Hot-melt extrusion (HME) is the most preferred and effective method for manufacturing amorphous solid dispersions at production scale, but it consumes large amounts of samples when used for formulation development. Herein, we show a novel approach to screen the polymers by overcoming the disadvantage of conventional HME screening by using a minimum quantity of active pharmaceutical ingredient (API). Vacuum Compression Molding (VCM) is a fusion-based method to form solid specimens starting from powders. This study aimed to investigate the processability of VCM for the creation of amorphous formulations and to compare its results with HME-processed formulations. Mixtures of indomethacin (IND) with drug carriers (Parteck^® MXP, Soluplus^®, Kollidon^® VA 64, Eudragit^® EPO) were processed using VCM and extrusion technology. Thermal characterization was performed using differential scanning calorimetry, and the solid-state was analyzed via X-ray powder diffraction. Dissolution studies in the simulated gastric fluid were performed to evaluate the drug release. Both technologies showed similar results proving the effectiveness of VCM as a screening tool for HME-based formulations.

中文翻译：

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真空压缩成型作为筛选工具，以研究载体对热熔挤出配方的适用性

热熔挤出（HME）是在生产规模上生产无定形固体分散体的最优选和有效的方法，但是在用于配方开发时会消耗大量样品。在这里，我们展示了一种通过使用最小量的活性药物成分（API）克服常规HME筛选的缺点来筛选聚合物的新颖方法。真空压缩成型（VCM）是一种基于融合的方法，可以从粉末开始形成固体样品。这项研究旨在调查VCM用于制备无定形配方的可加工性，并将其结果与HME加工的配方进行比较。吲哚美辛（IND）与药物载体（的Parteck的混合物^® MXP，Soluplus ^®，的Kollidon ^®VA 64，尤特奇^® EPO）是用VCM和挤压技术加工。使用差示扫描量热法进行热表征，并通过X射线粉末衍射分析固态。在模拟胃液中进行溶出度研究以评估药物释放。两种技术均显示出相似的结果，证明了VCM作为基于HME制剂的筛选工具的有效性。