BERLATI, FABIO,MENEGON, SERGIO,FARINA, PIERLUIGI,PROVVEDINI, DIEGO,BARCHIELLI, MARCO,MATTEI, ALBERTO
申请号：
CA3040018
公开号：
CA3040018A1
申请日:
2017.11.20
申请国别(地区):
CA
年份:
2018
代理人:
摘要：
The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKa from 5.5 to 9.0 at 25 °C according to an embodiment, the buffering agent may have a pKa from 7.5 to 8.5, preferably a pKa of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKa from 5.5 to 9.0 at 25 °C, preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.
