QbD Application for a Fixed-Dose Combination with Biowaiver Potential: Evaluations of In Vitro and In Vivo Applications


Sarisaltik-Yasin D., Uslu A., UYAR E., ERDİNÇ M., TEKSİN Z. Ş.

JOURNAL OF PHARMACEUTICAL INNOVATION, 2022 (Peer-Reviewed Journal) identifier

  • Publication Type: Article / Article
  • Publication Date: 2022
  • Doi Number: 10.1007/s12247-022-09633-1
  • Journal Name: JOURNAL OF PHARMACEUTICAL INNOVATION
  • Journal Indexes: Science Citation Index Expanded, Scopus, EMBASE, INSPEC
  • Keywords: 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

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).