| 发明名称 |
Saccharide free, storage stable thyroid hormone active drug formulations and methods for their production |
| 摘要 |
Embodiments of the present invention provide pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of an alditol sufficient to stabilize the levothyroxine sodium; and at least two excipients selected from a filler, a binder, and a lubricant. Such compositions are free of added monosaccharide, disaccharide, and an oligosaccharide and are storage stable. |
| 申请公布号 |
US8779000(B1) |
申请公布日期 |
2014.07.15 |
| 申请号 |
US201313947022 |
申请日期 |
2013.07.20 |
| 申请人 |
|
发明人 |
Parikh Nilesh;Hite William |
| 分类号 |
A61K31/195;A61K9/20;A61K9/14;A61K47/00;A61K47/06 |
主分类号 |
A61K31/195 |
| 代理机构 |
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代理人 |
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| 主权项 |
1. A pharmaceutical composition in unit dosage form that comprises: a therapeutically effective amount of a levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of an alditol sufficient to stabilize the levothyroxine sodium; and at least two excipients selected from the group consisting of a filler, a binder, and a lubricant, wherein:
the alditol is at least one member selected from the group consisting of a mannitol, a sorbitol, a maltitol, and a xylitol; the composition is free of added saccharide selected from the group consisting of a monosaccharide, a disaccharide, and an oligosaccharide; and the composition is storage stable. |
| 地址 |
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