Fibrous dosage forms by wet 3D-micro-patterning: Process design, manufacture, and drug release rate

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Recently, we have introduced fibrous dosage forms prepared by 3D-micro-patterning of drug-laden viscous melts. Such dosage forms enable predictable microstructures and increased drug release rates, and they can be manufactured continuously. However, melt processing is not applicable if the melting temperature of the formulation is greater than the degradation temperature of the drug or of the excipient. In this work, therefore, a continuous wet micro-patterning process that operates at ambient temperature is presented. The excipient is plasticized by a solvent and the patterned dosage form is solidified by air drying. Process models show that the micro-patterning time is the ratio of the fiber length in the dosage form and the velocity of the fiber stream. It was 1.3min in the experiments, but can be reduced further. The drying time is limited by the diffusive flux of solvent through the fibers: it was about 3min for the experimental conditions. Furthermore, models are developed to illustrate the effects of fiber radius, inter-fiber spacing, viscosity of the drug-excipient-solvent mixture, and drying conditions on the microstructure of the dosage form. Both models and experimental results show that for a viscosity of the wet fibers of the order 103Pa·s, the patterned microstructure is well preserved and the crossed fibers are well bonded. Finally, the drug release rate by the dosage forms is experimentally determined and theoretically modeled. The results of the experiments validate the models fairly.

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