Laboratory of Pharmaceutics and Biopharmaceutics, Université libre de Bruxelles, Campus de la Plaine, CP 207, Boulevard du Triomphe, Brussels 1050, Belgium.
Laboratory of Polymeric and Composite Materials (LPCM), Center of Innovation and Research in Materials and Polymers (CIRMAP), University of Mons, Place du Parc 23, B-7000 Mons, Belgium.
Int J Pharm. 2019 Oct 5;569:118581. doi: 10.1016/j.ijpharm.2019.118581. Epub 2019 Jul 29.
The purpose of this work was to investigate the feasibility to manufacture enteric capsules, which could be used in compounding pharmacies, by fused-deposition modeling. It is well-known that conventional enteric dip coating of capsules in community pharmacies or hospitals is a time-consuming process which is characterized by an erratic efficacy. Fused-deposition modeling was selected as a potential 3D printing method due its ease and low-cost implementation. Before starting to print the capsules, an effective sealing system was designed via a computer-aided design program. Hot melt extrusion was used to make printable enteric filaments. They were made of the enteric polymer, a plasticizer and a thermoplastic polymer, namely Eudragit® L100-55, polyethylene glycol 400 and polylactic acid, respectively. Riboflavine-5'-phosphate was selected as a coloured drug model to compare the efficacy of the 3D printed capsules to that of enteric dip coated capsules as they are currently produced in community pharmacies and hospitals. Different parameters of fabrication which could influence the dissolution profile of the model drug, such as the layer thickness or post-processing step, were studied. It was demonstrated that our 3D printed enteric capsules did not release the drug for 2 h in acid medium (pH 1.2). However, they completely dissolved within 45 min at pH 6.8 which allowed the release of a minimal amount of 85% w/w of drug as it was recommended by the European Pharmacopoeia 9th Edition for enteric products.
这项工作的目的是研究通过熔融沉积成型制造可用于复合药剂的肠溶胶囊的可行性。众所周知，传统的社区药房或医院的肠溶胶囊包衣是一个耗时的过程，其效果不稳定。熔融沉积成型因其易于实施和低成本而被选为一种潜在的 3D 打印方法。在开始打印胶囊之前，通过计算机辅助设计程序设计了一种有效的密封系统。热熔挤出法用于制造可打印的肠溶长丝。它们由肠溶聚合物、增塑剂和热塑性聚合物组成，分别为 Eudragit®L100-55、聚乙二醇 400 和聚乳酸。核黄素-5'-磷酸酯被选为有色药物模型，以比较 3D 打印胶囊与目前在社区药房和医院生产的肠溶包衣胶囊的效果。研究了不同的制造参数，如层厚或后处理步骤，这些参数可能会影响模型药物的溶解曲线。结果表明，我们的 3D 打印肠溶胶囊在酸性介质（pH 1.2）中 2 小时内不会释放药物。然而，它们在 pH 6.8 下完全溶解在 45 分钟内，这允许释放最小量的 85%w/w 的药物，因为这是欧洲药典第 9 版对肠溶产品的建议。
