AR125301A1 - Formulaciones de l-asparaginasa - Google Patents

Formulaciones de l-asparaginasa

Info

Publication number
AR125301A1
AR125301A1 ARP220100846A ARP220100846A AR125301A1 AR 125301 A1 AR125301 A1 AR 125301A1 AR P220100846 A ARP220100846 A AR P220100846A AR P220100846 A ARP220100846 A AR P220100846A AR 125301 A1 AR125301 A1 AR 125301A1
Authority
AR
Argentina
Prior art keywords
asparaginase
formulations
formulation
treatable
treatment
Prior art date
Application number
ARP220100846A
Other languages
English (en)
Inventor
Roja Narwal
Sekhar Kanapuram
Haripada Maity
Guifeng Jiang
Original Assignee
Jazz Pharmaceuticals Ireland Ltd
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 Jazz Pharmaceuticals Ireland Ltd filed Critical Jazz Pharmaceuticals Ireland Ltd
Publication of AR125301A1 publication Critical patent/AR125301A1/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)
    • A61K38/50Hydrolases (3) acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y305/00Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
    • C12Y305/01Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in linear amides (3.5.1)
    • C12Y305/01001Asparaginase (3.5.1.1)

Landscapes

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

Abstract

En la presente se proporcionan aquí formulaciones estables, acuosas, no liofilizadas de L-asparaginasa. También se proporcionan en la presente métodos para utilizar dichas formulaciones en el tratamiento de una o más enfermedades, trastornos, o afecciones (por ejemplo, cánceres tales como la Leucemia Linfoblástica Aguda (ALL) o el Linfoma Linfoblástico (LBL)) que son tratables por medio de la depleción de asparagina. Reivindicación 1: Una formulación acuosa, no liofilizada, que comprende: (i) una L-asparaginasa, en donde la L-asparaginasa comprende cuatro unidades monoméricas, en donde cada unidad monomérica tiene una secuencia de aminoácidos que es al menos 70% idéntica a la SEQ ID Nº 1; y (ii) uno o más estabilizadores, o uno o más tampones, o cualquier combinación de los mismos. Reivindicación 32: Un kit, que comprende: (i) una formulación de cualquiera de las reivindicaciones 1 - 21; e (ii) instrucciones para el tratamiento de una enfermedad, afección, o trastorno que es tratable por medio de la depleción de asparagina en un sujeto que lo necesita. Reivindicación 38: Una forma de dosificación unitaria, que comprende: (i) una formulación de cualquiera de las reivindicaciones 1 - 21; y (ii) uno o más excipientes farmacéuticamente aceptables.
ARP220100846A 2021-04-06 2022-04-05 Formulaciones de l-asparaginasa AR125301A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202163171429P 2021-04-06 2021-04-06

Publications (1)

Publication Number Publication Date
AR125301A1 true AR125301A1 (es) 2023-07-05

Family

ID=81748398

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP220100846A AR125301A1 (es) 2021-04-06 2022-04-05 Formulaciones de l-asparaginasa

Country Status (12)

Country Link
EP (1) EP4319818A1 (es)
JP (1) JP2024515555A (es)
KR (1) KR20230165799A (es)
CN (1) CN117377494A (es)
AR (1) AR125301A1 (es)
AU (1) AU2022256071A1 (es)
BR (1) BR112023019862A2 (es)
CA (1) CA3213726A1 (es)
CL (1) CL2023002983A1 (es)
CO (1) CO2023014093A2 (es)
MX (1) MX2023011693A (es)
WO (1) WO2022217231A1 (es)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007103290A2 (en) 2006-03-03 2007-09-13 Government Of The United States Of America, Represented By The Secretary, Department Of Health And Human Services Materials and methods directed to asparagine synthetase and asparaginase therapies
EP3463308B1 (en) * 2016-06-01 2021-12-01 Servier IP UK Limited Formulations of polyalkylene oxide-asparaginase and methods of making and using the same
EP4048303A1 (en) * 2019-10-25 2022-08-31 Jazz Pharmaceuticals Ireland Ltd. Recombinant l-asparaginase

Also Published As

Publication number Publication date
MX2023011693A (es) 2023-12-15
CN117377494A (zh) 2024-01-09
EP4319818A1 (en) 2024-02-14
BR112023019862A2 (pt) 2023-11-07
AU2022256071A1 (en) 2023-10-19
CO2023014093A2 (es) 2023-10-30
JP2024515555A (ja) 2024-04-10
CL2023002983A1 (es) 2024-04-12
KR20230165799A (ko) 2023-12-05
WO2022217231A1 (en) 2022-10-13
CA3213726A1 (en) 2022-10-13

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