RU2012134402A - Безконсервантные составы, содержащие инсулин, и системы и способы для перевода в аэрозольное состояние - Google Patents
Безконсервантные составы, содержащие инсулин, и системы и способы для перевода в аэрозольное состояние Download PDFInfo
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Abstract
1. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, содержащийзначительное количество водынезначительное количество инсулинагде состав является безконсервантным, что позволяет использовать вибрирующую пластину с отверстием для перевода состава в аэрозольное состояние, без существенного вспенивания состава.2. Состав, содержащий инсулин, по п.1, где инсулин имеет концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.3. Состав, содержащий инсулин, по п.1, где вода составляет от приблизительно 99,8% до приблизительно 97,0% объема, и человеческий инсулин составляет от приблизительно 0,2% до приблизительно 3,0% объема.4. Состав, содержащий инсулин, по п.1, где состав не содержит мета-крезола, крезола или фенола.5. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, состав, по существу состоит из:значительного количества водынезначительного количества инсулинанезначительного количества HCl; инезначительного количества NaOH;где состав является безконсервантным, так что состав можно распылять, используя вибрирующую пластину с отверстием без существенного вспенивания состава.6. Состав, содержащий инсулин, по п.5, где инсулин имеетконцентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.7. Состав, содержащий инсулин, по п.5, где вода составляет от приблизительно 99,8% до приблизительно 97,0% объема, человеческий инсулин составляет от приблизительно 0,2% до приблизительно 3,0% объема.8. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, где состав содер
Claims (22)
1. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, содержащий
значительное количество воды
незначительное количество инсулина
где состав является безконсервантным, что позволяет использовать вибрирующую пластину с отверстием для перевода состава в аэрозольное состояние, без существенного вспенивания состава.
2. Состав, содержащий инсулин, по п.1, где инсулин имеет концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.
3. Состав, содержащий инсулин, по п.1, где вода составляет от приблизительно 99,8% до приблизительно 97,0% объема, и человеческий инсулин составляет от приблизительно 0,2% до приблизительно 3,0% объема.
4. Состав, содержащий инсулин, по п.1, где состав не содержит мета-крезола, крезола или фенола.
5. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, состав, по существу состоит из:
значительного количества воды
незначительного количества инсулина
незначительного количества HCl; и
незначительного количества NaOH;
где состав является безконсервантным, так что состав можно распылять, используя вибрирующую пластину с отверстием без существенного вспенивания состава.
6. Состав, содержащий инсулин, по п.5, где инсулин имеет
концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.
7. Состав, содержащий инсулин, по п.5, где вода составляет от приблизительно 99,8% до приблизительно 97,0% объема, человеческий инсулин составляет от приблизительно 0,2% до приблизительно 3,0% объема.
8. Состав, содержащий инсулин, специально адаптированный для перевода в аэрозольное состояние, где состав содержит:
значительное количество воды
незначительное количество инсулина
где состав, является способным к переходу в аэрозольное состояние в виде спрея с помощью вибрирующей пластины с отверстием, имеющей множество отверстий, которая вибрирует с частотой в диапазоне от приблизительно 50 КГц до приблизительно 150 КГц, и где количество состава, содержащего инсулин, имеет объем вплоть приблизительно до 200 мкл, и время распыления 97% этого количества менее чем приблизительно 22 секунды.
9. Состав, содержащий инсулин, по п.8, где состав, содержащий инсулин, не содержит консервант, так что состав может быть переведен в аэрозольное состояние с помощью вибрирующей пластины с отверстием без существенного вспенивания состава.
10. Состав, содержащий инсулин, по п.8, где инсулин имеет
концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.
11. Способ перевода в аэрозольное состояние состава, содержащего инсулин, где способ содержит:
обеспечение состава, содержащего инсулин, содержащего значительное количество воды и незначительные количества инсулина, HC1 и NaOH;
подачу количества состава, содержащего инсулин, на заднюю поверхность пластины с отверстием, имеющей множество отверстий;
вибрацию пластины с отверстием, до тех пор пока состав, содержащий инсулин, находится на задней поверхности, где вибрация вызывает выброс поданного инсулина с передней поверхности пластины с отверстием в качестве спрей-аэрозоля без существенного вспенивания состава, содержащего инсулин.
12. Способ по п.11, где, по меньшей мере, выбрасывается приблизительно 97% состава.
13. Способ по п.12, где количество состава, содержащего инсулин, имеет объем вплоть приблизительно до 100 мкл, и где время распыления, по меньшей мере, 97% этого количества менее чем приблизительно 11 секунд.
14. Способ по п.11, дополнительно содержит пластину с отверстием, вибрирующую с амплитудой, меньшей чем приблизительно 2 мкм.
15. Способ по п.11, где спрей-аэрозоль содержит аэрозольные капли, имеющие средний размер в диапазоне от приблизительно 3 мкм до приблизительно 8 мкм.
16. Способ по п.11, где менее чем приблизительно 3% состава обращается в пену при вибрации пластины с отверстием.
17. Способ по п.11, где инсулин имеет концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.
18. Способ по п.11, где пластина с отверстием имеет отверстия с размером в диапазоне от приблизительно 3 мкм до приблизительно 8 мкм и вибрирует с частотой в диапазоне от приблизительно 50 КГц до приблизительно 150 КГц.
19. Система получения аэрозоля, содержащая:
ингалятор, содержащий корпус, образующий мундштук, и генератор аэрозоля, расположенный внутри корпуса, где генератор аэрозоля содержит способную вибрировать мембрану с передней поверхностью и задней поверхностью, и способный вибрировать элемент, используемый для вызова вибрации мембраны;
контейнер, содержащий объем состава, содержащего инсулин, по состоящего существу из значительного количества воды и незначительного количества инсулина, где состав является безконсервантным, так что состав можно распылять, используя вибрирующую пластину с отверстием без существенного вспенивания состава.
20. Система по п.19, где инсулин имеет концентрацию от приблизительно 100 IU/мл до приблизительно 1200 IU/мл человеческого инсулина.
21. Система по п.20, где пластина с отверстием имеет отверстия с размером в диапазоне от приблизительно 3 мкм до приблизительно 8 мкм.
22. Система по п.20, где вибрирующая мембрана выполнена с возможностью вибрировать с частотой меньшей чем приблизительно 2 мкм.
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US33576910P | 2010-01-12 | 2010-01-12 | |
US61/335,769 | 2010-01-12 | ||
US13/004,645 | 2011-01-11 | ||
US13/004,645 US9180261B2 (en) | 2010-01-12 | 2011-01-11 | Preservative free insulin formulations and systems and methods for aerosolizing |
PCT/US2011/020926 WO2011088071A1 (en) | 2010-01-12 | 2011-01-12 | Preservative free insulin formulations and systems and methods for aerosolizing |
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RU2012134402A true RU2012134402A (ru) | 2014-02-20 |
RU2548755C2 RU2548755C2 (ru) | 2015-04-20 |
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RU2012134402/15A RU2548755C2 (ru) | 2010-01-12 | 2011-01-12 | Бесконсервантные составы, содержащие инсулин, и системы и способы для перевода в аэрозольное состояние |
RU2012134422/14A RU2559171C2 (ru) | 2010-01-12 | 2011-01-12 | Системы ингалятора с бесконсервантной разовой дозой |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US11833291B2 (en) | 2010-01-12 | 2023-12-05 | Aerami Therapeutics, Inc. | Preservative-free single dose inhaler systems |
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