JP2025504249A - 液体ボツリヌス毒素製剤及びその使用 - Google Patents

液体ボツリヌス毒素製剤及びその使用 Download PDF

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Publication number
JP2025504249A
JP2025504249A JP2024547688A JP2024547688A JP2025504249A JP 2025504249 A JP2025504249 A JP 2025504249A JP 2024547688 A JP2024547688 A JP 2024547688A JP 2024547688 A JP2024547688 A JP 2024547688A JP 2025504249 A JP2025504249 A JP 2025504249A
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JP
Japan
Prior art keywords
liquid formulation
chelating agent
serum albumin
human serum
botulinum toxin
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2024547688A
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English (en)
Japanese (ja)
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JP2025504249A5 (https=
Inventor
アイゼレ カール－ハインツ
フィンク クラウス
ファウ．テイラー ハロルド
ヤツケ クラウディア
キューバッハ カチヤ
Original Assignee
メルツ・ファルマ・ゲーエムベーハー・ウント・コー・カーゲーアーアー
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Application filed by メルツ・ファルマ・ゲーエムベーハー・ウント・コー・カーゲーアーアー filed Critical メルツ・ファルマ・ゲーエムベーハー・ウント・コー・カーゲーアーアー
Publication of JP2025504249A publication Critical patent/JP2025504249A/ja
Publication of JP2025504249A5 publication Critical patent/JP2025504249A5/ja
Pending legal-status Critical Current

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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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A61K38/385—Serum albumin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66—Enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/06—Anti-spasmodics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Birds (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
JP2024547688A 2022-02-15 2023-02-14 液体ボツリヌス毒素製剤及びその使用 Pending JP2025504249A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP22156843 2022-02-15
EP22156843.9 2022-02-15
EP22183172 2022-07-05
EP22183172.0 2022-07-05
PCT/EP2023/053647 WO2023156389A1 (en) 2022-02-15 2023-02-14 Liquid botulinum toxin formulation and use thereof

Publications (2)

Publication Number Publication Date
JP2025504249A true JP2025504249A (ja) 2025-02-06
JP2025504249A5 JP2025504249A5 (https=) 2026-01-21

Family

ID=85202119

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024547688A Pending JP2025504249A (ja) 2022-02-15 2023-02-14 液体ボツリヌス毒素製剤及びその使用

Country Status (13)

Country Link
US (1) US20250152682A1 (https=)
EP (1) EP4479023A1 (https=)
JP (1) JP2025504249A (https=)
KR (1) KR20240141340A (https=)
CN (1) CN119031902A (https=)
AR (1) AR128514A1 (https=)
AU (1) AU2023221507A1 (https=)
CA (1) CA3243238A1 (https=)
CO (1) CO2024010940A2 (https=)
IL (1) IL315004A (https=)
MX (1) MX2024009970A (https=)
TW (1) TW202348248A (https=)
WO (1) WO2023156389A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025228877A1 (en) 2024-04-29 2025-11-06 Merz Therapeutics GmbH Botulinum toxin for the preventive treatment of migraine
WO2026021713A1 (en) 2024-07-23 2026-01-29 Merz Therapeutics GmbH Uses of magnetic nerve stimulation associated with botulinum neurotoxin administration

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7780967B2 (en) * 2000-02-08 2010-08-24 Allergan, Inc. Reduced toxicity Clostridial toxin pharmaceutical compositions
US20060269575A1 (en) * 2000-02-08 2006-11-30 Allergan, Inc. Botulinum toxin pharmaceutical compositions formulated with recombinant albumin
JP2006045173A (ja) * 2004-08-09 2006-02-16 Hidetoshi Tsuchida 表面修飾血清アルブミン−金属ポルフィリン複合体、およびそれを含有する酸素輸液
PT2271670E (pt) 2008-03-14 2014-11-28 Allergan Inc Ensaio imunobaseado da atividade do serotipo a da toxina botulínica
CA2766649C (en) * 2009-06-24 2016-08-23 Charles N.S. Soparkar Zinc supplementation to increase responsiveness to metalloprotease therapy
ES2653249T3 (es) 2011-09-29 2018-02-06 Cellsnap, Llc Composiciones y métodos para ensayos de toxigenicidad
AU2014301116B2 (en) 2013-06-28 2019-11-14 Merz Pharma Gmbh & Co. Kgaa Means and methods for the determination of the biological activity of Neurotoxin polypeptides in cells
PL3463432T3 (pl) * 2016-05-27 2021-04-19 Ipsen Biopharm Limited Ciekła formulacja neurotoksyny stabilizowana tryptofanem lub tyrozyną

Also Published As

Publication number Publication date
MX2024009970A (es) 2024-09-18
US20250152682A1 (en) 2025-05-15
AR128514A1 (es) 2024-05-15
KR20240141340A (ko) 2024-09-26
TW202348248A (zh) 2023-12-16
CN119031902A (zh) 2024-11-26
WO2023156389A1 (en) 2023-08-24
CA3243238A1 (en) 2023-08-24
EP4479023A1 (en) 2024-12-25
IL315004A (en) 2024-10-01
CO2024010940A2 (es) 2024-09-19
AU2023221507A1 (en) 2024-08-08

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