Novel oral fast-disintegrating drug delivery devices with predefined inner structure fabricated by Three-Dimensional Printing.

摘要

OBJECTIVES: Novel fast-disintegrating drug delivery devices with special inner structure characteristics were designed and fabricated using Three-Dimensional Printing. METHODS: Based on computer-aided design models, fast-disintegrating drug delivery devices containing loose powders were prepared automatically using the Three-Dimensional Printing system. The inner powder regions were prepared by depositing the binder solutions onto selected regions during the layer-printing process. RESULTS: The devices showed acceptable pharmacotechnical properties and fine hardness (63.4 N/cm(2)) due to the synergistic action of several binding mechanisms, but unsatisfactory friability, with 3.55% total mass loss during the friability tests. Scanning electron microscope images clearly showed that the printed regions were well bound, and that the drug particle size was reduced or individual particles could no longer be distinguished. In contrast, the unprinted regions were uncompacted, with cracks and fissures among the loose mixed powder. All the drug delivery devices disintegrated and wetted rapidly in in-vitro tests. The average disintegration and wetting times were 23.4 s and 67.6 s, respectively. Dissolution tests showed that 98.5% of the drug was released within 2 min. CONCLUSIONS: Three-Dimensional Printing offers strategies for the development of novel oral fast-disintegrating drug delivery devices.