ES3053508T2 - Liquid pharmaceutical composition of adalimumab - Google Patents
Liquid pharmaceutical composition of adalimumabInfo
- Publication number
- ES3053508T2 ES3053508T2 ES25179059T ES25179059T ES3053508T2 ES 3053508 T2 ES3053508 T2 ES 3053508T2 ES 25179059 T ES25179059 T ES 25179059T ES 25179059 T ES25179059 T ES 25179059T ES 3053508 T2 ES3053508 T2 ES 3053508T2
- Authority
- ES
- Spain
- Prior art keywords
- histidine
- pharmaceutical composition
- liquid pharmaceutical
- composition according
- zwitterionic
- 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
Classifications
-
- 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
- A61K9/0012—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
- 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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], 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)
Claims (15)
1. REIVINDICACIONES
1. Una composición farmacéutica líquida, que comprende adalimumab; histidina zwitteriónica; y un estabilizador de azúcar; en donde la composición está exenta de aminoácidos distintos de la histidina o comprende uno o más aminoácidos distintos de la histidina en una concentración colectiva de 0,1 mM como máximo;
en donde la histidina zwitteriónica está presente en una concentración entre 0,77mg/mL y 2,2 mg/mL o en una concentración entre 5 y 14 mM.
2. La composición farmacéutica líquida de acuerdo con la reivindicación 1, que comprende además un tensioactivo.
3. La composición farmacéutica líquida de acuerdo con la reivindicación 1 o la reivindicación 2, que comprende además un tonificante.
4. La composición farmacéutica líquida de acuerdo con cualquier reivindicación anterior, en donde el estabilizador de azúcar es un poliol de azúcar o un disacárido.
5. La composición farmacéutica líquida de acuerdo con la reivindicación 4, en donde el estabilizador de azúcar es trehalosa o manitol.
6. La composición farmacéutica líquida de acuerdo con la reivindicación 2, o cualquier reivindicación anterior dependiente de la misma, en donde el tensioactivo es polisorbato 80 o polisorbato 20.
7. La composición farmacéutica líquida de acuerdo con la reivindicación 3, o cualquier reivindicación anterior dependiente de la misma, en donde el tonificante no es amortiguador.
8. La composición farmacéutica líquida de acuerdo con la reivindicación 3, o cualquier reivindicación anterior dependiente de la misma, en donde el tonificante es o comprende una sal metálica.
9. La composición farmacéutica líquida de acuerdo con la reivindicación 8, en donde el tonificante es o comprende cloruro de sodio.
10. La composición farmacéutica líquida de acuerdo con cualquier reivindicación anterior, en donde la composición farmacéutica líquida comprende:
- Adalimumab;
- 5 a 14 mM de histidina zwitteriónica;
- 100 a 300 mM de un estabilizador de azúcar (por ejemplo, trehalosa);
- 10 a 200 mM un tonificante (por ejemplo, cloruro de sodio); y
Agua para inyección
- en donde la composición:
o tiene un pH entre 6,3 y 6,7 (por ejemplo, pH 6,4)
o está (sustancial o totalmente) libre de arginina; comprende arginina en una concentración de 0,1 mM como máximo;
o está (sustancial o totalmente) libre de aminoácidos distintos de la histidina o comprende uno o más aminoácidos distintos de la histidina en una concentración (colectiva) de 0,1 mM como máximo;
o está (sustancial o totalmente) libre de tensioactivos con la excepción opcional del polisorbato 80 o comprende uno o más de dichos tensioactivos (excluyendo opcionalmente el polisorbato 80) en una concentración (colectiva) de como máximo 1 mM; y/o
o está (sustancial o totalmente) exenta de agentes amortiguadores de fosfatos (por ejemplo, dihidrogenofosfato de sodio, hidrogenofosfato de disodio) o comprende un sistema de disolución amortiguadora de fosfatos en una concentración de 0,1 mM como máximo.
11. Un método de fabricación de una composición farmacéutica líquida, que comprende adalimumab, histidina zwitteriónica y un estabilizador de azúcar; en donde la composición no contiene aminoácidos distintos de la histidina o comprende uno o más aminoácidos distintos de la histidina en una concentración colectiva de como máximo 0.1 mM; y la composición comprende entre 0,77mg/mL y 2,2 mg/mL de histidina zwitteriónica o entre 5 y 14 mM de histidina zwitteriónica; en donde el método comprende: mezclar juntos, en agua, el adalimumab, la histidina zwitteriónica y el estabilizador de azúcar.
12. El método de acuerdo con la reivindicación 11, en donde el método involucra formar un sistema de disolución amortiguadora de histidina que comprenda la histidina zwitteriónica, en donde formar el sistema de disolución amortiguadora de histidina comprende mezclar la histidina zwitteriónica con clorhidrato de histidina.
13. El método de acuerdo con la reivindicación 11 o la reivindicación 12, en donde la composición farmacéutica líquida es como se reivindica en cualquiera de las reivindicaciones 1 a 10.
14. Una composición farmacéutica líquida de acuerdo con cualquiera de las reivindicaciones 1 a 10, o una
composición farmacéutica líquida obtenida por el método de acuerdo con cualquiera de las reivindicaciones 11 a 13, para su uso en el tratamiento de la artritis reumatoide, la artritis psoriásica, la espondilitis anquilosante, la enfermedad de Crohn, la colitis ulcerosa, la psoriasis crónica de moderada a grave y/o la artritis idiopática juvenil.
15. La composición farmacéutica líquida para su uso de acuerdo con la reivindicación 14, en donde el tratamiento es la artritis psoriásica, la espondilitis anquilosante, la enfermedad de Crohn, la colitis ulcerosa, la psoriasis crónica de moderada a grave y/o la artritis idiopática juvenil.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14169754.0A EP2946766B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES3053508T2 true ES3053508T2 (en) | 2026-01-22 |
Family
ID=50774705
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES14169754.0T Active ES2572919T3 (es) | 2014-05-23 | 2014-05-23 | Composición farmacéutica líquida |
| ES15724974.9T Active ES2683194T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida |
| ES25179059T Pending ES3053508T2 (en) | 2014-05-23 | 2015-05-15 | Liquid pharmaceutical composition of adalimumab |
| ES19215036T Active ES2955316T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida de adalimumab |
| ES18169979T Active ES2928738T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES14169754.0T Active ES2572919T3 (es) | 2014-05-23 | 2014-05-23 | Composición farmacéutica líquida |
| ES15724974.9T Active ES2683194T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES19215036T Active ES2955316T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida de adalimumab |
| ES18169979T Active ES2928738T3 (es) | 2014-05-23 | 2015-05-15 | Composición farmacéutica líquida |
Country Status (21)
| Country | Link |
|---|---|
| US (5) | US10493152B2 (es) |
| EP (6) | EP2946766B1 (es) |
| JP (3) | JP2017516847A (es) |
| CN (2) | CN106659781A (es) |
| AU (4) | AU2015263246B2 (es) |
| CA (2) | CA3050875A1 (es) |
| CY (1) | CY1120488T1 (es) |
| DE (2) | DE23189888T1 (es) |
| DK (3) | DK3148510T3 (es) |
| ES (5) | ES2572919T3 (es) |
| HK (1) | HK1257026A1 (es) |
| HR (1) | HRP20181226T1 (es) |
| HU (1) | HUE040097T2 (es) |
| IL (1) | IL249117B2 (es) |
| LT (1) | LT3148510T (es) |
| PL (1) | PL3148510T3 (es) |
| PT (1) | PT3148510T (es) |
| RS (1) | RS57772B1 (es) |
| SI (1) | SI3148510T1 (es) |
| SM (1) | SMT201800413T1 (es) |
| WO (1) | WO2015177058A1 (es) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE029849T2 (en) | 2014-05-23 | 2017-04-28 | Ares Trading Sa | Liquid pharmaceutical composition |
| 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 |
| CA3094966A1 (en) | 2018-03-29 | 2019-10-03 | Airway Therapeutics, Inc. | Systems and methods for characterizing surfactant protein d (sp-d) oligomers |
| EP3774875B1 (en) * | 2018-03-29 | 2026-03-18 | 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 |
| JP2022525556A (ja) * | 2019-03-18 | 2022-05-17 | アルヴォテック エイチエフ | Ｔｎｆ－アルファ抗体の高濃度水性製剤 |
| 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 |
| AU2024325145A1 (en) * | 2023-08-15 | 2026-02-05 | Amgen Inc. | Acidic buffered intravenous solution stabilizers for use in methods of treatment |
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2014
- 2014-05-23 EP EP14169754.0A patent/EP2946766B1/en not_active Not-in-force
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2015
- 2015-05-15 DE DE23189888.3T patent/DE23189888T1/de active Pending
- 2015-05-15 SM SM20180413T patent/SMT201800413T1/it unknown
- 2015-05-15 CA CA3050875A patent/CA3050875A1/en not_active Abandoned
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- 2015-05-15 WO PCT/EP2015/060817 patent/WO2015177058A1/en not_active Ceased
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- 2015-05-15 US US15/313,480 patent/US10493152B2/en active Active
- 2015-05-15 EP EP18169979.4A patent/EP3403646B1/en active Active
- 2015-05-15 SI SI201530341T patent/SI3148510T1/sl unknown
- 2015-05-15 DK DK15724974.9T patent/DK3148510T3/en active
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- 2015-05-15 JP JP2017513323A patent/JP2017516847A/ja not_active Withdrawn
- 2015-05-15 RS RS20180919A patent/RS57772B1/sr unknown
- 2015-05-15 CN CN201810768437.8A patent/CN108785670A/zh active Pending
- 2015-05-15 CA CA2947487A patent/CA2947487C/en active Active
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2018
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