고온용융압출법을 이용한 조절방출능을 가진 필라멘트와 그 필라멘트를 이용한 3D 프린팅 정제의 제조 및 평가

Preparation of Controlled-Release Filaments Utilized by Hot-Melt Extrusion Technology and Its Application to 3D Printing Dosage Forms

This study aimed to investigate the drug release-controlling capability and mechanical properties of filaments manufactured using hot-melt extrusion (HME) to prepare establish fundamental technologies related to the printability of 3D tablets and the controlled release of drugs. API-loaded filaments were prepared using HME. These filaments were used to manufacture cylindrical tablets using a 3D printer. Because the mechanical properties of the filaments are directly linked to their 3D printability, a 3-point bend test was conducted on the resulting filaments. Dissolution tests of API-loaded filaments and 3D-printed tablets were conducted in pH 1.2 and 6.8 buffer solutions. According to the 3-point bend test results, filaments made from single polymers were unsuitable for printing, however manufactured using binary polymer combinations based on HPC exhibited improved strength and flexibility compared with those manufactured using single polymers. Dissolution test results showed that the 3D-printed tablets continuously released the drug for 2, 4, or 6 h, depending on the polymer used, its ratio, and infill density. This study confirmed that the mechanical properties of filaments serve as a useful predictive measure for evaluating 3D printability and established a foundational technology for producing 3D-printed tablets with controlled release capabilities by combining polymers.