CL2015000051A1 - Una composicion farmaceutica acuosa estabilizada para almacenamiento a largo plazo que comprende etanercept y un estabilizante para prevenir, inhibir o reducir la presencia de particulas subvisibles en la composicion, donde el estabilizante comprende un tensioactivo, y donde la composicion esta libre de arginina como estabilizante. - Google Patents
Una composicion farmaceutica acuosa estabilizada para almacenamiento a largo plazo que comprende etanercept y un estabilizante para prevenir, inhibir o reducir la presencia de particulas subvisibles en la composicion, donde el estabilizante comprende un tensioactivo, y donde la composicion esta libre de arginina como estabilizante.Info
- Publication number
- CL2015000051A1 CL2015000051A1 CL2015000051A CL2015000051A CL2015000051A1 CL 2015000051 A1 CL2015000051 A1 CL 2015000051A1 CL 2015000051 A CL2015000051 A CL 2015000051A CL 2015000051 A CL2015000051 A CL 2015000051A CL 2015000051 A1 CL2015000051 A1 CL 2015000051A1
- Authority
- CL
- Chile
- Prior art keywords
- stabilizer
- composition
- etanercept
- arginine
- surfactant
- Prior art date
Links
- 239000003381 stabilizer Substances 0.000 title 3
- 239000000203 mixture Substances 0.000 title 2
- 239000004475 Arginine Substances 0.000 title 1
- 108010008165 Etanercept Proteins 0.000 title 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 title 1
- 229960000403 etanercept Drugs 0.000 title 1
- 230000007774 longterm Effects 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000012906 subvisible particle Substances 0.000 title 1
- 239000004094 surface-active agent Substances 0.000 title 1
Classifications
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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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- 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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- 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
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- A61K9/0012—Galenical forms characterised by the site of application
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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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- 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
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-
- A—HUMAN NECESSITIES
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
- C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
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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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Cell Biology (AREA)
- Zoology (AREA)
- Inorganic Chemistry (AREA)
- Toxicology (AREA)
- Dermatology (AREA)
- Pulmonology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Virology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261669480P | 2012-07-09 | 2012-07-09 | |
| US201361806235P | 2013-03-28 | 2013-03-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2015000051A1 true CL2015000051A1 (es) | 2015-07-31 |
Family
ID=49916504
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2015000051A CL2015000051A1 (es) | 2012-07-09 | 2015-01-08 | Una composicion farmaceutica acuosa estabilizada para almacenamiento a largo plazo que comprende etanercept y un estabilizante para prevenir, inhibir o reducir la presencia de particulas subvisibles en la composicion, donde el estabilizante comprende un tensioactivo, y donde la composicion esta libre de arginina como estabilizante. |
Country Status (19)
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| EP3351269B1 (en) | 2005-06-14 | 2020-01-29 | Amgen Inc. | Self-buffering protein formulations |
| HRP20180182T1 (hr) * | 2012-09-11 | 2018-04-20 | Coherus Biosciences, Inc. | Pravilno presavijeni etanercept visoke čistoće i izvanrednog prinosa |
| JP2016518386A (ja) * | 2013-05-02 | 2016-06-23 | マブキシェンス エス．アー． | ＴＮＦＲ：Ｆｃ融合ポリペプチドの代替配合物 |
| RU2715236C2 (ru) | 2014-03-26 | 2020-02-26 | Астекс Терапьютикс Лтд | Комбинации |
| JP6781508B2 (ja) * | 2014-11-18 | 2020-11-04 | 塩野義製薬株式会社 | 安定化されたペプチド組成物 |
| JOP20200201A1 (ar) | 2015-02-10 | 2017-06-16 | Astex Therapeutics Ltd | تركيبات صيدلانية تشتمل على n-(3.5- ثنائي ميثوكسي فينيل)-n'-(1-ميثيل إيثيل)-n-[3-(ميثيل-1h-بيرازول-4-يل) كينوكسالين-6-يل]إيثان-1.2-ثنائي الأمين |
| MX389818B (es) * | 2015-08-13 | 2025-03-20 | Landsteiner Scient S A De C V | Composicion de estabilidad mejorada de etanercept. |
| KR102429646B1 (ko) * | 2016-03-14 | 2022-08-04 | 산텐 세이야꾸 가부시키가이샤 | 메글루민 또는 그의 염을 포함하는 방부제 |
| JP6884858B2 (ja) * | 2016-10-21 | 2021-06-09 | アムジエン・インコーポレーテツド | 医薬製剤及びその製造方法 |
| CN116327963A (zh) * | 2016-11-21 | 2023-06-27 | 济世-伊沃泰克生物制品有限公司 | 一种眼科制剂及其用途 |
| MX2017013995A (es) * | 2017-10-31 | 2019-05-01 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina de fusion. |
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| MA52347A (fr) * | 2018-04-24 | 2021-03-03 | Amgen Inc | Procédé de fabrication de compositions pharmaceutiques injectables |
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| WO2021083910A1 (en) * | 2019-10-28 | 2021-05-06 | Astrazeneca Ab | Dry powder formulations containing leucine and trileucine |
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| EP2516467A2 (en) | 2009-12-23 | 2012-10-31 | Emergent Product Development Seattle, LLC | Compositions comprising tnf-alpha and il-6 antagonists and methods of use thereof |
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2013
- 2013-07-09 HK HK15110117.0A patent/HK1209343A1/xx unknown
- 2013-07-09 HK HK15110120.5A patent/HK1213174A1/zh unknown
- 2013-07-09 EP EP13817186.3A patent/EP2869817A4/en not_active Withdrawn
- 2013-07-09 PE PE2015000026A patent/PE20150762A1/es not_active Application Discontinuation
- 2013-07-09 JP JP2015521742A patent/JP2015525762A/ja active Pending
- 2013-07-09 WO PCT/US2013/049778 patent/WO2014011672A1/en not_active Ceased
- 2013-07-09 KR KR1020157000510A patent/KR20150030704A/ko not_active Withdrawn
- 2013-07-09 SG SG11201500138VA patent/SG11201500138VA/en unknown
- 2013-07-09 EA EA201590161A patent/EA029193B1/ru not_active IP Right Cessation
- 2013-07-09 BR BR112015000203A patent/BR112015000203A2/pt not_active IP Right Cessation
- 2013-07-09 IN IN5KON2015 patent/IN2015KN00005A/en unknown
- 2013-07-09 JP JP2015521752A patent/JP6271536B2/ja not_active Expired - Fee Related
- 2013-07-09 CN CN201380046666.4A patent/CN104661651A/zh active Pending
- 2013-07-09 MX MX2015000337A patent/MX2015000337A/es unknown
- 2013-07-09 WO PCT/US2013/049716 patent/WO2014011629A1/en not_active Ceased
- 2013-07-09 EP EP13816429.8A patent/EP2869816A4/en not_active Withdrawn
- 2013-07-09 CA CA2878508A patent/CA2878508A1/en not_active Abandoned
- 2013-07-09 AU AU2013290289A patent/AU2013290289B2/en not_active Expired - Fee Related
- 2013-07-09 BR BR112015000229A patent/BR112015000229A2/pt not_active IP Right Cessation
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2014
- 2014-12-31 IL IL236527A patent/IL236527A0/en unknown
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2015
- 2015-01-08 US US14/592,654 patent/US9662396B2/en not_active Expired - Fee Related
- 2015-01-08 CL CL2015000051A patent/CL2015000051A1/es unknown
- 2015-01-08 US US14/592,569 patent/US10822429B2/en not_active Expired - Fee Related
- 2015-01-09 DO DO2015000006A patent/DOP2015000006A/es unknown
- 2015-02-09 EC ECIEPI20154752A patent/ECSP15004752A/es unknown
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2020
- 2020-09-28 US US17/034,134 patent/US20210007991A1/en not_active Abandoned
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