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LIQUID PHARMACEUTICAL COMPOSITION INCLUDING NITIZINON
专利权人:
СВЕДИШ ОРФАН БИОВИТРУМ ИНТЕРНЭШНЛ АБ
发明人:
СВЕНССОН Леннарт,СИДЕН Ханс
申请号:
RU2014101990
公开号:
RU2014101990A
申请日:
2012.06.20
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A liquid pharmaceutical composition suitable for oral administration comprising a suspension of an effective amount of micronized 2- (2-nitro-4-trifluoromethylbenzoyl) -1,3-cyclohexanedione (nitisinone); and b) citric acid buffer with a pH in the range of 2.5 to 3.5, preferably pH 3.0.2. A composition according to claim 1, characterized in that the amount of nitisinone is from 1 to 10 mg / ml, preferably 4 mg / ml. A composition according to claim 1, further comprising one or more pharmaceutically acceptable components selected from the group consisting of suspending agents, sweeteners, preservatives, surfactants and flavors. A composition according to claim 3, characterized in that the suspending agent is hydroxypropyl methylcellulose. The composition of claim 4, wherein the suspending agent is hydroxypropyl methylcellulose in an amount of from 1 to 20 mg / ml, preferably 5 mg / ml. A composition according to claim 3, wherein the sweetener is glycerin. A composition according to claim 6, characterized in that the sweetener is glycerol in an amount of from 100 to 500 mg / ml, preferably 500 mg / ml. A composition according to claim 3, characterized in that the preservative is methyl paraben and / or propyl paraben. The composition of claim 8, wherein the preservatives are methylparaben in an amount of from 1 to 2 mg / ml, preferably 1.4 mg / ml, and propylparaben in an amount of from 0.1 to 0.2 mg / ml, preferably 0.14 mg / ml. 10. A composition according to claim 3, characterized in that the preservative is sodium benzoate in col1. Жидкая фармацевтическая композиция, пригодная для перорального приема, включающаяа) суспензию эффективного количества микронизированного 2-(2-нитро-4-трифторметилбензоил)-1,3-циклогександиона (нитизинона) иb) буфер на основе лимонной кислоты с рН в диапазоне значений от 2,5 до 3,5, предпочтительно, рН 3,0.2. Композиция по п. 1, отличающаяся тем, что количество нитизинона составляет от 1 до 10 мг/мл, предпочтительно, 4 мг/мл.3. Компози
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