CL2019001818A1 - Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante. - Google Patents
Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante.Info
- Publication number
- CL2019001818A1 CL2019001818A1 CL2019001818A CL2019001818A CL2019001818A1 CL 2019001818 A1 CL2019001818 A1 CL 2019001818A1 CL 2019001818 A CL2019001818 A CL 2019001818A CL 2019001818 A CL2019001818 A CL 2019001818A CL 2019001818 A1 CL2019001818 A1 CL 2019001818A1
- Authority
- CL
- Chile
- Prior art keywords
- monoclonal antibody
- aqueous pharmaceutical
- tnfa
- tnf
- pharmaceutical composition
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 101000611183 Homo sapiens Tumor necrosis factor Proteins 0.000 abstract 2
- 102100040247 Tumor necrosis factor Human genes 0.000 abstract 2
- 102000004169 proteins and genes Human genes 0.000 abstract 2
- 108090000623 proteins and genes Proteins 0.000 abstract 2
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 239000012634 fragment Substances 0.000 abstract 1
- 230000008014 freezing Effects 0.000 abstract 1
- 238000007710 freezing Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000012986 modification Methods 0.000 abstract 1
- 230000004048 modification Effects 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 238000010257 thawing Methods 0.000 abstract 1
Classifications
-
- 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
-
- 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
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/16—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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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]
-
- 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
-
- 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
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Molecular Biology (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
LA INVENCIÓN SE RELACIONA CON COMPOSICIONES FARMACÉUTICAS ACUOSAS MEJORADAS DE UN ANTICUERPO MONOCLONAL RECOMBINANTE PARA TNFA Y UN MÉTODO DE PRODUCCIÓN DEL MISMO. LA PRESENTE INVENCIÓN SE RELACIONA ADEMÁS CON EL USO DE COMPOSICIONES FARMACÉUTICAS ACUOSAS MEJORADAS DE UN ANTICUERPO MONOCLONAL RECOMBINANTE PARA TNFA PARA TRATAR ENFERMEDADES MEDIADAS POR TNFA. LA INVENCIÓN PROPUESTA PERMITE LA PREVENCIÓN DE INESTABILIDAD FÍSICO-QUÍMICA EXPRESADA EN LA FORMACIÓN DE CÚMULOS Y FRAGMENTOS DE PROTEÍNAS O EN LA MODIFICACIÓN DE PROTEÍNAS EN UNA SOLUCIÓN; ADEMÁS, PREVIENE LA INESTABILIDAD DURANTE LA CONGELACIÓN/DESCONGELACIÓN, LA AGITACIÓN Y EL MOVIMIENTO.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
RU2016152691A RU2665966C2 (ru) | 2016-12-30 | 2016-12-30 | Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα |
RU2017146821A RU2764521C2 (ru) | 2017-12-29 | 2017-12-29 | Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОа |
Publications (1)
Publication Number | Publication Date |
---|---|
CL2019001818A1 true CL2019001818A1 (es) | 2019-11-29 |
Family
ID=62710701
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CL2019001818A CL2019001818A1 (es) | 2016-12-30 | 2019-06-28 | Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante. |
Country Status (15)
Country | Link |
---|---|
EP (1) | EP3563867A4 (es) |
JP (1) | JP2020506955A (es) |
KR (1) | KR20190104043A (es) |
AU (1) | AU2017384942A1 (es) |
BR (1) | BR112019013673A2 (es) |
CL (1) | CL2019001818A1 (es) |
CR (1) | CR20190316A (es) |
EC (1) | ECSP19048656A (es) |
JO (1) | JOP20190162A1 (es) |
MX (1) | MX2019007911A (es) |
NI (1) | NI201900072A (es) |
PE (1) | PE20191550A1 (es) |
PH (1) | PH12019501530A1 (es) |
WO (1) | WO2018124948A1 (es) |
ZA (1) | ZA201904305B (es) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2021182874A1 (ko) * | 2020-03-13 | 2021-09-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
RU2745814C1 (ru) * | 2020-06-05 | 2021-04-01 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция левилимаба и ее применение |
BR112023019201A2 (pt) * | 2021-03-24 | 2023-10-17 | Japan Chem Res | Composição farmacêutica aquosa ou composição farmacêutica liofilizada |
Family Cites Families (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US521206A (en) | 1894-06-12 | Frank b | ||
EP0230574A3 (en) | 1986-01-31 | 1989-03-22 | Yale University | Pharmaceutical compositions against infections caused by lav/htlv iii virus and the use thereof |
DE3631229A1 (de) | 1986-09-13 | 1988-03-24 | Basf Ag | Monoklonale antikoerper gegen humanen tumornekrosefaktor (tnf) und deren verwendung |
DE68927671T2 (de) | 1988-12-19 | 1997-05-07 | American Cyanamid Co | Produkte zur Behandlung des Endotoxin -Schocks bei einem Säugetier |
US5959087A (en) | 1989-08-07 | 1999-09-28 | Peptide Technology, Ltd. | Tumour necrosis factor binding ligands |
US6498237B2 (en) | 1989-08-07 | 2002-12-24 | Peptech Limited | Tumor necrosis factor antibodies |
AU630497B2 (en) | 1989-09-05 | 1992-10-29 | Immunex Corporation | Tumor necrosis factor-alpha and -beta receptors |
GB8921123D0 (en) | 1989-09-19 | 1989-11-08 | Millar Ann B | Treatment of ards |
DE4037604A1 (de) | 1990-04-25 | 1991-10-31 | Bayer Ag | Verwendung von anti-tnf-antikoerpern als arzneimittel bei der behandlung von ischaemien und deren folgen |
CA2288429C (en) | 1991-03-15 | 2006-04-25 | Synergen, Inc. | Pegylation of polypeptides |
US5656272A (en) | 1991-03-18 | 1997-08-12 | New York University Medical Center | Methods of treating TNF-α-mediated Crohn's disease using chimeric anti-TNF antibodies |
DK0604418T3 (da) | 1991-03-29 | 1999-06-14 | Immunex Corp | Isolerede viralproteincytokinantagonister |
WO1993011793A1 (en) | 1991-12-17 | 1993-06-24 | Schering Corporation | Use of the combination of anti-tumor necrosis factor plus interleukin-6 to treat septic shock |
WO1993019751A1 (en) | 1992-04-02 | 1993-10-14 | Smithkline Beecham Corporation | Compounds useful for treating inflammatory diseases and inhibiting production of tumor necrosis factor |
ATE172880T1 (de) | 1992-08-28 | 1998-11-15 | Bayer Ag | Verwendung von monoklonalen anti-tnf-antikörpern für die behandlung von bakteriellen meningitiden |
AU670125B2 (en) | 1992-09-15 | 1996-07-04 | Immunex Corporation | Method of treating tnf-dependent inflammation using tumor necrosis factor antagonists |
WO1994008609A1 (en) | 1992-10-15 | 1994-04-28 | Dana-Farber Cancer Institute, Inc. | TREATMENT OF INSULIN RESISTANCE IN OBESITY LINKED TYPE II DIABETES USING ANTAGONISTS TO TNF-α FUNCTION |
DE4307508A1 (de) | 1993-03-10 | 1994-09-15 | Knoll Ag | Verwendung von anti-TNF-Antikörpern als Arzneimittel bei der Behandlung von Herzinsuffizienz (Herzmuskelschwäche) |
NZ278607A (en) | 1994-02-07 | 1999-05-28 | Knoll Ag | Use of tnf antagonists for treating disorders involving elevated serum levels of il-6 wherein the serum levels are 500pg/ml or above |
US6090382A (en) | 1996-02-09 | 2000-07-18 | Basf Aktiengesellschaft | Human antibodies that bind human TNFα |
CN101712720A (zh) | 1996-02-09 | 2010-05-26 | 艾博特生物技术有限公司 | 结合人TNFα的人抗体 |
UA81743C2 (uk) | 2000-08-07 | 2008-02-11 | Центокор, Инк. | МОНОКЛОНАЛЬНЕ АНТИТІЛО ЛЮДИНИ, ЩО СПЕЦИФІЧНО ЗВ'ЯЗУЄТЬСЯ З ФАКТОРОМ НЕКРОЗУ ПУХЛИН АЛЬФА (ФНПα), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ЙОГО МІСТИТЬ, ТА СПОСІБ ЛІКУВАННЯ РЕВМАТОЇДНОГО АРТРИТУ |
US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
KR20110138412A (ko) * | 2009-04-16 | 2011-12-27 | 애보트 바이오테라퓨틱스 코포레이션 | 항-ΤΝF-α 항체 및 그의 용도 |
MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
MX363700B (es) * | 2012-03-07 | 2019-03-29 | Cadila Healthcare Ltd | Formulaciones farmaceuticas de anticuerpos tnf-alfa. |
WO2016120413A1 (en) * | 2015-01-28 | 2016-08-04 | Mabxience S.A. | Pharmaceutical formulations for anti-tnf-alpha antibodies |
-
2017
- 2017-06-16 JO JOP/2019/0162A patent/JOP20190162A1/ar unknown
- 2017-12-29 EP EP17885720.7A patent/EP3563867A4/en not_active Withdrawn
- 2017-12-29 JP JP2019556787A patent/JP2020506955A/ja active Pending
- 2017-12-29 WO PCT/RU2017/050133 patent/WO2018124948A1/ru active Search and Examination
- 2017-12-29 PE PE2019001351A patent/PE20191550A1/es unknown
- 2017-12-29 BR BR112019013673A patent/BR112019013673A2/pt not_active IP Right Cessation
- 2017-12-29 MX MX2019007911A patent/MX2019007911A/es unknown
- 2017-12-29 CR CR20190316A patent/CR20190316A/es unknown
- 2017-12-29 AU AU2017384942A patent/AU2017384942A1/en active Pending
- 2017-12-29 KR KR1020197022011A patent/KR20190104043A/ko not_active Application Discontinuation
-
2019
- 2019-06-28 NI NI201900072A patent/NI201900072A/es unknown
- 2019-06-28 PH PH12019501530A patent/PH12019501530A1/en unknown
- 2019-06-28 CL CL2019001818A patent/CL2019001818A1/es unknown
- 2019-06-28 ZA ZA2019/04305A patent/ZA201904305B/en unknown
- 2019-07-09 EC ECSENADI201948656A patent/ECSP19048656A/es unknown
Also Published As
Publication number | Publication date |
---|---|
CR20190316A (es) | 2019-09-04 |
EP3563867A1 (en) | 2019-11-06 |
PE20191550A1 (es) | 2019-10-24 |
NI201900072A (es) | 2019-10-31 |
KR20190104043A (ko) | 2019-09-05 |
JP2020506955A (ja) | 2020-03-05 |
JOP20190162A1 (ar) | 2019-06-27 |
BR112019013673A2 (pt) | 2020-01-28 |
EP3563867A4 (en) | 2020-12-16 |
WO2018124948A8 (ru) | 2018-09-27 |
PH12019501530A1 (en) | 2020-02-24 |
ECSP19048656A (es) | 2019-07-31 |
MX2019007911A (es) | 2019-12-05 |
WO2018124948A1 (ru) | 2018-07-05 |
AU2017384942A1 (en) | 2019-08-08 |
ZA201904305B (en) | 2022-04-28 |
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