| 摘要 |
A lyophilized fosphenytoin sodium composition is disclosed for parenteral use. The composition can be reconstituted into a highly concentrated metastable aqueous solution at a pH of about 6.0 to about 10.0. The reconstituted fosphenytoin sodium from the composition has a solubility in an aqueous solution at pH 8.5 up to a concentration of about 380 mg/ml, which is higher than its solubility in non-reconstituted buffered aqueous solution at the same pH (140mg/ml or less). Because of the increased solution concentration, the lyophilized composition can be injected in decreased volumes, especially for intramuscular subcutaneous and intrathecal applications. The lyophilized fosphenytoin sodium composition is stable at room temperature and does not require refrigerated storage. |
