Dores Filipa, Kuźmińska Magdalena, Soares Cindy, Bohus Marton, A Shervington Leroy, Habashy Rober, Pereira Beatriz C, Peak Matthew, Isreb Abdullah, Alhnan Mohamed A
School of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston, Lancashire, UK.
School of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston, Lancashire, UK; Faculty of Pharmacy with the Laboratory Medicine Division, Medical University of Warsaw, Warsaw, Poland.
Eur J Pharm Sci. 2020 Sep 1;152:105430. doi: 10.1016/j.ejps.2020.105430. Epub 2020 Jun 17.
On demand manufacturing of patient-specific oral doses provides significant advantages to patients and healthcare staff. Several 3D printing (3DP) technologies have been proposed as a potential digital alternative to conventional manufacturing of oral tablets. For an additive manufacturing approach to be successful for on-demand preparation, a facile process with minimal preparation steps and training requirements is needed. A novel hybrid approach to the 3D printing process is demonstrated here based on combining both a solvent and heating to facilitate extrusion. The system employed a moderate elevated temperature range (65-100 °C), a brief drying period, and a simple set-up. In this approach, a compact material cylinder is used as a pharmaceutical ink to be extruded in a temperature-controlled metal syringe. The process proved compatible with hygroscopic polymers [Poly(vinyl alcohol (PVA) and polyvinylpyrrolidone (PVP)] and a number of pharmaceutical fillers (lactose, sorbitol and D-mannitol). The fabricated tablets demonstrated acceptable compendial weight and content uniformity as well as mechanical resistance. In vitro drug release of theophylline from 3D printed tablets was dependent on the nature of the polymer and its molecular weight. This reported approach offers significant advantages compared to other 3DP technologies: simplification of pre-product, the use of a moderate temperature range, a minimal drying period, and avoiding the use of mechanically complicated machinery. In the future, we envisage the use of this low-cost and facile approach to fabricate small batches of bespoke tablets.
按需制造患者定制的口服剂量对患者和医护人员具有显著优势。几种3D打印（3DP）技术已被提议作为传统口服片剂制造的潜在数字替代方案。要使增材制造方法成功用于按需制备，需要一个步骤最少、培训要求最低的简便流程。本文展示了一种基于溶剂和加热相结合以促进挤出的新型3D打印混合方法。该系统采用适度的高温范围（65 - 100°C）、短暂的干燥期和简单的设置。在这种方法中，一个紧凑的材料圆柱体被用作药物油墨，在温度控制的金属注射器中挤出。该工艺被证明与吸湿性聚合物[聚乙烯醇（PVA）和聚乙烯吡咯烷酮（PVP）]以及多种药物填充剂（乳糖、山梨醇和D - 甘露醇）兼容。制造的片剂显示出可接受的药典重量、含量均匀度以及机械抗性。茶碱从3D打印片剂的体外药物释放取决于聚合物的性质及其分子量。与其他3DP技术相比，该报道的方法具有显著优势：简化产品前期准备、使用适度的温度范围、最短的干燥期以及避免使用机械复杂的机器。未来，我们设想使用这种低成本且简便的方法来制造小批量定制片剂。
