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Claims for Patent: 9,101,592

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Claims for Patent: 9,101,592

Title:Stabilized granules containing glyceryl trinitrate
Abstract: Solid pharmaceutical preparation with the active substance glyceryl trinitrate for oromucosal or oral administration characterized in that it contains between 0.05 and 2 weight % glyceryl trinitrate, at least one carrier material, and at least one substance that reduces the volatility of the GTN, whereby this substance is a non-volatile ester stabilizer.
Inventor(s): Zimmeck; Thomas (Hohenlockstedt, DE), Ueck; Henning (Bekmunde, DE), Gehricke; Julia (Kiel, DE)
Assignee: G. POHL-BOSKAMP GMBH & CO. KG (Hohenlockstedt, DE)
Application Number:14/473,415
Patent Claims: 1. A solid pharmaceutical preparation comprising a homogenous admixture comprising phlegmatized glyceryl trinitrate (GTN) and at least one non-volatile polyethoxylated glyceride having a melting point not higher than 60.degree. C., the homogenous admixture absorbed to a porous, pharmaceutically suitable carrier.

2. The pharmaceutical preparation of claim 1, wherein the GTN content is 0.05-2% by weight of the composition.

3. The pharmaceutical preparation of claim 1, wherein the GTN content is 0.1-1% by weight of the composition.

4. The pharmaceutical preparation of claim 1, wherein the GTN content is 0.2% by weight of the composition.

5. The pharmaceutical preparation of claim 1, wherein the GTN content is 0.15% by weight of the composition.

6. The pharmaceutical preparation of claim 1, wherein the GTN content is 0.1% by weight of the composition.

7. The pharmaceutical preparation of claim 1, wherein the non-volatile polyethoxylated glyceride is solid or semi-solid at a temperature of 20.degree. C.

8. The pharmaceutical preparation of claim 1, wherein the polyethoxylated glyceride content is 0.2-10% by weight of the composition.

9. The pharmaceutical preparation of claim 1, wherein the polyethoxylated glyceride is oleoyl macrogol-glyceride.

10. The pharmaceutical preparation of claim 9, wherein the oleoyl macrogol-glyceride content is 2% by weight of the composition.

11. The pharmaceutical preparation of claim 1, wherein the mass ratio of the non-volatile polyethoxylated glycerides to GTN is between 2 and 40.

12. The pharmaceutical preparation of claim 1, wherein the mass ratio of diluent to the non-volatile polyethoxylated glycerides is between 1 and 9.5.

13. The pharmaceutical preparation of claim 1, wherein the carrier is selected from the group consisting of: dibasic calcium phosphate, magnesium aluminometasilicate, and isomalt.

14. The pharmaceutical preparation of claim 1, wherein the carrier is dibasic calcium phosphate.

15. The pharmaceutical preparation of claim 1 further comprising an excipient suitable for sublingual administration, wherein the excipient is selected from the group consisting of: water-soluble mono-, di-, and polysaccharides, as well as their respective alcohols.

16. The pharmaceutical preparation of claim 15, wherein the excipient is selected from the group consisting of: fructose, glucose, isomalt, lactose, maltose, maltitol, mannitol, sorbitol, sucrose, trehalose, and xylitol and mixtures thereof.

17. The pharmaceutical preparation of claim 16, wherein the excipient is isomalt.

18. The pharmaceutical preparation of claim 17, wherein the isomalt content is 70-95% by weight of the composition.

19. The pharmaceutical preparation of claim 17, wheren the composition further comprises xylitol as a second excipient, and wherein isomalt and xylitol combined are 20-95% by weight of the composition.

20. The pharmaceutical preparation of claim 1, wherein the preparation is in the form of a free-flowing powder or free-flowing granules.

21. The pharmaceutical preparation of claim 20, wherein the preparation is packaged as a single dose in the form of a stick pack or sachet.

22. The pharmaceutical preparation of claim 1, wherein the preparation further comprises at least 0.01-3.0% by weight of a flavoring agent.

23. The pharmaceutical preparation of claim 22, wherein the flavoring agent is peppermint.

24. A method of making the pharmaceutical preparation of claim 16, the method comprising the steps of: admixing the phlegmatized GTN with the at least one non-volatile polyethoxylated glyceride; absorbing the admixture to the porous, pharmaceutically suitable carrier to form an absorbate; and mixing the absorbate with the excipient.

25. The method of claim 24, wherein the at least one non-volatile polyethoxylated glyceride is oleoyl macrogol-glyceride.

26. The method of claim 24, wherein the excipient is isomalt.

27. A solid pharmaceutical preparation for oromucosal or oral administration comprising: 0.05-2% by weight phlegmatized glyceryl trinitrate (GTN); dibasic calcium phosphate; isomalt as an excipient; and at least one non-volatile polyethoxylated glyceride having a melting point not higher than 60.degree. C., wherein the solid pharmaceutical preparation is a homogeneous, free-flowing absorbate.

28. A solid pharmaceutical preparation consisting essentially of: a homogenous admixture comprising phlegmatized glyceryl trinitrate (GTN) and at least one non-volatile polyethoxylated glyceride having a melting point not higher than 60.degree. C., the homogenous admixture absorbed to a porous, pharmaceutically suitable carrier; an excipient; and a flavouring agent, wherein the GTN content is 0.05-2% by weight of the composition, wherein the polyethoxylated glyceride content is 0.2-10% by weight of the composition, wherein the excipient content is 70-95% by weight of the composition, and wherein the flavoring agent content is 0.01-3.0% by weight of the composition.

29. A solid pharmaceutical preparation for oromucosal or oral administration comprising: 0.05-2% by weight phlegmatized glyceryl trinitrate (GTN); dibasic calcium phosphate; isomalt as an excipient; and oleoyl macrogol-glyceride, wherein the solid pharmaceutical preparation is a homogeneous, free-flowing absorbate.
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