1996. The modified stretched-exponential model for characterization of NMR relaxation in porous media. J Magn Reson Ser A 118:214-220.
-
(1996)
J Magn Reson Ser A
, vol.118
, pp. 214-220
-
-
Peyron, M.1
Pierens, G.K.2
Lucas, A.J.3
Hall, L.D.4
Stewart, R.C.5
-
36
-
-
0027093737
-
Chemical stability of insulin. 4. Mechanisms and kinetics of chemical transformations in pharmaceutical formulation
-
Brange J. 1992. Chemical stability of insulin. 4. Mechanisms and kinetics of chemical transformations in pharmaceutical formulation. Acta Pharm Nordica 4:209-222.
-
(1992)
Acta Pharm Nordica
, vol.4
, pp. 209-222
-
-
Brange, J.1
-
37
-
-
0025088101
-
Chemical pathways of peptide degradation. I. Deamidation of adrenocorticotropic hormone
-
Bhatt NP, Patel K, Borchardt RT. 1990. Chemical pathways of peptide degradation. I. Deamidation of adrenocorticotropic hormone. Pharm Res 7:593-599.
-
(1990)
Pharm Res
, vol.7
, pp. 593-599
-
-
Bhatt, N.P.1
Patel, K.2
Borchardt, R.T.3
-
38
-
-
41749120612
-
-
Berlin, Heidelberg, New York: Springer
-
Mehrer H. 2007. Diffusion in Solids. Berlin, Heidelberg, New York: Springer. p. 127.
-
(2007)
Diffusion in Solids
, pp. 127
-
-
Mehrer, H.1
-
39
-
-
0003449101
-
-
2nd edition. Sausalito California: University Science Books
-
Taylor R. 1997. An introduction to error analysis. 2nd edition. Sausalito California: University Science Books.
-
(1997)
An Introduction to Error Analysis
-
-
Taylor, R.1
-
40
-
-
1842482311
-
Temperature and glass transition temperature-dependence of bimolecular reaction rates in lyophilized formulations described by the Adam-Gibbs-Vogel equation
-
Yoshioka SY, Aso Y, Kojima S. 2004. Temperature and glass transition temperature-dependence of bimolecular reaction rates in lyophilized formulations described by the Adam-Gibbs-Vogel equation. J Pharm Sci 93:1062-1069.
-
(2004)
J Pharm Sci
, vol.93
, pp. 1062-1069
-
-
Yoshioka, S.Y.1
Aso, Y.2
Kojima, S.3
-
41
-
-
0026356940
-
The effects of formulation and moisture on the stability of a freeze-dried monoclonal antibody-VINCA conjugate: A test of the WLF glass transition theory
-
Roy ML, Pikal MJ, Rickard EC, Maloney AM. 1991. The effects of formulation and moisture on the stability of a freeze-dried monoclonal antibody-VINCA conjugate: A test of the WLF glass transition theory. International Symposium on Biological Product Freeze-Drying and Formulation, Vol. 74, pp. 323-340.
-
(1991)
International Symposium on Biological Product Freeze-Drying and Formulation
, vol.74
, pp. 323-340
-
-
Roy, M.L.1
Pikal, M.J.2
Rickard, E.C.3
Maloney, A.M.4
-
42
-
-
85056927426
-
Mechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics
-
Rey L, May JC, editors New York: Marcel Dekker
-
Pikal MJ. 2004. Mechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics. In: Rey L, May JC, editors. Freeze-drying/ lyophilization of pharmaceutical and biological products. New York: Marcel Dekker. pp. 63-107.
-
(2004)
Freeze-drying/lyophilization of Pharmaceutical and Biological Products
, pp. 63-107
-
-
Pikal, M.J.1
-
43
-
-
33846202570
-
Degradation rate of lyophilized insulin, exhibiting an apparent Arrhenius behavior around glass transition temperature regardless of significant contribution of molecular mobility
-
DOI 10.1002/jps.20689
-
Yoshioka S, Miyazaki T, Aso Y. 2006. Degradation rate of lyophilized insulin, exhibiting an apparent Arrhenius behavior around glass transition temperature regardless of significant contribution of molecular mobility. J Pharm Sci 95:2684-2691. (Pubitemid 46093175)
-
(2006)
Journal of Pharmaceutical Sciences
, vol.95
, Issue.12
, pp. 2684-2691
-
-
Yoshioka, S.1
Miyazaki, T.2
Aso, Y.3
-
44
-
-
33646006376
-
Negligible contribution of molecular mobility to the degradation rate of insulin lyophilized with poly(vinylpyrrolidine)
-
Yoshioka S, Aso Y, Miyazaki T. 2006. Negligible contribution of molecular mobility to the degradation rate of insulin lyophilized with poly(vinylpyrrolidine). J Pharm Sci 95:939-943.
-
(2006)
J Pharm Sci
, vol.95
, pp. 939-943
-
-
Yoshioka, S.1
Aso, Y.2
Miyazaki, T.3
-
45
-
-
33646858787
-
b-Relaxation of insulin molecule in lyophilized formulations containing trehalose or dextran as a determinant of chemical reactivity
-
Yoshioka S, Miyazaki T, Aso Y. 2006. b-Relaxation of insulin molecule in lyophilized formulations containing trehalose or dextran as a determinant of chemical reactivity. Pharm Res 23:961-966.
-
(2006)
Pharm Res
, vol.23
, pp. 961-966
-
-
Yoshioka, S.1
Miyazaki, T.2
Aso, Y.3
-
46
-
-
23844530656
-
A quantitative assessment of the significance of molecular mobility as a determinant for the stability of lyophilized insulin formulations
-
DOI 10.1007/s11095-005-5262-z
-
Yoshioka S, Aso Y. 2005. A quantitative assessment of the significance of molecular mobility as a determinant for the stability of lyophilized insulin formulations. Pharm Res 22:1358-1364. (Pubitemid 41176040)
-
(2005)
Pharmaceutical Research
, vol.22
, Issue.8
, pp. 1358-1364
-
-
Yoshioka, S.1
Aso, Y.2
-
47
-
-
0028559724
-
Solid-phase aggregation of proteins under pharmaceutically relevant conditions
-
Constantino HR, Langer R, Klibanov AM. 1994. Solid-phase aggregation of proteins under pharmaceutically relevant conditions. J Pharm Sci 83: 1662-1669.
-
(1994)
J Pharm Sci
, vol.83
, pp. 1662-1669
-
-
Constantino, H.R.1
Langer, R.2
Klibanov, A.M.3
|