메뉴 건너뛰기




Volumn 32, Issue 6, 2006, Pages 765-778

The stability of insulin in solid formulations containing melezitose and starch. Effects of processing and excipients

Author keywords

Chemical stability; Freeze drying; Insulin; Lyophilization; SEDS; Spray drying; Starch microspheres

Indexed keywords

EXCIPIENT; INSULIN; MICROSPHERE; STARCH; TAUROCHOLIC ACID; WATER;

EID: 33746876037     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040600712458     Document Type: Article
Times cited : (11)

References (32)
  • 1
    • 0025102704 scopus 로고
    • The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state
    • Ahlneck, C., & Zografi, G. (1990). The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int.J.Pharm., 62 (2-3), 87-95.
    • (1990) Int.J.Pharm. , vol.62 , Issue.2-3 , pp. 87-95
    • Ahlneck, C.1    Zografi, G.2
  • 4
    • 0036367094 scopus 로고    scopus 로고
    • Rational design of stable lyophilized protein formulations: Theory and practice
    • Carpenter, J. F., Chang, B. S., Garzon-Rodriguez, W., & Randolph, T. W. (2002). Rational design of stable lyophilized protein formulations: theory and practice. Pharm.Biotechnol., 13, 109-133.
    • (2002) Pharm.Biotechnol. , vol.13 , pp. 109-133
    • Carpenter, J.F.1    Chang, B.S.2    Garzon-Rodriguez, W.3    Randolph, T.W.4
  • 5
    • 0024549238 scopus 로고
    • An infrared spectroscopic study of the interactions of carbohydrates with dried proteins
    • Carpenter, J. F., & Crowe, J. H. (1989). An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry, 28 (9), 3916-3922.
    • (1989) Biochemistry , vol.28 , Issue.9 , pp. 3916-3922
    • Carpenter, J.F.1    Crowe, J.H.2
  • 6
    • 0030586287 scopus 로고    scopus 로고
    • Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: Glass transition and protein conformation
    • Chang, B. S., Beauvais, R. M., Dong, A., & Carpenter, J. F. (1996a). Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein conformation. Arch Biochem Biophys, 331 (2), 249-258.
    • (1996) Arch. Biochem. Biophys. , vol.331 , Issue.2 , pp. 249-258
    • Chang, B.S.1    Beauvais, R.M.2    Dong, A.3    Carpenter, J.F.4
  • 7
    • 0030044405 scopus 로고    scopus 로고
    • Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist
    • Chang, B. S., Reeder, G., & Carpenter, J. F. (1996b). Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist. Pharm.Res., 13 (2), 243-249.
    • (1996) Pharm.Res. , vol.13 , Issue.2 , pp. 243-249
    • Chang, B.S.1    Reeder, G.2    Carpenter, J.F.3
  • 8
    • 0003950989 scopus 로고
    • New York: Chapman and Hall Chemistry Source Books 1987
    • Collins, R. M. (1987). Carbohydrates. New York: Chapman and Hall Chemistry Source Books 1987.
    • (1987) Carbohydrates
    • Collins, R.M.1
  • 10
    • 0036843324 scopus 로고    scopus 로고
    • Effects of drying methods and additives on the structure, function, and storage stability of subtilisin: Role of protein conformation and molecular mobility
    • DePaz, R. A., Dale, D. A., Barnett, C. C., Carpenter, J. F., Gaertner, A. L., & Randolph, T. W. (2002). Effects of drying methods and additives on the structure, function, and storage stability of subtilisin: role of protein conformation and molecular mobility. Enzyme Microb.Technol., 31 (6), 765-774.
    • (2002) Enzyme Microb.Technol. , vol.31 , Issue.6 , pp. 765-774
    • DePaz, R.A.1    Dale, D.A.2    Barnett, C.C.3    Carpenter, J.F.4    Gaertner, A.L.5    Randolph, T.W.6
  • 11
    • 4344638113 scopus 로고    scopus 로고
    • Recrystallisation behaviour of native and processed waxy maize starch in relation to the molecular characteristics
    • Elfstrand, L., Frigard, T., Andersson, R., Eliasson, A. C., Jonsson, M., Reslow, M., & Wahlgren, M. (2004). Recrystallisation behaviour of native and processed waxy maize starch in relation to the molecular characteristics. Carbohydr.Polym., 57 (4), 389-400.
    • (2004) Carbohydr.Polym. , vol.57 , Issue.4 , pp. 389-400
    • Elfstrand, L.1    Frigard, T.2    Andersson, R.3    Eliasson, A.C.4    Jonsson, M.5    Reslow, M.6    Wahlgren, M.7
  • 13
    • 0025513678 scopus 로고
    • Interfacial tension of polyethyleneglycoldextran-water systems: Influence of temperature and polymer molecular weight
    • Forciniti, D., & Kula, M. (1990). Interfacial tension of polyethyleneglycoldextran-water systems: Influence of temperature and polymer molecular weight. J. Biotechnol., 16, 279-296.
    • (1990) J. Biotechnol. , vol.16 , pp. 279-296
    • Forciniti, D.1    Kula, M.2
  • 14
    • 0029015405 scopus 로고
    • Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures
    • Hancock, B. C. (1995). Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm.Res., 12 (6), 799-806.
    • (1995) Pharm.Res. , vol.12 , Issue.6 , pp. 799-806
    • Hancock, B.C.1
  • 15
    • 10844244793 scopus 로고    scopus 로고
    • Complementary analytical HPLC methods for insulin-related degradation products
    • Hvass, A., Hach, M., & Jars, M. U. (2003). Complementary analytical HPLC methods for insulin-related degradation products. American Biotechnology Laboratory, 21 (2), 8-12.
    • (2003) American Biotechnology Laboratory , vol.21 , Issue.2 , pp. 8-12
    • Hvass, A.1    Hach, M.2    Jars, M.U.3
  • 16
    • 0036803204 scopus 로고    scopus 로고
    • Mechanisms for absorption enhancement of inhaled insulin by sodium taurocholate
    • Johansson, F., Hjertberg, E., Eirefelt, S., Tronde, A., & Hultkvist, B. (2002). Mechanisms for absorption enhancement of inhaled insulin by sodium taurocholate. Eur.J.Pharm.Sci., 17 (1-2), 63-71.
    • (2002) Eur.J.Pharm.Sci. , vol.17 , Issue.1-2 , pp. 63-71
    • Johansson, F.1    Hjertberg, E.2    Eirefelt, S.3    Tronde, A.4    Hultkvist, B.5
  • 17
    • 0032969861 scopus 로고    scopus 로고
    • Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid
    • Kreilgaard, L., Frokjaer, S., Flink, J. M., Randolph, T. W., & Carpenter, J. F. (1999). Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid. J.Pharm.Sci., 88 (3), 281-290.
    • (1999) J.Pharm.Sci. , vol.88 , Issue.3 , pp. 281-290
    • Kreilgaard, L.1    Frokjaer, S.2    Flink, J.M.3    Randolph, T.W.4    Carpenter, J.F.5
  • 18
    • 0031393964 scopus 로고    scopus 로고
    • The effect of operating and formulation variables on the morphology of spraydried protein particles
    • Maa, Y. F., Costantino, H. R., Nguyen, P. A., & Hsu, C. C. (1997). The effect of operating and formulation variables on the morphology of spraydried protein particles. Pharm Dev Technol, 2 (3), 213-223.
    • (1997) Pharm. Dev. Technol. , vol.2 , Issue.3 , pp. 213-223
    • Maa, Y.F.1    Costantino, H.R.2    Nguyen, P.A.3    Hsu, C.C.4
  • 19
    • 0031914743 scopus 로고    scopus 로고
    • Spray-drying of air-liquid interface sensitive recombinant human growth hormone
    • Maa, Y. F., Nguyen, P. A., & Hsu, S. W. (1998). Spray-drying of air-liquid interface sensitive recombinant human growth hormone. J.Pharm.Sci., 87 (2), 152-159.
    • (1998) J.Pharm.Sci. , vol.87 , Issue.2 , pp. 152-159
    • Maa, Y.F.1    Nguyen, P.A.2    Hsu, S.W.3
  • 20
    • 0345701503 scopus 로고    scopus 로고
    • Supercritical fluid processing of proteins: Lysozyme precipitation from aqueous solution
    • Moshashaée, S., Bisrat, M., Forbes, R. T., Quinn, E. A., Nyqvist, H., & York, P. (2003). Supercritical fluid processing of proteins: lysozyme precipitation from aqueous solution. J Pharm Pharmacol, 55 (2), 185-192.
    • (2003) J. Pharm. Pharmacol. , vol.55 , Issue.2 , pp. 185-192
    • Moshashaée, S.1    Bisrat, M.2    Forbes, R.T.3    Quinn, E.A.4    Nyqvist, H.5    York, P.6
  • 21
    • 0032409969 scopus 로고    scopus 로고
    • Supercritical Fluid Processing of Materials from Aqueous Solutions: The Application of SEDS to Lactose as a Model Substance
    • Palakodaty, S., York, P., Pritchard, J. (1998). Supercritical Fluid Processing of Materials from Aqueous Solutions: The Application of SEDS to Lactose as a Model Substance. Pharm.Res., 15 (12), 1835-1843.
    • (1998) Pharm.Res. , vol.15 , Issue.12 , pp. 1835-1843
    • Palakodaty, S.1    York, P.2    Pritchard, J.3
  • 22
    • 0030831389 scopus 로고    scopus 로고
    • The stability of insulin in crystalline and amorphous solids: Observation of greater stability for the amorphous form
    • Pikal, M. J., & Rigsbee, D. R. (1997). The stability of insulin in crystalline and amorphous solids: observation of greater stability for the amorphous form. Pharm.Res., 14 (10), 1379-1387.
    • (1997) Pharm.Res. , vol.14 , Issue.10 , pp. 1379-1387
    • Pikal, M.J.1    Rigsbee, D.R.2
  • 23
    • 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. (1995). Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using Fourier-transform infrared spectroscopy. Pharm.Res., 12 (9), 1250-1259.
    • (1995) Pharm.Res. , vol.12 , Issue.9 , pp. 1250-1259
    • Prestrelski, S.J.1
  • 24
    • 0030712895 scopus 로고    scopus 로고
    • Phase separation of excipients during lyophilization: Effects on protein stability
    • Randolph, T. W. (1997). Phase separation of excipients during lyophilization: effects on protein stability. J.Pharm.Sci., 86 (11), 1198-1203.
    • (1997) J.Pharm.Sci. , vol.86 , Issue.11 , pp. 1198-1203
    • Randolph, T.W.1
  • 25
    • 0029831538 scopus 로고    scopus 로고
    • How does residual water affect the solid-state degradation of drugs in the amorphous state?
    • Shalaev, E. Y. (1996). How does residual water affect the solid-state degradation of drugs in the amorphous state? J.Pharm.Sci., 85 (11), 1137-1141.
    • (1996) J.Pharm.Sci. , vol.85 , Issue.11 , pp. 1137-1141
    • Shalaev, E.Y.1
  • 26
    • 0029764145 scopus 로고    scopus 로고
    • Solid-state stability of human insulin I. Mechanism and the effect of water on the kinetics of degradation in lyophiles from pH 2-5 solutions
    • Strickley, R. G., & Anderson, B. D. (1996). Solid-state stability of human insulin I. Mechanism and the effect of water on the kinetics of degradation in lyophiles from pH 2-5 solutions. Pharm.Res., 13 (8), 1142-1153.
    • (1996) Pharm.Res. , vol.13 , Issue.8 , pp. 1142-1153
    • Strickley, R.G.1    Anderson, B.D.2
  • 27
    • 0037148657 scopus 로고    scopus 로고
    • The effect of process variables on the degradation and physical properties of spray dried insulin intended for inhalation
    • Ståhl, K., Claesson, M., Lilliehorn, P., Lindén, H., & Bäckström, K. (2002). The effect of process variables on the degradation and physical properties of spray dried insulin intended for inhalation. Int.J.Pharm., 233 (1-2), 227-237.
    • (2002) Int.J.Pharm. , vol.233 , Issue.1-2 , pp. 227-237
    • Ståhl, K.1    Claesson, M.2    Lilliehorn, P.3    Lindén, H.4    Bäckström, K.5
  • 29
    • 0025817772 scopus 로고
    • Cryoprotective effect of saccharides on denaturation of catalase by freeze-drying
    • Tokyo
    • Tanaka, K. (1991). Cryoprotective effect of saccharides on denaturation of catalase by freeze-drying. Chem Pharm Bull (Tokyo), 39 (5), 1091-1094.
    • (1991) Chem. Pharm. Bull. , vol.39 , Issue.5 , pp. 1091-1094
    • Tanaka, K.1
  • 30
    • 0033046867 scopus 로고    scopus 로고
    • Moisture effects on protein-excipient interactions in spray-dried powders. Nature of destabilizing effects of sucrose
    • Tzannis, S. T., & Prestrelski, S. J. (1999). Moisture effects on protein-excipient interactions in spray-dried powders. Nature of destabilizing effects of sucrose. J.Pharm.Sci., 88 (3), 360-370.
    • (1999) J.Pharm.Sci. , vol.88 , Issue.3 , pp. 360-370
    • Tzannis, S.T.1    Prestrelski, S.J.2
  • 31
    • 0034255393 scopus 로고    scopus 로고
    • Lyophilization and development of solid protein pharmaceuticals
    • Wang, W. (2000). Lyophilization and development of solid protein pharmaceuticals. Int.J.Pharm., 203 (1-2), 1-60.
    • (2000) Int.J.Pharm. , vol.203 , Issue.1-2 , pp. 1-60
    • Wang, W.1
  • 32
    • 0032960417 scopus 로고    scopus 로고
    • The effect of excipients on the molecular mobility of lyophilized formulations, as measured by glass transition temperature and NMR relaxation- based critical mobility temperature
    • Yoshioka, S., Aso, Y., & Kojima, S. (1996). The effect of excipients on the molecular mobility of lyophilized formulations, as measured by glass transition temperature and NMR relaxation- based critical mobility temperature. Pharm.Res., 16 (1), 135-140.
    • (1996) Pharm.Res. , vol.16 , Issue.1 , pp. 135-140
    • Yoshioka, S.1    Aso, Y.2    Kojima, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.