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Claims for Patent: 6,930,119

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Claims for Patent: 6,930,119

Title: Liquid pharmaceutical composition
Abstract:This invention relates to new pharmaceutical compositions and methods for their preparation, and in particular it relates to taste-masked liquid compositions comprising a solution of a histamine H.sub.2 -antagonist complexed with an alginate and also containing a humectant. The solution is buffered to a pH of between about 6 to 7. The inventive solution may be flavored and sweetened and preserved.
Inventor(s): Bobotas; George (Tarpon Springs, FL), Fawzy; Abdel A. (Dracut, MA)
Assignee: Reliant Pharmaceuticals, Inc. (Liberty Corner, NJ)
Application Number:10/198,271
Patent Claims: 1. A pharmaceutical composition for the oral administration of a therapeutically effective amount of nizatidine in the form of the free base, wherein said composition exhibits a non-bitter taste, said composition comprising a solution of: a therapeutically effective amount of nizatidine, and an alginate taste-masking agent capable of forming a complex there with,

wherein the ratio of nizatidine to the alginate is from 1:0.1 to 1:0.6 weight to weight, and further wherein the pH of the solution is from pH6.0 to 7.0.

2. The pharmaceutical composition according to claim 1, wherein said alginate taste-masking agent comprises sodium alginate.

3. The pharmaceutical composition according to claim 1, wherein the ratio of nizatidine to alginate is about 1:0.2 to about 1:0.4 weight:weight.

4. The pharmaceutical composition according to claim 1, further comprising a flavoring agent selected from the group consisting of natural and artificial flavors and mints.

5. The pharmaceutical composition according to claim 1 further comprising a sweetening agent selected from the group consisting of water-soluble natural sweetening agents, water-soluble artificial sweetening agents and mixtures thereof.

6. The pharmaceutical composition according to claim 5, wherein said water-soluble natural sweetening agent is selected from the group consisting of xylose, ribose, glucose, mannose, galactose, fructose, dextrose, sucrose, sugar, maltose, partially hydrolyzed starch, corn syrup solids, sorbitol, xylitol, mannitol and mixtures thereof.

7. The pharmaceutical composition according to claim 5, wherein said artificial sweetening agent is L-aspartylphenylalanine methyl ester.

8. The pharmaceutical composition according to claim 5, wherein said water-soluble artificial sweetening agent is selected from the group consisting of: sodium, or calcium saccharin salts, cyclamate salts, acesulfam-K, ammonium glycyrrhizinate, dipotassium glycyrrhizinate-and the free acid form of saccharin.

9. The pharmaceutical composition according to claim 4, wherein said flavoring agent is present in from about 0.01% to about 1% by weight/volume of the final composition.

10. The pharmaceutical composition according to claim 4, wherein said flavoring agent is one or more members selected from the group consisting of: peppermint, menthol, artificial vanilla, cinnamon, lemon, lime, orange, menthol, strawberry and bubblegum.

11. The pharmaceutical composition according to claim 1, further comprising a humectant.

12. The pharmaceutical composition according to claim 11, wherein the humectant is present in an amount from 8 to 15 percent w/v of the final composition.

13. The pharmaceutical composition according to claim 11, wherein the humectant is selected from the group consisting of glycerol, propylene glycol and mixtures thereof.

14. The pharmaceutical composition according to claim 1, wherein the pH of the solution is from pH 6.25 to 6.75.

15. The pharmaceutical composition according to claim 1, further comprising an artificial sweetness enhancer in from about 0.05 to about 1.5 percent w/v of the final composition.

16. The pharmaceutical composition according to claim 1, further comprising EDTA in an amount from about 0.05% w/v to about 0.1% w/v.
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