研究目的
To explore the feasibility of using selective laser sintering (SLS) 3D printing to fabricate orodispersable printlets (ODPs) containing ondansetron, comparing their performance to a commercial ODT product.
研究成果
SLS 3D printing was successfully used to manufacture ODPs with fast disintegration and drug release comparable to commercial ODTs, demonstrating the potential for personalized medicine.
研究不足
The study was limited by the small batch size of printlets (n=6) and the focus on a single drug (ondansetron). The potential for scaling up the manufacturing process and the applicability to other drugs were not explored.
1：Experimental Design and Method Selection:
The study utilized SLS 3D printing to fabricate ODPs with ondansetron-cyclodextrin complexes and mannitol as a filler.
2：Sample Selection and Data Sources:
Two formulations with different mannitol levels were prepared and compared to a commercial ODT.
3：List of Experimental Equipment and Materials:
Included a Desktop SLS printer, differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), SEM, and HPLC.
4：Experimental Procedures and Operational Workflow:
Involved preparation of drug-cyclodextrin complexes, 3D printing of formulations, and characterization of printlets.
5：Data Analysis Methods:
Included thermal analysis, mechanical properties testing, disintegration and dissolution testing, and drug content analysis.
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X-ray powder diffraction
MiniFlex 600
Rigaku
Used to obtain X-ray powder diffraction data of the samples.
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SEM
JSM‐840A Scanning Microscope
JEOL
Used to take images of the surface and cross‐section of the printlets.
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X-ray microcomputed tomography scanner
SkyScan1172
Bruker‐microCT
Examined the internal structure, density and porosity of the 3D printed formulations.
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HPLC system
Hewlett Packard 1050 Series
Agilent Technologies
Used for drug content analysis and determination of impurities.
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Desktop SLS printer
Sintratec Kit
Sintratec
Used for the selective laser sintering process to fabricate 3D printed printlets.
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Differential scanning calorimetry
Q2000 DSC
TA instruments
Used for thermal analysis of the powders and drug-loaded 3D printed formulations.
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