CA2586597C - Multiparticulate pharmaceutical form comprising mucoadhesively formulated nucleic acid active ingredients, and a process for producing the pharmaceutical form - Google Patents

Multiparticulate pharmaceutical form comprising mucoadhesively formulated nucleic acid active ingredients, and a process for producing the pharmaceutical form Download PDF

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Publication number
CA2586597C
CA2586597C CA2586597A CA2586597A CA2586597C CA 2586597 C CA2586597 C CA 2586597C CA 2586597 A CA2586597 A CA 2586597A CA 2586597 A CA2586597 A CA 2586597A CA 2586597 C CA2586597 C CA 2586597C
Authority
CA
Canada
Prior art keywords
pharmaceutical form
weight
active ingredient
form according
nucleic 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 - Lifetime
Application number
CA2586597A
Other languages
English (en)
French (fr)
Other versions
CA2586597A1 (en
Inventor
Rosario Lizio
Hans-Ulrich Petereit
Dave Trupti
Michael Gottschalk
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.)
Individual
Original Assignee
Roehm GmbH Darmstadt
Evonik Operations GmbH
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 Roehm GmbH Darmstadt, Evonik Operations GmbH filed Critical Roehm GmbH Darmstadt
Publication of CA2586597A1 publication Critical patent/CA2586597A1/en
Application granted granted Critical
Publication of CA2586597C publication Critical patent/CA2586597C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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)
CA2586597A 2004-12-10 2005-11-05 Multiparticulate pharmaceutical form comprising mucoadhesively formulated nucleic acid active ingredients, and a process for producing the pharmaceutical form Expired - Lifetime CA2586597C (en)

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
CA2586597A1 CA2586597A1 (en) 2006-06-15
CA2586597C true CA2586597C (en) 2013-09-10

Family

ID=35709359

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2586597A Expired - Lifetime CA2586597C (en) 2004-12-10 2005-11-05 Multiparticulate pharmaceutical form comprising mucoadhesively formulated nucleic acid active ingredients, and a process for producing the pharmaceutical form

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
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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
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

Family Cites Families (14)

* 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
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
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

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
CN101060835B (zh) 2013-01-02
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
BRPI0515815B1 (pt) 2019-02-05
PL1824457T3 (pl) 2016-07-29

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