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Volumn 64, Issue 3, 2006, Pages 316-325

Impact of freezing procedure and annealing on the physico-chemical properties and the formation of mannitol hydrate in mannitol-sucrose-NaCl formulations

Author keywords

Annealing; Freezing; Lyophilization; Mannitol hydrate; NaCl

Indexed keywords

MANNITOL; SODIUM CHLORIDE; SUCROSE;

EID: 33750065701     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2006.06.002     Document Type: Article
Times cited : (69)

References (37)
  • 1
    • 0025793265 scopus 로고
    • The effects of formulation variables on the stability of freeze-dried human growth hormone
    • Pikal M.J., Dellermann K.M., Roy M.L., and Riggin R.M. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm. Res. 8 (1991) 424-436
    • (1991) Pharm. Res. , vol.8 , pp. 424-436
    • Pikal, M.J.1    Dellermann, K.M.2    Roy, M.L.3    Riggin, R.M.4
  • 2
    • 0035994868 scopus 로고    scopus 로고
    • Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying
    • Izutsu K., and Kojima S. Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying. J. Pharm. Pharmacol. 54 (2002) 1033-1039
    • (2002) J. Pharm. Pharmacol. , vol.54 , pp. 1033-1039
    • Izutsu, K.1    Kojima, S.2
  • 3
    • 0031835707 scopus 로고    scopus 로고
    • Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy
    • Kasraian K., Spitznagel T.M., Juneau J.A., and Yim K. Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy. Pharm. Dev. Technol. 3 (1998) 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
  • 4
    • 0036285548 scopus 로고    scopus 로고
    • Mannitol-sucrose mixtures - versatile formulations for protein lyophilization
    • Johnson R., Kirchhoff C., and Gaud H. Mannitol-sucrose mixtures - versatile formulations for protein lyophilization. J. Pharm. Sci. 91 (2002) 914-922
    • (2002) J. Pharm. Sci. , vol.91 , pp. 914-922
    • Johnson, R.1    Kirchhoff, C.2    Gaud, H.3
  • 5
    • 21544482855 scopus 로고    scopus 로고
    • Physical characterization of formulations for the development of two stable freeze-dried proteins during both dried and liquid storage
    • Passot S., Fonseca F., Alarcon-Lorca M., Rolland D., and Marin M. Physical characterization of formulations for the development of two stable freeze-dried proteins during both dried and liquid storage. Eur. J. Pharm. Biopharm. 60 (2005) 335-348
    • (2005) Eur. J. Pharm. Biopharm. , vol.60 , pp. 335-348
    • Passot, S.1    Fonseca, F.2    Alarcon-Lorca, M.3    Rolland, D.4    Marin, M.5
  • 6
    • 27144435461 scopus 로고    scopus 로고
    • Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol - implications in freeze-drying
    • Liao X., Krishnamurthy R., and Suryanarayanan R. Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol - implications in freeze-drying. Pharm. Res. 22 (2005) 1978-1985
    • (2005) Pharm. Res. , vol.22 , pp. 1978-1985
    • Liao, X.1    Krishnamurthy, R.2    Suryanarayanan, R.3
  • 7
    • 0034029664 scopus 로고    scopus 로고
    • The influence of lyophilization on the polymorphic behavior of mannitol
    • Cannon A., and Trappler E. The influence of lyophilization on the polymorphic behavior of mannitol. PDA J. Pharm. Sci. Technol. 54 (2000) 13-22
    • (2000) PDA J. Pharm. Sci. Technol. , vol.54 , pp. 13-22
    • Cannon, A.1    Trappler, E.2
  • 8
    • 0036288731 scopus 로고    scopus 로고
    • Crystallization of mannitol below Tg′ during freeze-drying in binary and ternary aqueous systems
    • Pyne A., Surana R., and Suryanararyanan R. Crystallization of mannitol below Tg′ during freeze-drying in binary and ternary aqueous systems. Pharm. Res. 19 (2002) 901-908
    • (2002) Pharm. Res. , vol.19 , pp. 901-908
    • Pyne, A.1    Surana, R.2    Suryanararyanan, R.3
  • 9
    • 1342322942 scopus 로고    scopus 로고
    • 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., and 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. 9 (2004) 85-95
    • (2004) Pharm. Dev. Technol. , vol.9 , pp. 85-95
    • Lu, X.1    Pikal, M.2
  • 10
    • 0025793265 scopus 로고
    • The effects of formulation variables on the stability of freeze-dried human growth hormone
    • Pikal M.J., Dellermann K.M., Roy M.L., and Riggin R.M. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm. Res. 8 (1991) 427-436
    • (1991) Pharm. Res. , vol.8 , pp. 427-436
    • Pikal, M.J.1    Dellermann, K.M.2    Roy, M.L.3    Riggin, R.M.4
  • 11
    • 0031828085 scopus 로고    scopus 로고
    • The physical state of mannitol after freeze-drying: effect of mannitol concentration, freezing rate and a noncrystallizing cosolute
    • Kim A., Akers M., and Nail S. The physical state of mannitol after freeze-drying: effect of mannitol concentration, freezing rate and a noncrystallizing cosolute. J. Pharm. Sci. 87 (1998) 931-935
    • (1998) J. Pharm. Sci. , vol.87 , pp. 931-935
    • Kim, A.1    Akers, M.2    Nail, S.3
  • 12
    • 0031657680 scopus 로고    scopus 로고
    • Formulations of sugars with amino acids or mannitol - influence of concentration ratio on properties of the freeze-concentrate and the lyophilisate
    • Lueckel B., Bodmer D., Helk B., and Leuenberger H. Formulations of sugars with amino acids or mannitol - influence of concentration ratio on properties of the freeze-concentrate and the lyophilisate. Pharm. Dev. Technol. 3 (1998) 325-336
    • (1998) Pharm. Dev. Technol. , vol.3 , pp. 325-336
    • Lueckel, B.1    Bodmer, D.2    Helk, B.3    Leuenberger, H.4
  • 13
    • 12444308939 scopus 로고    scopus 로고
    • Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride
    • Telang C., Yu L., and Suryanararyanan R. Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride. Pharm. Res. 20 (2003) 660-667
    • (2003) Pharm. Res. , vol.20 , pp. 660-667
    • Telang, C.1    Yu, L.2    Suryanararyanan, R.3
  • 14
    • 0036209466 scopus 로고    scopus 로고
    • Effect of salts on the properties of aqueous sugar systems, in relation to biomaterial stabilization. 1. Water sorption behavior and ice crystallization/melting
    • Mazzobre M.F., Longinotti M.P., Corti H.R., and Buera M.P. Effect of salts on the properties of aqueous sugar systems, in relation to biomaterial stabilization. 1. Water sorption behavior and ice crystallization/melting. Cryobiology 43 (2001) 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
  • 15
    • 33646877875 scopus 로고    scopus 로고
    • Physico-chemical lyophilization behavior of mannitol, human serum albumin formulations
    • Hawe A., and Frieß W. Physico-chemical lyophilization behavior of mannitol, human serum albumin formulations. Eur. J. Pharm. Sci. 28 (2006) 224-232
    • (2006) Eur. J. Pharm. Sci. , vol.28 , pp. 224-232
    • Hawe, A.1    Frieß, W.2
  • 16
    • 0028824421 scopus 로고
    • Glycine crystallization during freezing: the effect of salt form, pH, and ionic strength
    • Akers M.J., Milton N., Byrn S.R., and Nail S.L. Glycine crystallization during freezing: the effect of salt form, pH, and ionic strength. Pharm. Res. 12 (1995) 1455-1461
    • (1995) Pharm. Res. , vol.12 , pp. 1455-1461
    • Akers, M.J.1    Milton, N.2    Byrn, S.R.3    Nail, S.L.4
  • 17
    • 33751124679 scopus 로고    scopus 로고
    • Crystalline and amorphous phases in the ternary system water-sucrose-sodium chloride
    • Shalaev E.Y., and Franks F. Crystalline and amorphous phases in the ternary system water-sucrose-sodium chloride. J. Phys. Chem. 100 (1996) 1144-1152
    • (1996) J. Phys. Chem. , vol.100 , pp. 1144-1152
    • Shalaev, E.Y.1    Franks, F.2
  • 18
    • 0000167612 scopus 로고
    • Phase behavior of the system trehalose-NaCl-water
    • Nicolajsen H., and Hvidt A. Phase behavior of the system trehalose-NaCl-water. Cryobiology 31 (1994) 199-205
    • (1994) Cryobiology , vol.31 , pp. 199-205
    • Nicolajsen, H.1    Hvidt, A.2
  • 19
    • 0032970823 scopus 로고    scopus 로고
    • Existence of a mannitol hydrate during freeze-drying and practical implications
    • Yu L., Milton N., Groleau E., Mishra D., and Vansickle R. Existence of a mannitol hydrate during freeze-drying and practical implications. J. Pharm. Sci. 88 (1999) 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
  • 20
    • 1542328823 scopus 로고    scopus 로고
    • Effect of sodium tetraborate and boric acid on nonisothermal mannitol crystallization in frozen solutions and freeze-dried solids
    • Izutsu K., Ocheda S.O., Aoyagi N., and Kojima S. Effect of sodium tetraborate and boric acid on nonisothermal mannitol crystallization in frozen solutions and freeze-dried solids. Int. J. Pharm. 273 (2004) 85-93
    • (2004) Int. J. Pharm. , vol.273 , pp. 85-93
    • Izutsu, K.1    Ocheda, S.O.2    Aoyagi, N.3    Kojima, S.4
  • 21
    • 0038175088 scopus 로고    scopus 로고
    • Crystallisation of amorphous mannitol is retarded using boric acid
    • Yoshinari T., Forbes R.T., York P., and Kawashima Y. Crystallisation of amorphous mannitol is retarded using boric acid. Int. J. Pharm. 258 (2003) 109-120
    • (2003) Int. J. Pharm. , vol.258 , pp. 109-120
    • Yoshinari, T.1    Forbes, R.T.2    York, P.3    Kawashima, Y.4
  • 22
    • 0028098067 scopus 로고
    • Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying
    • Izutsu K., Yoshioka S., and Terao T. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying. Chem. Pharm. Bull. 42 (1994) 5-8
    • (1994) Chem. Pharm. Bull. , vol.42 , pp. 5-8
    • Izutsu, K.1    Yoshioka, S.2    Terao, T.3
  • 23
    • 0031793406 scopus 로고    scopus 로고
    • Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-ige monoclonal antibody
    • Costantino H.R., Andya J.D., Nguyen P.A., Dasovich N., Sweeney T.D., Shire S.J., Hsu C.C., and Maa Y.F. Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-ige monoclonal antibody. J. Pharm. Sci. 87 (1998) 1406-1411
    • (1998) J. Pharm. Sci. , vol.87 , pp. 1406-1411
    • Costantino, H.R.1    Andya, J.D.2    Nguyen, P.A.3    Dasovich, N.4    Sweeney, T.D.5    Shire, S.J.6    Hsu, C.C.7    Maa, Y.F.8
  • 24
    • 0032969861 scopus 로고    scopus 로고
    • Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and in the dried solid
    • Kreilgaard L., Frokjaer S., Flink J.M., Randolph T.W., and Carpenter J.F. Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and in the dried solid. J. Pharm. Sci. 88 (1999) 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
  • 25
    • 0035897584 scopus 로고    scopus 로고
    • Amorphous pharmaceutical solids: preparation, characterization and stabilization
    • Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv. Drug Deliv. Rev. 48 (2001) 27-42
    • (2001) Adv. Drug Deliv. Rev. , vol.48 , pp. 27-42
    • Yu, L.1
  • 27
    • 0029941173 scopus 로고    scopus 로고
    • Freeze-drying: in situ observations using cryoenvironmental scanning electron microscopy and differential scanning calorimetry
    • Meredith P., Donald A., and Payne R. Freeze-drying: in situ observations using cryoenvironmental scanning electron microscopy and differential scanning calorimetry. J. Pharm. Sci. 85 (1996) 631-637
    • (1996) J. Pharm. Sci. , vol.85 , pp. 631-637
    • Meredith, P.1    Donald, A.2    Payne, R.3
  • 28
    • 0001498936 scopus 로고
    • Solid aqueous solution
    • Franks F. Solid aqueous solution. Pure Appl. Chem. 65 (1993) 2527-2537
    • (1993) Pure Appl. Chem. , vol.65 , pp. 2527-2537
    • Franks, F.1
  • 29
    • 0025006471 scopus 로고
    • The collapse temperature in freeze drying: dependence on measurement methodology and rate of water removal from the glassy phase
    • Pikal M.J., and Shah S. The collapse temperature in freeze drying: dependence on measurement methodology and rate of water removal from the glassy phase. Int. J. Pharm. 62 (1990) 165-186
    • (1990) Int. J. Pharm. , vol.62 , pp. 165-186
    • Pikal, M.J.1    Shah, S.2
  • 30
    • 0242353397 scopus 로고    scopus 로고
    • Solute crystallization in mannitol-glycine systems - implications on protein stabilization in freeze-dried formulations
    • Pyne A., Chatterjee K., and Suryanarayanan T. Solute crystallization in mannitol-glycine systems - implications on protein stabilization in freeze-dried formulations. J. Pharm. Sci. 92 (2003) 2272-2282
    • (2003) J. Pharm. Sci. , vol.92 , pp. 2272-2282
    • Pyne, A.1    Chatterjee, K.2    Suryanarayanan, T.3
  • 31
    • 0026586448 scopus 로고
    • Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry
    • te Booy M.P.W.M., de Ruiter R.A., and de Meere A.L.J. Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry. Pharm. Res. 9 (1992) 109-114
    • (1992) Pharm. Res. , vol.9 , pp. 109-114
    • te Booy, M.P.W.M.1    de Ruiter, R.A.2    de Meere, A.L.J.3
  • 32
    • 0028865701 scopus 로고
    • Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using Fourier-transform infrared spectroscopy
    • Prestrelski S.J., Pikal K.A., and Arakawa T. Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using Fourier-transform infrared spectroscopy. Pharm. Res. 12 (1995) 1250-1259
    • (1995) Pharm. Res. , vol.12 , pp. 1250-1259
    • Prestrelski, S.J.1    Pikal, K.A.2    Arakawa, T.3
  • 33
    • 0030586287 scopus 로고    scopus 로고
    • Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein confirmation
    • Chang B.S., Beauvais R.M., Dong A., and Carpenter J.F. Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein confirmation. Arch. Biochem. Biophys. 331 (1996) 249-258
    • (1996) Arch. Biochem. Biophys. , vol.331 , pp. 249-258
    • Chang, B.S.1    Beauvais, R.M.2    Dong, A.3    Carpenter, J.F.4
  • 35
    • 0034776736 scopus 로고    scopus 로고
    • Phase transitions of glycine in frozen aqueous solutions and during freeze-drying
    • Pyne A., and Suryanarayanan R. Phase transitions of glycine in frozen aqueous solutions and during freeze-drying. Pharm. Res. 18 (2001) 1448-1454
    • (2001) Pharm. Res. , vol.18 , pp. 1448-1454
    • Pyne, A.1    Suryanarayanan, R.2
  • 36
    • 0031770219 scopus 로고    scopus 로고
    • Characterization of phase transition during freeze-drying by in situ X-ray powder diffractometry
    • Cavatur R., and Suryanarayanan R. Characterization of phase transition during freeze-drying by in situ X-ray powder diffractometry. Pharm. Dev. Technol. 3 (1998) 579-586
    • (1998) Pharm. Dev. Technol. , vol.3 , pp. 579-586
    • Cavatur, R.1    Suryanarayanan, R.2
  • 37
    • 0031952684 scopus 로고    scopus 로고
    • Characterization of frozen aqueous solutions by low temperature X-ray powder diffractometry
    • Cavatur R., and Suryanarayanan R. Characterization of frozen aqueous solutions by low temperature X-ray powder diffractometry. Pharm. Res. 15 (1998) 193-198
    • (1998) Pharm. Res. , vol.15 , pp. 193-198
    • Cavatur, R.1    Suryanarayanan, R.2


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