HRP20211899T1 - Formulacija protutijela - Google Patents
Formulacija protutijela Download PDFInfo
- Publication number
- HRP20211899T1 HRP20211899T1 HRP20211899TT HRP20211899T HRP20211899T1 HR P20211899 T1 HRP20211899 T1 HR P20211899T1 HR P20211899T T HRP20211899T T HR P20211899TT HR P20211899 T HRP20211899 T HR P20211899T HR P20211899 T1 HRP20211899 T1 HR P20211899T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation according
- formulation
- stabilizer
- surfactant
- concentration
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title claims 12
- 239000000203 mixture Substances 0.000 title claims 12
- 239000003381 stabilizer Substances 0.000 claims 4
- 239000007853 buffer solution Substances 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 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
- 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-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
- 229920001213 Polysorbate 20 Polymers 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
- 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
- 229940090047 auto-injector Drugs 0.000 claims 1
- 229960001838 canakinumab Drugs 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
Classifications
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- A61K47/30—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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
-
- 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]
- C07K16/245—IL-1
Claims (10)
1. Tekuća farmaceutska formulacija, naznačena time, što sadrži 50 do 150 mg/ml protutijela ACZ885, puferski sustav i stabilizator, pri čemu je puferski sustav histidin, gdje formulacija ima pH od 6,2 do 6,8, dok je stabilizator manitol, sorbitol ili trehaloza, te pri čemu formulacija održava između 80% i 125% izvorne bioaktivnosti protutijela tijekom 24-36 mjeseci na 2-8°C.
2. Formulacija prema patentnom zahtjevu 1, naznačena time, što se puferski sustav koristi u koncentraciji od 10 do 50 mM.
3. Formulacija prema patentnom zahtjevu 1 ili 2, naznačena time, što navedeni stabilizator jest manitol.
4. Formulacija prema bilo kojem od patentnih zahtjeva 1-3, naznačena time, što se stabilizator koristi u koncentraciji od 50 mM do 300 mM.
5. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, što nadalje sadrži surfaktant.
6. Formulacija prema patentnom zahtjevu 5, naznačena time, što je surfaktant odabran iz skupine koja sadrži polisorbat 20 i polisorbat 80.
7. Formulacija prema patentnom zahtjevu 5 ili 6, naznačena time, što se surfaktant koristi u koncentraciji od 0,01-0,1% mase po volumenu.
8. Oblik za doziranje, naznačen time, što sadrži formulaciju prema bilo kojem od prethodnih patentnih zahtjeva.
9. Šprica, naznačena time, što sadrži formulaciju prema bilo kojem od patentnih zahtjeva 1-7.
10. Autoinjektor, naznačen time, što sadrži formulaciju prema bilo kojem od patentnih zahtjeva 1-7.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08170884A EP2196476A1 (en) | 2008-12-10 | 2008-12-10 | Antibody formulation |
EP16162699.9A EP3072906B1 (en) | 2008-12-10 | 2009-12-09 | Antibody formulation |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211899T1 true HRP20211899T1 (hr) | 2022-03-04 |
Family
ID=40637230
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211899TT HRP20211899T1 (hr) | 2008-12-10 | 2009-12-09 | Formulacija protutijela |
HRP20160754TT HRP20160754T1 (hr) | 2008-12-10 | 2016-06-27 | Formulacija protutijela |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160754TT HRP20160754T1 (hr) | 2008-12-10 | 2016-06-27 | Formulacija protutijela |
Country Status (32)
Country | Link |
---|---|
US (3) | US20110236398A1 (hr) |
EP (4) | EP2196476A1 (hr) |
JP (5) | JP6143416B2 (hr) |
KR (2) | KR20170044211A (hr) |
CN (3) | CN114225022A (hr) |
AU (1) | AU2009324371B2 (hr) |
BR (1) | BRPI0922730A2 (hr) |
CA (1) | CA2745938C (hr) |
CL (1) | CL2011001406A1 (hr) |
CO (1) | CO6361952A2 (hr) |
CY (2) | CY1117735T1 (hr) |
DK (2) | DK3072906T3 (hr) |
EC (1) | ECSP11011192A (hr) |
ES (2) | ES2579835T3 (hr) |
HK (1) | HK1159130A1 (hr) |
HR (2) | HRP20211899T1 (hr) |
HU (2) | HUE056626T2 (hr) |
IL (3) | IL264316B2 (hr) |
LT (1) | LT3072906T (hr) |
MA (1) | MA33023B1 (hr) |
MX (1) | MX2011006242A (hr) |
MY (2) | MY157772A (hr) |
NZ (1) | NZ592918A (hr) |
PE (1) | PE20120342A1 (hr) |
PL (2) | PL2376533T3 (hr) |
PT (2) | PT2376533T (hr) |
RU (2) | RU2563179C2 (hr) |
SI (2) | SI3072906T1 (hr) |
SM (1) | SMT201600222B (hr) |
TN (1) | TN2011000229A1 (hr) |
WO (1) | WO2010066762A1 (hr) |
ZA (1) | ZA201103362B (hr) |
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EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
US8221753B2 (en) | 2009-09-30 | 2012-07-17 | Tracon Pharmaceuticals, Inc. | Endoglin antibodies |
EP3216462A3 (en) | 2010-02-26 | 2017-12-20 | Novo Nordisk A/S | Stable antibody containing compositions |
NZ702494A (en) | 2010-03-01 | 2016-09-30 | Bayer Healthcare Llc | Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi) |
WO2011147921A1 (en) | 2010-05-28 | 2011-12-01 | Novo Nordisk A/S | Stable multi-dose compositions comprising an antibody and a preservative |
AR082319A1 (es) * | 2010-07-22 | 2012-11-28 | Biomarin Pharm Inc | Produccion de una n-acetilgalactosamina-6-sulfatasa humana activa altamente fosforilada y sus usos |
CA2807552A1 (en) | 2010-08-06 | 2012-02-09 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
DK2616090T3 (da) | 2010-09-17 | 2023-09-18 | Takeda Pharmaceuticals Co | Stabilisering af immunoglobuliner gennem vandig formulering med histidin ved svag syre til neutral ph |
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RS59076B1 (sr) * | 2012-03-16 | 2019-09-30 | Regeneron Pharma | Glodari koji eksprimiraju imunoglobulinske sekvence senzitivne na ph |
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US9303079B2 (en) | 2012-04-02 | 2016-04-05 | Moderna Therapeutics, Inc. | Modified polynucleotides for the production of cytoplasmic and cytoskeletal proteins |
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US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
US8883979B2 (en) * | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
UA115789C2 (uk) * | 2012-09-05 | 2017-12-26 | Трейкон Фармасутікалз, Інк. | Композиція антитіла до cd105 та її застосування |
US20150246969A1 (en) | 2012-09-20 | 2015-09-03 | Morphosys Ag | Treatment for rheumatoid arthritis |
WO2014078502A1 (en) * | 2012-11-16 | 2014-05-22 | Novartis Ag | Use of il-1 beta binding antibodies for treating peripheral arterial disease |
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US9023357B2 (en) | 2013-03-15 | 2015-05-05 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
TWI679019B (zh) | 2013-04-29 | 2019-12-11 | 法商賽諾菲公司 | 抗il-4/抗il-13之雙特異性抗體調配物 |
NL1040254C2 (en) * | 2013-05-17 | 2014-11-24 | Ablynx Nv | Stable formulations of immunoglobulin single variable domains and uses thereof. |
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US10206878B2 (en) * | 2014-05-28 | 2019-02-19 | Nono Inc. | Lyophilized formulation of TAT-NR2B9C with acetylation scavenger |
JP2017527560A (ja) * | 2014-09-03 | 2017-09-21 | メドイミューン・リミテッドMedImmune Limited | 安定抗il−4rアルファ抗体配合物 |
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EP3487584A1 (en) * | 2016-07-21 | 2019-05-29 | Novartis AG | Use of the il-1beta binding antibody canakinumab for treating or allevating symptoms of pulmonary sarcoidosis |
KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
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JP2020524694A (ja) * | 2017-06-22 | 2020-08-20 | ノバルティス アーゲー | がんの処置における使用のためのIL−1β結合性抗体 |
TWI795415B (zh) | 2017-07-07 | 2023-03-11 | 日商安斯泰來製藥股份有限公司 | 新穎的抗人類CEACAM5抗體Fab片段 |
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CN113967195A (zh) * | 2020-07-22 | 2022-01-25 | 三生国健药业(上海)股份有限公司 | 抗her2/pd1双特异性抗体冻干制剂及其制备方法 |
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 |
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PT2275119E (pt) | 1995-07-27 | 2013-11-21 | Genentech Inc | Formulação de proteína liofilizada isotónica estável |
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UA96473C2 (ru) * | 2007-03-22 | 2011-11-10 | Имклоун Ллк | Жидкая стойкая композиция, которая содержит антитело imc-а12 |
EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
WO2010100179A2 (en) | 2009-03-05 | 2010-09-10 | Novartis Ag | Self-forming gel system for sustained drug delivery |
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-
2008
- 2008-12-10 EP EP08170884A patent/EP2196476A1/en not_active Ceased
-
2009
- 2009-12-09 MX MX2011006242A patent/MX2011006242A/es active IP Right Grant
- 2009-12-09 EP EP20197506.7A patent/EP3792282A1/en active Pending
- 2009-12-09 WO PCT/EP2009/066675 patent/WO2010066762A1/en active Application Filing
- 2009-12-09 KR KR1020177009939A patent/KR20170044211A/ko not_active Application Discontinuation
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