₂liquid ginger extract has the equivalent amount of active compounds contained in tens of kilograms of fresh ginger.

On the other hand, the methods, compositions, and formulations described in this disclosure are also surprisingly well tolerated (see the following Examples; no tester reported the onset of any uncomfortable side effects) and they provide high concentrations of the active ginger compounds. For example, 2 grams of a composition produced according to the methods described herein contain an amount of active ginger compounds equivalent to those found in about 3.6 kilograms of fresh ginger, which would be impossible for a human to tolerate and consume from a regular diet.

The method described in this disclosure for improving bioaccesibility, solubility, and/or bioavailability of ginger extracts comprises providing an extract of ginger and mixing a source of lithium with the ginger extract thereby producing a water-soluble form of ginger extract. For purposes of the doctrine of equivalents, manufacturing or usage for the purposes described herein using a single or a mixture of water insoluble ginger active compounds shall be considered as equivalent to manufacturing or using the water-soluble ginger extract.

In a preferred embodiment, the source of ginger is total CO₂liquid ginger extract. This form of ginger that has not been yet utilized in the supplement industry but contains a much more diverse number of actives at much higher concentrations than common extracts found is the market such as the ethanolic extract. As can be seen difference in the number of peaks between FIGS. 3A and 3B, the variety of active compounds in the ginger alcoholic extract (representative of common ginger extracts found in the market) is much lower compared to total CO₂liquid ginger extract (albeit after reaction with a source of lithium).

It should also be noted that the methods described herein could be applied to produce water-soluble formulations of any isolated ginger compound, such as gingerol or shogaol.

The source of lithium may be selected from the group consisting of: metallic lithium, lithium hydroxide, and lithium hydride. None of metallic lithium, lithium hydroxide, and lithium hydride exist in nature; they are man-made chemicals.

One could theorize that metallic lithium, lithium hydroxide, and lithium hydride could be substituted for a lithium salt that is readily water soluble and result in an alkaline pH in solution (for example, salts of lithium with a weak acids like lithium citrate). Salts formed from a strong base and a weak acid are alkaline because when dissolved in water, the anion from the weak acid readily accepts a proton from water, generating hydroxide ions (OH⁻) and making the solution basic. Essentially, the weak acid part of the salt undergoes hydrolysis, producing more OH⁻ than H⁺, leading to an alkaline solution. In the exemplary case of lithium citrate, the citrate ion will readily react with water when in an aqueous solution to form unionized citric acid and hydroxide ions (OH⁻). For purposes of doctrine of equivalence, this would result in a similar alkaline solution comprising lithium and hydroxide ions. However as shown in Example 9, the use of lithium citrate, lithium lactate, or lithium ascorbate as the source of lithium did not result in any appreciable difference in solubility of the ginger extract. This may be to stereochemical blocking of the ginger compounds chemical moieties that interact with lithium. However, adding to the solution of lithium acid salt and ginger an excess of lithium (as Li, LiOH or LiH₂) results in the formation of a soluble complex. It is contemplated that removal of the anions from a lithium salt solution (such as with an ion exchange membrane or chemical conversion of the anion to a neutral or basic compound—for example nitrate to ammonia) will result in the formation of soluble complexes.

The weight ratio of the source of lithium and the extract of ginger mixed together is between 1:100 and 100:1, between 1:50 and 50:1, between 1:20 and 20 to 1, or between 1:10 and 10:1. In some implementations, the source of lithium and the extract of ginger is mixed with minimal amount of water—sufficient to achieve a saturated lithium hydroxide solution until a homogenous solution forms. The homogenous solution comprises the extract of ginger and the reacted form of the source of lithium and is usually colored orange to red.

For the preparation of softgels and capsules, the method further comprises diluting the homogenous solution with an additive to minimize the concentration of water so that the structure of gelatin needed for the softgel or capsule formulation is not disrupted. One method to reduce the water content would be to vacuum dry the water-soluble ginger extract until all water is removed. This results in the formation of a very sticky semisolid compound (FIG. 8). This compound is also water soluble albeit with a lower dissolution rate. In some aspects, the total concentration of water in the homogenous solution after dilution with the additive is less than 20%, less than 15%, less than 10%, or less than 5% by volume. The resulting solution is a water-soluble form of ginger extract. Components of the ginger extract and lithium ions can be detected and measured in the water-soluble form of ginger extract.

Preferably only a minimal amount of the source of lithium is mixed with the extract of ginger to provide water solubility to the ginger extract. Even more preferably, the amount of lithium is the minimal amount required to create a fully water-soluble ginger extract. In some aspects, for creating a fully dissolvable in water ginger extract, the weight ratio of the lithium element to the extract of ginger ranges from about 1:6000 to about 1:1, preferably about 1:600 to about 1:10, more preferably about 1:300 to about 1:20, even more preferably about 1:200 to about 1:40, still more preferably about 1:100 to about 1:50.

The resulting water-soluble form of ginger extract is at least partially soluble in water. For example, the solubility of the water-soluble form of ginger extract in water is at least about 1 mg/L or at least about 10 mg/L.

The disclosure also relates to compositions comprising an extract of ginger and a source of lithium, wherein the composition is a water-soluble form of ginger extract. It is of particular interest that the peak observed at 1255 nm in FIG. 3B, which denotes the presence of a phenolic ester, is not present in the FTIR of total CO₂liquid ginger extract before reaction with the source of lithium. This is surprising, as alkaline compounds such as lithium hydroxide are known to break down ester bonds instead of facilitating the formation. Thus, the reaction of total CO₂liquid ginger extract with the source of lithium yields new compounds. It is contemplated that these new compounds are esters of the phenolic compounds with gallic and cinnamic acid, which are naturally present in ginger. Thus, in some aspects, the composition comprises an ester of the phenolic compounds in ginger extract with gallic, vanillic, and cinnamic acid. For example, the composition comprises at least one of gingerol cinammate, gingerol gallate, gingerol vanillate, shogaol cinnamate, shogaol gallate, shogaol vanillate, paradol cinammate, paradol gallate, and paradol vanillate. FIGS. 9A-9F depict exemplary structures of some of the new compounds.

In some implementations, the composition further comprises one or more food or pharmaceutical additives. The additive is preferably a non-aqueous liquid, for example, a polyol, an alcohol, or an oil. In certain embodiments, the additive is propylene glycol, polyethylene glycol (for example PEG 400), glycerol, or ethanol.

The invention also contemplates formulations of said ginger solution with other ingredients that may synergistically work to treat any of the ginger treatable conditions.

Ingredients that may be included into ginger formulations to enhance its effects include but are not limited to1,3-DMAA; 1-androsterone; 1-epiandrosterone; 1,3-DMBA; 1,4-butanediol; 1,4-DMAA; 4-androsterone; 5-deca zol; 5-HTP; 5aOHP; 6-bromo-androstenedione; 7-methoxyflavone; 7,8-benzoflavone; abscess root; abuta; Acacia rigidula; acai; acerola; acetyl-L-carnitine or a salt, ester, or amide suitable for human ingestion thereof; ackee; aconite; activated charcoal; active hexose correlated compound (AHCC); adenosine; adrafinil; adrenal extract; adrue; aegeline; African wild potato; agar; agaricus mushroom; agave; agmatine or a salt, ester, or amide suitable for human ingestion thereof; agrimony; Ajuga nipponensis; alanine (including beta-alanine) or a salt, ester, or amide suitable for human ingestion thereof; Albizia julibrissin; Alchemilla; alder buckthorn; Aletris; alfalfa; algal oil; algin; alkanna; allspice; aloe; alpha lipoic acid; alpha-GPC; alpha-ketoglutarate (AKG); alpha-linolenic Acid (ALA); alpha-lipoic acid; alpine ragwort; Alpinia, amaranth; ambrette; American adder's tongue; American chestnut; American dogwood; American elder; American ginseng; American hellebore; American ivy; American mistletoe; American pawpaw; American spikenard; American white water lily; andarine; andiroba; Andrographis; androstenediol; androstenedione; androstenetrione; androsterone; Angel's Trumpet; Angelica archangelica; angostura; anhydrous crystalline maltose; aniracetam; anise; annatto; antineoplastons; antioxidants; apoaequorin; apple; apple cider vinegar; apple polyphenols; apricot; apricot kernel; arabinoxylan; arecoline; arenaria rubra; arimistane; Aristolochia; arnica; arrach; arrowroot; arsenic; Artemisia herba-alba, artichoke; arum; asafoetida; asarabacca; Ascophyllum nodosum; ascorbigen; ash; ashitaba; ashwagandha; Asian water plantain; asparagus (for example, Asparagus racemosus); aspartic acid or a salt, ester, or amide suitable for human ingestion thereof; aspen; astaxanthin; astragalus; Atlantic cedar; atractylodes; autumn crocus; avens; avocado; avocado soy unsaponifiables (ASU); avocado sugar extract; ayahuasca; ba ji tian; babassu; bach flower remedies; Bacillus coagulans; Bacopa monnieri; bael; Baikal skullcap; bamboo; banaba; banana; baobab; barley; basil; bay leaf; bayberry; bear's garlic; bee pollen; bee venom; beer; beeswax; beet; belladonna; benfotiamine; benzoin; berberine; bergamot; beta-carotene; beta-cryptoxanthin; beta-glucans; beta-hydroxybutyrate (BHB); beta-methylphenethylamine (BMPEA); beta-sitosterol; betaine anhydrous; betaine hydrochloride; betel nut; beth root; betony; Bifidobacterium animalis subsp. Lactis; Bifidobacterium bifidum; Bifidobacterium breve; Bifidobacterium longum; bilberry; biotin; birch; bishop's weed; bismuth; bismuth nitrate; bistort; bitter almond; bitter melon; bitter milkwort; bitter orange; bitter yam; bittersweet nightshade; black alder; black bryony; black cohosh; black currant; black haw; black hellebore; black hoof mushroom; black horehound; black mulberry; black mustard; black nightshade; black pepper; black psyllium; black raspberry; black rice; black root; black seed; black tea; black walnut; blackberry; blackthorn; blessed thistle; blond psyllium; bloodroot; blue cohosh; blue flag; blue-green algae; blueberry; bog bilberry; bog labrador tea; bogbean; bois de rose oil; boldo; boneset; borage; boron; Boswellia serrata; bovine cartilage; bovine colostrum; boxwood; branched-chain amino acids (BCAA); breadfruit; brewer's yeast; Brickellia, Bridelia, broccoli; broccoli sprout; bromelain; brown rice; brussels sprout; bryonia; buchu; buck's-horn plantain; buckhorn plantain; buckwheat; bugle; bugleweed; Bulbine natalensis; bulbous buttercup; Bupleurum; burdock; burning bush; burr marigold; butcher's broom; Butea superba; butterbur; buttercup; butternut; butylated hydroxytoluene (BHT); cabbage; cade; caffeic acid; caffeine; cajeput oil; calabar bean; calabash chalk; calamint; calamus; calanus oil; calcium; calcium d-glucarate; Calea zacatechichi; calendula; California poppy; Calotropis; calumba; camphor; camu camu; Canada balsam; Canadian fleabane; Canadian hemp; canaigre; cananga oil; cannabichromene (CBC); cannabidiol (CBD); cannabidivarin (CBDV); cannabigerol (CBG); cannabinol (CBN); cannabis; canola oil; canthaxanthin; capers; caprylic acid; capsicum; Caralluma; caraway; Carbon 60 (C60); cardamom; cardarine; carlina; carnitine or a salt, ester, or amide suitable for human ingestion thereof; carnosine or a salt, ester, or amide suitable for human ingestion thereof; carob; carqueja; carrageenan; carrot; cascara sagrada; cascarilla; casein peptide or protein; cashew; cassava; Cassia auriculata; Cassia cinnamon; Cassia nomame; cassie absolute; castor bean; castoreum; cat's claw; cat's foot; catechu; catnip; catuaba; cauliflower; Celastris paniculatus; celery; centaury; centrophenoxine; Cereus; cesium; cetylated fatty acids (CFAs); Ceylon cinnamon; Ceylon leadwort; cha de bugre; chaga; chanca Piedra; chaparral; chaulmoogra; cheken; chelation therapy products; chenopodium oil; chervil; chia; chickweed; chicory; Chinese cucumber; Chinese mallow; Chinese prickly ash; chirata; chitosan; chive; Chlorella; chlorine dioxide; chlorophyll; chlorophyllin; chokeberry; choline or a salt, ester, or amide suitable for human ingestion thereof, chondroitin sulfate; chromium; chrysanthemum; chrysin; chuchuhuasi; chymotrypsin; cilantro; cinchona; Cissus quadrangularis; Cistanche deserticola, citicoline; citric acid; citronella oil; clary sage; clay; Clematis recta; Clitoria ternatea; clivers; clove; clown's mustard plant; clubmoss; Cnidium; cobalt; coca; cocillana; cocoa; coconut; coconut oil; coconut water; cod liver oil; Codonopsis; coenzyme Q10; coffee; coffee charcoal; cola nut; Coleus; collagen type I (native) or type II (native) or peptides thereof; collard; colloidal minerals (for example, colloidal silver); colocynth; coltsfoot; columbine; coluracetam; Combretum micranthum; comfrey; common stonecrop; condurango; conjugated linoleic acid (CLA); Convolvulus pluricaulis; copaiba balsam; copper; coral; cordyceps; coriander; corkwood tree; corn poppy; corn silk; cornflower; Corydalis yanhusuo; costus; cotton; couch grass; cowhage; cowslip; cramp bark; cranberry; creatine or a salt, ester, or amide suitable for human ingestion thereof; croton seeds; cubebs; cucumber; cudweed; cumin; cursed buttercup; cyanostane; cyclamen; cypress; D-mannose; daffodil; damiana; dandelion; danshen; date palm; Datura wrightii; deanol; deer velvet; delta-8-tetrahydrocannabinol (Delta-8-THC); delta-9-tetrahydrocannabinol (THC); Dendrobium; desert parsley; devil's claw; devil's club; DHEA (for example, 19-nor-DHEA, 7-alpha-hydroxy-DHEA, 7-beta-hydroxy-DHEA, and 7-keto-DHEA); diacylglycerol; diatomaceous earth; diindolylmethane; diiodothyronine; dill; dimethylethanolamine (DMAE); dimethylglycine (DMG); dimethylhexylamine (DMHA); dimethylsulfoxide (DMSO); diosmin; divi-divi; docosahexaenoic acid (DHA); dodder; dolomite; dong quai; douglas fir; dragon fruit; dragon's blood; duckweed; dulse; durabolin; durian; dusty miller; dwarf elder; dwarf pine needle; dyer's broom; dymethazine; eastern hemlock; eastern red cedar; ecdysteroids; Echinacea; ecklonia cava; eicosapentaenoic acid (EPA); elderberry; elderflower; elecampane; elemi; eleuthero; ellagic acid; elm bark; emu oil; English adder's tongue; English horsemint; English ivy; English walnut; ephedra; epiandrosterone; epistane; equol; ergot; ergothioneine; eryngo; eucalyptus; Euphorbia cyparissias; Euphorbia hirta; European barberry; European buckthorn; European chestnut; European five-finger Grass; European mandrake; European mistletoe; Eurycoma longifolia; evening primrose; Evodia; eyebright; Fadogia agrestis; false unicorn; fennel; fenugreek; fermented milk; fermented wheat germ extract; fever bark; feverfew; ficin; field scabious; fig; figwort; fir; fireweed; fish oil; flaxseed; flaxseed oil; fluoride; fly agaric mushroom; fo-ti; folic acid; fool's parsley; forget-me-not; forskolin; forsythia; foxglove; frankincense; fringetree; frostwort; fructo-oligosaccharides (FOS); Fucus vesiculosus; fulvic acid; fumitory; galacto-oligosaccharides (GOS); galbanum; Galphimia glauca, gamboge; gamma butyrolactone (GBL); gamma-aminobutyric acid (GABA); gamma-hydroxybutyrate (GHB); gamma-linolenic acid (GLA); gamma-oryzanol; Garcinia, garden cress; gardenia; garlic; gelatin; Gelsemium; genistein combined polysaccharide; gentian; German chamomile; German ipecac; German sarsaparilla; germander; germanium; ginger; Ginkgo biloba, ginseng; globe flower; globemallow; glossy privet; glucomannan; glucosamine; glucuronolactone; glutathione; glutaurine; glycerol; glycine or a salt, ester, or amide suitable for human ingestion thereof; glycolic acid; glycomacropeptide; glyconutrients; goa powder; goat's rue; goji; golden ragwort; goldenrod; goldenseal; goldthread; gossypol; gotu kola; goutweed; grains of paradise; grape; grapefruit; gravel root; graviola; great plantain; greater burnet; greater celandine; Greek sage; green coffee; green tea; Griffonia simplicifolia; ground ivy; ground pine; groundsel; guaiac wood; guar gum; guarana; guarumo; guava; guggul; gum Arabic; gumweed; gymnema; halodrol-50; haronga; hartstongue; Hawaiian baby woodrose; hawthorn; hazelnut; heart's ease; heather; hedge mustard; hedge-hyssop; hemlock; hemlock water dropwort; hemp; hemp agrimony; hemp nettle; henbane; henna; herb Paris; herb Robert; Hercules club; hesperidin; hexadrone; hexylamine; Hibiscus sabdariffa; higenamine; histidine; holly; hollyhock; holy basil; homotaurine; honey; honeysuckle; hoodia; hops; hordenine; horny goat weed; horse chestnut; horsemint; horseradish; horsetail; hound's tongue; houseleek; hu zhang; humic acid; huperzine A; hyacinth bean; hyaluronic acid; hydrangea; hydrazine sulfate; hydroxymethylbutyrate (HMB); hyperimmune egg; hyssop; iboga; Iceland moss; idebenone; Ignatius bean; immortelle; Indian cassia; Indian gooseberry; Indian long pepper; Indian snakeroot; indigo pulchra; indium; indole-3-carbinol; inosine; inositol; inositol nicotinate; inulin; iodine; ip-6; ipecac; iporuru; ipriflavone; iron; Irvingia gabonensis; isatis; isopropylnorsynephrine; ivy gourd; jaborandi; jackfruit; jalap; Jamaican dogwood; jambolan; Japanese apricot; Japanese mint; Japanese persimmon; jasmine; java tea; Javanese turmeric; jequirity; jewelweed; jiaogulan; jimson weed; job's tears; jojoba; juniper; Justicia pectoralis; synthetic marijuana (for example, K2 or Spice); kale; kamala; kanna; kaolin; karaya gum; kava kava; kefir; ketogenic diet; khat; khella; kinetin; kiwi; knotweed; kohlrabi; kombucha; Korean pine; kousso; kratom; krill oil; kudzu; L-arginine or a salt, ester, or amide suitable for human ingestion thereof; L-carnitine or a salt, ester, or amide suitable for human ingestion thereof; L-citrulline or a salt, ester, or amide suitable for human ingestion thereof; L-cysteine or a salt, ester, or amide suitable for human ingestion thereof; L-glutamine or a salt, ester, or amide suitable for human ingestion thereof; L-ornithine or a salt, ester, or amide suitable for human ingestion thereof; L-aspartate or a salt, ester, or amide suitable for human ingestion thereof; L-phenylalanine or a salt, ester, or amide suitable for human ingestion thereof; L-theanine or a salt, ester, or amide suitable for human ingestion thereof; L-tryptophan or a salt, ester, or amide suitable for human ingestion thereof; L-tyrosine or a salt, ester, or amide suitable for human ingestion thereof; labdanum; laburnum; lactase; lactic acid; Lacticaseibacillus casei; Lacticaseibacillus paracasei; Lacticaseibacillus rhamnosus; Lactiplantibacillus pentosus; Lactiplantibacillus plantarum; Lactobacillus acidophilus; Lactobacillus crispatus; Lactobacillus delbrueckii; Lactobacillus gasseri; Lactobacillus helveticus; Lactobacillus jensenii; Lactobacillus johnsonii; lactoferrin; lady's bedstraw; laminaria; larch arabinogalactan; larch turpentine; lathyrus; Latilactobacillus sakei; laurelwood; lauric acid; lavender; lavender cotton; laxogenin; lecithin or a salt, ester, or amide suitable for human ingestion thereof; lemon; lemon balm; lemon eucalyptus; lemon verbena; lemongrass; lentinan; lesser celandine; levant berry; Levilactobacillus brevis; licorice; ligandrol; Ligilactobacillus salivarius; lily-of-the-valley; lime; limonene; Limosilactobacillus fermentum; Limosilactobacillus reuteri; linden; lingonberry; lion's mane mushroom; lipase; lithium; liver extract; liverwort; lobelia; logwood; Lorenzo's oil; lotus; lousewort; lovage; luffa; lunasin; lungmoss; lungwort; lupin; lutein; lychee; lycopene; lysine; m1-4add; maca; macadamia nut; mace; Madagascar periwinkle; madder; magnesium; magnolia; maidenhair fern; maitake mushroom; Malabar nut; male fern; malic acid; mallow; manaca; Manchurian thorn; manganese; mangosteen; manna; maqui; maral root; maritime pine; marjoram; marsh blazing star; marsh labrador tea; marsh marigold; marshmallow; masterwort; mastic; meadowsweet; medium chain triglycerides (MCTs); melanotan; melatonin; mentabolan; mercury herb; mesoglycan; methasterone; methionine; methoxydienone; methoxylated flavones; methyldiazinol; methylstenbolone; methylsulfonylmethane (MSM); methylsynephrine; mezereon; milk thistle; miracle fruit; molybdenum; moneywort; monolaurin; monterey pine; moringa; mormon tea; motherwort; mountain ash; mountain flax; mountain laurel; mouse-ear hawkweed; mugwort; muira puama; mullein; musk; myrcia; myrrh; myrtle; n-acetyl cysteine (NAC) or a salt, ester, or amide suitable for human ingestion thereof; N-acetyl-L-tyrosine or a salt, ester, or amide suitable for human ingestion thereof; N-methyltyramine; N,N-DMPEA; NADH; nasturtium; nattokinase; neem; nefiracetam; nerve root; New Jersey tea; New Zealand green-lipped mussel; niacin or a salt, ester, or amide suitable for human ingestion thereof; niacinamide; niauli oil; nickel; nicotinamide riboside; nicotine; nikko maple; noni; noopept; northern prickly ash; Norway spruce; nutmeg; nux vomica; oak moss; oats; oatstraw; octacosanol; octopamine; oleander; oleic acid; olive; olive oil; omega-6 fatty acids; onion; oolong tea; orchic extract; oregano; Oregon grape; oriental arborvitae; ornamental marigold; ornithine; ornithine ketoglutarate (OKG); orris; Oscillococcinum®; osha; ostarine; ostrich fern; oswego tea; ox-eye daisy; oxiracetam; padang cassia; pagoda tree; palm oil; palmitoylethanolamide (PEA); Panax ginseng; Panax notoginseng; pancreatic enzyme products; pangamic acid; pantethine; pantothenic acid or a salt, ester, or amide suitable for human ingestion thereof; pao pereira; papain; papaya; para-aminobenzoic acid (PABA); pareira; parsley; parsley piert; parsnip; partridgeberry; passion flower; pata de vaca; patchouli oil; pau d′arco; pea protein; peanut oil; pear; pectin; pedunculate oak; pellitory; pellitory-of-the-wall; pennyroyal; peony; peppermint; perilla; perillyl alcohol; periwinkle; Peru balsam; peyote; Phaseolus vulgaris; pheasant's eye; Phellodendron; phenethylamine (PEA); phenibut; phenpromethamine; phenylalanine or a salt, ester, or amide a salt, ester, or amide suitable for human ingestion thereof; phenylpiracetam; phlorizin; phosphate salts; phosphatidylcholine; phosphatidylserine; phytase; picamilon; Picrorhiza; Pimpinella; pine bark extract; Pinellia ternata; pink root; pipsissewa; piracetam; pitcher plant; plant sterols; pleurisy root; plum; Podophyllum; Poinsettia; poison ivy; pokeweed; polarity therapy; policosanol; polydextrose; Polypodium leucotomos; pomegranate; poplar; poppy seed; poria mushroom; potassium; potato; Potentilla, pramiracetam; pregnenolone; premorse; prickly pear cactus; procaine; progesterone; proline or a salt, ester, or amide a salt, ester, or amide suitable for human ingestion thereof; propionyl-l-carnitine or a salt, ester, or amide suitable for human ingestion thereof; propolis; proteolytic enzymes (proteases); psilocybin; pterostilbene; pu-erh tea; Pulsatilla; pumpkin; purple loosestrife; purple nut sedge; pygeum; Pyrethrum; pyrroloquinoline quinone (PQQ); pyruvate; quassia; quebracho blanco; queen's delight; quercetin; quillaia; quince; quinoa; Rabdosia rubescens; radish; raspberry ketone; Rauvolfia vomitoria, rauwolscine; red clover; red maple; red raspberry; red sandalwood; red soapwort; red yeast rice; red-spur valerian; reduced nicotinamide adenine dinucleotide (NADH); reed herb; Rehmannia; reishi mushroom; resveratrol; rhatany; Rhodiola; Rhodiola rosea; rhubarb; riboflavin; ribose; rice bran; rice bran arabinoxylan compound; rice protein, RNA, and DNA; rock rose; Roman chamomile; rooibos; rose geranium oil; rose hip; rosemary; royal jelly; rue; rupturewort; rusty-leaved rhododendron; rutin; rye grass; s-23; s-adenosyl methionine (SAMe); Saccharomyces boulardii; safed musli; safflower; saffron; sage; saigon cinnamon; salacia; Salatrim (short- and long-chain acyl triglyceride molecule); salep; Salvia divinorum; samphire; sandy everlasting; sangre de grado; sanicle; sarsaparilla; sassafras; savin tops; saw palmetto; scarlet pimpernel; Sceletium; Schisandra, schizandrol-A; Schizonepeta; Scopolia; Scotch broom; Scotch thistle; scurvy grass; sea buckthorn; sea moss; secretin; Securinega suffruticosa; selenium; self-heal; senega; senna; serine; serrapeptase; sesame; sessile oak; shark cartilage; shark liver oil; shea butter; shellac; shepherd's purse; shiitake mushroom; Siberian cocklebur; Sida cordifolia; silicon; Simaruba; sitostanol; skullcap; skunk cabbage; slippery elm; smartweed; smooth alder; snake skin; sodium; sodium bicarbonate; sodium tetrachloroaurate; solomon's seal; sorghum; sorrel; soy; soybean oil; Spanish broom; Spanish origanum oil; spearmint; spinach; spiny restharrow; spleen extract; spotted geranium; squalamine; squill; St. John's wort; star anise; star of Bethlehem; stavesacre; stenabolic; Stereospermum; stevia; stinging nettle; stone root; storax; strawberry; Streptococcus thermophilus; strontium; Strophanthus; succinate; sulbutiamine; sulforaphane; sulfur; suma; sumbul; summer savory; sundew; sunflower oil; superoxide dismutase (SOD); swallowroot; swamp milkweed; sweet almond; sweet Annie; sweet cherry; sweet cicely; sweet clover; sweet gale; sweet orange; sweet sumac; sweet vernal grass; sweet violet; sweet woodruff; syrian rue; tamarind; Tamarix dioica; tangerine; tannic acid; tansy; tansy ragwort; tapioca; tarragon; tart cherry; tartaric acid; taurine or a salt, ester, or amide suitable for human ingestion thereof; tea tree oil; teazle; Terminalia; testolone; tetrahydrocannabivarin (THCV); theacrine or a salt, ester, or amide suitable for human ingestion thereof; theaflavin; theanine; thiamine or a salt, ester, or amide a salt, ester, or amide suitable for human ingestion thereof; threonine or a salt, ester, or amide suitable for human ingestion thereof; thuja; thunder god vine; thyme; thymus extract; thyroid extract; tianeptine; timothy grass; tin; Tinospora cordifolia; tiratricol; tocotrienols; tolu balsam; tomato; tonka bean; toothed clubmoss; tormentil; tragacanth; trailing arbutus; transfer factor; traveler's joy; tree of heaven; tree tobacco; tree turmeric; trendione; tribulus; Trichopus zeylanicus; Tronadora; trypsin; tung seed; turkey corn; turkey tail mushroom; turmeric; turpentine oil; turtlehead; Tylophora; tyramine; tyrosine; ubiquinone (for example, coenzyme q10); umckaloabo; uridine; Usnea; uva ursi; uzara; valerian; vanadium; vanilla; verbena; veronica; vetiver; vietnamese coriander; vinpocetine; vitamin A or a salt, ester, or amide suitable for human ingestion thereof; vitamin B1 or a salt, ester, or amide suitable for human ingestion thereof; vitamin B12 or a salt, ester, or amide suitable for human ingestion thereof; vitamin B2 or a salt, ester, or amide suitable for human ingestion thereof; vitamin B6 or a salt, ester, or amide suitable for human ingestion thereof; vitamin B8 or a salt, ester, or amide suitable for human ingestion thereof, vitamin B9 or a salt, ester, or amide suitable for human ingestion thereof; vitamin C or a salt, ester, or amide suitable for human ingestion thereof; vitamin D or a salt, ester, or amide suitable for human ingestion thereof; vitamin E or a salt, ester, or amide suitable for human ingestion thereof; vitamin K or a salt, ester, or amide suitable for human ingestion thereof; vitamin O or a salt, ester, or amide suitable for human ingestion thereof; wafer ash; wahoo; wallflower; wasabi; water avens; water dock; water hemlock; watercress; wheat bran; wheatgrass; whey protein; white dead nettle flower; white hellebore; white horehound; white lily; white mulberry; white mustard; white oak; white pepper; white sandalwood; wild carrot; wild cherry; wild daisy; wild indigo; wild lettuce; wild mint; wild thyme; wild yam; willard water; willow bark; wine; winter cherry; winter savory; wintergreen; witch hazel; wood anemone; wood sage; wood sorrel; wormseed; wormwood; xanthan gum; Xanthoparmelia; xylitol; yarrow; yellow dock; yellow loosestrife; yellow toadflax; yerba mansa; yerba mate; yerba santa; yew; yin chen; ylang ylang oil; yogurt; yohimbe; yucca; zeaxanthin; zedoary; zinc; and zizyphus.

Compositions and/or formulations of the present invention may be administered in any form, including one of a capsule, a cachet, a pill, a tablet, a powder, a granule, a pellet, a bead, a particle, a troche, a lozenge, a pastille, a solution, an elixir, a syrup, a tincture, a suspension, an emulsion, a mouthwash, a spray, a drop, an ointment, a cream, a gel, a paste, a transdermal patch, a suppository, a pessary, cream, a gel, a paste, a foam, and combinations thereof for example. Compositions and/or formulations of the present invention may also include an acceptable additive (e.g. one of a solubilizer, an enzyme inhibiting agent, an anticoagulant, an antifoaming agent, an antioxidant, a coloring agent, a coolant, a cryoprotectant, a hydrogen bonding agent, a flavoring agent, a plasticizer, a preservative, a sweetener, a thickener, and combinations thereof) and/or an acceptable carrier (e.g. one of an excipient, a lubricant, a binder, a disintegrator, a diluent, an extender, a solvent, a suspending agent, a dissolution aid, an isotonization agent, a buffering agent, a soothing agent, an amphipathic lipid delivery system, and combinations thereof).

Implementations of the water-soluble form of ginger extract may conveniently be presented in unit dosage form. Unit dosage formulations may be those containing a daily dose or unit, a daily sub-dose, or an appropriate fraction thereof, of the administered components as described herein.

A dosage unit may include the water-soluble form of ginger extract admixed with a second pharmaceutically acceptable additive (in additive to the non-aqueous liquid used in the preparation of the water-soluble form of ginger extract).

The dosage for oral use of the water-soluble form of ginger extract can be from 1 to 30,000 mg per day, split into one or more dosages. For exercise performance enhancing purposes, the formulation is administered (for example, by ingestion) prior to exercise, for example any time between 3 days prior to exercise and right before exercise. This dosing schedule is unexpected, because current literature indicates that for ginger to be effective against DOMS, multiple doses must be taken for days or even weeks before exercise in order to have an effect (Compare Matsumura et al., “The Effects of Pre-Exercise Ginger Supplementation on Muscle Damage and Delayed Onset Muscle Soreness,” Phytother Res. 2015, 29 (6): 887-93; and Contreras, “The Effects of Ginger Supplementation on Delayed Onset Muscle Soreness,” 2018 Kinesiology Student Research from the University of Texas at Arlington accessible https://mavmatrix.uta.edu/kinesiology_studentwork/77/). Contreras found that acute administration of ginger at 2 grams one hour before exercise was ineffective in reduce DOMS. Accordingly, in some aspects, the oral use of the water-soluble form of ginger extract may be administered even a week before exercise. In some aspects, the formulation is administered between 24 hours to immediately before exercise. In certain implementations, the formulation is administered one (1) hour before exercise.

The dosage units may be in a form suitable for administration by standard routes. In general, the dosage units may be administered, by non-limiting example, by topical (including buccal and sublingual), transdermal, oral, rectal, ophthalmic (including intravitreal or intracameral), nasal, vaginal, and/or parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intratracheal, and epidural) routes.

For the exemplary purposes of this disclosure, oral delivery may be a particularly advantageous delivery route for administration to humans and animals of implementations of a pharmaceutical composition, optionally formulated with appropriate pharmaceutically acceptable additives to facilitate administration.

It should be appreciated that any of the components of particular implementations of the water-soluble form of ginger extract may be used as supplied commercially, or may be preprocessed by, by non-limiting example, any of the methods and techniques of agglomeration, air suspension chilling, air suspension drying, balling, coacervation, comminution, compression, pelletization, cryopelletization, extrusion, granulation, homogenization, inclusion compoundation, lyophilization, melting, mixed, molding, pan coating, solvent dehydration, sonication, spheronization, spray chilling, spray congealing, spray drying, or other processes known in the art depending in part on the dosage form desired. The various components may also be pre-coated or encapsulated as known in the art. It will also be clear to one of ordinary skill in the art that appropriate additives may also be introduced to the composition or during the processes to facilitate the preparation of the dosage forms, depending on the need of the individual process.

Those of ordinary skill in the art will be able to readily select manufacturing equipment and pharmaceutically acceptable additives or inert ingredients to manufacture implementations of the water-soluble form of ginger extract. For the exemplary purposes of this disclosure, some examples of pharmaceutically acceptable additives or inert ingredients and manufacturing process are included below, particularly those that relate to manufacture of implementations of the water-soluble form of ginger extract in tablet form. Notwithstanding the specific examples given, it will be understood that those of ordinary skill in the art will readily appreciate how to manufacture implementations of the water-soluble form of ginger extract according to the other methods of administration and delivery disclosed in this document.

A particular implementation of the water-soluble form of ginger extract may include a lubricant. Lubricants are any anti-sticking agents, glidants, flow promoters, and the like materials that perform a number of functions in tablet manufacture, for example, such as improving the rate of flow of the tablet granulation, preventing adhesion of the tablet material to the surface of the dies and punches, reducing interparticle friction, and facilitating the ejection of the tablets from the die cavity. Lubricants may comprise, for example, magnesium stearate, calcium stearate, talc, and colloidal silica.

Particular implementations of the water-soluble form of ginger extract may also include a binder. Binders are any agents used to impart cohesive qualities to powdered material through particle-particle bonding. Binders may include, for example, matrix binders (e.g., dry starch, dry sugars), film binders (e.g., celluloses, bentonite, sucrose), and chemical binders (e.g., polymeric cellulose derivatives, such as methyl cellulose, carboxy methyl cellulose, and hydroxy propyl cellulose); and other sugar, gelatin, non-cellulosic binders and the like.

Disintegrators may be used in particular implementations of the water-soluble form of ginger extract to facilitate the breakup or disintegration of tablets after administration. Disintegrators may include, for example, starch, starch derivatives, clays (e.g., bentonite), algins, gums (e.g., guar gum), cellulose, cellulose derivatives (e.g., methyl cellulose, carboxymethyl cellulose), croscarmellose sodium, croscarmellose cellulose, and other organic and inorganic materials.

Implementations of the water-soluble form of ginger extract may include diluents, or any inert substances added to increase the bulk of the water-soluble form of ginger extract to make a tablet a practical size for compression. Diluents may include, for example, calcium phosphate, calcium sulfate, lactose, mannitol, magnesium stearate, potassium chloride, and citric acid, among other organic and inorganic materials.

Buffering agents may be included in the water-soluble form of ginger extract and may be any one of an acid and a base, where the acid is, for example, propionic acid, p-toluene sulfonic acid, salicylic acid, stearic acid, succinic acid, tannic acid, tartaric acid, thioglycolic acid, or toluene sulfonic acid, and the base is, for example, ammonium hydroxide, potassium hydroxide, sodium hydroxide, sodium hydrogen carbonate, aluminum hydroxide, calcium carbonate, and other organic and inorganic chemicals.

Implementations of the water-soluble form of ginger extract may also be administered through use of amphipathic lipid delivery systems (such as liposomes and unilamellar vesicles), caplet systems, oral liquid systems, parenteral and/or intravenous systems, topical systems (creams, gels, transdermal patches, etc.), intranasal systems, rectal or vaginal systems, and many other delivery methods and/or systems known to those of ordinary skill in the art. Those of ordinary skill in the art will readily be able to select additional pharmaceutically acceptable additives to enable delivery of implementations of a pharmaceutical composition from the disclosure in this document.

With respect to delivery of particular implementations of the water-soluble form of ginger extract, for the exemplary purposes of this disclosure, softgels may be utilized. A softgel is an oral dosage form for medicine in the form of a specialized capsule. They consist of a shell surrounding a liquid fill. Softgels can allow for near instant release of the solution in the G.I. tract, ensuring rapid onset of action as well as enhanced bioaccesibility and bioavailability.

Tablets and other orally discrete dosage forms, such as capsules, cachets, pills, granules, pellets, beads, and particles, for example, may optionally be coated with one or more enteric coatings, seal coatings, film coatings, barrier coatings, compress coatings, fast disintegrating coatings, or enzyme degradable coatings for example. Multiple coatings may be applied for desired performance. Further, dosage forms may be designed for, by non-limiting example, immediate release, pulsatile release, controlled release, extended release, delayed release, targeted release, synchronized release, or targeted delayed release. For release/absorption control, carriers may be made of various component types and levels or thicknesses of coats. Such diverse carriers may be blended in a dosage form to achieve a desired performance. In addition, the dosage form release profile may be affected by a polymeric matrix composition, a coated matrix composition, a multi-particulate composition, a coated multi-particulate composition, an ion-exchange resin-based composition, an osmosis-based composition, or a biodegradable polymeric composition.