S Pham1, T S Wiedmann. 1. Dura Pharmaceuticals, San Diego, California 92121, USA.
Abstract
PURPOSE: The purpose of this study was to analyze a diffusion dryer as a means to remove organic solvents from aerosol particles of poorly water soluble drugs. METHODS: Aerosols of methanol, ethanol, and ethyl acetate were generated with an ultrasonic nebulizer, and inflow to outflow concentration ratio of vapor in a annular charcoal column was determined as a function of time by gas chromotography at two to four different airflow rates. In addition, the particle transmission efficiency was determined with an ethanol solution of the test compound, budesonide. The results were analyzed with equations originally developed for assessing the loss of drug from intravenous tubing along with independent measures of the adsorption isotherm of the vapors onto charcoal. RESULTS: Aerosol production was relatively constant with time, and the transmission of solid particles through the column occurred with efficiency nearing 100%. The inlet to outlet vapor concentration ratio was adequately described by a model of three resistances in series composed of the inner tube, the screen mesh, and the charcoal bed. CONCLUSIONS: The diffusion dryer was found to be satisfactory for the removal of methanol, ethanol, and ethyl acetate and the efficiency may be assessed from the adsorption isotherms on charcoal and the geometry of the dryer.
PURPOSE: The purpose of this study was to analyze a diffusion dryer as a means to remove organic solvents from aerosol particles of poorly water soluble drugs. METHODS: Aerosols of methanol, ethanol, and ethyl acetate were generated with an ultrasonic nebulizer, and inflow to outflow concentration ratio of vapor in a annular charcoal column was determined as a function of time by gas chromotography at two to four different airflow rates. In addition, the particle transmission efficiency was determined with an ethanol solution of the test compound, budesonide. The results were analyzed with equations originally developed for assessing the loss of drug from intravenous tubing along with independent measures of the adsorption isotherm of the vapors onto charcoal. RESULTS: Aerosol production was relatively constant with time, and the transmission of solid particles through the column occurred with efficiency nearing 100%. The inlet to outlet vapor concentration ratio was adequately described by a model of three resistances in series composed of the inner tube, the screen mesh, and the charcoal bed. CONCLUSIONS: The diffusion dryer was found to be satisfactory for the removal of methanol, ethanol, and ethyl acetate and the efficiency may be assessed from the adsorption isotherms on charcoal and the geometry of the dryer.