发明名称 |
INTRAVENOUS GANAXOLONE FORMULATIONS AND METHODS OF USE IN TREATING STATUS EPILEPTICUS AND OTHER SEIZURE DISORDERS |
摘要 |
The disclosure provides an injectable ganaxolone formulation comprising ganaxolone, sulfobutyl ether-β-cyclodextrin; and water. The injectable ganaxolone formulation optionally includes a surfactant and a pH modifier. The ganaxolone and sulfobutyl ether-β-cyclodextrin may be in an inclusion complex. The disclosure also provides a lyophilized powder of the ganaxolone/ sulfobutyl ether-β-cyclodextrin formulation that may be reconstituted in water for injection. The disclosure provides a method of treating a patient having a seizure disorder, stroke, or traumatic brain injury, comprising administering an effective amount of the injectable ganaxolone formulation comprising ganaxolone, sulfobutyl ether-β-cyclodextrin; and water. The disclosure also provides combination methods in which the injectable ganaxolone/ sulfobutyl ether-β-cyclodextrin formulation is administered in combination with at least one additional active agent. |
申请公布号 |
US2016228454(A1) |
申请公布日期 |
2016.08.11 |
申请号 |
US201615018258 |
申请日期 |
2016.02.08 |
申请人 |
MARINUS PHARMACEUTICALS, INC. |
发明人 |
Zhang Mingbao;Glowaky Raymond C. |
分类号 |
A61K31/573;A61K9/19;A61K9/08;A61K45/06;A61K47/48;A61K9/00 |
主分类号 |
A61K31/573 |
代理机构 |
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代理人 |
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主权项 |
1. An aqueous injectable ganaxolone formulation comprising
a) ganaxolone and sulfobutyl ether-β-cyclodextrin in an inclusion complex; and b) water. |
地址 |
Radnor PA US |