RU2017120901A - Способ проведения высокопроизводительной тестовой высокоэффективной жидкостной хроматографии - Google Patents

Способ проведения высокопроизводительной тестовой высокоэффективной жидкостной хроматографии Download PDF

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RU2017120901A
RU2017120901A RU2017120901A RU2017120901A RU2017120901A RU 2017120901 A RU2017120901 A RU 2017120901A RU 2017120901 A RU2017120901 A RU 2017120901A RU 2017120901 A RU2017120901 A RU 2017120901A RU 2017120901 A RU2017120901 A RU 2017120901A
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Эрик БОРСЬЕ
Хенрик Торстхольм РАСМУССЕН
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Вертекс Фармасьютикалз Инкорпорейтед
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Claims (32)

1. Способ проведения ВЭЖХ с высокой пропускной способностью, и указанный способ включает:
а) опускание контейнеров с предварительно взвешенными образцами в пластиковые колбы;
b) добавление раствора к каждому набору из контейнера и колбы через дозирующую насадку колбы;
c) взбалтывание каждого набора из пластиковой колбы, контейнера и раствора до растворения образца;
d) центрифугирование каждого набора из пластиковой колбы, контейнера и раствора;
е) загрузку аликвотного количества супернатанта, полученного на этапе центрифугирования, в колонку ВЭЖХ; и
f) запуск колонки с подвижной фазой.
2. Способ по п.1, в котором контейнеры из этапа а) представляют собой флаконы,
3. Способ по п.1, в котором пластиковые колбы из этапа а) представляют собой колбы из ПЭВП.
4. Способ по п.1, дополнительно включающий корреляцию результатов из способа по п.1 и PAT-измерений для непрерывного производства.
5. Способ по п.4, в котором непрерывное производство предназначено для получения фармацевтической композиции.
6. Способ по п. 5, в котором фармацевтическая композиция представляет собой таблетку.
7. Способ по п.6, в котором таблетка предназначена для лечения CFTR-опосредованного заболевания.
8. Способ по п.7, в котором CFTR-опосредованное заболевание представляет собой муковисцидоз (CF).
9. Способ по п.6, в котором таблетка содержит два АФИ.
10. Способ по п.9, в котором один АФИ является CF-корректирирующим средством.
11. Способ по п.9, в котором один АФИ является CF-потенцирующим средством.
12. Способ по п.9, в котором один АФИ является CF-корректирующим средством, и другой АФИ является CF-потенцирующим средством.
13. Способ по п.9, в котором один АФИ представляет собой
Figure 00000001
14. Способ по п.9, в котором один АФИ представляет собой
Figure 00000002
15. Способ по п.9, в котором один АФИ представляет собой
Figure 00000003
а другой АФИ представляет собой
Figure 00000002
Figure 00000003
16. Способ по п.15, в котором соединение
находится в форме 1, и
соединение
Figure 00000002
представляет собой по существу аморфное соединение в форме твердой дисперсии.
RU2017120901A 2014-11-18 2015-11-18 Способ проведения высокопроизводительной тестовой высокоэффективной жидкостной хроматографии RU2691136C2 (ru)

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US201462081181P 2014-11-18 2014-11-18
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TW202120517A (zh) 2019-08-14 2021-06-01 美商維泰克斯製藥公司 製備cftr調節劑之方法
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