HRP20161604T1 - Formulacija protutijela protiv il-17 - Google Patents
Formulacija protutijela protiv il-17 Download PDFInfo
- Publication number
- HRP20161604T1 HRP20161604T1 HRP20161604TT HRP20161604T HRP20161604T1 HR P20161604 T1 HRP20161604 T1 HR P20161604T1 HR P20161604T T HRP20161604T T HR P20161604TT HR P20161604 T HRP20161604 T HR P20161604T HR P20161604 T1 HRP20161604 T1 HR P20161604T1
- Authority
- HR
- Croatia
- Prior art keywords
- concentration
- antibody
- seq
- formulation according
- amino acid
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 239000007979 citrate buffer Substances 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- 239000003186 pharmaceutical solution Substances 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
Classifications
-
- 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
- C07K16/244—Interleukins [IL]
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- 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
- 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
- A61P35/00—Antineoplastic agents
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (8)
1. Farmaceutska formulacija, naznačena time što sadrži protutijelo protiv IL-17 u rasponu koncentracija od 80 mg/ml do 150 mg/ml, citratni pufer u koncentraciji od 20 mM, natrijev klorid u koncentraciji od 200 mM, polisorbat-80 u rasponu koncentracija od 0,02% (tež./vol.) do 0,03% (tež./vol.), te pH od 5,7, gdje protutijelo protiv IL-17 sadrži protutijelo s lakim lancem (LC) i teškim lancem (HC), gdje navedeni LC ima aminokiselinski slijed sa SEQ ID NO: 4, a navedeni HC ima aminokiselinski slijed sa SEQ ID NO: 5.
2. Farmaceutska formulacija u skladu s patentnim zahtjevom 1, naznačena time što je koncentracija protutijela protiv IL-17 80 mg/ml.
3. Farmaceutska formulacija u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačena time što je koncentracija polisorbata-80 0,03% (tež./vol.).
4. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što je formulacija farmaceutska otopinska formulacija protutijela protiv IL-17.
5. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačena time što sadrži protutijelo protiv IL-17 u koncentraciji od 80 mg/ml, citratni pufer u koncentraciji od 20 mM, natrijev klorid u koncentraciji od 200 mM, polisorbat-80 u koncentraciji od 0,03%, te pH od 5,7, gdje protutijelo protiv IL-17 sadrži protutijelo koje sadrži dva laka lanca (LC) i dva teška lanca (HC), gdje svaki LC ima aminokiselinski slijed sa SEQ ID NO: 4, a svaki HC ima aminokiselinski slijed sa SEQ ID NO: 5.
6. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što protutijelo protiv IL-17 sadrži protutijelo koje sadrži dva laka lanca (LC) i dva teška lanca (HC), gdje svaki LC ima aminokiselinski slijed sa SEQ ID NO: 4, a svaki HC ima aminokiselinski slijed sa SEQ ID NO: 5.
7. Farmaceutska formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je namijenjena upotrebi u terapiji.
8. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što je namijenjena upotrebi u liječenju reumatoidnog artritisa, psorijaze, ankilozantnog spondilitisa, psorijatičnog artritisa ili multiplog mijeloma.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261607671P | 2012-03-07 | 2012-03-07 | |
| EP13710214.1A EP2822590B1 (en) | 2012-03-07 | 2013-03-01 | Il-17 antibody formulation |
| PCT/US2013/028516 WO2013134052A1 (en) | 2012-03-07 | 2013-03-01 | Il-17 antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161604T1 true HRP20161604T1 (hr) | 2016-12-30 |
Family
ID=47892018
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161604TT HRP20161604T1 (hr) | 2012-03-07 | 2016-11-30 | Formulacija protutijela protiv il-17 |
Country Status (35)
| Country | Link |
|---|---|
| US (3) | US9376491B2 (hr) |
| EP (2) | EP3156073A1 (hr) |
| JP (1) | JP6117252B2 (hr) |
| KR (1) | KR101653082B1 (hr) |
| CN (1) | CN104159612B (hr) |
| AU (1) | AU2013230490B2 (hr) |
| BR (1) | BR112014021308B1 (hr) |
| CA (1) | CA2866128C (hr) |
| CL (1) | CL2014002204A1 (hr) |
| CY (1) | CY1118393T1 (hr) |
| DK (1) | DK2822590T3 (hr) |
| EA (1) | EA030742B1 (hr) |
| EC (1) | ECSP14017562A (hr) |
| ES (1) | ES2610707T3 (hr) |
| HK (1) | HK1199844A1 (hr) |
| HR (1) | HRP20161604T1 (hr) |
| HU (1) | HUE031290T2 (hr) |
| IL (1) | IL234053B (hr) |
| LT (1) | LT2822590T (hr) |
| MA (1) | MA37317B1 (hr) |
| ME (1) | ME02565B (hr) |
| MX (1) | MX362191B (hr) |
| MY (1) | MY167233A (hr) |
| NZ (1) | NZ627648A (hr) |
| PE (1) | PE20142275A1 (hr) |
| PH (1) | PH12014501985A1 (hr) |
| PL (1) | PL2822590T3 (hr) |
| PT (1) | PT2822590T (hr) |
| RS (1) | RS55417B1 (hr) |
| SG (1) | SG11201404491XA (hr) |
| SI (1) | SI2822590T1 (hr) |
| TN (1) | TN2014000341A1 (hr) |
| UA (1) | UA114620C2 (hr) |
| WO (1) | WO2013134052A1 (hr) |
| ZA (1) | ZA201405654B (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR103173A1 (es) * | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| CA3063324A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| WO2019027828A1 (en) | 2017-08-04 | 2019-02-07 | Eli Lilly And Company | DOSAGE SCHEME OF ANTI-IL-17 ANTIBODIES |
| CA3073597A1 (en) | 2017-08-23 | 2019-02-28 | Eli Lilly And Company | Treatment of genital psoriasis |
| MX2017016884A (es) * | 2017-12-19 | 2019-06-20 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina anti-tnfa. |
| CA3121288A1 (en) * | 2018-11-29 | 2020-06-04 | Harbour Biomed Therapeutics Limited | Anti-pd-l1 antibody preparation |
| CA3129901A1 (en) | 2019-02-18 | 2020-08-27 | Eli Lilly And Company | Therapeutic antibody formulation |
| WO2022135395A1 (zh) * | 2020-12-22 | 2022-06-30 | 百奥泰生物制药股份有限公司 | 稳定的抗体制剂及其制备方法和应用 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI2481753T1 (en) * | 2005-12-13 | 2018-06-29 | Eli Lilly And Company | Anti-IL-17 antibodies |
| JP5410985B2 (ja) * | 2006-12-05 | 2014-02-05 | クルセル ホランド ベー ヴェー | 液体抗狂犬病抗体製剤 |
| JP5743234B2 (ja) * | 2010-01-15 | 2015-07-01 | キリン−アムジェン・インコーポレーテッド | 抗体製剤及び治療レジメン |
-
2013
- 2013-03-01 KR KR1020147024733A patent/KR101653082B1/ko active Protection Beyond IP Right Term
- 2013-03-01 DK DK13710214.1T patent/DK2822590T3/en active
- 2013-03-01 WO PCT/US2013/028516 patent/WO2013134052A1/en active Application Filing
- 2013-03-01 EP EP16195503.4A patent/EP3156073A1/en not_active Withdrawn
- 2013-03-01 LT LTEP13710214.1T patent/LT2822590T/lt unknown
- 2013-03-01 AU AU2013230490A patent/AU2013230490B2/en active Active
- 2013-03-01 CA CA2866128A patent/CA2866128C/en active Active
- 2013-03-01 NZ NZ627648A patent/NZ627648A/en unknown
- 2013-03-01 RS RS20160994A patent/RS55417B1/sr unknown
- 2013-03-01 EA EA201491471A patent/EA030742B1/ru not_active IP Right Cessation
- 2013-03-01 ES ES13710214.1T patent/ES2610707T3/es active Active
- 2013-03-01 BR BR112014021308-9A patent/BR112014021308B1/pt active IP Right Grant
- 2013-03-01 JP JP2014560955A patent/JP6117252B2/ja active Active
- 2013-03-01 PL PL13710214T patent/PL2822590T3/pl unknown
- 2013-03-01 MX MX2014010710A patent/MX362191B/es active IP Right Grant
- 2013-03-01 UA UAA201409450A patent/UA114620C2/uk unknown
- 2013-03-01 HU HUE13710214A patent/HUE031290T2/hu unknown
- 2013-03-01 CN CN201380012452.5A patent/CN104159612B/zh active Active
- 2013-03-01 SI SI201330364A patent/SI2822590T1/sl unknown
- 2013-03-01 PE PE2014001367A patent/PE20142275A1/es active IP Right Grant
- 2013-03-01 SG SG11201404491XA patent/SG11201404491XA/en unknown
- 2013-03-01 MY MYPI2014702489A patent/MY167233A/en unknown
- 2013-03-01 EP EP13710214.1A patent/EP2822590B1/en active Active
- 2013-03-01 US US14/379,755 patent/US9376491B2/en active Active
- 2013-03-01 ME MEP-2016-259A patent/ME02565B/me unknown
- 2013-03-01 PT PT137102141T patent/PT2822590T/pt unknown
-
2014
- 2014-07-30 ZA ZA2014/05654A patent/ZA201405654B/en unknown
- 2014-08-06 TN TNP2014000341A patent/TN2014000341A1/fr unknown
- 2014-08-11 IL IL234053A patent/IL234053B/en active IP Right Grant
- 2014-08-19 CL CL2014002204A patent/CL2014002204A1/es unknown
- 2014-09-02 MA MA37317A patent/MA37317B1/fr unknown
- 2014-09-05 PH PH12014501985A patent/PH12014501985A1/en unknown
- 2014-09-05 EC ECIEPI201417562A patent/ECSP14017562A/es unknown
-
2015
- 2015-01-15 HK HK15100440.9A patent/HK1199844A1/zh unknown
-
2016
- 2016-06-10 US US15/178,583 patent/US9845353B2/en active Active
- 2016-11-30 HR HRP20161604TT patent/HRP20161604T1/hr unknown
- 2016-12-23 CY CY20161101339T patent/CY1118393T1/el unknown
-
2017
- 2017-11-10 US US15/808,939 patent/US10472416B2/en active Active
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