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MX2023003052A - Formulaciones que comprenden alfa-glucosidasa acida recombinante. - Google Patents

Formulaciones que comprenden alfa-glucosidasa acida recombinante.

Info

Publication number
MX2023003052A
MX2023003052A MX2023003052A MX2023003052A MX2023003052A MX 2023003052 A MX2023003052 A MX 2023003052A MX 2023003052 A MX2023003052 A MX 2023003052A MX 2023003052 A MX2023003052 A MX 2023003052A MX 2023003052 A MX2023003052 A MX 2023003052A
Authority
MX
Mexico
Prior art keywords
glucosidase
recombinant acid
formulations
acid alpha
mannose
Prior art date
Application number
MX2023003052A
Other languages
English (en)
Inventor
Hing Char
Sergey Tesler
Enrique Dilone
Hung Do
Russell Gotschall
Wendy Sunderland
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 MX2023003052A publication Critical patent/MX2023003052A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/24Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2405Glucanases
    • C12N9/2408Glucanases acting on alpha -1,4-glucosidic bonds
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/0102Alpha-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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulaciones farmacéuticas que comprenden una a-glucosidasa ácida recombinante, donde la a-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.
MX2023003052A 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa acida recombinante. MX2023003052A (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
MX2023003052A true MX2023003052A (es) 2023-04-05

Family

ID=58632586

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2023003051A MX2023003051A (es) 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa acida recombinante.
MX2023003052A MX2023003052A (es) 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa acida recombinante.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2023003051A MX2023003051A (es) 2016-03-30 2018-09-28 Formulaciones que comprenden alfa-glucosidasa acida recombinante.

Country Status (14)

Country Link
US (3) US10512676B2 (es)
JP (3) JP7510743B2 (es)
KR (4) KR102758570B1 (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) MX2023003051A (es)
NZ (1) NZ746713A (es)
SG (1) SG11201808455VA (es)
WO (1) WO2017173060A1 (es)
ZA (2) ZA201807183B (es)

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Also Published As

Publication number Publication date
IL283430B (en) 2022-07-01
BR112018069965A2 (pt) 2019-01-29
WO2017173060A1 (en) 2017-10-05
ZA201807183B (en) 2020-01-29
ZA201906938B (en) 2024-02-28
US20170333534A1 (en) 2017-11-23
MX2023003051A (es) 2023-04-05
SG11201808455VA (en) 2018-10-30
US20240066104A1 (en) 2024-02-29
US11491211B2 (en) 2022-11-08
JP2019510068A (ja) 2019-04-11
IL261995A (en) 2018-10-31
IL294012B2 (en) 2023-08-01
CL2018002768A1 (es) 2019-01-11
US10512676B2 (en) 2019-12-24
KR102444612B1 (ko) 2022-09-21
KR20250017756A (ko) 2025-02-04
IL261995B (en) 2021-06-30
NZ746713A (en) 2025-08-29
US20200171133A1 (en) 2020-06-04
JP7510743B2 (ja) 2024-07-04
AU2024203333A1 (en) 2024-06-20
KR102758570B1 (ko) 2025-01-23
KR20240001291A (ko) 2024-01-03
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IL294012A (en) 2022-08-01
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