Advancements in salbutamol sulphate formulation: Spray-drying technique for the production of porous particles with enhanced properties for inhalation drug delivery

SERAIN, MARCOS ANDRÉS; CASTRO-GUIJARRO, ANA CARLA; FLAMINI, MARINA INÉS; BUCALÁ, VERÓNICA; GALLO, LOREANA CAROLINA

DRYING TECHNOLOGY

TAYLOR & FRANCIS INC

Año: 2023 p. 1 - 18

0737-3937

A fast, simple and cost-effective technique has been used to produce spray-drying porousparticles of salbutamol sulfate (SS) for inhalation drug delivery. The particles were producedusing water as solvent and ammonium bicarbonate as pore-forming agent. A full factorialexperimental design (24) with a central point was used to evaluate the influence of processparameters (drying air inlet temperature, atomization air volume flowrate, feed volume flowrateand the pore-forming agent concentration) on process yield, moisture content, densitiesand particle size. In addition, particle morphology, in-vitro aerosolization properties, stabilityand cytotoxicity of selected samples were studied. Within the experimental design parameterswindow, it was shown that the highest inlet temperature and pore-forming agent concentrationwere the factors that more affected the process yield and tap density values.Particles with the lowest tap densities values exhibited porous morphology. In addition, thepore-forming agent concentration proved to be the most significant variable affecting particlesize. The highest pore-forming agent concentration, the largest particle size. The porousparticles exhibit remarkable aerosolization performance, surpassing the performance of previouslyreported SS porous particles and a commercial formulation. These powders showeda high process yield and the absence of ammonium bicarbonate in the final product, asconfirmed by FT-IR. Furthermore, the powders presented good stability even over long periodsof time and did not exhibit cytotoxicity on the murine alveolar macrophage cell lineRAW 264.7.