AR115713A1 - FORMULACIÓN ESTABLE DE ALTA CONCENTRACIÓN PARA ANTICUERPOS ANTI-FXIa - Google Patents
FORMULACIÓN ESTABLE DE ALTA CONCENTRACIÓN PARA ANTICUERPOS ANTI-FXIaInfo
- Publication number
- AR115713A1 AR115713A1 ARP190101919A ARP190101919A AR115713A1 AR 115713 A1 AR115713 A1 AR 115713A1 AR P190101919 A ARP190101919 A AR P190101919A AR P190101919 A ARP190101919 A AR P190101919A AR 115713 A1 AR115713 A1 AR 115713A1
- Authority
- AR
- Argentina
- Prior art keywords
- formulation
- high concentration
- formulations
- liquid
- liquid pharmaceutical
- Prior art date
Links
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
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K39/39591—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
- A61K47/10—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
- A61K47/16—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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
- F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
-
- 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)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Mechanical Engineering (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Genetics & Genomics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Drying Of Solid Materials (AREA)
- Glanulating (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
Formulaciones farmacéuticas líquidas de alta concentración particularmente adecuadas para la administración subcutánea, que comprenden anticuerpos humanos contra el factor de coagulación FXIa como ingrediente activo, en especial aquellos que se describen en el documento WO2013167669, que son estables como formulaciones líquidas durante un período largo. La presente también se refiere a liofilizados de la formulación líquida especificada con menor tiempo de reconstitución y también con el uso de estas formulaciones en la terapia y profilaxis de trastornos trombóticos o tromboembólicos. Reivindicación 1: Una formulación farmacéutica líquida estable caracterizada porque comprende el anticuerpo anti-FXIa 076D-M007-H04-CDRL3-N110D a una concentración de aproximadamente 100 mg/ml o más, histidina entre 10 y 20 mM, glicina entre 25 y 75 mM y arginina entre 50 y 75 mM, en donde la formulación tiene un pH de entre 4,7 y 5,3. Reivindicación 14: Liofilizado caracterizado porque se puede obtener mediante secado por congelamiento de una formulación farmacéutica líquida de acuerdo a una cualquiera de las reivindicaciones precedentes.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP2018068250 | 2018-07-05 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR115713A1 true AR115713A1 (es) | 2021-02-17 |
Family
ID=67139764
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP190101919A AR115713A1 (es) | 2018-07-05 | 2019-07-05 | FORMULACIÓN ESTABLE DE ALTA CONCENTRACIÓN PARA ANTICUERPOS ANTI-FXIa |
Country Status (15)
Country | Link |
---|---|
US (2) | US20210290534A1 (es) |
EP (2) | EP3817727A1 (es) |
JP (2) | JP2021529801A (es) |
KR (2) | KR20210028673A (es) |
CN (2) | CN112367975A (es) |
AR (1) | AR115713A1 (es) |
AU (2) | AU2019298656A1 (es) |
BR (2) | BR112020026789A2 (es) |
CA (2) | CA3105261A1 (es) |
IL (2) | IL279865A (es) |
MX (2) | MX2021000037A (es) |
PE (2) | PE20210462A1 (es) |
SG (2) | SG11202100028PA (es) |
TW (1) | TW202034898A (es) |
WO (2) | WO2020008035A1 (es) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR112020026789A2 (pt) * | 2018-07-05 | 2021-03-30 | Bayer Aktiengesellschaft | Formulação de alta concentração estável para anticorpos anti-fxia |
KR20230118167A (ko) * | 2020-12-11 | 2023-08-10 | 베링거 인겔하임 인터내셔날 게엠베하 | 다목적 적용을 위한 제형 |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2229043C (en) | 1995-08-18 | 2016-06-07 | Morphosys Gesellschaft Fur Proteinoptimierung Mbh | Protein/(poly)peptide libraries |
US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
WO2006008006A1 (en) | 2004-07-23 | 2006-01-26 | Bayer Technology Services Gmbh | Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) |
CA2701032C (en) | 2007-09-27 | 2021-01-26 | Amgen Inc. | Pharmaceutical formulations |
EP2578975A1 (en) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Rotary drum freeze-dryer |
EP2578974A1 (en) * | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Process line for the production of freeze-dried particles |
LT2847228T (lt) * | 2012-05-10 | 2018-11-12 | Bayer Pharma Aktiengesellschaft | Antikūnai, galintys jungtis prie koaguliacijos faktoriaus xi ir (arba) jo aktyvuotos formos faktoriaus xia, ir jų panaudojimas |
US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
CN104768578A (zh) | 2012-10-25 | 2015-07-08 | 米迪缪尼有限公司 | 稳定的低粘度抗体配制品 |
AU2015335743B2 (en) | 2014-10-23 | 2020-12-24 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
EP3167877A1 (en) * | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Method for the production of freeze-dried pellets comprising factor viii |
JP2019511531A (ja) * | 2016-04-13 | 2019-04-25 | メディミューン,エルエルシー | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 |
EP3254671B1 (en) * | 2016-06-10 | 2019-11-13 | Octapharma AG | High concentration immunoglobulin composition for pharmaceutical application |
US11168147B2 (en) * | 2016-12-23 | 2021-11-09 | Novartis Ag | Factor XI antibodies and methods of use |
BR112020026789A2 (pt) * | 2018-07-05 | 2021-03-30 | Bayer Aktiengesellschaft | Formulação de alta concentração estável para anticorpos anti-fxia |
-
2019
- 2019-07-05 BR BR112020026789-9A patent/BR112020026789A2/pt unknown
- 2019-07-05 AR ARP190101919A patent/AR115713A1/es unknown
- 2019-07-05 AU AU2019298656A patent/AU2019298656A1/en active Pending
- 2019-07-05 JP JP2021500070A patent/JP2021529801A/ja active Pending
- 2019-07-05 WO PCT/EP2019/068106 patent/WO2020008035A1/en active Application Filing
- 2019-07-05 MX MX2021000037A patent/MX2021000037A/es unknown
- 2019-07-05 KR KR1020217003293A patent/KR20210028673A/ko active Search and Examination
- 2019-07-05 CA CA3105261A patent/CA3105261A1/en not_active Abandoned
- 2019-07-05 SG SG11202100028PA patent/SG11202100028PA/en unknown
- 2019-07-05 US US17/257,827 patent/US20210290534A1/en not_active Abandoned
- 2019-07-05 CN CN201980044750.XA patent/CN112367975A/zh active Pending
- 2019-07-05 US US17/257,828 patent/US20210292434A1/en active Pending
- 2019-07-05 AU AU2019297498A patent/AU2019297498A1/en not_active Abandoned
- 2019-07-05 KR KR1020217003292A patent/KR20210029221A/ko unknown
- 2019-07-05 MX MX2021000028A patent/MX2021000028A/es unknown
- 2019-07-05 CA CA3105256A patent/CA3105256A1/en active Pending
- 2019-07-05 EP EP19735335.2A patent/EP3817727A1/en not_active Withdrawn
- 2019-07-05 SG SG11202100046UA patent/SG11202100046UA/en unknown
- 2019-07-05 PE PE2020002238A patent/PE20210462A1/es unknown
- 2019-07-05 WO PCT/EP2019/068071 patent/WO2020008022A1/en active Application Filing
- 2019-07-05 JP JP2021500069A patent/JP2021529800A/ja active Pending
- 2019-07-05 PE PE2020002228A patent/PE20210779A1/es unknown
- 2019-07-05 CN CN201980050959.7A patent/CN112543627A/zh active Pending
- 2019-07-05 EP EP19735338.6A patent/EP3817723A1/en active Pending
- 2019-07-05 TW TW108123732A patent/TW202034898A/zh unknown
- 2019-07-05 BR BR112020026492-0A patent/BR112020026492A2/pt not_active Application Discontinuation
-
2020
- 2020-12-30 IL IL279865A patent/IL279865A/en unknown
- 2020-12-30 IL IL279868A patent/IL279868A/en unknown
Also Published As
Publication number | Publication date |
---|---|
EP3817727A1 (en) | 2021-05-12 |
SG11202100028PA (en) | 2021-01-28 |
MX2021000037A (es) | 2021-03-25 |
KR20210029221A (ko) | 2021-03-15 |
BR112020026492A2 (pt) | 2021-04-06 |
JP2021529800A (ja) | 2021-11-04 |
JP2021529801A (ja) | 2021-11-04 |
AU2019297498A1 (en) | 2021-01-21 |
IL279868A (en) | 2021-03-01 |
IL279865A (en) | 2021-03-01 |
CA3105261A1 (en) | 2020-01-09 |
CN112367975A (zh) | 2021-02-12 |
CA3105256A1 (en) | 2020-01-09 |
BR112020026789A2 (pt) | 2021-03-30 |
US20210292434A1 (en) | 2021-09-23 |
MX2021000028A (es) | 2021-03-09 |
PE20210779A1 (es) | 2021-04-21 |
SG11202100046UA (en) | 2021-02-25 |
TW202034898A (zh) | 2020-10-01 |
WO2020008035A1 (en) | 2020-01-09 |
CN112543627A (zh) | 2021-03-23 |
WO2020008022A1 (en) | 2020-01-09 |
US20210290534A1 (en) | 2021-09-23 |
KR20210028673A (ko) | 2021-03-12 |
AU2019298656A1 (en) | 2021-01-28 |
EP3817723A1 (en) | 2021-05-12 |
PE20210462A1 (es) | 2021-03-08 |
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