CL2018002768A1 - Formulaciones que comprenden alfa-glucosidasa ácida recombinante - Google Patents

Formulaciones que comprenden alfa-glucosidasa ácida recombinante

Info

Publication number
CL2018002768A1
CL2018002768A1 CL2018002768A CL2018002768A CL2018002768A1 CL 2018002768 A1 CL2018002768 A1 CL 2018002768A1 CL 2018002768 A CL2018002768 A CL 2018002768A CL 2018002768 A CL2018002768 A CL 2018002768A CL 2018002768 A1 CL2018002768 A1 CL 2018002768A1
Authority
CL
Chile
Prior art keywords
glucosidase
recombinant acid
phosphate
formulations
acid alpha
Prior art date
Application number
CL2018002768A
Other languages
English (en)
Inventor
Russell Gotschall
Hung Do
Hing Char
Sergey Tesler
Wendy Sunderland
Enrique Diloné
Original Assignee
Amicus Therapeutics Inc
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 Amicus Therapeutics Inc filed Critical Amicus Therapeutics Inc
Publication of CL2018002768A1 publication Critical patent/CL2018002768A1/es

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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—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
    • A61K9/0087—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
    • A61K9/14—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
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2405—Glucanases
    • C12N9/2408—Glucanases acting on alpha -1,4-glucosidic bonds
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/0102—Alpha-glucosidase (3.2.1.20)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

FORMULACIONES FARMACÉUTICAS QUE COMPRENDEN UNA Α-GLUCOSIDASA ÁCIDA RECOMBINANTE, DONDE LA Α-GLUCOSIDASA ÁCIDA RECOMBINANTE SE EXPRESA EN CÉLULAS DE OVARIO DE HÁMSTER CHINO (CHO) Y TIENE UN CONTENIDO DE UNIDADES DE N-GLICANOS CON UNO O DOS RESIDUOS DE MANOSA-6-FOSFATO MAYOR QUE EL CONTENIDO DE UNIDADES DE N-GLICANOS CON UNO O DOS RESIDUOS DE MANOSA-6- FOSFATO DE LA ALGLUCOSIDASA ALFA; AL MENOS UN AMORTIGUADOR SELECCIONADO DEL GRUPO QUE CONSISTE EN EL CITRATO, EL FOSFATO Y LAS COMBINACIONES DE ÉSTOS; Y AL MENOS UN EXCIPIENTE SELECCIONADO DEL GRUPO QUE CONSISTE EN EL MANITOL, EL POLISORBATO 80 Y LAS COMBINACIONES DE ÉSTOS, DONDE LA FORMULACIÓN TIENE UN PH DE ENTRE APROXIMADAMENTE 5.0 Y APROXIMADAMENTE 7.0. MÉTODOS PARA TRATAR LA ENFERMEDAD DE POMPE DONDE SE USAN ESTAS FORMULACIONES FARMACÉUTICAS.
CL2018002768A 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa ácida recombinante CL2018002768A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662315436P 2016-03-30 2016-03-30
US201762457588P 2017-02-10 2017-02-10
US15/473,999 US10512676B2 (en) 2016-03-30 2017-03-30 Formulations comprising recombinant acid alpha-glucosidase

Publications (1)

Publication Number Publication Date
CL2018002768A1 true CL2018002768A1 (es) 2019-01-11

Family

ID=58632586

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2018002768A CL2018002768A1 (es) 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa ácida recombinante

Country Status (13)

Country Link
US (3) US10512676B2 (es)
JP (2) JP7510743B2 (es)
KR (3) KR102618519B1 (es)
AU (2) AU2017239641A1 (es)
BR (1) BR112018069965A2 (es)
CA (1) CA3019128A1 (es)
CL (1) CL2018002768A1 (es)
CO (1) CO2018011349A2 (es)
IL (4) IL283430B (es)
MX (2) MX2023003052A (es)
SG (1) SG11201808455VA (es)
WO (1) WO2017173060A1 (es)
ZA (2) ZA201807183B (es)

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WO2024151982A1 (en) * 2023-01-13 2024-07-18 Amicus Therapeutics, Inc. Gene therapy constructs for the treatment of pompe disease

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Also Published As

Publication number Publication date
KR102618519B1 (ko) 2023-12-28
KR20240001291A (ko) 2024-01-03
IL301319A (en) 2023-05-01
IL261995B (en) 2021-06-30
IL283430B (en) 2022-07-01
US20200171133A1 (en) 2020-06-04
US20170333534A1 (en) 2017-11-23
JP2022105010A (ja) 2022-07-12
ZA201807183B (en) 2020-01-29
IL283430A (en) 2021-06-30
US20240066104A1 (en) 2024-02-29
BR112018069965A2 (pt) 2019-01-29
KR102444612B1 (ko) 2022-09-21
AU2017239641A1 (en) 2018-10-18
IL294012B1 (en) 2023-04-01
CO2018011349A2 (es) 2019-02-08
JP2019510068A (ja) 2019-04-11
IL294012B2 (en) 2023-08-01
US10512676B2 (en) 2019-12-24
MX2023003052A (es) 2023-04-05
KR20220130258A (ko) 2022-09-26
MX2023003051A (es) 2023-04-05
WO2017173060A1 (en) 2017-10-05
AU2024203333A1 (en) 2024-06-20
US11491211B2 (en) 2022-11-08
ZA201906938B (en) 2024-02-28
CA3019128A1 (en) 2017-10-05
SG11201808455VA (en) 2018-10-30
IL294012A (en) 2022-08-01
JP7510743B2 (ja) 2024-07-04
KR20180124120A (ko) 2018-11-20
IL261995A (en) 2018-10-31

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