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Claims for Patent: 8,735,380

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Claims for Patent: 8,735,380

Title:Ulipristal acetate tablets
Abstract: The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: at least one diluent in an amount of 50 to 98.5 wt %, at least one binding agent in an amount of 0 to 10 wt %, at least one disintegrating agent in an amount of 0.5 to 10 wt %, and at least one lubricant in an amount of 0 to 10 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)
Application Number:13/140,219
Patent Claims: 1. A pharmaceutical tablet for oral administration comprising from 3 to 18 wt % ulipristal acetate, wherein ulipristal acetate is present in an amount ranging from 1 mg to 50 mg, from 60 to 95 wt % of a diluent selected from the group consisting of lactose monohydrate, microcrystalline cellulose, mannitol and combinations thereof, from 0 to 10 wt % of a binding agent, from 1 to 10 wt % of croscarmellose sodium, and from 0.5 to 5 wt % of magnesium stearate, wherein the tablet is an oral tablet, and wherein at least 80% (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 in a paddle apparatus at 37.degree. C..+-.0.5.degree. C., and pH=1.

2. The tablet of claim 1, wherein the binding agent is in an amount of 1 to 10 wt %.

3. The tablet of claim 1, wherein the diluent is in an amount of 65 to 92 wt %.

4. The tablet of claim 1, wherein the binding agent is in an amount of 1.5 to 8.5 wt %.

5. The tablet of claim 1, wherein croscarmellose sodium is in an amount of 1.5 to 8.5 wt %.

6. The tablet of claim 1, wherein magnesium stearate is in an amount of 0.5 to 4 wt %.

7. The tablet according to claim 1, comprising 5 to 30 mg of ulipristal acetate.

8. The tablet according to claim 1, comprising 5, 10 or 15 mg of ulipristal acetate.

9. The tablet according to claim 1, wherein the binding agent is selected from the group consisting of polymers.

10. The tablet according to claim 9, wherein the binding agent is selected from the group consisting of hydroxypropyl methyl cellulose and povidone.

11. The tablet according to claim 1, wherein the diluent is lactose monohydrate and the binding agent is povidone.

12. The tablet according to claim 1, wherein the diluent is microcrystalline cellulose.

13. The tablet according to claim 12, further comprising mannitol.

14. The tablet according to claim 12, further comprising talc.

15. The tablet according to claim 12, devoid of any binding agent.

16. The tablet according to claim 1, wherein the tablet comprises mannitol and microcrystalline cellulose, and wherein the tablet is devoid of a binding agent.

17. The tablet of claim 1, wherein the tablet is uncoated.

18. The tablet of claim 1, wherein the tablet comprises about 6.7 wt % of ulipristal acetate, about 61 wt % of microcrystalline cellulose, about 27 wt % of mannitol, about 1.7 wt % of croscarmellose sodium, about 2.6 wt % of talc and about 1 wt % of magnesium stearate.
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