QbD Application for a Fixed-Dose Combination with Biowaiver Potential: Evaluations of In Vitro and In Vivo Applications
JOURNAL OF PHARMACEUTICAL INNOVATION, vol.18, no.1, pp.164-181, 2023 (SCI-Expanded, Scopus)
- Publication Type: Article / Article
- Volume: 18 Issue: 1
- Publication Date: 2023
- Doi Number: 10.1007/s12247-022-09633-1
- Journal Name: JOURNAL OF PHARMACEUTICAL INNOVATION
- Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, INSPEC
- Page Numbers: pp.164-181
- Keywords: Fixed-dose combination, Quality by design, Design of experiments, Biowaiver, Amlodipine, Enalapril
- Inonu University Affiliated: Yes
Abstract
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).