JP2022500426A - クロストリジウム毒素−ヒアルロン酸組成物 - Google Patents

クロストリジウム毒素−ヒアルロン酸組成物 Download PDF

Info

Publication number
JP2022500426A
JP2022500426A JP2021514022A JP2021514022A JP2022500426A JP 2022500426 A JP2022500426 A JP 2022500426A JP 2021514022 A JP2021514022 A JP 2021514022A JP 2021514022 A JP2021514022 A JP 2021514022A JP 2022500426 A JP2022500426 A JP 2022500426A
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
hyaluronic acid
composition
salt
composition according
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
JP2021514022A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2020056371A5 (https=
JP2022500426A5 (https=
Inventor
シンディー ウー
ジェイムス カニンガム
マリアンヌ ド
ロン ブロイデ
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 JP2022500426A publication Critical patent/JP2022500426A/ja
Publication of JPWO2020056371A5 publication Critical patent/JPWO2020056371A5/ja
Publication of JP2022500426A5 publication Critical patent/JP2022500426A5/ja
Priority to JP2024098708A priority Critical patent/JP2024137952A/ja
Pending legal-status Critical Current

Links

Images

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
    • A61K9/08—Solutions
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • 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)
  • 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)
JP2021514022A 2018-09-13 2019-09-13 クロストリジウム毒素−ヒアルロン酸組成物 Pending JP2022500426A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024098708A JP2024137952A (ja) 2018-09-13 2024-06-19 クロストリジウム毒素－ヒアルロン酸組成物

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024098708A Division JP2024137952A (ja) 2018-09-13 2024-06-19 クロストリジウム毒素－ヒアルロン酸組成物

Publications (3)

Publication Number Publication Date
JP2022500426A true JP2022500426A (ja) 2022-01-04
JPWO2020056371A5 JPWO2020056371A5 (https=) 2022-09-21
JP2022500426A5 JP2022500426A5 (https=) 2022-09-21

Family

ID=68069925

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021514022A Pending JP2022500426A (ja) 2018-09-13 2019-09-13 クロストリジウム毒素−ヒアルロン酸組成物
JP2024098708A Pending JP2024137952A (ja) 2018-09-13 2024-06-19 クロストリジウム毒素－ヒアルロン酸組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024098708A Pending JP2024137952A (ja) 2018-09-13 2024-06-19 クロストリジウム毒素－ヒアルロン酸組成物

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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009511485A (ja) * 2005-10-06 2009-03-19 アラーガン、インコーポレイテッド 非タンパク質安定化クロストリジウム毒素医薬組成物
WO2009105369A1 (en) * 2008-02-22 2009-08-27 Allergan, Inc. Sustained release poloxamer containing pharmaceutical compositions
JP2012512162A (ja) * 2008-12-10 2012-05-31 アラーガン、インコーポレイテッド クロストリジウム毒素医薬組成物
US20120141532A1 (en) * 2007-12-12 2012-06-07 Blanda Wendy M Botulinum Toxin Formulation
JP2016540785A (ja) * 2013-12-12 2016-12-28 メディ−トックス インク 新しいボツリヌス毒素製剤の長期持続作用
WO2017148915A1 (en) * 2016-03-02 2017-09-08 Merz Pharma Gmbh & Co. Kgaa Composition comprising botulinum toxin
WO2018053004A2 (en) * 2016-09-13 2018-03-22 Allergan, Inc. Non-protein clostridial toxin compositions

Family Cites Families (9)

* 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
KR101604515B1 (ko) 2008-03-14 2016-03-17 알러간, 인코포레이티드 면역-기반 보툴리눔 독소 세로타입 ａ 활성 검정
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.

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009511485A (ja) * 2005-10-06 2009-03-19 アラーガン、インコーポレイテッド 非タンパク質安定化クロストリジウム毒素医薬組成物
US20120141532A1 (en) * 2007-12-12 2012-06-07 Blanda Wendy M Botulinum Toxin Formulation
WO2009105369A1 (en) * 2008-02-22 2009-08-27 Allergan, Inc. Sustained release poloxamer containing pharmaceutical compositions
JP2012512162A (ja) * 2008-12-10 2012-05-31 アラーガン、インコーポレイテッド クロストリジウム毒素医薬組成物
JP2016540785A (ja) * 2013-12-12 2016-12-28 メディ−トックス インク 新しいボツリヌス毒素製剤の長期持続作用
WO2017148915A1 (en) * 2016-03-02 2017-09-08 Merz Pharma Gmbh & Co. Kgaa Composition comprising botulinum toxin
WO2018053004A2 (en) * 2016-09-13 2018-03-22 Allergan, Inc. Non-protein clostridial toxin compositions
WO2018053021A1 (en) * 2016-09-13 2018-03-22 Allergan, Inc. Stabilized non-protein clostridial toxin compositions

Also Published As

Publication number Publication date
CA3112394A1 (en) 2020-03-19
EP3849512A1 (en) 2021-07-21
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

Similar Documents

Publication Publication Date Title
US12409211B2 (en) Non-protein Clostridial toxin compositions
US20230158129A1 (en) Clostridial toxin - hyaluronic acid compositions
HK40054617A (en) Clostridial toxin-hyaluronic acid compositions
HK40112145A (zh) 非蛋白质梭菌毒素组合物
NZ792036A (en) Stabilized non-protein clostridial toxin compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220912

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220912

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230612

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230615

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230817

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20240226