无定形固体分散体的3D打印:熔融沉积建模和粉末滴涂打印的比较

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics: X Pub Date : 2023-03-20 DOI:10.1016/j.ijpx.2023.100179
Nadine Gottschalk , Malte Bogdahn , Julian Quodbach
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引用次数: 3

摘要

如今,大量管道药物溶解性差,需要通过例如制造无定形固体分散体来提高溶解度。药物3D打印在生产无定形固体口服剂型方面具有巨大潜力。然而,3D打印技术在处理和片剂性能方面有很大差异。在这项研究中,通过熔融沉积建模和粉末滴印(也称为粘合剂喷射)印刷的非晶配方在固态性能和物理稳定性方面进行了表征。通过差示扫描量热法、粉末X射线衍射和偏光显微镜进行固态评估。通过非下沉溶解来评估无定形固体分散体的过饱和性能。我们进一步评估了3D打印技术的可加工性以及片剂在尺寸、质量和含量方面的均匀性。讨论了每种3D打印技术的挑战和局限性。这两种技术对于生产无定形制剂都是可行的。结果表明,熔融沉积模型更适合生产,因为再结晶倾向较低。尽管如此,长丝生产和印刷仍然是一个重大挑战。当配方无法通过熔融沉积建模进行打印时,滴涂粉末印刷可能是生产无定形片剂的可行替代方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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3D printing of amorphous solid dispersions: A comparison of fused deposition modeling and drop-on-powder printing

Nowadays, a high number of pipeline drugs are poorly soluble and require solubility enhancement by e.g., manufacturing of amorphous solid dispersion. Pharmaceutical 3D printing has great potential in producing amorphous solid oral dosage forms. However, 3D printing techniques differ greatly in terms of processing as well as tablet properties. In this study, an amorphous formulation, which had been printed via Fused Deposition Modeling and drop-on-powder printing, also known as binder jetting, was characterized in terms of solid-state properties and physical stability. Solid state assessment was performed by differential scanning calorimetry, powder X-ray diffraction and polarized microscopy. The supersaturation performance of the amorphous solid dispersion was assessed via non-sink dissolution. We further evaluated both 3D printing techniques regarding their processability as well as tablet uniformity in terms of dimension, mass and content. Challenges and limitations of each 3D printing technique were discussed. Both techniques are feasible for the production of amorphous formulations. Results indicated that Fused Deposition Modeling is better suited for production, as the recrystallization tendency was lower. Still, filament production and printing presented a major challenge. Drop-on-powder printing can be a viable alternative for the production of amorphous tablets, when a formulation is not printable by Fused Deposition Modeling.

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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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