发明名称 |
ORODISPERSIBLE TABLET CONTAINING ESTETROL |
摘要 |
The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit containing at least 100 µg of an estetrol component selected from estetrol, estetrol esters and combinations thereof; wherein the solid dosage unit can be obtained by a process comprising: ⋅ providing an aqueous liquid comprising water, estetrol component and optionally one or more other pharmaceutically acceptable ingredients; ⋅ mixing 1 part by weight of the aqueous liquid with 0.5-20parts by weight of the carrier particles to produce wet particles; ⋅ removing water from the wet particles to produce loaded particles; ⋅ optionally mixing the loaded particles with one or more tabletting excipients; and ⋅ forming the loaded particles or the mixture of loaded particles and the one or more tabletting excipients into a solid dosage unit. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. |
申请公布号 |
WO2016203044(A1) |
申请公布日期 |
2016.12.22 |
申请号 |
WO2016EP64181 |
申请日期 |
2016.06.20 |
申请人 |
MITHRA PHARMACEUTICALS S.A. |
发明人 |
JASPART, Séverine Francine Isabelle;PLATTEEUW, Johannes Jan;VAN DEN HEUVEL, Denny Johan Marijn |
分类号 |
A61K9/20;A61K31/565 |
主分类号 |
A61K9/20 |
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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