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Claims for Patent: 5,962,461

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Claims for Patent: 5,962,461

Title: Pleasant-tasting aqueous liquid composition of a bitter-tasting drug
Abstract:A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol. That aqueous medium consists essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 35 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants. The liquid composition is transparent and has a pleasant taste. The bitter tasting drugs claimed herein are vitamin and mineral preparations, trimethoprim, and guaifenesin.
Inventor(s): Anaebonam; Aloysius O. (Burlington, MA), Clemente; Emmett (Manchester, MA), Fawzy; Abdel A. (Groton, MA)
Assignee: Ascent Pediatrics, Inc. (Billerica, MA)
Application Number:09/011,156
Patent Claims: 1. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of a bitter-tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 35 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said liquid composition being transparent and having a pleasant taste when administered orally, wherein said bitter-tasting drug is selected from the group consisting of a vitamin preparation and minerals.

2. The liquid pharmaceutical composition according to claim 1 wherein said polyvinylpyrrolidone is present at about 7 to about 15 weight percent.

3. The liquid pharmaceutical composition according to claim 1 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

4. The liquid pharmaceutical composition according to claim 1 wherein said ammonium glycyrrhizinate is present at a weight ratio to said drug of about 1:50 to 2:1.

5. The liquid pharmaceutical composition according to claims 1 wherein said drug is present in an amount of about 0.5 to about 5 weight percent.

6. A liquid pharmaceutical composition comprising about 0.5 to about 5 weight percent of a bitter-tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said ammonium glycyrrhizinate being present at a weight ratio to said drug of about 1:50 to about 1:10 and said liquid composition being transparent and having a pleasant taste when administered orally, wherein said bitter-tasting drug is selected from the group consisting of a vitamin preparation or minerals.

7. The liquid pharmaceutical composition according to claim 6 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

8. The liquid pharmaceutical composition according to claim 7 wherein the weight ratio of said C.sub.3 polyol to said C.sub.6 polyol is about 1:4 to about 3:5.

9. The liquid pharmaceutical composition according to claim 6 wherein polyol other than a C.sub.6 polyol constitutes less than about 5 weight percent of said composition.

10. The liquid pharmaceutical composition according to claim 6 wherein said drug is present in an amount of about one to about 3 weight percent.

11. The liquid pharmaceutical composition according to claim 6 wherein said C.sub.3 -C.sub.6 polyol is present at about 45 to about 55 weight percent.

12. The liquid pharmaceutical composition according to claim 6 wherein said ammonium glycyrrhizinate is present at a weight ratio to said drug of about 1:50 to about 1:10.

13. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of trimethoprim dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said liquid composition being transparent and having a pleasant taste when administered orally.

14. The liquid pharmaceutical composition according to claim 13 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

15. The liquid pharmaceutical composition according to claim 1 wherein said ammonium glycyrrhizinate is present at a weight ratio to said trimethoprim of about 1:50 to 1:10.

16. The liquid pharmaceutical composition according to claim 13 wherein said trimethoprim is present in an amount of about 0.5 to about 5 weight percent.

17. A liquid pharmaceutical composition comprising about 0.5 to about 5 weight percent of trimethoprim dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said ammonium glycyrrhizinate being present at a weight ratio to said trimethoprim of about 1:50 to about 1:10 and said liquid composition being transparent and having a pleasant taste when administered orally.

18. The liquid pharmaceutical composition according to claim 17 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

19. The liquid pharmaceutical composition according to claim 17 wherein the weight ratio of said C.sub.3 polyol to said C.sub.6 polyol is about 1:4 to about 3:5.

20. The liquid pharmaceutical composition according to claim 17 wherein a polyol other than a C.sub.6 polyol constitutes less than about 5 weight percent of said composition.

21. The liquid pharmaceutical composition according to claim 17 wherein said trimethoprim is present in an amount of about one to about 3 weight percent.

22. A liquid pharmaceutical composition comprising a pharmaceutically effective amount of guaifenesin dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said liquid composition being transparent and having a pleasant taste when administered orally.

23. The liquid pharmaceutical composition according to claim 22 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

24. The liquid pharmaceutical composition according to claim 22 wherein said ammonium glycyrrhizinate is present at a weight ratio to said guaifenesin of about 1:50 to 1:10.

25. The liquid pharmaceutical composition according to claim 22 wherein said guaifenesin is present in an amount of about 0.5 to about 5 weight percent.

26. A liquid pharmaceutical composition comprising about 0.5 to about 5 weight percent of guaifenesin dissolved or dispersed in an aqueous medium that is free of ethanol, said aqueous medium consisting essentially of water, about 7 to about 15 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants, said ammonium glycyrrhizinate being present at a weight ratio to said guaifenesin of about 1:50 to about 1:10 and said liquid composition being transparent and having a pleasant taste when administered orally.

27. The liquid pharmaceutical composition according to claim 26 wherein said C.sub.3 -C.sub.6 polyol is present as a mixture of C.sub.3 polyols and C.sub.6 polyols.

28. The liquid pharmaceutical composition according to claim 26 wherein the weight ratio of said C.sub.3 polyol to said C.sub.6 polyol is about 1:4 to about 3:5.

29. The liquid pharmaceutical composition according to claim 6 wherein polyol other than a C.sub.6 polyol constitutes less than about 5 weight percent of said composition.

30. The liquid pharmaceutical composition according to claim 26 wherein said guaifenesin is present in an amount of about one to about 3 weight percent.
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