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PHARMACEUTICAL COMPOSITIONS INCLUDING NITROCATECHOL DERIVATIVES AND METHODS FOR PRODUCING THEM
专利权人:
С.А. (PT);БИАЛ-ПОРТЕЛА энд КА.
发明人:
ВАСКОНСЕЛОС Теофило Кардосо Де (PT),ЛИМА Рикардо Хорге ДОС Сантос (PT),БАРРОКАС Педро Мигель да Коста (PT),ПЕРЕЙРА Лигия София де Кастро (PT),КОСТА Руи Сердеира де Кампос (PT)
申请号:
RU2011143619/15
公开号:
RU2011143619A
申请日:
2010.03.31
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A stable composition comprising: at least one active pharmaceutical ingredient (API) selected from 2,5-dichloro-3- (5- (3,4-dihydroxy-5-nitrophenyl) -1,2,4- oxadiazol-3-yl) -4,6-dimethylpyridin 1-oxide and 5- [3- (2,5-dichloro-4,6-dimethylpyridin-3-yl) - [1,2,4] oxadiazol-5- silt] -3-nitrobenzene-1,2-diol and their salts, esters, hydrates, solvates and other derivatives; at least one filler; and at least one binder component; where at least one active pharmaceutical ingredient (API) is present in granular form. The stable composition according to claim 1, where at least one API is a combination of 2,5-dichloro-3- (5- (3,4-dihydroxy-5-nitrophenyl) -1,2,4-oxadiazole-3- il) -4,6-dimethylpyridine 1-oxide and 5- [3- (2,5-dichloro-4,6-dimethylpyridin-3-yl) - [1,2,4] oxadiazol-5-yl] -3 nitrobenzene-1,2-diol. 3. The stable composition according to claim 2, where less than 10% of the API decomposes in more than 15 days of storage at a temperature of 70 ° C and uncontrolled humidity, more than 6 months of storage at a temperature of 40 ° C and a relative humidity of 75%, and / or more than 3 years of storage at a relative humidity of 60% and a temperature of 30 ° C or 25 ° C. 4. The stable composition according to claim 3, wherein less than 5% of the API decomposes in more than 15 days of storage at a temperature of 70 ° C and uncontrolled humidity, more than 6 months of storage at a temperature of 40 ° C and a relative humidity of 75%, and / or more than 3 years of storage at a relative humidity of 60% and a temperature of 30 ° C or 25 ° C. 5. The stable composition according to claim 4, where less than 3% of the API decomposes in more than 15 days of storage at a temperature of 70 ° C and uncontrolled humidity, more than 6 months of storage at a temperature of 40 ° C and a relative humidity of 75%, and / or more than over 3 years of storage1. Устойчивая композиция, включающая:по крайней мере, один активный фармацевтический ингредиент (АФИ), выбранный из 2,5-дихлор-3-(5-(
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