BRPI0814252B8 - composição farmacêutica aquosa estável compreendendo natalizumabe, dose unitária, e seringa pré-cheia - Google Patents
composição farmacêutica aquosa estável compreendendo natalizumabe, dose unitária, e seringa pré-cheiaInfo
- Publication number
- BRPI0814252B8 BRPI0814252B8 BRPI0814252A BRPI0814252A BRPI0814252B8 BR PI0814252 B8 BRPI0814252 B8 BR PI0814252B8 BR PI0814252 A BRPI0814252 A BR PI0814252A BR PI0814252 A BRPI0814252 A BR PI0814252A BR PI0814252 B8 BRPI0814252 B8 BR PI0814252B8
- Authority
- BR
- Brazil
- Prior art keywords
- natalizumab
- pharmaceutical composition
- unit dose
- filled syringe
- aqueous pharmaceutical
- Prior art date
Links
- 229960005027 natalizumab Drugs 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 229940071643 prefilled syringe Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—Immunoglobulins [IGs], 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)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pulmonology (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Obesity (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
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 BRPI0814252A8 (pt) | 2019-01-29 |
| BRPI0814252B1 BRPI0814252B1 (pt) | 2019-12-10 |
| BRPI0814252B8 true 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 (enExample) |
| EP (2) | EP3461500A1 (enExample) |
| JP (2) | JP2010529999A (enExample) |
| CN (2) | CN103977404A (enExample) |
| AR (2) | AR067011A1 (enExample) |
| AU (1) | AU2008266051B2 (enExample) |
| BR (1) | BRPI0814252B8 (enExample) |
| CA (1) | CA2690382A1 (enExample) |
| CY (1) | CY1121208T1 (enExample) |
| DK (1) | DK2170390T3 (enExample) |
| EA (1) | EA020456B1 (enExample) |
| ES (1) | ES2707815T3 (enExample) |
| HR (1) | HRP20182146T1 (enExample) |
| HU (1) | HUE041555T2 (enExample) |
| IL (1) | IL202648B (enExample) |
| LT (1) | LT2170390T (enExample) |
| MX (2) | MX2009013593A (enExample) |
| NZ (2) | NZ582436A (enExample) |
| PL (1) | PL2170390T3 (enExample) |
| PT (1) | PT2170390T (enExample) |
| SI (1) | SI2170390T1 (enExample) |
| TR (1) | TR201820837T4 (enExample) |
| TW (1) | TWI614028B (enExample) |
| WO (1) | WO2008157356A2 (enExample) |
Families Citing this family (41)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004071439A2 (en) | 2003-02-10 | 2004-08-26 | Elan Pharmaceuticals, Inc. | Immunoglobulin formulation and method of preparation thereof |
| WO2011008770A2 (en) * | 2009-07-14 | 2011-01-20 | Biogen Idec Ma Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| SI3409289T1 (sl) | 2010-02-26 | 2020-12-31 | Novo Nordisk A/S | Stabilni sestavki, ki vsebujejo protitelo |
| PL2542257T3 (pl) | 2010-03-01 | 2018-01-31 | Bayer Healthcare Llc | Zoptymalizowane przeciwciała monoklonalne przeciwko inhibitorowi szlaku czynnika tkankowego (TFPI) |
| EA201291065A1 (ru) | 2010-04-16 | 2013-03-29 | Байоджен Айдек Ма Инк. | Антитела против vla-4 |
| AU2011257219B2 (en) | 2010-05-28 | 2014-12-04 | Novo Nordisk A/S | Stable multi-dose compositions comprising an antibody and a preservative |
| WO2013006461A1 (en) * | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Cholesterol-based media supplementals for cell culture |
| EA026410B1 (ru) * | 2011-10-18 | 2017-04-28 | Кохерус Байосайенсис, Инк. | Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| NZ629204A (en) * | 2012-02-16 | 2016-09-30 | Santarus Inc | Anti-vla1 (cd49a) antibody pharmaceutical compositions |
| CN104520326A (zh) * | 2012-06-21 | 2015-04-15 | Ucb医药有限公司 | 药物制剂 |
| BR112015000203A2 (pt) | 2012-07-09 | 2017-06-27 | Coherus Biosciences Inc | formulações de etanercept que exibem redução marcada em partículas sub-visíveis |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| WO2014043103A1 (en) | 2012-09-11 | 2014-03-20 | Coherus Biosciences, Inc. | Correctly folded etanercept in high purity and excellent yield |
| 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 |
| US20160250329A1 (en) * | 2013-10-29 | 2016-09-01 | Albumedix A/S | Antibody composition |
| CA2924448C (en) * | 2013-11-29 | 2021-12-14 | Genentech, Inc. | Antibody selection apparatus and methods |
| 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 |
| CN106573973A (zh) * | 2014-06-02 | 2017-04-19 | 法国化学与生物科技实验室 | Fc片段的产生 |
| MX2017004975A (es) * | 2014-10-18 | 2017-06-30 | Pfizer | Composiciones de anticuerpos anti-il-7r. |
| EP3463461A4 (en) | 2016-05-27 | 2020-05-20 | Alexion Pharmaceuticals, Inc. | Methods for treatment of refractory generalized myasthenia gravis |
| 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 |
| WO2018204374A1 (en) | 2017-05-02 | 2018-11-08 | Merck Sharp & Dohme Corp. | Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies |
| KR20200070355A (ko) | 2017-10-26 | 2020-06-17 | 알렉시온 파마슈티칼스, 인코포레이티드 | 발작성 야간 혈색소뇨 (pnh) 및 비정형 용혈성 요독 증후군 (ahus)의 치료를 위한 항-c5 항체의 투여량 및 투여 |
| US12433947B2 (en) * | 2018-04-10 | 2025-10-07 | Dr. Reddy's Laboratories Limited | Stable formulations of therapeutic antibody |
| WO2019236417A1 (en) | 2018-06-04 | 2019-12-12 | Biogen Ma Inc. | Anti-vla-4 antibodies having reduced effector function |
| US12312394B2 (en) | 2018-06-28 | 2025-05-27 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-C5 antibodies |
| BR112021008873A8 (pt) | 2018-11-07 | 2023-04-11 | Merck Sharp & Dohme | Formulação |
| 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 |
| EP4238578A4 (en) * | 2020-10-30 | 2024-09-11 | Eisai R&D Management Co., Ltd. | PHARMACEUTICAL COMPOSITION |
| EP4243932A1 (en) | 2020-11-14 | 2023-09-20 | Biogen MA Inc. | Biphasic subcutaneous dosing regimens for anti-vla-4 antibodies |
| WO2022221458A1 (en) | 2021-04-13 | 2022-10-20 | Biogen Ma Inc | Compositions and methods for treating chronic active white matter lesions / radiologically isolated syndrome |
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-
2008
- 2008-06-13 HU HUE08771026A patent/HUE041555T2/hu unknown
- 2008-06-13 WO PCT/US2008/066928 patent/WO2008157356A2/en not_active Ceased
- 2008-06-13 NZ NZ582436A patent/NZ582436A/en unknown
- 2008-06-13 TR TR2018/20837T patent/TR201820837T4/tr unknown
- 2008-06-13 CN CN201410163087.4A patent/CN103977404A/zh active Pending
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