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Claims for Patent: 9,320,716

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Claims for Patent: 9,320,716

Title:Controlled release and taste masking oral pharmaceutical compositions
Abstract: The invention relates to an oral pharmaceutical composition comprising an active agent, a macroscopically homogeneous structure and a gastro-resistant coating. The macroscopically homogeneous structure comprises at least one hydrophilic compound and at least one lipophilic compound and/or at least one amphiphilic compound. The macroscopically homogeneous structure controls the release of the active ingredient, and the gastro-resistant film prevents release of the active agent in the stomach.
Inventor(s): Villa; Roberto (Lecco, IT), Pedrani; Massimo (Gignese, IT), Ajani; Mauro (Milan, IT), Fossati; Lorenzo (Milan, IT)
Assignee: COSMO TECHNOLOGIES LIMITED (Dublin, IE)
Application Number:14/308,279
Patent Claims: 1. A controlled release oral pharmaceutical composition comprising: (i) budesonide in an amount effective to treat intestinal inflammatory disease; (ii) a macroscopically homogenous structure comprising: (a) at least one lipophilic compound and (b) at least one hydrophilic compound, wherein the macroscopically homogenous structure controls the release of the budesonide; and (iii) a gastro-resistant coating on the macroscopically homogenous structure that prevents release of budesonide in the stomach, wherein the macroscopically homogenous structure is a tablet.

2. The controlled release oral pharmaceutical composition according to claim 1, wherein the gastro-resistant coating is at least one compound selected from the group consisting of methacrylic acid polymers and cellulose derivatives.

3. The controlled release oral pharmaceutical composition according to claim 1, wherein the at least one hydrophilic compound is selected from the group consisting of an acrylic or methacrylic acid polymer or copolymer, an alkylvinyl polymer, a hydroxyalkyl cellulose, a carboxyalkyl cellulose, a polysaccharide, dextrin, pectin, starch, a natural or synthetic gum, and alginic acid.

4. The controlled release oral pharmaceutical composition according to claim 1, wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose or a carboxyalkyl cellulose.

5. The controlled release oral pharmaceutical composition according to claim 2, wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose.

6. The controlled release oral pharmaceutical composition according to claim 1, further comprising at least one amphiphilic compound.

7. The controlled release oral pharmaceutical composition according to claim 6, wherein the at least one amphiphilic compound is selected from the group consisting of lecithin, phosphatidylcholine, phosphatidylethanolamine, ceramide, and a glycol alkyl ether.

8. The controlled release oral pharmaceutical composition according to claim 6, wherein the at least one amphiphilic compound is lecithin.

9. The controlled release oral pharmaceutical composition according to claim 1, wherein the at least one lipophilic compound is selected from the group consisting of an unsaturated or hydrogenated alcohol or fatty acid, salt, ester, or amide thereof, a fatty acids mono-, di- or triglyceride, or a polyethoxylated derivative thereof, a wax, ceramide, and a cholesterol derivative.

10. The controlled release oral pharmaceutical composition according to claim 1, wherein the at least one lipophilic compound is stearic acid.

11. The controlled release oral pharmaceutical composition according to claim 1, further comprising at least one compound selected from the group consisting of a chitosan, a polyacrylamide, a natural or synthetic gum, and an acrylic acid polymer.

12. A controlled release oral pharmaceutical composition comprising: (i) budesonide in an amount effective to treat intestinal inflammatory disease; (ii) a macroscopically homogenous structure comprising: (a) at least one amphiphilic compound and (b) at least one hydrophilic compound, wherein the macroscopically homogenous structure controls the release of the budesonide; and (iii) a gastro-resistant coating on the macroscopically homogenous structure that prevents release of budesonide in the stomach, wherein the macroscopically homogenous structure is a tablet.

13. The controlled release oral pharmaceutical composition according to claim 12, wherein the gastro-resistant coating is at least one compound selected from the group consisting of methacrylic acid polymers and cellulose derivatives.

14. The controlled release oral pharmaceutical composition according to claim 12, wherein the at least one hydrophilic compound is selected from the group consisting of an acrylic or methacrylic acid polymer or copolymer, an alkylvinyl polymer, a hydroxyalkyl cellulose, a carboxyalkyl cellulose, a polysaccharide, dextrin, pectin, starch, a natural or synthetic gum, and alginic acid.

15. The controlled release oral pharmaceutical composition according to claim 12, wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose or a carboxyalkyl cellulose.

16. The controlled release oral pharmaceutical composition according to claim 12, wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose.

17. The controlled release oral pharmaceutical composition according to claim 12, wherein the at least one amphiphilic compound is selected from the group consisting of lecithin, phosphatidylcholine, phosphatidylethanolamine, ceramide, and a glycol alkyl ether.

18. The controlled release oral pharmaceutical composition according to claim 12, wherein the at least one amphiphilic compound is lecithin.

19. The controlled release oral pharmaceutical composition according to claim 12, further comprising at least one lipophilic compound selected from the group consisting of an unsaturated or hydrogenated alcohol or fatty acid, salt, ester, or amide thereof, a fatty acids mono-, di- or triglyceride, or a polyethoxylated derivative thereof, a wax, ceramide, and a cholesterol derivative.

20. The controlled release oral pharmaceutical composition according to claim 19, wherein the at least one lipophilic compound is stearic acid.

21. The controlled release oral pharmaceutical composition according to claim 12, further comprising at least one compound selected from the group consisting of a chitosan, a polyacrylamide, a natural or synthetic gum, and an acrylic acid polymer.

22. A controlled release oral pharmaceutical composition comprising: (i) budesonide in an amount effective to treat intestinal inflammatory disease; (ii) a macroscopically homogenous structure comprising: (a) budesonide; (b) at least one amphiphilic compound; (c) at least one lipophilic compound; and (d) at least one hydrophilic compound, wherein the macroscopically homogenous structure controls the release of the budesonide; and (iii) a gastro-resistant coating on the macroscopically homogenous structure that prevents release of budesonide in the stomach, wherein the macroscopically homogenous structure is a tablet.

23. The controlled release oral pharmaceutical composition according to claim 22, further comprising at least one compound selected from the group consisting of a chitosan, a polyacrylamide, a natural or synthetic gum, and an acrylic acid polymer.

24. The controlled release oral pharmaceutical composition according to claim 1, wherein the macroscopically homogenous structure comprises microcrystalline cellulose.

25. The controlled release oral pharmaceutical composition according to claim 12, wherein the macroscopically homogenous structure comprises microcrystalline cellulose.

26. The controlled release oral pharmaceutical composition according to claim 22, wherein the macroscopically homogenous structure comprises microcrystalline cellulose.

27. A method for treating intestinal inflammatory disease comprising administering to a patient the controlled release oral pharmaceutical composition according to claim 1.

28. A method for treating intestinal inflammatory disease comprising administering to a patient the controlled release oral pharmaceutical composition according to claim 12.

29. A method for treating intestinal inflammatory disease comprising administering to a patient the controlled release oral pharmaceutical composition according to claim 22.
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