AR076748A1 - Formulaciones estables de anticuerpos anti-tnf-alfa humanos con grandes concentraciones de proteinas. metodo de tratamiento - Google Patents
Formulaciones estables de anticuerpos anti-tnf-alfa humanos con grandes concentraciones de proteinas. metodo de tratamientoInfo
- Publication number
- AR076748A1 AR076748A1 ARP100101510A ARP100101510A AR076748A1 AR 076748 A1 AR076748 A1 AR 076748A1 AR P100101510 A ARP100101510 A AR P100101510A AR P100101510 A ARP100101510 A AR P100101510A AR 076748 A1 AR076748 A1 AR 076748A1
- Authority
- AR
- Argentina
- Prior art keywords
- approximately
- formulation
- seq
- amino acid
- acid sequence
- Prior art date
Links
Classifications
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- 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
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- 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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- 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
- A61K47/08—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
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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
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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
- A61K47/26—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- 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
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P21/00—Preparation of peptides or proteins
Abstract
Reivindicacion 1: Una formulacion farmacéutica líquida, caracterizada porque comprende más de 20 mg aproximadamente de un poliol y al menos 100 mg/ml aproximadamente de un anticuerpo anti-TNF-alfa humano, o una porcion de union al antígeno del mismo, que comprende una cadena liviana que comprende un dominio CDR3 cuya secuencia de aminoácidos se muestra en la SEQ ID N°: 3, o una modificacion de la SEQ ID N°: 3 por una sola sustitucion de alanina en la posicion 1, 4, 5, 7 u 8 o por una a cinco sustituciones de aminoácidos conservadores en las posiciones 1, 3, 4, 6, 7, 8 y/o 9, y una cadena pesada que comprende un dominio CDR3 cuya secuencia de aminoácidos que se muestra en la SEQ ID N°: 4, o una modificacion de la SEQ ID N°: 4 por una sola sustitucion de alanina en la posicion 2, 3, 4, 5, 6, 8, 9, 10 u 11 o por una a cinco sustituciones de aminoácidos conservadores en las posiciones 2, 3, 4, 5, 6, 8, 9, 10, 11 y/o 12, en donde la formulacion no contiene al excipiente NaCI. Reivindicacion 4: La formulacion de la reivindicacion 1, caracterizada porque la formulacion comprende 40-45 mg aproximadamente del poliol. Reivindicacion 5: La formulacion de cualquiera de las reivindicaciones 1-4, caracterizada porque el poliol es un alcohol de azucar. Reivindicacion 10: La formulacion de cualquiera de las reivindicaciones 1-6, caracterizada porque el anticuerpo es adalimumab. Reivindicacion 11: Una formulacion farmacéutica líquida, caracterizada porque tiene un valor de pH de entre 5,0 y 6,4 aproximadamente y que comprende al menos 100 mg/ml aproximadamente de un anticuerpo anti-TNF-alfa humano, o una porcion de union al antígeno del mismo, que comprende una cadena liviana que comprende un dominio CDR3 que comprende una secuencia de aminoácidos que se muestra en la SEQ ID N°: 3 y una cadena pesada que comprende un dominio CDR3 que comprende una secuencia de aminoácidos que se muestra en la SEQ ID N°: 4, en donde la formulacion no contiene NaCI y tiene una turbidez menor que 60 NTU aproximadamente después de un ensayo estándar de estrés por agitacion de 24 horas. Reivindicacion 21: La formulacion de cualquiera de las reivindicaciones 11-20, caracterizada porque contiene menos que un 1% aproximadamente de proteína agregada. Reivindicacion 26: Una formulacion farmacéutica líquida, caracterizada porque comprende al menos 100 mg/ml aproximadamente de un anticuerpo anti-TNF-alfa humano, o una porcion de union al antígeno del mismo, que comprende una cadena liviana que comprende un dominio CDR3 que comprende una secuencia de aminoácidos que se muestra en la SEQ ID N°: 3 y una cadena pesada que comprende un dominio CDR3 que comprende una secuencia de aminoácidos que se muestra en la SEQ ID N°: 4; más de 20 mg aproximadamente/ml de un alcohol de azucar; 0,1-2,0 mg/ml aproximadamente de un agente tensioactivo; 1,15-1,45 mg/ml aproximadamente de ácido cítrico * H2O; 0,2-0,4 mg/ml aproximadamente de citrato de sodio deshidratado; 1,35-1,75 mg/ml aproximadamente de Na2HPO4 * 2 H2O; 0,75-0,95 mg/ml aproximadamente de NaH2PO4 * 2 H2O, en donde la formulacion tiene una valor de pH de entre 4,7 y 6,5 aproximadamente y no comprende NaCI. Reivindicacion 29. La formulacion de la reivindicacion 26, caracterizada porque el agente tensioactivo es Polysorbate 80.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17538009P | 2009-05-04 | 2009-05-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR076748A1 true AR076748A1 (es) | 2011-07-06 |
Family
ID=43030509
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP100101510A AR076748A1 (es) | 2009-05-04 | 2010-05-04 | Formulaciones estables de anticuerpos anti-tnf-alfa humanos con grandes concentraciones de proteinas. metodo de tratamiento |
Country Status (16)
Country | Link |
---|---|
US (3) | US20100278822A1 (es) |
EP (1) | EP2427211A4 (es) |
JP (1) | JP2012526121A (es) |
KR (1) | KR20120038406A (es) |
CN (2) | CN102458469B (es) |
AR (1) | AR076748A1 (es) |
AU (1) | AU2010246168A1 (es) |
CA (1) | CA2760185A1 (es) |
IL (1) | IL215643A0 (es) |
MX (1) | MX2011011772A (es) |
NZ (2) | NZ613809A (es) |
RU (1) | RU2560701C2 (es) |
SG (2) | SG10201401995UA (es) |
TW (2) | TWI480064B (es) |
UY (1) | UY32609A (es) |
WO (1) | WO2010129469A1 (es) |
Families Citing this family (112)
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CA2760185A1 (en) | 2010-11-11 |
IL215643A0 (en) | 2012-01-31 |
NZ613809A (en) | 2015-02-27 |
WO2010129469A1 (en) | 2010-11-11 |
CN102458469A (zh) | 2012-05-16 |
TWI480064B (zh) | 2015-04-11 |
CN104490767A (zh) | 2015-04-08 |
JP2012526121A (ja) | 2012-10-25 |
TW201043263A (en) | 2010-12-16 |
CN102458469B (zh) | 2014-12-24 |
SG10201401995UA (en) | 2014-08-28 |
WO2010129469A8 (en) | 2012-02-23 |
KR20120038406A (ko) | 2012-04-23 |
EP2427211A1 (en) | 2012-03-14 |
RU2011149327A (ru) | 2013-06-10 |
EP2427211A4 (en) | 2013-05-01 |
TW201526923A (zh) | 2015-07-16 |
NZ595694A (en) | 2013-09-27 |
US20100278822A1 (en) | 2010-11-04 |
US20140141008A1 (en) | 2014-05-22 |
US20140141007A1 (en) | 2014-05-22 |
RU2560701C2 (ru) | 2015-08-20 |
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