US 20110206787A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0206787 A1 West et al. (43) Pub. Date: Aug. 25, 2011 (54) MORINDA CITRIFOLIA AND IRIDOID (60) Provisional application No. 61/307,262, ?led on Feb. BASED FORMULATIONS 23, 2010, provisional application No. 60/536,663, ?led on Jan. 15, 2004, provisional application No. (76) Inventors: Brett Justin West, Cedar Hills, UT 60/552,144, ?led on Mar, 10, 2004, provisional appli (US); Claude Jarakae Jensen, cation No. 60/335,343, ?led on Nov. 2, 2001, provi Cedar Hills, UT (Us); Afa Kehaati sional application No. 60/251,416, ?led on Dec. 5, Palu, American Fork, UT (US); 2000' ShiXin Deng, Lehi, UT (U S); Jlelfsfery A‘ Wasden’ Springv 111e, UT Publication Classi?cation ( ) (51) Int. Cl. (21) Appl. No.: 13/032,540 A61K 36/18 (200601) A61K 36/87 (2006.01) (22) Filed: Feb. 22, 2011 A61K 36/45 (2006.01) A61K 36/63 (2006.01) Related US. Application Data A61K 36/73 (2006.01) (60) Continuation-in-part of application No. 11/034,505, (200601) ?led on Jan. 13, 2005, Contmuatlon-m-part. of appli-. A611, 3/10 (2006(2006.01) 01) cationNo. 09/836,881, ?led onApr. 17, 2001 , noW Pat. ' No. 6,737,089, Continuation-in-part of application (52) US. Cl. ....... .. 424/732; 424/725; 424/774; 424/777; No. 11/253,130, ?led on Oct. 18, 2005, noW Pat. No. 424/773; 424/766; 424/765 7,244,463, Continuation-in-part of application No. 10/396,868, ?led on Mar. 25, 2003, noW abandoned, (57) ABSTRACT Continuation-in-part of application No. 11/360,550, ?led on Feb. 23, 2006, noW abandoned, Which is a Embodiments of the invention relate to forti?ed food and division of application No. 10/285,359, ?led on Oct. dietary supplement products Which may be administered to 31, 2002, noW Pat. No. 7,033,624, Which is a continu produce desirable physiological improvement. In particular, ation-in-part of application No. 10/006,014, ?led on embodiments of the invention relates to the administration of Dec. 4, 2001, noW abandoned. products enhanced With Morinda cilrifolia and iridoids. Patent Application Publication Aug. 25, 2011 Sheet 1 0f 6 US 2011/0206787 A1 Patent Application Publication Aug. 25, 2011 Sheet 2 0f 6 US 2011/0206787 A1 Patent Application Publication Aug. 25, 2011 Sheet 3 0f 6 US 2011/0206787 A1 gamma?“ Egg Patent Application Publication Aug. 25, 2011 Sheet 4 0f 6 US 2011/0206787 A1 acid Patent Application Publication Aug. 25, 2011 Sheet 5 0f 6 US 2011/0206787 A1 555 1 BAA AA 9.2K? 0.05; 0.05 5 15 15 25 25 55 55 4c HPLC chromatcgrams of Eridoid anaiysis in the different parts sf noni piants. {A} Nani fruitjuice; (B) dried fruit; (C) Eeaf; {D} mat; (E) seed; (F) ?ower. BAA, deacetyiasperuimidic acid; AA, asperuiosidic acid, The x and y-axes represent the running time (min) and peak abserbance {AU} respectiveiy. Patent Application Publication Aug. 25, 2011 Sheet 6 0f 6 US 2011/0206787 A1 $353K gamma,»:QUMEEQQmmmgmmEgg.swag$58, $5.;“6uzocm?mg2t.E2E62:$0E£32325m?mbxmEggnog 3%£235E22%gagégmm+W mag?“58%Ega A6322%u?momnl?mnmmm?mumwu£23,252,E?mtmuEst.uw?mzgmmEm US 2011/0206787 A1 Aug. 25,2011 MORINDA CITRIFOLIA AND IRIDOID particular, embodiments of the invention relates to the admin BASED FORMULATIONS istration of products enhanced With Morinda citrifolia and iridoids. PRIORITY CLAIM [0004] 2. Background [0005] Nutraceuticals may generally be de?ned as dietary [0001] This application claims priority to Us. Provisional products forti?ed to provide health and medical bene?ts, Application No. 61/307,262 ?led Feb. 23, 2010 Which claims including the prevention and treatment of disease. Nutraceu priority to Us. Provisional Patent Application No. 60/ 970, tical products include a Wide range of goods including iso 445, ?led on Sep. 6, 2007, entitled, “Morinda Citrifolia Based lated nutrients, dietary supplements, herbal products, pro Formulations for Regulating T Cell Immunomodulation in cessed foods and beverages. With recent breakthroughs in Neonatal Stock Animals,” is a continuation in part of Us. cellular-level nutraceuticals agents, researchers, and medical patent Ser. No. 11/034,505, ?led Jan. 13, 2005, entitled “Pro practitioners are developing therapies complimentary thera ?les of Lipid Proteins and Inhibiting HMG-COA Reductase,” pies into responsible medical practice and maintenance of Which claims priority to Provisional Application No. 60/536, good health. Generally, nutraceutical include a product iso 663, ?led Jan. 15, 2004 and claims priority to Provisional lated or puri?ed from foods, and are generally sold in forms Application No. 60/552,144, ?led Mar. 10, 2004, is a con that demonstrate a physiological bene?t or provide protection tinuation-in-part of Us. Pat. No. 6,737,089, ?led Apr. 17, against chronic disease. 2001, entitled “Morinda Citrifolia (Noni) Enhanced Animal [0006] There are multiple types of products that fall under Food Product”, and is a continuation-in-part of Us. Pat. No. the category of nutraceuticals. Nutraceuticals may be manu 7,244,463, ?led Oct. 18, 2001, entitled “Garcinia Man factured as dietary supplements, functional foods or medical gostana L. Enhanced Animal Food Product” and is a continu product. A dietary supplement is a product that contains nutri ation-in-part of Us. patent application Ser. No. 10/396,868, ents derived from food products that are concentrated in liq ?led Mar. 25, 2003, entitled “Preventative And Treatment uid, poWder or capsule form. A dietary supplement is a prod Effects Of Morinda Citirifolia As An Aromatase Inhibitor” uct taken by mouth that contains a dietary ingredient intended and claims priority to Us. Provisional Patent Application to supplement the diet. Dietary ingredients in these products Ser. No. 60/458,353, ?led Mar. 28, 2003, entitled “The Pos may include: vitamins, minerals, herbs or other botanicals, sible Estrogenic Effects Of Tahitian Noni Puree Juice Con and substances such as enZymes and metabolites. Dietary centrate-Dry Form”, and is a continuation-in-part of Us. supplements can also be extracts or concentrates, and may be patent application Ser. No. 11/360,550 ?led Feb. 23, 2006, found in many forms such as tablets capsules, softgels, gel entitled “Preventative and Treatment Effects of Morinda Cit caps, liquides or poWders. rifolia on Osteoarthritis and Its Related Conditions” Which is [0007] Functional foods include ordinary food that has a divisional of Us. patent application Ser. No. 10/285,359, components or ingredients added to give it a speci?c medical noW U.S. Pat. No. 7,033,624, ?led Oct. 31, 2002, entitled or physiological bene?t, other than a purely nutritional effect. “Preventative and Treatment Effects of Morinda Citrifolia on Functional foods may be designed to alloW consumers to eat Osteoarthritis and Its Related Conditions” Which claims pri enriched foods close to their natural state, rather than by ority to Us. Provisional Patent Application No. 60/335,343 taking dietary supplements manufactured in liquid or capsule ?led Nov. 2, 2001, entitled, “Methods for Treating Osteoar form. Functional foods may be produced in their naturally thritis” and is a continuation-in-part of Us. patent applica occurring form, rather than a capsule, tablet, or poWder, can tion Ser. No. 10/006,014 ?led Dec. 4, 2001, entitled “Tahitian be consumed in the diet as often as daily, and may be used to Noni Juice On Cox-1 And Cox-2 And Tahitian Noni Juice As regulate a biological process in hopes of preventing or con A Selective Cox-2 Inhibitor”, Which claims priority to Us. trolling disease. Provisional PatentApplication Ser. No. 60/251,416 ?led Dec. 5, 2000, entitled “Cox-1 and Cox-2 Inhibition Study on TNJ” SUMMARY OF THE INVENTION and is a continuation-in-part of Us. patent application Ser. No. 11/553,323, ?led Oct. 26, 2006, entitled “Preventative [0008] Some embodiments relate to formulations that pro and Treatment Effects of Morinda Citrifolia on Diabetes and vide a speci?c physiological bene?t. Some embodiments its Related Conditions” Which is a divisional of Us. patent relate to formulations designed to prevent or control disease. application Ser. No. 10/993,883, noW U.S. Pat. No. 7,186,422 Some embodiments comprise a processed Morinda citrifolia ?led Nov. 19, 2004, entitled “Preventative And Treatment products and a source of iridoids and methods for manufac Effects Of Morinda Citrifolia On Diabetes And Its Related turing the same. Conditions” Which is a divisional of Us. application Ser. No. [0009] Some embodiments provide a processed Morinda 10/286,167, noW U.S. Pat. No. 6,855,345 ?led Nov. 1,2002, citrifolia product selected from a group consisting of: extract entitled “Preventative And Treatment Effects Of Morinda from the leaves of Morinda citrifolia, leaf hot Water extract, Citrifolia On Diabetes And Its Related Conditions,” Which processed Morinda citrifolia leaf ethanol extract, processed claims priority to Us. Provisional Application Ser. No. Morinda citrifolia leaf steam distillation extract, Morinda 60/335,313, ?led Nov. 2, 2001, and entitled, “Methods for citrifolia fruit juice, Morinda citrifolia extract, Morinda cil Treating Conditions Related to Diabetes.” rifolia dietary ?ber, Morinda citrifolia puree juice, Morinda citrifolia puree, Morinda citrifolia fruit juice concentrate, BACKGROUND Morinda citrifolia puree juice concentrate, freeZe concen trated Morinda citrifolia fruit juice, Morinda citrifolia seeds, [0002] 1. Field of Invention Morinda citrifolia seed extracts, extracts from defatted [0003] Embodiments of the invention relate to forti?ed Morinda citrifolia seeds and evaporated concentration of food and dietary supplement products Which may be admin Morinda citrifolia fruit juice, in combination With an amount istered to produce desirable physiological improvement.