Wang Yingya, Genina Natalja, Müllertz Anette, Rantanen Jukka
Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Mille International ApS, Hellerup, Denmark.
Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
J Pharm Sci. 2023 Feb;112(2):506-512. doi: 10.1016/j.xphs.2022.08.030. Epub 2022 Aug 27.
Binder jetting (BJ) 3D printing is especially suitable for the fabrication of an orodispersible solid dosage form, as it is an efficient way to avoid the use of mechanical forces typical for compaction-based processes. However, one of the existing challenges related to pharmaceutical applications of BJ is the relatively high amount of binder needed in the primary powder to ensure the sufficient mechanical strength of printed products. In this study, a strategy based on pre-processing with a thin layer coating was explored. With this strategy, the matrix particles (lactose monohydrate) of the primary powder for BJ 3D printing were coated with the binder (polyvinylpyrrolidone, PVP). The investigated compositions of the primary powder contained PVP at three levels, namely, 10 %, 15% and 20% (w/w). The primary powder compositions were prepared with or without the coated lactose powder, and they were subsequently 3D BJ printed into oral solid products with paracetamol as a model active drug substance. The presence of coated lactose in the primary powder increased the interparticulate interactions in the BJ 3D printed products. Especially for the composition with a relatively small amount of binder (i.e., 10% and 15% w/w PVP in the primary powder), the use of coated particles significantly improved the resistance to crushing and decreased the disintegration time of printed products. In conclusion, thin layer coating is an effective way to pre-process primary powder particles for BJ 3D printing of oral solid products.
粘结剂喷射（BJ）3D打印特别适用于制备口腔崩解固体剂型，因为它是避免使用基于压实工艺的典型机械力的有效方法。然而，与BJ的药物应用相关的现有挑战之一是，为确保打印产品具有足够的机械强度，一次粉末中需要相对大量的粘结剂。在本研究中，探索了一种基于薄层包衣预处理的策略。采用该策略，用于BJ 3D打印的一次粉末的基质颗粒（一水乳糖）用粘结剂（聚乙烯吡咯烷酮，PVP）进行包衣。所研究的一次粉末组合物含有三个水平的PVP，即10%、15%和20%（w/w）。一次粉末组合物在有或没有包衣乳糖粉末的情况下制备，随后将它们3D BJ打印成以对乙酰氨基酚为模型活性药物的口服固体产品。一次粉末中包衣乳糖的存在增加了BJ 3D打印产品中的颗粒间相互作用。特别是对于粘结剂含量相对较少的组合物（即一次粉末中10%和15% w/w的PVP），使用包衣颗粒显著提高了抗粉碎性并缩短了打印产品的崩解时间。总之，薄层包衣是对用于口服固体产品BJ 3D打印的一次粉末颗粒进行预处理的有效方法。
