BRPI0515815B8 - forma medicamentosa de multipartículas contendo substâncias ativas de ácido nucléico formuladas mucoadesivas, bem como seu processo de preparação - Google Patents

forma medicamentosa de multipartículas contendo substâncias ativas de ácido nucléico formuladas mucoadesivas, bem como seu processo de preparação

Info

Publication number
BRPI0515815B8
BRPI0515815B8 BRPI0515815A BRPI0515815A BRPI0515815B8 BR PI0515815 B8 BRPI0515815 B8 BR PI0515815B8 BR PI0515815 A BRPI0515815 A BR PI0515815A BR PI0515815 A BRPI0515815 A BR PI0515815A BR PI0515815 B8 BRPI0515815 B8 BR PI0515815B8
Authority
BR
Brazil
Prior art keywords
drug form
nucleic acid
well
active substances
preparation process
Prior art date
Application number
BRPI0515815A
Other languages
English (en)
Portuguese (pt)
Inventor
Trupti Dave
- Ulrich Petereit Hans
Gottschalk Michael
Lizio Rosario
Original Assignee
Evonik Roehm Gmbh
Roehm 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 Evonik Roehm Gmbh, Roehm Gmbh filed Critical Evonik Roehm Gmbh
Publication of BRPI0515815A publication Critical patent/BRPI0515815A/pt
Publication of BRPI0515815B1 publication Critical patent/BRPI0515815B1/pt
Publication of BRPI0515815B8 publication Critical patent/BRPI0515815B8/pt

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
    • A61K9/48—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
    • 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
    • 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)
BRPI0515815A 2004-12-10 2005-11-05 forma medicamentosa de multipartículas contendo substâncias ativas de ácido nucléico formuladas mucoadesivas, bem como seu processo de preparação BRPI0515815B8 (pt)

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 (3)

Publication Number Publication Date
BRPI0515815A BRPI0515815A (pt) 2008-08-05
BRPI0515815B1 BRPI0515815B1 (pt) 2019-02-05
BRPI0515815B8 true BRPI0515815B8 (pt) 2021-05-25

Family

ID=35709359

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0515815A BRPI0515815B8 (pt) 2004-12-10 2005-11-05 forma medicamentosa de multipartículas contendo substâncias ativas de ácido nucléico formuladas mucoadesivas, bem como seu processo de preparação

Country Status (16)

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

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
WO2008002568A2 (en) * 2006-06-26 2008-01-03 Mutual Pharmaceutical Company, Inc. Active agent formulations, methods of making, and methods of use
WO2009012303A2 (en) * 2007-07-16 2009-01-22 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
WO2011090725A2 (en) * 2009-12-29 2011-07-28 Impax Laboratories, Inc. Gastroretentive solid oral dosage forms with swellable hydrophilic polymer
WO2011103920A2 (en) 2010-02-25 2011-09-01 Evonik Röhm Gmbh Pharmaceutical or neutraceutical formulation
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
WO2018170405A1 (en) * 2017-03-17 2018-09-20 Ohio State Innovation Foundation Nanoparticles for delivery of chemopreventive agents
US11690806B2 (en) 2018-05-24 2023-07-04 Celanese Eva Performance Polymers Llc Implantable device for sustained release of a macromolecular drug compound
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
KR20260007295A (ko) 2018-05-24 2026-01-13 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치
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
CN116887866A (zh) 2020-12-03 2023-10-13 巴特尔纪念研究院 聚合物纳米颗粒和dna纳米结构组合物及用于非病毒递送的方法
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
BR112023022439A2 (pt) 2021-04-26 2023-12-26 Celanese Eva Performance Polymers Llc Dispositivo implantável para liberação sustentada de um composto de fármaco macromolecular
JPWO2023249087A1 (https=) * 2022-06-24 2023-12-28
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

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW209174B (https=) 1991-04-19 1993-07-11 Takeda Pharm Industry Co Ltd
EP0859857B1 (en) * 1995-10-25 2005-05-04 OctoPlus B.V. Cationic polyacrylates and poly(alkyl)acrylates or the corresponding acrylamides for use in synthetic transfection systems
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
ES2288152T3 (es) * 1999-08-09 2008-01-01 Dainippon Sumitomo Pharma Co., Ltd. Preparaciones solidas que contienen polvo de quitosano y procedimiento de produccion asociado.
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
AU2002319653A1 (en) * 2001-07-20 2003-03-03 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
DE10353186A1 (de) 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Mehrschichtige Arzneiform, enthaltend eine in Bezug auf die Wirkstoffabgabe modulatorisch wirkende Substanz
DE10353196A1 (de) 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Mehrschichtige Arzneiform mit einer die Abgabe einer modulatorischen Substanz beeinflussenden Matrix
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
HK1110205A1 (en) 2008-07-11
CN101060835B (zh) 2013-01-02
KR20070085894A (ko) 2007-08-27
EP1824457B1 (de) 2016-02-17
HUE028793T2 (hu) 2017-01-30
BRPI0515815A (pt) 2008-08-05
EP1824457A1 (de) 2007-08-29
IL183753A (en) 2016-12-29
IL183753A0 (en) 2007-09-20
BRPI0515815B1 (pt) 2019-02-05
MX2007006343A (es) 2007-07-04
WO2006061069A1 (de) 2006-06-15
JP5578764B2 (ja) 2014-08-27
CA2586597C (en) 2013-09-10
DE102004059792A1 (de) 2006-06-14
PL1824457T3 (pl) 2016-07-29
KR101319773B1 (ko) 2013-10-17
TW200635617A (en) 2006-10-16
JP2008522989A (ja) 2008-07-03
SI1824457T1 (sl) 2016-06-30
US20090280183A1 (en) 2009-11-12
US8568778B2 (en) 2013-10-29
ES2569354T3 (es) 2016-05-10
CA2586597A1 (en) 2006-06-15
CN101060835A (zh) 2007-10-24

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Legal Events

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B25D Requested change of name of applicant approved

Owner name: EVONIK ROEHM GMBH (DE)

Free format text: NOME ALTERADO DE: ROEHM GMBH

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 05/02/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 05/02/2019, OBSERVADAS AS CONDICOES LEGAIS

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/11/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

B25G Requested change of headquarter approved

Owner name: ROEHM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: EVONIK DEGUSSA GMBH (DE)

B25D Requested change of name of applicant approved

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B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2854 DE 16-09-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.