RU2015104649A - Системы и способы доставки сухих порошковых лекарств - Google Patents

Системы и способы доставки сухих порошковых лекарств Download PDF

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RU2015104649A
RU2015104649A RU2015104649A RU2015104649A RU2015104649A RU 2015104649 A RU2015104649 A RU 2015104649A RU 2015104649 A RU2015104649 A RU 2015104649A RU 2015104649 A RU2015104649 A RU 2015104649A RU 2015104649 A RU2015104649 A RU 2015104649A
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inhaler according
dry powder
inhaler
diketopiperazine
container
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RU2015104649A
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RU2650035C2 (ru
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Чад С. СМАТНИ
Бенуа АДАМО
Брендан Ф. ЛАУРЕНЦИ
П. Спенсер КИНСИ
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Маннкайнд Корпорейшн
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001Particle size control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/002Details of inhalators; Constructional features thereof with air flow regulating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • A61M15/0025Mouthpieces therefor with caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/076General characteristics of the apparatus having air pumping means mouth operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/14Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/16Rotating swirling helical flow, e.g. by tangential inflows
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/20Flow characteristics having means for promoting or enhancing the flow, actively or passively

Abstract

1. Ингалятор сухого порошка, содержащий:a) первый элемент, содержащий мундштук;b) второй элемент, содержащий контейнер; иc) по меньшей мере, два жестких воздушных канала;при этом один из, по меньшей мере, двух жестких воздушных каналов при использовании выполнен с возможностью содержания дефлектора или стержня для направления движения сухого порошка внутри контейнера для порошка.2. Ингалятор по п. 1, имеющий значение сопротивления воздушному потоку от приблизительно 0,065 до, приблизительно, 0,200 √кПа/(л/мин).3. Ингалятор по п. 1, в котором сухой порошок является препаратом для пероральной ингаляции и содержит количество сухого порошка от приблизительно 1 до приблизительно 50 мг.4. Ингалятор по п. 1, в котором сухой порошок содержит дикетопиперазин или фармацевтически допустимую соль дикетопиперазина.5. Ингалятор 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, малонила, оксалила и глутарила.6. Ингалятор по п. 5, в котором дикетопиперазин является бис-3,6-(N-фумарил-4-аминобутил)-2,5-дикето-дикетопиперазином.7. Ингалятор по п. 3, в котором сухой порошок содержит лекарство или активное средство.8. Ингалятор по п. 7, в котором активное вещество является эндокринным гормоном, вакцинами, низкомолекулярными соединениями, включая антиастматические средства, вазодилататоры, вазоконстрикторы, миорелаксанты, агонисты и антагонисты нейтротрансмиттеров и т.п.9. Ингалятор по п. 3, в котором сухой порошок содержит пептид, полипептид или их фрагменты, низкомолекулярное органическое соединение или молекулу нуклеиновой кислоты.10. Ингалятор по п. 9, в котором упомянутый пептид является инсулином,

Claims (18)

1. Ингалятор сухого порошка, содержащий:
a) первый элемент, содержащий мундштук;
b) второй элемент, содержащий контейнер; и
c) по меньшей мере, два жестких воздушных канала;
при этом один из, по меньшей мере, двух жестких воздушных каналов при использовании выполнен с возможностью содержания дефлектора или стержня для направления движения сухого порошка внутри контейнера для порошка.
2. Ингалятор по п. 1, имеющий значение сопротивления воздушному потоку от приблизительно 0,065 до, приблизительно, 0,200 √кПа/(л/мин).
3. Ингалятор по п. 1, в котором сухой порошок является препаратом для пероральной ингаляции и содержит количество сухого порошка от приблизительно 1 до приблизительно 50 мг.
4. Ингалятор по п. 1, в котором сухой порошок содержит дикетопиперазин или фармацевтически допустимую соль дикетопиперазина.
5. Ингалятор 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, малонила, оксалила и глутарила.
6. Ингалятор по п. 5, в котором дикетопиперазин является бис-3,6-(N-фумарил-4-аминобутил)-2,5-дикето-дикетопиперазином.
7. Ингалятор по п. 3, в котором сухой порошок содержит лекарство или активное средство.
8. Ингалятор по п. 7, в котором активное вещество является эндокринным гормоном, вакцинами, низкомолекулярными соединениями, включая антиастматические средства, вазодилататоры, вазоконстрикторы, миорелаксанты, агонисты и антагонисты нейтротрансмиттеров и т.п.
9. Ингалятор по п. 3, в котором сухой порошок содержит пептид, полипептид или их фрагменты, низкомолекулярное органическое соединение или молекулу нуклеиновой кислоты.
10. Ингалятор по п. 9, в котором упомянутый пептид является инсулином, глюкагоном, глюкагоноподобным пептидом-1, паратиреоидным гормоном, дезоксирибонуклеазой, окситоцином, оксинтомодулином, пептидом YY, экзендином, их аналогами или их фрагментами.
11. Ингалятор по п. 9, в котором низкомолекулярное органическое соединение является вазодилататором, вазоконстриктором, агонистом нейротрансмиттера или антагонистом нейротрансмиттера.
12. Ингалятор по п. 1, в котором контейнер встроен в корпус контейнера и наполнен сухим порошком.
13. Ингалятор по п. 1, в котором ингалятор не содержит контейнер.
14. Ингалятор по п. 1, в котором контейнер обеспечен отдельно от ингалятора и наполнен сухим порошком.
15. Ингалятор по п. 1, в котором порошок является аморфным порошком.
16. Ингалятор по п. 11, в котором низкомолекулярное органическое соединение является триптаном или опиатом.
17. Ингалятор по п. 16, в котором триптан является суматриптаном или ризатриптаном.
18. Способ доставки сухого порошка субъекту, содержащий введение субъекту эффективного количества аморфного порошкового лекарственного препарата с помощью ингалятора сухого порошка по п. 1.
RU2015104649A 2012-07-12 2013-07-12 Системы и способы доставки сухих порошковых лекарств RU2650035C2 (ru)

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US201261671041P 2012-07-12 2012-07-12
US61/671,041 2012-07-12
PCT/US2013/050392 WO2014012069A2 (en) 2012-07-12 2013-07-12 Dry powder drug delivery systems and methods

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