KR20190078572A - 액상의 약학 조성물 - Google Patents
액상의 약학 조성물 Download PDFInfo
- Publication number
- KR20190078572A KR20190078572A KR1020197011677A KR20197011677A KR20190078572A KR 20190078572 A KR20190078572 A KR 20190078572A KR 1020197011677 A KR1020197011677 A KR 1020197011677A KR 20197011677 A KR20197011677 A KR 20197011677A KR 20190078572 A KR20190078572 A KR 20190078572A
- Authority
- KR
- South Korea
- Prior art keywords
- pharmaceutical composition
- liquid pharmaceutical
- weeks
- concentration
- lactic acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- 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
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/16—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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
-
- 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
- A61K9/08—Solutions
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16196625 | 2016-10-31 | ||
| EP16196625.4 | 2016-10-31 | ||
| PCT/EP2017/077793 WO2018078162A1 (en) | 2016-10-31 | 2017-10-30 | Liquid pharmaceutical composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| KR20190078572A true KR20190078572A (ko) | 2019-07-04 |
Family
ID=57218780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020197011677A Ceased KR20190078572A (ko) | 2016-10-31 | 2017-10-30 | 액상의 약학 조성물 |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US11291725B2 (https=) |
| EP (2) | EP3532029B1 (https=) |
| JP (2) | JP2019536761A (https=) |
| KR (1) | KR20190078572A (https=) |
| CN (1) | CN110062620B (https=) |
| AU (1) | AU2017351805A1 (https=) |
| BR (1) | BR112019006853B1 (https=) |
| CA (1) | CA3040342A1 (https=) |
| DK (1) | DK3532029T3 (https=) |
| ES (1) | ES2882181T3 (https=) |
| HU (1) | HUE054858T2 (https=) |
| MY (1) | MY192532A (https=) |
| RU (1) | RU2019116756A (https=) |
| SG (1) | SG11201902531QA (https=) |
| WO (1) | WO2018078162A1 (https=) |
| ZA (1) | ZA201901736B (https=) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022045857A3 (ko) * | 2020-08-31 | 2022-04-21 | (주)셀트리온 | 안정한 약제학적 제제 |
| KR102554775B1 (ko) | 2023-02-07 | 2023-07-12 | 한국코러스 주식회사 | 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형 |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| KR20190078572A (ko) * | 2016-10-31 | 2019-07-04 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| MA54095A (fr) * | 2018-10-31 | 2022-02-09 | Richter Gedeon Nyrt | Formulations pharmaceutiques aqueuses |
| CA3164227A1 (en) * | 2019-12-10 | 2021-06-17 | Mitotech S.A. | Polymer matrixes for different compositions of mitochondrially targeted antioxidants |
| IL296276A (en) * | 2020-03-10 | 2022-11-01 | Tiziana Life Sciences Plc | Compositions of il-6/il-6r antibodies and methods of use thereof |
| EP3714902B1 (en) * | 2020-03-13 | 2024-08-28 | LEK Pharmaceuticals d.d. | Stabilization of pharmaceutical compositions comprising polysorbate |
| WO2022006051A1 (en) * | 2020-06-29 | 2022-01-06 | Anovent Pharmaceutical (U.S.), Llc | Formulation of tocilizumab and method for treating covid-19 by inhalation |
| WO2022234594A1 (en) * | 2021-05-07 | 2022-11-10 | Dr. Reddy’S Laboratories Limited | A method of improving stability of an antibody formulation |
| US20230090654A1 (en) * | 2021-08-24 | 2023-03-23 | Homology Medicines, Inc. | Adeno-associated virus formulations |
| EP4590335A1 (en) * | 2022-08-26 | 2025-07-30 | ASLAN Pharmaceuticals Pte Ltd | High concentration anti-il13r antibody formulation |
| WO2024257040A1 (en) * | 2023-06-14 | 2024-12-19 | Enzene Biosciences Limited | Composition and stable liquid formulations comprising humanized anti-human interleukin 6 (il-6) receptor monoclonal antibodies |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5795965A (en) | 1991-04-25 | 1998-08-18 | Chugai Seiyaku Kabushiki Kaisha | Reshaped human to human interleukin-6 receptor |
| JP5485489B2 (ja) | 2000-08-11 | 2014-05-07 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| CN101721362B (zh) | 2002-02-14 | 2018-07-03 | 中外制药株式会社 | 包含抗体的溶液制剂 |
| GB0700523D0 (en) * | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| JP2009034095A (ja) * | 2007-07-06 | 2009-02-19 | Sanyo Chem Ind Ltd | タンパク質含有水溶液安定化剤、タンパク質含有水溶液の安定化方法及びタンパク質含有水溶液 |
| MX2010002348A (es) * | 2007-08-27 | 2010-07-30 | Biogenerix Ag | Formulacion liquida de g-csf. |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| KR20190120439A (ko) * | 2010-11-08 | 2019-10-23 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| CN108771655A (zh) | 2011-10-28 | 2018-11-09 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
| EA201590061A1 (ru) * | 2012-06-21 | 2015-05-29 | Юсб Фарма С.А. | Фармацевтическая композиция |
| CN102961745B (zh) * | 2012-09-27 | 2015-02-18 | 苏州康聚生物科技有限公司 | 抗体组合物制剂及其应用 |
| KR20190078572A (ko) * | 2016-10-31 | 2019-07-04 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
-
2017
- 2017-10-30 KR KR1020197011677A patent/KR20190078572A/ko not_active Ceased
- 2017-10-30 EP EP17797579.4A patent/EP3532029B1/en active Active
- 2017-10-30 CN CN201780067178.XA patent/CN110062620B/zh active Active
- 2017-10-30 AU AU2017351805A patent/AU2017351805A1/en not_active Abandoned
- 2017-10-30 EP EP21164822.5A patent/EP3964197A1/en active Pending
- 2017-10-30 BR BR112019006853-8A patent/BR112019006853B1/pt active IP Right Grant
- 2017-10-30 SG SG11201902531QA patent/SG11201902531QA/en unknown
- 2017-10-30 DK DK17797579.4T patent/DK3532029T3/da active
- 2017-10-30 MY MYPI2019001479A patent/MY192532A/en unknown
- 2017-10-30 WO PCT/EP2017/077793 patent/WO2018078162A1/en not_active Ceased
- 2017-10-30 HU HUE17797579A patent/HUE054858T2/hu unknown
- 2017-10-30 US US16/346,215 patent/US11291725B2/en active Active
- 2017-10-30 CA CA3040342A patent/CA3040342A1/en active Pending
- 2017-10-30 ES ES17797579T patent/ES2882181T3/es active Active
- 2017-10-30 JP JP2019522329A patent/JP2019536761A/ja active Pending
- 2017-10-30 RU RU2019116756A patent/RU2019116756A/ru unknown
-
2019
- 2019-03-20 ZA ZA201901736A patent/ZA201901736B/en unknown
-
2022
- 2022-02-24 US US17/680,155 patent/US20220175924A1/en active Pending
- 2022-07-22 JP JP2022117520A patent/JP7473603B2/ja active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022045857A3 (ko) * | 2020-08-31 | 2022-04-21 | (주)셀트리온 | 안정한 약제학적 제제 |
| KR102554775B1 (ko) | 2023-02-07 | 2023-07-12 | 한국코러스 주식회사 | 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형 |
Also Published As
| Publication number | Publication date |
|---|---|
| US20190262450A1 (en) | 2019-08-29 |
| RU2019116756A (ru) | 2020-11-30 |
| JP2022166006A (ja) | 2022-11-01 |
| JP7473603B2 (ja) | 2024-04-23 |
| MY192532A (en) | 2022-08-26 |
| HUE054858T2 (hu) | 2021-10-28 |
| SG11201902531QA (en) | 2019-05-30 |
| RU2019116756A3 (https=) | 2021-02-26 |
| WO2018078162A1 (en) | 2018-05-03 |
| CA3040342A1 (en) | 2018-05-03 |
| BR112019006853B1 (pt) | 2021-08-24 |
| ZA201901736B (en) | 2020-11-25 |
| AU2017351805A1 (en) | 2019-04-11 |
| CN110062620A (zh) | 2019-07-26 |
| EP3532029A1 (en) | 2019-09-04 |
| EP3964197A1 (en) | 2022-03-09 |
| US11291725B2 (en) | 2022-04-05 |
| JP2019536761A (ja) | 2019-12-19 |
| CN110062620B (zh) | 2023-12-05 |
| ES2882181T3 (es) | 2021-12-01 |
| DK3532029T3 (da) | 2021-06-07 |
| BR112019006853A2 (pt) | 2019-06-25 |
| US20220175924A1 (en) | 2022-06-09 |
| EP3532029B1 (en) | 2021-04-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0105 | International application |
Patent event date: 20190423 Patent event code: PA01051R01D Comment text: International Patent Application |
|
| PG1501 | Laying open of application | ||
| A201 | Request for examination | ||
| PA0201 | Request for examination |
Patent event code: PA02012R01D Patent event date: 20200908 Comment text: Request for Examination of Application |
|
| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
Comment text: Notification of reason for refusal Patent event date: 20220927 Patent event code: PE09021S01D |
|
| E601 | Decision to refuse application | ||
| PE0601 | Decision on rejection of patent |
Patent event date: 20230404 Comment text: Decision to Refuse Application Patent event code: PE06012S01D Patent event date: 20220927 Comment text: Notification of reason for refusal Patent event code: PE06011S01I |