Particle-size distribution of bitolterol mesylate solution delivered by four compressed-air nebulizer devices.

The particle-size distribution of bitolterol mesylate solution delivered by four types of compressed-air nebulizers was determined. Before nebulization, bitolterol mesylate solution 0.2% w/v was diluted to 0.0833% w/v with 0.9% sodium chloride solution. The following commercially available nebulizers were tested: DeVilbiss Nebulizer Model 645, Hudson 1720 (Updraft) Hand Held Nebulizer, Bard Inspiron 002220 Mini-Neb Nebulizer, and Bunn Mini Mist Set model 0140-041. The particle-size distribution of nebulized solutions was determined with a cascade impactor contained in an in vitro apparatus designed to simulate use by a patient. Assays of bitolterol mesylate in the cascade impactor apparatus were done by high-performance liquid chromatography. Only slight differences were found in the particle-size distributions among the four types of nebulizers; the calculated average particle size ranged from 3.0 to 3.6 micron. All nebulizers tested showed satisfactory, comparable particle-size distributions and performance with bitolterol mesylate solution.