Stabilization of Rasburicase and Physico‐Chemical Characterization of the Resulting Injectable Formulation

References

• Geigert J. Overview of the stability and handling of recombinant protein drugs. J. Parent. Sci. Technol. 1989; 43(5)220–224
   PubMedGoogle Scholar
• Pikal M. J. Freeze—Drying of Proteins, Part II : Formulation Selection Biopharm. October, 1990; 26–30
   Google Scholar
• Pui C. H., Sima J., Camita B. (2000) Blood, Meeting Info. 42nd Annual meeting of the America Society of Hematology, San FranciscoCA, USA, December, 01–052000. American Society of Hematology, 11–96, Part I, pp719a. print
   Google Scholar
• Pui C. H., Mahmoud H. H., Wiley J. M., Woods G. M., Leverger G., Camitta B., Hastings C., Blaney S., Relling M. V., Reaman G. H. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma. J. Clin. Oncol. 2000; 19(3)697–704
   Web of Science ®Google Scholar
• Colloc'h N., El Hajji M., Bachet B., Lhermite G., Schiltz M., Prange T., Castro B., Mornon J. P. Crystal structure of the protein drug urate oxidase—inhibitor complex at 2.05 Å resolution. Nat. Struct. Biol. 1997; 4: 947–952, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• Legoux R., Delpech B., Dumont X., Guillemot J. C., Ramond P., Shire D., Caput D., Ferrara P., Loison G. Cloning and expression in Escherichia coli of the gene encoding Aspergillus flavus urate oxidase. J. Biol. Chem. 1992; 267(12)8565–8570, [PUBMED], [INFOTRIEVE]
   PubMed Web of Science ®Google Scholar
• 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, [PUBMED], [INFOTRIEVE], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• 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, [CROSSREF]
   PubMed Web of Science ®Google Scholar
• 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, [CROSSREF]
   PubMed Web of Science ®Google Scholar
• 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
   Web of Science ®Google Scholar
• 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, [CROSSREF]
   Web of Science ®Google Scholar
• 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, [CROSSREF]
   Web of Science ®Google Scholar
• 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
   Google Scholar
• 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°
   Google Scholar
• Bayol A., Capdevielle J., Malazzi P., Buzy A., Bonnet M. C., Colloch's N., Mornon J. P., Loyaux D., Ferrara P. Modification of a reactive cysteine explains differences between rasburicase and Uricozyme®, a natural Aspergillus flavus uricase. Biotechnol. Appl. Biochem. 2002; 36: 21–31, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• 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, [PUBMED], [INFOTRIEVE]
   PubMed Web of Science ®Google Scholar
• Izutsu K. L., Yoshioka S., Terao T. Decrease protein‐stabilizing effects of cryoprotectants due to crystallization. Pharm. Res. 1993; 10–8: 1232–1237, [CROSSREF]
   Web of Science ®Google Scholar
• 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, [PUBMED], [INFOTRIEVE], [CSA]
   PubMed Web of Science ®Google Scholar
• 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, [CROSSREF]
   Google Scholar
• Chang B. S., Randall C. S. Use of subambient thermal analysis to optimize protein lyophilization. Cryobiology 1992; 29: 632, [CROSSREF]
   Web of Science ®Google Scholar
• Franks F. Freeze‐drying from empiricism to predictability. Cryo‐lett. 1990; 11: 93–110
   Google Scholar
• Ediger M. D., Angell C. A., Nagel S. R. Supercooled liquids and glasses. J. Phys. Chem. 1996; 100: 13200–13212, [CROSSREF]
   Web of Science ®Google Scholar
• Guo Y., Byrn S., Zographi G. Physical characteristics and chemical degradation of amorphous Quinapril hydrochloride. J. Pharm. Sci. 2000; 89(1)128–143, [PUBMED], [INFOTRIEVE], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Scherer G. W. Theory of relaxation. J. Non‐Cryst. Solids 1990; 123: 75–89, [CROSSREF]
   Web of Science ®Google Scholar
• 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, [PUBMED], [INFOTRIEVE], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• 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 [CROSSREF]
   Google Scholar