ABSTRACT:
The challenge of developing disease-specific targeted drug delivery systems has become a prime choice for the formulation scientists to make products suitable for clinical use. One of the ways of achieving this aspect is by encapsulating the drug in lipids in a vesicular structure in the form of liposomes. The therapeutic performance of these lipid vesicles depends on their supramolecular structure which can greatly modify the target product profile (TPP) like circulation time, site specific release and bioavailability. The critical quality attributes (CQAs) includes particle size, entrapment efficiency, polydispersity index, surface charge and thermodynamic properties of the membrane effects its in vivo performance. The critical material attributes (CMA ) like lipid composition, selection of surfactant and production and critical process control parameters (CPP) have greater impact on the stability and therapeutic performance of these products. Therefore, a successful liposomal drug delivery needs a designing of process flow and a description of the process parameters and process controls for its manufacturing, stability and marketing. This review focuses on the rationality of the factors qualifying the regulatory requirements for the development of new liposomal product for targeted drug delivery.