BRPI0814252A8 - composição farmacêutica aquosa compreendendo natalizumab - Google Patents
composição farmacêutica aquosa compreendendo natalizumabInfo
- Publication number
- BRPI0814252A8 BRPI0814252A8 BRPI0814252A BRPI0814252A BRPI0814252A8 BR PI0814252 A8 BRPI0814252 A8 BR PI0814252A8 BR PI0814252 A BRPI0814252 A BR PI0814252A BR PI0814252 A BRPI0814252 A BR PI0814252A BR PI0814252 A8 BRPI0814252 A8 BR PI0814252A8
- Authority
- BR
- Brazil
- Prior art keywords
- natalizumab
- pharmaceutical composition
- aqueous pharmaceutical
- vla
- relates
- Prior art date
Links
Classifications
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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
-
- 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
- A61K47/16—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
- A61K9/0012—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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- 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
-
- 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
-
- 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
-
- 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
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- A61P37/02—Immunomodulators
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- 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
- C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
-
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Mycology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Neurology (AREA)
- Pulmonology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Obesity (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
Abstract
composição farmacêutica aquosa compreendendo natalizumab a presente invenção refere-se às formulações do anticorpo de ligação vla-4.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US94407607P | 2007-06-14 | 2007-06-14 | |
| PCT/US2008/066928 WO2008157356A2 (en) | 2007-06-14 | 2008-06-13 | Antibody formulations |
Publications (4)
| Publication Number | Publication Date |
|---|---|
| BRPI0814252A2 BRPI0814252A2 (pt) | 2015-04-14 |
| BRPI0814252A8 true BRPI0814252A8 (pt) | 2019-01-29 |
| BRPI0814252B1 BRPI0814252B1 (pt) | 2019-12-10 |
| BRPI0814252B8 BRPI0814252B8 (pt) | 2021-05-25 |
Family
ID=39956053
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0814252A BRPI0814252B8 (pt) | 2007-06-14 | 2008-06-13 | composição farmacêutica aquosa estável compreendendo natalizumabe, dose unitária, e seringa pré-cheia |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US20080311119A1 (pt) |
| EP (2) | EP2170390B1 (pt) |
| JP (2) | JP2010529999A (pt) |
| CN (2) | CN103977404A (pt) |
| AR (2) | AR067011A1 (pt) |
| AU (1) | AU2008266051B2 (pt) |
| BR (1) | BRPI0814252B8 (pt) |
| CA (1) | CA2690382A1 (pt) |
| CY (1) | CY1121208T1 (pt) |
| DK (1) | DK2170390T3 (pt) |
| EA (1) | EA020456B1 (pt) |
| ES (1) | ES2707815T3 (pt) |
| HR (1) | HRP20182146T1 (pt) |
| HU (1) | HUE041555T2 (pt) |
| IL (1) | IL202648B (pt) |
| LT (1) | LT2170390T (pt) |
| MX (2) | MX2009013593A (pt) |
| NZ (2) | NZ595526A (pt) |
| PL (1) | PL2170390T3 (pt) |
| PT (1) | PT2170390T (pt) |
| SI (1) | SI2170390T1 (pt) |
| TR (1) | TR201820837T4 (pt) |
| TW (1) | TWI614028B (pt) |
| WO (1) | WO2008157356A2 (pt) |
Families Citing this family (43)
| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2358763C2 (ru) | 2003-02-10 | 2009-06-20 | Элан Фармасьютикалз, Инк. | Композиции иммуноглобулина и способ их получения |
| CA2765220A1 (en) * | 2009-07-14 | 2011-01-20 | Biogen Idec Ma Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| BR112012021576A2 (pt) | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| SMT202000306T1 (it) | 2010-04-16 | 2020-07-08 | Biogen Ma Inc | Anticorpi anti-vla-4 |
| RU2012153786A (ru) | 2010-05-28 | 2014-07-10 | Ново Нордиск А/С | Стабильные многодозовые композиции, содержащие антитело и консервант |
| WO2013006461A1 (en) * | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Cholesterol-based media supplementals for cell culture |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| HK1200718A1 (en) * | 2011-10-18 | 2015-08-14 | 科荣生生物科学公司 | Etanercept formulations stabilized with sodium chloride |
| CA2864539C (en) * | 2012-02-16 | 2022-06-07 | Santarus, Inc. | Antibody formulations |
| PE20150190A1 (es) * | 2012-06-21 | 2015-02-13 | Ucb Pharma Sa | Formulacion farmaceutica |
| IN2015KN00005A (pt) | 2012-07-09 | 2015-07-31 | Coherus Biosciences Inc | |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| EA031324B1 (ru) | 2012-09-11 | 2018-12-28 | Кохерус Байосайенсис, Инк. | Правильно свернутый этанерцепт с высокой чистотой и высоким уровнем выхода |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| CN103217525B (zh) * | 2013-03-21 | 2015-04-29 | 上海执诚生物科技股份有限公司 | 一种含有提高胱抑素c胶乳包被抗体的稳定性的组合物、稳定剂及其制备方法和用途 |
| EP3062814A1 (en) * | 2013-10-29 | 2016-09-07 | Albumedix A/S | Antibody composition |
| JP7156777B2 (ja) * | 2013-11-29 | 2022-10-19 | ジェネンテック, インコーポレイテッド | 抗体選択装置及び方法 |
| US10059761B2 (en) | 2014-03-12 | 2018-08-28 | Prothena Biosciences Limited | Anti-Laminin4 antibodies specific for LG4-5 |
| US20170002077A1 (en) * | 2014-03-13 | 2017-01-05 | Prothena Biosciences Limited | Combination treatment for multiple sclerosis |
| AU2015270152A1 (en) * | 2014-06-02 | 2016-12-08 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Production of Fc fragments |
| KR20170065662A (ko) * | 2014-10-18 | 2017-06-13 | 화이자 인코포레이티드 | 항-il-7r 항체 조성물 |
| JP2019517473A (ja) | 2016-05-27 | 2019-06-24 | アレクシオン ファーマシューティカルズ インコーポレイテッドAlexion Pharmaceuticals, Inc. | 難治性全身型重症筋無力症の処置のための方法 |
| GB201612317D0 (en) | 2016-07-15 | 2016-08-31 | Philogen Spa | Antibody compositions |
| GB201703062D0 (en) * | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| 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 |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| AU2018263868A1 (en) | 2017-05-02 | 2019-12-12 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
| CA3080187A1 (en) | 2017-10-26 | 2019-05-02 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) |
| AU2019251453A1 (en) * | 2018-04-10 | 2020-11-26 | Dr. Reddy’S Laboratories Limited | Stable formulations of therapeutic antibody |
| US12037398B2 (en) | 2018-06-04 | 2024-07-16 | Biogen Ma Inc. | Anti-VLA-4 antibodies having reduced effector function |
| WO2020006266A1 (en) | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| KR102885113B1 (ko) | 2018-10-18 | 2025-11-13 | 머크 샤프 앤드 돔 엘엘씨 | 항-rsv 항체의 제제 및 그의 사용 방법 |
| CN120842406A (zh) | 2018-10-31 | 2025-10-28 | 默沙东有限责任公司 | 抗人pd-1抗体晶体及其使用方法 |
| CN113316458B (zh) | 2018-11-07 | 2024-08-02 | 默沙东有限责任公司 | 抗lag3抗体和抗pd-1抗体的共制剂 |
| KR20220034169A (ko) * | 2019-07-10 | 2022-03-17 | 리제너론 파아마슈티컬스, 인크. | 감소된 수준의 숙주 세포 단백질을 포함하는 방법 및 조성물 |
| AU2020337093B2 (en) * | 2019-08-30 | 2025-02-27 | Kashiv Biosciences, Llc | Novel formulation of highly concentrated pharmacologically active antibody |
| CN113134081A (zh) * | 2020-01-20 | 2021-07-20 | 上海君实生物医药科技股份有限公司 | 抗btla抗体药物组合物及其用途 |
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| EP2053961A4 (en) | 2006-08-09 | 2013-05-01 | Biogen Idec Inc | METHOD FOR DISPENSING A MEDICAMENT |
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