QbD 기반 이중 방출 제어 매트릭스 정제의 개발 및 용출 특성

In this study, a dual-release matrix tablet (DRMT) containing sarpogrelate HCl (SGH) was developed by varying the amount HPMC K100M and Eudragit® RSPO according to approach of quality by design (QbD). For this experimental, we were evaluated dissolution rate at 2, 8 and 24 hours and compared it with the commercially available Sapodifil® SR 300 mg for application as DRMT system. Optimization was achieved through a 2-factor, 3-level full factorial design, focusing on the total amount of polymer (X1) and Eudragit® RSPO (X2) within it, with a defined design space for these variables. The dissolution rate at 2 and 8 hours of the prepared DRMT was affected by the total amount of polymer and amount of Eudragit® RSPO to polymer and either showed a linear or quadratic pattern (p