A study of the potential of spray drying for the production of respirable particles of protein drugs

TL;DRAbstract

The objective of this study was to determine whether spray drying is an appropriate method for the production of respirable particles of therapeutic proteins. Meeting this objective requires that active, stable, dry powders in the 1-5$\\mu$m size range be obtained. A model protein, $\\beta$-galactosidase, was used throughout the study. The first part of the experimental work focused on the effect of various processing and formulation variables on the critical quality attributes of the spray dried protein (residual activity, moisture content, particle size and yield). Statistically designed experiments were used so that both direct and interactive effects of the variables could be identified, and the most appropriate formulation and process established. In order to obtain acceptable product yields and moisture contents, relatively harsh drying conditions were required. This necessitated the inclusion of a stabilizer in the formulation to preserve enzyme activity. Trehalose was found to

Chat with Paper

AI Agents for this Paper