Micro-valve technology for flexible processing of drug nanosuspensions into solid oral dosage forms

Beschreibung

Manufacturing tools with a continuous adjustability of the dispensed amount of fluid are of interest for applications in early drug development, continuous manufacturing or personalized medicine to facilitate the flexible manufacturing of solid oral dosage forms. A thorough understanding of the working principle of the investigated piezo-actuated micro-valve regarding the relationship between fluid properties, process parameters and the resulting mass flow was established using Newtonian model fluids and non-Newtonian drug nanosuspensions. Furthermore, the breakup behavior of the ejected liquid jet and its behavior during impact onto a flat and solid substrate was analyzed by high-speed imaging. From established phase diagrams a comprehensive understanding of the impact behavior could be obtained, including an operational range for the controlled depositioning of the ejected liquid on the substrate. Moreover, drug nanosuspensions were dispensed onto different placebo substrates demonstrating the feasibility of manufacturing tablet-, capsule- and polymer film based dosage forms. Finally, the impact of forced drying methods on the properties of film based dosage forms was investigated using convection and radiation drying. Even intense drying processes with drying times below one minute could be realized, while maintaining the nanoparticulate drug structure and without compromising the dissolution performance.

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Bastian Bonhoeffer

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Drug nanosupension forced drying high speed imaging individualized drug therapy jet break-up length jet impact behavior micro-valve nanotechnology personalized medicine solid oral dosage form

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