Abstract
In this study, colloidal silica microparticles containing solubilizing excipient were prepared using the spray‐drying process to enhance dissolution and oral absorption of lercanidipine hydrochloride. Several measurements including scanning electron microscopy, powder X‐ray diffraction, particle size determination, in vitro dissolution, and pharmacokinetic study were conducted in rats. Among the tested solubilizing excipients, d‐α‐tocopheryl polyethylene glycol 1000 succinate (TPGS) dramatically enhanced the solubility of lercanidipine hydrochloride through micelle solubilization. In addition, TPGS‐colloidal silica microparticles at the ratio of 1:10:10 (drug:TPGS:colloidal silica) showed rapid dissolution rate in all dissolution media and displayed higher area under the curve and maximum plasma concentration values compared with raw lercanidipine hydrochloride. Therefore, amorphous TPGS‐colloidal silica microparticles fabricated using the spray‐drying process have great potential in the clinical application of lercanidipine hydrochloride.
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