Regulatory and Scientific Evaluation of Liposomal Delivery Systems: A WBCIL Perspective

Liposomal products have a demonstrated advantage over their non-liposomal counterparts in terms of improving their levels of bioavailability and absorption. It is established from scientific studies that nutraceuticals encapsulated in liposomes are able to reach their designated sites without losing out on their functionalities or biological activities. Unlike non-liposomal nutraceuticals wherein molecules go through significant levels of metabolic breakdown before they are even able to reach their target and start to address the ailments. This results in reduced nutritional benefits. However, for liposomal nutraceuticals, molecules can reach their target, where metabolic and enzymatic activities have little to no-effect on liposomal forms. This clear-cut advantage has brought down the dosage requirements of nutraceutical and mineral actives encapsulated in liposomes. However, when it comes to the approval of the liposomal nutraceutical products there remains a gap in the understanding for the approval of liposomal nutraceuticals. This article addresses the gap by bringing forward the understanding of the regulation of the liposomal drugs already approved by the regulatory agencies and applying this understanding for seeking approval of liposomal nutraceuticals. This article discusses the analyses required for meeting the regulatory requirements at different stages of introducing a new liposomal product into the market. An illustration describing the overall goal in improving the understanding of the scientific and regulatory perspectives is attached below.