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Details for Patent: 8,895,051

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Details for Patent: 8,895,051

Title:Flavoring systems for pharmaceutical compositions and methods of making such compositions
Abstract: A flavoring system for a liquid pharmaceutical composition and pharmaceutical compositions containing such flavoring systems are disclosed. Flavoring systems of the invention include at least one sweetening agent, at least two flavored ingredients, and at least one flavor modifier selected from the group consisting of citric acid, sodium citrate, sodium chloride, and mixtures thereof. At least two of the flavored ingredients are selected from the group consisting of a vanilla flavored ingredient, a peppermint flavored ingredient, a menthol flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof. The one or more sweetening agents comprise glycerin, monoammonium glycyrrhizinate, saccharin sodium, acesulfame potassium, high fructose corn syrup, and/or mixtures thereof. Pharmaceutical compositions of the invention include a flavoring system of the invention, a solvent system, and at least one pharmaceutically active agent, such as lopinavir or derivatives thereof, ritonavir or derivatives thereof, or mixtures thereof. Methods for making such liquid pharmaceutical compositions are also disclosed.
Inventor(s): Alani; Laman (Hillsborough, CA), Gauwitz; Donald P. (McHenry, IL), Kaul; Dilip (Hillsborough, NJ), Lipari; John M. (Racine, WI), Ghosh; Soumojeet (Gurnee, IL), Marsh; Kennan C. (Lake Forest, IL), Whelan; Richard H. (Norfolk, MA), Petrossian; Vanik D. (Waban, MA)
Assignee:
Filing Date:May 10, 2013
Application Number:13/891,890
Claims:1. A flavoring system of a liquid pharmaceutical composition, said system comprising: (a) one or more sweetening agents selected from the group consisting of glycerin, monoammonium glycyrrhizinate, acesulfame potassium, high fructose corn syrup, saccharin sodium and mixtures thereof; and (b) two or more flavored ingredients selected from the group consisting of a menthol flavored ingredient, a peppermint flavored ingredient, a vanilla flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof; and (c) flavor modifiers comprising sodium citrate, sodium chloride and citric acid.

2. The flavoring system of claim 1, wherein the one or more sweetening agents comprises high fructose corn syrup.

3. The flavoring system of claim 1, wherein the one or more sweetening agents is present in an amount of between about 20% by weight and about 67% by weight based upon the total weight of the pharmaceutical composition.

4. The flavoring system of claim 1, wherein the menthol flavored ingredient is menthol crystals, and the peppermint flavored ingredient is peppermint oil.

5. The flavoring system of claim 1, wherein the total amount of flavor modifiers included in the flavoring system is at least about 0.10% by weight to about 1.0% by weight based upon the total weight of the liquid pharmaceutical composition.

6. The flavoring system of claim 1, wherein the sodium citrate is present in an amount of about 0.20% by weight, sodium chloride is present in an amount of about 0.35% by weight, and citric acid is present in an amount of about 0.11% by weight based upon the total weight of the liquid pharmaceutical composition.

7. The flavoring system of claim 1, said flavoring systems comprising at least three of the flavored ingredients.

8. The flavoring system of claim 1, said flavoring systems comprising all four of the flavored ingredients.

9. The flavoring system of claim 1, wherein at least two sweetening agents are included in the flavoring system.

10. The flavoring system of claim 1, wherein at least three sweetening agents are included in the flavoring system.

11. The flavoring system of claim 1, wherein at least four sweetening agents are included in the flavoring system.

12. The flavoring system of claim 1, wherein the total amount of the sweetening agents is at least about 20% by weight to about 67% by weight based upon the total weight of the liquid pharmaceutical composition.

13. The flavoring system of claim 1, wherein the one or more sweetening agents is selected from the group consisting of citric acid in an amount of about 0.10 to about 0.25 weight percent, sodium citrate less than about 0.25 weight percent, and sodium chloride in an amount of less than about 0.40 weight percent.

14. The flavoring system of claim 1, wherein the one or more sweetening agents is selected from the group consisting of glycerin in an amount of about 5 to about 30 weight percent, monoammonium glycyrrhizinate in an amount of about 0.35 to about 0.65 weight percent, saccharin sodium in an amount of about 0.05 to about 0.85 weight percent, acesulfame potassium in an amount of about 0.35 to about 0.85 weight percent, and high fructose corn syrup in an amount of about 14.5 to about 33.6 weight percent.

15. The flavoring system of claim 1, wherein the one or more sweetening agents is selected from the group consisting of high fructose corn syrup in an amount of about 16.6% by weight, glycerin in an amount of about 5.5% to about 8.5% by weight, monoammonium glycyrrhizinate in an amount of about 0.58% by weight, saccharin sodium in an amount of about 0.40% by weight; and acesulfame potassium in an amount of about 0.40% by weight based upon the total weight of the liquid pharmaceutical composition.

16. The flavoring system of claim 1, wherein the flavoring system is included in an amount of at least about 20% by weight based upon the total weight of the liquid pharmaceutical composition.

17. The flavoring system of claim 1, wherein the flavored ingredients are present in an amount of between about 1.4% by weight and about 3.5% by weight based upon the total weight of the pharmaceutical composition.

18. The flavoring system of claim 17, wherein the total amount of flavored ingredients is at least about 2.4% by weight to about 2.8% by weight based upon the total weight of the liquid pharmaceutical composition.

19. The flavoring system of claim 18, wherein the total amount of flavored ingredients is about 2.6% by weight based upon the total weight of the liquid pharmaceutical composition.

20. The flavoring system of claim 1, wherein the two or more flavored ingredients are selected from the group consisting of a cotton candy flavored ingredient in an amount of at least about 0.55% to about 1.10% by weight; a peppermint flavored ingredient in an amount of at least about 0.15% to about 0.60% by weight; a menthol flavored ingredient in an amount of at least about 0.03% to about 0.25% by weight; and a vanilla flavored ingredient in an amount of at least about 0.70% to about 1.5% by weight based upon the total weight of the liquid pharmaceutical composition.

21. The flavoring system of claim 20, wherein (a) the peppermint flavored ingredient is peppermint oil in an amount of about 0.30% by weight; (b) the menthol flavored ingredient is menthol crystals in an amount of about 0.05% by weight; (c) the vanilla flavored ingredient is vanilla flavor in an amount of about 1.25% by weight; and (d) the cotton candy flavored ingredient is cotton candy flavor in an amount of about 1.00% by weight, wherein all amounts by weight are based upon the total weight of the pharmaceutical composition.

22. The flavoring system of claim 1, wherein the flavoring system is compatible with a solvent system, said solvent system comprising two or more solubilizing agents selected from the group consisting of water, alkyl alcohols, alkylene glycols, and mixtures thereof.

23. The flavoring system of claim 22, wherein the solvent system is present in an amount of between about 32% and about 69% by weight based upon the total weight of the pharmaceutical composition.

24. The flavoring system of claim 22, wherein the solvent system comprises one or more alkyl alcohols and one or more alkylene glycols.

25. The flavoring system of claim 22, wherein the one or more alkyl alcohols comprise ethanol and the one or more alkylene glycols comprise propylene glycol.

26. The flavoring system of claim 22, wherein the solvent system comprises three or more solubilizing agents selected from the group consisting of water, ethanol, propylene glycol, and mixtures thereof.

27. The flavoring system of claim 1, wherein the flavoring system is present in an amount of between about 20% and about 70% by weight based upon the total weight of the pharmaceutical composition.

28. The flavoring system of claim 27, wherein the flavoring system is included in an amount of at least about 22% by weight to about 68% by weight based upon the total weight of the liquid pharmaceutical composition.

29. The flavoring system of claim 28, wherein the flavoring system is included in an amount of at least about 27% by weight to about 29.5% by weight based upon the total weight of the liquid pharmaceutical composition.

30. The flavoring system of claim 1, wherein the liquid pharmaceutical composition comprises a pharmaceutically active agent, wherein said agent has a flavor profile that is undesirably high in the bitter basic taste.

31. The flavoring system of claim 30, wherein the pharmaceutically active agent comprises ritonavir, lopinavir or mixtures thereof.
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