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PHARMACEUTICAL COMPOSITIONS COMPRISING CLEVIDIPINE AND METHODS FOR PRODUCING LOW IMPURITY CONCENTRATIONS OF THE SAME
专利权人:
HOSPIRA, INC.;THE MEDICINES COMPANY
发明人:
MOTHERAM, RAJESHWAR,KRISHNA, GOPAL,DING, MIN,FLOOD KEITH,RAMAKRISHNA KORNEPATI
申请号:
NZ59120509
公开号:
NZ591205A
申请日:
2009.07.29
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed is a pharmaceutical composition comprising an oil-in-water emulsion of clevidipine (as pictured) or any of its pharmaceutically acceptable salts as an active ingredient, and a degradant H168/79 wherein the amount of degradant is approximately equal to or less than about 1.5 per cent on a weight by weight basis. Also disclosed is a method of reducing impurities in a composition comprising clevidipine, comprising: heating an oil to between to about 70 degrees C to about 82 degrees C; adding to the heated oil clevidipine and heating the mixture to about 78 degrees Celsius to about 82 degrees Celsius; adding to the mixture egg yolk phospholipids; and adding an aqueous phase; wherein the pH is adjusted to about 6 to about 8.8; homogenizing the emulsion. Further disclosed is the use of the composition for the manufacture of a medicament for treating or preventing hypertension in a patient.
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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