| 发明名称 |
ALDITOL-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 one or more of a monosaccharide, a disaccharide, and an oligosaccharide sufficient to stabilize the levothyroxine sodium; and two or more of a filler, a binder, and a lubricant. Such compositions are free of added alditol and are storage stable |
| 申请公布号 |
US2016331711(A1) |
申请公布日期 |
2016.11.17 |
| 申请号 |
US201615222845 |
申请日期 |
2016.07.28 |
| 申请人 |
Parikh Nilesh;Hite William C. |
发明人 |
Parikh Nilesh;Hite William C. |
| 分类号 |
A61K31/198;A61K47/32;A61K47/20;A61K47/02;A61K47/10;A61K47/26;A61K47/12 |
主分类号 |
A61K31/198 |
| 代理机构 |
|
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 a saccharide 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 saccharide is at least one member selected from the group consisting of a monosaccharide, a disaccharide, and an oligosaccharide; the composition is free of added alditol; and the composition is storage stable. |
| 地址 |
Irvine CA US |
