메뉴 건너뛰기




Volumn 2, Issue 3, 1997, Pages 257-264

Glass fragility and the stability of pharmaceutical preparations- excipient selection

Author keywords

Carbohydrate glass; Fragility; Glass transition; Stability; Sucrose; T0; Trehalose

Indexed keywords

CARBOHYDRATE; EXCIPIENT; GLASS; SUCROSE; TREHALOSE;

EID: 0031392295     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.3109/10837459709031445     Document Type: Article
Times cited : (50)

References (34)
  • 2
    • 0001904754 scopus 로고
    • Freeze-drying of proteins. I. Process design
    • M. J. Pikal, Freeze-drying of proteins. I. Process design, Biopharm., 3, 18-27 (1990).
    • (1990) Biopharm. , vol.3 , pp. 18-27
    • Pikal, M.J.1
  • 3
    • 0001904754 scopus 로고
    • Freeze-drying of proteins. II. Formulation selection
    • M. J. Pikal, Freeze-drying of proteins. II. Formulation selection, Biopharm., 3, 26-30 (1990).
    • (1990) Biopharm. , vol.3 , pp. 26-30
    • Pikal, M.J.1
  • 4
    • 0003220389 scopus 로고
    • Freeze-drying of proteins: Process, formulation and stability
    • J. L. Cleland and R. Langer, eds., American Chemical Society Symposia Series No.567
    • M. J. Pikal, Freeze-drying of proteins: process, formulation and stability, in Formulations and Delivery of Proteins and Peptides, (J. L. Cleland and R. Langer, eds.), American Chemical Society Symposia Series No.567, 1994, pp. 120-133.
    • (1994) Formulations and Delivery of Proteins and Peptides , pp. 120-133
    • Pikal, M.J.1
  • 5
    • 0001844127 scopus 로고
    • Freeze-drying: From empiricism to predictability
    • F. Franks, Freeze-drying: from empiricism to predictability, Cryoletters, 11, 93-110 (1990).
    • (1990) Cryoletters , vol.11 , pp. 93-110
    • Franks, F.1
  • 7
    • 0002562268 scopus 로고    scopus 로고
    • Trehalose and novel hydrophobic sugar glasses in drug stabilization and delivery
    • D. R. Karsa and R. A. Stephenson, eds., RSC, Cambridge
    • E. M. Gribbon, R. H. M. Hatley, T. Gard, J. Blair, J. Kampinga, and B. J. Roser, Trehalose and novel hydrophobic sugar glasses in drug stabilization and delivery, in Chemical Aspects of Drug Delivery Systems (D. R. Karsa and R. A. Stephenson, eds.), RSC, Cambridge, 1996, pp. 138-145.
    • (1996) Chemical Aspects of Drug Delivery Systems , pp. 138-145
    • Gribbon, E.M.1    Hatley, R.H.M.2    Gard, T.3    Blair, J.4    Kampinga, J.5    Roser, B.J.6
  • 8
    • 85023311020 scopus 로고
    • Stable enzymes by water removal
    • W. J. J. van den Tweel, A. Harder, and R. M. Buitelaar, eds., Elsevier, Amsterdam
    • F. Franks and R. H. M Hatley, Stable enzymes by water removal, in Stability and Stabilization of Enzymes (W. J. J. van den Tweel, A. Harder, and R. M. Buitelaar, eds.), Elsevier, Amsterdam, 1993, pp. 45-54.
    • (1993) Stability and Stabilization of Enzymes , pp. 45-54
    • Franks, F.1    Hatley, R.H.M.2
  • 9
    • 0002398428 scopus 로고
    • Materials science and the production of shelf stable biologicals
    • F. Franks, R. H. M. Hatley, and S. F. Mathias, Materials science and the production of shelf stable biologicals, Biopharm., 14, 38-5 (1991).
    • (1991) Biopharm. , vol.14 , pp. 38-45
    • Franks, F.1    Hatley, R.H.M.2    Mathias, S.F.3
  • 10
    • 0025006297 scopus 로고
    • Dry, instant blood typing plate for bedside use
    • D. Blakeley, B. Tolliday, C. A. L. S. Colaco, and B. Roser, Dry, instant blood typing plate for bedside use, Lancet, 336, 854-855 (1990).
    • (1990) Lancet , vol.336 , pp. 854-855
    • Blakeley, D.1    Tolliday, B.2    Colaco, C.A.L.S.3    Roser, B.4
  • 11
    • 14744285620 scopus 로고
    • Extraordinary stability of enzymes dried in trehalose: Simplified molecular biology
    • C. A. L. S. Colaco, S. Sen, M. Thangavelu, S Pinder, and B. Roser, Extraordinary stability of enzymes dried in trehalose: simplified molecular biology. Biotech, 10, 1007-1011 (1992).
    • (1992) Biotech , vol.10 , pp. 1007-1011
    • Colaco, C.A.L.S.1    Sen, S.2    Thangavelu, M.3    Pinder, S.4    Roser, B.5
  • 13
    • 0002509009 scopus 로고
    • Trehalose drying: A novel replacement for freeze-drying
    • B. J. Roser, Trehalose drying: a novel replacement for freeze-drying, Biopharm. 5, 44-53 (1991).
    • (1991) Biopharm. , vol.5 , pp. 44-53
    • Roser, B.J.1
  • 14
    • 0029976428 scopus 로고    scopus 로고
    • Stabilisation of a pharmaceutical drug substance by freeze-drying: A case study
    • R. H. M. Hatley, F. Franks, S. Brown, G. Sandhu, and M. Gray, Stabilisation of a pharmaceutical drug substance by freeze-drying: a case study, Drug Stability 1, 2-12 (1996).
    • (1996) Drug Stability , vol.1 , pp. 2-12
    • Hatley, R.H.M.1    Franks, F.2    Brown, S.3    Sandhu, G.4    Gray, M.5
  • 15
    • 18344412166 scopus 로고
    • The effective use of differential scanning calorimetry in the optimisation of freeze-drying processes and formulations
    • R. H. M. Hatley, The effective use of differential scanning calorimetry in the optimisation of freeze-drying processes and formulations, J. Biol. Standardization, 74, 105-122 (1992).
    • (1992) J. Biol. Standardization , vol.74 , pp. 105-122
    • Hatley, R.H.M.1
  • 16
    • 0026461489 scopus 로고
    • Freeze-drying: From empiricism to predicability. The significance of glass transitions
    • F. Franks. Freeze-drying: from empiricism to predicability. The significance of glass transitions, J. Biol. Standardization, 74, 9-19 (1992).
    • (1992) J. Biol. Standardization , vol.74 , pp. 9-19
    • Franks, F.1
  • 17
    • 0026208884 scopus 로고
    • Applications of DSC in the development of improved freeze-drying processes for labile biologicals
    • R. H. M. Hatley and F. Franks. Applications of DSC in the development of improved freeze-drying processes for labile biologicals, J. Thermal Analysis, 37, 1905-1914 (1991).
    • (1991) J. Thermal Analysis , vol.37 , pp. 1905-1914
    • Hatley, R.H.M.1    Franks, F.2
  • 18
    • 0028268210 scopus 로고
    • The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids
    • B. C. Hancock and G. Zografi, The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids, Pharm. Res., 11, 471-477 (1994).
    • (1994) Pharm. Res. , vol.11 , pp. 471-477
    • Hancock, B.C.1    Zografi, G.2
  • 19
    • 0026586448 scopus 로고
    • Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry
    • M. P. W. M. te Booy, R. A. de Ruiter, and A. J. de Meere, Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry, Pharm. Res., 9, 109-114 (1992).
    • (1992) Pharm. Res. , vol.9 , pp. 109-114
    • Te Booy, M.P.W.M.1    De Ruiter, R.A.2    De Meere, A.J.3
  • 20
    • 0025793265 scopus 로고
    • The effects of formulation variables on the stability of freeze-dried human growth hormone
    • M. J. Pikal, K. M. Dellerman, M. L. Roy, and R. M Riggin, The effects of formulation variables on the stability of freeze-dried human growth hormone, Pharm. Res., 8, 427-436 (1991).
    • (1991) Pharm. Res. , vol.8 , pp. 427-436
    • Pikal, M.J.1    Dellerman, K.M.2    Roy, M.L.3    Riggin, R.M.4
  • 21
    • 0003080917 scopus 로고
    • Chemical reaction kinetics in relation to glass temperatures in frozen food polymer solutions
    • W. L. Kerr, M. H. Lim, D. S. Reid, and H. Chen, Chemical reaction kinetics in relation to glass temperatures in frozen food polymer solutions, J. Sci. Food Agric., 61, 51-56 (1993).
    • (1993) J. Sci. Food Agric. , vol.61 , pp. 51-56
    • Kerr, W.L.1    Lim, M.H.2    Reid, D.S.3    Chen, H.4
  • 22
    • 0001159547 scopus 로고
    • Interactions of stabilizers with proteins during freezing and drying
    • J. L. Cleland and R. Langer, eds, American Chemical Society Symposia 567
    • J. F. Carpenter, S. J. Perstrelski, T. J. Anchordoguy, and T. Arkawa, Interactions of stabilizers with proteins during freezing and drying, in Formulations and Delivery of Proteins and Peptides (J. L. Cleland and R. Langer, eds), American Chemical Society Symposia 567, 1994, pp. 134-147.
    • (1994) Formulations and Delivery of Proteins and Peptides , pp. 134-147
    • Carpenter, J.F.1    Perstrelski, S.J.2    Anchordoguy, T.J.3    Arkawa, T.4
  • 23
    • 0009071257 scopus 로고
    • Formation of glasses from liquids and biopolymers
    • C. A. Angell, Formation of glasses from liquids and biopolymers, Science, 267, 1924-1935 (1995).
    • (1995) Science , vol.267 , pp. 1924-1935
    • Angell, C.A.1
  • 25
    • 0009733128 scopus 로고
    • The relationship between glass transition temperature and stability of freeze-dried human growth hormone
    • Nov. 5-9, Miami Beach Florida
    • M. J. Pikal, D. R. Rigsbee, and M. L. Roy, The relationship between glass transition temperature and stability of freeze-dried human growth hormone, Symposia Abstract for The 10th AAPS Annual Meeting, Nov. 5-9, 1995, Miami Beach Florida.
    • (1995) Symposia Abstract for the 10th AAPS Annual Meeting
    • Pikal, M.J.1    Rigsbee, D.R.2    Roy, M.L.3
  • 26
    • 0029015405 scopus 로고
    • Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures
    • B. C. Hancock, S. L. Shamblin, and G. Zografi, Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures, Pharm. Res., 12, 799-806 (1995).
    • (1995) Pharm. Res. , vol.12 , pp. 799-806
    • Hancock, B.C.1    Shamblin, S.L.2    Zografi, G.3
  • 27
    • 0026413564 scopus 로고
    • Relaxation in liquids, polymers and plastic crystals - Patterns and problems
    • C. A. Angell, Relaxation in liquids, polymers and plastic crystals - patterns and problems, J. Non-Cryst. Solids, 131, 13-31 (1991).
    • (1991) J. Non-Cryst. Solids , vol.131 , pp. 13-31
    • Angell, C.A.1
  • 29
    • 0027526185 scopus 로고
    • Melting and glass transitions of low molecular weight carbohydrates
    • Y. Roos, Melting and glass transitions of low molecular weight carbohydrates, Carbohydrate Res., 238, 39-48 (1993).
    • (1993) Carbohydrate Res. , vol.238 , pp. 39-48
    • Roos, Y.1
  • 31
    • 33845184276 scopus 로고
    • Phase relations and vitrification in saccharide water solutions and the trehalose anomaly
    • J. L. Green and C. A. Angell, Phase relations and vitrification in saccharide water solutions and the trehalose anomaly, J. Phys. Chem., 93, 2880-2882 (1989).
    • (1989) J. Phys. Chem. , vol.93 , pp. 2880-2882
    • Green, J.L.1    Angell, C.A.2
  • 32
    • 0344263976 scopus 로고
    • The bug in the box
    • R. Gray, The bug in the box, Pharm. Tech. Europe, 6, 20-32 (1994).
    • (1994) Pharm. Tech. Europe , vol.6 , pp. 20-32
    • Gray, R.1
  • 33
    • 0021198926 scopus 로고
    • Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial
    • M. J. Pikal, M. L. Roy, and S. Shar, Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial, J. Pharm. Sci., 73, 1224-1237 (1984).
    • (1984) J. Pharm. Sci. , vol.73 , pp. 1224-1237
    • Pikal, M.J.1    Roy, M.L.2    Shar, S.3
  • 34
    • 2642636968 scopus 로고    scopus 로고
    • Freeze drying of proteins
    • V. H. L Lee, ed. 2nd Edition, Marcel Dekker, New York
    • M. J. Pikal, Freeze drying of proteins,. in Peptide and Protein Delivery, (V. H. L Lee, ed.) 2nd Edition, Marcel Dekker, New York, 1996.
    • (1996) Peptide and Protein Delivery
    • Pikal, M.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.