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

Info

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
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
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 (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
BRPI0713533A2 (pt) * 2006-06-26 2012-04-17 Mutual Pharmaceutical Co formulações de agente ativo, métodos de fabricação, e métodos de uso
US20110038939A1 (en) * 2007-07-16 2011-02-17 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
BR112012021445B8 (pt) 2010-02-25 2022-07-05 Evonik Roehm Gmbh formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade
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
CN110603057A (zh) * 2017-03-17 2019-12-20 俄亥俄州创新基金会 用于递送化学预防剂的纳米颗粒
MX2020012459A (es) 2018-05-24 2021-04-28 Celanese Eva Performance Polymers Llc Dispositivo implantable para liberacion sostenida de un compuesto de farmaco macromolecular.
KR20260007295A (ko) 2018-05-24 2026-01-13 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치
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
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
CA3203975A1 (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
CA3216359A1 (en) 2021-04-07 2022-10-13 Battelle 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
WO2023249087A1 (ja) * 2022-06-24 2023-12-28 三生医薬株式会社 医薬組成物およびその製造方法
AU2024353375A1 (en) 2023-09-29 2026-04-09 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025122954A1 (en) 2023-12-08 2025-06-12 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
ES2242198T3 (es) 1995-10-25 2005-11-01 Octoplus B.V. Poliacrilatos y poli(alquil) acrilatos cationicos o las correspondientes acrilamidas para utilizar en sistemas de transfeccion sinteticos.
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
CN1162183C (zh) * 1999-08-09 2004-08-18 大日本制药株式会社 含有脱乙酰壳多糖粉末的固体制剂及其生产工艺
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
US20030017195A1 (en) * 2001-07-20 2003-01-23 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
SI1824457T1 (sl) 2016-06-30
CN101060835A (zh) 2007-10-24
JP2008522989A (ja) 2008-07-03
US8568778B2 (en) 2013-10-29
BRPI0515815B8 (pt) 2021-05-25
ES2569354T3 (es) 2016-05-10
KR101319773B1 (ko) 2013-10-17
BRPI0515815B1 (pt) 2019-02-05
CN101060835B (zh) 2013-01-02
EP1824457A1 (de) 2007-08-29
IL183753A0 (en) 2007-09-20
HUE028793T2 (hu) 2017-01-30
PL1824457T3 (pl) 2016-07-29
EP1824457B1 (de) 2016-02-17
US20090280183A1 (en) 2009-11-12
WO2006061069A1 (de) 2006-06-15
JP5578764B2 (ja) 2014-08-27
DE102004059792A1 (de) 2006-06-14
HK1110205A1 (en) 2008-07-11
IL183753A (en) 2016-12-29
CA2586597A1 (en) 2006-06-15
TW200635617A (en) 2006-10-16
KR20070085894A (ko) 2007-08-27
MX2007006343A (es) 2007-07-04
BRPI0515815A (pt) 2008-08-05

Similar Documents

Publication Publication Date Title
CA2586597C (en) Multiparticulate pharmaceutical form comprising mucoadhesively formulated nucleic acid active ingredients, and a process for producing the pharmaceutical form
CA2570608C (en) Multiparticle pharmaceutical form for low-solubility active substances and a process for preparing the pharmaceutical form
CN101484149B (zh) 具有多层的分隔层的药物剂型
CN101663027B (zh) 包含肠溶包衣的可促进药物释放的固体剂型
CN101111230B (zh) 包含对活性成分具有调节释放作用的小丸的多颗粒药用形式
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
KR101454056B1 (ko) 에탄올의 영향에 대하여 내성을 가지는 비-오피오이드용 ｐｈ-의존성 조절 방출 제약 조성물
US9821024B2 (en) Immunomodulatory compositions
KR101535701B1 (ko) 에탄올의 영향에 대하여 내성을 갖는 비-오피오이드용 ｐｈ-의존성 조절 방출 제약 조성물
CN103501767A (zh) 适合于药物或营养制品剂型的包衣组合物
JP2008534531A (ja) 調節物質の送達に影響を及ぼすマトリックスを有するペレットを有する多粒子の医薬剤形
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
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
EEER Examination request
W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-4-4-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20251024

H13 Ip right lapsed

Free format text: ST27 STATUS EVENT CODE: N-4-6-H10-H13-H100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE AND LATE FEE NOT PAID BY DEADLINE OF NOTICE

Effective date: 20260204

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: N-6-6-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260210