A Novel, Nontoxic and Scalable Process to Produce Lipidic Vehicles.

Abstract

Lipidic vehicles are novel industrial products, utilized as components for pharmaceutical, cosmeceutical and nutraceutical formulations. The present study concerns a newly invented method to produce lipidic vehicles in the nanoscale that is simple, nontoxic, versatile, time-efficient, low-cost and easy to scale up. The process is a modification of the heating method (MHM) and comprises (i) providing a mixture of an amphiphilic lipid and a charged lipid and/or a fluidity regulator in a liquid medium composed of water and a liquid polyol, (ii) stirring and heating the mixture in two heating steps, wherein the temperature of the second step is higher than the temperature of the first step and (iii) allowing the mixture to cool down to room temperature. The process leads to the self-assembly of nanoparticles of small size and good homogeneity, compared with conventional approaches that require additional size reduction steps. In addition, the incorporation of bioactive molecules, such as drugs, inside the nanoparticles is possible, while lyophilization of the products provides long-term stability. Most importantly, the absence of toxic solvents and the simplicity guarantee the safety and scalability of the process, distinguishing it from most prior art processes to produce lipidic vehicles.