Praziquantel (PZQ) has been the standard treatment for schistosomiasis for over 40 years and is included in the WHO Model List of Essential Drugs. However, there is currently no available paediatric formulation on the market, with current treatments involving the off-label use of praziquantel, with dose adjustments accomplished by the splitting of commercial tablets for adults. In addition, the API has an unpleasant taste and alongside various other formulation challenges which includes low water solubility and dose adjustment requirements based on the patient’s weight. Amorphous solid dispersions have been evaluated to overcome such hurdles, with fused deposition modelling (FDM) 3D printing (3DP) being evaluated in past research. One of the technical limitations of FDM 3DP is the high dependency on the physical and mechanical properties of the filaments produced via hot melt extrusion (HME) for printing feasibility, and the difficulty in producing adequate filaments. In this work, direct powder extrusion (DPE) 3DP was evaluated to produce 35 wt% PZQ Printlets™, with improved solubility and taste masking properties.
Printlets in two different doses (~100 and 150 mg) were successfully produced from HME extrudates in pellet and powder form, eliminating the dependence on ideal filament characteristics for FDM 3DP. In vitro dissolution studies displayed a greater than four-fold increase in PZQ release when compared to the pure API. In addition, in vitro taste masking results showed the printed formulations to be within the acceptable taste thresholds of ‘tolerated’ and ‘well tolerated’. This work demonstrates the unique potential of DPE 3DP in customising PZQ formulations, with a specific focus on paediatric patients.
You can read the full article here: https://www.mdpi.com/1999-4923/13/8/1114/htm