CA3112394A1 - Clostridial toxin - hyaluronic acid compositions - Google Patents

Clostridial toxin - hyaluronic acid compositions Download PDF

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Publication number
CA3112394A1
CA3112394A1 CA3112394A CA3112394A CA3112394A1 CA 3112394 A1 CA3112394 A1 CA 3112394A1 CA 3112394 A CA3112394 A CA 3112394A CA 3112394 A CA3112394 A CA 3112394A CA 3112394 A1 CA3112394 A1 CA 3112394A1
Authority
CA
Canada
Prior art keywords
hyaluronic acid
pharmaceutical composition
composition
cross
salt
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
CA3112394A
Other languages
English (en)
French (fr)
Inventor
Cindy Wu
James Cunningham
Marianne DO
Ron Broide
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.)
Allergan Inc
Original Assignee
Allergan Inc
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 Allergan Inc filed Critical Allergan Inc
Publication of CA3112394A1 publication Critical patent/CA3112394A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/06Antiarrhythmics
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24Metalloendopeptidases (3.4.24)
    • C12Y304/24069Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Toxicology (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CA3112394A 2018-09-13 2019-09-13 Clostridial toxin - hyaluronic acid compositions Pending CA3112394A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862731063P 2018-09-13 2018-09-13
US62/731,063 2018-09-13
PCT/US2019/051173 WO2020056371A1 (en) 2018-09-13 2019-09-13 Clostridial toxin-hyaluronic acid compositions

Publications (1)

Publication Number Publication Date
CA3112394A1 true CA3112394A1 (en) 2020-03-19

Family

ID=68069925

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3112394A Pending CA3112394A1 (en) 2018-09-13 2019-09-13 Clostridial toxin - hyaluronic acid compositions

Country Status (10)

Country Link
US (2) US20200108129A1 (https=)
EP (1) EP3849512A1 (https=)
JP (2) JP2022500426A (https=)
KR (2) KR20210057129A (https=)
CN (1) CN112888454A (https=)
AU (1) AU2019339519A1 (https=)
BR (1) BR112021004771A2 (https=)
CA (1) CA3112394A1 (https=)
MX (2) MX2021002992A (https=)
WO (1) WO2020056371A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
BR112019004935A2 (pt) 2016-09-13 2019-06-04 Allergan, Inc. composições de toxina clostridial não proteíca estabilizada
CN115397399B (zh) * 2020-04-08 2025-06-27 玫帝托克斯股份有限公司 一种易于控制排出速度且稳定的肉毒杆菌毒素预填充式注射器剂型
US20240050538A1 (en) * 2020-12-18 2024-02-15 Atgc Co., Ltd. Pharmaceutical composition for long-term storage of liquid formulation of botulinum toxin
US20250295741A1 (en) 2022-11-07 2025-09-25 Allergan, Inc. Prevention of post-operative atrial fibrillation with a botulinum toxin
AU2023392523A1 (en) 2022-12-15 2025-04-10 Merz Pharma Gmbh & Co. Kgaa Injectable gel comprising botulinum toxin and uses thereof
WO2025151741A1 (en) * 2024-01-10 2025-07-17 Brown David Donaldson Methods of treating migraine headache or tension headache with hyaluronic acid

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4636524A (en) 1984-12-06 1987-01-13 Biomatrix, Inc. Cross-linked gels of hyaluronic acid and products containing such gels
US5099013A (en) 1985-03-12 1992-03-24 Biomatrix, Inc, Hylan preparation and method of recovery thereof from animal tissues
US4713448A (en) 1985-03-12 1987-12-15 Biomatrix, Inc. Chemically modified hyaluronic acid preparation and method of recovery thereof from animal tissues
US5143724A (en) 1990-07-09 1992-09-01 Biomatrix, Inc. Biocompatible viscoelastic gel slurries, their preparation and use
US7758872B1 (en) 2003-02-07 2010-07-20 Eric Finzi Method of treating depression
WO2006096163A1 (en) 2005-03-03 2006-09-14 Allergan, Inc. Animal product free system and process for purifying a botulinum toxin
AU2016204034B2 (en) * 2005-10-06 2017-12-21 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
US9044477B2 (en) * 2007-12-12 2015-06-02 Allergan, Inc. Botulinum toxin formulation
US9107815B2 (en) * 2008-02-22 2015-08-18 Allergan, Inc. Sustained release poloxamer containing pharmaceutical compositions
KR101604515B1 (ko) 2008-03-14 2016-03-17 알러간, 인코포레이티드 면역-기반 보툴리눔 독소 세로타입 a 활성 검정
KR20110106346A (ko) * 2008-12-10 2011-09-28 알러간, 인코포레이티드 클로스트리디움 독소 약제학적 조성물
MX2011009621A (es) 2009-03-13 2011-12-16 Allergan Inc Celulas utiles para ensayos de actividad del serotipo a de la toxina botulinica baados en inmunoensayos.
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
MX395130B (es) * 2016-03-02 2025-03-24 Merz Pharma Gmbh & Co Kgaa Composicion que comprende toxina botulinica
BR112019004935A2 (pt) * 2016-09-13 2019-06-04 Allergan, Inc. composições de toxina clostridial não proteíca estabilizada

Also Published As

Publication number Publication date
EP3849512A1 (en) 2021-07-21
JP2022500426A (ja) 2022-01-04
CN112888454A (zh) 2021-06-01
US20230158129A1 (en) 2023-05-25
US20200108129A1 (en) 2020-04-09
KR20250124258A (ko) 2025-08-19
WO2020056371A1 (en) 2020-03-19
KR20210057129A (ko) 2021-05-20
JP2024137952A (ja) 2024-10-07
MX2024007080A (es) 2024-06-21
AU2019339519A1 (en) 2021-05-06
BR112021004771A2 (pt) 2021-11-09
MX2021002992A (es) 2021-11-12

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