選択的レーザー焼結方式3Dプリンタの特性を生かした医薬品製剤設計

抄録

3D printing has emerged as a promising technology for the production of personalized medicines, enabling freeform design and on-demand manufacturing. Selective laser sintering (SLS) is a solvent-free powder bed fusion technique capable of simultaneously fabricating dosage forms and inducing drug amorphization. However, the optimization of printing parameters and the reuse of powder materials remain key challenges for pharmaceutical applications. In this study, printlets containing either acetaminophen or indomethacin were fabricated using an SLS 3D printer with Kollidon^® VA64 as a thermoplastic polymeric excipient. The effects of SLS process parameters on printlet formability and drug dissolution were evaluated. The results demonstrated that printing temperature strongly influenced formability, with optimal values varying between formulations. Although the reuse of powder was not feasible due to physicochemical changes in the drug upon heat exposure, high manufacturing efficiency was achieved by maximizing the number of printlets produced per batch. Furthermore, indomethacin was successfully amorphized during the printing process, leading to a marked improvement in its dissolution behavior. These findings suggest that SLS 3D printing can serve as a one-step manufacturing platform for preparing amorphous solid dispersions and enabling flexible design of dosage forms for poorly water-soluble drugs.