| 主权项 |
1. A multi-dose nasal spray device for delivery of theophylline to a human's nasal epithelium that delivers a dosage unit in a plume upon actuation, wherein the dosage unit comprises from 10 μg to 200 μg of theophylline in a pharmaceutically acceptable carrier comprising one or more excipients; and wherein the plume is characterized by:
(a) a total volume of from 25 μL to 200 μL; and (b) a droplet size distribution characterized by one or more of the following:
(i) less than 5% of the droplets in the plume having a size of less than 10 μm,(ii) a D10 of greater than 12.5 μm, wherein 10% of the droplets in the plume have a size less than the D10,(iii) a D50 of from 30 to 70 μm, wherein 50% of the droplets in the plume have a size less than the D50,(iv) a D90 of less than 200 μm, wherein 90% of the droplets in the plume have a size less than the D90, and(v) a span of from 1 to 6, wherein the span is calculated according to: (D90−D10)/D50. |
