期刊
PHARMACEUTICS
卷 13, 期 8, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics13081114
关键词
3D printing; 3D printed drug products; printing pharmaceuticals and medicines; personalized therapeutics; oral drug delivery systems and technologies; taste masking; translational pharmaceutics; material extrusion additive manufacturing; M3DIMAKER printer; pediatric treatments
资金
- Oswaldo Cruz Foundation (Fiocruz) [VPPIS-001-FIO-18-41]
- Universite de Toulouse
- IMT Mines Albi-Rapsodee Center
- Engineering and Physical Sciences Research Council (EPSRC) UK [EP/S023054/1]
This study demonstrates the successful preparation of pediatric Printlets(TM) of praziquantel using DPE 3DP technology, addressing the lack of suitable pediatric formulations for schistosomiasis treatment. The technology showed excellent taste masking capabilities and significantly increased praziquantel release, potentially overcoming the main formulation hurdles of the drug.
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 (TM) (3D printed tablets) of amorphous solid dispersions of praziquantel with Kollidon(R) VA 64 and surfactants (Span (TM) 20 or Kolliphor(R) 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.
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