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Title:
エステトロール成分を含有する口腔内崩壊性投与単位
Document Type and Number:
Japanese Patent JP6866560
Kind Code:
B2
Abstract:
The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of:• 0.1-25 wt.% of estetrol particles containing at least 80 wt.% of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and• 75-99.9 wt.% of one or more pharmaceutically acceptable ingredients;the solid dosage unit comprising at least 100 µg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 µm to 50 µm.The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Inventors:
Jaspearl, Ceverine Francine Isabel
Plateau, Johannes Jean
Van den Hubel, Denny Joanne Malein
Application Number:
JP2017564402A
Publication Date:
April 28, 2021
Filing Date:
June 17, 2016
Export Citation:
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Assignee:
S-Tetra Society Preve A Responsabilites Limited
International Classes:
A61K31/565; A61K9/16; A61K9/20; A61K47/10; A61K47/26; A61K47/32; A61K47/36; A61K47/38; A61K47/42; A61P15/00; A61P19/10; A61P35/00
Foreign References:
WO2002094276A1
US20050070488
US20070286819
WO2000042955A1
Attorney, Agent or Firm:
Ikeda adult
Junichiro Sakamaki
Masakazu Noda