DK2170390T3 - Natalizumabantistofformuleringer - Google Patents
Natalizumabantistofformuleringer Download PDFInfo
- Publication number
- DK2170390T3 DK2170390T3 DK08771026.5T DK08771026T DK2170390T3 DK 2170390 T3 DK2170390 T3 DK 2170390T3 DK 08771026 T DK08771026 T DK 08771026T DK 2170390 T3 DK2170390 T3 DK 2170390T3
- Authority
- DK
- Denmark
- Prior art keywords
- antibody
- composition
- natalizumab
- formulation
- vla
- 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
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- 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
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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
- A61K9/0012—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
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- 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
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- 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
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- 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 [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)
- Veterinary Medicine (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)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Genetics & Genomics (AREA)
- Pulmonology (AREA)
- Physical Education & Sports Medicine (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
Claims (14)
1. Stabil vandig farmaceutisk sammensætning til subkutan eller intramuskulær indgivelse til et individ, hvor sammensætningen omfatter natalizumab ved en koncentration på 120 til 190 mg/mL, en phosphatbuffer ved en koncentration på 5 mM til 30 mM, natriumchlorid ved en koncentration mellem 100 mM og 200 mM og polysorbat 80 i en mængde af 0,01 % til 0,1 % (vægt/volumen), og hvor sammensætningen har et pH på 5,5 til pH 6,5, og hvor natalizumab omfatter letkædeaminosyresekvensen ifølge SEQ ID NO: 1 og tungkædeaminosyresekvensen ifølge SEQ ID NO: 2.
2. Sammensætning ifølge krav 1, hvor phosphatbufferen er en natriumphosphatbuffer.
3. Sammensætning ifølge krav 1, hvor natriumchlorid er til stede ved 140 mM.
4. Sammensætning ifølge krav 1, hvor natalizumab er ved en koncentration på 150 mg/mL.
5. Sammensætning ifølge krav 1, hvor sammensætningen omfatter natalizumab ved en koncentration på 140 til 160 mg/ml, en natriumphosphatbuffer ved en koncentration på 5 mM til 15 mM, natriumchlorid ved en koncentration på 130 til 150 mM og polysorbat 80 i en mængde af 0,01 % til 0,1 % (vægt/volumen), og hvor sammensætningen har et pH på 5,5 til 6,5.
6. Sammensætning ifølge krav 1, hvor sammensætningen omfatter natalizumab ved en koncentration på 150 mg/ml, en natriumphosphatbuffer ved en koncentration på 10 mM, natriumchlorid ved en koncentration på 140 mM og polysorbat 80 i en mængde af 0,04 % (vægt/volumen), og hvor sammensætningen har et pH på 5,5 til 6,5.
7. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, hvor sammensætningen er stabil i mindst 12 måneder ved en temperatur på 2 °C til 8 °C.
8. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, hvor sammensætningen er stabil i mindst 24 måneder ved en temperatur på 2 °C til 8 °C.
9. Sammensætning ifølge et hvilket som helst af kravene 1 til 8 til anvendelse som et lægemiddel.
10.Sammensætning ifølge et hvilket som helst af kravene 1-8 til anvendelse i behandling afen inflammatorisk, immun eller autoimmun lidelse.
11 .Sammensætning ifølge krav 10, hvor lidelsen er multipel sklerose, astma, rheumatoid arthritis, diabetes eller Crohns sygdom.
12. Enhedsdosis af sammensætningen ifølge et af kravene 1-8, hvor enhedsdosen er 0,25 til 1,5 mL.
13. Forfyldt injektionssprøjte, der omfatter sammensætningen ifølge et hvilket som helst af kravene 1-8, hvor sammensætningen er i form af en væskeopløsning.
14. Forfyldt injektionssprøjte ifølge krav 13, der indeholder en enhedsdosis på 0,25 til 1,5 mL af sammensætningen.
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 (1)
| Publication Number | Publication Date |
|---|---|
| DK2170390T3 true DK2170390T3 (da) | 2019-01-21 |
Family
ID=39956053
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08771026.5T DK2170390T3 (da) | 2007-06-14 | 2008-06-13 | Natalizumabantistofformuleringer |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US20080311119A1 (da) |
| EP (2) | EP3461500A1 (da) |
| JP (2) | JP2010529999A (da) |
| CN (2) | CN101778640A (da) |
| AR (2) | AR067011A1 (da) |
| AU (1) | AU2008266051B2 (da) |
| BR (1) | BRPI0814252B8 (da) |
| CA (1) | CA2690382A1 (da) |
| CY (1) | CY1121208T1 (da) |
| DK (1) | DK2170390T3 (da) |
| EA (1) | EA020456B1 (da) |
| ES (1) | ES2707815T3 (da) |
| HR (1) | HRP20182146T1 (da) |
| HU (1) | HUE041555T2 (da) |
| IL (1) | IL202648B (da) |
| LT (1) | LT2170390T (da) |
| MX (2) | MX2009013593A (da) |
| NZ (2) | NZ595526A (da) |
| PL (1) | PL2170390T3 (da) |
| PT (1) | PT2170390T (da) |
| SI (1) | SI2170390T1 (da) |
| TR (1) | TR201820837T4 (da) |
| TW (1) | TWI614028B (da) |
| WO (1) | WO2008157356A2 (da) |
Families Citing this family (33)
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| SI3417875T1 (sl) | 2003-02-10 | 2021-01-29 | Biogen Ma Inc. | Formulacija imunoglobulina in metode za njegovo pripravo |
| WO2011008770A2 (en) * | 2009-07-14 | 2011-01-20 | Biogen Idec Ma Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| MX2012009755A (es) | 2010-02-26 | 2012-09-12 | Novo Nordisk As | Composiciones que contienen anticuerpo estable. |
| BR112012022258A2 (pt) | 2010-03-01 | 2016-10-25 | Bayer Healthcare Llc | anticorpos monoclonais otimizados contra inibidor de trajetória de fator de tecido ( tfpi) |
| PL3202789T3 (pl) | 2010-04-16 | 2020-09-21 | Biogen Ma Inc. | Przeciwciała anty-vla-4 |
| WO2011147921A1 (en) | 2010-05-28 | 2011-12-01 | 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 |
| KR20140079491A (ko) * | 2011-10-18 | 2014-06-26 | 코히러스 바이오사이언시즈, 인코포레이티드 | 당과 폴리올과의 배합물로 안정화된 에타너셉트 제형 |
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| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
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| 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 |
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| JP2003520852A (ja) | 2000-01-27 | 2003-07-08 | アメリカン・サイアナミド・カンパニー | α−スルホニルヒドロキサム酸誘導体を製造する方法 |
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| SI3417875T1 (sl) * | 2003-02-10 | 2021-01-29 | Biogen Ma Inc. | Formulacija imunoglobulina in metode za njegovo pripravo |
| CA2478458A1 (en) | 2004-08-20 | 2006-02-20 | Michael Panzara | Treatment of pediatric multiple sclerosis |
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| US20110184747A1 (en) | 2006-08-09 | 2011-07-28 | Carmen Bozic | Method for distribution of a drug |
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