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Patent Searching and Data


Title:
TABLET FORM INCLUDING ULIPRISTAL ACETATE AND THE METHODS FOR ITS PREPARATION
Document Type and Number:
WIPO Patent Application WO/2017/216637
Kind Code:
A4
Abstract:
The invention refers to a tablet form for oral administration, including ulipristal acetate, as desintegrated agent sodium starch glycolate and as diluent a mixture from lactose monohydrate and microcrystallline cellulose. The components in the tablet composition are in the following quantity ratios: from 3,33 to 10 wt % micronised ulipristal acetate, from 2 to 8 wt % sodium starch glycolate, from 88 to 89 wt % mixture from lactose monohydrate and microcrystallline cellulose, povidone in a quantity of 3 wt % and 1 wt % magnesium stearate.The invention relates also to a method for production the same pharmaceutical form.

Inventors:
GAU YEONG-SHUN (TW)
LAI CHIEH-SHAN (TW)
WENG MU-DIAN (TW)
Application Number:
PCT/IB2017/000932
Publication Date:
July 19, 2018
Filing Date:
August 04, 2017
Export Citation:
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Assignee:
ALVOGEN MALTA OPERATIONS ROW LTD (MT)
International Classes:
A61K9/20; A61K9/00; A61K31/57
Attorney, Agent or Firm:
VALCHEVA, Emiliya Nikolova (BG)
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Claims:
AMENDED CLAIMS

received by the International Bureau on 29 May 2018 (29.05.2018)

Patent claims

1. Tablet form, including ulipristal acetate micronised, disintegrating agent, diluent, povidone and magnesium stearate, characterized by that, the disintegrating agent is sodium starch glycolate, the diluent is a mixture from lactose monohydrate and microcrystallline cellulose, and the a components of the tablet mixture are in the following quantity ratios: from 3,33 to 10 wt % micronised ulipristal acetate, from 2 to 8 wt % sodium starch glycolate, from 88 to 89 wt % mixture from lactose monohydrate and microcrystallline cellulose, povidone in a quantity of 3 wt % and 1 wt % magnesium stearate.

2. Tablet form, according to claim 1 , wherein the desintegrated agent sodium starch glycolate is in a quantity of 4 wt % relations to the total weight of the tablet.

3. Tablet formulation, according to claims 1 and 2, wherein lactose monohydrate and microcrystallline cellulose in the composition of the diluent are in a ratio of 1 :7,8.

4. Tablet formulation, according to any of claims 1 to 3, wherein the povidone is povidone K 30.

5. Method for preparation of the tablet formulation, including ulipristal acetate, according any of claims 1 to 4, wherein the necessary quantities of ulipristal acetate, sodium starch glycolate, microcrystallline cellulose and lactose monohydrate are mixed, the mixture is wetted with preliminary prepared water solution of povidone, it is granuled, and the resulting granules are dried, after that they are powdered with magnesium stearate and are compressed for the tablets preparation.