Micronization of Salbutamol Sulfate by Supercritical Antisolvent Precipitation: The Effect of Process Parameters on the Size and Morphology of Particles

Abstract

A study was made of the applicability of supercritical antisolvent precipitation to producing microparticles of the antiasthmatic drug salbutamol sulfate that are suitable for manufacturing the drug in inhalation dosage form. Depending on the salbutamol concentration in the initial solution, the flow rate of the solution, and pressure, either spherical or needle-like particles 0.7–8.5 μm in size form. The dependence of the average particle size on the salbutamol concentration in the initial solution is nonmonotonic. The conditions were determined under which the obtained salbutamol particles meet the shape and size requirements for fabrication of inhalation dosage forms.