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

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 pr...

Full description

Saved in:
Bibliographic Details
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
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics12121164