RU2012116358A - Производство таблетки с помощью пресс-формы с использованием радиочастотного излучения и плавкого связующего вещества - Google Patents

Производство таблетки с помощью пресс-формы с использованием радиочастотного излучения и плавкого связующего вещества Download PDF

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RU2012116358A
RU2012116358A RU2012116358/15A RU2012116358A RU2012116358A RU 2012116358 A RU2012116358 A RU 2012116358A RU 2012116358/15 A RU2012116358/15 A RU 2012116358/15A RU 2012116358 A RU2012116358 A RU 2012116358A RU 2012116358 A RU2012116358 A RU 2012116358A
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tablet
specified
powder mixture
binder
radio frequency
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Фрэнк Дж. БАНИК
Гарри С. САУДЕН
Джозеф Р. ЛУБЕР
Лео Б. КРИКСУНОВ
Кристофер И. ШИМЧАК
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МакНЕЙЛ-ППС, ИНК.
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Abstract

1. Способ получения таблетки, включающий прессование порошковой смеси в плите пресс-формы с получением таблетированной формы, причем указанная порошковая смесь содержит фармацевтически активное вещество и плавкое связующее вещество, и воздействие радиочастотным излучением на указанную таблетированную форму в течение времени, достаточного для размягчения или расплавления указанного связующего вещества внутри указанной таблетированной формы с получением указанной таблетки.2. Способ по п.1, в котором указанное связующее вещество представляет собой связующее вещество, расплавляемое РЧ-излучением, с температурой плавления от приблизительно 40°C до приблизительно 140°C.3. Способ по п.1, в котором указанное связующее вещество, расплавляемое РЧ-излучением, представляет собой полиэтиленгликоль.4. Способ по п.1, в котором указанная порошковая смесь содержит от приблизительно 0,01 до приблизительно 30 процентов по весу указанного фармацевтически активного вещества и от приблизительно 1 до приблизительно 30 процентов по весу указанного плавкого связующего вещества.5. Способ по п.1, в котором указанная порошковая смесь дополнительно содержит один или более углеводов, выбираемых из группы, состоящей из моногидрата декстрозы, маннита, эритрита, декстрозы, лактозы, сорбита, изомальта, сахарозы, декстратов и мальтодекстринов.6. Способ по п.1, в котором указанная порошковая смесь содержит от приблизительно 30 до приблизительно 95 процентов по весу указанного одного или более углеводов.7. Способ по п.1, в котором указанное радиочастотное излучение применяют к указанной таблетированной форме в указанной плите пресс-формы.8. Способ п�

Claims (21)

1. Способ получения таблетки, включающий прессование порошковой смеси в плите пресс-формы с получением таблетированной формы, причем указанная порошковая смесь содержит фармацевтически активное вещество и плавкое связующее вещество, и воздействие радиочастотным излучением на указанную таблетированную форму в течение времени, достаточного для размягчения или расплавления указанного связующего вещества внутри указанной таблетированной формы с получением указанной таблетки.
2. Способ по п.1, в котором указанное связующее вещество представляет собой связующее вещество, расплавляемое РЧ-излучением, с температурой плавления от приблизительно 40°C до приблизительно 140°C.
3. Способ по п.1, в котором указанное связующее вещество, расплавляемое РЧ-излучением, представляет собой полиэтиленгликоль.
4. Способ по п.1, в котором указанная порошковая смесь содержит от приблизительно 0,01 до приблизительно 30 процентов по весу указанного фармацевтически активного вещества и от приблизительно 1 до приблизительно 30 процентов по весу указанного плавкого связующего вещества.
5. Способ по п.1, в котором указанная порошковая смесь дополнительно содержит один или более углеводов, выбираемых из группы, состоящей из моногидрата декстрозы, маннита, эритрита, декстрозы, лактозы, сорбита, изомальта, сахарозы, декстратов и мальтодекстринов.
6. Способ по п.1, в котором указанная порошковая смесь содержит от приблизительно 30 до приблизительно 95 процентов по весу указанного одного или более углеводов.
7. Способ по п.1, в котором указанное радиочастотное излучение применяют к указанной таблетированной форме в указанной плите пресс-формы.
8. Способ по п.1, в котором указанную порошковую смесь прессуют с нагрузкой менее 0,3 килоньютон.
9. Способ по п.1, в котором указанное радиочастотное излучение имеет частоту от приблизительно 1 МГц до 100 МГц.
10. Способ по п.1, в котором средний размер частиц указанной порошковой смеси составляет менее 500 микрон.
11. Способ по п.1, в котором рассасывание указанной таблетки во рту при помещении на язык занимает менее приблизительно 30 секунд.
12. Способ по п.1, в котором указанная таблетка удовлетворяет критериям таблеток для рассасывания в полости рта, как указано в проекте руководства Управления по контролю за продуктами питания и лекарственными средствами, опубликованном в апреле 2007 года.
13. Способ по п.1, в котором твердость указанной таблетки составляет менее 700 грамм по результатам, полученным с помощью анализатора текстуры TA-XT2i, оснащенного зондом с плоским торцом диаметром 7 миллиметров.
14. Способ по п.1, в котором плотность указанной таблетки составляет менее 0,8 г/куб.см.
15. Способ по п.1, содержащий следующие этапы:
(i) введение указанной порошковой смеси в формовочную полость в указанной плите пресс-формы;
(ii) прессование указанной порошковой смеси путем введения по меньшей мере одного формовочного устройства в указанную плиту пресс-формы с усилием, достаточным для получения таблетированной формы;
(iii) применение указанного радиочастотного излучения к указанной таблетированной форме в указанной формовочной полости для получения указанной таблетки; и
(iv) извлечение указанной таблетки из указанной формовочной полости.
16. Способ по п.4, дополнительно содержащий стадию охлаждения указанной таблетки в указанной пресс-форме перед извлечением указанной таблетки из указанной пресс-формы.
17. Способ по п.2, в котором указанное по меньшей мере одно формовочное устройство испускает указанное радиочастотное излучение на указанную таблетированную форму.
18. Способ по п.2, в котором плита пресс-формы испускает указанное радиочастотное излучение на указанную таблетированную форму.
19. Способ по п.1, в котором указанную порошковую смесь прессуют с использованием верхнего формовочного устройства и нижнего формовочного устройства, и по меньшей мере одно из указанного верхнего формовочного устройства или нижнего формовочного устройства испускает указанное радиочастотное излучение на указанную таблетированную форму.
20. Способ по п.1, в котором поверхность указанной таблетки дополнительно подвергают инфракрасному облучению, при этом большинство значений длины волн указанного инфракрасного излучения находится в диапазоне от приблизительно 0,5 до приблизительно 5 микрометров.
21. Таблетка, полученная в соответствии со способом по п.1.
RU2012116358/15A 2009-09-24 2010-09-23 Производство таблетки с помощью пресс-формы с использованием радиочастотного излучения и плавкого связующего вещества RU2545989C2 (ru)

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