CN101060835B - 包含粘膜粘附性配制的核酸活性成分的多颗粒状药物剂型以及制备所述药物剂型的方法 - Google Patents

包含粘膜粘附性配制的核酸活性成分的多颗粒状药物剂型以及制备所述药物剂型的方法 Download PDF

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Publication number
CN101060835B
CN101060835B CN200580037293XA CN200580037293A CN101060835B CN 101060835 B CN101060835 B CN 101060835B CN 200580037293X A CN200580037293X A CN 200580037293XA CN 200580037293 A CN200580037293 A CN 200580037293A CN 101060835 B CN101060835 B CN 101060835B
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China
Prior art keywords
dosage form
pharmaceutical dosage
polymer
nucleic acid
acid
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Expired - Fee Related
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CN200580037293XA
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English (en)
Chinese (zh)
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CN101060835A (zh
Inventor
R·利齐奥
H-U·彼得莱特
D·特鲁普提
M·古特斯查克
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Roma Chemical Co ltd
Evonik Operations GmbH
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Evonik Roehm GmbH
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5192—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN200580037293XA 2004-12-10 2005-11-05 包含粘膜粘附性配制的核酸活性成分的多颗粒状药物剂型以及制备所述药物剂型的方法 Expired - Fee Related CN101060835B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102004059792A DE102004059792A1 (de) 2004-12-10 2004-12-10 Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Nukleinsäure-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
DE102004059792.8 2004-12-10
PCT/EP2005/011864 WO2006061069A1 (de) 2004-12-10 2005-11-05 Multipartikuläre arzneiform, enthaltend mucoadhaesiv formulierte nukleinsäure-wirkstoffe, sowie ein verfahren zur herstellung der arzneiform

Publications (2)

Publication Number Publication Date
CN101060835A CN101060835A (zh) 2007-10-24
CN101060835B true CN101060835B (zh) 2013-01-02

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CN200580037293XA Expired - Fee Related CN101060835B (zh) 2004-12-10 2005-11-05 包含粘膜粘附性配制的核酸活性成分的多颗粒状药物剂型以及制备所述药物剂型的方法

Country Status (16)

Country Link
US (1) US8568778B2 (enExample)
EP (1) EP1824457B1 (enExample)
JP (1) JP5578764B2 (enExample)
KR (1) KR101319773B1 (enExample)
CN (1) CN101060835B (enExample)
BR (1) BRPI0515815B8 (enExample)
CA (1) CA2586597C (enExample)
DE (1) DE102004059792A1 (enExample)
ES (1) ES2569354T3 (enExample)
HU (1) HUE028793T2 (enExample)
IL (1) IL183753A (enExample)
MX (1) MX2007006343A (enExample)
PL (1) PL1824457T3 (enExample)
SI (1) SI1824457T1 (enExample)
TW (1) TW200635617A (enExample)
WO (1) WO2006061069A1 (enExample)

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US8048413B2 (en) 2006-05-17 2011-11-01 Helene Huguet Site-specific intestinal delivery of adsorbents, alone or in combination with degrading molecules
US20080050450A1 (en) * 2006-06-26 2008-02-28 Mutual Pharmaceutical Company, Inc. Active Agent Formulations, Methods of Making, and Methods of Use
JP2010533730A (ja) * 2007-07-16 2010-10-28 ノースイースタン・ユニバーシティ 安定した治療用ナノ粒子
DE102008048729A1 (de) * 2008-09-24 2010-03-25 Add Technologies Ltd Advanced Drug Delivery Multipartikuläre Tabletten und Verfahren zur deren Herstellung
WO2011090725A2 (en) * 2009-12-29 2011-07-28 Impax Laboratories, Inc. Gastroretentive solid oral dosage forms with swellable hydrophilic polymer
ES2561652T3 (es) 2010-02-25 2016-02-29 Evonik Röhm Gmbh Formulación farmacéutica o nutracéutica
CN102250878B (zh) * 2011-06-03 2013-01-23 吉林大学 一种基于固相介质表面电荷的反转提取dna的方法
US9107851B2 (en) * 2012-10-15 2015-08-18 New Jersey Institute Of Technology Solventless mixing process for coating pharmaceutical ingredients
JP6912876B2 (ja) * 2016-10-06 2021-08-04 三洋化成工業株式会社 アクリル系医薬固形製剤用添加剤
AU2018234844B2 (en) * 2017-03-17 2024-01-25 Ohio State Innovation Foundation Nanoparticles for delivery of chemopreventive agents
US11689849B2 (en) 2018-05-24 2023-06-27 Nureva, Inc. Method, apparatus and computer-readable media to manage semi-constant (persistent) sound sources in microphone pickup/focus zones
MX2020012458A (es) 2018-05-24 2021-04-28 Celanese Eva Performance Polymers Llc Dispositivo implantable para liberacion sostenida de un compuesto de farmaco macromolecular.
US11690806B2 (en) 2018-05-24 2023-07-04 Celanese Eva Performance Polymers Llc Implantable device for sustained release of a macromolecular drug compound
DE102020002360A1 (de) * 2020-04-18 2021-10-21 Friedrich-Schiller-Universität Jena Nanopartikel enthaltend Komplexe aus Nukleinsäuren und kationischen Copolymeren, Verfahren zu deren Herstellung und deren Verwendung zum Gentransfer in Zellen
US20220175812A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
CN117120020A (zh) * 2021-03-30 2023-11-24 塞拉尼斯伊娃高性能聚合物公司 用于递送核酸包封颗粒的植入式医疗器件
AU2022253899A1 (en) 2021-04-07 2023-10-26 Battelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
WO2022231930A1 (en) 2021-04-26 2022-11-03 Celanese Eva Performance Polymers Llc Implantable device for sustained release of a macromolecular drug compound
US20250367120A1 (en) * 2022-06-24 2025-12-04 Sunsho Pharmaceutical Co., Ltd. Pharmaceutical composition and method for producing same
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
US12441996B2 (en) 2023-12-08 2025-10-14 Battelle Memorial Institute Use of DNA origami nanostructures for molecular information based data storage systems

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US20040224019A1 (en) * 2004-03-03 2004-11-11 Adi Shefer Oral controlled release system for targeted drug delivery into the cell and its nucleus for gene therapy, DNA vaccination, and administration of gene based drugs

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Also Published As

Publication number Publication date
IL183753A0 (en) 2007-09-20
US8568778B2 (en) 2013-10-29
EP1824457A1 (de) 2007-08-29
CA2586597C (en) 2013-09-10
DE102004059792A1 (de) 2006-06-14
BRPI0515815A (pt) 2008-08-05
HK1110205A1 (en) 2008-07-11
BRPI0515815B1 (pt) 2019-02-05
SI1824457T1 (sl) 2016-06-30
BRPI0515815B8 (pt) 2021-05-25
US20090280183A1 (en) 2009-11-12
WO2006061069A1 (de) 2006-06-15
IL183753A (en) 2016-12-29
JP5578764B2 (ja) 2014-08-27
TW200635617A (en) 2006-10-16
KR101319773B1 (ko) 2013-10-17
HUE028793T2 (hu) 2017-01-30
MX2007006343A (es) 2007-07-04
JP2008522989A (ja) 2008-07-03
PL1824457T3 (pl) 2016-07-29
CA2586597A1 (en) 2006-06-15
CN101060835A (zh) 2007-10-24
KR20070085894A (ko) 2007-08-27
ES2569354T3 (es) 2016-05-10
EP1824457B1 (de) 2016-02-17

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