A Proposed Methodology for a Risk Assessment-Based Liposome Development Process

• Published in: Pharmaceutics 2020-11, Vol.12 (12), p.1164
• Main Authors: Németh, Zsófia, Pallagi, Edina, Dobó, Dorina Gabriella, Csóka, Ildikó
• Format: Article
• Language: English
• Subjects: critical factors; Design of experiments; Drug dosages; Generations; liposome formulation; Nanoparticles; Pharmaceutical industry; Polyethylene glycol; quality by design; quality planning; Risk assessment; Software; thin-film hydration method
• ISSN: 1999-4923; 1999-4923
• DOI: 10.3390/pharmaceutics12121164

The requirements of a liposomal formulation vary depending on the pharmaceutical indication, the target patient population, and the corresponding route of administration. Different preparation methods require various material attributes (MAs) (properties and characteristics of the components) and process parameters (PPs) (settings of the preparation method). The identification of the quality target product profile for a liposome-based formulation, the critical quality attributes of the liposomes, and the possible MAs and PPs that may influence the key characteristics of the vesicles facilitates pharmaceutical research. Researchers can systematise their knowledge by using the quality by design (QbD) approach. The potential factors that influence the quality of the product can be collected and studied through a risk assessment process. In this paper, the requirements of a liposome formulation prepared via the thin-film hydration preparation technique are presented; furthermore, the possible factors that have an impact on the quality of the final product and have to be considered and specified during the development of a liposomal formulation are herein identified and collected. The understanding and the application of these elements of QbD in the pharmaceutical developments help to influence the quality, the achievements, and the success of the formulated product.