An overview of lipid based vesicular systems: stability and regulatory considerations

Lipid based drug delivery systems are used to encapsulate the active substance within or interior space of the lipid bilayer. The lipid-based drug products are designed to improve the stability in-vivo and pharmacokinetics behavior of active substances. However, understanding of the factors that affect the stability is critical for rationale development of lipid based drug delivery systems with desired pharmacokinetics and bio-distribution. Lyophilization is one primary approach to improve the stability of lipid based systems. The article presents an overview of the characteristics of the lipid based drug delivery systems as drug carriers, particularly in relation to stability, regulatory considerations. Further, the present review emphasizes the formulation problems and marketed formulation of lipid-based systems.