메뉴 건너뛰기




Volumn 30, Issue 8, 2004, Pages 877-889

Stabilization of rasburicase and physico-chemical characterization of the resulting injectable formulation

Author keywords

Chromatography; Differential scanning calorimetry; Lyophilisate; Rasburicase; Thermostimulated current spectroscopy; Uricase

Indexed keywords

8 AZAHYPOXANTHINE; 8 AZAXANTHINE; ALANINE; ALPHA CYCLODEXTRIN; ASPARTIC ACID; BETA CYCLODEXTRIN; BUFFER; CYSTEINE; EDETATE SODIUM; EXCIPIENT; GAMMA CYCLODEXTRIN; GLUTAMIC ACID; HISTIDINE; LACTOSE; MANNITOL; OROTIC ACID; PHOSPHATE; RASBURICASE; UNCLASSIFIED DRUG; XANTHINE; XANTHINE DERIVATIVE;

EID: 5544283593     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-200034582     Document Type: Article
Times cited : (3)

References (26)
  • 1
    • 0024427560 scopus 로고
    • Overview of the stability and handling of recombinant protein drugs
    • Geigert, J. Overview of the stability and handling of recombinant protein drugs. J. Parent. Sci. Technol. 1989, 43 (5), 220-224.
    • (1989) J. Parent. Sci. Technol. , vol.43 , Issue.5 , pp. 220-224
    • Geigert, J.1
  • 2
    • 0001904754 scopus 로고
    • Freeze - Drying of Proteins, Part II: Formulation Selection
    • October
    • Pikal, M.J. Freeze - Drying of Proteins, Part II: Formulation Selection. Biopharm; October 1990; 26-30.
    • (1990) Biopharm. , pp. 26-30
    • Pikal, M.J.1
  • 3
    • 5544246053 scopus 로고    scopus 로고
    • 42nd Annual meeting of the America Society of Hematology, San Francisco, CA, USA, December 01-05, 2000; American Society of Hematology, pp719a. print
    • Pui, C.H.; Sima, J.; Camita, B. In Blood, Meeting Info, 42nd Annual meeting of the America Society of Hematology, San Francisco, CA, USA, December 01-05, 2000; American Society of Hematology, 2000; 11-96, Part I, pp719a. print.
    • (2000) Blood, Meeting Info , Issue.1 PART , pp. 1196
    • Pui, C.H.1    Sima, J.2    Camita, B.3
  • 7
    • 0026480313 scopus 로고
    • High-level of a peroxisomal enzyme: Aspergillus flavus uricase accumulates intracellularly and is active in Saccharomyces cerevisiae
    • Leplatois, P.; Le Douarin, B.; Loison, G. High-level of a peroxisomal enzyme: Aspergillus flavus uricase accumulates intracellularly and is active in Saccharomyces cerevisiae. Gene 1992, 122, 139-145.
    • (1992) Gene , vol.122 , pp. 139-145
    • Leplatois, P.1    Le Douarin, B.2    Loison, G.3
  • 8
    • 0028964062 scopus 로고
    • Study of pH and temperature - Induced transitions in urate oxidase (Uox-EC 1.7.3.3.) by microcalorimetry (DSC), size exclusion chromatography (SEC) and enzymatic activity experiments
    • Bayol, A.; Dupin, P.; Boe, J.F.; Claudy, P.; Letoffe, J.M. Study of pH and temperature - induced transitions in urate oxidase (Uox-EC 1.7.3.3.) by microcalorimetry (DSC), size exclusion chromatography (SEC) and enzymatic activity experiments. Biophys. Chemist. 1995, 54, 229-235.
    • (1995) Biophys. Chemist. , vol.54 , pp. 229-235
    • Bayol, A.1    Dupin, P.2    Boe, J.F.3    Claudy, P.4    Letoffe, J.M.5
  • 9
    • 0036281438 scopus 로고    scopus 로고
    • Molecular mobility study of amorphous and crystalline phases of a pharmaceutical product by thermally stimulated current spectroscopy
    • Boutonnet-Fagegaltier, N.; Ménégotto, J.; Lamure, A.; Duplaa, H.; Caron, A.; Lacabanne, C.; Bauer, M. Molecular mobility study of amorphous and crystalline phases of a pharmaceutical product by thermally stimulated current spectroscopy. J. Pharm. Sci. 2002, 91 (6), 1548-1560.
    • (2002) J. Pharm. Sci. , vol.91 , Issue.6 , pp. 1548-1560
    • Boutonnet-Fagegaltier, N.1    Ménégotto, J.2    Lamure, A.3    Duplaa, H.4    Caron, A.5    Lacabanne, C.6    Bauer, M.7
  • 10
    • 0033279469 scopus 로고    scopus 로고
    • Combined dielectric spectroscopy and thermally stimulated currents studies of secondary relaxation process in amorphous Poly(ethylene terephthalate)
    • Menegotto, J.; Demont, P.; Bernes, A.; Lacabanne, C. Combined dielectric spectroscopy and thermally stimulated currents studies of secondary relaxation process in amorphous Poly(ethylene terephthalate). J. Polym. Sci., Part B, Polym. Phys. 1999, 37, 3494-3503.
    • (1999) J. Polym. Sci., Part B, Polym. Phys. , vol.37 , pp. 3494-3503
    • Menegotto, J.1    Demont, P.2    Bernes, A.3    Lacabanne, C.4
  • 11
    • 0035117346 scopus 로고    scopus 로고
    • Secondary dielectric dielectric-relaxation in amorphous poly(ethylene terephthalate): Combined thermally stimulated and isothermal depolarization current investigations
    • Menegotto, J.; Demont, P.; Lacabanne, C. Secondary dielectric dielectric-relaxation in amorphous poly(ethylene terephthalate): combined thermally stimulated and isothermal depolarization current investigations. Polymer 2001, 42, 4375-4383.
    • (2001) Polymer , vol.42 , pp. 4375-4383
    • Menegotto, J.1    Demont, P.2    Lacabanne, C.3
  • 12
    • 0028494863 scopus 로고
    • Study of cooperative relaxation modes in complex systems by thermally stimulated current spectroscopy
    • Lacabanne, C.; Lamure, A.; Teyssedre, G.; Bernes, A.; Mourgues, M. Study of cooperative relaxation modes in complex systems by thermally stimulated current spectroscopy. J. Non-Cryst. Solids 1994, 172-174, 884-890.
    • (1994) J. Non-Cryst. Solids , vol.172-174 , pp. 884-890
    • Lacabanne, C.1    Lamure, A.2    Teyssedre, G.3    Bernes, A.4    Mourgues, M.5
  • 13
    • 5544233479 scopus 로고    scopus 로고
    • Stable Freeze-Dried Formulation Comprising a Protein Assay kit. Patent, EP0682944B1 1999/US serial no. 5,763,409, 1998
    • Bayol, A.; Breul, T.; Dupin, P.; Faure, P. Stable Freeze-Dried Formulation Comprising a Protein Assay kit. Patent, EP0682944B1 1999/US serial no. 5,763,409, 1998.
    • Bayol, A.1    Breul, T.2    Dupin, P.3    Faure, P.4
  • 14
    • 5544222515 scopus 로고
    • Parenteral formulations of proteins and peptides: Stability and stabilizers (1988)
    • 42-S4-S26 Technical Report N°.
    • Yu-Chang, J.W.; Hanson, M.A. Parenteral formulations of proteins and peptides: stability and stabilizers (1988). J. Parent. Sci. Technol. 1988, 10 (Supp.), 42-S4-S26 Technical Report N°.
    • (1988) J. Parent. Sci. Technol. , vol.10 , Issue.SUPPL.
    • Yu-Chang, J.W.1    Hanson, M.A.2
  • 16
    • 0018789680 scopus 로고
    • Increased thermal stability of proteins in the presence of sugars and polyols
    • Back, J.F.; Oakenful, D.; Smith, M.B. Increased thermal stability of proteins in the presence of sugars and polyols. Biochemistry 1979, 18, 5191-5196.
    • (1979) Biochemistry , vol.18 , pp. 5191-5196
    • Back, J.F.1    Oakenful, D.2    Smith, M.B.3
  • 17
    • 0027337054 scopus 로고
    • Decrease protein-stabilizing effects of cryoprotectants due to crystallization
    • Izutsu, K.L.; Yoshioka, S.; Terao, T. Decrease protein-stabilizing effects of cryoprotectants due to crystallization. Pharm. Res. 1993, 10-8, 1232-1237.
    • (1993) Pharm. Res. , vol.10 , Issue.8 , pp. 1232-1237
    • Izutsu, K.L.1    Yoshioka, S.2    Terao, T.3
  • 18
    • 0028098067 scopus 로고
    • Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying
    • Izutsu, K.L.; Yoshioka, S.; Terao, T. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying. Chem. Pharm. Bull. 1994, 42 (1), 5-8.
    • (1994) Chem. Pharm. Bull. , vol.42 , Issue.1 , pp. 5-8
    • Izutsu, K.L.1    Yoshioka, S.2    Terao, T.3
  • 19
    • 0242353397 scopus 로고    scopus 로고
    • Solute crystallization in mannitol-glycine systems - Imlications on protein stabilization in freeze-dried formulations
    • Pyne, A.; Chatterjee, K.; Suryanarayanan, R. Solute crystallization in mannitol-glycine systems - imlications on protein stabilization in freeze-dried formulations. J. Pharm. Sci. Nov 2003, 11, 2272-2283.
    • (2003) J. Pharm. Sci. Nov , vol.11 , pp. 2272-2283
    • Pyne, A.1    Chatterjee, K.2    Suryanarayanan, R.3
  • 20
    • 0000818501 scopus 로고
    • Use of subambient thermal analysis to optimize protein lyophilization
    • Chang, B.S.; Randall, C.S. Use of subambient thermal analysis to optimize protein lyophilization. Cryobiology 1992, 29, 632.
    • (1992) Cryobiology , vol.29 , pp. 632
    • Chang, B.S.1    Randall, C.S.2
  • 21
    • 0001844127 scopus 로고
    • Freeze-drying from empiricism to predictability
    • Franks, F. Freeze-drying from empiricism to predictability. Cryo-lett. 1990, 11, 93-110.
    • (1990) Cryo-lett. , vol.11 , pp. 93-110
    • Franks, F.1
  • 23
    • 0033971208 scopus 로고    scopus 로고
    • Physical characteristics and chemical degradation of amorphous Quinapril hydrochloride
    • Guo, Y.; Byrn, S.; Zographi, G. Physical characteristics and chemical degradation of amorphous Quinapril hydrochloride. J. Pharm. Sci. 2000, 89 (1), 128-143.
    • (2000) J. Pharm. Sci. , vol.89 , Issue.1 , pp. 128-143
    • Guo, Y.1    Byrn, S.2    Zographi, G.3
  • 24
  • 25
    • 0031828085 scopus 로고    scopus 로고
    • The physical state of mannitol after freeze-drying: Effects of mannitol concentration, freezing rate, and a non-crystallizing cosolute
    • Kim, A.L.; Akers, M.J.; Nail, S.L. The physical state of mannitol after freeze-drying: effects of mannitol concentration, freezing rate, and a non-crystallizing cosolute. J. Pharm. Sci. 1998, 87, 931-935.
    • (1998) J. Pharm. Sci. , vol.87 , pp. 931-935
    • Kim, A.L.1    Akers, M.J.2    Nail, S.L.3
  • 26
    • 5544255120 scopus 로고    scopus 로고
    • Effect of vacuum drying on protein-mannitol interactions: The physical state of mannitol and protein structur in the dried state
    • Art 10
    • Sharma, V.K.; Kalonia, D.S. Effect of vacuum drying on protein-mannitol interactions: the physical state of mannitol and protein structur in the dried state. AAPS PharmSciTech 2004, 5 (1), 1-11, Art 10.
    • (2004) AAPS PharmSciTech , vol.5 , Issue.1 , pp. 1-11
    • Sharma, V.K.1    Kalonia, D.S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.