Purpose: To design a nanocomposite formulation system of lipid-regulating drugs with versatile approaches using layered double hydroxide (LDH) material. Methods: The co-precipitation technique has been used to prepare the selected drugs [bezafibrate (BZF) and clofibric acid (CF)]-LDH nanocomposites. The nanocomposite materials (BZF-LDH and CF-LDH) were characterized by X-ray powder diffraction, infrared spectroscopy, thermogravimetric analysis, and scanning electron microscopy. The in vitro study was investigated in simulated gastrointestinal solutions at 36.8°C. Results: X-ray measurement and spectroscopic analysis indicated the formation of fully monophase drug-nanocomposites. The nanocomposites' gallery heights were calculated to be 23.5 and 16.3Å for BZF and CF, respectively. The new gallery heights indicated that BZF and CF drugs have been stacked into LDH as a monolayer with a staggered inter-digitated arrangement. The size of the nanocomposites described by SEM microscopy was ∼0.1 μm. The nanocomposite formulation has improved the drugs properties (thermal stability, dissolution, and controlled release) beside the achievement of drug target delivery. Conclusions: Nanocomposites composed of lipid-regulating drugs (BZF and CF) with LDH were successfully synthesized as a new formulation system of this drug category. The LDH nanocomposite formulation system has improved the drugs release properties.
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