Abstract
Successful liposomal formulations in the clinic are severely limited due to poor translational capability of the traditional bench techniques to clinical production settings. The gold standard for liposome bench manufacturing is a multi-step and parameter dependent extrusion method. Moreover, these parameters need re-optimization for clinical production. The microfluidics technique utilizes vigorous mixing of fluids at a nanoliter scale to produce liposomes in batches from milliliters to a couple liters. The fine control of process parameters results in improved reproducibility between batches. It is inherently scalable; however, the characteristics of liposomes produced by microfluidics both in vitro and in vivo have never been compared to those produced using extrusion. In this manuscript, we describe the comparison between the traditional extrusion method to microfluidics, the new paradigm in liposome production and scale-up.
Graphical abstract shows two methods to prepare liposomes: extrusion, which has challenges with scale-up, and microfluidics, which is scale-up efficient. Both methods produce liposomes that are identical in size and in vitro and in vivo behavior. Thus, substitution of extrusion, the gold standard of making liposomes, with a precise and scalable microfluidics platform is a viable option. [Display omitted]