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PE20241337A1 - Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa - Google Patents

Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa

Info

Publication number
PE20241337A1
PE20241337A1 PE2024000465A PE2024000465A PE20241337A1 PE 20241337 A1 PE20241337 A1 PE 20241337A1 PE 2024000465 A PE2024000465 A PE 2024000465A PE 2024000465 A PE2024000465 A PE 2024000465A PE 20241337 A1 PE20241337 A1 PE 20241337A1
Authority
PE
Peru
Prior art keywords
pharmaceutical formulation
hyaluronidase
antibodies
aliquot
immunoglobulin
Prior art date
Application number
PE2024000465A
Other languages
English (en)
Inventor
Joris Hoefinghoff
Peter Leidenmuehler
Bagirath Gangadharan
Norbert Haider
Andras Nagy
Zhaoyang Li
Original Assignee
Takeda Pharmaceuticals Co
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 Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co
Publication of PE20241337A1 publication Critical patent/PE20241337A1/es

Links

Classifications

    • 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)
    • C12N9/2474Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • 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)
    • C12Y302/01035Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se proporciona una formulacion farmaceutica concentrada de una inmunoglobulina (IG), combinaciones, composiciones y kits que contienen una composicion de inmunoglobulina (IG) y una composicion de hialuronidasa soluble formuladas para administracion subcutanea. Dichos productos se pueden utilizar en metodos para tratar enfermedades o afecciones tratables con IG. En particular, se refiere a un kit que comprende: (a) un primer recipiente que comprende una formulacion farmaceutica de hialuronidasa humana recombinante en un portador farmaceuticamente aceptable; (b) un segundo recipiente que comprende una formulacion farmaceutica de IgG al 20% (p/v) en un portador farmaceuticamente aceptable; y (c) instrucciones que proporcionan orientacion para la infusion subcutanea secuencial en un primer sitio de infusion, (i), una primera alicuota de una dosis predeterminada de la formulacion farmaceutica de hialuronidasa humana recombinante y, (ii), despues de (i), una primera alicuota de una dosis predeterminada de la formulacion farmaceutica de IgG al 20% (p/v).
PE2024000465A 2021-09-14 2022-09-14 Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa PE20241337A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163243832P 2021-09-14 2021-09-14
PCT/IB2022/058670 WO2023042096A1 (en) 2021-09-14 2022-09-14 Facilitated delivery of concentrated antibody formulations using hyaluronidase

Publications (1)

Publication Number Publication Date
PE20241337A1 true PE20241337A1 (es) 2024-07-03

Family

ID=83508634

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2024000465A PE20241337A1 (es) 2021-09-14 2022-09-14 Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa

Country Status (15)

Country Link
US (1) US20240392273A1 (es)
EP (1) EP4401758A1 (es)
JP (1) JP2024535021A (es)
KR (1) KR20240055077A (es)
CN (1) CN118139636A (es)
AU (1) AU2022347379A1 (es)
CA (1) CA3232451A1 (es)
CL (1) CL2024000725A1 (es)
CR (1) CR20240161A (es)
EC (1) ECSP24028472A (es)
IL (1) IL311429A (es)
MX (1) MX2024003093A (es)
PE (1) PE20241337A1 (es)
TW (1) TW202327644A (es)
WO (1) WO2023042096A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202440064A (zh) 2022-12-22 2024-10-16 美商哈洛賽恩公司 用於高容量施予之玻尿酸酶調製劑

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ES2342456T3 (es) 2001-02-22 2010-07-07 Terumo Kabushiki Kaisha Bomba de jeringuilla.
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Also Published As

Publication number Publication date
MX2024003093A (es) 2024-04-08
AU2022347379A1 (en) 2024-03-21
CA3232451A1 (en) 2023-03-23
ECSP24028472A (es) 2024-05-31
JP2024535021A (ja) 2024-09-26
CN118139636A (zh) 2024-06-04
KR20240055077A (ko) 2024-04-26
EP4401758A1 (en) 2024-07-24
IL311429A (en) 2024-05-01
WO2023042096A1 (en) 2023-03-23
CR20240161A (es) 2024-08-23
US20240392273A1 (en) 2024-11-28
CL2024000725A1 (es) 2024-09-27
TW202327644A (zh) 2023-07-16

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