MX2017005575A - Formulacion farmaceutica de anticuerpos anti-tnf alfa. - Google Patents
Formulacion farmaceutica de anticuerpos anti-tnf alfa.Info
- Publication number
- MX2017005575A MX2017005575A MX2017005575A MX2017005575A MX2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A
- Authority
- MX
- Mexico
- Prior art keywords
- tnf
- antibody formulation
- alpha antibody
- pharmaceutical
- pharmaceutical anti
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 239000007788 liquid Substances 0.000 abstract 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 abstract 1
- 229910019142 PO4 Inorganic materials 0.000 abstract 1
- 229960002964 adalimumab Drugs 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 abstract 1
- 239000010452 phosphate Substances 0.000 abstract 1
Classifications
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/26—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
- 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
- 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
-
- 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
-
- 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
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Se proporcionan formulaciones farmacéuticas de anticuerpos estables líquidas al almacenamiento. En particular, se describen las formulaciones farmacéuticas liquidas acuosas de Adalimumab basadas en sistemas tampón alternativos a citrato/fosfato y contenedores farmacéuticos como dispositivos autoinyectables que contienen las mismas.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
HU1400510A HUP1400510A1 (hu) | 2014-10-28 | 2014-10-28 | Gyógyászati TNFalfa ellenes antitest készítmény |
PCT/EP2015/074986 WO2016066688A1 (en) | 2014-10-28 | 2015-10-28 | Pharmaceutical anti-tnf-alpha antibody formulation |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2017005575A true MX2017005575A (es) | 2017-09-01 |
Family
ID=89991627
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2017005575A MX2017005575A (es) | 2014-10-28 | 2015-10-28 | Formulacion farmaceutica de anticuerpos anti-tnf alfa. |
Country Status (18)
Country | Link |
---|---|
US (2) | US20170252437A1 (es) |
EP (2) | EP3428189A1 (es) |
BR (1) | BR112017009021A2 (es) |
CA (1) | CA2989930A1 (es) |
CY (1) | CY1120937T1 (es) |
DE (4) | DE202015009509U1 (es) |
DK (1) | DK3212667T3 (es) |
ES (1) | ES2703586T3 (es) |
HR (1) | HRP20182006T1 (es) |
HU (2) | HUP1400510A1 (es) |
LT (1) | LT3212667T (es) |
MX (1) | MX2017005575A (es) |
PL (1) | PL3212667T3 (es) |
PT (1) | PT3212667T (es) |
RS (1) | RS58172B1 (es) |
SI (1) | SI3212667T1 (es) |
TR (1) | TR201816518T4 (es) |
WO (1) | WO2016066688A1 (es) |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10376582B2 (en) | 2013-10-16 | 2019-08-13 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
HUP1400510A1 (hu) | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
EP3247718B1 (en) | 2015-01-21 | 2021-09-01 | Outlook Therapeutics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
CN109563161A (zh) | 2016-02-03 | 2019-04-02 | 安口生物公司 | 用于提高抗体稳定性的缓冲制剂 |
BR112018076377A2 (pt) | 2016-06-30 | 2019-03-26 | Celltrion Inc. | formulação farmacêutica líquida estável |
HUP1600456A2 (en) | 2016-07-19 | 2018-01-29 | Richter Gedeon Nyrt | Novel cell-based tnf-alpha binding assay |
WO2018119142A1 (en) * | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
EP3372242A1 (en) * | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP3372241A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
BR112019019162A2 (pt) * | 2017-03-16 | 2020-04-14 | Lg Chemical Ltd | formulação líquida de um anticorpo anti-tnf-a e método para preparar a formulação líquida |
WO2018184692A1 (en) * | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
WO2018184693A1 (en) * | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
EA201900360A1 (ru) * | 2017-12-29 | 2019-12-30 | Закрытое Акционерное Общество "Биокад" | ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα |
JP7465260B2 (ja) * | 2018-09-20 | 2024-04-10 | テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハー | 充填済シリンジおよび自動注射器 |
EP3909607A4 (en) * | 2019-01-11 | 2022-10-26 | Samsung Bioepis Co., Ltd. | PHARMACEUTICAL COMPOSITION WITH ANTIBODIES, DEVICE CONTAINING THIS AND USE THEREOF |
WO2021182874A1 (ko) * | 2020-03-13 | 2021-09-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
DE102020129648A1 (de) * | 2020-11-10 | 2022-05-12 | Leopold MTX GmbH | Pharmazeutische zusammensetzung |
IL314523A (en) * | 2022-01-27 | 2024-09-01 | Janssen Biotech Inc | Improved protein compositions |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5945098A (en) | 1990-02-01 | 1999-08-31 | Baxter International Inc. | Stable intravenously-administrable immune globulin preparation |
US6090382A (en) | 1996-02-09 | 2000-07-18 | Basf Aktiengesellschaft | Human antibodies that bind human TNFα |
PL188192B1 (pl) | 1996-02-09 | 2004-12-31 | Abbott Lab Bermuda Ltd | Izolowane ludzkie przeciwciało albo jego część wiążąca antygen, rekombinowane ludzkie przeciwciało albo jego część wiążąca antygen, kompozycje farmaceutyczne, izolowane kwasy nukleinowe, rekombinowany wektor ekspresyjny, komórka gospodarza, sposób syntetyzowania przeciwciała ludzkiego, które wiąże ludzki TNFalfa, sposób hamowania aktywności ludzkiego TNFalfa in vitro, przeciwciało albo jego częśćwiążąca antygen, zastosowanie przeciwciała albo jego części wiążącej antygen |
FI20021199A (fi) | 2002-06-19 | 2003-12-20 | Kemira Growhow Oy | Menetelmä tuotantoa rajoittavien paikkakohtaisten kasvutekijöiden analysoimiseksi |
US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
EP3216462A3 (en) * | 2010-02-26 | 2017-12-20 | Novo Nordisk A/S | Stable antibody containing compositions |
EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
GB201112429D0 (en) * | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
SG11201403792TA (en) * | 2012-01-23 | 2014-10-30 | Regeneron Pharma | Stabilized formulations containing anti-ang2 antibodies |
NZ629261A (en) | 2012-03-07 | 2017-08-25 | Cadila Healthcare Ltd | Pharmaceutical formulations of tnf-alpha antibodies |
WO2013186230A1 (en) * | 2012-06-12 | 2013-12-19 | Boehringer Ingelheim International Gmbh | Pharmaceutical formulation for a therapeutic antibody |
PT2892550T (pt) | 2012-09-07 | 2020-03-27 | Coherus Biosciences Inc | Formulações aquosas estáveis de adalimumab |
EP2727602A1 (en) | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
US20150368333A1 (en) | 2013-01-24 | 2015-12-24 | Glaxosmithkline Intellectual Property Development Limited | Tnf-alpha antigen-binding proteins |
HUP1400510A1 (hu) | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
-
2014
- 2014-10-28 HU HU1400510A patent/HUP1400510A1/hu unknown
-
2015
- 2015-10-28 PL PL15808356T patent/PL3212667T3/pl unknown
- 2015-10-28 DE DE202015009509.7U patent/DE202015009509U1/de active Active
- 2015-10-28 LT LTEP15808356.8T patent/LT3212667T/lt unknown
- 2015-10-28 DE DE18190279.2T patent/DE18190279T1/de active Pending
- 2015-10-28 US US15/519,631 patent/US20170252437A1/en not_active Abandoned
- 2015-10-28 RS RS20181458A patent/RS58172B1/sr unknown
- 2015-10-28 BR BR112017009021A patent/BR112017009021A2/pt not_active Application Discontinuation
- 2015-10-28 HU HUE15808356A patent/HUE040621T2/hu unknown
- 2015-10-28 EP EP18190279.2A patent/EP3428189A1/en not_active Withdrawn
- 2015-10-28 EP EP15808356.8A patent/EP3212667B1/en active Active
- 2015-10-28 TR TR2018/16518T patent/TR201816518T4/tr unknown
- 2015-10-28 DE DE202015009619.0U patent/DE202015009619U1/de active Active
- 2015-10-28 PT PT15808356T patent/PT3212667T/pt unknown
- 2015-10-28 MX MX2017005575A patent/MX2017005575A/es unknown
- 2015-10-28 WO PCT/EP2015/074986 patent/WO2016066688A1/en active Application Filing
- 2015-10-28 DE DE202015009016.8U patent/DE202015009016U1/de active Active
- 2015-10-28 SI SI201530450T patent/SI3212667T1/sl unknown
- 2015-10-28 DK DK15808356.8T patent/DK3212667T3/en active
- 2015-10-28 ES ES15808356T patent/ES2703586T3/es active Active
- 2015-10-28 CA CA2989930A patent/CA2989930A1/en active Pending
-
2018
- 2018-11-19 CY CY181101218T patent/CY1120937T1/el unknown
- 2018-11-29 HR HRP20182006TT patent/HRP20182006T1/hr unknown
-
2021
- 2021-04-05 US US17/222,261 patent/US20220016244A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
DE202015009509U9 (de) | 2018-05-30 |
BR112017009021A2 (pt) | 2018-02-06 |
PT3212667T (pt) | 2018-12-20 |
US20220016244A1 (en) | 2022-01-20 |
SI3212667T1 (sl) | 2018-11-30 |
EP3212667B1 (en) | 2018-09-19 |
TR201816518T4 (tr) | 2018-11-21 |
WO2016066688A1 (en) | 2016-05-06 |
RS58172B1 (sr) | 2019-03-29 |
CA2989930A1 (en) | 2016-05-06 |
US20170252437A1 (en) | 2017-09-07 |
DK3212667T3 (en) | 2018-12-03 |
PL3212667T3 (pl) | 2019-02-28 |
EP3428189A1 (en) | 2019-01-16 |
EP3212667A1 (en) | 2017-09-06 |
HRP20182006T1 (hr) | 2019-01-25 |
CY1120937T1 (el) | 2019-12-11 |
HUE040621T2 (hu) | 2019-03-28 |
DE202015009619U1 (de) | 2018-08-29 |
DE18190279T1 (de) | 2019-07-11 |
DE202015009509U1 (de) | 2018-01-18 |
LT3212667T (lt) | 2018-12-10 |
DE202015009016U1 (de) | 2016-06-24 |
ES2703586T3 (es) | 2019-03-11 |
HUP1400510A1 (hu) | 2016-05-30 |
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