Micro/nanoemulsion technology has substantial commercial value. In relation to the nutraceutical area alone, the market value is estimated as a 250 billion dollar business world-wide. Consequently, the ability to incorporate lipid soluble nutraceuticals into beverages (the fastest-growing component of the food industry) as well as low or no fat foods is of important interest.
University of Massachusetts Lowell (Lowell, MA) Dr. Robert Nicolosi, Professor and Director, Center for Health & Disease Research, and Associate Professor and Program Coordinator Nutritional Science Thomas Wilson reveal uniform microfluidized nanoemulsions made using high shear stress technology in U.S. Patent Application 20080274195.
This invention provides a new methodology for developing better and more efficient nanoemulsion delivery mechanisms. This technology efficiently tackles three issues pertaining nanoemulsions: 1) improvement in temperature and pH stability, 2) improved bioavailability and 3) improved shelf life due to microbial resistance. Using, for example, Microfluidizer® processor equipment for generating nanoparticulate compositions these three tasks were successfully addressed and positively advance this technology’s capabilities for a variety of applications.
This technology is versatile and could be instrumental by many different markets such as cosmetics, health diagnostics, drug therapeutics and biotechnologies. This type of delivery vehicle technology may also be used to incorporate lipid soluble nutraceuticals into beverages and low or no fat foods.
The uniform nanoemulsion can be used in a compound such as a pharmaceutical, nutraceutical, or cosmeceutical compound. The uniform nanoemulsions exhibit improved pharmacokinetic parameters when compared to conventional nanoparticulate compositions and/or nanoemulsions. They also are developing a method of making a bacteria-resistant nanoemulsion.
According to Nicolosi and Wilson, the improved method of making these uniform nanoemulsions utilizes microfluidization which differs in both process and mechanics when compared to conventional milling and grinding techniques used to generate nanoparticulate compositions. Further, the improvement results, in part, from a novel step of mixing a substantially soluble compound into a heated dispersion medium. This is unlike current nanoparticulate composition methods that mix an insoluble compound with an unheated dispersion medium. Further, these nanoemulsions are observed to be bacterial-resistant and stable to extremes in both temperature and pH changes. Consequently, these nanoemulsions are expected to have a significantly prolonged shelf-life than currently available nanoemulsions.
According to Nicolosi and Wilson their method includes: a) providing; i) a premix comprising a compound and a liquid dispersion medium, wherein said compound has a solubility greater than 30 mg/ml in said medium; and ii) a microfluidizer capable of maintaining at least 25,000 PSI; b) using a single pass exposure of said premix to said microfluidizer to create a population of nanoemulsion particles having diameters ranging approximately between 10-110 nm.
The improved nanoemulsion has a uniform and discrete range of very small particle nano-sized diameters. This uniformity results in improved bioavailability of incorporated compounds (i.e., pharmaceuticals or nutraceuticals) as reflected in various pharmacokinetic parameters including, but not limited to, decreased Tmax, increased Cmax, and increased AUC.
The dispersion medium can be selected from the group consisting of aqueous media and oil-based media. The aqueous media can be water, ringers solution, dextrose, and short chain alcohols. The acauious media may also be an oil-based media is selected from the group including saturated and unsaturated oils from vegetable and marine sources, silicone oils, mineral oils, and plant-derived oils. The compound may also be selected from the group including a plant sterol, cod liver oil, tocopherol, lecithin, lutein, zeaxanthin, and soy protein.
The patent pending technology is available for license from UMass Commercial Ventures and Intellectual Property (CVIP) Office (600 Suffolk St. 2nd Floor, Lowell, MA 01854 USA, Fax: 978-934-6012 email: email@example.com).