-
2
-
-
1242314686
-
Design of freeze-drying processes for pharmaceuticals: Practical advice
-
Tang X, Pikal MJ. 2004. Design of freeze-drying processes for pharmaceuticals: Practical advice. Pharm Res 21: 191-200.
-
(2004)
Pharm Res
, vol.21
, pp. 191-200
-
-
Tang, X.1
Pikal, M.J.2
-
4
-
-
0035946615
-
Solid lipid nanoparticles: Production, characterization and applications
-
Mehnert W, Mäder K. 2001. Solid lipid nanoparticles: Production, characterization and applications. Adv Drug Deliv Rev 47: 165-196.
-
(2001)
Adv Drug Deliv Rev
, vol.47
, pp. 165-196
-
-
Mehnert, W.1
Mäder, K.2
-
5
-
-
34347375558
-
Lyophilization of biopharmaceuticals
-
In, Costantino HR, Pikal MJ, editors., Arlington: American Association of Pharmaceutical Scientists
-
Chang BS, Patro SY. 2004. Freeze-drying process development for protein pharmaceuticals. In: Costantino HR, Pikal MJ, editors. Lyophilization of biopharmaceuticals. Arlington: American Association of Pharmaceutical Scientists, pp 113-138.
-
(2004)
Freeze-drying process development for protein pharmaceuticals
, pp. 113-138
-
-
Chang, B.S.1
Patro, S.Y.2
-
6
-
-
2342627492
-
Formulation development of protein dosage forms
-
Akers MJVV, Stickelmeyer M. 2002. Formulation development of protein dosage forms. Pharm Biotechnol 14: 47-127.
-
(2002)
Pharm Biotechnol
, vol.14
, pp. 47-127
-
-
Akers, M.J.V.V.1
Stickelmeyer, M.2
-
7
-
-
24144452806
-
Correlation of laboratory and production freeze drying cycles
-
Kuu WY, Hardwick LM, Akers MJ. 2005. Correlation of laboratory and production freeze drying cycles. Int J Pharm 302: 56-67.
-
(2005)
Int J Pharm
, vol.302
, pp. 56-67
-
-
Kuu, W.Y.1
Hardwick, L.M.2
Akers, M.J.3
-
8
-
-
0001844127
-
Freeze-drying: From empiricism to predictability
-
Franks F. 1990. Freeze-drying: From empiricism to predictability. Cryo-Letters 11: 93-110.
-
(1990)
Cryo-Letters
, vol.11
, pp. 93-110
-
-
Franks, F.1
-
9
-
-
27944460586
-
The devitrification temperatures of solutions of a carbohydrate series
-
Luyet BJ. 1939. The devitrification temperatures of solutions of a carbohydrate series. J Phys Chem 43: 881-885.
-
(1939)
J Phys Chem
, vol.43
, pp. 881-885
-
-
Luyet, B.J.1
-
10
-
-
0017785395
-
Non-equilibrium freezing behaviour of aqueous systems
-
MacKenzie AP. 1971. Non-equilibrium freezing behaviour of aqueous systems. Phil Trans R Soc Lond B 278: 167-189.
-
(1971)
Phil Trans R Soc Lond B
, vol.278
, pp. 167-189
-
-
MacKenzie, A.P.1
-
11
-
-
71649096560
-
Cryoprotectants for freeze drying of drug nano-suspensions: Effect of freezing rate
-
Lee MK, Kim MY, Kim S, Lee J. 2009. Cryoprotectants for freeze drying of drug nano-suspensions: Effect of freezing rate. J Pharm Sci 98: 4808-4817.
-
(2009)
J Pharm Sci
, vol.98
, pp. 4808-4817
-
-
Lee, M.K.1
Kim, M.Y.2
Kim, S.3
Lee, J.4
-
12
-
-
0025006471
-
The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from glassy phase
-
Pikal MJ, Shah S. 1990. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from glassy phase. Int J Pharm 62: 165-186.
-
(1990)
Int J Pharm
, vol.62
, pp. 165-186
-
-
Pikal, M.J.1
Shah, S.2
-
13
-
-
0031835707
-
Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy
-
Kasraian K, Spitznagel TM, Juneau JA, Yim K. 1998. Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy. Pharm Dev Technol 3: 233-239.
-
(1998)
Pharm Dev Technol
, vol.3
, pp. 233-239
-
-
Kasraian, K.1
Spitznagel, T.M.2
Juneau, J.A.3
Yim, K.4
-
14
-
-
0030456850
-
Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-asparaginase
-
Adams GDJ, Ramsay JR. 1996. Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-asparaginase. J Pharm Sci 85: 1301-1305.
-
(1996)
J Pharm Sci
, vol.85
, pp. 1301-1305
-
-
Adams, G.D.J.1
Ramsay, J.R.2
-
15
-
-
76549137455
-
Apparatus for microscopic observations during freeze-drying (AFBR freeze-drying microscope model 2)
-
MacKenzie AP. 1964. Apparatus for microscopic observations during freeze-drying (AFBR freeze-drying microscope model 2). Biodynamica 9: 213-222.
-
(1964)
Biodynamica
, vol.9
, pp. 213-222
-
-
MacKenzie, A.P.1
-
16
-
-
68949109864
-
Freeze-dry microscopy of protein/sugar mixtures: Drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data
-
Meister E, Gieseler H. 2009. Freeze-dry microscopy of protein/sugar mixtures: Drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data. J Pharm Sci 98: 3072-3087.
-
(2009)
J Pharm Sci
, vol.98
, pp. 3072-3087
-
-
Meister, E.1
Gieseler, H.2
-
17
-
-
0031807819
-
Mixing behavior of colyophilized binary systems
-
Shamblin SL, Taylor LS, Zografi G. 1998. Mixing behavior of colyophilized binary systems. J Pharm Sci 87: 694-701.
-
(1998)
J Pharm Sci
, vol.87
, pp. 694-701
-
-
Shamblin, S.L.1
Taylor, L.S.2
Zografi, G.3
-
18
-
-
0030443488
-
Effects of phase separating systems on lyophilized hemoglobin
-
Heller MC, Carpenter JF, Randolph TW. 1996. Effects of phase separating systems on lyophilized hemoglobin. J Pharm Sci 85: 1358-1362.
-
(1996)
J Pharm Sci
, vol.85
, pp. 1358-1362
-
-
Heller, M.C.1
Carpenter, J.F.2
Randolph, T.W.3
-
19
-
-
0030712895
-
Phase separation of excipients during lyophilization: Effects on protein stability
-
Randolph TW. 1997. Phase separation of excipients during lyophilization: Effects on protein stability. J Pharm Sci 86: 1198-1203.
-
(1997)
J Pharm Sci
, vol.86
, pp. 1198-1203
-
-
Randolph, T.W.1
-
20
-
-
0029855850
-
Effect of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers
-
Izutsu K, Yoshioka S, Kojima S, Randolph TW, Carpenter JF. 1996. Effect of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers. Pharm Res 13: 1393-1400.
-
(1996)
Pharm Res
, vol.13
, pp. 1393-1400
-
-
Izutsu, K.1
Yoshioka, S.2
Kojima, S.3
Randolph, T.W.4
Carpenter, J.F.5
-
21
-
-
17844407208
-
Effect of polymer size and cosolutes on phase separation of poly(vinylpyrrolidone) (PVP) and dextran in frozen solutions
-
Izutsu K, Aoyagi N, Kojima S. 2005. Effect of polymer size and cosolutes on phase separation of poly(vinylpyrrolidone) (PVP) and dextran in frozen solutions. J Pharm Sci 94: 709-717.
-
(2005)
J Pharm Sci
, vol.94
, pp. 709-717
-
-
Izutsu, K.1
Aoyagi, N.2
Kojima, S.3
-
22
-
-
33748730527
-
Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration
-
Izutsu K, Heller M, Randolph TW, Carpenter JF. 1998. Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration. J Chem Soc Faraday Trans 94: 411-418.
-
(1998)
J Chem Soc Faraday Trans
, vol.94
, pp. 411-418
-
-
Izutsu, K.1
Heller, M.2
Randolph, T.W.3
Carpenter, J.F.4
-
23
-
-
0022811695
-
The nature of phase separation in aqueous two-polymer systems
-
Gustafsson A, Wennerstorm H, Tjerneld F. 1986. The nature of phase separation in aqueous two-polymer systems. Polymer 27: 1768-1770.
-
(1986)
Polymer
, vol.27
, pp. 1768-1770
-
-
Gustafsson, A.1
Wennerstorm, H.2
Tjerneld, F.3
-
24
-
-
0014716308
-
Partition of cell particles and macromolecules in polymer two-phase systems
-
Albertsson PA. 1970. Partition of cell particles and macromolecules in polymer two-phase systems. Adv Protein Chem 24: 309-341.
-
(1970)
Adv Protein Chem
, vol.24
, pp. 309-341
-
-
Albertsson, P.A.1
-
25
-
-
0033637883
-
Freeze-concentration separates proteins and polymer excipients into different amorphous phases
-
Izutsu K, Kojima S. 2000. Freeze-concentration separates proteins and polymer excipients into different amorphous phases. Pharm Res 17: 1316-1322.
-
(2000)
Pharm Res
, vol.17
, pp. 1316-1322
-
-
Izutsu, K.1
Kojima, S.2
-
26
-
-
85025558417
-
Concentration and purification of proteins by means of two-phase systems: Membraneless osmosis process
-
Tolstoguzov VB. 1988. Concentration and purification of proteins by means of two-phase systems: Membraneless osmosis process. Food Hydrocolloids 2: 195-207.
-
(1988)
Food Hydrocolloids
, vol.2
, pp. 195-207
-
-
Tolstoguzov, V.B.1
-
27
-
-
0033959890
-
Phase separation of polyelectrolytes and non-ionic polymers in frozen solutions
-
Izutsu K, Kojima S. 2000. Phase separation of polyelectrolytes and non-ionic polymers in frozen solutions. Phys Chem Chem Phys 2: 123-127.
-
(2000)
Phys Chem Chem Phys
, vol.2
, pp. 123-127
-
-
Izutsu, K.1
Kojima, S.2
-
28
-
-
0036285548
-
Mannitol-sucrose mixtures-Versatile formulations for protein lyophilization
-
Johnson RE, Kirchhoff CF, Gaud HT. 2002. Mannitol-sucrose mixtures-Versatile formulations for protein lyophilization. J Pharm Sci 91: 914-922.
-
(2002)
J Pharm Sci
, vol.91
, pp. 914-922
-
-
Johnson, R.E.1
Kirchhoff, C.F.2
Gaud, H.T.3
-
29
-
-
67651202371
-
Freezing-induced phase separation and spatial microheterogeneity in protein solutions
-
Dong J, Hubel A, Bischof JC, Aksan A. 2009. Freezing-induced phase separation and spatial microheterogeneity in protein solutions. J Phys Chem B 113: 10081-10087.
-
(2009)
J Phys Chem B
, vol.113
, pp. 10081-10087
-
-
Dong, J.1
Hubel, A.2
Bischof, J.C.3
Aksan, A.4
-
30
-
-
1142269554
-
Collapse temperature of freeze-dried Lactobacillus bulgaricus suspensions and protective media
-
Fonseca F, Passot S, Cunin O, Marin M. 2004. Collapse temperature of freeze-dried Lactobacillus bulgaricus suspensions and protective media. Biotechnol Prog 20: 229-238.
-
(2004)
Biotechnol Prog
, vol.20
, pp. 229-238
-
-
Fonseca, F.1
Passot, S.2
Cunin, O.3
Marin, M.4
-
31
-
-
0003578648
-
Aqueous two-phase partitioning
-
1st edition., New York: Marcel Dekker.
-
Zaslavsky BY. 1995. Aqueous two-phase partitioning. 1st edition. New York: Marcel Dekker.
-
(1995)
-
-
Zaslavsky, B.Y.1
-
32
-
-
55749088198
-
Characterization of amorphous API:polymer mixtures using X-ray powder diffraction
-
Newman A, Engers D, Bates S, Ivanisevic I, Kelly RC, Zografi G. 2008. Characterization of amorphous API:polymer mixtures using X-ray powder diffraction. J Pharm Sci 97: 4840-4856.
-
(2008)
J Pharm Sci
, vol.97
, pp. 4840-4856
-
-
Newman, A.1
Engers, D.2
Bates, S.3
Ivanisevic, I.4
Kelly, R.C.5
Zografi, G.6
-
33
-
-
1942498890
-
Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase
-
Wang DQ, Hey JM, Nail SL. 2004. Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase. J Pharm Sci 93: 1253-1263.
-
(2004)
J Pharm Sci
, vol.93
, pp. 1253-1263
-
-
Wang, D.Q.1
Hey, J.M.2
Nail, S.L.3
-
34
-
-
27244462333
-
Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying
-
Anchordoquy TJ, Izutsu KI, Randolph TW, Carpenter JF. 2001. Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying. Arch Biochem Biophys 390: 35-41.
-
(2001)
Arch Biochem Biophys
, vol.390
, pp. 35-41
-
-
Anchordoquy, T.J.1
Izutsu, K.I.2
Randolph, T.W.3
Carpenter, J.F.4
-
35
-
-
18044391843
-
Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer
-
Tang XC, Nail SL, Pikal MJ. 2005. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharm Res 22: 685-700.
-
(2005)
Pharm Res
, vol.22
, pp. 685-700
-
-
Tang, X.C.1
Nail, S.L.2
Pikal, M.J.3
-
36
-
-
58149233995
-
A procedure to optimize scale-up for the primary drying phase of lyophilization
-
Kramer T, Kremer DM, Pikal MJ, Petre WJ, Shalaev EY, Gatlin LA. 2008. A procedure to optimize scale-up for the primary drying phase of lyophilization. J Pharm Sci 98: 307-318.
-
(2008)
J Pharm Sci
, vol.98
, pp. 307-318
-
-
Kramer, T.1
Kremer, D.M.2
Pikal, M.J.3
Petre, W.J.4
Shalaev, E.Y.5
Gatlin, L.A.6
-
37
-
-
35848946390
-
Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring
-
De Beer TR, Allesø M, Goethals F, Coppens A, Heyden YV, De Diego HL, Rantanen J, Verpoort F, Vervaet C, Remon JP, Baeyens WR. 2007. Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring. Anal Chem 79: 7992-8003.
-
(2007)
Anal Chem
, vol.79
, pp. 7992-8003
-
-
De Beer, T.R.1
Allesø, M.2
Goethals, F.3
Coppens, A.4
Heyden, Y.V.5
De Diego, H.L.6
Rantanen, J.7
Verpoort, F.8
Vervaet, C.9
Remon, J.P.10
Baeyens, W.R.11
-
38
-
-
34547212342
-
Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying
-
Gieseler H, Kessler WJ, Finson M, Davis SJ, Mulhall PA, Bons V, Debo DJ, Pikal MJ. 2007. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. J Pharm Sci 96: 1776-1793.
-
(2007)
J Pharm Sci
, vol.96
, pp. 1776-1793
-
-
Gieseler, H.1
Kessler, W.J.2
Finson, M.3
Davis, S.J.4
Mulhall, P.A.5
Bons, V.6
Debo, D.J.7
Pikal, M.J.8
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