IN2015KN00005A - Etanercept formulations exhibiting marked reduction in sub-visible particles - Google Patents

Etanercept formulations exhibiting marked reduction in sub-visible particles

Info

Publication number
IN2015KN00005A
IN2015KN00005A IN5/KOLNP/2015A IN5KON2015A IN2015KN00005A IN 2015KN00005 A IN2015KN00005 A IN 2015KN00005A IN 5KON2015 A IN5KON2015 A IN 5KON2015A IN 2015KN00005 A IN2015KN00005 A IN 2015KN00005A
Authority
IN
India
Prior art keywords
sub
visible particles
marked reduction
formulations exhibiting
etanercept formulations
Prior art date
Application number
IN5/KOLNP/2015A
Inventor
Mark Manning
Brian Murphy
Douglas Farrar
Alan Herman
Original Assignee
Coherus Biosciences, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US201261669480P priority Critical
Priority to US201261669480P priority
Priority to US201361806235P priority
Priority to US201361806235P priority
Priority to PCT/US2013/049778 priority patent/WO2014011672A1/en
Application filed by Coherus Biosciences, Inc. filed Critical Coherus Biosciences, Inc.
Priority to US201514592569 priority
Publication of IN2015KN00005A publication Critical patent/IN2015KN00005A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, with substantial reduction in sub-visible particles, and methods of manufacture of these compositions, methods of administration, and articles of manufacture.
IN5/KOLNP/2015A 2012-07-09 2015-01-01 Etanercept formulations exhibiting marked reduction in sub-visible particles IN2015KN00005A (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US201261669480P true 2012-07-09 2012-07-09
US201261669480P 2012-07-09
US201361806235P true 2013-03-28 2013-03-28
US201361806235P 2013-03-28
PCT/US2013/049778 WO2014011672A1 (en) 2012-07-09 2013-07-09 Etanercept formulations exhibiting marked reduction in sub-visible particles
US201514592569 2015-01-08

Publications (1)

Publication Number Publication Date
IN2015KN00005A true IN2015KN00005A (en) 2015-07-31

Family

ID=49916504

Family Applications (1)

Application Number Title Priority Date Filing Date
IN5/KOLNP/2015A IN2015KN00005A (en) 2012-07-09 2015-01-01 Etanercept formulations exhibiting marked reduction in sub-visible particles

Country Status (18)

Country Link
US (2) US20150125532A1 (en)
EP (2) EP2869817A4 (en)
JP (2) JP6271536B2 (en)
KR (1) KR20150030704A (en)
CN (1) CN104661651A (en)
AU (1) AU2013290289B2 (en)
BR (2) BR112015000203A2 (en)
CA (1) CA2878508A1 (en)
CL (1) CL2015000051A1 (en)
DO (1) DOP2015000006A (en)
EA (1) EA029193B1 (en)
HK (2) HK1209343A1 (en)
IL (1) IL236527D0 (en)
IN (1) IN2015KN00005A (en)
MX (1) MX2015000337A (en)
PE (1) PE07622015A1 (en)
SG (1) SG11201500138VA (en)
WO (2) WO2014011629A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2015015051A (en) * 2013-05-02 2016-06-10 Mabxience S A Alternative formulations for tnfr: fc fusion polypeptides.
US20180200325A1 (en) * 2014-11-18 2018-07-19 Shionogi & Co., Ltd. Stabilized peptide composition
MX2015010517A (en) * 2015-08-13 2017-02-13 Landsteiner Scient S A De C V Etanercept composition having improved stability.
WO2019087108A1 (en) * 2017-10-31 2019-05-09 Probiomed S.A. De C.V. Stable pharmaceutical formulation of a fusion protein

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US20010021380A1 (en) 1999-04-19 2001-09-13 Pluenneke John D. Soluble tumor necrosis factor receptor treatment of medical disorders
WO2000062790A2 (en) 1999-04-19 2000-10-26 Immunex Corporation Soluble tumor necrosis factor receptor treatment of medical disorders
US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
AU2003219958B2 (en) * 2002-02-27 2006-01-05 Immunex Corporation Polypeptide formulation
US20060177444A1 (en) * 2003-03-20 2006-08-10 Tatsuo Horizoe Concomitant drug as therapeutic agent for inflammatory bowel disease
AU2004262014B2 (en) * 2003-08-01 2010-06-17 Amgen Inc. Crystalline tumor necrosis factor receptor 2 polypeptides
EA011857B8 (en) * 2003-10-14 2012-08-30 Интермьюн, Инк. Macrocyclic carboxylic acids and acylsulfonamides as inhibitors of hcv replication
US20060008415A1 (en) * 2004-06-25 2006-01-12 Protein Design Labs, Inc. Stable liquid and lyophilized formulation of proteins
KR101367544B1 (en) * 2005-06-10 2014-02-26 추가이 세이야쿠 가부시키가이샤 Stabilizer for protein preparation comprising meglumine and use thereof
PT1962886E (en) * 2005-12-20 2014-01-07 Squibb Bristol Myers Co Stable protein formulations
CA2649538C (en) * 2006-04-21 2014-06-03 Yatin Gokarn Buffering agents for biopharmaceutical formulations
CL2007002880A1 (en) * 2006-10-06 2008-05-09 Amgen Inc Stable formulation comprising an acetic acid buffer, glutamic acid buffer or succinic acid buffer with a pH of 4.5 to 7, at least one excipient comprising a sugar or a polyol, and an anti-receptor factor d
US7705132B2 (en) * 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
TWI629064B (en) * 2007-11-30 2018-07-11 艾伯維生物技術有限責任公司 Protein formulations and manufacturing method therefor
CA2714006A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
PT2331090T (en) * 2008-09-19 2018-02-07 Pfizer Stable liquid antibody formulation
ES2684921T3 (en) * 2010-05-10 2018-10-05 Intas Pharmaceuticals Limited liquid formulation containing an Fc polypeptide domain of an immunoglobulin
WO2012013980A1 (en) * 2010-07-30 2012-02-02 Arecor Limited Stabilized aqueous antibody compositions
JP2012049074A (en) 2010-08-30 2012-03-08 Makita Corp Battery pack of electric tool
WO2012143418A1 (en) * 2011-04-20 2012-10-26 Sandoz Ag STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc
UY34105A (en) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Etanercept stable liquid formulation
CA2840711A1 (en) * 2011-07-01 2013-01-10 Biogen Idec Ma Inc. Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use
MX2014004725A (en) * 2011-10-18 2015-02-05 Coherus Biosciences Inc Etanercept formulations stabilized with amino acids.

Also Published As

Publication number Publication date
HK1209343A1 (en) 2016-04-01
EA029193B1 (en) 2018-02-28
MX2015000337A (en) 2015-09-25
EP2869816A4 (en) 2016-04-20
KR20150030704A (en) 2015-03-20
BR112015000229A2 (en) 2017-06-27
DOP2015000006A (en) 2015-05-31
SG11201500138VA (en) 2015-03-30
EA201590161A1 (en) 2015-07-30
HK1213174A1 (en) 2016-06-30
US20150125532A1 (en) 2015-05-07
EP2869817A1 (en) 2015-05-13
EP2869817A4 (en) 2016-04-06
AU2013290289A1 (en) 2015-01-29
US9662396B2 (en) 2017-05-30
JP2015525762A (en) 2015-09-07
IL236527D0 (en) 2015-02-26
CN104661651A (en) 2015-05-27
WO2014011672A1 (en) 2014-01-16
JP2015525763A (en) 2015-09-07
EP2869816A1 (en) 2015-05-13
JP6271536B2 (en) 2018-01-31
CL2015000051A1 (en) 2015-07-31
PE07622015A1 (en) 2015-06-20
AU2013290289B2 (en) 2018-03-29
US20150196645A1 (en) 2015-07-16
CA2878508A1 (en) 2014-01-16
BR112015000203A2 (en) 2017-06-27
WO2014011629A1 (en) 2014-01-16

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