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STABLE COMPOSITIONS OF EASY BISPHOSPHONATE WITH PROPERTIES OF FAST SOLUBILIZATION
专利权人:
ЕФФРХ ФАРМАСЬЮТИКАЛЗ СА (CH)
发明人:
ХЭЙВОРД Маршал А (US),ШМИДТ Тимо (CH)
申请号:
RU2013109765/15
公开号:
RU2013109765A
申请日:
2011.12.05
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A stable effervescent composition in the form of a tablet, granule or powder, not containing fillers that can react with the sizzling component of an organic acid, including: an effective amount of a bisphosphonate inhibitor of bone resorption, a sizzling organic acid component, a sizzling base component; where the specified composition does not contain polyol as binders and lubricants used for tableting; has a loss on drying of 0.25% (m / m) or less; has a total disintegration time of not more than 180 seconds if placed in 3-8 fluid ounces of water at 520 ° C; and said bisphosphonate is incorporated as a micronized particle or by spray drying and is completely solubilized in 2 minutes without stirring. 2. The composition of claim 1, which has been tabletted and has a tablet hardness of 35 to 120 Newton. 3. A composition according to claim 2, having a tablet hardness ranging from 60 to 90 Newton. A composition according to claim 1, having a disintegration time of 60 to 130 seconds. The composition according to claim 1, wherein the sizzling organic acid component contains 20-70% monosodium citrate. A composition according to claim 1, wherein the sizzling organic acid component contains 30-60% monosodium citrate. The composition of claim 1, wherein the sizzling organic acid component contains 40-50% of monosodium citrate. A composition according to claim 1, further comprising a buffer system of sodium carbonate, sodium bicarbonate and 20-70% monosodium citrate, which as a result gives a pH of 4-7 when dissolved in 200 ml of water. The composition of claim 8, wherein the buffer system results in a pH of 5-6 when dissolved in 200 ml of water. The composition of claim 8, having an acid neutralizing ability of 5-20 mEq. per tablet1. Стабильная шипучая композиция в виде таблетки, гранулы или порошка, не содержащая наполнители, которые могут вступать в реакцию с шипящим компонентом-органической кислотой, включающая:эффективное количество бисфосфонатного ингибитора резорб
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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