Immediate-released pelletized solid dispersion containing fenofibrate: formulation, in vitro characterization, and bioequivalence studies in experimental beagle dogs

Publication date: Available online 3 September 2019Source: International Journal of PharmaceuticsAuthor(s): Chien Ngoc Nguyen, Cuong Viet Pham, Giap Le Thien, Bao Tran Ngoc, Ha Le Thi, Chang Pham Thi Huyen, Thuan Nguyen ThiAbstractThere have been many strategies to increase solubility, dissolution rates, and oral bioavailability of fenofibrate such as micronization, nanonization, solid dispersion, and emulsion so far. To our knowledge, only first three technologies have been applied in producing marketed products, and no combination of solid dispersion and pellet has been found even in laboratory-based reports. Therefore, the aim of this study was to develop novel solid dispersion-based pellets via a one-step process directly from fenofibrate powder using layering method. Developed fenofibrate pellets were in vitro characterized on size distribution, dissolution rates, sensory evaluation and stability. In addition, the transformation from crystalline fenofibrate to amorphous fenofibrate, and intermolecular interactions of fenofibrate in solid dispersion were confirmed using physico-chemical methods. The dissolution rate of pellets containing fenofibrate was significantly higher than that of the reference, Lipanthyl® 160 mg tablets at early stage, satisfying the criteria in USP 38. The pellets, then, were packed in hard capsules for bioequivalence studies in experimental beagle dogs using a validated HPLC assay. Final findings of the present study should be beneficial for fur...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research