CA2884182C - Stable aqueous formulations of adalimumab - Google Patents

Stable aqueous formulations of adalimumab Download PDF

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Publication number
CA2884182C
CA2884182C CA2884182A CA2884182A CA2884182C CA 2884182 C CA2884182 C CA 2884182C CA 2884182 A CA2884182 A CA 2884182A CA 2884182 A CA2884182 A CA 2884182A CA 2884182 C CA2884182 C CA 2884182C
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Canada
Prior art keywords
composition
adalimumab
buffer
concentration
citrate
Prior art date
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Active
Application number
CA2884182A
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English (en)
French (fr)
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CA2884182A1 (en
Inventor
Mark Manning
Robert W. Payne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coherus Oncology Inc
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Coherus Biosciences Inc
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Publication date
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Application filed by Coherus Biosciences Inc filed Critical Coherus Biosciences Inc
Priority to CA3153799A priority Critical patent/CA3153799A1/en
Publication of CA2884182A1 publication Critical patent/CA2884182A1/en
Application granted granted Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
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    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
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    • C—CHEMISTRY; METALLURGY
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    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
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    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C—CHEMISTRY; METALLURGY
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    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Pulmonology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Communicable Diseases (AREA)
CA2884182A 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab Active CA2884182C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3153799A CA3153799A1 (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201261698138P 2012-09-07 2012-09-07
US61/698,138 2012-09-07
US201361769581P 2013-02-26 2013-02-26
US61/769,581 2013-02-26
US201361770421P 2013-02-28 2013-02-28
US61/770,421 2013-02-28
PCT/US2013/058618 WO2014039903A2 (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3153799A Division CA3153799A1 (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab

Publications (2)

Publication Number Publication Date
CA2884182A1 CA2884182A1 (en) 2014-03-13
CA2884182C true CA2884182C (en) 2022-06-14

Family

ID=50237778

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3153799A Pending CA3153799A1 (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab
CA2884182A Active CA2884182C (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA3153799A Pending CA3153799A1 (en) 2012-09-07 2013-09-06 Stable aqueous formulations of adalimumab

Country Status (31)

Country Link
US (39) US20140186361A1 (OSRAM)
EP (2) EP2892550B1 (OSRAM)
JP (3) JP6463268B2 (OSRAM)
KR (3) KR102238677B1 (OSRAM)
CN (1) CN104768576A (OSRAM)
AR (1) AR092470A1 (OSRAM)
AU (3) AU2013312300A1 (OSRAM)
BR (1) BR112015004984A2 (OSRAM)
CA (2) CA3153799A1 (OSRAM)
CL (1) CL2015000574A1 (OSRAM)
CY (1) CY1123407T1 (OSRAM)
DK (1) DK2892550T3 (OSRAM)
DO (1) DOP2015000051A (OSRAM)
EA (2) EA201791717A1 (OSRAM)
EC (1) ECSP15013227A (OSRAM)
ES (1) ES2784861T3 (OSRAM)
HR (1) HRP20200434T1 (OSRAM)
HU (1) HUE049282T2 (OSRAM)
IL (2) IL237583B (OSRAM)
LT (1) LT2892550T (OSRAM)
MX (1) MX2015003007A (OSRAM)
PE (2) PE20191815A1 (OSRAM)
PL (1) PL2892550T3 (OSRAM)
PT (1) PT2892550T (OSRAM)
RS (1) RS60226B1 (OSRAM)
SG (2) SG10201705668XA (OSRAM)
SI (1) SI2892550T1 (OSRAM)
SM (1) SMT202000147T1 (OSRAM)
TW (2) TWI698253B (OSRAM)
UY (1) UY35351A (OSRAM)
WO (1) WO2014039903A2 (OSRAM)

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