Nanocomposite formulation system of lipid-regulating drugs based on layered double hydroxide: synthesis, characterization and drug release properties.

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 16.3 Å 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.