AR128514A1 - Formulación líquida de toxina botulínica y su uso - Google Patents

Formulación líquida de toxina botulínica y su uso

Info

Publication number
AR128514A1
AR128514A1 ARP230100336A ARP230100336A AR128514A1 AR 128514 A1 AR128514 A1 AR 128514A1 AR P230100336 A ARP230100336 A AR P230100336A AR P230100336 A ARP230100336 A AR P230100336A AR 128514 A1 AR128514 A1 AR 128514A1
Authority
AR
Argentina
Prior art keywords
liquid formulation
serum albumin
human serum
botulinum toxin
tryptophan
Prior art date
Application number
ARP230100336A
Other languages
English (en)
Inventor
Eisele Karl Dr
- Dr Fink Klaus Heinz
Taylor Harold V Dr
Jatzke Claudia Dr
Khbach Katja Dr
Original Assignee
Merz Pharma Gmbh & 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 & Co Kgaa filed Critical Merz Pharma Gmbh & Co Kgaa
Publication of AR128514A1 publication Critical patent/AR128514A1/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
    • A61K9/0012Galenical 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
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • 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)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/44Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/06Anti-spasmodics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Birds (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

La presente invención está relacionada con una formulación líquida que comprende (i) toxina botulínica, (ii) albúmina de suero humano (ASH), y opcionalmente (iii) un agente de tonicidad y/o (iv) un agente de tamponamiento. En un aspecto, la formulación líquida está caracterizada por una concentración muy baja de iones férricos. En otro aspecto, la formulación líquida se caracteriza por la ausencia o la muy baja concentración de triptófano y/o N-acetil-triptófano. De acuerdo con la presente invención, la formulación líquida se puede preparar mediante un método que comprende los pasos de poner en contacto albúmina de suero humano con un agente quelante para obtener una mezcla y remover el agente quelante de la mezcla. Asimismo, la presente invención está relacionada con el uso de la formulación líquida para el tratamiento de indicaciones terapéuticas y afecciones cosméticas. Reivindicación 1: Una formulación líquida, que comprende (i) toxina botulínica y (ii) albúmina de suero humano, donde la formulación líquida contiene iones de Fe³⁺ en una concentración menor que 1 mM, preferentemente menor que 500 nM, y más preferentemente menor que 250 nM. Reivindicación 2: Una formulación líquida, que comprende (i) toxina botulínica y (ii) albúmina de suero humano, donde la formulación líquida no contiene o no contiene más de 50 mM de triptófano y N-acetil-triptófano. Reivindicación 6: La formulación líquida de cualquiera de las reivindicaciones 1 a 5, donde la albúmina de suero humano está presente en la formulación líquida en una cantidad de 0,001 - 1,00% p/v.
ARP230100336A 2022-02-15 2023-02-14 Formulación líquida de toxina botulínica y su uso AR128514A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22156843 2022-02-15
EP22183172 2022-07-05

Publications (1)

Publication Number Publication Date
AR128514A1 true AR128514A1 (es) 2024-05-15

Family

ID=85202119

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP230100336A AR128514A1 (es) 2022-02-15 2023-02-14 Formulación líquida de toxina botulínica y su uso

Country Status (7)

Country Link
KR (1) KR20240141340A (es)
AR (1) AR128514A1 (es)
AU (1) AU2023221507A1 (es)
CO (1) CO2024010940A2 (es)
IL (1) IL315004A (es)
TW (1) TW202348248A (es)
WO (1) WO2023156389A1 (es)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060269575A1 (en) * 2000-02-08 2006-11-30 Allergan, Inc. Botulinum toxin pharmaceutical compositions formulated with recombinant albumin
US7780967B2 (en) * 2000-02-08 2010-08-24 Allergan, Inc. Reduced toxicity Clostridial toxin pharmaceutical compositions
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
SI2271670T1 (sl) 2008-03-14 2015-01-30 Allergan, Inc. Preizkusi aktivnosti serotipa A botulin toksina na podlagi imunosti
ES2615281T3 (es) * 2009-06-24 2017-06-06 Charles N.S. Soparkar Suplementación con cinc para aumentar la capacidad de respuesta al tratamiento con metaloproteasa
ES2653249T3 (es) 2011-09-29 2018-02-06 Cellsnap, Llc Composiciones y métodos para ensayos de toxigenicidad
RU2704808C2 (ru) 2013-06-28 2019-10-31 Мерц Фарма Гмбх Энд Ко. Кгаа Средства и способы для определения биологической активности полипептидов нейротоксина в клетках
RS62832B1 (sr) 2016-05-27 2022-02-28 Ipsen Biopharm Ltd Tečna neurotoksin formulacija stabilizovana sa triptofanom ili tirozinom

Also Published As

Publication number Publication date
IL315004A (en) 2024-10-01
AU2023221507A1 (en) 2024-08-08
KR20240141340A (ko) 2024-09-26
TW202348248A (zh) 2023-12-16
CO2024010940A2 (es) 2024-09-19
WO2023156389A1 (en) 2023-08-24

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