发明名称 |
A STABLE MONTELUKAST SOLUTION |
摘要 |
A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described. |
申请公布号 |
EP3134076(A1) |
申请公布日期 |
2017.03.01 |
申请号 |
EP20150783284 |
申请日期 |
2015.02.27 |
申请人 |
R.P. Scherer Technologies, LLC |
发明人 |
BHAVSAR, Krunal;GROTHER, Leon Paul;AXE, Philip |
分类号 |
A61K9/08;A61K9/16 |
主分类号 |
A61K9/08 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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