CN102387791A - 用于稳定蛋白的不含哺乳动物赋形剂的制剂 - Google Patents

用于稳定蛋白的不含哺乳动物赋形剂的制剂 Download PDF

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Publication number
CN102387791A
CN102387791A CN2010800162576A CN201080016257A CN102387791A CN 102387791 A CN102387791 A CN 102387791A CN 2010800162576 A CN2010800162576 A CN 2010800162576A CN 201080016257 A CN201080016257 A CN 201080016257A CN 102387791 A CN102387791 A CN 102387791A
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CN
China
Prior art keywords
formulation
composition
protein
term
botulinum toxin
Prior art date
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Pending
Application number
CN2010800162576A
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English (en)
Chinese (zh)
Inventor
哈罗德·泰勒
马库斯·伯格
杰德·J·曼德
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.)
Merz Pharma GmbH and Co KGaA
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Merz Pharma GmbH and Co KGaA
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Publication date
Application filed by Merz Pharma GmbH and Co KGaA filed Critical Merz Pharma GmbH and Co KGaA
Priority to CN201710546734.3A priority Critical patent/CN107789620A/zh
Publication of CN102387791A publication Critical patent/CN102387791A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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    • 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
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    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K8/34—Alcohols
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    • A61K8/8176—Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
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    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics 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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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
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    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/52—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from bacteria or Archaea
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
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    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91—Injection
    • 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
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against 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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  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
CN2010800162576A 2009-04-17 2010-04-16 用于稳定蛋白的不含哺乳动物赋形剂的制剂 Pending CN102387791A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710546734.3A CN107789620A (zh) 2009-04-17 2010-04-16 用于稳定蛋白的不含哺乳动物赋形剂的制剂

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US21295209P 2009-04-17 2009-04-17
EP09005470A EP2248518B1 (en) 2009-04-17 2009-04-17 Formulation for stabilizing proteins, peptides or mixtures thereof.
EP09005470.1 2009-04-17
US61/212,952 2009-04-17
PCT/EP2010/002360 WO2010118888A1 (en) 2009-04-17 2010-04-16 Formulation for stabilizing proteins, which is free of mammalian excipients

Related Child Applications (1)

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CN201710546734.3A Division CN107789620A (zh) 2009-04-17 2010-04-16 用于稳定蛋白的不含哺乳动物赋形剂的制剂

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CN102387791A true CN102387791A (zh) 2012-03-21

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CN201710546734.3A Pending CN107789620A (zh) 2009-04-17 2010-04-16 用于稳定蛋白的不含哺乳动物赋形剂的制剂

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US (2) US9198856B2 (enExample)
EP (2) EP2248518B1 (enExample)
JP (1) JP5718313B2 (enExample)
KR (1) KR101708952B1 (enExample)
CN (2) CN102387791A (enExample)
AU (1) AU2010237270B2 (enExample)
BR (1) BRPI1014034A2 (enExample)
CA (1) CA2758754A1 (enExample)
ES (1) ES2606567T3 (enExample)
HK (1) HK1248556A1 (enExample)
IL (1) IL215354A0 (enExample)
IN (1) IN2011KN04251A (enExample)
MX (1) MX2011010801A (enExample)
RU (1) RU2539388C2 (enExample)
WO (1) WO2010118888A1 (enExample)
ZA (1) ZA201108433B (enExample)

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CN105534783A (zh) * 2015-12-29 2016-05-04 杭州芭黎雅医疗美容诊所有限公司 一种自体胶原童颜组合物以及用于制备该组合物的方法
CN109172530A (zh) * 2018-11-23 2019-01-11 南京新百药业有限公司 含有缩宫素的药物组合物及其制备方法
CN110267535A (zh) * 2017-02-08 2019-09-20 巴克曼实验室国际公司 化学制剂以及使用该化学制剂的结垢控制方法
CN110312505A (zh) * 2017-01-20 2019-10-08 株式会社大熊 包含肉毒杆菌毒素的稳定液体组合物

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US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
US8168206B1 (en) 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
US9161970B2 (en) * 2007-12-12 2015-10-20 Allergan, Inc. Dermal filler
US9044477B2 (en) * 2007-12-12 2015-06-02 Allergan, Inc. Botulinum toxin formulation
CN105833254A (zh) * 2008-12-10 2016-08-10 阿勒根公司 梭菌毒素药物组合物
RU2011125775A (ru) 2008-12-31 2013-02-10 Реванс Терапьютикс, Инк. Составы на основе ботулотоксина для инъекции
KR101975051B1 (ko) 2009-06-25 2019-05-03 레반스 테라퓨틱스, 아이엔씨. 알부민­불포함 보툴리눔 독소 제제
NZ605928A (en) 2010-07-29 2015-02-27 Eleven Biotherapeutics Inc Chimeric il-1 receptor type i agonists and antagonists
US9173944B2 (en) 2010-10-12 2015-11-03 Merz Pharma Gmbh & Co. Kgaa Formulation suitable for stabilizing proteins, which is free of mammalian excipients
WO2012074285A2 (ko) * 2010-11-30 2012-06-07 (주)아모레퍼시픽 펩타이드 또는 단백질 안정화제
US8920795B2 (en) * 2011-03-31 2014-12-30 Medy-Tox Inc. Lyophilized preparation of botulinum toxin
SE536091C2 (sv) * 2011-04-14 2013-04-30 Pep Tonic Medical Ab Farmaceutisk komposition innehållande oxytocin eller fragment eller varianter därav och åtminstone en icke-jonisk cellulosaeter
ES2884813T3 (es) 2013-03-13 2021-12-13 Buzzard Pharmaceuticals AB Formulaciones de citoquina quimérica para administración ocular
US9084720B2 (en) 2013-05-07 2015-07-21 BioBlast Pharma Ltd. Compositions and methods for treating oculopharyngeal muscular dystrophy
EP2994145B1 (en) 2013-05-07 2023-01-04 Bio Blast Pharma Ltd. Treatment of oculopharyngeal muscular dystrophy by intravenous administration of trehalose
WO2015014487A1 (en) * 2013-07-30 2015-02-05 Merz Pharma Gmbh & Co. Kgaa Process for preparing a highly pure neurotoxic component of a botulinum toxin and uses thereof
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
KR102557798B1 (ko) 2014-12-23 2023-07-19 메르츠 파마 게엠베하 운트 코. 카가아 보툴리눔 독소 사전충전된 용기
US10494661B2 (en) * 2015-01-27 2019-12-03 Bgi Shenzhen Stabilizer for preserving biological samples
US9744209B2 (en) 2015-01-30 2017-08-29 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9937223B2 (en) 2015-01-30 2018-04-10 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9375478B1 (en) 2015-01-30 2016-06-28 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9687526B2 (en) 2015-01-30 2017-06-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9750785B2 (en) 2015-01-30 2017-09-05 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9925233B2 (en) 2015-01-30 2018-03-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
PT3432916T (pt) 2016-09-13 2019-11-20 Allergan Inc Composições de toxina clostrídica não-proteica estabilizadas
WO2019157453A1 (en) 2018-02-12 2019-08-15 Trilogy Therapeutics, Inc. Caspofungin compositions for inhalation
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