Enhanced oral bioavailability and controlled release of dutasteride by a novel dry elixir
Issue title: Frontiers in Biomedical Engineering and Biotechnology – Proceedings of the 2nd International Conference on Biomedical Engineering and Biotechnology, 11–13 October 2013, Wuhan, China
Affiliations: College of Pharmacy, The Catholic University of Korea, Bucheon, Gyeonggi 420-743, Republic of Korea | Department of Chemistry, University of Massachusetts-Amherst, 710 North Pleasant St., Amherst, Massachusetts 01003, USA | Molecular Recognition Research Center, Korea Institute of Science and Technology, Seoul 136-791, Republic of Korea
Abstract: To develop a solid dosage form of dutasteride for improving its oral bioavailability, a novel dry elixir (DE) system was fabricated. DEs incorporating dextrin and/or xanthan gum were prepared using spray-drying and evaluated by morphology, ethanol content, crystallinity, dissolution and oral bioavailability. DEs were spherical with a smooth surface and had an average particle size of 20–25 μm. The ethanol content could be easily varied by controlling the spray-drying temperature. The dissolution profiles of dutasteride from each DE proved to be much faster than that of dutasteride powder due to the amorphous state and a high amount of incorporated ethanol. In particular, the pharmacokinetic profiles of dutasteride were significantly altered depending on the proportions of dextrin and xanthan gum. Blood concentrations of dutasteride from DE formulations were similar to those of market products and much greater than those of native dutasteride. Interestingly, the dissolution and pharmacokinetic profiles were easily controlled by changing the ratio of dextrin to xanthan gum. The data suggests that a DE using dextrin and/or xanthan gum could provide an applicable solid dosage form to improve the dissolution and bio-availability of dutasteride as well as to modulate its pharmacokinetics.
