JP6043627B2 - アルブミン非含有ボツリヌス毒素製剤 - Google Patents

アルブミン非含有ボツリヌス毒素製剤 Download PDF

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Publication number
JP6043627B2
JP6043627B2 JP2012517802A JP2012517802A JP6043627B2 JP 6043627 B2 JP6043627 B2 JP 6043627B2 JP 2012517802 A JP2012517802 A JP 2012517802A JP 2012517802 A JP2012517802 A JP 2012517802A JP 6043627 B2 JP6043627 B2 JP 6043627B2
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Prior art keywords
botulinum toxin
liquid composition
positively charged
gly
lyophilizate
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Expired - Fee Related
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JP2012517802A
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Japanese (ja)
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JP2012531442A5 (enExample
JP2012531442A (ja
Inventor
スチュアート エイ. トンプソン
スチュアート エイ. トンプソン
カーチス エル. リュエッグ
カーチス エル. リュエッグ
ジェイコブ エム. ウォー
ジェイコブ エム. ウォー
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Revance Therapeuticals Inc
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Revance Therapeuticals Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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)
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    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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    • 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
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    • 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
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/494Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
    • A61K8/4946Imidazoles or their condensed derivatives, e.g. benzimidazoles
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    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4993Derivatives containing from 2 to 10 oxyalkylene groups
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
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    • A61K8/66Enzymes
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    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
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    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
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    • AHUMAN NECESSITIES
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    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
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    • 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
    • AHUMAN NECESSITIES
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    • 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
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/008Preparations for oily skin
    • AHUMAN NECESSITIES
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    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/08Anti-ageing preparations
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Birds (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • Toxicology (AREA)
  • Rheumatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
JP2012517802A 2009-06-25 2010-06-25 アルブミン非含有ボツリヌス毒素製剤 Expired - Fee Related JP6043627B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US22043309P 2009-06-25 2009-06-25
US61/220,433 2009-06-25
PCT/US2010/040104 WO2010151840A2 (en) 2009-06-25 2010-06-25 Albumin-free botulinum toxin formulations

Publications (3)

Publication Number Publication Date
JP2012531442A JP2012531442A (ja) 2012-12-10
JP2012531442A5 JP2012531442A5 (enExample) 2013-08-08
JP6043627B2 true JP6043627B2 (ja) 2016-12-14

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JP2012517802A Expired - Fee Related JP6043627B2 (ja) 2009-06-25 2010-06-25 アルブミン非含有ボツリヌス毒素製剤

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Country Link
US (6) US9340587B2 (enExample)
EP (1) EP2445521A4 (enExample)
JP (1) JP6043627B2 (enExample)
KR (5) KR20210141783A (enExample)
CN (1) CN102869373B (enExample)
AU (1) AU2010265888A1 (enExample)
BR (1) BRPI1015938A2 (enExample)
CA (1) CA2766521C (enExample)
CO (1) CO6491076A2 (enExample)
IL (2) IL268980B (enExample)
MX (3) MX344583B (enExample)
SG (1) SG177357A1 (enExample)
WO (1) WO2010151840A2 (enExample)

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BRPI0513850A (pt) * 2004-07-26 2008-05-20 Merz Pharma Gmbh & Co Kgaa composição terapêutica com uma neurotoxina botulìnica
BRPI0608249A2 (pt) * 2005-03-03 2009-12-08 Revance Therapeutics Inc formulação, método para aplicação tópica e kit para distribuição transdérmica de toxina botulìnica
US8168206B1 (en) * 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
HRP20180739T1 (hr) 2008-12-31 2018-06-29 Revance Therapeutics, Inc. Injekcijske formulacije botulinskog toksina
CA2766521C (en) * 2009-06-25 2020-07-21 Revance Therapeutics, Inc. Albumin-free botulinum toxin formulations
JP5951490B2 (ja) * 2009-10-21 2016-07-13 ルバンス セラピュティックス インク.Revance Therapeutics,Inc. 非複合ボツリヌス神経毒素を精製するための方法およびシステム
HRP20171483T1 (hr) 2011-01-07 2017-12-01 Revance Therapeutics, Inc. Topikalni pripravak koji se sastoji od botulinskog toksina i boje
MX2014011376A (es) 2012-03-22 2014-10-14 Revance Therapeutics Inc Metodo de tratamiento de arrugas mediante agentes quimiodenervantes topicos.
US20140242110A1 (en) * 2013-02-28 2014-08-28 Dt Scimed, Llc Dose, localization, and formulation of botulinum toxins in skin and muscle
MX369534B (es) * 2013-09-08 2019-11-11 Pfizer Composiciones de neisseria meningitidis y sus metodos.
US9480731B2 (en) 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
US9943576B2 (en) * 2014-04-30 2018-04-17 Allergan, Inc. Formulations of biologics for intravesical instillation
JP6798993B2 (ja) 2014-12-23 2020-12-09 メルツ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディト ゲゼルシャフト アウフ アクティーン ボツリヌス毒素プレフィルド容器
WO2016124213A1 (en) * 2015-02-03 2016-08-11 Merz Pharma Gmbh & Co. Kgaa Botulinum toxin prefilled container
SG10202004337WA (en) * 2015-10-29 2020-06-29 Revance Therapeutics Inc Injectable botulinum toxin formulations and methods of use thereof having long duration of therapeutic or cosmetic effect
WO2018038301A1 (en) 2016-08-26 2018-03-01 Hugel Inc. Stabilized liquid formulation of botulinum toxin and preparation method thereof
WO2018038585A1 (ko) * 2016-08-26 2018-03-01 주식회사 에이비바이오 보툴리눔 독소 및 안정화제를 포함하는 액상 제형 및 이의 제조방법
HUE046449T2 (hu) * 2016-09-13 2020-03-30 Allergan Inc Stabilizált, nem fehérje eredetû, clostridiális toxin készítmények
US11311496B2 (en) * 2016-11-21 2022-04-26 Eirion Therapeutics, Inc. Transdermal delivery of large agents
KR101744900B1 (ko) * 2017-01-20 2017-06-08 주식회사 대웅 보툴리눔 독소를 포함하는 안정한 액상 조성물
WO2018213710A1 (en) * 2017-05-18 2018-11-22 Revance Therapeutics, Inc. Methods of treatment for cervical dystonia
EP3641746B1 (en) 2017-06-19 2024-11-20 President And Fellows Of Harvard College Methods and compositions for treating a microbial infection
CA3068292A1 (en) * 2017-06-26 2019-01-03 Bonti, Inc. Clostridial neurotoxin formulations and use
WO2019046311A1 (en) 2017-08-28 2019-03-07 Revance Therapeutics, Inc. TRANSMUCOSAL COMPOSITIONS OF BOTULINUM TOXIN, KITS AND METHODS FOR TREATING BLADDER DISORDERS
MX2020005785A (es) * 2017-12-04 2020-10-28 Revance Therapeutics Inc Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto.
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