(12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey Et Al

(12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey Et Al

USOO8383114B2 (12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey et al. (45) Date of Patent: Feb. 26, 2013 (54) PHARMACEUTICAL FORMULATIONS 6,919,426 B2 7/2005 Boone et al. 7,030,226 B2 4/2006 Sun et al. (75) Inventors: Christopher J. Sloey, Newbury Park, 7,084.2457,037.498 B2 8/20065, 2006 CohenHolmes et et al. al. CA (US); Camille Vergara, Calabasas, 7,153,507 B2 12/2006 van de Winkel et al. CA (US); Jason Ko. Thousand Oaks, CA 7,217,689 B1 5/2007 Elliott et al. (US); Tiansheng Li, Newbury Park, CA 7,220,410 B2 5/2007 Kim et al. (US) 2002/0155998 A1 10/2002 Young et al. 2002/01992 13 A1 12/2002 Tomizuka et al. 2003/0023586 A1 1/2003 Knorr (73) Assignee: Amgen Inc., Thousand Oaks, CA (US) 2003, OO31667 A1 2/2003 Deo et al. - 2003, OO77753 A1 4, 2003 Tischer (*) Notice: Subject to any disclaimer, the term of this 2003/0082749 A1 5/2003 Sun et al. patent is extended or adjusted under 35 2003/01 18592 A1 6/2003 Ledbetter et al. U.S.C. 154(b) by 0 days. 2003/0.133939 A1 7/2003 Ledbetter et al. 2003. O138421 A1 7/2003 van de Winkel et al. 2003.0143202 A1 7/2003 Binley et al. (21) Appl. No.: 12/680,128 2003/0194404 A1 10, 2003 Greenfeder et al. 2003. O19515.6 A1 10, 2003 Minet al. (22) PCT Filed: Sep. 29, 2008 2003/0215444 A1 11/2003 Elliott 2003,0229023 A1 12/2003 Oliner et al. (86). PCT No.: PCT/US2008/078193 2003/0235582 Al 12/2003 Singh et al. 2004/0009902 A1 1/2004 Boimeet al. S371 (c)(1), 2004/0018191 A1 1/2004 Wang et al. (2), (4) Date: Jul. 12, 2010 2004f0071694 A1 4/2004 DeVries et al. 2004f0071702 A1 4/2004 van de Winkel et al. 2004/0086503 A1 5/2004 Cohen et al. (87) PCT Pub. No.: WO2009/043049 2004/0091961 A1 5/2004 Evans et al. PCT Pub. Date: Apr. 2, 2009 2004/OO97712 A1 5, 2004 Varnum et al. 9 2004/0143857 A1 7/2004 Young et al. O O 2004/O157293 A1 8, 2004 Evans et al. (65) Prior Publication Data 2004/0175379 A1 9, 2004 DeVries et al. US 2010/O297106A1 Nov. 25, 2010 (Continued) Related U.S. Application Data FOREIGN PATENT DOCUMENTS EP 404097 A2 12, 1990 (60) Provisional application No. 60/975,780, filed on Sep. EP 1188.445 A1 3f2002 27, 2007. (Continued) (51) Int. Cl. OTHER PUBLICATIONS C07K I4/00 (2006.01) Altschul et al., “Basic Local Alignment Research Tool”, J Mol Biol (52) U.S. Cl. ........................ 424/134.1: 514/12: 530/350 215: 403-410 (1990). (58) Field of Classification Search ........................ None Biocca, et al., “Expression and targeting of intracellular antibodies in See application file for complete search history. mammalian cells, EMBO J. 9:101-108, 1990. Bird et al., “Single-Chain Antigen-Binding Proteins, Science 242:423-426, (1988). (56) References Cited Bruggermann et al., “Designer Mice: The Production of Human Antibody Repertoires in Transgenic Animals.”Year in Immuno. 7:33 U.S. PATENT DOCUMENTS (1993). 4.703,008 A 10, 1987 Lin Caton and Koprowski. “Influenza virus hemagglutinin-specific anti 5.44 1868 A 8, 1995 Lin bodies isolated from a combinatorial expression library are closely 5,547.933 A 8, 1996 Lin related to the immune response of the donor.” Proc. Natl. Acad. Sci. 5,618,698 A 4, 1997 Lin USA, 87:6450-6454. 1990. 5,621,080 A 4, 1997 Lin Chothia et al., “Canonical Structures for the Hypervariable Regions 5,686.292 A 11/1997 Schwall et al. of Immunoglobulins,” J. Mol.Biol. 196:901-917 (1987). 5,756,349 A 5, 1998 Lin Co, et al., “A Humanized Antibody Specific for the Platelet Integrin 5,767,078 A 6, 1998 Johnson et al. gplb/lla.” J. Immunol. 152, 2968-2976 (1994). 5,773,569 A 6/1998 Wrighton et al. Cohen, et al., “Combination Therapy Enhances the Inhibition of 5,789,554 A 8/1998 Leung et al. Tumor Growth with the Fully Human Anti-Type 1 Insulin-Like 5,830,851 A 1 1/1998 Wrighton et al. Growth Factor Receptor Monoclonal Antibody CP-751,871.” Clini 5,856.298 A 1/1999 Strickland cal Cancer Res. 11:2063-73 (2005). 5,955.422 A 9, 1999 Lin 5,986,047 A 1 1/1999 Wrighton et al. (Continued) 6,030,086 A 2/2000 Thomas 6,310,078 B1 10/2001 Connolly et al. Primary Examiner — Yunsoo Kim 6,391,633 B1 5, 2002 Stern et al. (74) Attorney, Agent, or Firm — Marshall, Gerstein & Borun 6,468,529 B1 10/2002 Schwall et al. LLP 6,583,272 B1 6, 2003 Bailon 6,586,398 B1 7/2003 Kinstler et al. (57) ABSTRACT 6,750,369 B2 6/2004 Connolly et al. A stable pharmaceutical formulation is provided that com 6,756,480 B2 6/2004 Kostenuik et al. prises a biologically active protein and an excipient selected 6,803,453 B1 10, 2004 Brunkow et al. 6,835,809 B1 12/2004 Liu et al. from carnitine, creatine or creatinine. 6,900,292 B2 5, 2005 Sun et al. 6 Claims, 12 Drawing Sheets US 8,383,114 B2 Page 2 U.S. PATENT DOCUMENTS WO WO-03/059951 A2 T 2003 2004/0175824 A1 9, 2004 Sun et al. W8 W888. Ai E58. 2004/O181033 A1 9, 2004 Han et al. WO WO-2004/002417 A2 1, 2004 2004/O197324 A1* 10, 2004 Liu et al. .................... 424,130.1 WO WO-2004/002424 A2 1, 2004 2004/0202655 A1 10, 2004 Morton et al. WO WO-2004/009627 A1 1, 2004 2004/0228859 A1 11/2004 Graus et al. WO WO-2004/O18667 A1 3, 2004 2004/0229318 A1 11/2004 Heavner WO WO-2004/O24761 A1 3, 2004 2004/0248815 A1 12/2004 Connolly et al. WO WO-2004/033651 A2 4/2004 2004/0265307 Al 12/2004 Singh et al. WO WO-2004/035603 A2 4/2004 2004/0266690 A1 12, 2004 Pool WO WO-2004/043382 A2 5, 2004 2005, 0004353 A1 1/2005 Welcher et al. WO WO-2004/058988 A2 T 2004 2005, OOO8642 A1 1/2005 Graus et al. WO WO-2004/073092 A2 8, 2004 2005, OO19914 A1 1/2005 Staerk et al. WO WO-2004/101600 A2 11/2004 2005, 0026834 A1 2/2005 Cox et al. WO WO-2004/101606 A2 11/2004 2005/OO37421 A1 2/2005 Honda et al. WO WO-2004/101611 A2 11/2004 2005, OO74821 A1 4, 2005 Wild et al. WO WO-2004/106373 A1 12/2004 2005, OO84906 A1 4/2005 Goetsch et al. WO WO-2005/001025 A2 1, 2005 2005.0089932 A1 4/2005 Kolkman et al. WO WO-2005/001136 A1 1, 2005 2005, 0096461 A1 5, 2005 COX WO WO-2005/O1697O A2 2/2005 2005/O107297 A1 5, 2005 Holmes et al. WO WO-2005/017107 A2 2, 2005 2005/0107591 A1 5, 2005 Cox WO WO-2005/021579 A2 3, 2005 2005, 0112694 A1 5, 2005 Carter et al. WO WO-2005/O25606 A1 3, 2005 2005, 0118643 A1 6/2005 Burgess et al. WO WO-2005/032460 A2 4/2005 2005, 0124045 A1 6, 2005 Sun et al. WO WO-2005/047331 A2 5, 2005 2005, 0124564 A1 6/2005 Binley et al. WO WO-2005/051327 A2 6, 2005 2005. O136049 A1 6, 2005 Ledbetter et al. WO WO-2005/058967 A2 6, 2005 2005. O136063 A1 6/2005 Wang et al. WO WO-2005/0638O8 A1 7/2005 2005, 0137329 A1 6, 2005 Holmes et al. WO WO-2005/063809 A1 7/2005 2005. O142642 A1 6, 2005 Sun et al. WO WO-2005, O70451 A1 8, 2005 2005.0143292 A1 6, 2005 DeFrees et al. WO WO-2005/081687 A2 9, 2005 2005/O153879 A1 7/2005 Svetina et al. WO WO-2005.084711 A1 9, 2005 2005. O158822 A1 7, 2005 Pecker WO WO-2005/092369 A2 10, 2005 2005. O158832 A1 7/2005 Young et al. WO WO-2005,100403 A2 10, 2005 2005/0170457 A1 8, 2005 Pool et al. WO WO-2005,103076 A2 11/2005 2005/O181359 A1 8/2005 Optelten et al. WO WO 2006/02646 A2 1, 2006 2005, 0181482 A1 8, 2005 Meade et al. WO WO-2006/013472 A2 2, 2006 2005, 0186203 A1 8/2005 Singh et al. WO WO-2006,29094 A2 3, 2006 2005, 0192211 A1 9, 2005 Gillies et al. WO WO-2006,50959 A2 5, 2006 2005/0202538 A1 9, 2005 Gillies et al. WO WO-2006/069202 A2 6, 2006 2005/0227289 A1 10/2005 Reilly et al. WO WO-2006081171 A1 8, 2006 2005/0244408 A1 11/2005 Cohen et al. WO WO-2006,138729 A2 12/2006 2005/0244409 A1 11/2005 Erickson-Miller et al. WO WO-2007,000328 A1 1, 2007 2005/0249728 A1 1 1/2005 Singh et al. WO WO-2007/01 1941 A2 1, 2007 2006,0040358 A1 2/2006 Ligensa et al. WO WO-2007/O12614 A2 2, 2007 2006,0040858 A1 2/2006 Holmes et al. WO WO-2007/057748 A2 5/2007 2006/0088906 A1 4/2006 DeFrees et al. WO WO-98.24893 A2 6, 2011 2006/0111279 A1 5, 2006 DeFrees et al. 2006, O135431 A1 6, 2006 Minet al. OTHER PUBLICATIONS 2007/0110747 A1 5/2007 Paszty et al.

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    32 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us