Details for Patent: 9,616,023

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)
Filing Date:	Jul 06, 2015
Application Number:	14/792,158
Claims:	1. A solid pharmaceutical preparation comprising a homogenous admixture comprising a stabilizer and glyceryl trinitrate (GTN) phlegmatized in medium chain triglycerides, the stabilizer comprising at least one triglyceride that is solid or semi-solid at a temperature of 20.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 triglyceride content is 0.2-10% by weight of the composition. 4. The pharmaceutical preparation of claim 1, wherein the triglyceride is hard fat in accordance with USP/NF. 5. The pharmaceutical preparation of claim 1, wherein the carrier is selected from the group consisting of: dibasic calcium phosphate, magnesium aluminometasilicate, and isomalt. 6. 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. 7. The pharmaceutical preparation of claim 6, 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. 8. The pharmaceutical preparation of claim 1, wherein the preparation is in the form of a free-flowing powder or free-flowing granules. 9. The pharmaceutical preparation of claim 1, wherein the preparation further comprises at least 0.01-3.0% by weight of a flavoring agent. 10. The pharmaceutical preparation of claim 1, wherein the homogeneous admixture comprises a further stabilizer that comprises monoglycerides or diglycerides or mixtures of both. 11. The pharmaceutical preparation of claim 10, wherein the further stabilizer is glycerol monocaprylocaprate. 12. A solid pharmaceutical preparation comprising a homogenous admixture comprising glycerol monocaprylocaprate as a stabilizer and glyceryl trinitrate (GTN) phlegmatized in medium chain triglycerides, the stabilizer having a melting point not higher than 60.degree. C., the homogenous admixture absorbed to a porous, pharmaceutically suitable carrier. 13. The pharmaceutical preparation of claim 12, wherein the GTN content is 0.05-2% by weight of the composition. 14. The pharmaceutical preparation of claim 12, wherein the monoglyceride content is 0.2-10% by weight of the composition. 15. The pharmaceutical preparation of claim 12, wherein the carrier is selected from the group consisting of: dibasic calcium phosphate, magnesium aluminometasilicate, and isomalt. 16. The pharmaceutical preparation of claim 12 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. 17. The pharmaceutical preparation of claim 16, 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. 18. The pharmaceutical preparation of claim 12, wherein the preparation is in the form of a free-flowing powder or free-flowing granules. 19. The pharmaceutical preparation of claim 12, wherein the preparation further comprises at least 0.01-3.0% by weight of a flavoring agent. 20. The pharmaceutical preparation of claim 12, wherein the homogeneous admixture comprises a further stabilizer that is triglyceride, the further stabilizer having a melting point not higher than 60.degree. C. 21. The pharmaceutical preparation of claim 20, wherein the further stabilizer is a solid triglyceride. 22. The pharmaceutical preparation of claim 12, wherein the stabilizer further comprises diglycerides. 23. A solid pharmaceutical preparation comprising a homogenous admixture comprising glycerol monooleate as a stabilizer and glyceryl trinitrate (GTN) phlegmatized in medium chain triglycerides, the stabilizer having a melting point not higher than 60.degree. C., the homogenous admixture absorbed to a porous, pharmaceutically suitable carrier. 24. The pharmaceutical preparation of claim 23, wherein the GTN content is 0.05-2% by weight of the composition. 25. The pharmaceutical preparation of claim 23, wherein the monoglyceride content is 0.2-10% by weight of the composition. 26. The pharmaceutical preparation of claim 23, wherein the carrier is selected from the group consisting of: dibasic calcium phosphate, magnesium aluminometasilicate, and isomalt. 27. The pharmaceutical preparation of claim 23 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. 28. The pharmaceutical preparation of claim 27, 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. 29. The pharmaceutical preparation of claim 23, wherein the preparation is in the form of a free-flowing powder or free-flowing granules. 30. The pharmaceutical preparation of claim 23, wherein the preparation further comprises at least 0.01-3.0% by weight of a flavoring agent. 31. The pharmaceutical preparation of claim 23, wherein the homogeneous admixture comprises a further stabilizer that is triglyceride, the further stabilizer having a melting point not higher than 60.degree. C. 32. The pharmaceutical preparation of claim 23, wherein the further stabilizer is a solid triglyceride. 33. The pharmaceutical preparation of claim 23, wherein the stabilizer further comprises diglycerides.