HRP20191923T1 - Postupci i sastavi za isporuku arilsulfataze a u cns - Google Patents

Postupci i sastavi za isporuku arilsulfataze a u cns Download PDF

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Publication number
HRP20191923T1
HRP20191923T1 HRP20191923TT HRP20191923T HRP20191923T1 HR P20191923 T1 HRP20191923 T1 HR P20191923T1 HR P20191923T T HRP20191923T T HR P20191923TT HR P20191923 T HRP20191923 T HR P20191923T HR P20191923 T1 HRP20191923 T1 HR P20191923T1
Authority
HR
Croatia
Prior art keywords
stable aqueous
optionally
concentration
polysorbate
formula
Prior art date
Application number
HRP20191923TT
Other languages
English (en)
Croatian (hr)
Inventor
Nazila Salamat-Miller
Katherine Taylor
Paul Campolieto
Zahra Shahrokh
Jing Pan
Lawrence Charnas
Teresa Leah Wright
Pericles Calias
Original Assignee
Shire Human Genetic Therapies, 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 Shire Human Genetic Therapies, Inc. filed Critical Shire Human Genetic Therapies, Inc.
Publication of HRP20191923T1 publication Critical patent/HRP20191923T1/hr

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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
    • 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)
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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
    • A61K47/26—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
    • A61K9/14—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • 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
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
HRP20191923TT 2010-06-25 2011-06-25 Postupci i sastavi za isporuku arilsulfataze a u cns HRP20191923T1 (hr)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US35885710P 2010-06-25 2010-06-25
US36078610P 2010-07-01 2010-07-01
US38786210P 2010-09-29 2010-09-29
US201161435710P 2011-01-24 2011-01-24
US201161442115P 2011-02-11 2011-02-11
US201161476210P 2011-04-15 2011-04-15
US201161495268P 2011-06-09 2011-06-09
EP11799037.4A EP2585104B1 (en) 2010-06-25 2011-06-25 Methods and compositions for cns delivery of arylsulfatase a
PCT/US2011/041926 WO2011163650A2 (en) 2010-06-25 2011-06-25 Methods and compositions for cns delivery of arylsulfatase a

Publications (1)

Publication Number Publication Date
HRP20191923T1 true HRP20191923T1 (hr) 2020-01-10

Family

ID=46888844

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191923TT HRP20191923T1 (hr) 2010-06-25 2011-06-25 Postupci i sastavi za isporuku arilsulfataze a u cns

Country Status (26)

Country Link
US (1) US9770410B2 (https=)
EP (3) EP3964230A1 (https=)
JP (1) JP6045493B2 (https=)
KR (5) KR102537084B1 (https=)
CN (1) CN103282046B (https=)
AU (5) AU2011270670B2 (https=)
BR (1) BR112012033216B1 (https=)
CA (1) CA2803003C (https=)
CY (2) CY1122282T1 (https=)
DK (1) DK2585104T3 (https=)
ES (1) ES2754776T3 (https=)
HR (1) HRP20191923T1 (https=)
IL (3) IL291556B2 (https=)
LT (1) LT2585104T (https=)
ME (1) ME03647B (https=)
MX (2) MX344795B (https=)
NZ (2) NZ605873A (https=)
PL (2) PL3626257T3 (https=)
RS (1) RS59468B1 (https=)
RU (1) RU2671503C2 (https=)
SI (1) SI2585104T1 (https=)
SM (1) SMT201900589T1 (https=)
TW (1) TWI667037B (https=)
UA (1) UA115650C2 (https=)
WO (1) WO2011163650A2 (https=)
ZA (1) ZA201300675B (https=)

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RS62620B1 (sr) 2010-06-25 2021-12-31 Shire Human Genetic Therapies Metode i kompozicije za isporuku cns akrilsulfataze a
SMT201600385T1 (it) 2010-06-25 2017-03-08 Shire Human Genetic Therapies Trasporto di agenti terapeutici all’snc
NZ605873A (en) 2010-06-25 2015-02-27 Shire Human Genetic Therapies Methods and compositions for cns delivery of arylsulfatase a
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Publication number Publication date
CA2803003A1 (en) 2011-12-29
ME03647B (me) 2020-07-20
CY1122282T1 (el) 2020-11-25
UA115650C2 (uk) 2017-12-11
KR20200035167A (ko) 2020-04-01
MX344795B (es) 2017-01-05
KR20180059580A (ko) 2018-06-04
IL291556B1 (en) 2023-10-01
AU2021236557B2 (en) 2025-01-30
NZ605873A (en) 2015-02-27
SMT201900589T1 (it) 2020-03-13
KR101997935B1 (ko) 2019-10-04
AU2025202376A1 (en) 2025-04-24
LT2585104T (lt) 2019-10-25
JP2013538788A (ja) 2013-10-17
PL3626257T3 (pl) 2022-03-28
MX2013000323A (es) 2013-06-05
EP2585104A2 (en) 2013-05-01
EP3626257B1 (en) 2021-08-04
NZ702799A (en) 2016-08-26
US20120009171A1 (en) 2012-01-12
TW201206464A (en) 2012-02-16
TWI667037B (zh) 2019-08-01
IL291556B2 (en) 2024-02-01
AU2011270670A1 (en) 2013-02-14
PL2585104T3 (pl) 2020-01-31
CA2803003C (en) 2022-11-22
CY1124910T1 (el) 2023-01-05
DK2585104T3 (da) 2019-10-14
EP2585104A4 (en) 2014-01-15
KR20230079472A (ko) 2023-06-07
CN103282046B (zh) 2015-05-13
BR112012033216B1 (pt) 2022-10-11
RU2012154574A (ru) 2014-07-27
KR20130135821A (ko) 2013-12-11
KR102094094B1 (ko) 2020-03-27
CN103282046A (zh) 2013-09-04
ES2754776T3 (es) 2020-04-20
AU2019204051A1 (en) 2019-08-29
WO2011163650A3 (en) 2013-06-13
US9770410B2 (en) 2017-09-26
EP3626257A1 (en) 2020-03-25
IL273854B (en) 2022-04-01
WO2011163650A2 (en) 2011-12-29
KR20210131449A (ko) 2021-11-02
AU2019204051B2 (en) 2021-07-22
EP2585104B1 (en) 2019-08-21
RU2671503C2 (ru) 2018-11-01
SI2585104T1 (sl) 2019-11-29
IL291556A (en) 2022-05-01
KR102537084B1 (ko) 2023-05-26
IL273854A (en) 2020-05-31
AU2021236557A1 (en) 2021-10-28
JP6045493B2 (ja) 2016-12-14
MX382443B (es) 2025-03-11
AU2011270670B2 (en) 2017-01-12
KR102318997B1 (ko) 2021-10-29
AU2017202289B2 (en) 2019-03-14
RS59468B1 (sr) 2019-11-29
BR112012033216A2 (pt) 2020-08-25
KR102720061B1 (ko) 2024-10-22
IL223758B (en) 2020-04-30
AU2017202289A1 (en) 2017-04-27
EP3964230A1 (en) 2022-03-09
ZA201300675B (en) 2017-11-29

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