KR20050044365A - Igg 항체의 안정한 액상 약학 제형물 - Google Patents
Igg 항체의 안정한 액상 약학 제형물 Download PDFInfo
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- KR20050044365A KR20050044365A KR1020047006962A KR20047006962A KR20050044365A KR 20050044365 A KR20050044365 A KR 20050044365A KR 1020047006962 A KR1020047006962 A KR 1020047006962A KR 20047006962 A KR20047006962 A KR 20047006962A KR 20050044365 A KR20050044365 A KR 20050044365A
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- A—HUMAN NECESSITIES
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- 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
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- 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
- C07K16/249—Interferons
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- 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
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- 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
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- 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
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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
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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
- A61K9/08—Solutions
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- 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
-
- 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]
-
- 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]
- C07K16/246—IL-2
-
- 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
- C07K16/2851—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
- C07K16/2854—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
-
- 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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
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- Proteomics, Peptides & Aminoacids (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Abstract
Description
Na-숙시네이트(pH6.0) 및 Na-포스페이트(pH6.5) 완충액 중에서 5 및 45℃에서 T=0 및 T=4주에 형광 조명으로 결정된 시료의 투명도 | ||||||
시료 | 포스페이트T=0투명도 | 포스페이트T=3 주투명도, 5℃ | 포스페이트T=3 주투명도,45℃ | 숙시네이트T=0투명도 | 숙시네이트T=3 주투명도, 5℃ | 숙시네이트T=3 주투명도,45℃ |
Tween-80 | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
EDTA | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
NaCl | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
메티오닌 | 투명 | 투명 | 투명 | 투명 | 혼탁 | 투명 |
글리신 | 투명 | 투명 | 투명 | 투명 | 혼탁 | 투명 |
세린 | 투명 | 투명 | 투명 | 투명 | 혼탁 | 투명 |
프롤린 | 투명 | 투명 | 투명 | 투명 | 혼탁 | 투명 |
리신 | 투명 | 혼탁 | 투명 | 투명 | 혼탁 | 투명 |
MgCl2 | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
Tween-20 | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
글리세롤 | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
에탄올 | 투명 | 투명 | 투명 | 투명 | 투명 | 투명 |
Claims (13)
- 하기를 포함하는 안정한 액상 약학 제형물:약 pH 5.5 내지 약 pH 6.5 의 pH를 갖는 약 20-60mM 숙시네이트 완충액,약 0.01% - 0.1 % 폴리소르베이트,제형물의 등장성삼투압(isotonicity)에 기여하는 장성 조절제(tonicity modifier), 및 50mg/mL 초과의 항체.
- 하기를 포함하는 안정한 액상 약학 제형물:약 pH 5.5 내지 약 pH 6.5 의 pH를 갖는 약 30-70mM 히스티딘 완충액,약 0.01% - 0.1 % 폴리소르베이트,제형물의 등장성삼투압에 기여하는 장성 조절제, 및 50mg/mL 초과의 항체.
- 제 1 항 또는 제 2 항에 있어서, 상기 항체 농도가 100mg/mL을 초과하는 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 상기 장성 조절제가 NaCl 또는 MgCl2인 안정한 액상 약학 제형물.
- 제 4 항에 있어서, 상기 NaCl은 75 -150mM인 안정한 액상 약학 제형물.
- 제 4 항에 있어서, 상기 MgCl2가 1 -100mM인 안정한 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 상기 pH가 약 6.0 내지 6.5 인 안정한 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 상기 폴리소르베이트가 약 0.02 - 0.04%의 농도인 안정한 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 0.01 내지 0.5%의 EDTA를 추가로 함유하는 안정한 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 상기 제형물이 약 2-8℃에서 1년 이상 안정한, 안정한 액상 약학 제형물.
- 제 1 항 또는 제 2 항에 있어서, 상기 제형물이 약 23-27℃에서 6개월 이상 안정한, 안정한 액상 약학 제형물.
- 하기를 포함하는 액상 약학 제형물:약 pH 5.5 내지 약 pH 6.5 의 pH를 갖는 약 20-60mM 숙시네이트 완충액,약 0.01% - 0.05 % 폴리소르베이트,약 75-150mM 소디움 클로라이드, 및다클리주매브(Daclizumab), 플린토주매브(Flintozumab), HAIL-12 및 HuEP5C7로 이루어지는 군에서 선택된 50mg/mL 초과의 항체.
- 하기를 포함하는 액상 약학 제형물:약 pH 5.5 내지 약 pH 6.5 의 pH를 갖는 약 30-70mM 히스티딘 완충액,약 0.01% - 0.05 % 폴리소르베이트,약 75-150mM 소디움 클로라이드, 및다클리주매브, 플린토주매브, HAIL-12 및 HuEP5C7로 이루어지는 군에서 선택된 50mg/mL 초과의 항체.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US33750901P | 2001-11-08 | 2001-11-08 | |
US60/337,509 | 2001-11-08 |
Publications (2)
Publication Number | Publication Date |
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KR20050044365A true KR20050044365A (ko) | 2005-05-12 |
KR100913714B1 KR100913714B1 (ko) | 2009-08-24 |
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Application Number | Title | Priority Date | Filing Date |
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KR1020047006962A KR100913714B1 (ko) | 2001-11-08 | 2002-11-08 | Igg 항체의 안정한 액상 약학 제형물 |
Country Status (17)
Country | Link |
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US (3) | US20030138417A1 (ko) |
EP (1) | EP1441589B1 (ko) |
JP (2) | JP5290489B2 (ko) |
KR (1) | KR100913714B1 (ko) |
CN (1) | CN1292655C (ko) |
AT (1) | ATE556591T1 (ko) |
AU (1) | AU2002363339B2 (ko) |
CA (1) | CA2466034C (ko) |
CY (1) | CY2016044I1 (ko) |
DK (1) | DK1441589T3 (ko) |
ES (1) | ES2392073T3 (ko) |
HK (1) | HK1074750A1 (ko) |
IL (2) | IL161677A0 (ko) |
LU (1) | LU93314I2 (ko) |
NZ (1) | NZ532896A (ko) |
PT (1) | PT1441589E (ko) |
WO (1) | WO2003039485A2 (ko) |
Cited By (1)
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- 2002-11-08 CN CNB028267273A patent/CN1292655C/zh not_active Expired - Fee Related
- 2002-11-08 EP EP02802895A patent/EP1441589B1/en not_active Expired - Lifetime
- 2002-11-08 WO PCT/US2002/036093 patent/WO2003039485A2/en active Application Filing
- 2002-11-08 AT AT02802895T patent/ATE556591T1/de active
-
2004
- 2004-04-29 IL IL161677A patent/IL161677A/en active IP Right Grant
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2005
- 2005-08-17 HK HK05107139A patent/HK1074750A1/xx not_active IP Right Cessation
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2010
- 2010-11-24 US US12/954,512 patent/US20110070231A1/en not_active Abandoned
- 2010-12-10 JP JP2010276222A patent/JP2011068675A/ja active Pending
-
2011
- 2011-09-06 US US13/226,372 patent/US8465739B2/en not_active Expired - Lifetime
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2016
- 2016-11-17 LU LU93314C patent/LU93314I2/fr unknown
- 2016-12-09 CY CY2016044C patent/CY2016044I1/el unknown
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20150009593A (ko) * | 2012-05-18 | 2015-01-26 | 제넨테크, 인크. | 고농도 모노클로날 항체 제제 |
US12018091B2 (en) | 2012-05-18 | 2024-06-25 | Genentech, Inc. | High-concentration monoclonal antibody formulations |
Also Published As
Publication number | Publication date |
---|---|
PT1441589E (pt) | 2012-08-13 |
CN1292655C (zh) | 2007-01-03 |
JP2005508981A (ja) | 2005-04-07 |
US20110318343A1 (en) | 2011-12-29 |
HK1074750A1 (en) | 2005-11-25 |
JP2011068675A (ja) | 2011-04-07 |
DK1441589T3 (da) | 2012-08-06 |
NZ532896A (en) | 2007-08-31 |
CN1612689A (zh) | 2005-05-04 |
AU2002363339B2 (en) | 2008-02-07 |
CY2016044I2 (el) | 2017-07-12 |
LU93314I2 (ko) | 2019-11-20 |
EP1441589A2 (en) | 2004-08-04 |
IL161677A0 (en) | 2004-09-27 |
CA2466034A1 (en) | 2003-05-15 |
KR100913714B1 (ko) | 2009-08-24 |
EP1441589A4 (en) | 2007-07-04 |
CA2466034C (en) | 2012-12-18 |
JP5290489B2 (ja) | 2013-09-18 |
WO2003039485A2 (en) | 2003-05-15 |
US20110070231A1 (en) | 2011-03-24 |
CY2016044I1 (el) | 2017-07-12 |
ATE556591T1 (de) | 2012-05-15 |
US8465739B2 (en) | 2013-06-18 |
EP1441589B1 (en) | 2012-05-09 |
ES2392073T3 (es) | 2012-12-04 |
IL161677A (en) | 2010-06-16 |
US20030138417A1 (en) | 2003-07-24 |
WO2003039485A3 (en) | 2004-02-12 |
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