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COMPOSITIONS FOR THE PRODUCTION OF IMMEDIATE TABLETS FOR ORAL ADMINISTRATION CONTAINING LOW-DOSED MIFEPRISTON FOR THE TREATMENT OF ENDOMETRIOSIS, TABLETS PRODUCED FROM SUCH COMPOSITIONS AND TIPS
专利权人:
ВАЛФАРМА ИНТЕРНЭШНЛ С.П.А. (IT)
发明人:
ВАЛДУЧЧИ Роберто (IT),АВАНЕСЯН Серож (IT)
申请号:
RU2015101725
公开号:
RU2015101725A
申请日:
2013.06.21
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. Compositions for the manufacture of instant tablets for oral administration for use in the treatment of endometriosis, which contain mifepristone in an amount of from 3 to 10% wt./wt. in combination with suitable diluents, binders, disintegrants (disintegrants), lubricants (lubricants) and glidants (glidants), in which the diluents have a moisture content of 1 to 10 wt. %, in which microcrystalline cellulose is the diluent, anhydrous colloidal silicon dioxide is the glidant, croscarmellose sodium is the disintegrant, polyvinylpyrrolidone is the binder and magnesium stearate is the lubricant. 2. The composition of claim 1, wherein said components are present in the following amounts: 3. A method for the manufacture of immediate-acting tablets for oral administration, comprising the step of directly compressing the composition according to paragraphs. 1 and 2.4. The method according to claim 3, in which: a) the premix is prepared by mixing the active ingredient with an equivalent amount of microcrystalline cellulose and sieved; b) the remaining microcrystalline cellulose, binder and disintegrant are sieved and mixed with each other; c) the mixture obtained in ( b) a premix containing the active ingredient is added, and finally lubricants and glidants are added; e) the resulting mixture is compressed into tablets. 5. Immediate oral tablet, consisting of: mifepristone 6%; microcrystalline cellulose 85.7%; polyvinylpyrrolidone 4%; croscarmellose sodium 3%; magnesium stearate 1%; anhydrous colloidal silicon dioxide 0.3% .6. A tablet according to claim 5 for the treatment of endometriosis.1. Композиции для изготовления таблеток немедленного действия для перорального приема для применения при лечении эндометриоза, которые содержат мифепристон в количестве от 3 до 10% мас./мас. в комбинации с подходящими разбавителями, связывающими веществами, дезинтегрантами (разрыхлителями), лубрикантами (смазывающими веществами) и глидантами (скользящими веществами), в которых разбавит
来源网站:
中国工程科技知识中心
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http://www.ckcest.cn/home/

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