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Claims for Patent: 7,585,493

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Claims for Patent: 7,585,493

Title:Thin-film drug delivery article and method of use
Abstract: An article for use in an aerosol device, for producing an aerosol of a drug composition is disclosed. The article includes a heat-conductive substrate having a surface with a selected surface area, and a drug composition film on the substrate surface having a selected film thickness of between 0.05 and 20 .mu.m. The film thickness is such that an aerosol formed by vaporizing the drug composition by heating the substrate and condensing the vaporized compound contains 10% or less drug-degradation product and at least 50% of the total amount of drug composition contained in the film. The selected substrate surface area is such as to yield an effective human therapeutic dose of the drug aerosol. Also disclosed are methods of making and using the article.
Inventor(s): Hale; Ron L. (Woodside, CA), Lu; Amy (Los Altos, CA), Myers; Daniel J. (Mountain View, CA), Rabinowitz; Joshua D. (Mountain View, CA), Wensley; Martin J. (San Francisco, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Mountain View, CA)
Application Number:10/633,877
Patent Claims: 1. An article for use in an aerosol device, for producing an aerosol, comprising a heat conductive substrate having a surface with a surface area, and a film comprising a drug composition on the surface, the film having a film thickness, wherein the drug composition and film thickness are selected from the group consisting of the following combinations: alprazolam, film thickness between 0.1 and 10 .mu.m; amoxapine, thickness between 2 and 20 .mu.m; apomorphine HCl, film thickness between 0.1 and 5 .mu.m; atropine, film thickness between 0.1 and 10 .mu.m; budesonide, film thickness between 0.05 and 20 .mu.m; bumetanide film thickness between 0.1 and 5 .mu.m; buprenorphine, film thickness between 0.05 and 10 .mu.m; butorphanol, film thickness between 0.1 and 10 .mu.m; celecoxib, film thickness between 2 and 20 .mu.m; chlorpheniramine, film thickness between 0.05 and 20 .mu.m; ciclesonide, film thickness between 0.05 and 5 .mu.m; clomipramine, film thickness between 1 and 8 .mu.m; diazepam, film thickness between 0.05 and 20 .mu.m; diphenhydramine, film thickness between 0.05 and 20 .mu.m; donepezil, film thickness between 1 and 10 .mu.m; eletriptan, film thickness between 0.2 and 20 .mu.m; fentanyl, film thickness between 0.05 and 5 .mu.m; granisetron, film thickness between 0.05 and 20 .mu.m; hydromorphone, film thickness between 0.05 and 10 .mu.m; lorazepam, film thickness between 0.05 and 20 .mu.m; loxapine, film thickness between 1 and 20 .mu.m; midazolam, film thickness between 0.05 and 20 .mu.m; morphine, film thickness between 0.2 and 10 .mu.m; nalbuphine, film thickness between 0.2 and 5 .mu.m; naratriptan, film thickness between 0.2 and 5 .mu.m; olanzapine, film thickness between 1 and 20 .mu.m; parecoxib, film thickness between 0.5 and 2 .mu.m; paroxetine, film thickness between 1 and 20 .mu.m; prochlorperazine, film thickness between 0.1 and 20 .mu.m; quetiapine, film thickness between 1 and 20 .mu.m; ropinirole, film thickness between 0.05 and 20 .mu.m; sertraline, film thickness between 1 and 20 .mu.m; sibutramine, film thickness between 0.5 and 2 .mu.m; sildenafil, film thickness between 0.2 and 3 .mu.m; sumatriptan, film thickness between 0.2 and 6 .mu.m; tadalafil, film thickness between 0.2 and 5 .mu.m; valdecoxib, film thickness between 0.5 and 10 .mu.m; and vardenafil, film thickness between 0.1 and 2 .mu.m; venlafaxine, film thickness between 2 and 20 .mu.m; zaleplon, film thickness between 0.05 and 20 .mu.m; and zolpidem, film thickness between 0.1 and 10 .mu.m; wherein an aerosol formed by vaporizing the drug composition by heating the substrate and condensing the vaporized drug composition contains 10% by weight or less drug degradation products and at least 50% of the total amount of drug composition in the film, and wherein the substrate surface area is such as to yield an effective human therapeutic dose of the drug aerosol.

2. The article of claim 1, wherein said substrate surface area is between about 0.05-100 cm.sup.2.

3. The article of claim 1, wherein said substrate surface is impermeable.

4. The article of claim 1, wherein said substrate comprises a material selected from the group consisting of metals, polymers, ceramics, and glass.

5. The article of claim 4, wherein said material is a metal selected from the group consisting of stainless steel and aluminum.

6. The article of claim 1, wherein said substrate has a contiguous surface area of greater than 1 mm.sup.2 and a material density of greater than 0.5 g/cc.

7. The article of claim 1, wherein said aerosol has 5% by weight or less drug degradation products.

8. A method of forming an effective human therapeutic inhalation dose of a drug composition aerosol having 10% or less drug degradation products and an aerosol particle mass median aerodynamic diameter (MMAD) between 0.01 and 3 .mu.m, comprising (a) providing a heat conductive substrate having a surface with a surface area, and a film comprising a drug composition on the surface, the film having a film thickness, wherein the drug composition and film thickness are selected from the group consisting of the following combinations: alprazolam, film thickness between 0.1 and 10 .mu.m; amoxapine, thickness between 2 and 20 .mu.m; apomorphine HCl, film thickness between 0.1 and 5 .mu.m; atropine, film thickness between 0.1 and 10 .mu.m; budesonide, film thickness between 0.05 and 20 .mu.m; bumetanide film thickness between 0.1 and 5 .mu.m; buprenorphine, film thickness between 0.05 and 10 .mu.m; butorphanol, film thickness between 0.1 and 10 .mu.m; celecoxib, film thickness between 2 and 20 .mu.m; chlorpheniramine, film thickness between 0.05 and 20 .mu.m; ciclesonide, film thickness between 0.05 and 5 .mu.m; clomipramine, film thickness between 1 and 8 .mu.m; diazepam, film thickness between 0.05 and 20 .mu.m; diphenhydramine, film thickness between 0.05 and 20 .mu.m; donepezil, film thickness between 1 and 10 .mu.m; eletriptan, film thickness between 0.2 and 20 .mu.m; fentanyl, film thickness between 0.05 and 5 .mu.m; granisetron, film thickness between 0.05 and 20 .mu.m; hydromorphone, film thickness between 0.05 and 10 .mu.m; lorazepam, film thickness between 0.05 and 20 .mu.m; loxapine, film thickness between 1 and 20 .mu.m; midazolam, film thickness between 0.05 and 20 .mu.m; morphine, film thickness between 0.2 and 10 .mu.m; nalbuphine, film thickness between 0.2 and 5 .mu.m; naratriptan, film thickness between 0.2 and 5 .mu.m; olanzapine, film thickness between 1 and 20 .mu.m; parecoxib, film thickness between 0.5 and 2 .mu.m; paroxetine, film thickness between 1 and 20 .mu.m; prochlorperazine, film thickness between 0.1 and 20 .mu.m; quetiapine, film thickness between 1 and 20 .mu.m; ropinirole, film thickness between 0.05 and 20 .mu.m; sertraline, film thickness between 1 and 20 .mu.m; sibutramine, film thickness between 0.5 and 2 .mu.m; sildenafil, film thickness between 0.2 and 3 .mu.m; sumatriptan, film thickness between 0.2 and 6 .mu.m; tadalafil, film thickness between 0.2 and 5 .mu.m; valdecoxib, film thickness between 0.5 and 10 .mu.m; and vardenafil, film thickness between 0.1 and 2 .mu.m; venlafaxine, film thickness between 2 and 20 .mu.m; zaleplon, film thickness between 0.05 and 20 .mu.m; and zolpidem, film thickness between 0.1 and 10 .mu.m; (b) heating the substrate to a temperature between 300.degree. C. and 500.degree. C., thereby vaporizing a at least a portion of the drug composition film, and (c) flowing a gas during said heating across the substrate at a gas flow rate effective to produce a desired size of aerosol particles by condensation.

9. The method according to claim 8, wherein said heating vaporizes the drug composition film on the substrate within a time period of 2 seconds.

10. The method according to claim 9, wherein said heating vaporizes the drug composition film on the substrate within a time period of 0.5 seconds.

11. The method of claim 8, wherein said flowing is at a gas flow rate of between 4 and 50 L/minute.

12. The method of claim 8, wherein the aerosol contains 5% by weight or less drug degradation products.
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