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Manufacturing and Process Scale-Up

(275) Pharmacokinetics of a Liposomal Amphotericin B Prepared using Simplified Thin Film Hydration Method

Introduction: Amphotericin B (AmB), a potent antifungal agent, has limited clinical use due to its toxicity. To alleviate this, liposome formulations such as AmBisome® have been developed. This study is aimed to develop a generic alternative of AmBisome, DKF-5122, a liposome AmB formulation, using thin-film hydration that meets the liposomal physicochemical equivalence and bioequivalence compared to AmBisome®. Formulation & manufacturing of DKF-5122 applied QbD approach to optimize CQAs and CPPs, thereby increasing process robustness, ensuring reproducibility, and maintaining consistent quality.

Learning Objectives:

  • Explore the generic and regulatory compliant formulation development of a complex liposomal AmB.
  • Optimize the manufacturing process of liposomes using QbD approaches.
  • Evaluate liposomal formulations for equivalence based on physicochemical & bioequivalence studies.