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转向基于熔融沉积建模的3D打印药物剂型连续平台:了解层取向对制剂性能的影响。

Veering to a Continuous Platform of Fused Deposition Modeling Based 3D Printing for Pharmaceutical Dosage Forms: Understanding the Effect of Layer Orientation on Formulation Performance.

作者信息

Kulkarni Vineet R, Chakka Jaidev, Alkadi Faez, Maniruzzaman Mohammed

机构信息

Pharmaceutical Engineering and 3D Printing (PharmE3D) Lab, Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX 78705, USA.

出版信息

Pharmaceutics. 2023 Apr 23;15(5):1324. doi: 10.3390/pharmaceutics15051324.

Abstract

Three-dimensional (3D) printing of pharmaceuticals has been centered around the idea of personalized patient-based 'on-demand' medication. Fused deposition modeling (FDM)-based 3D printing processes provide the capability to create complex geometrical dosage forms. However, the current FDM-based processes are associated with printing lag time and manual interventions. The current study tried to resolve this issue by utilizing the dynamic -axis to continuously print drug-loaded printlets. Fenofibrate (FNB) was formulated with hydroxypropyl methylcellulose (HPMC AS LG) into an amorphous solid dispersion using the hot-melt extrusion (HME) process. Thermal and solid-state analyses were used to confirm the amorphous state of the drug in both polymeric filaments and printlets. Printlets with a 25, 50, and 75% infill density were printed using the two printing systems, i.e., continuous, and conventional batch FDM printing methods. Differences between the two methods were observed in the breaking force required to break the printlets, and these differences reduced as the infill density went up. The effect on in vitro release was significant at lower infill densities but reduced at higher infill densities. The results obtained from this study can be used to understand the formulation and process control strategies when switching from conventional FDM to the continuous printing of 3D-printed dosage forms.

摘要

药物的三维(3D)打印一直围绕着基于患者个性化的“按需”给药理念。基于熔融沉积建模(FDM)的3D打印工艺能够制造复杂的几何形状剂型。然而,当前基于FDM的工艺存在打印延迟时间和人工干预的问题。本研究试图通过利用动态轴连续打印载药打印件来解决这一问题。使用热熔挤出(HME)工艺将非诺贝特(FNB)与羟丙基甲基纤维素(HPMC AS LG)制成无定形固体分散体。通过热分析和固态分析来确认聚合物长丝和打印件中药物的无定形状态。使用两种打印系统,即连续式和传统批量FDM打印方法,打印填充密度为25%、50%和75%的打印件。观察到两种方法在打印件断裂所需的断裂力方面存在差异,并且随着填充密度的增加,这些差异减小。在较低填充密度下,对体外释放的影响显著,但在较高填充密度下影响减小。本研究获得的结果可用于理解从传统FDM转换为3D打印剂型的连续打印时的制剂和工艺控制策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3578/10224244/0e878f5b977d/pharmaceutics-15-01324-g001.jpg

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