AU2023222384A1 - Liquid botulinum toxin formulation and use thereof - Google Patents

Liquid botulinum toxin formulation and use thereof Download PDF

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Publication number
AU2023222384A1
AU2023222384A1 AU2023222384A AU2023222384A AU2023222384A1 AU 2023222384 A1 AU2023222384 A1 AU 2023222384A1 AU 2023222384 A AU2023222384 A AU 2023222384A AU 2023222384 A AU2023222384 A AU 2023222384A AU 2023222384 A1 AU2023222384 A1 AU 2023222384A1
Authority
AU
Australia
Prior art keywords
liquid formulation
present
botulinum toxin
hsa
edta
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
AU2023222384A
Other languages
English (en)
Inventor
Karl-Heinz Eisele
Klaus Fink
Claudia Jatzke
Katja KÜHBACH
Harold V. Taylor
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merz Pharma GmbH and Co KGaA
Original Assignee
Merz Pharma GmbH and Co KGaA
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 Merz Pharma GmbH and Co KGaA filed Critical Merz Pharma GmbH and Co KGaA
Publication of AU2023222384A1 publication Critical patent/AU2023222384A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • 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
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/27—Zinc; Compounds 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
    • A61K8/40—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
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/51—Chelating agents
    • 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)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Birds (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
AU2023222384A 2022-02-15 2023-02-14 Liquid botulinum toxin formulation and use thereof Pending AU2023222384A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP22156850 2022-02-15
EP22156850.4 2022-02-15
PCT/EP2023/053634 WO2023156385A1 (en) 2022-02-15 2023-02-14 Liquid botulinum toxin formulation and use thereof

Publications (1)

Publication Number Publication Date
AU2023222384A1 true AU2023222384A1 (en) 2024-08-08

Family

ID=80682748

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2023222384A Pending AU2023222384A1 (en) 2022-02-15 2023-02-14 Liquid botulinum toxin formulation and use thereof

Country Status (13)

Country Link
US (1) US20250161186A1 (https=)
EP (1) EP4479012A1 (https=)
JP (1) JP2025504247A (https=)
KR (1) KR20240150786A (https=)
CN (1) CN118829442A (https=)
AR (1) AR128515A1 (https=)
AU (1) AU2023222384A1 (https=)
CA (1) CA3243198A1 (https=)
CO (1) CO2024010938A2 (https=)
IL (1) IL314995A (https=)
MX (1) MX2024009969A (https=)
TW (1) TW202400223A (https=)
WO (1) WO2023156385A1 (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 (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06192118A (ja) * 1992-09-28 1994-07-12 Wisconsin Alumni Res Found ボツリヌス毒素を含む異常に過敏な筋運動障害の治療用薬剤組成物およびその製造方法
US7037680B2 (en) * 1993-09-21 2006-05-02 The United States Of America As Represented By The Secretary Of The Army Recombinant light chains of botulinum neurotoxins and light chain fusion proteins for use in research and clinical therapy
AU4746096A (en) * 1995-06-06 1996-12-24 Wisconsin Alumni Research Foundation Analogs of botulinum toxin and pharmaceutical compositions o f botulinum toxin
PT2271670E (pt) 2008-03-14 2014-11-28 Allergan Inc Ensaio imunobaseado da atividade do serotipo a da toxina botulínica
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
WO2017188618A1 (en) * 2016-04-26 2017-11-02 Korea Prime Pharm Co., Ltd. A novel composition comprising botulinum toxin
CA3060669A1 (en) * 2017-04-28 2018-11-01 Bonti, Inc. Botulinum neurotoxins production methods
MX2021014486A (es) * 2020-03-31 2022-01-04 Obi Pharma Inc Complejo de la toxina tipo a de clostridium botulinum, formulacion y uso del mismo.

Also Published As

Publication number Publication date
IL314995A (en) 2024-10-01
US20250161186A1 (en) 2025-05-22
JP2025504247A (ja) 2025-02-06
WO2023156385A1 (en) 2023-08-24
MX2024009969A (es) 2024-09-18
CA3243198A1 (en) 2023-08-24
KR20240150786A (ko) 2024-10-16
TW202400223A (zh) 2024-01-01
EP4479012A1 (en) 2024-12-25
CO2024010938A2 (es) 2024-09-19
AR128515A1 (es) 2024-05-15
CN118829442A (zh) 2024-10-22

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