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Details for Patent: 6,939,550

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Details for Patent: 6,939,550

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)
Filing Date:Nov 15, 2002
Application Number:10/298,175
Claims:1. A syrup formulation containing an antihistaminic amount of azatadine 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 about 1 mg/mL.

5. The syrup of claim 1, 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 formulation containing azatadine and about 0.05 to about 5 mg/mL of a sodium salt of ethylenediaminetetraacetic acid.

10. The syrup of claim 9, which the salt of ethylenediaminetetraacetic acid comprises about 0.1 to about 1 mg/mL.

11. The syrup of claim 9, in which the salt of ethylenediaminetetraacetic acid comprises about 0.25 to about 0.5 mg/mL.

12. The syrup of claim 9, further containing an analgesic.

13. The syrup of claim 9, further containing a decongestant selected from the group consisting of pseudoephedrine and phenylpropanolamine.

14. An antihistaminic syrup formulation containing azatadine and about 0.05 to about 5 mg/mL of the disodium salt of ethylenediaminetetraacetic acid.

15. The syrup of claim 14, in which the disodium salt of ethylenediaminetetraacetic acid comprises about 0.1 to about 1 mg/mL.

16. The syrup of claim 14, in which the disodium salt of ethylenediaminetetrascetic acid comprises about 0.25 to about 0.5 mg/mL.

17. The syrup of claim 14, further containing an analgesic.

18. The syrup of claim 14, further containing a decongestant selected from the group consisting of pseudoephedrine and phenylpropanolamine.

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