RU2013102529A - Системы и способы доставки сухих порошковых лекарств - Google Patents
Системы и способы доставки сухих порошковых лекарств Download PDFInfo
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Abstract
1. Ингалятор сухого порошка, содержащий:a) мундштук;b) корпус контейнера; иc) по меньшей мере, один жесткий воздушный канал;при этом ингалятор сухого порошка сконфигурирован с возможностью испускания более чем, приблизительно, 75% сухого порошка из контейнера, ориентированного в корпусе контейнера, в виде частиц порошка за одну ингаляцию, и испускаемые частицы порошка имеют объемный медианный геометрический диаметр меньше, чем, приблизительно, 5 микрометров, когда указанная одна ингаляция через мундштук создает максимальное давление при вдохе, приблизительно, 2 кПа в течение двух секунд.2. Ингалятор сухого порошка по п. 1, имеющий значение сопротивления воздушному потоку в диапазоне от, приблизительно, 0,065 (√кПа)/литр в минуту до, приблизительно, 0,200 (√кПа)/литр в минуту.3. Ингалятор сухого порошка по п. 1, в котором сухой порошок является препаратом для легочной доставки и содержит количество от, приблизительно, 1 мг до, приблизительно, 30 мг сухого порошка.4. Ингалятор сухого порошка по п. 1, в котором сухой порошок содержит дикетопиперазин или фармацевтически допустимую соль дикетопиперазина.5. Ингалятор сухого порошка по п. 4, в котором дикетопиперазин имеет формулу 2,5-дикето-3,6-бис(N-X-4-аминобутил)пиперазин, где X выбрано из группы, состоящей из фумарила, сукцинила, малеила и глутарила.6. Ингалятор сухого порошка по п. 5, в котором дикетопиперазин является (бис-3,6-(N-фумарил-4-аминобутил)-2,5-дикето-дикетопиперазином.7. Ингалятор сухого порошка по п. 1, в котором сухой порошок содержит лекарство или активное средство.8. Ингалятор сухого порошка по п. 7, в котором активное средство является эндокринным гормоном.9. Ингалятор сухого поро�
Claims (23)
1. Ингалятор сухого порошка, содержащий:
a) мундштук;
b) корпус контейнера; и
c) по меньшей мере, один жесткий воздушный канал;
при этом ингалятор сухого порошка сконфигурирован с возможностью испускания более чем, приблизительно, 75% сухого порошка из контейнера, ориентированного в корпусе контейнера, в виде частиц порошка за одну ингаляцию, и испускаемые частицы порошка имеют объемный медианный геометрический диаметр меньше, чем, приблизительно, 5 микрометров, когда указанная одна ингаляция через мундштук создает максимальное давление при вдохе, приблизительно, 2 кПа в течение двух секунд.
2. Ингалятор сухого порошка по п. 1, имеющий значение сопротивления воздушному потоку в диапазоне от, приблизительно, 0,065 (√кПа)/литр в минуту до, приблизительно, 0,200 (√кПа)/литр в минуту.
3. Ингалятор сухого порошка по п. 1, в котором сухой порошок является препаратом для легочной доставки и содержит количество от, приблизительно, 1 мг до, приблизительно, 30 мг сухого порошка.
4. Ингалятор сухого порошка по п. 1, в котором сухой порошок содержит дикетопиперазин или фармацевтически допустимую соль дикетопиперазина.
5. Ингалятор сухого порошка по п. 4, в котором дикетопиперазин имеет формулу 2,5-дикето-3,6-бис(N-X-4-аминобутил)пиперазин, где X выбрано из группы, состоящей из фумарила, сукцинила, малеила и глутарила.
6. Ингалятор сухого порошка по п. 5, в котором дикетопиперазин является (бис-3,6-(N-фумарил-4-аминобутил)-2,5-дикето-дикетопиперазином.
7. Ингалятор сухого порошка по п. 1, в котором сухой порошок содержит лекарство или активное средство.
8. Ингалятор сухого порошка по п. 7, в котором активное средство является эндокринным гормоном.
9. Ингалятор сухого порошка по п. 1, в котором сухой порошок содержит пептид, полипептид или их фрагменты, малую органическую молекулу или молекулу нуклеиновой кислоты.
10. Ингалятор сухого порошка по п. 9, в котором упомянутый пептид является инсулином, глюкагоном, глюкагоноподобным пептидом-1, паратироидным гормоном, окситоцином, оксинтомодулином, пептидом YY, экзендином, их аналогами или их фрагментами.
11. Ингалятор сухого порошка по п. 9, в котором малая органическая молекула является вазодилататором, вазоконстриктором, агонистом нейротрансмиттера или антагонистом нейротрансмиттера.
12. Ингалятор сухого порошка по п. 1, в котором одна ингаляция создает площадь под кривой (AUC) для кривой зависимости давления от времени в течение одной секунды, по меньшей мере, приблизительно, 1,0, 1,1 или 1,2 кПа×сек.
13. Ингалятор сухого порошка по п. 1, в котором контейнер встроен в корпус контейнера и наполнен сухим порошком.
14. Ингалятор сухого порошка по п. 1, в котором в ингаляторе отсутствует контейнер.
15. Ингалятор сухого порошка по п. 1, в котором контейнер обеспечен отдельно от ингалятора и наполнен сухим порошком.
16. Способ доставки сухого порошка с использованием ингалятора сухого порошка с высоким сопротивлением, при этом упомянутый способ содержит следующие этапы:
обеспечивают ингалятор сухого порошка со значением сопротивления воздушному потоку в диапазоне от, приблизительно, 0,065 (√кПа)/литр в минуту до, приблизительно, 0,200 (√кПа)/литр в минуту, и содержащий дозу сухого порошка,
прилагают достаточное усилие для достижения максимального давления при вдохе, по меньшей мере, 2 кПа в течение 2 секунд; и
создают площадь под кривой в течение первой секунды (AUC0-1sec) для кривой зависимости давления при вдохе от времени, по меньшей мере, приблизительно 1,0, 1,1 или 1,2 кПа×сек; при этом, больше, чем 75% дозы сухого порошка выпускается или испускается из ингалятора в виде частиц порошка.
17. Способ по п. 16, в котором сухой порошок является препаратом для легочной доставки и содержит количество от, приблизительно, 1 мг до, приблизительно, 30 мг сухого порошка.
18. Способ по п. 17, в котором сухой порошок содержит дикетопиперазин или фармацевтически допустимую соль дикетопиперазина.
19. Способ по п. 18, в котором дикетопиперазин имеет формулу 3,6-бис(N-X-4-аминобутил)-2,5-дикетопиперазин, где X выбрано из группы, состоящей из фумарила, сукцинила, малеила и глутарила.
20. Способ по п. 19, в котором дикетопиперазин является бис-3,6-(N-фумарил-4-аминобутил)-2,5-дикето-дикетопиперазином.
21. Способ по п. 16, в котором сухой порошковый препарат содержит лекарство или активное средство, выбранное из группы, состоящей из малой органической молекулы, пептида, полипептида, белка или молекулы нуклеиновой кислоты.
22. Способ по п. 21, в котором малая органическая молекула является вазоактивным средством, агонистом нейротрансмиттера, антагонистом нейротрансмиттера или стероидной молекулой.
23. Способ по п. 20, в котором сухой порошковый препарат содержит микрочастицы фумарил дикетопиперазина, которые, при выпуске из ингалятора сухого порошка, характеризуются наличием объемного медианного геометрического диаметра (VMGD) в диапазоне от, приблизительно, 2 мкм до 8 мкм и геометрического стандартного отклонения меньше, чем 4 мкм.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US35703910P | 2010-06-21 | 2010-06-21 | |
| US61/357,039 | 2010-06-21 | ||
| US41177510P | 2010-11-09 | 2010-11-09 | |
| US61/411,775 | 2010-11-09 | ||
| PCT/US2011/041303 WO2011163272A1 (en) | 2010-06-21 | 2011-06-21 | Dry powder drug delivery system and methods |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2014133362/14A Division RU2571331C1 (ru) | 2010-06-21 | 2011-06-21 | Системы и способы доставки сухих порошковых лекарств |
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| RU2013102529A true RU2013102529A (ru) | 2014-07-27 |
| RU2531455C2 RU2531455C2 (ru) | 2014-10-20 |
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| RU2013102529/14A RU2531455C2 (ru) | 2010-06-21 | 2011-06-21 | Системы и способы доставки сухих порошковых лекарств |
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| US9006175B2 (en) | 1999-06-29 | 2015-04-14 | Mannkind Corporation | Potentiation of glucose elimination |
| DK2280021T3 (en) | 1999-06-29 | 2016-05-02 | Mannkind Corp | Pharmaceutical formulations comprising insulin complexed to a diketopiperazine |
| US7080644B2 (en) | 2000-06-28 | 2006-07-25 | Microdose Technologies, Inc. | Packaging and delivery of pharmaceuticals and drugs |
| ES2300568T3 (es) | 2002-03-20 | 2008-06-16 | Mannkind Corporation | Aparato de inhalacion. |
| JP2007523700A (ja) | 2004-02-24 | 2007-08-23 | マイクロドース・テクノロジーズ・インコーポレーテッド | 流動方向検出吸入器 |
| DE602005024413D1 (de) | 2004-08-20 | 2010-12-09 | Mannkind Corp | Katalyse der diketopiperazinsynthese |
| AU2005277041B2 (en) | 2004-08-23 | 2012-03-22 | Mannkind Corporation | Diketopiperazine salts, diketomorpholine salts or diketodioxane salts for drug delivery |
| US7799344B2 (en) | 2005-09-14 | 2010-09-21 | Mannkind Corporation | Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents |
| CN104383546B (zh) | 2006-02-22 | 2021-03-02 | 曼金德公司 | 用于改善包含二酮哌嗪和活性剂的微粒的药物性质的方法 |
| US9119777B2 (en) | 2008-05-30 | 2015-09-01 | Microdose Therapeutx, Inc. | Methods and compositions for administration of oxybutynin |
| US8439033B2 (en) | 2007-10-09 | 2013-05-14 | Microdose Therapeutx, Inc. | Inhalation device |
| US8785396B2 (en) | 2007-10-24 | 2014-07-22 | Mannkind Corporation | Method and composition for treating migraines |
| US8371294B2 (en) | 2008-02-29 | 2013-02-12 | Microdose Therapeutx, Inc. | Method and apparatus for driving a transducer of an inhalation device |
| US8485180B2 (en) | 2008-06-13 | 2013-07-16 | Mannkind Corporation | Dry powder drug delivery system |
| US20190262557A1 (en) * | 2010-03-04 | 2019-08-29 | Mannkind Corporation | Dry powder drug delivery system |
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- 2011-06-21 KR KR1020137001630A patent/KR20130117755A/ko not_active Application Discontinuation
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| KR20130117755A (ko) | 2013-10-28 |
| US9358352B2 (en) | 2016-06-07 |
| US20160243322A1 (en) | 2016-08-25 |
| RU2531455C2 (ru) | 2014-10-20 |
| AU2011271097A1 (en) | 2013-01-10 |
| BR112012033060A2 (pt) | 2018-02-27 |
| JP6385673B2 (ja) | 2018-09-05 |
| RU2014133362A (ru) | 2015-12-10 |
| AU2011271097B2 (en) | 2014-11-27 |
| US20130104887A1 (en) | 2013-05-02 |
| IL223742A (en) | 2016-06-30 |
| CA2801936A1 (en) | 2011-12-29 |
| WO2011163272A1 (en) | 2011-12-29 |
| EP2582421A1 (en) | 2013-04-24 |
| RU2571331C1 (ru) | 2015-12-20 |
| CA2801936C (en) | 2021-06-01 |
| US9662461B2 (en) | 2017-05-30 |
| MX2012015093A (es) | 2013-05-28 |
| MX359281B (es) | 2018-09-21 |
| JP2013530756A (ja) | 2013-08-01 |
| CN102985125A (zh) | 2013-03-20 |
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