Biopolymeric 3D printed implantable scaffolds as a potential adjuvant treatment for acute post-operative pain management.

BACKGROUND: Pain is characterized as a major symptom induced by tissue damage occurring from surgical procedures, whose potency is being experienced subjectively, while current pain relief strategies are not always efficient in providing individualized treatment. 3D printed implantable devices hold the potential to offer a precise and customized medicinal approach, targeting both tissue engineering and drug delivery. RESEARCH DESIGN AND METHODS: Polycaprolactone (PCL) and PCL - chitosan (CS) composite scaffolds loaded with procaine (PRC) were fabricated by bioprinting. Geometrical features including dimensions, pattern, and infill of the scaffolds were mathematically optimized and digitally determined, aiming at developing structurally uniform 3D printed models. Printability studies based on thermal imaging of the bioprinting system were performed, and physicochemical, surface, and mechanical attributes of the extruded scaffolds were evaluated. The release rate of PRC was examined at different time intervals up to 1 week. RESULTS: Physicochemical stability and mechanical integrity of the scaffolds were studied, while in vitro drug release studies revealed that CS contributes to the sustained release dynamic of PRC. CONCLUSIONS: The printing extrusion process was capable of developing implantable devices for a local and sustained delivery of PRC as a 7-day adjuvant regimen in post-operative pain management.

A novel hot-melt extrusion formulation of albendazole for increasing dissolution properties.

The main aim of the research focused on the production of hot-melt extrusion (HME) formulations with increased dissolution properties of albendazole (ABZ). Therefore, HME was applied as a continuous manufacturing technique to produce amorphous solid dispersions of the poorly water soluble drug ABZ combined with the polymer matrix polyvinylpyrrolidone PVP K12. HME formulations of ABZ-PVP K12 comprised a drug content of 1%, 5% and 10% w/w. The main analytical characterisation techniques used were scanning electron microscopy (SEM), micro-computed tomography (µ-CT), X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) and dissolution profile studies. The application of SEM, XRPD and DSC evidenced drug physical transformation from crystalline to amorphous state and therefore, the achievement of an amorphous solid dispersion. The introduction of a novel technique, µ-CT, to characterise the internal structure of these materials revealed key information regarding materials distribution and void content. Dissolution profile studies evidenced a high increase in drug release profile compared to pure ABZ. These promising results can lead to a great enhancement of the oral bioavailability of ABZ dosage forms. Therefore, HME is a potential continuous manufacturing technique to overcome ABZ poor solubility properties and lead to a significant increase in the therapeutic effect.

Investigation of an 11mm diameter twin screw granulator: Screw element performance and in-line monitoring via image analysis.

As twin screw granulation (TSG) provides one with many screw element options, characterization of each screw element is crucial in optimizing the screw configuration in order to obtain desired granule attributes. In this study, the performance of two different screw elements - distributive feed screws and kneading elements - was studied in an 11 mm TSG at different liquid-to-solid (L/S) ratios. The kneading element configuration was found to break large granules more efficiently, leading to narrower granule size distributions. While pharmaceutical industry shifts toward continuous manufacturing, inline monitoring and process control are gaining importance. Granules from an 11 mm TSG were analysed using the Eyecon™, a real-time high speed direct imaging system, which has been used to capture accurate particle size distribution and particle count. The size parameters and particle count were then assessed in terms of their ability to be a suitable control measure using the Shewhart control charts. d10 and particle count were found to be good indicators of the change in L/S ratio. However, d50 and d90 did not reflect the change, due to their inherent variability even when the process is at steady state.