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Claims for Patent: 8,236,285

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Claims for Patent: 8,236,285

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:12/576,457
Patent Claims: 1. A method of administering zolpidem to a mammal to provide transmucosal absorption of a pharmacologically effective amount of zolpidem through the oral mucosa of the mammal to the systemic circulatory system of the mammal, comprising: spraying the oral mucosa of the mammal with a buccal spray composition comprising in weight percent of the composition: zolpidem or a pharmaceutically acceptable salt thereof in an amount of between 0.1 and 25 percent by weight of the total composition; a polar solvent in an amount between 10 and 97 percent by weight of the total composition; and a propellant in an amount between 2 and 10 percent by weight of the total composition, wherein said propellant is a C.sub.3 to C.sub.8 hydrocarbon of linear or branched configuration; and wherein said spraying the oral mucosa results in transmucosal absorption of a pharmacologically effective amount of zolpidem through the oral mucosa to the systemic circulatory system of said mammal.

2. The method of claim 1, wherein the composition further comprises a taste mask and/or flavoring agent in an amount between 0.05 and 10 percent by weight of the total composition.

3. The method of claim 2, wherein the polar solvent is present in an amount between 20 and 97 percent by weight of the total composition, the zolpidem or a pharmaceutically acceptable salt thereof is present in an amount between 0.1 and 15 percent by weight of the total composition, the propellant is present in an amount between 2 and 5 percent by weight of the composition, and the taste mask and/or flavoring agent is present in an amount between 0.1 and 5 percent by weight of the total composition.

4. The method of claim 3, wherein the polar solvent is present in an amount between 25 and 97 percent by weight of the total composition, the zolpidem or a pharmaceutically acceptable salt thereof is present in an amount between 0.2 and 10 percent by weight of the total composition, the propellant is present in an amount between 2 and 4 percent by weight of the composition, and taste mask and/or flavoring agent is present in an amount between 0.1 and 2.5 percent by weight of the total composition.

5. The method of claim 1, wherein the polar solvent is selected from the group consisting of polyethyleneglycols 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.

6. The method of claim 1, wherein the polar solvent comprises polyethylene glycol.

7. The method of claim 1, wherein the polar solvent comprises ethanol.

8. The method of claim 2, wherein the flavoring agent is selected from the group consisting of synthetic or natural oil of peppermint, oil of spearmint, citrus oil, fruit flavors, sweeteners, and mixtures thereof.

9. The method of claim 1, wherein the propellant is selected from the group consisting of propane, N-butane, iso-butane, N-pentane, iso-pentane, neo-pentane, and mixtures thereof.

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