BR112018001178A2 - composição, processo de produção de liófilo, liófilo, processo de preparação de produtos e produto de droga - Google Patents

composição, processo de produção de liófilo, liófilo, processo de preparação de produtos e produto de droga

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Publication number
BR112018001178A2
BR112018001178A2 BR112018001178A BR112018001178A BR112018001178A2 BR 112018001178 A2 BR112018001178 A2 BR 112018001178A2 BR 112018001178 A BR112018001178 A BR 112018001178A BR 112018001178 A BR112018001178 A BR 112018001178A BR 112018001178 A2 BR112018001178 A2 BR 112018001178A2
Authority
BR
Brazil
Prior art keywords
lyophil
composition
product
nucleic acid
production process
Prior art date
Application number
BR112018001178A
Other languages
English (en)
Inventor
Liu Dong
Yin Haiqing
Wang Liping
Adami Roger
Ying Wenbin
Wang Yuwei
Original Assignee
Nitto Denko Corp
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 Nitto Denko Corp filed Critical Nitto Denko Corp
Publication of BR112018001178A2 publication Critical patent/BR112018001178A2/pt

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/713—Double-stranded nucleic acids or oligonucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/5123—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/111—General methods applicable to biologically active non-coding nucleic acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/14—Type of nucleic acid interfering N.A.
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/32—Special delivery means, e.g. tissue-specific

Abstract

a presente invenção fornece composições para preparar liófilos sólidos de um ou mais agentes ativos de ácidos nucleicos, que podem ser reconstituídos na forma de produtos de drogas. a composição pode incluir uma suspensão aquosa de nanopartículas de lipídios em soluções farmaceuticamente aceitáveis, em que as nanopartículas de lipídios encapsulam um ou mais agentes ativos de ácidos nucleicos, um composto de dextrina e um composto de sacarídeo. os agentes ativos de ácidos nucleicos podem ser moléculas de rnai capazes de mediar a interferência de rna, bem como outros rnas e oligonucleotídeos.
BR112018001178A 2015-07-22 2016-07-22 composição, processo de produção de liófilo, liófilo, processo de preparação de produtos e produto de droga BR112018001178A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562195356P 2015-07-22 2015-07-22
PCT/US2016/043537 WO2017015552A1 (en) 2015-07-22 2016-07-22 Compositions and methods for nanoparticle lyophile forms

Publications (1)

Publication Number Publication Date
BR112018001178A2 true BR112018001178A2 (pt) 2018-09-11

Family

ID=57834582

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018001178A BR112018001178A2 (pt) 2015-07-22 2016-07-22 composição, processo de produção de liófilo, liófilo, processo de preparação de produtos e produto de droga

Country Status (23)

Country Link
US (3) US10300018B2 (pt)
EP (1) EP3324932B1 (pt)
JP (2) JP6875373B2 (pt)
KR (1) KR20180030698A (pt)
CN (2) CN108024957B (pt)
AU (1) AU2016297153B2 (pt)
BR (1) BR112018001178A2 (pt)
CA (1) CA2992849C (pt)
CY (1) CY1123984T1 (pt)
DK (1) DK3324932T3 (pt)
EA (1) EA035761B1 (pt)
ES (1) ES2862191T3 (pt)
HR (1) HRP20210523T1 (pt)
HU (1) HUE053990T2 (pt)
IL (2) IL288342B2 (pt)
LT (1) LT3324932T (pt)
MX (1) MX2018000891A (pt)
PL (1) PL3324932T3 (pt)
PT (1) PT3324932T (pt)
RS (1) RS61607B1 (pt)
SI (1) SI3324932T1 (pt)
TW (1) TWI732773B (pt)
WO (1) WO2017015552A1 (pt)

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WO2019116062A1 (en) 2017-12-12 2019-06-20 Lead Biotherapeutics Ltd. Solid lipid nanoparticle for intracellular release of active substances and method for production the same
CN108813619A (zh) * 2018-07-19 2018-11-16 广州市汉廷食品有限公司 一种无公害食品添加剂及其制备工艺
JP7430713B2 (ja) 2018-09-28 2024-02-13 ナットクラッカー セラピューティクス， インコーポレイテッド 核酸送達のための脂質化カチオン性ペプチド化合物を含む脂質ナノ粒子製剤
WO2020102668A1 (en) * 2018-11-16 2020-05-22 Nitto Denko Corporation Rna interference delivery formulation and methods for malignant tumors
KR20220070251A (ko) * 2019-09-26 2022-05-30 니치유 가부시키가이샤 지질 나노 입자의 동결 건조 조성물
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Also Published As

Publication number Publication date
IL257029B (en) 2021-12-01
TW201717914A (zh) 2017-06-01
CN108024957B (zh) 2021-08-24
IL288342A (en) 2022-01-01
PT3324932T (pt) 2021-04-06
US11737982B2 (en) 2023-08-29
US20190231695A1 (en) 2019-08-01
AU2016297153B2 (en) 2021-02-25
JP2018521083A (ja) 2018-08-02
IL288342B2 (en) 2024-02-01
JP7268079B2 (ja) 2023-05-02
PL3324932T3 (pl) 2021-07-05
US20170020819A1 (en) 2017-01-26
MX2018000891A (es) 2018-06-11
CY1123984T1 (el) 2022-05-27
IL288342B1 (en) 2023-10-01
US20240000710A1 (en) 2024-01-04
CN113679689A (zh) 2021-11-23
US10300018B2 (en) 2019-05-28
EA201890367A1 (ru) 2018-06-29
CA2992849C (en) 2023-06-13
HUE053990T2 (hu) 2021-08-30
EA035761B1 (ru) 2020-08-06
SI3324932T1 (sl) 2021-07-30
WO2017015552A1 (en) 2017-01-26
JP2021119161A (ja) 2021-08-12
EP3324932B1 (en) 2021-03-10
CN108024957A (zh) 2018-05-11
TWI732773B (zh) 2021-07-11
DK3324932T3 (da) 2021-04-06
JP6875373B2 (ja) 2021-05-26
LT3324932T (lt) 2021-04-26
KR20180030698A (ko) 2018-03-23
AU2016297153A1 (en) 2018-03-01
CA2992849A1 (en) 2017-01-26
RS61607B1 (sr) 2021-04-29
CN113679689B (zh) 2023-09-01
EP3324932A4 (en) 2019-03-06
EP3324932A1 (en) 2018-05-30
ES2862191T3 (es) 2021-10-07
IL257029A (en) 2018-03-29
HRP20210523T1 (hr) 2021-05-14

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