IN2014CN02591A - - Google Patents
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- Publication number
- IN2014CN02591A IN2014CN02591A IN2591CHN2014A IN2014CN02591A IN 2014CN02591 A IN2014CN02591 A IN 2014CN02591A IN 2591CHN2014 A IN2591CHN2014 A IN 2591CHN2014A IN 2014CN02591 A IN2014CN02591 A IN 2014CN02591A
- Authority
- IN
- India
- Prior art keywords
- etanercept
- combination
- present
- fragmentation
- arginine
- Prior art date
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Classifications
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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
- 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
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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
- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/191—Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
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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
- A61K47/02—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
- A61K47/12—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
- A61K47/16—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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- 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
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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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
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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
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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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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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
- 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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- A61P17/06—Antipsoriatics
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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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
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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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- 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
- 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
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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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
- C07K14/81—Protease inhibitors
-
- 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
Abstract
The present invention is a stable aqueous pharmaceutical composition comprising etanercept in combination with stabilizers to reduce instability aggregation misfolding and/or fragmentation of the etanercept during storage of the formulation; said stabilizer comprising a combination of a sugar and a polyol. Various technical terms used in the following discussion are defined below in the section entitled 'Definitions' and throughout the remainder of the specification. The stabilized etanercept formulations of the present invention which ar optionally and preferably free of arginine elicit long term storage stability.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161548518P | 2011-10-18 | 2011-10-18 | |
US201261669480P | 2012-07-09 | 2012-07-09 | |
PCT/US2012/060748 WO2013059412A1 (en) | 2011-10-18 | 2012-10-18 | Etanercept formulations stabilized with combinations of sugars and polyols |
Publications (1)
Publication Number | Publication Date |
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IN2014CN02591A true IN2014CN02591A (en) | 2015-06-26 |
Family
ID=48136153
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
IN2592CHN2014 IN2014CN02592A (en) | 2011-10-18 | 2012-10-18 | |
IN2591CHN2014 IN2014CN02591A (en) | 2011-10-18 | 2012-10-18 | |
IN2527CHN2014 IN2014CN02527A (en) | 2011-10-18 | 2012-10-18 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
IN2592CHN2014 IN2014CN02592A (en) | 2011-10-18 | 2012-10-18 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
IN2527CHN2014 IN2014CN02527A (en) | 2011-10-18 | 2012-10-18 |
Country Status (27)
Country | Link |
---|---|
US (21) | US9302002B2 (en) |
EP (6) | EP2768854A4 (en) |
JP (6) | JP6220789B2 (en) |
KR (7) | KR20140091705A (en) |
CN (6) | CN104010654B (en) |
AR (6) | AR088383A1 (en) |
AU (6) | AU2012326170B2 (en) |
BR (6) | BR112014009022A2 (en) |
CA (6) | CA2851639C (en) |
CY (1) | CY1121843T1 (en) |
DK (1) | DK2768525T3 (en) |
EA (6) | EA027325B1 (en) |
ES (1) | ES2734070T3 (en) |
HK (6) | HK1200719A1 (en) |
HR (1) | HRP20191215T1 (en) |
HU (1) | HUE045624T2 (en) |
IL (6) | IL231827A0 (en) |
IN (3) | IN2014CN02592A (en) |
LT (1) | LT2768525T (en) |
MX (7) | MX367054B (en) |
PL (1) | PL2768525T3 (en) |
PT (1) | PT2768525T (en) |
RS (1) | RS59179B1 (en) |
SG (6) | SG11201401576WA (en) |
SI (1) | SI2768525T1 (en) |
TW (6) | TWI595883B (en) |
WO (6) | WO2013059410A1 (en) |
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ES2776657T3 (en) | 2005-06-14 | 2020-07-31 | Amgen Inc | Self-buffering protein formulations |
US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
JP6220789B2 (en) * | 2011-10-18 | 2017-10-25 | コヒラス・バイオサイエンシズ・インコーポレイテッド | Etanercept formulation stabilized by a combination of sugar and polyol |
BR112015000203A2 (en) * | 2012-07-09 | 2017-06-27 | Coherus Biosciences Inc | etanercept formulations exhibiting marked reduction in sub-visible particles |
CN104902914B (en) * | 2012-09-11 | 2019-01-01 | 科荣生生物科学公司 | The Etanercept of high-purity and excellent yield correctly folded |
RU2663727C2 (en) * | 2013-05-02 | 2018-08-08 | Мабксьенсе С.А. | Alternative compositions for tnfr:fc chimerical polypeptides |
WO2015056613A1 (en) * | 2013-10-15 | 2015-04-23 | Meiji Seikaファルマ株式会社 | Stabilized polypeptide aqueous preparation |
MX2016004605A (en) * | 2013-10-24 | 2016-11-14 | Astrazeneca Ab | Stable, aqueous antibody formulations. |
US9700595B2 (en) | 2013-11-29 | 2017-07-11 | Ares Trading Sa | Liquid formulation of a fusion protein comprising TNFR and Fc region |
IS3008B (en) | 2014-05-14 | 2018-12-15 | Calor ehf | A peptide or protein stabilizing formulation |
US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
US20180200325A1 (en) * | 2014-11-18 | 2018-07-19 | Shionogi & Co., Ltd. | Stabilized peptide composition |
CA2970577A1 (en) * | 2014-12-22 | 2016-06-30 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP3236942A1 (en) * | 2014-12-23 | 2017-11-01 | Drug Discovery Laboratory AS | Protein compositions and use thereof |
IL253218B (en) | 2014-12-31 | 2022-08-01 | Lg Chemical Ltd | Method for preparing tnfr-fc fusion protein containing target content of impurities |
CN104694355B (en) * | 2015-03-20 | 2016-09-28 | 吉林大学 | Radix Puerariae liver-protection health-care wine and preparation method thereof |
MX2015010517A (en) * | 2015-08-13 | 2017-02-13 | Landsteiner Scient S A De C V | Etanercept composition having improved stability. |
JP5938762B1 (en) * | 2015-09-01 | 2016-06-22 | 日揮株式会社 | Microcapsule preparation and production method thereof |
CN105748414A (en) * | 2016-03-02 | 2016-07-13 | 张光泉 | Anti-infection micafungin freeze-drying composition and preparation method thereof |
JPWO2017179683A1 (en) * | 2016-04-15 | 2019-02-21 | Meiji Seikaファルマ株式会社 | Stabilized pharmaceutical composition of Micafungin |
MX2019004580A (en) * | 2016-10-21 | 2019-08-12 | Amgen Inc | Pharmaceutical formulations and methods of making the same. |
WO2018080196A2 (en) | 2016-10-28 | 2018-05-03 | (주)셀트리온 | Stable pharmaceutical formulation |
MX2017013995A (en) * | 2017-10-31 | 2019-05-01 | Probiomed S A De C V | Stable pharmaceutical formulation of a fusion protein. |
CN111110842B (en) * | 2017-11-30 | 2020-12-11 | 百奥泰生物制药股份有限公司 | Liquid preparation of humanized antibody for treating IL-6 related diseases |
KR102494021B1 (en) * | 2017-12-22 | 2023-02-06 | 삼성바이오에피스 주식회사 | Liquid composition containing VEGF antagonist |
CA3042126A1 (en) | 2018-05-03 | 2019-11-03 | Michael A. Portman | Methods of treating kawasaki disease |
CN111228225B (en) * | 2018-11-28 | 2022-08-26 | 鲁南制药集团股份有限公司 | Recombinant human tumor necrosis factor receptor-Fc fusion protein freeze-dried preparation |
GB201911461D0 (en) | 2019-08-09 | 2019-09-25 | Arecor Ltd | Novel composition |
KR20220122993A (en) * | 2019-11-26 | 2022-09-05 | 코메라 라이프 사이언시스, 인코포레이티드 | Excipient compounds for biopolymer formulations |
IL305010A (en) | 2021-02-17 | 2023-10-01 | Arecor Ltd | Aqueous composition of an engineered protein construct comprising an fc domain |
CN114788809B (en) * | 2022-01-25 | 2023-04-14 | 江苏广承药业有限公司 | Loratadine liquid preparation |
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