MX2020003413A - Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia. - Google Patents

Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia.

Info

Publication number
MX2020003413A
MX2020003413A MX2020003413A MX2020003413A MX2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A
Authority
MX
Mexico
Prior art keywords
rna
therapy
preparation
storage
present disclosure
Prior art date
Application number
MX2020003413A
Other languages
English (en)
Inventor
Heinrieh HAAS
Sebastian Horner
Borquez Isaae Hernan Esparza
Thomas Michael Hiller
Ferdia Bates
Original Assignee
BioNTech SE
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BioNTech SE filed Critical BioNTech SE
Publication of MX2020003413A publication Critical patent/MX2020003413A/es

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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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers
    • A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/713—Double-stranded nucleic acids or oligonucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • 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
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0008—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0075—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the delivery route, e.g. oral, subcutaneous
    • 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
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1277—Preparation processes; Proliposomes
    • 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
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente descripción se relaciona con un método para preparar partículas de lipoplejo-ARN para el suministro de ARN a los tejidos objetivo, después de la administración parenteral, en particular después de la administración intravenosa, y las composiciones que comprenden tales partículas de lipoplejo-ARN. La presente descripción también se relaciona con métodos que permiten preparar las partículas de lipoplejo-ARN de una manera industrial que cumple con las GMP. Además, la presente descripción se relaciona con un método y con composiciones para almacenar las partículas de lipoplejo-ARN sin la pérdida sustancial de la calidad del producto y en particular, sin la pérdida sustancial de la actividad del ARN.
MX2020003413A 2017-10-20 2018-10-18 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia. MX2020003413A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762574965P 2017-10-20 2017-10-20
PCT/EP2018/078587 WO2019077053A1 (en) 2017-10-20 2018-10-18 PREPARATION AND STORAGE OF APPROPRIATE LIPOSOMAL RNA FORMULATIONS FOR THERAPY

Publications (1)

Publication Number Publication Date
MX2020003413A true MX2020003413A (es) 2020-07-20

Family

ID=63965663

Family Applications (3)

Application Number Title Priority Date Filing Date
MX2020003413A MX2020003413A (es) 2017-10-20 2018-10-18 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia.
MX2024001210A MX2024001210A (es) 2017-10-20 2020-07-13 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia
MX2024001218A MX2024001218A (es) 2017-10-20 2020-07-13 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia.

Family Applications After (2)

Application Number Title Priority Date Filing Date
MX2024001210A MX2024001210A (es) 2017-10-20 2020-07-13 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia
MX2024001218A MX2024001218A (es) 2017-10-20 2020-07-13 Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia.

Country Status (23)

Country Link
US (3) US11395799B2 (es)
EP (2) EP3697384A1 (es)
JP (3) JP2021500324A (es)
KR (2) KR102762217B1 (es)
CN (3) CN111246845A (es)
AR (2) AR113782A1 (es)
AU (2) AU2018350846B2 (es)
CA (1) CA3078292A1 (es)
DK (1) DK3858333T3 (es)
ES (1) ES3062541T3 (es)
FI (1) FI3858333T3 (es)
HR (1) HRP20260181T1 (es)
IL (1) IL273852B1 (es)
LT (1) LT3858333T (es)
MX (3) MX2020003413A (es)
PL (1) PL3858333T3 (es)
PT (1) PT3858333T (es)
RS (1) RS67724B1 (es)
RU (1) RU2022103533A (es)
SG (1) SG11202002579SA (es)
TW (2) TW201927288A (es)
WO (1) WO2019077053A1 (es)
ZA (1) ZA202001675B (es)

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US20250108008A1 (en) 2025-04-03
IL273852B1 (en) 2026-04-01
MX2024001218A (es) 2024-02-12
DK3858333T3 (da) 2026-02-23
AU2018350846A1 (en) 2020-04-23
WO2019077053A1 (en) 2019-04-25
JP2023052184A (ja) 2023-04-11
US20200246267A1 (en) 2020-08-06
HRP20260181T1 (hr) 2026-03-27
BR112020007470A2 (pt) 2020-10-27
MX2024001210A (es) 2024-11-08
US20210161818A1 (en) 2021-06-03
JP2021500324A (ja) 2021-01-07
LT3858333T (lt) 2026-02-25
AU2023201185B2 (en) 2025-05-08
CN111246845A (zh) 2020-06-05
AR127361A2 (es) 2024-01-17
RU2020113577A3 (es) 2022-02-16
JP2025003984A (ja) 2025-01-14
PL3858333T3 (pl) 2026-03-23
AU2023201185A1 (en) 2023-04-06
AR113782A1 (es) 2020-06-10
KR20200100619A (ko) 2020-08-26
EP3697384A1 (en) 2020-08-26
US11395799B2 (en) 2022-07-26
ES3062541T3 (en) 2026-04-13
CA3078292A1 (en) 2019-04-25
CN114344486A (zh) 2022-04-15
TW202146031A (zh) 2021-12-16
ZA202001675B (en) 2021-07-28
AU2018350846B2 (en) 2022-12-08
EP3858333B1 (en) 2025-11-26
EP3858333A1 (en) 2021-08-04
KR20250024524A (ko) 2025-02-18
IL273852A (en) 2020-05-31
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