CN118829442A - 液体肉毒杆菌毒素制剂及其用途 - Google Patents

液体肉毒杆菌毒素制剂及其用途 Download PDF

Info

Publication number
CN118829442A
CN118829442A CN202380022129.XA CN202380022129A CN118829442A CN 118829442 A CN118829442 A CN 118829442A CN 202380022129 A CN202380022129 A CN 202380022129A CN 118829442 A CN118829442 A CN 118829442A
Authority
CN
China
Prior art keywords
liquid formulation
botulinum toxin
present
liquid
hsa
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
CN202380022129.XA
Other languages
English (en)
Chinese (zh)
Inventor
卡尔-海因茨·艾泽勒
克劳斯·芬克
哈罗德·V·泰勒
克劳迪娅·亚茨克
卡特娅·屈巴赫
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 CN118829442A publication Critical patent/CN118829442A/zh
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)
CN202380022129.XA 2022-02-15 2023-02-14 液体肉毒杆菌毒素制剂及其用途 Pending CN118829442A (zh)

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
CN118829442A true CN118829442A (zh) 2024-10-22

Family

ID=80682748

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202380022129.XA Pending CN118829442A (zh) 2022-02-15 2023-02-14 液体肉毒杆菌毒素制剂及其用途

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
AU2023222384A1 (en) 2024-08-08

Similar Documents

Publication Publication Date Title
JP6235176B2 (ja) 非タンパク質安定化クロストリジウム毒素医薬組成物
AU2017394571B2 (en) Stable liquid composition comprising botulinum toxin
CN118829442A (zh) 液体肉毒杆菌毒素制剂及其用途
NZ520201A (en) Botulinum toxin pharmaceutical compositions comprising a polysaccharide
JP2024542906A (ja) ボツリヌス毒素を含む安定した液状製剤
CA3243238A1 (en) Formulation of liquid botulinum toxin and its use
JP7603832B2 (ja) 長期保存が可能なボツリヌス毒素凍結乾燥製剤組成物
HK40116988A (zh) 液体肉毒杆菌毒素制剂及其用途
TW202525330A (zh) 液體肉毒桿菌毒素製劑及其製作方法
KR20240060315A (ko) 보툴리눔 독소를 포함하는 안정한 액상 제제
KR20260052068A (ko) 보툴리눔 독소 액체 제형 및 그 용도
HK40113170A (zh) 液体肉毒杆菌毒素制剂及其用途
AU2016204034B2 (en) Non-protein stabilized clostridial toxin pharmaceutical compositions
AU2012202088B2 (en) Non-protein stabilized clostridial toxin pharmaceutical compositions
AU2013202329A1 (en) Non-protein stabilized clostridial toxin pharmaceutical compositions

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40116988

Country of ref document: HK