BRPI0821474A2 - formulação farmacêutica líquida estável - Google Patents
formulação farmacêutica líquida estávelInfo
- Publication number
- BRPI0821474A2 BRPI0821474A2 BRPI0821474A BRPI0821474A BRPI0821474A2 BR PI0821474 A2 BRPI0821474 A2 BR PI0821474A2 BR PI0821474 A BRPI0821474 A BR PI0821474A BR PI0821474 A BRPI0821474 A BR PI0821474A BR PI0821474 A2 BRPI0821474 A2 BR PI0821474A2
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical formulation
- liquid pharmaceutical
- stable liquid
- stable
- formulation
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
Classifications
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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
-
- 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
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- 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
- 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
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
-
- 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
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (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)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Marine Sciences & Fisheries (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US1741807P | 2007-12-28 | 2007-12-28 | |
| US61/017,418 | 2007-12-28 | ||
| US1788107P | 2007-12-31 | 2007-12-31 | |
| US61/017,881 | 2007-12-31 | ||
| PCT/US2008/088201 WO2009086400A2 (en) | 2007-12-28 | 2008-12-23 | Recombinant vwf formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0821474A2 true BRPI0821474A2 (pt) | 2017-05-09 |
| BRPI0821474B1 BRPI0821474B1 (pt) | 2021-03-30 |
| BRPI0821474B8 BRPI0821474B8 (pt) | 2021-05-25 |
Family
ID=40591819
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0821474A BRPI0821474B8 (pt) | 2007-12-28 | 2008-12-23 | formulação farmacêutica líquida estável |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20090192076A1 (pt) |
| EP (2) | EP2244814B1 (pt) |
| JP (3) | JP5784907B2 (pt) |
| KR (2) | KR20160091434A (pt) |
| CN (2) | CN105816858B (pt) |
| AR (1) | AR069989A1 (pt) |
| AU (1) | AU2008345135C1 (pt) |
| BR (1) | BRPI0821474B8 (pt) |
| CA (1) | CA2710762A1 (pt) |
| ES (1) | ES2887187T3 (pt) |
| MX (1) | MX2010007150A (pt) |
| NZ (1) | NZ586383A (pt) |
| SG (2) | SG187410A1 (pt) |
| TW (3) | TWI515006B (pt) |
| WO (1) | WO2009086400A2 (pt) |
Families Citing this family (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8652782B2 (en) * | 2006-09-12 | 2014-02-18 | Longhorn Vaccines & Diagnostics, Llc | Compositions and methods for detecting, identifying and quantitating mycobacterial-specific nucleic acids |
| US9481912B2 (en) | 2006-09-12 | 2016-11-01 | Longhorn Vaccines And Diagnostics, Llc | Compositions and methods for detecting and identifying nucleic acid sequences in biological samples |
| US9683256B2 (en) | 2007-10-01 | 2017-06-20 | Longhorn Vaccines And Diagnostics, Llc | Biological specimen collection and transport system |
| US11041215B2 (en) | 2007-08-24 | 2021-06-22 | Longhorn Vaccines And Diagnostics, Llc | PCR ready compositions and methods for detecting and identifying nucleic acid sequences |
| US11041216B2 (en) | 2007-10-01 | 2021-06-22 | Longhorn Vaccines And Diagnostics, Llc | Compositions and methods for detecting and quantifying nucleic acid sequences in blood samples |
| CA2861667C (en) | 2007-10-01 | 2017-06-13 | Longhorn Vaccines And Diagnostics, Llc | Biological specimen collection and transport system and methods of use |
| CN105816858B (zh) | 2007-12-28 | 2024-10-18 | 武田药品工业株式会社 | 重组vwf配方 |
| US11197916B2 (en) | 2007-12-28 | 2021-12-14 | Takeda Pharmaceutical Company Limited | Lyophilized recombinant VWF formulations |
| EP2349314B1 (en) * | 2008-10-21 | 2013-02-27 | Baxter International Inc. | Lyophilized recombinant vwf formulations |
| AU2010290131C1 (en) | 2009-08-24 | 2015-12-03 | Amunix Operating Inc. | Coagulation factor VII compositions and methods of making and using same |
| KR101808751B1 (ko) | 2009-11-13 | 2017-12-13 | 그리폴스 테라퓨틱스 인코포레이티드 | 폰 빌레브란트 인자(vWF)-함유 제제, 및 그와 관련된 방법, 키트 및 용도 |
| US20130034573A1 (en) * | 2009-12-22 | 2013-02-07 | Celldex Therapeutics, Inc. | Vaccine compositions |
| JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| ES2682249T3 (es) * | 2011-06-10 | 2018-09-19 | Baxalta GmbH | Tratamiento de una enfermedad de la coagulación mediante la administración de VWF recombinante |
| DK2804623T3 (da) | 2012-01-12 | 2019-11-11 | Bioverativ Therapeutics Inc | Kimære faktor viii-polypeptider og anvendelser deraf |
| CA2864126A1 (en) | 2012-02-15 | 2013-08-22 | Biogen Idec Ma Inc. | Recombinant factor viii proteins |
| BR112014020694A2 (pt) | 2012-02-15 | 2018-05-08 | Amunix Operating Inc. | proteína de fusão do fator viii compreendendo polipeptídeo do fator viii fusionado a polipeptí-deo recombinante estendido (xten) e seu método de fabricação, ácido nucleico, vetores, célula hospedeira, bem como composição farmacêutica e seu uso no tratamento de coagulopatia, episódio de hemorragia e hemofilia a |
| HRP20200007T1 (hr) | 2012-07-11 | 2020-03-20 | Bioverativ Therapeutics Inc. | Kompleks proteina faktora viii s xten i von willebrandovim faktorom, te njegova uporaba |
| NL1040254C2 (en) * | 2013-05-17 | 2014-11-24 | Ablynx Nv | Stable formulations of immunoglobulin single variable domains and uses thereof. |
| US10548953B2 (en) | 2013-08-14 | 2020-02-04 | Bioverativ Therapeutics Inc. | Factor VIII-XTEN fusions and uses thereof |
| AU2015204646B2 (en) | 2014-01-10 | 2020-08-27 | Bioverativ Therapeutics Inc. | Factor VIII chimeric proteins and uses thereof |
| PL3158055T3 (pl) * | 2014-06-13 | 2020-03-31 | Csl Limited | Ulepszone wytwarzanie rekombinowanego czynnika von Willebranda w bioreaktorze |
| BR112018002150A2 (pt) | 2015-08-03 | 2018-09-18 | Bioverativ Therapeutics Inc | proteínas de fusão do fator ix e métodos de fabricação e uso das mesmas |
| CA3027998A1 (en) | 2016-06-27 | 2018-01-04 | Baxalta Incorporated | Syringe stabilizer |
| IL319473A (en) | 2016-12-02 | 2025-05-01 | Bioverativ Therapeutics Inc | Methods for treating hemophilic arthritis using chimeric blood clotting factors |
| CA3069295A1 (en) | 2017-07-07 | 2019-01-10 | Baxalta Incorporated | Treatment of gastrointestinal bleeding in patients with severe von willebrand disease by administration of recombinant vwf |
| CN107966567B (zh) * | 2017-11-21 | 2018-12-18 | 浙江夸克生物科技有限公司 | 一种触珠蛋白测定试剂盒 |
| CA3094644A1 (en) * | 2018-03-21 | 2019-09-26 | Baxalta Incorporated | Separation of vwf and vwf propeptide by chromatographic methods |
| BR112020022164A2 (pt) | 2018-05-18 | 2021-02-02 | Bioverativ Therapeutics Inc. | métodos de tratamento de hemofilia a |
| US12128090B2 (en) | 2019-02-01 | 2024-10-29 | Takeda Pharmaceutical Company Limited | Methods of prophylactic treatment using recombinant VWF (rVWF) |
| US20230041240A1 (en) * | 2020-01-30 | 2023-02-09 | Leukocare Ag | Reduction of Adsorption |
| ES3040184T3 (en) * | 2020-03-18 | 2025-10-29 | Gi Innovation Inc | Fusion protein preparation comprising il-2 and cd80 proteins |
| AU2021278562A1 (en) | 2020-05-29 | 2022-12-01 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing formulation |
| CN119173446A (zh) | 2022-03-08 | 2024-12-20 | 赤盾医疗有限公司 | 机器人药物制备系统中的流体转移站 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CA7972A (en) * | 1877-10-05 | Edward M. Lowdon | Improvements in lamps | |
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| JPS62502589A (ja) | 1985-04-11 | 1987-10-08 | ザ・チヤイルドレンズ・メデイカル・センタ−・コ−ポレ−シヨン | フオン・ビルブラント因子 |
| US5900476A (en) * | 1986-05-30 | 1999-05-04 | The Scripps Research Institute | Therapeutic domains of van Willebrand factor |
| ATE283864T1 (de) * | 1991-06-20 | 2004-12-15 | Aventis Behring L L C | Ein verfahren zur herstellung therapeutisch wirksamer bruchstücke von von willebrand-faktor |
| US5847086A (en) | 1991-06-20 | 1998-12-08 | Centeon L.L.C. | Therapeutic fragments of von Willebrand factor |
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| DE4435485C1 (de) | 1994-10-04 | 1996-03-21 | Immuno Ag | Verfahren zur Gewinnung von hochreinem von Willebrand-Faktor |
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| GB0509443D0 (en) * | 2005-05-09 | 2005-06-15 | Prometic Biosciences Ltd | Affinity adsorbents for factor VIII and von willebrand's factor |
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| ES2390354T3 (es) * | 2005-07-22 | 2012-11-12 | Amgen, Inc | Liofilizados de proteínas concentrados, procedimientos y usos |
| HRP20120994T1 (hr) * | 2006-02-07 | 2012-12-31 | Shire Human Genetic Therapies, Inc. | Stabilizirana smjesa glukocerebrozidaze |
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| WO2008127654A2 (en) * | 2007-04-11 | 2008-10-23 | The University Of North Carolina At Chapel Hill | Methods and compositions for intra-articular coagulation proteins |
| RU2469739C2 (ru) * | 2007-04-26 | 2012-12-20 | БАЙЕР ХЕЛСКЕА ЛЛСи | Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии |
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| FR2920429B1 (fr) * | 2007-08-30 | 2012-10-05 | Lfb Biotechnologies | Procede de purification du facteur viii et du facteur von willebrand |
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| DE102008032361A1 (de) * | 2008-07-10 | 2010-01-21 | Csl Behring Gmbh | Der Einsatz von Faktor VIII und vWF bzw. vWF-enthaltenden Konzentraten zur Therapie der durch Thrombocyten-Inhibitoren induzierte Koagulopathie |
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2008
- 2008-12-23 CN CN201610221805.8A patent/CN105816858B/zh active Active
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- 2008-12-23 EP EP08866246.5A patent/EP2244814B1/en active Active
- 2008-12-23 JP JP2010540873A patent/JP5784907B2/ja active Active
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- 2008-12-23 TW TW103123730A patent/TWI600437B/zh active
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