An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

Liposomal formulation development is a challenging process. Certain factors have critical influence on the characteristics of liposomes, and even relevant properties can vary based predefined interests research. In this paper, Quality by Design-guided Risk Assessment (RA)-based study was performed to determine Critical Material Attributes Process Parameters an “intermediate” active pharmaceutical ingredient-free liposome prepared via thin-film hydration method, collect future carrier system show process narrowing general initial RA for specific case. The theoretical design proved through experimental models. investigated covered working temperature, ratio between wall-forming agents (phosphatidylcholine cholesterol), PEGylated phospholipid content (DPPE-PEG2000), type media (saline or phosphate-buffered saline solutions) cryoprotectants (glucose, sorbitol trehalose). characterisation results (size, surface charge, thermodynamic behaviours, formed structure bonds) liposomes supported outcomes updated RA. findings be used as basis particular with specified circumstances.