HRP20210890T1 - Farmaceutska formulacija s pripravkom protiv egfr antitijela - Google Patents
Farmaceutska formulacija s pripravkom protiv egfr antitijela Download PDFInfo
- Publication number
- HRP20210890T1 HRP20210890T1 HRP20210890TT HRP20210890T HRP20210890T1 HR P20210890 T1 HRP20210890 T1 HR P20210890T1 HR P20210890T T HRP20210890T T HR P20210890TT HR P20210890 T HRP20210890 T HR P20210890T HR P20210890 T1 HRP20210890 T1 HR P20210890T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical formulation
- concentration
- formulation according
- egfr antibody
- tonic
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 9
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 230000001256 tonic effect Effects 0.000 claims 4
- 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 3
- 239000004471 Glycine Substances 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 2
- 229940040526 anhydrous sodium acetate Drugs 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 102000009465 Growth Factor Receptors Human genes 0.000 claims 1
- 108010009202 Growth Factor Receptors Proteins 0.000 claims 1
- 229940116977 epidermal growth factor Drugs 0.000 claims 1
- 102000052116 epidermal growth factor receptor activity proteins Human genes 0.000 claims 1
- 108700015053 epidermal growth factor receptor activity proteins Proteins 0.000 claims 1
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- YOHYSYJDKVYCJI-UHFFFAOYSA-N n-[3-[[6-[3-(trifluoromethyl)anilino]pyrimidin-4-yl]amino]phenyl]cyclopropanecarboxamide Chemical compound FC(F)(F)C1=CC=CC(NC=2N=CN=C(NC=3C=C(NC(=O)C4CC4)C=CC=3)C=2)=C1 YOHYSYJDKVYCJI-UHFFFAOYSA-N 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- 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
- C07K2317/90—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)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Biomedical Technology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Inorganic Chemistry (AREA)
Claims (6)
1. Farmaceutska formulacija koja sadrži antitijelo na receptor za anti-epidermalni faktor rasta (EGFR), bezvodni natrijev acetat i polisorbat 80,
pri čemu u farmaceutsku formulaciju nije uključen natrijev klorid (NaCl),
pri čemu je anti-EGFR antitijelo GC1118A,
pri čemu se anti-EGFR protutijelo sadrži u koncentraciji od 2 do 10 mg/ml,
pri čemu se bezvodni natrijev acetat sadrži u koncentraciji od 10 do 100 mM, i
pri čemu je polisorbat 80 sadržan u koncentraciji od 0.05 do 2.0 mg/ml.
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time, da nadalje sadrži tonifikator odabran između manitola, glicina ili njihove kombinacije.
3. Farmaceutska formulacija prema zahtjevu 1, naznačena time, da se pH farmaceutske formulacije kreće od pH 5.3 do 6.1.
4. Farmaceutska formulacija prema zahtjevu 2, naznačena time, da je tonifikator manitol i sadrži koncentraciju od 1 do 20% (m/v).
5. Farmaceutska formulacija prema zahtjevu 2, naznačena time, da je tonifikator glicin i sadrži koncentraciju od 1 do 10% (m/v).
6. Farmaceutska formulacija prema zahtjevu 2, naznačena time, da je tonifikator smjesa manitola i glicina koji se miješaju u težinskom omjeru 5: 1 do 1: 5, a sadrži koncentraciju od 1 do 10% (m/v).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020150008677A KR101776879B1 (ko) | 2015-01-19 | 2015-01-19 | 항-egfr 항체를 포함하는 약학 제제 |
EP16740356.7A EP3247394B1 (en) | 2015-01-19 | 2016-01-15 | Pharmaceutical formulation comprising anti-egfr antibody |
PCT/KR2016/000472 WO2016117883A2 (en) | 2015-01-19 | 2016-01-15 | Pharmaceutical formulation comprising anti-egfr antibody |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20210890T1 true HRP20210890T1 (hr) | 2021-07-23 |
Family
ID=56417907
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20210890TT HRP20210890T1 (hr) | 2015-01-19 | 2021-06-04 | Farmaceutska formulacija s pripravkom protiv egfr antitijela |
Country Status (13)
Country | Link |
---|---|
US (1) | US10918717B2 (hr) |
EP (1) | EP3247394B1 (hr) |
JP (1) | JP6545806B2 (hr) |
KR (1) | KR101776879B1 (hr) |
CN (1) | CN107249634B (hr) |
DK (1) | DK3247394T3 (hr) |
ES (1) | ES2874593T3 (hr) |
HR (1) | HRP20210890T1 (hr) |
HU (1) | HUE054716T2 (hr) |
PL (1) | PL3247394T3 (hr) |
PT (1) | PT3247394T (hr) |
SI (1) | SI3247394T1 (hr) |
WO (1) | WO2016117883A2 (hr) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102208378B1 (ko) * | 2017-08-17 | 2021-01-28 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
CN111665352B (zh) * | 2020-06-23 | 2024-05-17 | 广州市丹蓝生物科技有限公司 | 一种储存剂及由其制备的抗体溶液制剂及其应用 |
WO2024058201A1 (ja) * | 2022-09-16 | 2024-03-21 | 国立研究開発法人量子科学技術研究開発機構 | 放射性医薬組成物の中間体の製造方法、放射性医薬組成物の中間体の精製用キット |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR930010489B1 (ko) | 1991-06-05 | 1993-10-25 | 김경환 | 온상용 하우스의 지지골조 |
EP0831880A4 (en) | 1995-06-07 | 2004-12-01 | Imclone Systems Inc | ANTIBODIES AND FRAGMENTS OF ANTIBODIES INHIBITING TUMOR GROWTH |
US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
ATE454137T1 (de) * | 2001-07-25 | 2010-01-15 | Facet Biotech Corp | Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab |
DE10355251A1 (de) | 2003-11-26 | 2005-06-23 | Merck Patent Gmbh | Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor |
AU2006232378A1 (en) * | 2005-04-01 | 2006-10-12 | Amgen Inc. | Epidermal growth factor receptor gene copy number |
CA2654794A1 (en) * | 2006-06-14 | 2007-12-21 | Imclone Systems Incorporated | Lyophilized formulations of anti-egfr antibodies |
AU2007307107B2 (en) * | 2006-10-06 | 2011-11-03 | Amgen Inc. | Stable antibody formulations |
EP2089428B1 (en) | 2006-10-27 | 2013-11-20 | AbbVie Biotechnology Ltd | Crystalline anti-htnfalpha antibodies |
KR101108642B1 (ko) * | 2009-09-29 | 2012-02-09 | 주식회사 녹십자 | 표피 성장 인자 수용체에 특이적으로 결합하는 항체 |
RU2548772C2 (ru) | 2009-11-20 | 2015-04-20 | Биокон Лимитед | Составы антитела |
AU2010338305A1 (en) | 2009-12-29 | 2012-05-24 | F. Hoffmann-La Roche Ag | Antibody formulation |
CN102946861B (zh) * | 2010-03-01 | 2016-01-20 | 西托戴恩有限公司 | 浓缩蛋白制剂及其用途 |
CA2831957A1 (en) | 2011-04-07 | 2012-10-11 | Amgen Inc. | Novel egfr binding proteins |
US20150231220A1 (en) * | 2012-03-27 | 2015-08-20 | Mogam Biotechnology Research Institute | Epitopes of epidermal growth factor receptor surface antigen and use thereof |
BR112015014853A2 (pt) * | 2012-12-21 | 2017-08-22 | Glenmark Pharmaceuticals Sa | Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura |
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 |
MX2016003256A (es) * | 2013-09-12 | 2016-06-07 | Halozyme Inc | Anticuerpos modificados del receptor de factor de crecimiento anti-epidermico y metodos de uso de los mismos. |
-
2015
- 2015-01-19 KR KR1020150008677A patent/KR101776879B1/ko active IP Right Grant
-
2016
- 2016-01-15 EP EP16740356.7A patent/EP3247394B1/en active Active
- 2016-01-15 CN CN201680006198.1A patent/CN107249634B/zh active Active
- 2016-01-15 ES ES16740356T patent/ES2874593T3/es active Active
- 2016-01-15 PT PT167403567T patent/PT3247394T/pt unknown
- 2016-01-15 DK DK16740356.7T patent/DK3247394T3/da active
- 2016-01-15 JP JP2017537953A patent/JP6545806B2/ja active Active
- 2016-01-15 US US15/544,335 patent/US10918717B2/en active Active
- 2016-01-15 WO PCT/KR2016/000472 patent/WO2016117883A2/en active Application Filing
- 2016-01-15 PL PL16740356T patent/PL3247394T3/pl unknown
- 2016-01-15 HU HUE16740356A patent/HUE054716T2/hu unknown
- 2016-01-15 SI SI201631198T patent/SI3247394T1/sl unknown
-
2021
- 2021-06-04 HR HRP20210890TT patent/HRP20210890T1/hr unknown
Also Published As
Publication number | Publication date |
---|---|
WO2016117883A8 (en) | 2017-07-20 |
JP2018502139A (ja) | 2018-01-25 |
KR20160089136A (ko) | 2016-07-27 |
EP3247394B1 (en) | 2021-05-12 |
EP3247394A2 (en) | 2017-11-29 |
DK3247394T3 (da) | 2021-06-07 |
US10918717B2 (en) | 2021-02-16 |
SI3247394T1 (sl) | 2021-08-31 |
KR101776879B1 (ko) | 2017-09-08 |
PL3247394T3 (pl) | 2021-08-30 |
HUE054716T2 (hu) | 2021-09-28 |
US20170368175A1 (en) | 2017-12-28 |
ES2874593T3 (es) | 2021-11-05 |
WO2016117883A3 (en) | 2016-09-01 |
WO2016117883A2 (en) | 2016-07-28 |
PT3247394T (pt) | 2021-06-14 |
EP3247394A4 (en) | 2018-06-06 |
CN107249634A (zh) | 2017-10-13 |
CN107249634B (zh) | 2021-11-16 |
JP6545806B2 (ja) | 2019-07-17 |
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