JOURNAL OF PHARMACEUTICAL INNOVATION, 2022 (Peer-Reviewed Journal)
Article / Article
JOURNAL OF PHARMACEUTICAL INNOVATION
Science Citation Index Expanded, Scopus, EMBASE, INSPEC
Fixed-dose combination, Quality by design, Design of experiments, Biowaiver, Amlodipine, Enalapril, QUALITY-BY-DESIGN, IMMEDIATE-RELEASE, TABLET FORMULATION, AMLODIPINE, ENALAPRIL, OPTIMIZATION, HYPERTENSION, INJURY, SPACE
Purpose The purpose of this study was to use the quality by design (QbD) approach to design a directly compressed fixed-dose combination (FDC) tablet comprising amlodipine besylate and enalapril maleate with biowaiver potential in alignment with the Biopharmaceutical Classification System (BCS).