DK3241547T3 - Lyofiliseret præparat af botulinumtoksin - Google Patents

Lyofiliseret præparat af botulinumtoksin Download PDF

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Publication number
DK3241547T3
DK3241547T3 DK17168989.6T DK17168989T DK3241547T3 DK 3241547 T3 DK3241547 T3 DK 3241547T3 DK 17168989 T DK17168989 T DK 17168989T DK 3241547 T3 DK3241547 T3 DK 3241547T3
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DK
Denmark
Prior art keywords
lyofilized
botulinum toxin
toxin preparation
preparation
botulinum
Prior art date
Application number
DK17168989.6T
Other languages
English (en)
Inventor
Hyun Ho Jung
Gi Hyeok Yang
Chang Hoon Rhee
Hack Woo Kim
Sung Bum Kim
Seung Hwan Baek
Original Assignee
Medy-Tox 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47282510&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3241547(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Medy-Tox Inc filed Critical Medy-Tox Inc
Application granted granted Critical
Publication of DK3241547T3 publication Critical patent/DK3241547T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • 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
    • 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
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • 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
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Toxicology (AREA)
  • Urology & Nephrology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
DK17168989.6T 2011-03-31 2012-03-30 Lyofiliseret præparat af botulinumtoksin DK3241547T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20110029577 2011-03-31
EP12765216.2A EP2692350B2 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin

Publications (1)

Publication Number Publication Date
DK3241547T3 true DK3241547T3 (da) 2020-08-17

Family

ID=47282510

Family Applications (2)

Application Number Title Priority Date Filing Date
DK12765216.2T DK2692350T4 (da) 2011-03-31 2012-03-30 Lyofiliseret præparat af botulinumtoksin
DK17168989.6T DK3241547T3 (da) 2011-03-31 2012-03-30 Lyofiliseret præparat af botulinumtoksin

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK12765216.2T DK2692350T4 (da) 2011-03-31 2012-03-30 Lyofiliseret præparat af botulinumtoksin

Country Status (22)

Country Link
US (3) US8920795B2 (da)
EP (3) EP3241547B1 (da)
JP (3) JP5826914B2 (da)
KR (1) KR101395064B1 (da)
CN (2) CN103596580A (da)
AU (2) AU2012233845B2 (da)
BR (1) BR112013025256B1 (da)
CA (1) CA2831908C (da)
CO (1) CO6821888A2 (da)
DK (2) DK2692350T4 (da)
ES (2) ES2810098T3 (da)
HK (1) HK1246174A1 (da)
HU (1) HUE050037T2 (da)
IL (1) IL228607B (da)
MX (2) MX338436B (da)
PL (2) PL2692350T5 (da)
PT (1) PT3241547T (da)
RU (2) RU2640922C1 (da)
SG (3) SG194039A1 (da)
SI (1) SI3241547T1 (da)
WO (1) WO2012134240A2 (da)
ZA (1) ZA201308115B (da)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100852822B1 (ko) * 2004-07-26 2008-08-18 메르츠 파마 게엠베하 운트 코. 카가아 보툴리눔 신경독소를 포함하는 치료 조성물
US8323666B2 (en) * 2005-08-01 2012-12-04 Allergan, Inc. Botulinum toxin compositions
JP5259710B2 (ja) * 2007-07-10 2013-08-07 メディ‐トックス、インク. ボツリヌス毒素の安定性が改善された薬学的液状組成物
DK3332805T3 (da) 2008-12-31 2022-05-16 Revance Therapeutics Inc Injicerbare botulinumtoksinformuleringer
BRPI1015938A2 (pt) * 2009-06-25 2016-09-27 Revance Therapeutics Inc formulações da toxina botulínica livre de albumina
EP3241547B1 (en) * 2011-03-31 2020-05-20 Medy-Tox Inc. Lyophilized preparation of botulinum toxin
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
DK3188706T3 (da) 2014-09-02 2020-01-20 American Silver Llc Botulinumtoksin og kolloide sølvpartikler
EP3207936B1 (en) * 2014-11-18 2021-04-21 Shionogi & Co., Ltd. Stable peptide composition
KR101737387B1 (ko) 2015-06-01 2017-05-18 유용우 2차 발효 홍삼을 이용한 건강기능식품의 제조방법
SG11201805195YA (en) * 2016-03-02 2018-07-30 Merz Pharma Gmbh & Co Kgaa Composition comprising botulinum toxin
KR20240023684A (ko) 2016-09-13 2024-02-22 알레간 인코포레이티드 안정화된 비단백질 클로스트리듐 독소 조성물
KR101744900B1 (ko) 2017-01-20 2017-06-08 주식회사 대웅 보툴리눔 독소를 포함하는 안정한 액상 조성물
CN107540732B (zh) * 2017-08-31 2020-07-14 青海省畜牧兽医科学院 一种d型肉毒毒素的仿生矿化加工方法及应用
KR101968873B1 (ko) * 2018-09-21 2019-04-29 아이큐어 주식회사 세포 침투 효과가 우수한 보툴리늄 유래 펩타이드를 포함하는 화장료 조성물
KR102259423B1 (ko) * 2018-11-30 2021-06-02 주식회사 휴온스바이오파마 보툴리눔 독소의 안정화 액상 조성물
WO2020111852A1 (ko) * 2018-11-30 2020-06-04 주식회사 휴온스글로벌 보툴리눔 독소의 안정화 액상 조성물
EP3927355A1 (en) 2019-02-21 2021-12-29 Merz Pharma GmbH & Co. KGaA Novel uses of botulinum neurotoxin for the treatment of tremor
CN110637814B (zh) * 2019-10-22 2021-11-19 青海省畜牧兽医科学院 一种d型肉毒毒素的微囊化制备方法
WO2021086123A1 (ko) * 2019-10-31 2021-05-06 휴젤㈜ 보툴리눔 독소에 대한 마이크로 구조체 제형화 기술
EP4186520A4 (en) 2020-07-23 2024-05-01 Medytox Inc. THERAPEUTIC AGENT AGAINST CANCER
KR102414997B1 (ko) * 2020-09-29 2022-06-29 주식회사 엘지생활건강 안정성이 개선된 재조합 보툴리눔 독소 경쇄 단백질 조성물
KR20220114183A (ko) * 2021-02-08 2022-08-17 주식회사 대웅 장기 저장이 가능한 보툴리눔 독소 동결건조 제형 조성물
KR20230001260A (ko) 2021-06-28 2023-01-04 (주)메디톡스 재조합 보툴리눔 독소 타입 a 경쇄, 재조합 보툴리눔 독소 및 이의 조성물, 용도 및 방법
KR20230001254A (ko) 2021-06-28 2023-01-04 (주)메디톡스 재조합 보툴리눔 독소 타입 a 경쇄, 재조합 보툴리눔 독소 및 이의 조성물, 용도 및 방법
KR102427362B1 (ko) 2021-11-11 2022-08-01 (주)이니바이오 보툴리눔 독소 제제의 건조 공정
CA3238234A1 (en) * 2021-11-15 2023-05-19 Medytox Inc. Botulinum neurotoxin composition

Family Cites Families (15)

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US5756468A (en) * 1994-10-13 1998-05-26 Wisconsin Alumni Research Foundation Pharmaceutical compositions of botulinum toxin or botulinum neurotoxin and methods of preparation
US20030118598A1 (en) 2000-02-08 2003-06-26 Allergan, Inc. Clostridial toxin pharmaceutical compositions
PT1398038E (pt) * 2000-02-08 2007-02-28 Allergan Inc Composições farmacêuticas de toxina botulínica
DE10333317A1 (de) 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
GB2416122A (en) 2004-07-12 2006-01-18 Ipsen Ltd Botulinum neurotoxin composition
US8323666B2 (en) * 2005-08-01 2012-12-04 Allergan, Inc. Botulinum toxin compositions
CN101175478A (zh) * 2005-10-06 2008-05-07 阿勒根公司 非蛋白稳定的梭菌毒素药物组合物
US8137677B2 (en) 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
MX2009012570A (es) * 2007-06-01 2010-03-15 Merz Pharma Gmbh & Co Kgaa Proceso para proveer un relajante muscular estable a la temperatura a base del componente neurotoxico de la toxina botulinica en forma solida.
JP5259710B2 (ja) * 2007-07-10 2013-08-07 メディ‐トックス、インク. ボツリヌス毒素の安定性が改善された薬学的液状組成物
CN105833254A (zh) * 2008-12-10 2016-08-10 阿勒根公司 梭菌毒素药物组合物
KR101135449B1 (ko) * 2009-03-10 2012-04-13 한국과학기술연구원 헤파라나제 활성 측정용 이온 복합체 나노 입자 및 그 제조방법
EP2248518B1 (en) * 2009-04-17 2013-01-16 Merz Pharma GmbH & Co. KGaA Formulation for stabilizing proteins, peptides or mixtures thereof.
EP3241547B1 (en) * 2011-03-31 2020-05-20 Medy-Tox Inc. Lyophilized preparation of botulinum toxin
US20130236446A1 (en) * 2012-03-12 2013-09-12 William J. Binder Treatment of migraine headache with diffusion of toxin in non-muscle related areas of the mouth

Also Published As

Publication number Publication date
SG10201605324PA (en) 2016-08-30
JP2014509644A (ja) 2014-04-21
US9198958B2 (en) 2015-12-01
US20150064166A1 (en) 2015-03-05
PL2692350T3 (pl) 2017-10-31
EP2692350A2 (en) 2014-02-05
RU2013148119A (ru) 2015-05-27
HK1246174A1 (zh) 2018-09-07
JP2016199599A (ja) 2016-12-01
EP2692350A4 (en) 2014-12-10
ES2810098T3 (es) 2021-03-08
WO2012134240A2 (ko) 2012-10-04
ES2636680T5 (es) 2023-10-31
ZA201308115B (en) 2014-07-30
JP5826914B2 (ja) 2015-12-02
IL228607A0 (en) 2013-12-31
MX355771B (es) 2018-04-30
EP3241547A1 (en) 2017-11-08
AU2012233845B2 (en) 2015-11-19
CN103596580A (zh) 2014-02-19
EP2692350B1 (en) 2017-05-03
AU2016201040A1 (en) 2016-03-10
PL3241547T3 (pl) 2021-02-08
DK2692350T3 (da) 2017-08-21
KR101395064B1 (ko) 2014-05-19
EP2692350B2 (en) 2023-06-28
CO6821888A2 (es) 2013-12-31
CA2831908C (en) 2018-11-13
SG10202013124XA (en) 2021-02-25
CN109925284A (zh) 2019-06-25
AU2012233845A1 (en) 2013-10-31
WO2012134240A3 (ko) 2013-01-03
EP3756656A1 (en) 2020-12-30
IL228607B (en) 2018-10-31
JP2016020382A (ja) 2016-02-04
PT3241547T (pt) 2020-08-26
KR20120112248A (ko) 2012-10-11
RU2640922C1 (ru) 2018-01-12
JP6173547B2 (ja) 2017-08-02
HUE050037T2 (hu) 2020-11-30
DK2692350T4 (da) 2023-09-04
MX2013011119A (es) 2014-02-27
ES2636680T3 (es) 2017-10-06
BR112013025256B1 (pt) 2022-01-18
SG194039A1 (en) 2013-11-29
US8920795B2 (en) 2014-12-30
PL2692350T5 (pl) 2023-10-09
US20140086900A1 (en) 2014-03-27
JP6005239B2 (ja) 2016-10-12
SI3241547T1 (sl) 2020-10-30
EP3241547B1 (en) 2020-05-20
US20160089442A1 (en) 2016-03-31
CA2831908A1 (en) 2012-10-04
AU2016201040B2 (en) 2017-05-25
RU2574011C2 (ru) 2016-01-27
BR112013025256A2 (pt) 2017-02-07
MX338436B (es) 2016-04-18

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