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 (2006.01)(2006 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?

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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

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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. In of iridoids sourced from at least one of a variety of plants. US 2011/0206787 A1 Aug. 25, 2011

[0010] Preferred embodiments are formulated to provide a Morinda cilrifolia product preferably includes Morinda cil physiological bene?t. For example some embodiments may rifolia fruit juice, Which juice is preferably present in an selectively inhibit COX-1/COX-2, regulate TNF U and amount capable of maximiZing the desired physiological ben Nitric oxide and 5-LOX, increases IFN- Cl secretion, inhibit e?t Without causing negative side effects When the composi histamine release, inhibit human neutrophils, regulate tion is administered to a mammal. Products from Morinda elastase enZyme activity, inhibit the complement pathWay, cilrifolia may include one more parts of the Morinda cilrifo inhibits the groWth microbials including gram — and gram + lia L. plant, including but not limited to the: fruit, including bacteria, inhibit DNA repair systems, inhibit cancer cell the fruit juice and fruit pulp and concentrates thereof, leaves, groWth & cytotoxic to cancer cells, inhibits platelets aggre including leaf extract, seeds, including the seed oil, ?oWers, gations, provide DPPH scavenging effects, provide antiviral roots, bark, and Wood. activity including anti-HSV, anti-RSV, and anti-VSV activity, [0021] Some compositions of the present invention com provide antispasmodic activity, provide Wound-healing and prise Morinda cilrifolia extracts present betWeen about 1 and neuroprotective activities. 5 percent of the Weight of the total composition. Other such percentage ranges include: about 0.1 and 50 percent; about 85 BRIEF DESCRIPTION OF THE DRAWINGS and 99 percent; about 5 and 10 percent; about 10 and 15 percent; about 15 and 20 percent; about 20 and 50 percent; [0011] In order that the matter in Which the above-recited and about 50 and 100 percent. and other advantages of the invention are obtained, a more particular description of the invention brie?y described above [0022] In some Morinda cilrifolia compositions of the Will be rendered by reference to speci?c embodiments thereof present invention, Morinda cilrifolia fruit juice evaporative concentrate is present, the evaporative concentrate having a Which are illustrated in the appended draWings. Understand ing that these draWings depict only typical embodiments of concentration strength (described further herein) betWeen about 8 and 12 percent. Other suchpercentage ranges include: the invention and are not therefore to be considered to be about 4 and 12 percent; and about 0.5 and 12 percent. limiting of its scope, the invention Will be described and explained With additional speci?city and detail through the [0023] In some Morinda cilrifolia compositions of the use of the accompanying draWings in Which: present invention, Morinda cilrifolia fruit juice freeZe con [0012] FIG. 1 depicts the structural formula for common centrate is present, the freeZe concentrate having a concen iridoids according to some embodiments of the invention; tration strength (described further herein) betWeen about 4 and 6 percent. Other such percentage ranges include: about [0013] FIG. 2 depicts the structural formula for common 0.5 and 2 percent; and about 0.5 and 6 percent. iridoids according to some embodiments of the invention; [0014] FIG. 3 depicts results from studies demonstrating [0024] One or more Morinda cilrifolia extracts can be fur the DNA protective activity of iridoid containing plant prod ther combined With other ingredients or carriers (discussed further herein) to produce a pharmaceutical Morinda cilrifo ucts according to some embodiments of the invention; lia product or composition (“pharmaceutical” herein refer [0015] FIG. 4 depicts the chemical structures of deacety ring to any drug or product designed to improve the health of lasperulosidic acid and asperulosidic acid; living organisms such as human beings or mammals, includ [0016] FIG. 5 depicts HPLC chromatograms of iridoid ing nutraceutical products) that is also a Morinda cilrifolia of analysis in the different parts of noni plant; and the present invention. Examples of pharmaceutical Morinda [0017] FIG. 6 depicts a comparison of iridoid contenst in cilrifolia products may include, but are not limited to, orally the methanolic extracts of noni fruits collected from different administered solutions and intravenous solutions. tropical areas WorldWide. [0025] Methods of the present invention also include the obtaining of Morinda cilrifolia compositions and extracts, DETAILED DESCRIPTION OF THE INVENTION including Morinda cilrifolia fruit juice and concentrates [0018] It Will be readily understood that the components of thereof. It Will be noted that some of the embodiments of the the present invention, as generally described herein, could be present invention contemplate obtaining the Morinda cilrifo arranged and designed in a Wide variety of different con?gu lia fruit juice pre-made. Various methods of the present inven rations. Thus, the folloWing more detailed description of tion shall be described in more detail further herein. embodiments of the compositions and methods of the present [0026] The folloWing disclosure of the present invention is invention is not intended to limit the scope of the invention, as grouped into subheadings. The utiliZation of the subheadings claimed, but is merely representative of the presently pre is for convenience of the reader only and is not to be construed ferred embodiments of the invention. The scope of the inven as limiting in any sense. tion is, therefore, indicated by the appended claims rather General Description of the Morinda cilrifolia L. Plant than by the foregoing description. All changes that come [0027] The Indian Mulberry or Morinda cilrifolia plant is Within the meaning and range of equivalency of the claims are knoWn scienti?cally as Morinda Cilrifolia L. The plant is to be embraced Within their scope. native to SoutheastAsia and has spread in early times to a vast [0019] Embodiments of the present invention feature meth area from India to eastern Polynesia. It groWs randomly in the ods and compositions designed to provide a physiological Wild, and it has been cultivated in plantations and small indi bene?t comprising a combination of a processed Morinda vidual groWing plots. Although the fruit has been eaten by cilrifolia product and a source of iridoids. The physiological several nationalities as food, the most common use of the bene?t arising from the synergistic combination of a compo Morinda cilrifolia plant has traditionally been as a red and nent derived from the Indian Mulberry or Morinda cilrifolia yelloW dye source. L. plant and a source of iridoids. [0028] The Morinda cilrifolia plant is rich in natural ingre [0020] Embodiments of the present invention comprise dients including: (from the leaves): alanine, anthraquinones, Morinda cilrifolia compositions, each of Which include one arginine, ascorbic acid, aspartic acid, calcium, beta-carotene, or more processed Morinda cilrifolia L. products. The cysteine, cystine, glycine, glutamic acid, glycosides, histi US 2011/0206787 A1 Aug. 25, 2011

dine, iron, leucine, isoleucine, methionine, niacin, phenyla [0031] In some embodiments, the primary leaf extract is lanine, phosphorus, proline, resins, ribo?avin, serine, beta subsequently pasteurized. The primary leaf extract may be sitosterol, thiamine, threonine, tryptophan, tyrosine, ursolic pasteurized preferably at a temperature ranging from 70 to 80 acid, and valine; (from the ?owers): acacetin-7-o-beta-d(+) degrees Celsius and for a period of time su?icient to destroy glucopyranoside, 5,7-dimethyl-apigenin-4'-o-beta-d(+)-ga any objectionable organisms Without major chemical alter lactopyranoside, and 6,8-dimethoxy-3-methylan ation of the extract. Pasteurization may also be accomplished thraquinone-l -o -beta-rhamno syl-glucopyrano side; (from the according to various radiation techniques or methods. fruit): acetic acid, asperuloside, butanoic acid, benzoic acid, [0032] In some embodiments of the present invention, the benzyl alcohol, l-butanol, caprylic acid, decanoic acid, (E) pasteurized primary leaf extract is placed into a centrifuge 6-dodeceno-gamma-lactone, (Z,Z,Z)-8,l l,l4-eicosatrienoic decanter Where it is centrifuged to remove or separate any acid, elaidic acid, ethyl decanoate, ethyl hexanoate, ethyl remaining leaf juice therein from other materials, including octanoate, ethyl palmitate, (Z)-6-(ethylthiomethyl) benzene, chlorophyll. Once the centrifuge cycle is completed, the leaf eugenol, glucose, heptanoic acid, 2-heptanone, hexanal, hex extract is in a relatively puri?ed state. This puri?ed leaf anamide, hexanedioic acid, hexanoic acid (hexoic acid), extract is then pasteurized again in a similar manner as dis l-hexanol, 3-hydroxy-2-butanone, lauric acid, limonene, cussed above to obtain a puri?ed primary leaf extract. linoleic acid, 2-methylbutanoic acid, 3-methyl-2-buten- 1 -ol, [0033] Preferably, the primary leaf extract, Whether pas 3-methyl-3-buten-l-ol, methyl decanoate, methyl elaidate, teurized and/ or puri?ed, is further fractionated into tWo indi methyl hexanoate, methyl 3-methylthio-propanoate, methyl vidual fractions: a dry hexane fraction, and an aqueous octanoate, methyl oleate, methyl palmitate, 2-methylpro methanol fraction. This is accomplished preferably in a gas panoic acid, 3-methylthiopropanoic acid, myristic acid, chromatograph containing silicon dioxide and CH2Cl2 nonanoic acid, octanoic acid (octoic acid), oleic acid, palmitic MeOH ingredients using methods Well knoWn in the art. In acid, potassium, scopoletin, undecanoic acid, (Z,Z)-2,5-un some embodiments of the present invention, the methanol decadien- 1 -ol, and vomifol; (from the roots): anthraquinones, fraction is further fractionated to obtain secondary methanol asperuloside (rubichloric acid), damnacanthal, glycosides, fractions. In some embodiments, the hexane fraction is fur morindadiol, morindine, morindone, mucilaginous matter, ther fractionated to obtain secondary hexane fractions. nor-damnacanthal, rubiadin, rubiadin monomethyl ether, res [0034] One or more of the leaf extracts, including the pri ins, soranjidiol, sterols, and trihydroxymethyl mary leaf extract, the hexane fraction, methanol fraction, or anthraquinone-monomethyl ether; (from the root bark): any of the secondary hexane or methanol fractions may be alizarin, chlororubin, glycosides (pentose, hexose), morinda combined With the fruit juice of the fruit of the Morinda diol, morindanigrine, morindine, morindone, resinous mat cilrifolia plant to obtain a leaf serum (the process of obtaining ter, rubiadin monomethyl ether, and soranjidiol; (from the the fruit juice to be described further herein). In some Wood): anthragallol-2,3-dimethylether; (from the tissue cul embodiments, the leaf serum is packaged and frozen ready for ture): damnacanthal, lucidin, lucidin-3-primeveroside, and shipment; in others, it is further incorporated into a nutraceu morindone-6beta-primeveroside; (from the plant): alizarin, tical product as explained herein. alizarin-alpha-methyl ether, anthraquinones, asperuloside, Processing Morinda cilrifolia Fruit hexanoic acid, morindadiol, morindone, morindogenin, [0035] Some embodiments of the present invention include octanoic acid, and ursolic acid. a composition comprising fruit juice of the Morinda cilrifolia Processing Morinda cilrifolia Leaves plant. In some embodiments the fruit may be processed in [0029] The leaves of the Morinda cilrifolia plant are one order to make it palatable for human consumption and possible component of the Morinda cilrifolia plant that may included in the compositions of the present invention. Pro be present in some compositions of the present invention. For cessed Morinda cilrifolia fruitjuice can be prepared by sepa example, some compositions comprise leaf extract and/or rating seeds and peels from the juice and pulp of a ripened leaf juice as described further herein. Some compositions Morinda cilrifolia fruit; ?ltering the pulp from the juice; and comprise a leaf serum that is comprised of both leaf extract packaging the juice. Alternatively, rather than packaging the and fruit juice obtained from the Morinda cilrifolia plant. juice, the juice can be immediately included as an ingredient Some compositions of the present invention comprise leaf in another product, frozen or pasteurized. In some embodi serum and/or various leaf extracts as incorporated into a ments of the present invention, the juice and pulp can be nutraceutical product (“nutraceutical” herein referring to any pureed into a homogenous blend to be mixed With other product designed to improve the health of living organisms ingredients. Other processes include freeze drying the fruit such as human beings or mammals). and juice. The fruit and juice can be reconstituted during [0030] In some embodiments of the present invention, the production of the ?nal juice product. Still other processes Morinda cilrifolia leaf extracts are obtained using the folloW may include air drying the fruit and juices prior to being ing process. First, relatively dry leaves from the Morinda masticated. cilrifolia L. plant are collected, cut into small pieces, and [0036] In a currently preferred process of producing placed into a crushing deviceipreferably a hydraulic Morinda cilrifolia fruit juice, the fruit is either hand picked or pressiWhere the leaf pieces are crushed. In some embodi picked by mechanical equipment. The fruit can be harvested ments, the crushed leaf pieces are then percolated With an When it is at least one inch (2-3 cm) and up to 12 inches (24-36 alcohol such as ethanol, methanol, ethyl acetate, or other cm) in diameter. The fruit preferably has a color ranging from alcohol-based derivatives using methods knoWn in the art. a dark green through a yelloW-green up to a White color, and Next, in some embodiments, the alcohol and all alcohol gradations of color in betWeen. The fruit is thoroughly soluble ingredients are extracted from the crushed leaf pieces, cleaned after harvesting and before any processing occurs. leaving a leaf extract that is then reduced With heat to remove [0037] The fruit is alloWed to ripen or age from 0 to 14 days, all the liquid therefrom. The resulting dry leaf extract Will but preferably for 2 to 3 days. The fruit is ripened or aged by herein be referred to as the “primary leaf extract.” being placed on equipment so that the fruit does not contact US 2011/0206787 Al Aug. 25, 2011

the ground. The fruit is preferably covered With a cloth or teuriZed in circumstances Where the sugar content or Water netting material during aging, but the fruit can be aged With activity Was suf?ciently loW enough to prevent microbial out being covered. When ready for further processing the fruit groWth. is light in color, such as a light green, light yelloW, White or Processing Morinda cilrifolia Seeds translucent color. The fruit is inspected for spoilage or for [0043] Some Morinda cilrifolia compositions of the excessive green color and ?rmness. Spoiled and hard green present invention include seeds from the Morinda cilrifolia fruit is separated from the acceptable fruit. plant. In some embodiments of the present invention, Morinda cilrifolia seeds are processed by pulveriZing them [0038] The ripened and aged fruit is preferably placed in into a seed poWder in a laboratory mill. In some embodi plastic lined containers for further processing and transport. ments, the seed poWder is left untreated. In some embodi The containers of aged fruit can be held from 0 to 30 days, but ments, the seed poWder is further defatted by soaking and preferably the fruit containers are held for 7 to 14 days before stirring the poWder in hexaneipreferably for 1 hour at room processing. The containers can optionally be stored under temperature (Drug:Hexane-Ratio 1:10). The residue, in some refrigerated conditions prior to further processing. The fruit is embodiments, is then ?ltered under vacuum, defatted again unpacked from the storage containers and is processed (preferably for 30 minutes under the same conditions), and through a manual or mechanical separator. The seeds and peel ?ltered under vacuum again. The poWder may be kept over are separated from the juice and pulp. night in a fume hood in order to remove the residual hexane. [0039] The juice and pulp can be packaged into containers [0044] Still further, in some embodiments of the present for storage and transport. Alternatively, the juice and pulp can invention, the defatted and/ or untreated poWder is extracted, be immediately processed into a ?nished juice product. The preferably With ethanol 50% (m/m) for 24 hours at room containers can be stored in refrigerated, froZen, or room tem temperature at a drug solvent ratio of 1:2. perature conditions. The Morinda cilrifolia juice and pulp are Processing Morinda cilrifolia Oil preferably blended in a homogenous blend, after Which they [0045] Some embodiments of the present invention may may be mixed With other ingredients, such as ?avorings, comprise oil extracted from the Morinda Cilrifolia plant. The method for extracting and processing the oil is described in sWeeteners, nutritional ingredients, botanicals, and colorings. US. patent application Ser. No. 09/3 84,785, ?led on Aug. 27, The ?nished juice product is preferably heated and pasteur 1999 and issued as US. Pat. No. 6,214,351 onApr. 10, 2001, iZed at a minimum temperature of 181° F. (83° C.) or higher Which is incorporated by reference herein. The Morinda cil up to 212° F. (100° C.). Another product manufactured is rifolia oil typically includes a mixture of several different Morinda cilrifolia puree and puree juice, in either concentrate fatty acids as triglycerides, such as palmitic, stearic, oleic, and or diluted form. Puree is essentially the pulp separated from linoleic fatty acids, and other fatty acids present in lesser the seeds and is different than the fruit juice product described quantities. In addition, the oil preferably includes an antioxi herein. dant to inhibit spoilage of the oil. Conventional food grade [0040] The product is ?lled and sealed into a ?nal container antioxidants are preferably used. of plastic, glass, or another suitable material that can With stand the processing temperatures. The containers are main Iridoids tained at the ?lling temperature or may be cooled rapidly and [0046] Embodiments of the present invention comprise a then placed in a shipping container. The shipping containers source of iridoids compositions, each of Which include one or are preferably Wrapped With a material and in a manner to more processed plant or naturally occurring. Iridoids are a maintain or control the temperature of the product in the ?nal class of secondary metabolites found in a Wide variety of containers. plants and in some animals. Iridoids represent a large and still [0041] The juice and pulp may be further processed by expanding group of cyclopenta[c]pyran monoterpenoids separating the pulp from the juice through ?ltering equip found in a number of folk medicinal plants used as bitter ment. The ?ltering equipment preferably consists of, but is tonics, sedatives, hypotensives, antipyretics, cough medi not limited to, a centrifuge decanter, a screen ?lter With a siZe cines, remedies for Wounds and skin disorder. Typical struc from 1 micron up to 2000 microns, more preferably less than tural formulas for common iridoids are depicted in FIGS. 1 500 microns, a ?lter press, a reverse osmosis ?ltration device, and 2. There are at least three different types of Iridoids: and any other standard commercial ?ltration devices. The Glycosidic iridoids With a sugar molecule attach to the operating ?lter pressure preferably ranges from 0.1 psig up to monoterpene cyclic ring; Non-Glycosidic Iridoids Without a about 1000 psig. The How rate preferably ranges from 0.1 sugar molecule attach to the monoterpene cyclic ring; and g.p.m. up to 1000 g.p.m., and more preferably betWeen 5 and Secoiridoid iridoids knoWn for its bitterness and function as 50 g.p .m. The Wet pulp is Washed and ?ltered at least once and deterrence for herbivores but it is simply a class of Iridoids up to 10 times to remove any juice from the pulp. The result derived from deoxyloganic acid via oxidation to carboxyl at ing pulp extract typically has a ?ber content of 10 to 40 C11. percent by Weight. The resulting pulp extract is preferably [0047] The iridoid source may be selected from a variety of pasteuriZed at a temperature of 181° F. (83° C.) minimum and plant families and species including (referred to as “List A” then packed in drums for further processing or made into a beloW in the formulations section of this application): Scro high ?ber product. phylariaceae, Rubiaceae, Gentianaceae, Apocynaceae, [0042] The ?ltered juice and the Water from Washing the Adoxaceae, Lamiaceae, Bignoniaceae, Oleaceae, Verben Wet pulp are preferably mixed together. The ?ltered juice may aceae, Hydrangeaceae, Orobancaceae, Eucommiaceae, Scro be vacuum evaporated to a brix of 40 to 70 and a moisture of phulariaceae, Acanthaceae, Galium verum, Morinda of?ci 0.1 to 80 percent, more preferably from 25 to 75 percent. The nalis, Galium melanantherum, Pyrola calliatha, Radix resulting concentrated Morinda cilrifolia juice may or may Morindae, Pyrola xinjiangensis, Pyrola elliptica, Coussarea not be pasteuriZed. For example, the juice Would not be pas platyphylla, Craibiodendron henryi, Crotalaria emarginella, US 2011/0206787 A1 Aug. 25, 2011

Cranberry, Saprosma scortechinii, Galium rivale, Arbutus Stacbytarpbeta mutabilis, Penstemon strictus, Duranta andrachne, G. humifusum, G. paschale, G. mirum, G. mace plumeri, Sesamum angolense, Rebmannia glutinosa, Paren donicum, G. rhodopeum, G. aegeum, Galium aparine, Vac tucellia viscose, Melampyrum arvense, Gardenia jasmi cinium myrtillus, Vaccinium bracteatum, Bilberry, Blue noides, Randia Formosa, Oldenlandia diffusa, Castilleja inte berry, Olive, Morinda lucida, Lingonberries, Morinda gra, Eupbrasia rostkoviana, Fouquieria diguetii, Penstemon parvifolia, Saprosma scortechinii, Arbutus andrachne, Cor nitidus, Feretia apodantbera, Randia cantbioides, Asystasia nus Canadensis, Cornus suecica, Galium species, Liquidam bella, Viburnum urceolatum, Gentiana depressa, Syring a bar formasans, Arbutus andrachne, Rhododendron luteum, reticulate, DeutZia scabra, Eccremocarpus scaber, Cistanche Arbutus unedo, Subfamily Rubioideae, S. sagittatum, S. con salsa, Rebmannia glutinosa, Catalpa ovate, Myoporum volvulifolium, Arctostaphylos uva-ursi, Andromeda polifo deserti, Teucrium marum, Gelsemium sempervirens, Vibur lia, Tripetaleia paniculata, Asperula adorata, Randia canthio num urceolatum, Argylia radiate, Morinda lucida, Thunber ides, Tecomella undulate, Thunbergia alata, Thunbergia gia gandi?ora, Thunbergia alata, Thunbergia laurifolia, fragrans, MentZelia albescens, DeutZia scabra, Verbascum MentZelia cordifolia, Angelonia integerrima, Linaria gensti lychnitis, MentZelia linleyi, MentZelia lindleyi, MentZelia folia, Caryopteris mongholica, Linaria arcusangeli, Leonurus lindbeimerii, MentZelia involucrate, Randia canthioides, persicus, Tubebuia impetiginosa, Phyllarthron madagascar Lamiastrum galeobdolon, Teucrium bircanicum, Teucrium iense, Phsostegia virginiana, Harpagophytum procumbens, arduini, Betonica of?cinalis, Barleria prionitis, Harpagophy Caryopteris clandonensis, Cymbalaria muralis, Scrophularia tum procumbens, Ajuga decumbens, Anarrhinum orientale, buergeriana, Caryopteris mongholica, Caryopteris clandon Linaria clementei, Kickxia spuria, Veronicastrum sibiricum, ensis, Verbascum undulatum, Globularia dumulosa, Pedicu Physostegia virginiana, Betonica of?cinalis, Clerodendrum laris artselaeri, Utricularia vulgaris, Pedicularis chinensis, thomsonae, Rebmannia glutinosa, Aj uga reptans, Rebmannia Verbascum phlomoides, Plantago subulata, Clerodendrum glutinosa, Penstemon nemorosus, Capraria bi?ora, Rogeria inerme, Scrophularia lepidota, Globularia davisiana, Globu adenophylla, Ajuga spectabilis, Avecennia o?icinalis, Plan laria cordifolia, Holmskioldia sanguine, Gmelina philippen tago asiatica, Vitex negundo, Penstemon cardWellii, Tecoma sis, Scrophularia nodosa, PicrorhiZa kurroa, Gmelina cbrysantha, Odontites verna, Verbascum sinuatum, Verbas arborea, Penstemon neWberryi, Asystasia intrusa, Catalpa cum nigrum, Verbascum laxum, Buddleja globosa, Vitex fructus, Scrophularia scorodonia, Premna subscandens, Cat agnuscastus, Penstemon eriantberus, Vitex rotundifolia, alpa ovate, Verbascum spinosum, Scrophularia auriculata, Euphrasia rostkoviana, Tecoma beptaphylla, Plantago media, Scrophularia lepidota, Veronica hederifolia, Tabebuia impe Castilleja Wightii, Rebmannia glutinosa, Tecoma bepta tiginosa, Veronica pectinata var. glandulosa, Baleria strigosa, phylla, Castilleja rbexifolia, Utricularia australis, Verbascum Pedicularis procera, Crescentia cujete, Thunbergia grandi saccatum, Verbascum sinuatum, Verbascum georgicum, ?ora, Thunbergia laurifolia, Viburnum suspensum, Pedicu Premna odorata, Premana japonica, Verbascum pulverulen laris kansuensis, Nepeta Cilicia, Euphrasia pectinata, Penste tum, Scrophularia scopolii, Scropbularia ningpoensis, mon parryi, Penstemon barrettiae, Tecoma capensis, Veronica o?icinalis, Besseya plantaginea, Veronicastrum Pedicularis plicata, Vitex altissima, Veronica anagallis sibiricum, Catalpa speciosa, Tabebuia rosea, PicrorbiZa kur aquatica, Clerodendrum ineinie, Vitex agnus-castus, Dipsa rooa, Veronica bellidioides, Penstemon nemorosus, Globu cus asperoides, Chioccoca alba, Alangium lamarckii, Cornus laria alypum, Pinguicula vulgaris, Globularia Arabica, Anti capitata, Strychnos nuX-vomica, Alangium platanifolia var. rrbinum orontium, RetZia capensis, Pbaulopsis imbricate, trilobum, Gentiana linearis, SWertia franchetiana, Picconia Macfadyena cynancboides, PauloWnia tomentosa, Asystasia excels, Clerodendrum inerme, Verbenoxylum reitZii, Leonu bella, Rebmannia glutinosa, Erantbemum pulcbellum, rus persicus, Avicennia germinans, Canthium berberidifo Hygropbila difformis, Boscbniakia rossica, Linaria cymbal lium, Clerodendrum inerme, Avicennia of?cinalis, Lippia aria, Satureja vulgaris, Lamium amplexicaule, Viburnum graveolens, Ajuga pseudoiva, Barleria lupulina, Calycophyl betulifolium, Viburnum bupebense, Tecoma stans, Plantago lum spruceanum, Phlomis capitata, Phlomis nissolii, Premna arenaria, Campsidium valdivianum, Campsis chinensis, barbata, Plantago alpine, Avicennia marina, Galium humi Tecoma capensis, Penstemon pinifolius, Eupbrasia salisbur fusum, Morinda coreia, Saprosma scortechinii, Plantago gensis, Clerodendrum incisum, Clerodendrum incisum, Cle atrata, P. maritime, P. subulata, Erinus alpines, Paederia scan rodendrum ugandense, Lamourouxia multi?da, Nepeta dens, Tocoyena Formosa, Fagraea blumei, Hedyotis chrysot cataria, Argylia radiate, Linaria cymbalaria, Monocbasma richa, Paederia scandens, J asmium hemsleyi, Eucnide barto savatieri, Veronica anagallis-aquatica, Avicennia of?nalis, nioides, RauWol?a serpentine, Picconi, excels, Gentiana Avicennia marina, Gentian, pedicellata, Alangium platanifo kurroo, Nepeta cadmea, Gmelina philippensis, Penstemon lium, Lonicera coerulea, SWertica japonica, Melampyrum mucronatus, Citharexylum caudatum, Phlomis aurea, Eremo cristatum, Monochasma savatieri, Vitex negundo, Avicennia stachys glabra, Phlomis rigida, P. tuberose, Pedicularis pli marina, Tarenna graveolens, Argylia radiate, Veronica ana cata, Duranta erecta, Bouchea ?uminensis, Phlomis brun gallis-aquatica, Castilleja integra, Galium verum, Arbutus neogaleata, Barleria lupulina, ZaluZianskya capensis, unedo, Galium mollugo, Andromeda polifolia, Gelsemium Thevetia peruviana, Plantago lagopus, Gardenoside (and its sempervirens, Verbena brasiliensis, Gelsemium sempervi acid hydrolysis product), Asperuloside (and its acid hydroly rens, Randia dumetorum, Penstemon barbatus, Odontites sis product), Canthium schimperianum, Plantago arbore vema, Gentiana verna, Erytbraea centaurium, Gentiana scens, P. ovate, P. Webbii, Plantago cornuti, Plantago hook pyrenaica, Desfontainia spinosa, Lonicera periclymenum, eriana, Plantago altissima, Penstemon secudi?orus, Strycbnos roborans, Pedicularis palustris, Penstemon nitidus, Viburnum luZonicum, Galium lovcense, Nyetanthes arbor Citbarexylum fruticosum, Fouquieria diguetii, Nyctantbes tristis, Rothmania macrophylla, Myxopyrun smilacifolium, arbortristis, Mussaenda, Besseya plantaginea, Stacbytarpbeta Nepeta racemosa, Linaria japonica, Viburnum ayavacense, jamaicensis, Cantbium subcordatum, Barleria lupulina, Bar Viburnum tinus, Viburnum rhytidophyllum, Vibumum lan leria prionitis, Plectronia odorata, Salvia digitaloides, tana var. discolor, Viburnum prunifolium, Centranthus longi US 2011/0206787 A1 Aug. 25, 2011

?orus,V1bumum sargenti, Plumeria obtuse, Dunnia sinensis, designed to improve the health of living organisms such as Morinda morindoides, Caryopteris clandonensis, Vitex human beings or mammals, including nutraceutical prod rotundifolia, Globularia dumulosa, Pedicularis artselaeri, ucts). Cymbaria mongolica, Pedicularis kansuensis f. albi?ora, [0051] In some embodiments various extracts may be uti Phlomis umbrosa, Dunnia sinensis, Gelsemium sempervi liZed from one or more of the plants listed above. In some rens, Verbena littoralis, Syringia afghanica, Tabebuia impe embodiments the extracts may comprise 7b-Acetoxy-10-O tiginosa, Patrinia scabra, Catalpa fructus, Scrophularia lepi -acetyl-8a-hydroxydecapetaloside (Compound 2),10-Ac dota, Lasianthus Wallichii, Crescentia cujete, Kickxia elatine, etoxymajoroside, 7-O-Acetyl-10-O-acetoxyloganin, 6-O K. spuria, K. commutate, Linaria arcusangeli, L. ?ava, Acetylajugol, 6-O(2_-O-Acetyl-3_-O-cinnamoyl-4_-O-p Coelospermum billardieri, Randia spinosa, Asperula maxi methoxy cinnamoyl-a-Lrhamnopyranosyl) catalpol, 6-O moWicZii, Wulfenia carinthiaca, Fagraea blumei, Daph (3_-O-Acetyl-2_-O-trans-cinnamoyl)-a-L-rhamnopyranosyl niphyllum calycinum, Penstemon ricbardsonii, Nardostachys catalpol, 8-O-Acetylclandonoside, 8-O-Acetyl-6-O-(p-cou chinensis, Sambucus ebulus, Penstemon confertus, Sambu maroyl)harpagide, 8-O-Acetyl-6-O-trans-p-coumaroylshan cus ebulus, Penstemon serrulatus, Penstemon birsutus, Vibur Zhiside, 6-Acetyl deacetylasperuloside, 8-O-Acetyl-1-epi num furcatum, Viburnum betulifolium, Vibumum japoni shanZhigenin methyl ester, Acetylgaertneroside, 10-O cum, Allamanda neriifolia, Plumeria acutifolia, Allamanda Acetylgeniposidic acid, 10-O-Acetyl-8a catbartica, Alstonia boonei, Actinidia polygama, Patrinia vil hydroxydecapetaloside, 8-O-Acetyl-6b-hydroxyipolamide, losa, Patrinia gibbosa, Posoqueria latifolia, Strycbnos spi 2-O-Acetyllamiridoside, 3-O-Acetylloganic acid, 4-O nosa, Kigelia pinnata, Centrantbus ruber, Cerbera mangbas, Acetylloganic acid, 6-O-Acetylloganic acid, 6b-Acetyl-7b MentZelia spp., Teucrium marum, Eucommia ulmoides, (E) -p -methoxycinnamoyl-myxopyro side, 6b -Ac etyl -7b - Aucuba japonica, Gelsemium sempervirens, Syring a amu (Z) -p -methoxycinnamoyl-myxopyro side, 1 O-O rensis, Strychnos spinosa, Lonicera alpigena, Nauclea dider Acetylmonotropein, 8-O-Acetylmussaeno side, 10-O Acetylpatrino side, 3 -O-Acetylpatrino side, 6-O richii, Olea europaea, Ligustrum japonicum, SWertia Acetylplumieride-p -E-coumarate, 6-O-Acetylplumieride-p japonica, SWertia mileensis, Crucksbanksia verticillata, Gen Z-coumarate, 6-O-Acetylscandoside, 8-O tiana asclepiadea, Jasminum multi?orum, Menyantbes trifo AcetylshanZhigenin methyl ester, 8-O-AcetylshanZhiside, liate, Jasminum mesnyi, Jasminum aZoricum, Jasminum Acuminatuside, Agnucastoside A (6-O-Foliamenthoylmus sambac, Centaurium erythraea, Centaurium littorale, Genti saenosidic acid), Agnucastoside B (6-O-(6,7-Dihydrofoliam ana gelida, Gentiana scabra, Jasmium burnile var. revolutum, enthoyl)-mussaenosidic acid), Agnucastoside C (7-O-trans Syring a vulgaris, Osmantbus ilicifolius, Ligustrum ovalifo p-Coumaroyl-6-O-trans-caffeoyl-8-epi-loganic acid), lium, Ligustrum obtusifolium, Gentiana pyrenaica, Isertia Alatoside, Alboside I, Alboside II, Alboside III, Alpinoside, baenkeana, Olea europaea, Osmantbus fragrans, Exacum tet Angeloside, 6-O-b-D-Apiofuranosylmussaenosidic acid, ragonum, Hydrangea macrophylla, Hydrangea scandens, 2-O-Apiosylgardoside, Aquaticoside A (6-O-BenZoyl-8-epi Abelia grandi?ora, Dipsacus laciniatus, Scaevola racemig loganic acid), Aquaticoside B (6-O-p-HydroxybenZoyl-8 era, Erytbraea centaurium, Lisiantbus jefensis, Alyxia rein epi-log-anic acid), Aquaticoside C (6-O-BenZoylgardoside), Wardtii, Desfontainia spinosa, Patrinia saniculaefolia, Plan Arborescoside, Arborescosidic acid, Arborside D, Arcusan tago asiatica, Plantago species, Gentiana species, geloside, Artselaenin A, Artselaenin C, Artselaenin B, Aspe Hapagophytum species, Pterocephalus perennis subsp. ruloide A, Asperuloide B, Asperuloide C, Asperulosidic acid Perennis, Morinda citrifolia, Campsis grandi?ora, Hera ethyl ester, 6-O-a-L-(2-O-BenZoyl,3-O-trans-p-coumaroyl) cleum rapula, Syring a dilatata , Bartsia alpine, Hedyotis rhamnopyranosylcatalpol, 10-O-BenZoyldeacetylasperulo diffusa, Sickingia Williamsii, Buddleja cordobensis, Borreria sidic acid, 6-O-BenZoyl-8-epi-loganic acid, 6-O-BenZoylgar Verticillata and combinations thereof. doside, 10-O-Benzoylglobularigenin, 10-Bisfoliamenthoyl catalpol, Blumeoside A Blumeoside B, Blumeoside C, [0048] Some embodiments may utilize an iridoid source Blumeoside D, Boucheoside, Brunneogaleatoside, 3b-Bu from any of the parts of the listed plants plant alone, in toxy-3,4-dihydroaucubin, 6-O-Butylaucubin, 6-O-Butyl combination With each other or in combination With other epi-aucubin, 6-O-Caffeoylajugol, 10-O-Caffeoylaucubin, ingredients. For example the leaves including leaf extracts, 6-O-trans-Caffeoylcaryoptosidic acid, 10-O-trans-p-Caf fruit, bark, seeds including seed oil, roots, oils, juice includ feoylcatalpol, 10-O-E-Caffeoylgeniposidic acid, 2-Caffeoyl ing the fruit juice and fruit pulp and concentrates thereof, or mussaenosidic acid, 6-O-trans-Caffeoylnegundoside, Cary other product from the list of plants may be utiliZed as an optosidic acid, Caudatoside A, Caudatoside B, Caudatoside iridoid source. Thus, While some of the parts of the plants are C, Caudatoside D, Caudatoside E, Caudatoside F, Chlorotu not mentioned above, some embodiments may use of one or beroside, 10-O-(Cinnamoyl)-6-(desacetyl-alpinosidyl)cat more parts selected from all of the parts of the plant. alpol, 10-O-E-Cinnamoylgeniposidic acid, 8-O-Cinnamoyl [0049] Some compositions of the present invention com mussaenosidic acid, 8-Cinnamoylmyoporoside, prise a source of iridoids present betWeen about 1 and 5 7b-Cinnamoyloxyugandoside (Serratoside A), 7-O-trans-p percent of the Weight of the total composition. Other such Coumaroyl-6-O-trans-caffeoyl-8-epi-loganic acid, 6-O-a-L percentage ranges include: about 0.01 and 0.1 percent; about (2-O-trans-Cinnamoyl)-rhamnopyranosylcatalpol, 6-O-a-L 0.1 and 50 percent; about 85 and 99 percent; about 5 and 10 (3-O-trans-Cinnamoyl)-rhamnopyranosylcatalpol, 6-O-a-L percent; about 10 and 15 percent; about 15 and 20 percent; (4-O-trans-Cinnamoyl)-rhamnopyranosylcatalpol, about 20 and 50 percent; and about 50 and 100 percent. Citrifolinin A, Citrifolinoside A, Clandonensine, Clandono [0050] In some embodiments the source of iridoids may be side, Clandonoside II, Coelobillardin, 6-O-trans-p-Couma combined With other ingredients or carriers (discussed further royl-8-O-acetylshanZhiside methyl ester, 6-O-cis-p-Couma herein) to produce a pharmaceutical grade source of iridoids royl-8-O-acetylshanZhiside methyl ester, 6-O-(p (“pharmaceutical” herein referring to any drug or product Coumaroyl)antirrinoside, 10-O-cis-p

US 2011/0206787 A1 Aug. 25, 2011

cinnamoylharpagide, 6-O-E-p-Methoxycinnamoylhar cholactone, 3-0-AllosylcerberidoI, 3-O-Allosylcyclocerberi pagide, 1b-Methoxy-4-epi-gardendiol, 1b-Methoxy-4-epi dol, 3-0-Allosylepoxycerbeeridol, Alpigenoside, Amarogen mussaenin A, 1a-MethoXy-4-epi-mussaenin A, tin, AmarosWerin, 6'-O-Apiosylebuloside m, AZoricin, 3, Methoxygaertneroside, lb-Methoxygardendiol, 4-Methoxy IO-Bis-O-allosylcerberidol, Boonein, 13-0-Caffeoylplurni Z-globularimin, 4-MethoXy-Z-globularinin, 4-MethoXy-E eride, Centauroside, Cerberic acid, Cerberidol, Cerberinic globularimin, 4-MethoXy-E-globularinin, 6-O-[3-O-(trans acid, Cerbinal, Confertoside, 4'-O-cis-p-Cournaroyl-7a-rnor p-MethoXycinnamoyl)-a -L-rhamnopyranosyl]-aucubin, ronisi, 4'-O-truns-p-Coumaroyl-7a-morronisi, 4'-O-cis-p lb-Methoxylmussaenin A, 6-O-Methyl-epi-aucubin, Cournaroyl-7P-rnorronisi, 4'-O-truns-p-Coumaroyl-7-mor Muralioside (7b-Hydroxyharpagide), Myxopyroside, ronisi, 13-O-Coumaroylplumieride, Cyclocerberidol, Nepetacilicioside, Nepetanudoside, Nepetanudoside B, Decentapicrin A, kentapicrin B, Decentapicrin C, Deglucos Nepetanudoside C, Nepetanudoside D, Nepetaracemoside A, errulatoside, Deglucosyl plumieride, Dehydroiridodialo-P Nepetaracemoside B, Ningpogenin (revision of 1-dehy D-gentiobioside, Dehydroiridomyrmecin, 5,6-Dehydrojasr droXy-3,4-dihydroaucubingenin), Of?cinosidic acid (5-Hy ninin, Demethyloleuropein, 1 -Deoxyeucomrniol, droxy-10-O-(p-methoxycinnamoyl)-adoxosidic acid), 9'-hxyjasminigenin, 10-Deoxyptrinoside, 10-Deoxyptrino Ovatic acid methyl ester-7-046-O-p-HydroXybenZoye-b -D side aglycone, 10-Deoxypensternide, 13-Deoxyplumieride, glucopyranoside, OVatolactone-7-O-(6-O-p-hydroxyben Desacetylcentapicrin, Desfontainic acid, Desfontainoside, Zoyl)-b-D-glucopyranoside, 7-Oxocarpensioside, Paederos 2',3'-O-Diacetyl?1rcatoside C, 8,9-Didehydro-7-hydroxy candoside, Paederosidic acid methyl ester, Patrinioside, dolichodial, Diderroside, 7,7-O-Dihydroebuloside, Dihydr Pedicularis-lactone, Phlomiside, Phlomoidoside (6-O-(4-O cepinepetalactone, Dihydrofoliamenthin, 8.9-Dihydrojasrni p-Coumaroyl-b-D-Xylopyranosyl)-aucubin), Phlomurin, nin, Dihydropensternide, P-Dihydroplurnericinic acid Phlorigidoside A (2-O-Acetyllamiridoside), Phlorigidoside glucosyl ester, Dihydroserruloside, Dolichodial, Dolicholac B (8-O-Acetyl-6b-hydroxyipolamide), Phlorigidoside C tone, Ebuloside, 8-epi-Dihydropensternide, 7-epi-Hy (5-Deoxysesamoside), Picconioside 1, Picroside IV, Picro drangenoside A, 7-epi-Hydrangenoside C, 7-epi-Hy side V (6-m-MethoXybenZoylcatalpol), Pikuroside, Plicato drangenoside E, 8-epi-Kingiside, 8-epi-Valerosidate, 7-rpt side A, Plicatoside B, Premnaodoroside D, Premnaodoroside Vogeloside, Epoxycerberidol, 1 l-Ethoxyviburtinal, E, Premnaodoroside F [isomeric mixture of A and B in ratio Eucommioside 1, Eucommioside II, Fliederoside 1,2'-O-Fo (1:1)], Premnaodoroside G (isomeric mixture of (C) and (D)), liarnenthoyldihydropensternide, Furcatoside A, Furcatoside Premnosidic acid, Proceroside (7-Oxocarpensioside), Randi B, Furcatoside C, Gelidoside I, Gelsemiol, Gelsemiol-l-glu noside, SaletpangponosideA [6-O-(4-O-b-Glucopyranosyl) coside, Gelsemiol-3-glucoside, Gentiogenal, Gentiopicral, trans-p-coumaroyl-8-O-acetylshanZhiside methyl ester], Gentiopicroside, 7-O-Gentiroylsecologanol, Gibboside, Saletpangponoside B, Saletpangponoside C, Sammangao G'-O-~-~-Glucosylgentiopicrosid, (7iR)-Haenkeanoside I, side C (Melittoside 3-O-b-glucopyranoside), Saprosmoside (7S)-Haenkeanoside I, Hiiragilide, Hydrangenoside A A, Saprosmoside B, Saprosmoside C, Saprosmoside D, Hydrangenoside B, Hydrangenoside C, Hydrangenoside D, Saprosmoside E, Saprosmoside F, Saprosmoside G, Sapros Hydrangmoside E, Hydrangenoside F, Hydrangenoside G, moside H, Scorodioside (6-O-(3-O-Acetyl-2_-O-trans-cin 9"-Hydroxyasmesoside, 9"-Hydroxyjasmesosldic acid, namoyl)-a-L-rhamnopyranosyl catalpol), Scrolepidoside, (7R)-IO-Hydroxymorroniside, (7s)-IO-Hydroxymorroni Scrophuloside A1, Scrophuloside A2, Scrophuloside A3, side, 10-Hydroxyoleoside dimethyl ester, IO-Hydroxyoleu Scrophuloside A4, Scrophuloside A5, Scrophuloside A6, ropein, Ibotalactone A, Ibotalactone B, Iridodialo-P-D-gen Scrophuloside A7, Scrophuloside A8, Scrophuloside B4 tiobioside, Lsoactinidialactone, lsoallamandicin, [6-O-(2_-O-Acetyl-3_-O-cinnamoyl-4_-O-p-methoxy cin lsodehydroiridomyrmecin, Isodihydroepinepetalacton, namoyl-a-L rhamnopyranosyl)catalpol], Scrovalentinoside, Isodolichodial, Isoepiiridomyrmecin, (7R)-lsohaenkeano Senburiside III, Senburiside IV, Serratoside A, Serratoside B, side, (7S)-lsohaenkeanoside, Lsoligustroside, isoneonepeta ShanZhigenin methyl ester, 6-O-Sinapoyl scandoside methyl lactone, IsonueZhenide, Lsooleuropein, 8-lsoplumieride, ester, Sintenoside, Stegioside I, Stegioside II, Stegioside III, IsosWeroside, Jasrnesoside, Jasminin-10"-O-glucoside, Jas Syringafghanoside, 7,10,2,6-Tetra-O-acetylisosuspensolide minoside, Jasmisnyiroside, Jasmolactone A, Jasmolactone B, F, 7,10,2,3-Tetra-O-acetylisosuspensolide F, 7,10,2i,3_ Jasmolactone B dimethylare, Jasmolactone C, Jasmolactone Tetra-O-acetylsuspensolide F, Ihunaloside, 7,10,2-Tri-O D, Jasmolactone D tetramethylare, Jasmoside, Jiofuran, Jio acetylpatrinoside, 7,10, Z-Tri-O-acetylsuspensolide F, 6-O glutolide, Kingiside aglycone, Laciniatoside V, Latifonin, a-L-(2-O-,3-O-,4-O-TribenZoyl)-rhamnopyranosylcatalpol, Ligustaloside A, Ligusraloside B, Ligusraloside B dimethyl 6-O-(3i,4i,5_-TrimethoxybenZoyl)ajugol, Unbuloside acetal, Ligustrosidic acid, Ligustrosidic acid methyl ester, (6-O-[(2 -O-trans -Feruloyl) -a-L-rhamnopyrano syl] -aucu Lilacoside, Lisianthoside, Menthiafolin, MentZerriol, bin), Urphoside A, Urphoside B, Verbaspinoside (6-O-[(2_ 7a-MethoXysWeroside, 3-0-Methylallamancin, 3-0-Mrthyla O-trans-Cinnamoyl)-a -L-rhamnopyrano syl] -catalpol), llamcin, Methyl glucooleoside, Methylgrandi?oroside, Viburtinoside I, Viburtinoside II, Viburtinoside III, Viburti (7R)-O -Methylhaenkeanoside, (7S)-O-Methylhaenkeano noside IV, Viburtinoside V, Viteoid I, Viteoid II, Wulfenoside side, (7R)-O-Methylisohaenkeanosidel, (7S)-O-Mrthyliso [(10-O-(Cinnamoylalpinosidyl)-6-(desacetyl-alpinosidyl) haenkranoside, (7R)-O-Methylmorronisidr, (7S)-O-Methyl catalpol)], Yopaaoside A, Yopaaoside B, Yopaaoside C, morroniside, Methyl syramuraldehydate, 6'-O-[(2R) ZaluZioside (6b-Hydroxygardoside methyl ester), Abelioside Methyl-3-Veratroyloxypropanoyl, 6'-0-[(2R)-MethyI-3 A, AbeliosideA dimethyl acetal, Abelioside B, 10-Acetoxyo veratroyloxypropanoyl, 7a-Morroniside, 7P-Morroniside, leuropein, 2'-O -Acetyldihydropenstemide, 2'-O-Acetyl Nardosrachin, NeonueZhenide, Neooleuropein, 4aa,7a,7a patrinoside, 13-0-Acetylplumieride, 7-O-Acetylsecologa Nepetalactone, 4aa, 7a, 7a P-Nepetalactone, 4ap, 70,7a nol, 2'-O-AcetylsWert~amain1, 10-O-Acetylviburnalloside, P-Nepetalactone, Nepetariasidc, Nepetaside, Norviburtinal, Actinidialactone, Allamancin I, Allarncidin A, Allarncidin B, Oleoactcosidr, 7a-morroniside, 7P-morronisidr, Olebechina Allamcidin B P-c-glucose, Allamcin, Allaneroside, Allodoli coside, OlmnueZhenide, Oleoside dimethyl ester, Oleu US 2011/0206787 A1 Aug. 25, 2011

ropeinic acid, Oleuropeinic acid methyl ester, Oleuroside, [0054] Preferred embodiments are formulated to provide a OruWacin, Oxysporone, Patrinalloside, Penstebioside, Pen physiological bene?t. For example, some embodiments may stemide aglycone, Plumenoside, Plumiepoxide, la-Plum provide an anti-in?ammatory activity selectively inhibit ieride, Plumieride coumarare, Plumieride coumarate gluco COX-l/COX-2 and/or by regulating regulate TNFB, Nitric side, Plumieridine, Posoquenin, la-Protoplumericin A, oxide and S-LOX; regulate immunomodulation by increases Protoplumericin A, Protoplumericin B, Pulorarioside, IFN- Q secretion; provide antiallergic activity by inhibiting Rehmaglutin, Sambacin, Sambacolignoside, SambacosideA, histamine release; provide anti-arthritic activity by inhibiting Sambacoside E, Sambacoside F, Scabraside, Scaevoloside, human neutrophils, regulating elastase enzyme activity, Secologanin dimethyl acetal, Secologanol, Secologanoside, inhibiting the complement pathWay; provide antimicrobial Secologanoside dimethyl ester, Secoxyloganin, Serrulatolo activity by inhibiting the groWth of various microbials includ ing gram — and gram + bacteria; providing antifungal activity side, Serrulatoloside aglycon, Serrulatoside, Serruloside, by inhibiting DNA repair systems; provide anticancer activity Stryspinolactone, Suspensolide A, Suspensolide A aglycone, by inhibiting cancer cell groWth and by being cytotoxic to Suspensolide B, Suspensolide C, SWertiamarin, Syringalac cancer cells; provide anticoagulant activity by inhibiting tonr A, Syringalactonr B, 6'-0-Vanilloyl-8-ept-kingiside, platelets aggregations; provide antioxidant activity by pro Vibumalloside, Villosol, Villosoloside, Adoxoside, Agnu viding DPPH scavenging effects; provide antiviral activity side, Allarnnmdin, Allamdin, Amaropentin, Antirride, Anti including anti-HSV, anti-RSV, and anti-VSV activity; pro rrinoside, Asperuloside, Asperulosidic acid, Aucubin, Aucu vide antispasmodic activity; provide Wound-healing activity bin Acetate, Aucuboside, Aucubieenin-l-P-i~onialtopidc, by stimulating the groWth of human dermal ?broblasts; and Haldrinal, Darlerin, Dartsioeide, Iloschnalosiile, Cantleyo provide neuroprotective activities by blocking the release of side, Caryoptoeide, Catalpol, CatalpolYonoacetate, Catalpo lactate dehydrogenase (LDH), and enhancing Nerve GroWth side, Centapicrin, 7-Chlorodeutziol, Comin, Uaphylloslde, Factor-potentiating (NGF) activity. Deacetyl-Asperuloside, Decaloside, Decapetaloside, 5-9 [0055] Methods of the present invention also include manu Dehydro-nepetalactcne, Deoxl-amaropentin, l0-Deoxy facturing a composition comprising an iridoid source and/or Aucubin, Deoxyloeanin, Deutziol, Didrovaltrate, Dihydrofo extracts. Each of the methods described above in the discus liamenthin, Dihydropenstemide, Dihydroplumericin, 8-Di sion relevant to processing the Morinda citrifolia plant prod hydro Plumericinic acid, Durantoride-I, Elenolide, Epoxyde ucts may likeWise be utilized to process the constitutive ele culoside, Erythroccntaurine, IO-Ethylapodanthoside, ments of plant being utilized as a source of iridoids. Eucommiol, Eustomoruside, Eustomoside, Eustoside, Fere [0056] For example the leaves of one or more of the plants toside, Foliamenthin, Forsythide, Forsythide Methyl Ester, listed above may be processed. For example, some composi llethyl Grandiiloroside, ll-llethyl Isoside, Lllneroeide, tions comprise leaf extract and/or leaf juice. Some composi Jlioporoeide, 3lononielittoeirle, 3l6notropein, Monotro tions comprise a leaf serum that is comprised of both leaf nein, Jlorroniside, 3luesaenoside, Saucledd, Seomatatabiol, extract and fruit juice obtained from one or more plants. Some Sepetalactcne, Suzhenide, Jdontoride, Odontosidc Aretate, I compositions of the present invention comprise leaf serum Jleuropein, Opulus Iridoid, Opului lridoid, Onin-arin, 7-Clx and/or various leaf extracts as incorporated into a nutraceu ologanin, I’aederoelde, I’nederoaidic, I’atrinoside, tical product (“nutraceutical” herein referring to any product I’lumericin, Lieptoside, Sarracenin, Scabroside, Scandoside, designed to improve the health of living organisms such as Scandoride, Srrophularioride, Cutellariosid, ecoealioside, human beings or mammals). Secologanir, Secolopanin, Ecoivloeanin, Shanzhiside llethyl [0057] In some embodiments of the present invention, the Ester, Specioside, Stilberiecside, Strictoside, Sn-eroside l, leaf extracts are obtained using the folloWing process. First, SWertiamnrin, S-lvestroside-I, yl-estroside-II, Svl-estroside relatively dry leaves from the selected plant or plants are III, Svrineoside, TLretnoeide, Tecomoside, Tecoside, Teu collected, cut into small pieces, and placed into a crushing crium, Teucriuni Lactone B, Teucrium Lactone C, Teucriuni deviceipreferably a hydraulic pressiWhere the leaf pieces Lactone D, Vaccinioside, Valechlorine, Valeridine, Valerosi are crushed. In some embodiments, the crushed leaf pieces date and Taltrate, Haqnlpol. are then percolated With an alcohol such as ethanol, methanol, [0052] Methods of the present invention comprise the ethyl acetate, or other alcohol-based derivatives using meth administration and/or consumption of a combination of a ods knoWn in the art. Next, in some embodiments, the alcohol processed Morinda citrifolia product and a source of iridoids and all alcohol-soluble ingredients are extracted from the in an amount designed to produce a desirable physiological crushed leaf pieces, leaving a leaf extract that is then reduced response. It Will be understood that speci?c dosage levels of With heat to remove all the liquid therefrom. The resulting dry any compositions that Will be administered to any particular leaf extract Will herein be referred to as the “primary leaf patient Will depend upon a variety of factors, including the extract.” patient’s age, body Weight, general health, gender, diet, time [0058] In some embodiments, the primary leaf extract is of administration, route of administration, rate of excretion, subsequently pasteurized. The primary leaf extract may be drug combination, and the severity of the particular diseases pasteurized preferably at a temperature ranging from 70 to 80 undergoing therapy or in the process of incubation. degrees Celsius and for a period of time su?icient to destroy [0053] Studies performed have revealed that Iridoids in any objectionable organisms Without major chemical alter combination With a processed Morinda citrifolia product ation of the extract. Pasteurization may also be accomplished exhibit unexpected synergistic bioactivity including; neuro according to various radiation techniques or methods. protective, anti-tumor, anti-in?ammatory, anti-oxidant, car [0059] In some embodiments of the present invention, the diovascular, anti-hepatotoxic, choleretic, hypoglycemic, pasteurized primary leaf extract is placed into a centrifuge hypolipidemic, antispasmodic, antiviral, antimicrobial, decanter Where it is centrifuged to remove or separate any immunomodulator, antiallergic, anti-leishmanial, and mol remaining leaf juice therein from other materials, including luscicidal effect. chlorophyll. Once the centrifuge cycle is completed, the leaf US 2011/0206787 A1 Aug. 25, 2011

extract is in a relatively puri?ed state. This puri?ed leaf ?avoring, other natural juices or juice concentrates such as a extract is then pasteurized again in a similar manner as dis natural grape juice concentrate or a natural blueberry juice cussed above to obtain a puri?ed primary leaf extract. concentrate; carrier ingredients; and others as Will be further [0060] Preferably, the primary leaf extract, Whether pas explained herein. teuriZed and/or puri?ed, is further fractionated into tWo indi [0067] Any compositions having the leaf extract from the vidual fractions: a dry hexane fraction, and an aqueous plant or plants being utiliZed a as source of iridoids and the methanol fraction. This is accomplished preferably in a gas Morinda cilrifolia leaves, may comprise one or more of the chromatograph containing silicon dioxide and CH2Cl2 folloWing: the primary leaf extract, the hexane fraction, MeOH ingredients using methods Well knoWn in the art. In methanol fraction, the secondary hexane and methanol frac some embodiments of the present invention, the methanol tions, the leaf serum, or the nutraceutical leaf product. fraction is further fractionated to obtain secondary methanol [0068] In some embodiments of the present invention, fractions. In some embodiments, the hexane fraction is fur active ingredients from the plant or plants being utiliZed as a ther fractionated to obtain secondary hexane fractions. source of iridoids and the Morinda cilrifolia plant may be [0061] One or more of the leaf extracts, including the pri extracted out using various procedures and processes. For mary leaf extract, the hexane fraction, methanol fraction, or instance, the active ingredients may be isolated and extracted any of the secondary hexane or methanol fractions may be out using alcohol or alcohol-based solutions, such as metha combined With the processed Morinda cilrifolia product to nol, ethanol, and ethyl acetate, and other alcohol-based obtain a leaf serum. In some embodiments, the leaf serum is derivatives using methods knoWn in the art. These active packaged and froZen ready for shipment; in others, it is fur ingredients or compounds may be isolated and further frac ther incorporated into a nutraceutical product as explained tioned or separated from one another into their constituent herein. parts. Preferably, the compounds are separated or fractioned [0062] Some embodiments of the present invention include to identify and isolate any active ingredients that might help to a composition comprising fruit juice from one or more of the prevent disease, enhance health, or perform other similar listed plants. Each of the methods described above in the functions. In addition, the compounds may be fractioned or discussion relevant to processing the Morinda cilrifolia juice separated into their constituent parts to identify and isolate products may likeWise be utiliZed to process the fruit of the any critical or dependent interactions that might provide the plant being utiliZed as a source of iridoids. same health-bene?ting functions just mentioned. [0063] Some embodiments comprise the use of seeds from [0069] Any components and compositions of Morinda cil the list of plants provided. Each of the methods described rifolia and/or ingredients from the plant or plants being uti above in the discussion relevant to processing seeds from the liZed as a source of iridoids may be further incorporated into Morinda cilrifolia plant may likeWise be utiliZed to process a nutraceutical product (again, “nutraceutical” herein refer the seeds of plant being utiliZed as a source of iridoids. ring to any product designed to improve the health of living [0064] Some embodiments of the present invention may organisms). Examples of nutraceutical products may include, comprise oil extracted from the plant and/ or plants selected as but are not limited to: topical products, oral compositions and the source of iridoids. Each of the methods described above in various other products as may be further discussed herein. the discussion relevant to processing the Morinda cilrifolia [0070] Oral compositions may take the form of, for plant to produce an oil extract may likeWise be utiliZed to example, tablets, loZenges, aqueous or oily suspensions, dis process the constitutive elements of plant being utiliZed as a persible poWders or granules, emulsions, syrups, or elixirs. source of iridoids. Such compositions may contain one or more agents such as sWeetening agents, ?avoring agents, coloring agents, and pre Compositions and Their Use serving agents. They may also contain one or more additional [0065] The present invention features compositions and ingredients such as vitamins and minerals, etc. Tablets may be methods for providing a desirable physiological effect. Sev manufactured to contain one or more Morinda cilrifolia com eral embodiments of the Morinda cilrifolia and iridoid com ponents and ingredient(s) from the plant or plants being uti positions comprise various different ingredients, each liZed as a source of iridoids in admixture With non-toxic, embodiment comprising one or more forms of a processed pharmaceutically acceptable excipients that are suitable for Morinda cilrifolia and a source of iridoids as explained the manufacture of tablets. These excipients may be, for herein. example, inert diluents, granulating and disintegrating [0066] Compositions of the present invention may com agents, binding agents, and lubricating agents. The tablets prise any of a number of Morinda cilrifolia components such may be uncoated or they may be coated by knoWn techniques as: extract from the leaves of Morinda cilrifolia, leaf hot to delay disintegration and absorption in the gastrointestinal Water extract, processed Morinda cilrifolia leaf ethanol tract and thereby provide sustained action over a longer extract, processed Morinda cilrifolia leaf steam distillation period. For example, a time delay material such as glyceryl extract, Morinda cilrifolia fruit juice, Morinda cilrifolia monostearate or glyceryl distearate may be used. extract, Morinda cilrlfolia dietary ?ber, Morinda cilrlfolia [0071] Aqueous suspensions may be manufactured to con puree juice, Morinda cilrifolia puree, Morinda cilrifolia fruit tain the Morinda cilrifolia components and ingredient(s) juice concentrate, Morinda cilrifolia puree juice concentrate, from the plant or plants being utiliZed as a source of iridoids freeZe concentrated Morinda cilrifolia fruit juice, Morinda in admixture With excipients suitable for the manufacture of cilrifolia seeds, Morinda cilrifolia seed extracts, extracts aqueous suspensions. Examples of such excipients include, taken from defatted Morinda cilrifolia seeds, and evaporated but are not limited to: suspending agents such as sodium concentration of Morinda cilrifolia fruit juice in combination carboxymethyl-cellulose, methylcellulose, hydroxy-propyl With a source of iridoids. Compositions of the present inven methycellulose, sodium alginate, polyvinyl-pyrrolidone, tion may also include various other ingredients. Examples of gum tragacanth and gum acacia; dispersing or Wetting agents other ingredients include, but are not limited to: arti?cial such as a naturally-occurring phosphatide like lecithin, or US 2011/0206787 A1 Aug. 25, 2011

condensation products of an alkylene oxide With fatty acids amount by Weight betWeen about 0.1 -80 percent; a processed such as polyoxyethylene stearate, or condensation products source of iridoids present in an amount by Weight betWeen of ethylene oxide With long chain aliphatic alcohols such as about 01-20 percent; and a carrier medium present in an heptadecaethylene-oxycetanol, or condensation products of amount by Weight betWeen about 20-90 percent. ethylene oxide With partial esters derived from fatty acids and [0078] The processed Morinda cilrifolia product and/or a hexitol such as polyoxyethylene sorbitor monooleate, or processed source of iridoids is the active ingredient or con condensation products of ethylene oxide With partial esters tains one or more active ingredients, such as quercetin, rutin, derived from fatty acids and hexitol anhydrides such as poly scopoletin, octoanoic acid, potassium, vitamin C, terpenoids, ethylene sorbitan monooleate. alkaloids, anthraquinones (such as nordamnacanthal, morin [0072] Typical sweetening agents may include, but are not done, rubiandin, B-sitosterol, carotene, vitamin A, ?avone limited to: natural sugars derived from corn, sugar beets, glycosides, linoleic acid, AliZarin, amino acides, acubin, sugar cane, potatoes, tapioca, or other starch-containing L-asperuloside, caproic acid, caprylic acid, ursolic acid, and sources that can be chemically or enZymatically converted to a putative proxeronine and others. Active ingredients may be crystalline chunks, poWders, and/or syrups. Also, sWeeteners extracted utiliZing aqueous or organic solvents including can comprise arti?cial or high-intensity sWeeteners, some of various alcohol or alcohol-based solutions, such as methanol, Which may include aspartame, sucralose, stevia, saccharin, ethanol, and ethyl acetate, and other alcohol-based deriva etc. The concentration of sWeeteners may be betWeen from 0 tives using any knoWn process in the art. The active iridoid to 50 percent by Weight of the composition, and more pref ingredients and/ or quercetin and rutin may be present in erably betWeen about 1 and 5 percent by Weight. amounts by Weight ranging from 0.01-10 percent of the total [0073] Typical ?avoring agents can include, but are not formulation or composition. These amounts may be concen limited to, arti?cial and/or natural ?avoring ingredients that trated as Well into a more potent concentration in Which they contribute to palatability. The concentration of ?avors may are present in amounts ranging from 10 to 100 percent. range, for example, from 0 to 15 percent by Weight of the [0079] The composition comprising Morinda cilrifolia and composition. Coloring agents may include food-grade arti? a source of iridoids may be manufactured for oral consump cial or natural coloring agents having a concentration ranging tion. It may contain one or more agents selected from the from 0 to 10 percent by Weight of the composition. group consisting of sWeetening agents, ?avoring agents, col [0074] Typical nutritional ingredients may include vita oring agents, preserving agents, and other medicinal agents as mins, minerals, trace elements, herbs, botanical extracts, bio directed. active chemicals, and compounds at concentrations from 0 to [0080] The folloWing compositions or formulations repre 10 percent by Weight of the composition. Examples of vita sent some of the preferred embodiments contemplated by the mins include, but are not limited to, vitamins A, B1 through present invention. B12, C, D, E, Folic Acid, Pantothenic Acid, Biotin, etc. Examples of minerals and trace elements include, but are not Formulation One limited to, calcium, chromium, copper, cobalt, boron, mag [0081] nesium, iron, selenium, manganese, molybdenum, potas sium, iodine, Zinc, phosphorus, etc. Herbs and botanical extracts may include, but are not limited to, alfalfa grass, bee pollen, chlorella poWder, Dong Quai poWder, Echinacea root, % Range Ingredient Gingko Biloba extract, Horsetail herb, Indian mulberry, shi 30-90 Puri?ed Water take mushroom, spirulina seaWeed, grape seed extract, etc. 1.0-60 Noni Fruit Juice Typical bioactive chemicals may include, but are not limited 0.5-30 Grape Juice Concentrate to, caffeine, ephedrine, L-carnitine, creatine, lycopene, etc. 0.5-30 Blueberry Juice Concentrate 0.01-3 Olive Leaf Extract [0075] The ingredients to be utiliZed in a topical dermal 0 1-35 Plant’s Extract from ListA product may include any that are safe for intemaliZing into the body of a mammal and may exist in various forms, such as gels, lotions, creams, ointments, etc., each comprising one or more carrier agents. Formulation TWo [0076] In one exemplary embodiment, a composition of the [0082] present invention comprises one or more of a processed Morinda cilrifolia component present in an amount by Weight betWeen about 0.01 and 100 percent by Weight, and prefer ably betWeen 0.01 and 95 percent by Weight in combination % Range Ingredients With a processed iridoid source present in an amount by 40-80 Puri?ed Water Weight betWeen about 0.01 and 100 percent by Weight, and 1.0-50 Noni Fruit Juice preferably betWeen 0.01 and 95 percent by Weight. Several 0.5-30 Apple Juice Concentrate embodiments of formulations are included in Us. Pat. No. 0.5-25 Mango Juice Concentrate 6,214,351, issued on Apr. 10, 2001, Which are herein incor 0.5-20 Passion Fruit Juice Concentrate 0.001-1 0 Natural Flavor porated by reference. HoWever, these compositions are only 0.001-1 0 Natural Color intended to be exemplary, as one ordinarily skilled in the art 0.001-1 0 Oligofructose Will recogniZe other formulations or compositions compris 0.001-1 0 Fructose ing the processed Morinda cilrifolia product. 0.001 -1 0 Konjac/Xanthan Gum 0.001-1.0 Vegetable Protein Isolate [0077] In another exemplary embodiment, the internal 0 1-35 Plant’s Extract from ListA composition comprises the ingredients of: processed Morinda cilrifolia fruit juice or puree juice present in an US 2011/0206787 A1 Aug. 25, 2011 12

Formulation Three [0083] -continued % Range Ingredient

0.001-1.0 Natural Color % Range B Version Ingredients 0.001-1.0 Oligofructose 0.001-1.0 Fructose 1.0-90 1.0-50 Puri?ed Water 0.001-1.0 Konjac/Xanthan Gurn 1.0-90 1.0-50 Noni Fruit Juice 0.001-1.0 Vegetable Protein Isolate 05-50 05-50 Noni LeafTea

Formulation Eight Formulation Four [0088] [0084]

% Range Ingredient % Range Ingredient 50-100% Morinda cimfolia fruit nectar from pure noni puree from 1.0-90 Puri?ed Water French Polynesia 10.-50 Noni Fruit Juice 3-3 0% Natural Grape Juice Concentrate 0.5-50 Noni LeafTea 3-30% Natural Blueberry Juice Concentrate 0.1-35 Plants Extract from List A 0-15% J/zris vinzfera (White Grape) Juice Concentrate 0-5% Natural Flavors 0-15% OZea europaea (Olive) Leaf Extract 0-15% Vaccinium macrocarpum (Cranberry) Juice Concentrate Formulation Five 0-15% Gurn Arabic* 0-15% Xanthan Gurn* [0085] *sorne sizes exclude these ingredients

% Range Ingredient Formulation Nine 40- 80 Puri?ed Water 1.0-50 Noni Fruit Juice [0089] 0.5-35 Grape Juice Concentrate 0.5-35 Concord Grape Juice Concentrate 0.001-2 Natural Grape Type Flavor 0.001-3 Konjac/Xanthan Gurn % Range Ingredient 0.1-35 Plant’s Extract from List A 50-100% Morinda cimfolia Fruit Nectar From Pure Noni Puree From French Polynesia 10-75% J/zris Zabrusca (Concord Grape) Juice Concentrate Formulation Six 5-50% J/zris vinzfera (White Grape) Juice Concentrate 0-15% Gurn Arabic* [0086] 0-15% Xanthan Gurn* 0-5% Natural Flavor

*sorne sizes exclude these ingredients % Range Ingredient

1.0-90 Puri?ed Water Formulation Ten 1.0-90 Noni Fruit Juice 0.5-60 Grape Juice Concentrate [0090] 0.5-90 Concord Grape Juice Concentrate 0.001-2 Natural Grape Type Flavor 0.001-3 0.001-1.0 % Range Ingredient

10-75% Morinda cimfolia Fruit Nectar From Pure Noni Puree From Formulation Seven French Polynesia 10-75% MaZus pumila (Apple) Juice Concentrate [0087] 5-50% Mangzfera indica (Mango) Juice Concentrate 3-30% Passz?ora eduZis (Passionfruit) Juice Concentrate 0-5% Natural Flavor 0-15% Natural Color or Concentrates (apple, cherry, radish, sWeet % Range Ingredient potato) 0-15% Gurn Arabic* 1.0-90 Puri?ed Water 0-15% Xanthan Gurn* 1.0-9 Noni Fruit Juice 0- 15% Oligofructose 0.5-60 Apple Juice Concentrate 0-15% Fructose 0.5-60 Mango Juice Concentrate 0-15% Vegetable Protein Isolate 0.5-60 Passion Fruit Juice Concentrate 0.001 - 1 .0 Natural Flavor *sorne sizes exclude these ingredients US 2011/0206787 A1 Aug. 25, 2011 13

Formulation Eleven Formulation Fifteen

[0091] [0095]

% Range Ingredient % Range Ingredient 50-95% Water (Aqua/Eau) 50-l00% Morinda cimfolia (Noni) Fruit Puree 0-1 5% Polymethylsilsesquioxane 10-75% Morinda cimfolia (Noni) Leaf Tea 0-20% Glycerin 0-20% Propanediol 0-20% Cyclopentasiloxane 0-20% Cyclotetrasiloxane Formulation TWelve 0-20% Caprylic/Capric Triglyceride 0-20% Sodium Polyacrylate 0-20% Dimethicone [0092] 0-1 5% Hydrogenated Polydecene 0-1 5% Butylene Glycol 0-1 5% Cyclohexasiloxane 0-1 5% Phenoxyethanol % Range Ingredient 0-l5% Morinda cimfolia (Noni) Leaf Juice 0-1 5% PEG/PPG- 14/4 Dimethicone 50-l00% Morinda cimfolia Fruit Nectar From Pure Noni Puree From 0-1 5% Dimethiconol French Polynesia 0-l5% Avena sariva (Oat) Kernel Extract 3-30% Natural Grape Juice Concentrate 0-l5% Tropaeolum majus Flower Extract 3-30% Natural Blueberry Juice Concentrate 0-l5% Morinda cimfolia (Noni) Seed Oil 0-5% Natural Flavors 0-1 5% Caprylyl Glycol 0-l5% Gum Arabic* 0-1 5% Aminomethyl Propanol 0- l5% Xanthan Gum* 0-l5% Sodium PCA 0-1 5% Ethylhexylglycerin *some sizes exclude these ingredients 0-1 5% Panthenol 0-5% Trideceth-6 0-5% Hexylene Glycol Formulation Thirteen 0-5% Tetrasodium EDTA 0-5% Fragrance (P?I‘?Lll'H) 0-5% Carbomer [0093] 0-5% Polysorbate 20 0-5% Sodium Hyaluronate 0-5% Methylparaben 0-5% Ethylparaben 0-5% Propylparaben % Range Ingredient 0-5% Butylparaben 0-5% Isobutylparaben 35-90% Morinda cimfolia (Noni) Fruit Nectar from Pure Noni Puree 0-5% Vegetable Oil and from Juice Concentrate from French Polynesia 0-5% Tocopherol 15-60% Camus mas (Cornelian Cherry) Puree 0-5% Palmitoyl Oligopeptide 5-50% Camus o?icinalis Reconstituted Juice 0-5% Palmitoyl Tetrapeptide-7 5-50% J/zris vinzfera (White Grape) Juice Concentrate 0-5% Phospholipids 5-50% Vaccinium corymbosum (Blueberry) Juice from Concentrate 0-5% Rosmarinus oj?cinalis (Rosemary) Leaf Extract 0-l5% Przmus cerasus (Red Sour Cherry) Juice Concentrate 0-5% Tocopheryl Acetate 0-l5% J/zris Zabrusca (Concord Grape) Juice Concentrate 0-5% Retinyl Palmitate 0-5% Natural Flavor 0-5% Ascorbyl Palmitate 0-l5% OZea europea (Olive) Leaf Extract 0-5% Quaternium- 15 0-l5% Vaccinium macrocarpum (Cranberry) Juice Conc. 0-5% EDTA *some sizes exclude these ingredients

Formulation Sixteen Formulation Fourteen [0096] [0094]

% Range Ingredient % Range Ingredient 50-95% Water (Aqua/Eau) 35-90% Morinda cimfolia Fruit Nectar From Pure Noni Puree From 3-30% Aloe barbadensis Leaf Juice French Polynesia 0- l 5% Caprylic/Capric Triglyceride 5-50% J/zlis vinzfera (White Grape) Juice Concentrate 0-l5% Sinorhizobium meZiZori Ferment Filtrate 3-30% MaZus domesrica (Apple) Juice Concentrate 0- l 5% Propanediol 0-l5% Ribes nigrum (Black Currant) Juice Concentrate 0-l5% Carlhamus rinclorius (Saf?oWer) Seed Oil 0-l5% J/zlis Zabrusca (Concord Grape) Juice Concentrate 0-l5% Prunus armeniaca (Apricot) Kernel Oil 0-l5% Vaccinium corymbosum (Blueberry) Juice Concentrate 0- l 5% Glycerin 0-5% Natural Flavors 0- l 5% Cetyl Alcohol 0-l5% Rubus idaeus (Red Raspberry) Juice Concentrate 0-l5% Morinda cimfolia (Noni) Fruit Juice 0-5% Glyceryl Stearate 0-5% PEG-100 Stearate