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Claims for Patent: 6,514,520

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Claims for Patent: 6,514,520

Title: Stabilized antihistamine syrup
Abstract:An antihistaminic syrup is stabilized against degradation of the active ingredient, by the addition of and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid such as a salt of ethylenediaminetetraacetic acid.
Inventor(s): Munayyer; Farah J. (West Caldwell, NJ), Guazzo; Frank (Bridgewater, NJ), Stupak; Elliot I. (West Caldwell, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ), Sequeira; Joel A. (Edison, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:09/899,764
Patent Claims: 1. An antihistaminic syrup formulation comprising descarboethoxyloratadine and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.

2. The syrup of claim 1, wherein the aminopolycarboxylic acid is selected from the group consisting of: iminodiacetic acid; methyliminodiacetic acid; nitrilotriacetic acid; ethylenediaminetetraacetic acid; diethylenetriaminepentaacetic acid; 1,2-diaminocyclohexane-tetraacetic acid; N-hydroxyethylenediaminetriacetic acid; and any combination of two or more thereof.

3. The syrup of claim 1, wherein the aminopolycarboxylic acid comprises ethylenediaminetetraacetic acid.

4. The syrup of claim 1, in which the aminopolycarboxylic acid comprises about 0.1 to 1 mg/mL.

5. The syrup of claim 3, in which the aminopolycarboxylic acid comprises about 0.25 to about 0.5 mg/mL.

6. The syrup of claim 1, further containing a therapeutically effective amount of a decongestant, an analgesic, an antitussive, an expectorant, or any combination of two or more thereof.

7. The syrup of claim 1, further containing a decongestant selected from the group consisting of pseudoephedrine and phenylpropanolamine.

8. The syrup of claim 1, further containing the decongestant pseudoephedrine.

9. An antihistaminic syrup comprising descarboethoxyloratadine and an aminopolycarboxylic acid or a salt thereof.

10. The antihistaminic syrup of claim 9, wherein the aminopolycarboxylic acid or salt is present in an amount sufficient to inhibit degradation of said descarboethoxyloratadine.

11. The antihistaminic syrup of claim 9, wherein the aminopolycarboxylic acid is selected from the group consisting of: iminodiacetic acid; methyliminodiacetic acid; nitrilotriacetic acid; ethylenediaminetetraacetic acid; diethylenetriaminepentaacetic acid; 1,2-diaminocyclohexane-tetraacetic acid; N-hydroxyethylenediaminetriacetic acid; and a combination of two or more thereof.

12. The antihistaminic syrup of claim 9, wherein the aminopolycarboxylic acid comprises ethylenediaminetetraacetic acid.

13. The antihistaminic syrup of claim 12, wherein the ethylenediaminetetraacetic acid or salt is present in an amount sufficient to inhibit degradation of said descarboethoxyloratadine.

14. A syrup formulation comprising descarboethoxyloratadine and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof, sufficient to inhibit degradation of said descarboethoxyloratadine.

15. The syrup of claim 14, wherein the aminopolycarboxylic acid comprises ethylenediaminetetraacetic acid.

16. The syrup of claim 15, wherein the ethylenediamine tetraacetic acid is present in an amount of about 0.25 to about 0.5 mg/mL.

17. The syrup of claim 14, further comprising a therapeutically effective amount of a decongestant, analgesic, antitussive, expectorant or a combination of two or more thereof.

18. The syrup of claim 14, further comprising pseudoephedrine or a salt thereof.

19. The syrup of claim 18, further comprising an analgesic.

20. The syrup of claim 14, further comprising a decongestant and an analgesic.
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