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( 12 ) United States Patent US009833513B2 (12 ) United States Patent ( 10 ) Patent No. : US 9 ,833 ,513 B2 Larson et al. (45 ) Date of Patent: Dec . 5 , 2017 ( 54 ) LIQUID PROTEIN FORMULATIONS FOR CO7K 16 /241 ( 2013 .01 ) ; CO7K 16 / 2839 INJECTION COMPRISING ( 2013 . 01 ) ; COZK 16 /2863 (2013 .01 ) ; COOK 1 -BUTYL - 3 -METHYLIMIDAZOLIUM 16 / 2887 ( 2013 .01 ) ; CO7K 16 / 32 ( 2013 . 01 ) ; METHANESULFONATE AND USES A61K 38/ 00 ( 2013 .01 ) THEREOF (58 ) Field of Classification Search ( 71 ) Applicant : EAGLE BIOLOGICS , INC ., None Woodcliff Lake, NJ (US ) See application file for complete search history . (72 ) Inventors: Alyssa M . Larson , Dana Point, CA (US ) ; Kevin Love, Boston , MA (US ) ; (56 ) References Cited Alisha K . Weight, Mill Creek , WA (US ) ; Alan Crane , Waban , MA (US ) ; U . S . PATENT DOCUMENTS Robert S . Langer, Newton , MA (US ) ; 3 ,682 , 174 A 8 / 1972 Cohen Alexander M . Klibanov, Boston , MA 4 ,092 ,410 A 5 / 1978 Ogata et al . (US ) 4 ,171 , 698 A 10 / 1979 Genese 5 , 001 ,000 A 3 / 1991 Rohrbacher et al . 5 , 034 ,506 A 7 / 1991 Summerton et al . ( 73 ) Assignee : Eagle Biologics , Inc. , Woodcliff Lake, 5 , 142 ,047 A 8 / 1992 Summerton et al . NJ (US ) 5 , 166 ,315 A 11/ 1992 Summerton et al. 5 ,217 , 866 A 6 / 1993 Summerton et al. ( * ) Notice : Subject to any disclaimer , the term of this 5 ,334 , 162 A 8 / 1994 Harris patent is extended or adjusted under 35 5 , 356 , 802 A 10 / 1994 Chandrasegaran U . S . C . 154 ( b ) by 507 days . 5 ,454 ,786 A 10 / 1995 Harris 5 , 487 , 994 A 1 / 1996 Chandrasegaran (21 ) Appl. No. : 14/ 484 ,053 5 ,506 , 337 A 4 / 1996 Summerton et al. 5 ,521 , 063 A 5 / 1996 Summerton et al . 5 ,527 ,675 A 6 / 1996 Coull (22 ) Filed : Sep . 11, 2014 5 , 539 , 082 A 7 / 1996 Nielsen et al . 5 ,569 , 193 A 10 / 1996 Hofstetter et al . ( 65 ) Prior Publication Data 5 ,608 , 038 A 3 / 1997 Eibl et al . US 2015 / 0071922 A1 Mar . 12, 2015 5 ,623 ,049 A 4 / 1997 Lobberding et al . 5 ,698 ,685 A 12/ 1997 Summerton et al. 5 ,714 ,331 A 2 / 1998 Buchardt et al. Related U . S . Application Data 5 , 736 , 336 A 4 / 1998 Buchardt et al . (60 ) Provisional application No . 62 / 030 , 521, filed on Jul. ( Continued ) 29 , 2014 , provisional application No . 62 /026 ,497 , filed on Jul. 18 , 2014 , provisional application No . FOREIGN PATENT DOCUMENTS 62/ 008, 050 , filed on Jun . 5 , 2014 , provisional application No. 61 / 988 ,005 , filed on May 2 , 2014 , EP 1981824 10 /2008 provisional application No . 61/ 946 ,436 , filed on Feb . EP 2335725 6 / 2011 28 , 2014 , provisional application No . 61/ 943, 197 , (Continued ) filed on Feb . 21, 2014 , provisional application No . 61 / 940 ,227 , filed on Feb . 14 , 2014 , provisional OTHER PUBLICATIONS application No. 61/ 876 ,621 , filed on Sep . 11 , 2013 . Earle and Seddon , “ Ionic liquids green solvents for the future” , (51 ) Int . CI. Pure Appl . Chem ., 72 ( 7 ) : 1391 - 8 ( 2000 ) . A61K 39 /395 ( 2006 .01 ) (Continued ) A61K 47 /06 ( 2006 .01 ) A61K 47 / 24 ( 2006 .01 ) A61K 9 /00 ( 2006 .01 ) Primary Examiner — Yunsoo Kim A61K 47 / 20 ( 2006 . 01 ) ( 74 ) Attorney , Agent, or Firm — Baker & Hostetler LLP A61K 47 / 22 ( 2006 . 01 ) CO7K 16 /22 ( 2006 .01 ) COOK 16 / 24 ( 2006 . 01 ) (57 ) ABSTRACT COZK 16 / 28 ( 2006 . 01 ) A61K 47 / 18 ( 2017 .01 ) Concentrated , low - viscosity , low - volume liquid pharmaceu A61K 9 / 19 ( 2006 .01 ) tical formulations of proteins have been developed . Such CO7K 16 /32 ( 2006 . 01 ) formulations can be rapidly and conveniently administered A61K 38 /00 ( 2006 .01 ) by subcutaneous or intramuscular injection , rather than by (52 ) U . S . CI. lengthy intravenous infusion . These formulations include CPC . .. A61K 47 / 06 ( 2013 .01 ) ; A61K 9 / 0019 low -molecular -weight and / or high -molecular - weight pro (2013 .01 ) ; A61K 9 / 19 (2013 .01 ) ; A61K teins , such as mAbs, and viscosity - reducing ionic liquids. 39 / 3955 ( 2013 .01 ) ; A61K 47/ 186 ( 2013 .01 ) ; A61K 47/ 20 (2013 . 01) ; A61K 47 / 22 (2013 . 01) ; A61K 47 / 24 ( 2013 .01 ) ; C07K 16 / 22 ( 2013 .01 ) ; 26 Claims, No Drawings US 9 ,833 Page, 513 2 B2 (56 ) References Cited 2016 /0074515 Al 3 /2016 Soane et al . 2016 /0090419 Al 3 / 2016 Morichika et al. U . S . PATENT DOCUMENTS 2016 /0193346 A17 / 2016 Houston et al . 2016 /0367675 Al 12 /2016 Liu et al. 5 , 773 ,571 A 6 / 1998 Nielsen et al. 2017 /0049888 AL 2 /2017 Liu et al. 5 , 779 ,668 A 7 / 1998 Grabenkort 5 , 786 , 571 A 7 / 1998 Bethel et al. FOREIGN PATENT DOCUMENTS 5 ,819 , 988 A 10 / 1998 Sawhney et al. 5 . 871, 736 A 2 / 1999 Bruegger et al . EP 2538973 1 / 2013 5 , 962 ,405 A 10 / 1999 Seelich wo W00244321 A2 6 / 2002 6 ,065 ,645 A 5 /2000 Sawhney et al . 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