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Claims for Patent: 7,691,880

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Claims for Patent: 7,691,880

Title:Methylphenidate solution and associated methods of administration and production
Abstract:A methylphenidate solution and associated methods of administration and production, which includes methylphenidate and at least one organic acid dissolved in a solvent system, where the solvent system includes at least one non-aqueous solvent. The solvent system may include water. The non-aqueous solvent can include, but is not limited to polyols and glycols and associated mixtures thereof. Pharmaceutical additives such as flavorings, colorants, buffers, preservatives and mixtures thereof may be optionally added to the methylphenidate solution.
Inventor(s): Herman; Clifford J. (St. Louis, MO)
Assignee: Mallinckrodt Inc. (Hazelwood, MO)
Application Number:10/554,133
Patent Claims: 1. An oral methylphenidate HCl solution comprising: about 0.1 mg/ml to about 10.0 mg/ml methylphenidate HCl; and about 0.5 mg/ml to about 5.0 mg/ml of at least one organic acid, the methylphenidate HCl and the at least one organic acid being dissolved in a solvent system, the solvent system comprising: about 10% to about 45% water; about 30% to about 70% of at least one polyol solvent; about 10% to about 70% of at least one glycol solvent; and wherein the oral methylphenidate HCl solution is storage stable.

2. The methylphenidate HCl solution according to claim 1, wherein the at least one organic acid is selected from the group consisting of acetic acid, ascorbic acid, citric acid, fumaric acid, malic acid, succinic acid, tartaric acid and mixtures thereof.

3. The methylphenidate HCL solution according to claim 1, wherein the at least one polyol solvent is selected from the group consisting of glycerin, sorbitol, sucrose, fructose and mixtures thereof.

4. The methylphenidate HCl solution according to claim 1, wherein the at least one glycol solvent is selected from the group consisting of propylene glycol, polyalkylene glycol products and mixtures thereof.

5. The methylphenidate HCl solution according to claim 1, further including at least one pharmaceutical additive selected from the group consisting of flavorings, colorants, buffers, preservatives and mixtures thereof.

6. An oral methylphenidate HCl solution comprising: about 0.1 mg/ml to about 10.0 mg/ml methylphenidate HCl; and about 0.5 mg/ml to about 3.0 mg/ml of at least one organic acid, the methylphenidate HCl and the at least one organic acid being dissolved in a solvent system, the solvent system comprising: about 10% to about 45% water; about 40% to about 60% of at least one polyol solvent; about 10% to about 30% of at least one glycol solvent; and wherein the oral methylphenidate HCl solution is storage stable.

7. The methylphenidate HCl solution according to claim 6, wherein at least one organic acid is selected from the group consisting of acetic acid, ascorbic acid, citric acid, fumaric acid, malic acid, succine acid, tartaric acid and mixtures thereof.

8. The methylphenidate HCl solution according to claim 6, wherein the at least one polyol solvent is selected from the group consisting of glycerin, sorbitol, sucrose, fructose and mixtures thereof.

9. The methylphenidate HCl solution according to claim 6, wherein the at least one glycol solvent is selected from the group consisting of propylene glycol, polyalkylene glycol products and mixtures thereof.

10. The methylphenidate HCl solution according to claim 6, further including at least one pharmaceutical additive selected from the group consisting of flavorings, colorants, buffers, preservatives and mixtures thereof.

11. An oral methylphenidate HCl solution comprising: about 0.1 mg/ml to about 10.0 mg/ml methylphenidate HCl; and about 0.5 mg/ml to about 1.5 mg/ml of at least one organic acid, the methylphenidate HCl and the at least one organic acid being dissolved in a solvent system, the solvent system comprising: about 30% to about 40% water; about 45% to about 55% of at least one polyol solvent; about 10% to about 20% of at least one glycol solvent; and wherein the oral methylphenidate HCl solution is storage stable.

12. The methylphenidate HCl solution according to claim 11, wherein the at least one organic acid includes citric acid.

13. The methylphenidate HCl solution according to claim 11, wherein the at least one polyol solvent includes glycerin.

14. The methylphenidate HCl solution according to claim 11, wherein the at least one glycol solvent includes polyethylene glycol.

15. The methylphenidate HCl solution according to claim 11, further including at least one pharmaceutical additive selected from the group consisting of flavorings, colorants, buffer, preservatives and mixtures thereof.
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