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ORAL DOSAGE FORMS AND KITS CONTAINING PROGESTERON
专利权人:
ЛИПОСИН ИНК. (US)
发明人:
НАЧАЕГАРИ Сатиш Кумар (US),ГИЛИЯР Чандрашекар (US),НАЧИАППАН Чидамбарам (US),ПАТЕЛ Махеш (US),ВЕНКАТЕШВАРАН Сринивансан (US)
申请号:
RU2015116932
公开号:
RU2015116932A
申请日:
2013.10.04
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. An oral dosage form for long-term administration, comprising: a certain amount of progesterone; an pharmaceutically acceptable carrier; however, when a single dose is administered to a non-pregnant woman in the follicular phase, said oral dosage form provides at least 0.20 ng / ml serum sprogesterone. 2. Oral dosage form according to claim 1, characterized in that when a single dose is administered to a subject, said oral dosage form provides a total serum Cpregnanov of not more than 40 ng / ml. 3. An oral dosage form according to claim 1, characterized in that when a single dose is administered to a subject, said oral dosage form provides serum C progesterone of not more than 10 ng / ml. An oral dosage form according to claim 1, characterized in that, when a single dose is administered to a subject, said oral dosage form provides serum sprogesterone of 1.5 ng / ml or less. Oral dosage form according to claim 1, characterized in that said oral dosage form has such an in vitro release rate that when measured using a type 1 device for determining the dissolution rate according to USP in 900 ml of deionized water containing 2.0% (wt. ./vol.) sodium lauryl sulfate, at 100 rpm, from the indicated oral dosage form, approximately 10% by weight of progesterone or less is released in the first 60 minutes, and at least at least 10% by weight of the indicated oral dosage form is released 70 wt.% Progesterone. 6. Oral dosage form according to claim 1, characterized in that the progesterone content in said oral dosage form1. Пероральная лекарственная форма для долгосрочного введения, содержащая:некоторое количество прогестерона; ифармацевтически приемлемый носитель;при этом при введении одной дозы небеременной женщине в фолликулярной фазе указанная пероральная лекарственная форма обеспечивает Спрогестерона в сыворотке, составляющую по меньшей мере 0,20 нг/мл.2. Пероральная лекарственная форма по п. 1, отличающаяся тем, что при введении одной дозы субъекту указанная пероральна
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