MX2021000037A - Nueva formulacion estable de alta concentracion para anticuerpos anti-fxia. - Google Patents
Nueva formulacion estable de alta concentracion para anticuerpos anti-fxia.Info
- Publication number
- MX2021000037A MX2021000037A MX2021000037A MX2021000037A MX2021000037A MX 2021000037 A MX2021000037 A MX 2021000037A MX 2021000037 A MX2021000037 A MX 2021000037A MX 2021000037 A MX2021000037 A MX 2021000037A MX 2021000037 A MX2021000037 A MX 2021000037A
- Authority
- MX
- Mexico
- Prior art keywords
- stable high
- formulations
- concentration formulation
- novel stable
- fxia antibodies
- Prior art date
Links
Classifications
-
- 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
- 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
- A61K9/16—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
- 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
-
- 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
-
- 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)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (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)
- Microbiology (AREA)
- Mycology (AREA)
- General Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Glanulating (AREA)
Abstract
Nuevas 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 periodo largo. La invención 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.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP2018068250 | 2018-07-05 | ||
PCT/EP2019/068106 WO2020008035A1 (en) | 2018-07-05 | 2019-07-05 | NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2021000037A true MX2021000037A (es) | 2021-03-25 |
Family
ID=67139764
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2021000028A MX2021000028A (es) | 2018-07-05 | 2019-07-05 | Metodo para la produccion de granulos liofilizados que comprenden un anticuerpo anti-factor xia (fxia) de la coagulacion. |
MX2021000037A MX2021000037A (es) | 2018-07-05 | 2019-07-05 | Nueva formulacion estable de alta concentracion para anticuerpos anti-fxia. |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2021000028A MX2021000028A (es) | 2018-07-05 | 2019-07-05 | Metodo para la produccion de granulos liofilizados que comprenden un anticuerpo anti-factor xia (fxia) de la coagulacion. |
Country Status (15)
Country | Link |
---|---|
US (2) | US20210290534A1 (es) |
EP (2) | EP3817723A1 (es) |
JP (2) | JP2021529800A (es) |
KR (2) | KR20210028673A (es) |
CN (2) | CN112367975A (es) |
AR (1) | AR115713A1 (es) |
AU (2) | AU2019297498A1 (es) |
BR (2) | BR112020026789A2 (es) |
CA (2) | CA3105261A1 (es) |
IL (2) | IL279865A (es) |
MX (2) | MX2021000028A (es) |
PE (2) | PE20210779A1 (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 |
---|---|---|---|---|
CA3105261A1 (en) * | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody |
EP4259200A1 (en) * | 2020-12-11 | 2023-10-18 | Boehringer Ingelheim International GmbH | Formulation for multi-purpose application |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE219517T1 (de) | 1995-08-18 | 2002-07-15 | Morphosys Ag | Protein-/(poly)peptidbibliotheken |
US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
AU2005263465B2 (en) * | 2004-07-23 | 2010-07-29 | Bayer Healthcare Llc | 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 |
HUE040580T2 (hu) * | 2012-05-10 | 2019-03-28 | Bayer Pharma AG | XI. véralvadási faktorhoz és/vagy XIA aktivált alakjához kötõdni képes ellenanyagok és alkalmazásuk |
US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
BR112015008186A2 (pt) | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
EA038462B1 (ru) | 2014-10-23 | 2021-08-31 | Эмджен Инк. | Снижение вязкости фармацевтических составов |
EP3167877A1 (en) * | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Method for the production of freeze-dried pellets comprising factor viii |
ES2962373T3 (es) * | 2016-04-13 | 2024-03-18 | Medimmune Llc | Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas |
EP3254671B1 (en) * | 2016-06-10 | 2019-11-13 | Octapharma AG | High concentration immunoglobulin composition for pharmaceutical application |
CN110325550B (zh) * | 2016-12-23 | 2024-03-08 | 诺华股份有限公司 | 因子xi抗体和使用方法 |
CA3105261A1 (en) * | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody |
-
2019
- 2019-07-05 CA CA3105261A patent/CA3105261A1/en not_active Abandoned
- 2019-07-05 MX MX2021000028A patent/MX2021000028A/es unknown
- 2019-07-05 BR BR112020026789-9A patent/BR112020026789A2/pt unknown
- 2019-07-05 WO PCT/EP2019/068106 patent/WO2020008035A1/en active Application Filing
- 2019-07-05 JP JP2021500069A patent/JP2021529800A/ja active Pending
- 2019-07-05 CN CN201980044750.XA patent/CN112367975A/zh active Pending
- 2019-07-05 US US17/257,827 patent/US20210290534A1/en active Pending
- 2019-07-05 MX MX2021000037A patent/MX2021000037A/es unknown
- 2019-07-05 BR BR112020026492-0A patent/BR112020026492A2/pt not_active Application Discontinuation
- 2019-07-05 EP EP19735338.6A patent/EP3817723A1/en active Pending
- 2019-07-05 SG SG11202100028PA patent/SG11202100028PA/en unknown
- 2019-07-05 US US17/257,828 patent/US20210292434A1/en active Pending
- 2019-07-05 PE PE2020002228A patent/PE20210779A1/es unknown
- 2019-07-05 WO PCT/EP2019/068071 patent/WO2020008022A1/en active Application Filing
- 2019-07-05 CN CN201980050959.7A patent/CN112543627A/zh active Pending
- 2019-07-05 PE PE2020002238A patent/PE20210462A1/es unknown
- 2019-07-05 TW TW108123732A patent/TW202034898A/zh unknown
- 2019-07-05 SG SG11202100046UA patent/SG11202100046UA/en unknown
- 2019-07-05 JP JP2021500070A patent/JP2021529801A/ja active Pending
- 2019-07-05 KR KR1020217003293A patent/KR20210028673A/ko active Search and Examination
- 2019-07-05 EP EP19735335.2A patent/EP3817727A1/en not_active Withdrawn
- 2019-07-05 AU AU2019297498A patent/AU2019297498A1/en not_active Abandoned
- 2019-07-05 KR KR1020217003292A patent/KR20210029221A/ko unknown
- 2019-07-05 AU AU2019298656A patent/AU2019298656A1/en active Pending
- 2019-07-05 CA CA3105256A patent/CA3105256A1/en active Pending
- 2019-07-05 AR ARP190101919A patent/AR115713A1/es unknown
-
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 |
---|---|
AU2019298656A1 (en) | 2021-01-28 |
PE20210779A1 (es) | 2021-04-21 |
SG11202100046UA (en) | 2021-02-25 |
IL279865A (en) | 2021-03-01 |
JP2021529801A (ja) | 2021-11-04 |
JP2021529800A (ja) | 2021-11-04 |
AU2019297498A1 (en) | 2021-01-21 |
KR20210028673A (ko) | 2021-03-12 |
WO2020008035A1 (en) | 2020-01-09 |
TW202034898A (zh) | 2020-10-01 |
AR115713A1 (es) | 2021-02-17 |
BR112020026492A2 (pt) | 2021-04-06 |
KR20210029221A (ko) | 2021-03-15 |
US20210292434A1 (en) | 2021-09-23 |
CN112543627A (zh) | 2021-03-23 |
WO2020008022A1 (en) | 2020-01-09 |
EP3817723A1 (en) | 2021-05-12 |
SG11202100028PA (en) | 2021-01-28 |
MX2021000028A (es) | 2021-03-09 |
BR112020026789A2 (pt) | 2021-03-30 |
US20210290534A1 (en) | 2021-09-23 |
CA3105256A1 (en) | 2020-01-09 |
EP3817727A1 (en) | 2021-05-12 |
CN112367975A (zh) | 2021-02-12 |
PE20210462A1 (es) | 2021-03-08 |
CA3105261A1 (en) | 2020-01-09 |
IL279868A (en) | 2021-03-01 |
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