Title:
LYOPHILIZED FORMULATION SEALED IN GLASS VIAL
Document Type and Number:
WIPO Patent Application WO/2019/225568
Kind Code:
A1
Abstract:
The present invention provides a lyophilized formulation sealed in a glass vial and containing a treatment drug and a surfactant, the invention being characterized in that the glass vial has a sulfur-treated or VIST-treated inner surface.
Inventors:
YAMASHITA SHOGO (JP)
YOSHIZAWA YUTA (JP)
YOSHIZAWA YUTA (JP)
Application Number:
PCT/JP2019/020014
Publication Date:
November 28, 2019
Filing Date:
May 21, 2019
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
International Classes:
A61J1/05; A61K9/19; A61K39/395; A61K47/10; A61K47/18; A61K47/26; A61P43/00
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HINTON PRXIONG JMJOHLFS MGTANG MTKELLER STSURUSHITA N.: "An engineered human IgGl antibody with longer serum half-life.", J IMMUNOL, vol. 176, no. 1, 1 January 2006 (2006-01-01), pages 346 - 56
GHETIE VPOPOV SBORVAK JRADU CMATESOI DMEDESAN COBER RJWARD ES: "Increasing the serum persistence of an IgG fragment by random mutagenesis.", NAT BIOTECHNOL, vol. 15, no. 7, July 1997 (1997-07-01), pages 637 - 40, XP000876642, DOI: 10.1038/nbt0797-637
FARMACO, vol. 54, no. 8, 30 August 1999 (1999-08-30), pages 497 - 516
CANCER J, vol. 14, no. 3, May 2008 (2008-05-01), pages 154 - 69
CLELAND ET AL., CRIT. REV. THER. DRUG CARRIER SYST., vol. 10, no. 4, 1993, pages 307 - 77
WANG, INT. J. PHARM., vol. 185, no. 2, 1999, pages 129 - 88
WANG, INT. J. PHARM., vol. 203, no. 1-2, 2000, pages 1 - 60
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CARL, A. K. BORREBAECKJAMES, W. LARRICK: "THERAPEUTIC MONOCLONAL ANTIBODIES", 1990, MACMILLAN PUBLISHERS LTD
SATO, K. ET AL., CANCER RES, vol. 53, 1993, pages 851 - 856
TSURUSHITA NHINTON PRKUMAR S.: "Design of humanized antibodies: from anti-Tac to Zenapax.", METHODS, vol. 36, no. 1, May 2005 (2005-05-01), pages 69 - 83, XP004852554, DOI: 10.1016/j.ymeth.2005.01.007
RAJPAL ABEYAZ NHABER LCAPPUCCILLI GYEE HBHATT RRTAKEUCHI TLERNER RACREA R.: "A general method for greatly improving the affinity of antibodies by using combinatorial libraries.", PROC NATL ACAD SCI U.S.A., vol. 102, no. 24, 14 June 2005 (2005-06-14), pages 8466 - 71, XP055727599, DOI: 10.1073/pnas.0503543102
EWERT SHONEGGER APLUCKTHUN A.: "Stability improvement of antibodies for extracellular and intracellular applications: CDR grafting to stable frameworks and structure-based framework engineering.", METHODS, vol. 34, no. 2, October 2004 (2004-10-01), pages 184 - 99, XP004526805, DOI: 10.1016/j.ymeth.2004.04.007
KIM SJPARK YHONG HJ.: "Antibody engineering for the development of therapeutic antibodies.", MOL CELLS, vol. 20, no. 1, 31 August 2005 (2005-08-31), pages 17 - 29
HINTON PRXIONG JMJOHLFS MGTANG MTKELLER STSURUSHITA N.: "An engineered human IgGl antibody with longer serum half-life.", J IMMUNOL, vol. 176, no. 1, 1 January 2006 (2006-01-01), pages 346 - 56
GHETIE VPOPOV SBORVAK JRADU CMATESOI DMEDESAN COBER RJWARD ES: "Increasing the serum persistence of an IgG fragment by random mutagenesis.", NAT BIOTECHNOL, vol. 15, no. 7, July 1997 (1997-07-01), pages 637 - 40, XP000876642, DOI: 10.1038/nbt0797-637
FARMACO, vol. 54, no. 8, 30 August 1999 (1999-08-30), pages 497 - 516
CANCER J, vol. 14, no. 3, May 2008 (2008-05-01), pages 154 - 69
CLELAND ET AL., CRIT. REV. THER. DRUG CARRIER SYST., vol. 10, no. 4, 1993, pages 307 - 77
WANG, INT. J. PHARM., vol. 185, no. 2, 1999, pages 129 - 88
WANG, INT. J. PHARM., vol. 203, no. 1-2, 2000, pages 1 - 60
CHI ET AL., PHARM. RES., vol. 20, no. 9, 2003, pages 1325 - 36
Attorney, Agent or Firm:
ONO, Shinjiro et al. (JP)
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