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Claims for Patent: 9,415,053

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Claims for Patent: 9,415,053

Title:Solid, orally administrable pharmaceutical composition
Abstract: The present invention relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin- -5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, and its use for the prophylaxis and/or treatment of diseases.
Inventor(s): Benke; Klaus (Bergisch Gladbach, DE)
Assignee: Bayer Intellectual Property GmbH (Monheim, DE)
Application Number:14/250,863
Patent Claims: 1. A process for the preparation of a solid, orally administrable pharmaceutical composition comprising an active compound (I) that is 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin- -5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, comprising the following steps: (a) first preparing granules comprising the active compound (I) in hydrophilized form using fluidized bed granulation for moist granulation; (b) and converting the granules into the pharmaceutical composition.

2. The process according to claim 1, wherein the active compound (I) is employed in crystalline form.

3. The process according to claim 2, wherein the active compound (I) is employed in micronized form.

4. The process according to claim 1, wherein the active compound (I) suspended in the granulating liquid is introduced into the moist granulation.

5. The process according to claim 1, wherein the resulting pharmaceutical composition is a tablet rapidly releasing the active compound (I).

6. A solid, orally administrable pharmaceutical composition comprising an active compound (I) that is 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin- -5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form prepared by a process comprising the following steps: (a) first preparing granules comprising the active compound (I) in hydrophilized form using fluidized bed granulation for moist granulation; (b) and converting the granules into the pharmaceutical composition.

7. The pharmaceutical composition according to claim 6, comprising the active compound (I) in crystalline form.

8. The pharmaceutical composition according to claim 7, comprising the active compound (I) in micronized form.

9. The pharmaceutical composition according to claim 6, wherein the active compound (I) is present in a concentration of 1 to 60% based on the total mass of the composition.

10. The pharmaceutical composition according to claim 6, further comprising sodium lauryl sulphate as a wetting agent.

11. The pharmaceutical composition according to claim 10, wherein said sodium lauryl sulphate is present in a concentration of 0.1 to 5%, based on the total mass.

12. The pharmaceutical composition according to claim 6, further comprising hydroxypropylmethylcellulose as a hydrophilic binding agent.

13. The pharmaceutical composition according to claim 12, wherein said hydroxypropylmethylcellulose is present in a concentration of 1 to 15%, based on the total mass.

14. The pharmaceutical composition according to claim 6 that is in the form of a tablet.

15. The pharmaceutical composition according to claim 14 that is in the form of a rapid-release tablet.

16. The pharmaceutical composition according to claim 15, characterized in that the tablet is covered with a coating.

17. A method for the prophylaxis and/or treatment of thromboembolic diseases comprising administering an effective amount of the pharmaceutical composition of claim 6 to a patient in need thereof.

18. The process according to claim 1, wherein the granules are converted into the pharmaceutical composition with the addition of pharmaceutically suitable additives.

19. The process of claim 1, wherein the granules are converted into the pharmaceutical composition by tableting, filling into capsules, or filling into sachets.

20. The process according to claim 1, wherein the granules are converted into the pharmaceutical composition by a converting process selected from tableting, filling into capsules, and filling into sachets, and further wherein the converting process comprises adding pharmaceutically suitable additives.

21. The process according to claim 20, wherein the converting process is tableting.

22. The solid, orally administrable pharmaceutical composition of claim 6, wherein the granules are converted into the pharmaceutical composition with the addition of pharmaceutically suitable additives.

23. The solid, orally administrable pharmaceutical composition of claim 6, wherein the granules are converted into the pharmaceutical composition by tableting, filling into capsules, or filling into sachets.

24. The solid, orally administrable pharmaceutical composition of claim 6, wherein the granules are converted into the pharmaceutical composition by a converting process selected from tableting, filling into capsules, and filling into sachets, and further wherein the converting process comprises adding pharmaceutically suitable additives.
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