DE23189888T1 - Flüssige pharmazeutische zusammensetzung von adalimumab - Google Patents
Flüssige pharmazeutische zusammensetzung von adalimumab Download PDFInfo
- Publication number
- DE23189888T1 DE23189888T1 DE23189888.3T DE23189888T DE23189888T1 DE 23189888 T1 DE23189888 T1 DE 23189888T1 DE 23189888 T DE23189888 T DE 23189888T DE 23189888 T1 DE23189888 T1 DE 23189888T1
- Authority
- DE
- Germany
- Prior art keywords
- liquid pharmaceutical
- pharmaceutical composition
- histidine
- free
- concentration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000007788 liquid Substances 0.000 title claims abstract 18
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 18
- 229960002964 adalimumab Drugs 0.000 title claims abstract 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims abstract 15
- 239000000203 mixture Substances 0.000 claims abstract 13
- 150000001413 amino acids Chemical class 0.000 claims abstract 8
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims abstract 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims abstract 8
- 229920000053 polysorbate 80 Polymers 0.000 claims abstract 8
- 229940068968 polysorbate 80 Drugs 0.000 claims abstract 8
- 239000004094 surface-active agent Substances 0.000 claims abstract 8
- 239000004475 Arginine Substances 0.000 claims abstract 6
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract 6
- 239000008363 phosphate buffer Substances 0.000 claims abstract 6
- 239000003795 chemical substances by application Substances 0.000 claims abstract 5
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims abstract 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims abstract 3
- 235000019799 monosodium phosphate Nutrition 0.000 claims abstract 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims abstract 3
- 239000003381 stabilizer Substances 0.000 claims abstract 3
- 239000000126 substance Substances 0.000 claims abstract 3
- 238000002347 injection Methods 0.000 claims abstract 2
- 239000007924 injection Substances 0.000 claims abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- 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 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- RAXXELZNTBOGNW-UHFFFAOYSA-N 1H-imidazole Chemical group C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 239000004386 Erythritol Substances 0.000 claims 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 1
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 230000003139 buffering effect Effects 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- 235000019414 erythritol Nutrition 0.000 claims 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 1
- 229940009714 erythritol Drugs 0.000 claims 1
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims 1
- 229960000367 inositol Drugs 0.000 claims 1
- 239000000832 lactitol Substances 0.000 claims 1
- 235000010448 lactitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 1
- 229960003451 lactitol Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 150000005846 sugar alcohols Chemical class 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 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
- A61K9/0012—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
- A61K38/00—Medicinal preparations containing peptides
-
- 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
-
- 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
- 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
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- 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
-
- 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
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
-
- 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
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Dermatology (AREA)
- Rheumatology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Transplantation (AREA)
- Diabetes (AREA)
- Pain & Pain Management (AREA)
- Ophthalmology & Optometry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14169754 | 2014-05-23 | ||
| EP14169754.0A EP2946766B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
| EP23189888.3A EP4249060A3 (en) | 2014-05-23 | 2015-05-15 | Liquid pharmaceutical composition of adalimumab |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE23189888T1 true DE23189888T1 (de) | 2024-03-21 |
Family
ID=50774705
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE23189888.3T Pending DE23189888T1 (de) | 2014-05-23 | 2015-05-15 | Flüssige pharmazeutische zusammensetzung von adalimumab |
| DE25179059.8T Pending DE25179059T1 (de) | 2014-05-23 | 2015-05-15 | Flüssige pharmazeutische zusammensetzung von adalimumab |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE25179059.8T Pending DE25179059T1 (de) | 2014-05-23 | 2015-05-15 | Flüssige pharmazeutische zusammensetzung von adalimumab |
Country Status (21)
| Country | Link |
|---|---|
| US (5) | US10493152B2 (enExample) |
| EP (6) | EP2946766B1 (enExample) |
| JP (3) | JP2017516847A (enExample) |
| CN (2) | CN108785670A (enExample) |
| AU (4) | AU2015263246B2 (enExample) |
| CA (2) | CA3050875A1 (enExample) |
| CY (1) | CY1120488T1 (enExample) |
| DE (2) | DE23189888T1 (enExample) |
| DK (3) | DK3148510T3 (enExample) |
| ES (4) | ES2572919T3 (enExample) |
| HK (1) | HK1257026A1 (enExample) |
| HR (1) | HRP20181226T1 (enExample) |
| HU (1) | HUE040097T2 (enExample) |
| IL (1) | IL249117B2 (enExample) |
| LT (1) | LT3148510T (enExample) |
| PL (1) | PL3148510T3 (enExample) |
| PT (1) | PT3148510T (enExample) |
| RS (1) | RS57772B1 (enExample) |
| SI (1) | SI3148510T1 (enExample) |
| SM (1) | SMT201800413T1 (enExample) |
| WO (1) | WO2015177058A1 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2600488T3 (es) * | 2014-05-23 | 2017-02-09 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2607489T3 (es) * | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3824906A1 (en) | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| EP3459527B1 (en) * | 2017-09-20 | 2022-11-23 | Tillotts Pharma Ag | Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization |
| US12385894B2 (en) | 2018-03-29 | 2025-08-12 | Airway Therapeutics, Inc. | Systems and methods for characterizing surfactant protein D (SP-D) oligomers |
| AU2019243707B2 (en) * | 2018-03-29 | 2023-12-07 | Airway Therapeutics, Inc. | Methods and compositions comprising surfactant protein D (SP-D) |
| WO2020138517A1 (ko) * | 2018-12-24 | 2020-07-02 | 삼성바이오에피스 주식회사 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
| CA3125927A1 (en) * | 2019-01-11 | 2020-07-16 | Samsung Bioepis Co., Ltd. | Pharmaceutical composition comprising antibody, device comprising same, and use thereof |
| US20230203147A1 (en) * | 2019-03-18 | 2023-06-29 | Alvotech Hf | Aqueous formulations of tnf-alpha antibodies in high concentrations |
| CN115429751B (zh) * | 2022-09-21 | 2023-11-17 | 景泽生物医药(合肥)股份有限公司 | 一种人重组卵泡刺激素注射剂及其制备方法 |
| WO2025038671A2 (en) * | 2023-08-15 | 2025-02-20 | Amgen Inc. | Acidic buffered intravenous solution stabilizers for use in methods of treatment |
Family Cites Families (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6388197A (ja) * | 1986-09-30 | 1988-04-19 | Tosoh Corp | モノクロナル抗体の安定化方法 |
| US6090382A (en) | 1996-02-09 | 2000-07-18 | Basf Aktiengesellschaft | Human antibodies that bind human TNFα |
| DE69721548T2 (de) | 1996-02-09 | 2004-04-01 | Abbott Laboratories(Bermuda)Ltd. | HUMANE ANTIKÖRPER WELCHE AN HUMANEN TNFalpha BINDEN |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US5900404A (en) | 1997-08-15 | 1999-05-04 | Amgen Inc. | Chemical modification of proteins to improve biocompatibility and bioactivity |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| DK1610820T4 (da) * | 2003-04-04 | 2013-11-04 | Genentech Inc | Høj-koncentration antistof- og proteinformuleringer |
| WO2005072772A1 (en) | 2004-01-30 | 2005-08-11 | Suomen Punainen Risti Veripalvelu | Pharmaceutical compositions |
| CN101048427B (zh) | 2004-07-23 | 2015-01-14 | 健泰科生物技术公司 | 抗体或其片段的结晶 |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| DK1865986T3 (en) | 2005-03-08 | 2016-04-11 | Pfizer Prod Inc | The anti-CTLA-4 antibody compositions |
| ES2424042T3 (es) | 2005-06-07 | 2013-09-26 | Esbatech - A Novartis Company Llc | Anticuerpos estables y solubles que inhiben TNF± |
| TWI661833B (zh) | 2007-11-30 | 2019-06-11 | 百慕達商艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
| US8080518B2 (en) | 2007-12-05 | 2011-12-20 | Arbor Vita Corporation | Co-administration of an agent linked to an internalization peptide with an anti-inflammatory |
| EP3011953A1 (en) | 2008-10-29 | 2016-04-27 | Ablynx N.V. | Stabilised formulations of single domain antigen binding molecules |
| TW201021831A (en) | 2008-11-17 | 2010-06-16 | Genentech Inc | Method and formulation for reducing aggregation of a macromolecule under physiological conditions |
| NZ613809A (en) | 2009-05-04 | 2015-02-27 | Abbvie Biotechnology Ltd | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
| RU2626512C2 (ru) | 2010-03-01 | 2017-07-28 | Цитодин, Инк. | Концентрированные белковые фармацевтические составы и их применение |
| US20110223208A1 (en) | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| KR102218495B1 (ko) | 2010-03-22 | 2021-02-19 | 제넨테크, 인크. | 단백질-함유 제제의 안정화에 유용한 조성물 및 방법 |
| EP2399604A1 (en) | 2010-06-25 | 2011-12-28 | F. Hoffmann-La Roche AG | Novel antibody formulation |
| MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| WO2013006454A1 (en) | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use |
| GB201112429D0 (en) | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| SG11201405475UA (en) | 2012-03-07 | 2014-10-30 | Cadila Healthcare Ltd | Pharmaceutical formulations of tnf-alpha antibodies |
| EP2863951A1 (en) * | 2012-06-12 | 2015-04-29 | Boehringer Ingelheim International GmbH | Pharmaceutical formulation for a therapeutic antibody |
| MX2015003007A (es) * | 2012-09-07 | 2015-06-05 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab. |
| BR112015008186A2 (pt) | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| AR093297A1 (es) * | 2012-10-31 | 2015-05-27 | Amgen Res Munich Gmbh | Formulacion liquida que comprende un compuesto neutralizante de gm-csf |
| EP2914289B1 (en) | 2012-10-31 | 2019-05-22 | Takeda GmbH | Lyophilized formulation comprising gm-csf neutralizing compound |
| EP2727602A1 (en) | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
| BR112015009924A2 (pt) | 2012-11-01 | 2017-12-05 | Abbvie Inc | formulações de proteína imunoglobulina de domínio variável duplo estáveis |
| CN104707146B (zh) | 2013-12-16 | 2019-04-16 | 浙江海正药业股份有限公司 | 一种含有阿达木单抗的药物组合物 |
| IN2014MU00610A (enExample) | 2014-02-21 | 2015-09-25 | Tata Motors Ltd | |
| US10688187B2 (en) | 2014-04-02 | 2020-06-23 | Intas Pharmaceuticals Ltd. | Liquid pharmaceutical composition of adalimumab |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2600488T3 (es) | 2014-05-23 | 2017-02-09 | Ares Trading S.A. | Composición farmacéutica líquida |
| AU2017213775A1 (en) * | 2016-02-03 | 2018-08-16 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| AU2018207367B2 (en) | 2017-01-11 | 2024-02-15 | Celltrion Inc. | Stable Liquid Formula |
| KR20220152540A (ko) | 2020-03-13 | 2022-11-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
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