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PHARMACEUTICAL COMPOSITION OF RHEIN OR DIACEREIN 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:
RU2012131949/15
公开号:
RU2012131949A
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 containing from about 20 mg to about 45 mg of rhein or diacerein, or their salts, or esters, or prodrugs, and optionally one or more pharmaceutically acceptable excipients, and the composition is prepared by a method comprising the stage of wet granulation, and has an immediate release profile. 2. The composition according to claim 1, where the composition does not show significant differences in one or both parameters of the rate and degree of absorption of rhein or diacerein, or their salts, or esters, or prodrugs, compared with the preparative form of diacerein with a dosage of 50 mg sold under the trade The name Art. 50.3. The composition of claim 1, wherein the maximum plasma concentration (C) of the composition is from about 3.15 to about 6.0 μg / ml. The composition according to claim 1, where the time to reach the maximum plasma concentration (T) of the composition is from about 2.2 to about 5.0 hours. The composition of claim 1, wherein the area under the concentration versus time (AUC) curve of the composition is from about 16.4 to about 40 μg h / ml. The composition according to claim 1, which has the following solubility profile: more than 60% of diacerein is released within 60 minutes, and the indicated release rate is measured in apparatus 2 (USP, solubility, paddle stirrer, 75 rpm) using 1000 ml of phosphate buffer with pH 5.7 at 37 ° C ± 0.5 ° C. 7. The composition of claim 1, wherein said composition comprises one or more of: tablets, capsules, powder, plates, caplets, granules, pellets, encapsulated granules, mini-tablets, mini-tablets in a capsule, encapsulated pellets, sachets, balls, spheroids, suspensions and tablets in a tablet. 8. The composition according to claim 1, which1. Фармацевтическая композиция, содержащая от около 20 мг до около 45 мг реина или диацереина, или их солей, или сложных эфиров, или пролекарств, и необязательно один или более фармацевтически приемлемых наполнителей, и указанная композиция и
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