Development of a Robust Control Strategy for Fixed-Dose Combination Bilayer Tablets with Integrated Quality by Design, Statistical, and Process Analytical Technology Approach

• Hauptverfasser: Myung-Hee Chun (Verfasst von), Ji Yeon Kim (Verfasst von), Eun-Seok Park (Verfasst von), Du Hyung Choi (Verfasst von)
• Format: Buch
• Veröffentlicht: MDPI AG, 2021-09-01T00:00:00Z.
• Schlagworte: article
• Online-Zugang: Connect to this object online.

Control strategy and quality by design (QbD) are widely used to develop pharmaceutical products and improve drug quality; however, studies on fixed-dose combination (FDC) bilayer tablets are limited. In this study, the bilayer tablet consisted of high-dose metformin HCl in a sustained-release layer...