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Abstract
Drug-phospholipid complexes have emerged as potential drug delivery systems for poorly soluble drugs. The purpose of this study was to investigate the effect of processing methods on the physicochemical and biopharmaceutical performance of the telmisartan-phospholipid complex. In this study, telmisartan-phospholipid complexes were prepared using solvent evaporation (TELPLC-SE), freeze-drying (TELPLC-FD), and spray drying (TELPLC-SD) methods and subjected to a comparative investigation of solid-state characteristics (FTIR, DSC, and PXRD analysis), solubility, dissolution profiles, particle size, zeta potential, particle morphology (SEM analysis) and pharmacokinetic studies. The solvent evaporation method was found to be associated with the most significant FTIR peak shift/shape change, highest solubility advantage (TELPLC-SE 8.98 ± 1.08 µg/mL, TELPLC-SD 6.98 ± 1.38 µg/mL, TELPLC-FD 7.95 ± 1.02 µg/mL), maximum in-vitro drug release (TELPLC-SE 87.81 ± 4.64%, TELPLC-FD 84.71 ± 4.84 %, TELPLC-SD 79.93 ± 3.54 %) and highest peak plasma concentration (Cmax) of telmisartan (TELPLC-SE Cmax: 2.40 ± 1.34 µg/mL, TELPLC-SD Cmax: 2.20 ± 1.1 µg/mL, TELPLC-FD Cmax: 1.4 ± 1.3 µg/mL) whereas freeze-drying method was linked to the highest depression in melting point endotherm and spray drying method was associated to the maximum reduction in XRD peak intensity, the largest particle size and the lowest zeta potential. This study definitively answers the questions regarding the effect of processing methods on the telmisartan-phospholipid complex. Further studies are needed to explore the effect of process and formulation parameters.
