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

Info

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
Authority
CN
China
Prior art keywords
dosage form
pharmaceutical dosage
polymer
nucleic acid
acid
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.)
Expired - Fee Related
Application number
CN200580037293XA
Other languages
English (en)
Chinese (zh)
Other versions
CN101060835A (zh
Inventor
R·利齐奥
H-U·彼得莱特
D·特鲁普提
M·古特斯查克
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.)
Roma Chemical Co ltd
Evonik Operations GmbH
Original Assignee
Evonik Roehm GmbH
Roehm GmbH Darmstadt
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 Evonik Roehm GmbH, Roehm GmbH Darmstadt filed Critical Evonik Roehm GmbH
Publication of CN101060835A publication Critical patent/CN101060835A/zh
Application granted granted Critical
Publication of CN101060835B publication Critical patent/CN101060835B/zh
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

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
    • A61K9/20—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

Landscapes

  • 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)
  • Nanotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (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
DE102004059792.8 2004-12-10
DE102004059792A DE102004059792A1 (de) 2004-12-10 2004-12-10 Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Nukleinsäure-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
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

Family

ID=35709359

Family Applications (1)

Application Number Title Priority Date Filing Date
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)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8048413B2 (en) 2006-05-17 2011-11-01 Helene Huguet Site-specific intestinal delivery of adsorbents, alone or in combination with degrading molecules
AU2007265452A1 (en) * 2006-06-26 2008-01-03 Mutual Pharmaceutical Company, Inc. Active agent formulations, methods of making, and methods of use
EP2164475A2 (en) * 2007-07-16 2010-03-24 NorthEastern University Therapeutic stable nanoparticles
DE102008048729A1 (de) * 2008-09-24 2010-03-25 Add Technologies Ltd Advanced Drug Delivery Multipartikuläre Tabletten und Verfahren zur deren Herstellung
EP2521570A4 (en) * 2009-12-29 2015-05-13 Impax Laboratories Inc SOLID ORAL DOSAGE FORMS WITH GASTRORETTENTION EFFECT, COMPRISING AN INFLATABLE HYDROPHILIC POLYMER
MX346316B (es) 2010-02-25 2017-03-15 Evonik Roehm Gmbh Formulacion farmaceutica o nutraceutica.
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
US11033496B2 (en) * 2017-03-17 2021-06-15 The Regents Of The University Of Michigan Nanoparticles for delivery of chemopreventive agents
EP3803866A4 (en) 2018-05-24 2022-03-16 Nureva Inc. METHOD, APPARATUS, AND COMPUTER READABLE MATERIALS FOR MANAGING SEMI-CONSTANT (PERSISTENT) SOUND SOURCES IN MICROPHONE CATCH/HOME AREAS
CA3087238A1 (en) 2018-05-24 2019-11-28 Celanese EVA Performance Polymers Corporation Implantable device for sustained release of a macromolecular drug compound
CN111989068B (zh) 2018-05-24 2024-10-25 塞拉尼斯伊娃高性能聚合物公司 用于持续释放大分子药物化合物的可植入器件
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
IL303390A (en) 2020-12-03 2023-08-01 Battelle Memorial Institute Compositions of polymer nanoparticles and DNA nanostructures and methods for non-viral transport
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
WO2022216977A1 (en) 2021-04-07 2022-10-13 Batelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
EP4329734A4 (en) 2021-04-26 2025-04-02 Celanese EVA Performance Polymers LLC Implantable device for the delayed release of a macromolecular drug compound
EP4545069A4 (en) * 2022-06-24 2026-06-10 Sunsho Pharmaceutical Co Ltd PHARMACEUTICAL COMPOSITION AND ITS PRODUCTION PROCESS
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
AU2024393766A1 (en) 2023-12-08 2026-06-18 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW209174B (enExample) 1991-04-19 1993-07-11 Takeda Pharm Industry Co Ltd
DE69634697T2 (de) 1995-10-25 2006-05-04 Octoplus B.V. Kationische polyacrylate und poly(alkyl)acrylate oder die entsprechende acrylamide zur verwendung in synthetischen transfektions-systemen
GB9700624D0 (en) * 1997-01-14 1997-03-05 Danbiosyst Uk Drug delivery composition
US6730735B2 (en) 1997-07-03 2004-05-04 West Pharmaceutical Services Drug Delivery & Clinical Research Centre Limited Conjugate of polyethylene glycol and chitosan
AU778049B2 (en) 1999-08-09 2004-11-11 Dainippon Sumitomo Pharma Co., Ltd. Solid preparation containing chitosan powder and process for producing the same
US7803392B2 (en) * 2000-12-27 2010-09-28 University Of Kentucky Research Foundation pH-Sensitive mucoadhesive film-forming gels and wax-film composites suitable for topical and mucosal delivery of molecules
WO2003007913A2 (en) * 2001-07-20 2003-01-30 Samir Mitragotri Method for oral drug delivery
US7670627B2 (en) 2002-12-09 2010-03-02 Salvona Ip Llc pH triggered targeted controlled release systems for the delivery of pharmaceutical active ingredients
DE10332160A1 (de) 2003-07-15 2005-02-03 Röhm GmbH & Co. KG Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Peptid- oder Protein-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
DE10353196A1 (de) * 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Mehrschichtige Arzneiform mit einer die Abgabe einer modulatorischen Substanz beeinflussenden Matrix
DE10353186A1 (de) * 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Mehrschichtige Arzneiform, enthaltend eine in Bezug auf die Wirkstoffabgabe modulatorisch wirkende Substanz
DE102004036437A1 (de) * 2004-07-27 2006-03-23 Röhm GmbH & Co. KG Multipartikuläre Arzneiform für wenig lösliche Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
DE102006035549A1 (de) * 2006-07-27 2008-01-31 Evonik Röhm Gmbh Arzneiform mit mindestens zweischichtiger Trennschicht

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

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

Similar Documents

Publication Publication Date Title
US8568778B2 (en) Multiparticulate form of administration, comprising nucleic acid-containing mucoadhesive active ingredients, and method for producing said form of administration
CN101484149B (zh) 具有多层的分隔层的药物剂型
JP5455305B2 (ja) わずかに溶解性の作用物質用の多粒子の剤形、並びに前記剤形の製造方法
CN101663027B (zh) 包含肠溶包衣的可促进药物释放的固体剂型
CN101137354B (zh) 聚合物混合物在生产经包衣的药物制剂中的应用和具有混合聚合物包衣的药物制剂
CA2532487C (en) Multiparticle pharmaceutical dosage form containing a mucoadhesively formulated peptide or protein active substances, and a method for producing said pharmaceutical dosage form
CN104394854A (zh) 具有增强活性和降低毒性的包括硝呋替莫的硝基呋喃的新型制剂
Na et al. pH-sensitive polymers for drug delivery
CN102648221A (zh) 含α-生育酚接枝侧链的丙烯酸和/或甲基丙烯酸类聚合物
HK1110205B (en) Multiparticulate form of administration, comprising nucleic acid-containing mucoadhesive active ingredients, and method for producing said form of administration
NZ718686A (en) Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1110205

Country of ref document: HK

C14 Grant of patent or utility model
GR01 Patent grant
REG Reference to a national code

Ref country code: HK

Ref legal event code: GR

Ref document number: 1110205

Country of ref document: HK

CP01 Change in the name or title of a patent holder
CP01 Change in the name or title of a patent holder

Address after: Essen, Germany

Patentee after: Evonik Operations Ltd.

Address before: Essen, Germany

Patentee before: EVONIK DEGUSSA GmbH

Address after: Darmstadt, Germany

Patentee after: Roma Chemical Co.,Ltd.

Address before: Darmstadt, Germany

Patentee before: EVONIK ROHM GmbH

TR01 Transfer of patent right
TR01 Transfer of patent right

Effective date of registration: 20200623

Address after: Essen, Germany

Patentee after: EVONIK DEGUSSA GmbH

Address before: Darmstadt, Germany

Patentee before: Roma Chemical Co.,Ltd.

CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20130102

CF01 Termination of patent right due to non-payment of annual fee