Lipoidal-Nano Architecture for Parental Drug Delivery: Formulation Development and Regulatory Concerns

Abstract

<jats:sec> <jats:title>:</jats:title> <jats:p>The nanoparticles as drug carriers have demonstrated enhanced targeting, sustained/controlled drug release as evident from numerous investigations which have shown promising outcomes facilitating the wellbeing of humans in a desired manner. The lipid based nanoparticulates are biodegradable and considered biocompatible by virtue of being composed of lipid moieties mimicking physiological lipids of biological systems which is their prime advantage over the other polymeric systems. A variety of such lipid carriers have been reported to be delivered from parenteral route. However, there are certain pitfalls which are associated with lipid nanoparticulates such as toxicity, poor scale up potential, immunological reactions and absence of straight forward regulatory guidelines which address the issues of lipoidal nanocarriers such as their classification, approval and compliance of governmental policies. Therefore attention must be given to address the technological and regulatory challenges associated with lipoidal nano-formulations for parenteral administration to smoothen the approval process throughout the world and bringing the same to the terminal users on time. </jats:p> </jats:sec>