MX2021005015A - Formulaciones farmaceuticas acuosas. - Google Patents
Formulaciones farmaceuticas acuosas.Info
- Publication number
- MX2021005015A MX2021005015A MX2021005015A MX2021005015A MX2021005015A MX 2021005015 A MX2021005015 A MX 2021005015A MX 2021005015 A MX2021005015 A MX 2021005015A MX 2021005015 A MX2021005015 A MX 2021005015A MX 2021005015 A MX2021005015 A MX 2021005015A
- Authority
- MX
- Mexico
- Prior art keywords
- aqueous pharmaceutical
- pharmaceutical formulations
- histidine
- pharmaceutical formulation
- stabilizing
- Prior art date
Links
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
- 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
-
- 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
- C07K16/2866—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 cytokines, lymphokines, interferons
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
En la presente se describe una formulación farmacéutica acuosa que comprende un anticuerpo específico para el receptor de interleucina (IL)-6, por ejemplo, Tocilizumab; y una cantidad efectiva de histidina para estabilizar el anticuerpo. De acuerdo con modalidades, la histidina se presenta en la formulación farmacéutica acuosa a una concentración de 50 mM a 200 mM para lograr el efecto estabilizante.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862753084P | 2018-10-31 | 2018-10-31 | |
PCT/CN2019/113112 WO2020088346A1 (en) | 2018-10-31 | 2019-10-24 | Aqueous pharmaceutical formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2021005015A true MX2021005015A (es) | 2021-07-21 |
Family
ID=70463495
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2021005015A MX2021005015A (es) | 2018-10-31 | 2019-10-24 | Formulaciones farmaceuticas acuosas. |
Country Status (11)
Country | Link |
---|---|
US (1) | US20210393783A1 (es) |
EP (1) | EP3873437A4 (es) |
JP (2) | JP7411652B2 (es) |
KR (1) | KR20210094552A (es) |
AU (1) | AU2019372568A1 (es) |
BR (1) | BR112021008155A2 (es) |
CA (1) | CA3117245A1 (es) |
IL (1) | IL282343A (es) |
MA (1) | MA54095A (es) |
MX (1) | MX2021005015A (es) |
WO (1) | WO2020088346A1 (es) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PE20212185A1 (es) | 2019-02-18 | 2021-11-11 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos |
EP4149421A1 (en) * | 2020-05-15 | 2023-03-22 | F. Hoffmann-La Roche AG | Prevention of visible particle formation in parenteral protein solutions |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
AR080428A1 (es) * | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
WO2012064627A2 (en) * | 2010-11-08 | 2012-05-18 | Genentech, Inc. | Subcutaneously administered anti-il-6 receptor antibody |
JP2019510078A (ja) * | 2016-02-23 | 2019-04-11 | セセン バイオ, インコーポレイテッド | Il−6アンタゴニスト製剤およびその使用 |
MA46334A (fr) * | 2016-09-27 | 2019-08-07 | Fresenius Kabi Deutschland Gmbh | Composition pharmaceutique liquide |
AU2017351805A1 (en) * | 2016-10-31 | 2019-04-11 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition |
CN107760760A (zh) * | 2017-09-28 | 2018-03-06 | 中国食品药品检定研究院 | 一种快速测定il‑6/il‑6受体抗体药物生物学活性的方法 |
-
2019
- 2019-10-24 US US17/290,092 patent/US20210393783A1/en active Pending
- 2019-10-24 BR BR112021008155-0A patent/BR112021008155A2/pt unknown
- 2019-10-24 CA CA3117245A patent/CA3117245A1/en active Pending
- 2019-10-24 WO PCT/CN2019/113112 patent/WO2020088346A1/en unknown
- 2019-10-24 MA MA054095A patent/MA54095A/fr unknown
- 2019-10-24 MX MX2021005015A patent/MX2021005015A/es unknown
- 2019-10-24 KR KR1020217016403A patent/KR20210094552A/ko unknown
- 2019-10-24 EP EP19879433.1A patent/EP3873437A4/en active Pending
- 2019-10-24 AU AU2019372568A patent/AU2019372568A1/en active Pending
- 2019-10-24 JP JP2021523191A patent/JP7411652B2/ja active Active
-
2021
- 2021-04-14 IL IL282343A patent/IL282343A/en unknown
-
2023
- 2023-12-25 JP JP2023218125A patent/JP2024041791A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
BR112021008155A2 (pt) | 2021-08-10 |
JP7411652B2 (ja) | 2024-01-11 |
MA54095A (fr) | 2022-02-09 |
AU2019372568A1 (en) | 2021-05-20 |
EP3873437A4 (en) | 2022-08-03 |
KR20210094552A (ko) | 2021-07-29 |
CA3117245A1 (en) | 2020-05-07 |
WO2020088346A1 (en) | 2020-05-07 |
JP2024041791A (ja) | 2024-03-27 |
JP2022506042A (ja) | 2022-01-17 |
US20210393783A1 (en) | 2021-12-23 |
EP3873437A1 (en) | 2021-09-08 |
IL282343A (en) | 2021-05-31 |
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