公开(公告)号：US20170143719A1

公开(公告)日：2017-05-25

申请号：US15355868

申请日：2016-11-18

申请人： EUROHEALTH INTERNATIONAL SARL

发明人： Michael G. Parker ,  Scott S. Wilson ,  Yasmeen Chahal ,  Kelly W. Hovius ,  David E. McAnany

IPC分类号： A61K31/515 ,  A61K9/00 ,  A61J1/06 ,  B65B7/16 ,  B65B3/00 ,  B65B55/02 ,  A61K9/08 ,  A61K47/10

CPC分类号： A61K31/515 ,  A61J1/06 ,  A61K9/0019 ,  A61K9/08 ,  A61K47/10 ,  B65B3/003 ,  B65B7/16 ,  B65B55/02

摘要： Stable phenobarbital sodium solutions for injection that do not generate impurities during extended storage. These solutions include phenobarbital sodium in an amount of 15 to 200 mg/mL; a C1-C4 alcohol such as ethanol in an amount of 105 to 160 mg/mL; and a glycol such as propylene glycol in an amount of between 620 and 830 mg/mL and have a pH of between 9 and 12 which is adjusted to that range by adding acid or base, as required. No more than 50 mg/mL water is present including any water introduced by the acid or base. The solutions contain no more than 0.8% of phenyl ethyl acetyl urea impurity as well as no detectable amount of phenyl butyric acid after two years storage at room temperature.