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Claims for Patent: 7,632,517

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Claims for Patent: 7,632,517

Title:Buccal, polar and non-polar spray containing zolpidem
Abstract:Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.
Inventor(s): Dugger, III; Harry A. (Flemington, NJ), Abd El-Shafy; Mohammed (Hauppauge, NY)
Assignee: Novadel Pharma Inc. (Flemington, NJ)
Application Number:10/671,715
Patent Claims: 1. A method of treating insomnia in a human patient, comprising: providing an oral spray composition comprising zolpidem or a pharmaceutically acceptable salt thereof in an amount of between 2.5 and 20 percent by weight of the total composition; a polar solvent in an amount between 15 and 60 percent by weight of the total composition; and water; and spraying the composition on the oral mucosa of the patient to provide transmucosal absorption of an amount of zolpidem through the oral mucosa to the systemic circulatory system of the patient sufficient to treat the patient's insomnia.

2. The method of claim 1, wherein the composition further comprises a taste mask and/or flavoring agent in an amount of between 0.1 and 10 percent by weight of the total composition.

3. The method of claim 1, wherein the zolpidem or a pharmaceutically acceptable salt thereof is present in an amount between 2.5 and 15 percent by weight of the total composition.

4. The method of claim 1, wherein the zolpidem or a pharmaceutically acceptable salt thereof is present in an amount between 2.5 and 10 percent by weight of the total composition.

5. The method of claim 1, wherein the pharmaceutically acceptable salt thereof is zolpidem tartrate.

6. The method of claim 1, wherein the polar solvent is present in an amount between 25 and 50 percent by weight of the total composition.

7. The method of claim 1, wherein the polar solvent is present in an amount between 30 and 45 percent by weight of the total composition.

8. The method of claim 1, wherein the polar solvent is selected from the group consisting of polyethylene glycols having a molecular weight between 400 and 1000, C.sub.2 to C.sub.8 mono- and poly-alcohols, and C.sub.7 to C.sub.18 alcohols of linear or branched configuration.

9. The method of claim 1, wherein the polar solvent is polyethylene glycol.

10. The method of claim 1, wherein the polar solvent is ethanol.

11. The method of claim 1, wherein the polar solvent is propylene glycol.

12. The method of claim 1, wherein the composition comprises a flavoring agent selected from the group consisting of synthetic or natural oil of peppermint, oil of spearmint, citrus oil, fruit flavors, sweeteners, and mixtures thereof.

13. The method of claim 1, wherein the amount of the spray is predetermined.

14. The method of claim 1, wherein the composition is propellant free.

15. The method of claim 1, wherein the composition further comprises a buffer.

16. The method of claim 1, wherein the composition comprises zolpidem tartrate and propylene glycol.

17. The method of claim 16, wherein the zolpidem tartrate is present in an amount between 2.5 and 10 percent by weight of the total composition.

18. The method of claim 17, wherein the propylene glycol is present in an amount between 20 and 45 percent by weight of the total composition.

19. The method of claim 18, further comprising a buffer.

20. The method of claim 19, further comprising a flavorant or taste masking agent.

21. The method of claim 20, wherein the composition is propellant free.
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