RU2019110510A - Частицы, конъюгированные с пептидом - Google Patents

Частицы, конъюгированные с пептидом Download PDF

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RU2019110510A
RU2019110510A RU2019110510A RU2019110510A RU2019110510A RU 2019110510 A RU2019110510 A RU 2019110510A RU 2019110510 A RU2019110510 A RU 2019110510A RU 2019110510 A RU2019110510 A RU 2019110510A RU 2019110510 A RU2019110510 A RU 2019110510A
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particles
antigen
disease
composition according
allergen
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RU2019110510A
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RU2813163C2 (ru
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Лонни Д ШЕЙ
Стивен Д. МИЛЛЕР
Джонатан Вун Тек ЯП
Даниэль Р. ГЕТТЗ
Деррик МАККАРТИ
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Норсвестерн Юниверсити
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Claims (18)

1.     Композиция, содержащая поверхностно-функционализированные биоразлагаемые частицы, содержащие один или более инкапсулированных антигенов, где частица имеет отрицательный дзета-потенциал, и при этом указанная частица имеет диаметр от 200 до 2000 нанометров, где дзета-потенциал частицы составляет от приблизительно -100 мВ до приблизительно 0 мВ.
2.     Композиция по п. 1, где указанная частица имеет диаметр от 400 до 800 нанометров.
3.     Композиция по п. 1, где антиген предусматривает аутоиммунный антиген, антиген, экспрессируемый в ткани, подлежащей трансплантации субъекту, фермент, предназначенный для ферментозаместительной терапии, или аллерген, где необязательно указанный антиген содержит по меньшей мере часть белка, выбранного из группы, состоящей из: основного белка миелина, ацетилхолинового рецептора, эндогенного антигена, миелин-олигодендроцитарного гликопротеина, антигена бета-клеток поджелудочной железы, инсулина, глутаматдекарбоксилазы (GAD), коллагена 11 типа, gp39 человеческого хряща, fp130-RAPS, протеолипидного белка, фибрилларина, малого ядрышкового белка, рецептора тиреотропного фактора, гистонов, гликопротеина gp70, пируватдегидрогеназа-дигидролипоамидацетилтрансферазы (PCD-E2), антигена волосяных фолликулов, А-глиадина, глиадина, инсулина, проинсулина, специфичного для островков белка, связанного с каталитической субъединицей глюкозо-6-фосфатазы (IGRP), человеческого тропомиозина изоформы 5, пыльцы гречки заметной (BaGP), аллергена персика Pru p 3, аллергена молока альфа-s1-казеина, аллергена сельдерея Api g 1, аллергена бразильского ореха Bere1, аллергена молока B-лактоглобулина, бычьего сывороточного альбумина, аллергена фундука Cor a 1.04, гликопротеина, связанного с миелином, аквапорина, α3-цепи коллагена IV типа, аллергена яиц овальбумина, адвата, антигемофильного фактора, когената, элоктата, слитного белка рекомбинантного фактора VIII и Fc, рефакто, Novo VIIa, рекомбинантного фактора VII, эптакога альфа, геликсата, монанина, фактора коагуляции IX, вилата, цередазы, аглюцеразы, церезима, имиглюцеразы, Elelso, талиглюцеразы альфа, фабразима, агалсидазы бета, альдуразима, альфа-L-идуронидазы, миозима, кислой глюкозидазы, элапразы, идуронат-2-сульфатазы, наглазим арилсульфатазы B или N-ацетилгалактозамин-4-сульфатазы.
4.     Композиция по п. 1, где частицы содержат сополимер лактида и гликолида (PLG), где необязательно частицы содержат PLG с соотношением полимолочная кислота:полигликолевая кислота в сополимере, составляющем 50:50.
5.     Композиция по п. 1, где поверхностная функционализация представляет собой карбоксилирование, где необязательно карбоксилирование обеспечивается за счет применения поли(этилен-малеинового ангидрида) (PEMA).
6.     Композиция по п. 1, где частицы имеют дзета-потенциал, составляющий от -30 мВ до -80 мВ.
7.     Композиция по п. 1, где частицы имеют дзета-потенциал, составляющий от -50 мВ до -40 мВ.
8.     Композиция по п. 1, где частицы имеют дзета-потенциал, составляющий от -25 мВ до -70 мВ.
9.     Композиция по п. 1, где частицы имеют средний размер после синтеза, составляющий 600 нм, и средний заряд после синтеза, составляющий от -40 мВ до -60 мВ.
10.     Композиция по п. 1, дополнительно содержащая фармацевтически приемлемые вспомогательные вещества.
11.     Композиция по п. 8, где частицы содержат сополимер лактида и гликолида (PLG), и где указанные PLG-частицы имеют соотношение лактид:гликолид в сополимере, составляющее 50:50, где необязательно i) диаметр указанных PLG-частиц составляет от 400 до 800 нанометров или ii) где поверхностная функционализация представляет собой карбоксилирование, где необязательно карбоксилирование обеспечивается за счет применения поли(этилен-малеинового ангидрида) (PEMA).
12.     Композиция по п. 1, где композиция является лиофилизированной, и где частица имеет дзета-потенциал от -25 до -70 мВ.
13.     Композиция по п. 12, где частицы содержат сополимер лактида и гликолида (PLG), и где указанные PLG-частицы имеют соотношение лактид:гликолид в сополимере, составляющее 50:50.
14.     Композиция по п. 1, предназначенная для применения в индуцировании у нуждающегося в этом субъекта антиген-специфической толерантности, при этом способ предусматривает введение фармацевтической композиции, содержащей поверхностно-функционализированные частицы по п. 1.
15.     Композиция по п. 14, где частицы являются лиофилизированными, а
способ предусматривает восстановление лиофилизированных частиц с получением восстановленной фармацевтической композиции, содержащей поверхностно-функционализированные частицы, и введение восстановленной фармацевтической композиции указанному нуждающемуся в этом субъекту.
16.     Композиция по п. 14, где антиген представляет собой специфический аутоиммунный антиген, антиген, экспрессируемый в ткани, подлежащей трансплантации субъекту, фермент, предназначенный для ферментозаместительной терапии, или аллерген.
17.     Композиция по п. 14, где антиген ассоциирован с заболеванием или нарушением, выбранным из группы, состоящей из ревматоидного артрита (РА), системной красной волчанки (СКВ), сахарного диабета I типа, сахарного диабета II типа, рассеянного склероза (РС), иммуноопосредованного бесплодия, такого как преждевременная недостаточность яичников, склеродермии, болезни Шегрена, витилиго, алопеции (облысения), полигландулярной недостаточности, болезни Грейвса, гипотиреоза, полимиозита, пузырчатки обыкновенной, пузырчатки листовидной, воспалительного заболевания кишечника, включая болезнь Крона и язвенный колит, аутоиммунного гепатита, включая связанный с вирусом гепатита В (ВГВ) и вирусом гепатита С (ВГC), гипопитуитаризма, болезни «трансплантат против хозяина» (GvHD), миокардита, болезни Аддисона, аутоиммунных заболеваний кожи, увеита, злокачественной анемии, целиакии, гипопаратиреоза, оптикомиелита, мембранозной нефропатии, буллезного пемфигоида, обыкновенной пузырчатки, миастении гравис, тиреоидита Хашимото, аутоиммунных полигландулярных синдромов I типа и II типа, паранеопластической пузырчатки, буллезной пузырчатки, герпетиформного дерматита, линейного IgA-дерматоза, буллезного приобретенного эпидермолиза, узелковой эритемы, пемфигоида беременных, рубцового пемфигоида, эссенциальной криоглобулинемии смешанного типа, хронической буллезной болезни детского возраста, гемолитической анемии, тромбоцитопенической пурпуры, синдрома Гудпасчера, аутоиммунной нейтропении, миастении гравис, миастенического синдрома Итона – Ламберта, синдрома мышечной скованности, острого рассеянного энцефаломиелита, синдрома Гийена – Барре, хронической воспалительной демиелинизирующей полирадикулонейропатии, мультифокальной моторной нейропатии с блоком проводимости, хронической нейропатии с моноклональной гаммапатией, опсоклонического-миоклонического синдрома, мозжечковой дегенерации, энцефаломиелита, ретинопатии, первичного билиарного склероза, склерозирующего холангита, глютензависимой энтеропатии, анкилозирующего спондилита, реактивного артрита, полимиозита/дерматомиозита, смешанного заболевания соединительной ткани, синдрома Бехчета, псориаза, узелкового полиартериита, аллергического ангиита и гранулематоза (болезни Черджа – Стросса), синдрома полиангиита «с перекрытием», аллергического васкулита, гранулематоза Вегенера, височного артериита, артериита Такаясу, болезни Кавасаки, изолированного васкулита центральной нервной системы, облитерирующего тромбангиита, саркоидоза, гломерулонефрита, криопатий, аллергического заболевания или состояния, аллергии и астмы.
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