Development of generic liposome products for drug delivery

Document Type

Chapter

Publication Date

4-12-2024

Abstract

Liposomal formulations have gained significant attention as an effective drug delivery system due to their unique properties like biocompatibility, biodegradability, and the ability to encapsulate both hydrophilic and hydrophobic drugs. In this chapter, we discuss the general considerations for the design of generic liposomal formulations, their critical quality attributes, composition of marketed liposomal formulations, and various manufacturing methods such as thin film hydration, double-emulsification technique, and solvent injection method. We also explore the different methods of drug loading, including passive drug loading, active drug loading, and lipid drug conjugation. Additionally, we discuss various processing techniques such as ultrasonication, French pressure cell techniques, micro emulsification techniques, and extrusion of preformed liposomes. The regulatory considerations pertaining to generic liposomal product development are taken into account. Overall, this chapter provides a comprehensive overview of the design and manufacturing of liposomal formulations for drug delivery, which can guide researchers and clinicians in the development of effective generic liposomal formulations for several applications.

DOI

10.1016/B978-0-443-15491-1.00010-9

Language

English

https://doi.org/10.1016/B978-0-443-15491-1.00010-9

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