Общество с ограниченной ответственностью "Остерос Биомедика" (RU)
发明人:
Иванова Екатерина Алексеевна (RU),КАРПЕЙСКИЙ Александр (US),ЗИННЕН Шон П. (US),КАРАЛЛИ Лиза Лынн (US),САЛУРИАЛАМ Рина Диана (US)
申请号:
RU2015151450
公开号:
RU2015151450A
申请日:
2015.12.01
申请国别(地区):
RU
年份:
2017
代理人:
摘要:
The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumor preparation, which ensures the hydrolytic and physical stability of said preparation, as well as to a method for producing a dosage form of this type. The stable dosage form is a lyophilizate comprising an etidronate-cytarabine conjugate or a pharmaceutically acceptable salt thereof, and a stabilizer, which is a divalent metal salt, in a molar ratio of stabilizer to conjugate of 1:1 to 20:1. A dosage form of this type ensures the hydrolytic and physical stability of the conjugate during long-term storage, and the stability of solutions of the conjugate for parenteral administration during clinical use.