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SOLID PREPARATION FORMS OF OSPEMIFEN
专利权人:
ХОРМОС МЕДИКАЛ ЛТД. (FI)
发明人:
ЛЕХТОЛА Вели-Матти (FI),ХАЛОНЕН Кайя (FI)
申请号:
RU2011112362/15
公开号:
RU2011112362A
申请日:
2011.03.31
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A solid dosage form comprising granular materials containing from 30 to 90 mg of ospemifene or a pharmaceutically acceptable salt thereof in combination with one or more intragranular excipients, where at least one intragranular excipient is a disintegrant. ! 2. The dosage form according to claim 1, where the baking powder is present in an amount of from 0.1 to 10 wt.% By weight of granular materials, while at least 80% of the formulation is dissolved within 30 minutes after the start of testing the specified formulation by dissolution at pH 9.8 in accordance with the blade method according to the 24th Pharmacopoeia of the United States. ! 3. The dosage form according to claim 1 or 2, wherein ospemifene is in the form of a free base. ! 4. The dosage form according to claim 1 or 2, wherein the baking powder is selected from the group consisting of povidone, crospovidone, carboxymethyl cellulose, methyl cellulose, alginic acid, croscarmellose sodium, sodium starch glycolate, starch, formaldehyde-casein, or combinations thereof. ! 5. The dosage form according to claim 4, wherein the disintegrant is sodium starch glycolate. ! 6. The dosage form according to any one of claims 1, 2 or 5, wherein the granular materials are made by wet granulation. ! 7. The dosage form according to claim 3, where the granular materials are made by wet granulation. !8. The dosage form according to claim 4, wherein the granular materials are made by wet granulation. ! 9. A method of preparing ospemifene or a pharmaceutically acceptable salt thereof, comprising granules1. Твердая лекарственная препаративная форма, включающая гранулированные материалы, содержащие от 30 до 90 мг оспемифена или его фармацевтически приемлемой соли в комбинации с одним или несколькими внутригранулярными эксципиентами, где, по меньшей мере, один внутригранулярный эксципиент представляет собой разрыхлитель. ! 2. Лекарственная препаративная форма по п.1, где разрыхлитель присутствует в количестве от 0,1 до 10 мас.
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