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PHARMACEUTICAL COMPOSITION CONTAINING RHINE OR DIACEREIN PARTICLES AND METHOD FOR PRODUCING IT
专利权人:
ВОКХАРДТ РИСЕРЧ СЕНТЕР (IN)
发明人:
ДАБРЕ Рахул (IN),ДЖАИН Гириш Куамр (IN),САНДАЛ Рошанлал (IN),ТХАККАР Викрант (IN)
申请号:
RU2012131951/15
公开号:
RU2012131951A
申请日:
2012.07.25
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A pharmaceutical composition comprising particles of rhein or diacerein, or their salts, or esters, or prodrugs, in which the average particle size is from about 0.1 μm to about 30 μm. A pharmaceutical composition containing from about 20 mg to about 45 mg of rhein or diacerein, or their salts, or esters, or prodrugs, in which the average particle size is from about 0.1 μm to about 30 μm, and optionally one or more pharmaceutically acceptable excipients. 3. The composition according to claim 2, wherein the composition does not show significant differences in one or both parameters of the rate and extent of absorption of rhein or diacerein, or their salts, or esters, or prodrugs, compared with the diacerein formulation with a dosage of 50 mg sold under trade name Art 50.4. The composition according to claim 2, for which the maximum plasma concentration (C) of the composition is from about 3.15 to about 6.0 μg / ml. The composition according to claim 2, for which the time to reach the maximum plasma concentration (T) of the composition is from about 2.2 to about 5.0 hours. The composition according to claim 2, for which the area under the concentration-time curve (AUC) of the composition is from about 16.4 to about 40 μg per h / ml. The composition according to claim 2, wherein the composition can be taken with or without food. The composition of claim 2, wherein said composition has the following solubility profile: more than 85% of diacerein is released within 20 minutes, and the indicated release rate is measured in apparatus 2 (USP, solubility, paddle stirrer, 75 rpm) using 1000 ml pH 5.7 phosphate buffer at 37 ° C ± 0.5 ° C. 9. The composition of claim 2, wherein said composition1. Фармацевтическая композиция, содержащая частицы реина или диацереина, или их солей, или сложных эфиров, или пролекарств, в которой средний размер частиц составляет от около 0,1 мкм до около 30 мкм.2. Фармацевтическая композиция, содержащая от около 20 мг до около 45 мг реина или диа
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