BR112021021359A2 - Injeção de secukinumabe estável, método de preparação e uso da mesma - Google Patents
Injeção de secukinumabe estável, método de preparação e uso da mesmaInfo
- Publication number
- BR112021021359A2 BR112021021359A2 BR112021021359A BR112021021359A BR112021021359A2 BR 112021021359 A2 BR112021021359 A2 BR 112021021359A2 BR 112021021359 A BR112021021359 A BR 112021021359A BR 112021021359 A BR112021021359 A BR 112021021359A BR 112021021359 A2 BR112021021359 A2 BR 112021021359A2
- Authority
- BR
- Brazil
- Prior art keywords
- stable
- mmol
- secukinumab
- injection
- preparation
- Prior art date
Links
- 229960004540 secukinumab Drugs 0.000 title abstract 6
- 238000002347 injection Methods 0.000 title abstract 5
- 239000007924 injection Substances 0.000 title abstract 5
- 238000002360 preparation method Methods 0.000 title abstract 3
- 238000000034 method Methods 0.000 abstract 2
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 abstract 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 229930182817 methionine Natural products 0.000 abstract 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
- 229920000053 polysorbate 80 Polymers 0.000 abstract 1
- 229940068968 polysorbate 80 Drugs 0.000 abstract 1
- 238000013112 stability test Methods 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical group O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 239000008215 water for injection Substances 0.000 abstract 1
Classifications
-
- 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
- C07K16/244—Interleukins [IL]
-
- 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
- A61K39/39533—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
- 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
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
injeção de secukinumabe estável, método de preparação e uso da mesma. a presente invenção se refere a uma injeção de secukinumabe estável e a um método de preparação para tal. a injeção de secukinumabe estável é composta dos seguintes ingredientes: 50 mg/ml - 300 mg/ml de secukinumabe, 5 mmol/l - 50 mmol/l de histidina e um hidrocloreto de histidina, 5 mmol/l - 50 mmol/l de metionina, 150 mmol/l - 400 mmol/l de um álcool de açúcar de baixo peso molecular, e 0,01% a 0,02% de polissorbato 80, em que o restante é água para injeção, e o ph é 5,0 a 7,0. testes de estabilidade provam que a qualidade da injeção de secukinumabe estável é estável, em que a estabilidade da mesma é superior àquela de variedades comerciais no mercado, e a mesma tem vários indicadores que satisfazem as regulamentações relevantes da farmacopeia chinesa, e tem bons prospectos de aplicação.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910412754.0A CN110179746A (zh) | 2019-05-17 | 2019-05-17 | 一种稳定的苏金单抗注射剂及其制备方法 |
| PCT/CN2020/090776 WO2020233540A1 (zh) | 2019-05-17 | 2020-05-18 | 一种稳定的苏金单抗注射剂及其制备方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112021021359A2 true BR112021021359A2 (pt) | 2021-12-14 |
Family
ID=67716762
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112021021359A BR112021021359A2 (pt) | 2019-05-17 | 2020-05-18 | Injeção de secukinumabe estável, método de preparação e uso da mesma |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20220177563A1 (pt) |
| EP (1) | EP3970744A4 (pt) |
| JP (1) | JP7196333B2 (pt) |
| CN (2) | CN110179746A (pt) |
| BR (1) | BR112021021359A2 (pt) |
| MX (1) | MX2021012672A (pt) |
| WO (1) | WO2020233540A1 (pt) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3129901A1 (en) | 2019-02-18 | 2020-08-27 | Eli Lilly And Company | Therapeutic antibody formulation |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
| CN110124030A (zh) * | 2019-06-10 | 2019-08-16 | 通化东宝生物科技有限公司 | 一种苏金单抗注射液及其制备方法 |
| EP4251197A1 (en) * | 2020-11-25 | 2023-10-04 | Dr. Reddy's Laboratories Ltd. | Stable therapeutic protein formulation and methods of making the same |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000186046A (ja) * | 1998-10-14 | 2000-07-04 | Snow Brand Milk Prod Co Ltd | 慢性関節リウマチ治療剤及び診断方法 |
| GB0417487D0 (en) * | 2004-08-05 | 2004-09-08 | Novartis Ag | Organic compound |
| US9345661B2 (en) * | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
| CA2813849C (en) * | 2010-11-05 | 2021-06-15 | Novartis Ag | Secukinumab for use in the treatment of ankylosing spondylitis |
| CN104666242B (zh) * | 2013-11-26 | 2018-01-02 | 信达生物制药(苏州)有限公司 | 一种稳定的抗TNF‑α抗体制剂及其用途 |
| KR20170018810A (ko) | 2014-06-10 | 2017-02-20 | 메이지 세이카 파루마 가부시키가이샤 | 안정한 아달리무맙 수성 제제 |
| CN105727285B (zh) * | 2014-12-10 | 2018-06-19 | 信达生物制药(苏州)有限公司 | 一种单克隆抗体在治疗神经退行性疾病中的应用 |
| CN104922668B (zh) * | 2014-12-10 | 2019-08-23 | 信达生物制药(苏州)有限公司 | 一种稳定的抗vegf抗体制剂及其用途 |
| AR103173A1 (es) * | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| FI3769781T3 (fi) | 2015-08-19 | 2023-06-07 | Astrazeneca Ab | Stabiili anti-ifnar1-formulaatio |
| GB201612043D0 (en) * | 2016-07-11 | 2016-08-24 | Crescendo Biologics Ltd | Composition for treatment of disorders |
| CN109862880A (zh) * | 2016-09-27 | 2019-06-07 | 德国费森尤斯卡比有限公司 | 液体药物组合物 |
| JP2021008406A (ja) | 2017-09-29 | 2021-01-28 | アステラス製薬株式会社 | 改良型ヒト化抗ヒトα９インテグリン抗体含有医薬組成物 |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
-
2019
- 2019-05-17 CN CN201910412754.0A patent/CN110179746A/zh active Pending
-
2020
- 2020-05-18 JP JP2021556363A patent/JP7196333B2/ja active Active
- 2020-05-18 US US17/441,366 patent/US20220177563A1/en active Pending
- 2020-05-18 BR BR112021021359A patent/BR112021021359A2/pt unknown
- 2020-05-18 WO PCT/CN2020/090776 patent/WO2020233540A1/zh active Application Filing
- 2020-05-18 CN CN202080036881.6A patent/CN113840622B/zh active Active
- 2020-05-18 MX MX2021012672A patent/MX2021012672A/es unknown
- 2020-05-18 EP EP20809851.7A patent/EP3970744A4/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3970744A1 (en) | 2022-03-23 |
| CN113840622B (zh) | 2023-12-01 |
| JP2022526490A (ja) | 2022-05-25 |
| CN110179746A (zh) | 2019-08-30 |
| CN113840622A (zh) | 2021-12-24 |
| US20220177563A1 (en) | 2022-06-09 |
| MX2021012672A (es) | 2021-11-12 |
| WO2020233540A1 (zh) | 2020-11-26 |
| JP7196333B2 (ja) | 2022-12-26 |
| EP3970744A4 (en) | 2023-03-08 |
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