Direct Powder Extrusion 3D Printing of Praziquantel to Overcome Neglected Disease Formulation Challenges in Paediatric Populations

For the last 40 years, praziquantel has been the standard treatment for schistosomiasis, a neglected parasitic disease affecting more than 250 million people worldwide. However, there is no suitable paediatric formulation on the market, leading to off-label use and the splitting of commercial tablet...

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Published in:Pharmaceutics 2021-07, Vol.13 (8), p.1114-19/1114
Main Authors: Boniatti, Janine, Januskaite, Patricija, Fonseca, Laís B. da, Viçosa, Alessandra L., Amendoeira, Fábio C., Tuleu, Catherine, Basit, Abdul W., Goyanes, Alvaro, Ré, Maria-Inês
Format: Article
Language:English
Subjects:
3-D printers
3D printed drug products
3D printing
Drug dosages
Galenic pharmacology
Life Sciences
oral drug delivery systems and technologies
Patients
Pediatrics
personalized therapeutics
Pharmaceutical sciences
Pharmaceuticals
Polymers
printing pharmaceuticals and medicines
Surfactants
taste masking
Tropical diseases
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Summary:For the last 40 years, praziquantel has been the standard treatment for schistosomiasis, a neglected parasitic disease affecting more than 250 million people worldwide. However, there is no suitable paediatric formulation on the market, leading to off-label use and the splitting of commercial tablets for adults. In this study, we use a recently available technology, direct powder extrusion (DPE) three-dimensional printing (3DP), to prepare paediatric Printlets™ (3D printed tablets) of amorphous solid dispersions of praziquantel with Kollidon® VA 64 and surfactants (Span™ 20 or Kolliphor® SLS). Printlets were successfully printed from both pellets and powders obtained from extrudates by hot melt extrusion (HME). In vitro dissolution studies showed a greater than four-fold increase in praziquantel release, due to the formation of amorphous solid dispersions. In vitro palatability data indicated that the printlets were in the range of praziquantel tolerability, highlighting the taste masking capabilities of this technology without the need for additional taste masking excipients. This work has demonstrated the possibility of 3D printing tablets using pellets or powder forms obtained by HME, avoiding the use of filaments in fused deposition modelling 3DP. Moreover, the main formulation hurdles of praziquantel, such as low drug solubility, inadequate taste, and high and variable dose requirements, can be overcome using this technology.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics13081114