Theaflavin compositions, related processes and methods of use

#The present invention relates to processes for production of purified theaflavin extract, compositions which result from the processes, oral dosage forms, and methods of use.

#Theaflavin (catechin dimer joined at B rings) and its derivatives, known collectively as theaflavins, are antioxidant polyphenols Flavan-3-ols formed from catechins during enzymatic oxidation (fermentation). Theaflavins generally comprise a mixture of theaflavin, theaflavin-3-gallate, theaflavin-3′-gallate and theaflavin-3,3′-digallate.

#Theaflavins have positive health benefits directly linked to the antioxidant properties of these compounds. The benefits include the ability to effect lower blood lipid levels (e.g. cholesterol), control of inflammation, as well as anti-tumor effects. See, e.g., Maron D J, et al., Cholesterol-Lowering Effect of a Theaflavin-Enriched Green Tea Extract: a Randomized Controlled Trial, Arch. Intern. Med. 163 (12): 1448 (2003). See, also, Lorentz, M., et al., Basic Res Cardiol. 2009 January; 104(1):100; Manna, S., et al., J Nutr Biochem. 2009 May; 20(5):337.

#FIG. 1 displays a process embodiment of the present invention for manufacturing theaflavins.

#Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which this invention belongs. All publications and patents referred to herein are incorporated by reference including U.S. Pat. Nos. 7,427,622; 7,157,493 and 7,288,680.

#As used herein the term organic solvent refers to any inert organic solvent that solubilizes tea leaf polyphenols including but not limited to esters, alcohols, ketones and ethers. The term inert as used herein refers to an organic solvent that does not otherwise affect the oxidation of polyphenols to theaflavins in the processes described herein. Esters for use as organic solvent in processes described herein include, but are not limited to, for example, methyl acetate, ethyl acetate, propyl acetate, and isopropyl acetate. Alcohols for use as organic solvent in processes described herein include, but are not limited to, for example, ethyl alcohol, propyl alcohol, and isopropyl alcohol. Ketones for use as organic solvent in processes described herein include, but are not limited to, for example, acetone and butanone. Ethers for use as organic solvent in processes described herein include, but are not limited to, for example, diethyl ether, dipropyl ether, and methyl-tert-butyl ether.

#The term organic stock substrate solution, as used herein, refers to an organic tea leaf extract containing polyphenols.