BR112023006710A2 - Métodos de fabricação de nanopartícula lipídica e composições derivadas da mesma - Google Patents

Métodos de fabricação de nanopartícula lipídica e composições derivadas da mesma

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Publication number
BR112023006710A2
BR112023006710A2 BR112023006710A BR112023006710A BR112023006710A2 BR 112023006710 A2 BR112023006710 A2 BR 112023006710A2 BR 112023006710 A BR112023006710 A BR 112023006710A BR 112023006710 A BR112023006710 A BR 112023006710A BR 112023006710 A2 BR112023006710 A2 BR 112023006710A2
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BR
Brazil
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methods
disclosed
manufacturing methods
nalnps
lnp
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BR112023006710A
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English (en)
Inventor
Drew Weissman
Manuel Carrasco
Daro Buschmann Michael
Mikell Paige
Gabriel Alameh Mohamad
Suman Alishetty
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George Mason Res Foundation Inc
Univ Pennsylvania
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Application filed by George Mason Res Foundation Inc, Univ Pennsylvania filed Critical George Mason Res Foundation Inc
Publication of BR112023006710A2 publication Critical patent/BR112023006710A2/pt

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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/06—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton
    • C07C229/10—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings
    • C07C229/16—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of hydrocarbon radicals substituted by amino or carboxyl groups, e.g. ethylenediamine-tetra-acetic acid, iminodiacetic acids
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K48/0033—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the non-active part clearly interacts with the delivered nucleic acid the non-active part being non-polymeric
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    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
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    • C07D211/26—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms with hydrocarbon radicals, substituted by nitrogen atoms
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    • C07D295/125—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms with substituted hydrocarbon radicals attached to ring nitrogen atoms substituted by singly or doubly bound nitrogen atoms with the ring nitrogen atoms and the substituent nitrogen atoms attached to the same carbon chain, which is not interrupted by carbocyclic rings
    • C07D295/13—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms with substituted hydrocarbon radicals attached to ring nitrogen atoms substituted by singly or doubly bound nitrogen atoms with the ring nitrogen atoms and the substituent nitrogen atoms attached to the same carbon chain, which is not interrupted by carbocyclic rings to an acyclic saturated chain
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    • C12N15/88—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using amphiphile liposome vesicle
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    • 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

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Abstract

métodos de fabricação de nanopartícula lipídica e composições derivadas da mesma. são divulgados neste documento métodos para aumentar a potência de nanopartículas lipídicas carregadas com ácido nucleico (nalnps) por meio de certas técnicas de fabricação de lnp novas e surpreendentemente superiores. também são divulgadas composições farmacêuticas contendo nalnps fabricados de acordo com os métodos de fabricação descritos neste documento. os métodos divulgados neste documento superam grandes dificuldades técnicas e altos custos associados às técnicas de fabricação de lnp anteriores. os métodos divulgados neste documento, portanto, aprimoram muito a produção industrial de lnps de maneiras inesperadas proporcionando, assim, nalnps mais potentes para distribuição de ácido nucleico. especificamente, a invenção divulgada neste documento se refere a métodos que mostram nalnps de maior potência devido ao aumento da concentração de mistura dos lipídios e mrna durante a montagem.
BR112023006710A 2020-10-14 2021-10-13 Métodos de fabricação de nanopartícula lipídica e composições derivadas da mesma BR112023006710A2 (pt)

Applications Claiming Priority (5)

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US202063091603P 2020-10-14 2020-10-14
US202063091616P 2020-10-14 2020-10-14
US202163179872P 2021-04-26 2021-04-26
US202163179885P 2021-04-26 2021-04-26
PCT/US2021/054839 WO2022081752A1 (en) 2020-10-14 2021-10-13 Methods of lipid nanoparticle manufacture and compostions derived therefrom

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KR (1) KR20230118715A (pt)
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BR (1) BR112023006710A2 (pt)
CA (2) CA3195123A1 (pt)
IL (1) IL301890A (pt)
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CN116813493A (zh) * 2022-03-21 2023-09-29 苏州科锐迈德生物医药科技有限公司 一种脂质化合物及基于其的脂质载体、核酸脂质纳米粒组合物和药物制剂
KR102560772B1 (ko) * 2022-03-21 2023-07-28 주식회사 메디치바이오 신규한 이온화지질 및 이를 이용한 지질나노입자 조성물
WO2023220734A2 (en) * 2022-05-13 2023-11-16 The Trustees Of The University Of Pennsylvania Bisphosphonate lipids, lipid nanoparticle compositions comprising the same, and methods of use thereof for targeted delivery
WO2023232747A1 (en) * 2022-05-30 2023-12-07 BioNTech SE Complexes for delivery of nucleic acids
WO2024040195A1 (en) 2022-08-17 2024-02-22 Capstan Therapeutics, Inc. Conditioning for in vivo immune cell engineering

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US2853689A (en) * 1954-02-10 1958-09-23 Jackson Anton Printed circuit contact receptacle
WO2010062322A2 (en) * 2008-10-27 2010-06-03 Massachusetts Institute Of Technology Modulation of the immune response
NO2355851T3 (pt) * 2008-11-10 2018-09-01
RU2573409C2 (ru) * 2009-11-04 2016-01-20 Дзе Юниверсити Оф Бритиш Коламбиа Содержащие нуклеиновые кислоты липидные частицы и относящиеся к ним способы
AU2012353463B2 (en) * 2011-12-12 2017-08-24 Kyowa Hakko Kirin Co., Ltd. Lipid nanoparticles containing combinations of cationic lipids
PT3368507T (pt) * 2015-10-28 2023-02-07 Acuitas Therapeutics Inc Novos lípidos e formulações de nanopartículas lipídicas para distribuição de ácidos nucleicos
JP2019533707A (ja) * 2016-11-10 2019-11-21 トランスレイト バイオ， インコーポレイテッド Ｍｒｎａ担持脂質ナノ粒子を調製する改善されたプロセス
WO2020051223A1 (en) * 2018-09-04 2020-03-12 The Board Of Regents Of The University Of Texas System Compositions and methods for organ specific delivery of nucleic acids
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IL301890A (en) 2023-06-01
TW202229228A (zh) 2022-08-01
US20220218622A1 (en) 2022-07-14
AU2021362206A1 (en) 2023-05-18
JP2023546175A (ja) 2023-11-01
CA3195093A1 (en) 2022-04-21
KR20230118715A (ko) 2023-08-11
EP4228658A1 (en) 2023-08-23
WO2022081752A1 (en) 2022-04-21
CA3195123A1 (en) 2022-04-21
AU2021360494A1 (en) 2023-05-18
EP4229208A1 (en) 2023-08-23
TW202228725A (zh) 2022-08-01
WO2022081750A1 (en) 2022-04-21
JP2023546908A (ja) 2023-11-08
MX2023004371A (es) 2023-07-26

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