Product Formulation and Process Design for Commercial Production of Soluable Phytosterols

Commercially available products rich in phytosterol may now be used to cut serum low-density lipoprotein by as much as 14 percent. Unfortunately, phytosterols are poorly soluble and therefore present unique problems concerning their ability to suppress cholesterol absorption in the gut. This impediment often leads to sub-optimal dosing and poor performance of phytosterol compounds and restricts their use in nutraceuticals and functional food products. One promising approach to enhancing the dissolution rate of such compounds is to formulate them as micro- and nano-size particles. The purpose of this Phase II SBIR is to produce amorphous phytosterol powders with rates of dissolution in water and body fluids that significantly exceed what is currently available in the commercial market. We will also demonstrate the physical stability of the amorphous particles over an 18 month shelf life. Finally, the Phase II work will provide an engineering design and analysis for integrating a CAN-BD process with an existing system for manufacturing phytosterol powders on a commercial scale.