ABSTRACT
The purpose of the current study is the development and the in vitro evaluation of a novel device for the nasal delivery of biodegradable polymeric films. The Matrix-Piston nasal Device (MPD) was designed and then printed employing Fused Deposition Modeling. Particularly, the CAD model of MPD was produced considering the human anatomical features of the nasal cavity and aiming to deliver the formulation on the olfactory region. The device consists of two independent parts constructed by different materials. For the 3D-printing process, different materials were tested to decide the most applicable for each part. More precisely, Thermoplastic Polyurethene (TPU) polymer was selected to print the matrix, while Acrylonitrile Butadiene Styrene (ABS) for the piston. Furthermore, two nasal casts were printed to be used for the assessment of the device. Namely, an hydroxypropyl-methyl cellulose-based drug-free film, containing polyethylene glycol 400 as plasticizer and methyl-ß-cyclodextrin as permeation enhancer, was formed on the MPD to be tested for its ability to be detached from the device and positioned on the artificial olfactory region of the nasal cast. The deposition of the film on the targeted area of the semi-realistic nasal cast took place successfully.