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|Title:||Ulipristal acetate tablets|
|Abstract:||The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: a diluent in an amount of 60 to 95 wt %, a binding agent in an amount of 1 to 10 wt %, croscarmellose sodium in an amount of 1 to 10 wt %, and magnesium stearate in an amount of 0 to 5 wt %.|
|Inventor(s):||Gainer; Erin (Paris, FR), Guillard; Helene (Paris, FR), Gicquel; Denis (Orgeval, FR), Henrion; Marianne (Paris, FR), Gnakamene; Celine (Paris, FR)|
|Assignee:||Laboratoire HRA Pharma (Paris, FR)|
1. A pharmaceutical tablet for oral administration comprising: 3 to 18 wt % of ulipristal acetate, wherein ulipristal acetate is present in the tablet in an amount
ranging from 5 mg to 50 mg, 60 to 95 wt % of a diluent selected from the group consisting, of lactose monohydrate and mannitol, 1 to 10 wt % of a binding agent selected from the group consisting of hydroxypropyl methyl cellulose and povidone, 1 to 10 wt
% of croscarmellose sodium, and 0 to 5 wt % magnesium stearate, wherein the tablet is an oral tablet and is uncoated, and wherein at least about 90% (w/w) of ulipristal acetate present in the tablet is dissolved within about 20 minutes when the tablet is
subjected to an in vitro dissolution assay according to the general monograph of the European Pharmacopoeia .sctn.2.9.3, at 37.degree.C..+-.0.5.degree.C., a rotation speed of 50 rpm and pH=1.
2. The tablet of claim 1, wherein the dUuent is in an amount of 65 to 92 wt %.
3. The tablet of claim 1, wherein the binding agent is in an amount of 1.5 to 8.5 wt %.
4. The tablet of claim 1, wherein croscarmellose sodium is in an amount of 1.5 to 8.5 wt %.
5. The tablet of claim 1, wherein magnesium stearate is in an amount of 0.5 to 4 wt %.
6. The tablet according to claim comprising 10 wt % ulipristal acetate.
7. The tablet according to claim 1, comprising 5 to 30 mg ulipristal acetate.
8. The tablet according to claim 1, wherein the diluent is lactose monohydrate and the binding agent is povidone.
9. The tablet according to claim 1, comprising ulipristal acetate 6 to 12 wt %, lactose monohydrate 71 to 87 wt %, povidone 4.5 to 5.5 wt %, croscarmellose sodium 4.5 to 5.5 wt % and magnesium stearate 1 to 4 wt %.
10. The tablet of claim 9, comprising ulipristal acetate 10 wt %, lactose monohydrate 79 wt %, povidone 5 wt %, croscarmellose sodium 5 wt % and magnesium stearate 1 wt %.
11. A method of manufacturing the tablet according to claim 1, the method comprising mixing the ingredients and ulipristal acetate and forming a tablet.
12. The tablet of claim 1, comprising 5 mg ulipristal acetate.
13. The tablet of claim 1, comprising 10 mg ulipristal acetate.
14. The tablet of claim 1, comprising 15 mg ulipristal acetate.
15. The tablet of claim 1, comprising 20 mg ulipristal acetate.
16. The tablet of claim 1, comprising 30 mg ulipristal acetate.
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