Abstract
This work aimed to prepare a pediatric formulation for Spironolactone a poor water soluble drug characterized by incomplete oral bioavailability, bitter taste, and tendency to destabilize in aqueous media. Regarding to the good solubility of Spironolactone in lipid materials, lipid nanoparticles seemed to be an excellent way to overcome these issues. In an attempt to prevent eventual stability problems linked to lipid nanoparticles, we dried the prepared nanosuspensions into redispersible powder, in association with pediatric adapted drying carriers. A comparison study between drying methods have been conducted. Fluid Bed Drying was introduced as a novel method of drying lipid nanoparticles. This method was compared to usual methods; freeze drying and spray drying. The comparison took into account quality of the obtained powder and its redispersibility, palatability, drug stability during the process and the effect of the drying method on particle size, entrapment efficiency and dissolution behavior of Spironolactone. The obtained preparations showed size increase of nanoparticles, significant differences about chemical stability and dissolution behavior of same formulas dried with different techniques have been noticed. Thanks to excellent entrapment of drug substance into nanoparticles, the extemporaneous prepared nanosuspensions exhibited a palatable sweaty taste adapted to the needs of pediatric patients.
Published Version
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