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, cilt.18, sa.1, ss.164-181, 2023 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 18 Sayı: 1
  • Basım Tarihi: 2023
  • Doi Numarası: 10.1007/s12247-022-09633-1
  • Dergi Adı: JOURNAL OF PHARMACEUTICAL INNOVATION
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, INSPEC
  • Sayfa Sayıları: ss.164-181
  • Anahtar Kelimeler: 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
  • Gazi Üniversitesi Adresli: Evet

Özet

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).