1. Advancements in salbutamol sulphate formulation: Spray-drying technique for the production of porous particles with enhanced properties for inhalation drug delivery.
- Author
-
Serain, Marcos Andrés, Castro-Guijarro, Ana Carla, Flamini, Marina Inés, Bucalá, Verónica, and Gallo, Loreana Carolina
- Subjects
- *
SPRAY drying , *ALBUTEROL , *AMMONIUM bicarbonate , *FACTORIAL experiment designs , *CYTOTOXINS , *SULFATES , *SPRAYING & dusting in agriculture - Abstract
A fast, simple and cost-effective technique has been used to produce spray-drying porous particles of salbutamol sulfate (SS) for inhalation drug delivery. The particles were produced using water as solvent and ammonium bicarbonate as pore-forming agent. A full factorial experimental design (24) with a central point was used to evaluate the influence of process parameters (drying air inlet temperature, atomization air volume flowrate, feed volume flowrate and the pore-forming agent concentration) on process yield, moisture content, densities and particle size. In addition, particle morphology, in-vitro aerosolization properties, stability and cytotoxicity of selected samples were studied. Within the experimental design parameters window, it was shown that the highest inlet temperature and pore-forming agent concentration were the factors that more affected the process yield and tap density values. Particles with the lowest tap densities values exhibited porous morphology. In addition, the pore-forming agent concentration proved to be the most significant variable affecting particle size. The highest pore-forming agent concentration, the largest particle size. The porous particles exhibit remarkable aerosolization performance, surpassing the performance of previously reported SS porous particles and a commercial formulation. These powders showed a high process yield and the absence of ammonium bicarbonate in the final product, as confirmed by FT-IR. Furthermore, the powders presented good stability even over long periods of time and did not exhibit cytotoxicity on the murine alveolar macrophage cell line RAW 264.7. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF