DOP2013000252A - FORMULACION PARA ANTICUERPO ANTI-a4ß7 - Google Patents
FORMULACION PARA ANTICUERPO ANTI-a4ß7Info
- Publication number
- DOP2013000252A DOP2013000252A DO2013000252A DO2013000252A DOP2013000252A DO P2013000252 A DOP2013000252 A DO P2013000252A DO 2013000252 A DO2013000252 A DO 2013000252A DO 2013000252 A DO2013000252 A DO 2013000252A DO P2013000252 A DOP2013000252 A DO P2013000252A
- Authority
- DO
- Dominican Republic
- Prior art keywords
- antibody
- formulations
- formulation
- antibody anti
- chelator
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 4
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 230000003078 antioxidant effect Effects 0.000 abstract 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000002738 chelating agent Substances 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
Classifications
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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
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- 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
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- 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
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- 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
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
- A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
-
- 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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—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 integrin superfamily
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Virology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Transplantation (AREA)
- Oncology (AREA)
- Emergency Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Endocrinology (AREA)
- Obesity (AREA)
- Communicable Diseases (AREA)
- Hematology (AREA)
- Tropical Medicine & Parasitology (AREA)
- AIDS & HIV (AREA)
Abstract
Se describen formulaciones de anticuerpo que comprenden una mezcla de un anticuerpo anti-a4ß7, un antioxidante o quelante y al menos Un aminoácido libre. Las formulaciones descritas pueden tener una estabilidad mejorada, una formación de agregados reducida o ambas. La presente invención proporciona además un regimen de dosificación seguro de estas formulaciones de anticuerpo que es fácil de seguir y que da como resultado una cantidad terapéuticamente eficaz del anticuerpo anti-a4ß7 in vivo.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161481522P | 2011-05-02 | 2011-05-02 | |
US201161544054P | 2011-10-06 | 2011-10-06 |
Publications (1)
Publication Number | Publication Date |
---|---|
DOP2013000252A true DOP2013000252A (es) | 2013-12-31 |
Family
ID=46147702
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DO2013000252A DOP2013000252A (es) | 2011-05-02 | 2013-10-29 | FORMULACION PARA ANTICUERPO ANTI-a4ß7 |
Country Status (37)
Country | Link |
---|---|
US (6) | US10040855B2 (es) |
EP (4) | EP3311834A1 (es) |
JP (5) | JP6190359B2 (es) |
KR (7) | KR102493433B1 (es) |
CN (4) | CN107998388B (es) |
AR (1) | AR086238A1 (es) |
AU (5) | AU2012250872B2 (es) |
CA (2) | CA2834900C (es) |
CL (3) | CL2013003145A1 (es) |
CO (1) | CO6801648A2 (es) |
CR (1) | CR20130556A (es) |
CY (1) | CY1119436T1 (es) |
DK (1) | DK2704742T3 (es) |
DO (1) | DOP2013000252A (es) |
EA (1) | EA032625B1 (es) |
EC (1) | ECSP22046340A (es) |
ES (1) | ES2646717T3 (es) |
GE (1) | GEP20186866B (es) |
HK (1) | HK1253911A1 (es) |
HR (1) | HRP20171457T1 (es) |
HU (1) | HUE036664T2 (es) |
IL (6) | IL305583A (es) |
LT (1) | LT2704742T (es) |
ME (1) | ME02858B (es) |
MX (4) | MX367097B (es) |
MY (1) | MY188820A (es) |
PE (1) | PE20141672A1 (es) |
PH (2) | PH12018502221A1 (es) |
PL (1) | PL2704742T3 (es) |
PT (1) | PT2704742T (es) |
RS (1) | RS56429B1 (es) |
SG (1) | SG194730A1 (es) |
SI (1) | SI2704742T1 (es) |
TW (5) | TWI832619B (es) |
UY (1) | UY34054A (es) |
WO (1) | WO2012151247A2 (es) |
ZA (2) | ZA201308168B (es) |
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HUE039605T2 (hu) | 2010-01-06 | 2019-01-28 | Dyax Corp | Plazma kallikreint kötõ proteinek |
PL2624865T3 (pl) * | 2010-10-06 | 2018-11-30 | Regeneron Pharmaceuticals, Inc. | Stabilizowane preparaty zawierające przeciwciała przeciwko receptorowi interleukiny-4 (IL-4R) |
KR102320178B1 (ko) | 2011-01-06 | 2021-11-02 | 다케다 파머수티컬 컴패니 리미티드 | 혈장 칼리크레인 결합 단백질 |
RU2604139C2 (ru) | 2011-01-28 | 2016-12-10 | Санофи Байотекнолоджи | Фармацевтические композиции, содержащие антитела к pcsk9 человека |
UA116189C2 (uk) | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
WO2012151247A2 (en) | 2011-05-02 | 2012-11-08 | Millennium Pharmaceuticals, Inc. | FORMULATION FOR ANTI-α4β7 ANTIBODY |
CA2840232A1 (en) | 2011-07-06 | 2013-01-10 | Nestec S.A. | Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha |
AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
US9764093B2 (en) * | 2012-11-30 | 2017-09-19 | Sio2 Medical Products, Inc. | Controlling the uniformity of PECVD deposition |
CA2906624A1 (en) | 2013-03-15 | 2014-09-25 | Dyax Corp. | Anti-plasma kallikrein antibodies |
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KR101712245B1 (ko) * | 2013-11-29 | 2017-03-06 | 아레스 트레이딩 에스.에이. | TNFR 및 면역글로블린 Fc 영역을 포함하는 융합 단백질을 포함하는 액상 제제 |
WO2015148790A1 (en) | 2014-03-27 | 2015-10-01 | Dyax Corp. | Compositions and methods for treatment of diabetic macular edema |
RU2713653C2 (ru) | 2014-10-06 | 2020-02-06 | Кемосентрикс, Инк. | КОМБИНИРОВАННАЯ ТЕРАПИЯ ИНГИБИТОРАМИ С-С ХЕМОКИНОВОГО РЕЦЕПТОРА 9 (CCR9) И АНТИТЕЛАМИ, БЛОКИРУЮЩИМИ α4β7-ИНТЕГРИН |
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