Brain health supplement

Abstract

Described herein are brain health supplement compositions. For example, provided herein are brain health supplement compositions comprising phosphatidylserine, a ginkgo extract, and a bacopa monnieri extract.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 340,367, filed on May 10, 2022. The disclosure of the prior application is considered part of the disclosure of the present application (and is incorporated by reference into the disclosure of the present application). Technical Field

[0003] The present invention relates to the field of brain health supplements. For example, the present invention relates to brain health supplement compositions that can be used to increase memory recall in humans or animals. Background Art

[0004] Many people experience memory-related problems that impair their overall quality of life. To date, there has been a lack of pharmaceutical approaches developed to treat memory-related problems. Over the past decade, more than two hundred promising drug candidates for dementia have failed in clinical trials, indicating that memory-related problems, particularly dementia, can be highly complex. In addition, few, if any, dietary supplements are available to treat memory-related problems. Summary of the invention

[0005] Provided herein are brain health supplement compositions. For example, provided herein are brain health supplement compositions that can be used for human or animal consumption. Provided herein are brain health supplement compositions that can improve memory recall. Typically, provided herein are brain health supplement compositions that include phosphatidylserine, Ginkgo biloba extract, and Bacopa monnieri extract.

[0006] Generally, the brain health supplement composition described herein can improve the brain health and memory recall, memory retention and mental acuity of the subject applying the composition (e.g., by providing neurotransmission support and improving neurological health). As provided herein, the brain health supplement composition can include one or more of the following benefits. The combination of ingredients in the composition comprising phosphatidylserine, ginkgo extract and Bacopa monnieri extract provides a diverse and complementary mechanism of action for the overall brain health and memory of the subject. For example, the brain health supplement composition provided herein can act through a neuroprotective antioxidant mechanism and / or can change different neurotransmitters (e.g., serotonin, 5-hydroxytryptamine, dopamine, acetylcholine and gamma-aminobutyric acid) to provide cognitive benefits. In some cases, the brain health supplement composition can also play a role in enhancing cholinergic function (e.g., by increasing acetylcholine release), thereby providing cognitive benefits. In addition, the brain health supplement composition provided herein can have an antioxidant effect, inhibit β-amyloid peptide aggregation and / or reduce peripheral benzodiazepines. In some cases, the combination of phosphatidylserine, ginkgo extract, and Bacopa monnieri extract in the composition can provide a synergistic effect, resulting in a level of brain health benefit that is greater than that achieved by using phosphatidylserine, ginkgo extract, or Bacopa monnieri extract alone, or greater than that achieved by using two of the three ingredients without the third.

[0007] Generally, one aspect of the present disclosure is characterized in that a composition comprises phosphatidylserine, ginkgo extract and bacopa extract, consists of phosphatidylserine, ginkgo extract and bacopa extract or consists essentially of them, wherein the composition is formulated into a tablet, capsule or soft gel. The composition may comprise about 8% to about 14% by weight of phosphatidylserine, about 9% to about 20% by weight of ginkgo extract and about 11% to about 23% by weight of bacopa extract. The composition may comprise about 8% to about 10% by weight of phosphatidylserine, about 11% to about 17% by weight of ginkgo extract and about 13% to about 19% by weight of bacopa extract. The composition may comprise about 8.75% by weight of phosphatidylserine, about 14% by weight of ginkgo extract and about 16% by weight of bacopa extract. In some cases, one tablet, capsule or soft gel comprises a full portion of the composition. In some cases, two tablets combined, two capsules combined, or two soft gels combined comprise a full serving of the composition. In some cases, three tablets combined, three capsules combined, or three soft gels combined comprise a full serving of the composition. A full serving of the composition can comprise about 25 mg to about 1200 mg of phosphatidylserine, about 40 mg to about 400 mg of Ginkgo extract, and about 100 mg to about 800 mg of Bacopa monnieri extract.

[0008] The composition may further include one or more of calcium carbonate powder, microcrystalline cellulose (MCC, such as MCC 101, etc.), cross-linked carboxymethyl cellulose sodium, stearic acid, silicon dioxide, and magnesium stearate. The composition may include about 25% by weight to about 37% by weight of calcium carbonate powder, about 7% by weight to about 10% by weight of MCC, about 3.5% by weight to about 5.5% by weight of cross-linked carboxymethyl cellulose sodium, about 1% by weight to about 2% by weight of stearic acid, about 1% by weight to about 2% by weight of silicon dioxide, and about 0.5% by weight to about 1% by weight of magnesium stearate. A full portion of the composition may include about 350mg to about 450mg of calcium carbonate powder, about 50mg to about 150mg of MCC, about 45mg to about 75mg of cross-linked carboxymethyl cellulose sodium, about 17.5mg to about 30mg of stearic acid, about 20mg to about 30mg of silicon dioxide, and about 10mg to about 15mg of magnesium stearate.

[0009] Tablets, capsules or soft gels may include a coating, wherein the coating includes cellulose, calcium carbonate powder and carnauba wax. The composition may include about 1.6% to about 2.4% by weight of cellulose, about 0.5% to about 1.3% by weight of calcium carbonate powder in the coating, and about 0.008% to about 0.012% by weight of carnauba wax. The composition may include about 1.65% by weight of cellulose, about 0.6% by weight of calcium carbonate powder in the coating, and about 0.01% by weight of carnauba wax.

[0010] In some cases, the tablet, capsule, or soft gel dissolves in water in less than 60 minutes. In some cases, the tablet, capsule, or soft gel does not dissolve in water in less than 60 minutes. In some cases, the tablet, capsule, or soft gel includes a pH-dependent coating thereon. In some cases, the pH-dependent coating is insoluble at a pH of less than about 5, less than about 4.5, less than about 4, or less than about 3.5. In some cases, the pH-dependent coating dissolves at a pH of more than about 5, more than about 5.5, more than about 6, more than about 6.5, or more than about 7. In some cases, the pH-dependent coating comprises one or more of methacrylic acid copolymer, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethyl ethyl cellulose, shellac, and zein.

[0011] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those of ordinary skill in the art to which the invention belongs. Although methods and materials similar or equivalent to the methods and materials described herein can be used to implement the present invention, suitable methods and materials are described below. All publications, patent applications, patents and other references mentioned herein are incorporated herein by reference in their entirety. In the event of a conflict, the present specification including definitions shall prevail. In addition, materials, methods and examples are illustrative only and are not intended to be limiting.

[0012] The details of one or more embodiments of the invention are set forth in the description which follows. Other features, objects, and advantages of the invention will be apparent from the description and from the claims. DETAILED DESCRIPTION

[0013] Provided herein are brain health supplement compositions comprising phosphatidylserine, ginkgo extract and bacopa extract. For example, provided herein are brain health supplement compositions that can comprise about 8% by weight to about 14% by weight of phosphatidylserine, about 9% by weight to about 20% by weight of ginkgo extract and about 11% by weight to about 23% by weight of bacopa extract. The brain health supplement compositions can be in the form of liquids, solutions, suspensions, tablets, powders, creams, mists, atomized vapors, aerosols, soft gelatin capsules, hard gelatin capsules, gels, candies, milkshakes, sticks and supplementary foods. For example, the brain health supplement compositions can be formulated into tablets, capsules or soft gels.

[0014] As described herein, the brain health supplement composition provided herein comprises phosphatidylserine.Phosphatidylserine can be obtained using any suitable process, and can be from any suitable source.In some cases, phosphatidylserine can be obtained from sunflower seed extract (for example, sunflower (Helianthus annuus) extract).In some cases, phosphatidylserine can be commercially available.The brain health supplement composition provided herein can comprise the phosphatidylserine of any suitable amount.For example, at least 5 % by weight (for example, at least 5,6,7,8,9,10,11,12,13,14,15,20 or 25 % by weight) of the brain health supplement composition provided herein can be phosphatidylserine.In some cases, the brain health supplement composition can comprise the phosphatidylserine of about 5 % by weight to about 20 % by weight. For example, the brain health supplement composition can include about 5% to about 18% by weight phosphatidylserine, about 5% to about 15% by weight phosphatidylserine, about 8% to about 14% by weight, about 7% to about 12% by weight phosphatidylserine, about 8% to about 10% by weight phosphatidylserine, or about 8.75% by weight phosphatidylserine.

[0015] In some cases, the brain health supplement compositions provided herein can include about 25 mg to about 1500 mg (e.g., about 25 mg to about 1200 mg, about 25 mg to about 1000 mg, about 50 mg to about 500 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, or about 75 mg to about 125 mg) of phosphatidylserine. In some cases, the brain health supplement compositions provided herein can be formulated to include an amount of phosphatidylserine that allows for convenient administration of a daily dose of about 25 mg to about 1500 mg (e.g., about 25 mg to about 1200 mg, about 25 mg to about 1000 mg, about 50 mg to about 500 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, or about 75 mg to about 125 mg) of phosphatidylserine. In some cases, the brain health supplement composition provided herein can be formulated to include a certain amount of phosphatidylserine so that the daily dose is about 25mg to about 1200mg (for example, about 75mg to about 125mg). Phosphatidylserine can be provided in any suitable form. For example, phosphatidylserine can be provided as liquid or gel, wherein phosphatidylserine is present in liquid or gel with an amount of about 70 % by weight. When the brain health supplement composition includes an amount of about 100mg of phosphatidylserine, wherein phosphatidylserine is provided as a solution of 70 % by weight, and the amount of phosphatidylserine in the brain health supplement is about 100mg and the gross weight of the solution is about 143mg.

[0016] The brain health supplement compositions provided herein also include a Bacopa extract. Bacopa extracts can be obtained using any suitable method, including methods described elsewhere (see, for example, PCT Publication No. WO2006097043). In some cases, Bacopa extracts can be commercially available. The brain health supplement compositions provided herein can include any suitable amount of Bacopa extracts. For example, at least 8% by weight (e.g., at least 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30% by weight) of the brain health supplement compositions provided herein can be Bacopa extracts. In some cases, the brain health supplement composition can include about 10% by weight to about 30% by weight of Bacopa extracts. For example, the brain health supplement composition can include about 10% to about 30% by weight of Bacopa monnieri extract, about 10% to about 25% by weight of Bacopa monnieri extract, about 11% to about 23% by weight of Bacopa monnieri extract, about 13% to about 19% by weight of Bacopa monnieri extract, or about 16% by weight of Bacopa monnieri extract.

[0017] In some cases, the brain health supplement compositions provided herein can include about 25 mg to about 800 mg (e.g., about 100 mg to about 800 mg, about 150 mg to about 600 mg, about 200 mg to about 600 mg, about 200 mg to about 500 mg, about 100 mg to about 450 mg, about 100 mg to about 400 mg, about 200 mg to about 400 mg, or about 250 mg to about 350 mg) of Bacopa monnieri extract. In some cases, the brain health supplement compositions provided herein can be formulated to include an amount of Bacopa monnieri extract such that a daily dose of about 25 mg to about 800 mg (e.g., about 100 mg to about 800 mg, about 150 mg to about 600 mg, about 200 mg to about 600 mg, about 200 mg to about 600 mg, about 100 mg to about 450 mg, about 100 mg to about 400 mg, about 200 mg to about 400 mg, or about 250 mg to about 350 mg) of Bacopa monnieri extract can be conveniently administered. In some cases, the brain health supplement compositions provided herein can be formulated to include an amount of Bacopa monnieri extract such that a daily dose of about 100 mg to about 800 mg, or about 250 mg to about 350 mg.

[0018] In some cases, the Bacopa extract can include at least 10% by weight (e.g., 10, 20, 30, 35, 40, 45, 50, 55, 60, or 70%) of Bacopasides (e.g., one or more of Bacopasides I, II, III, IV, V, VI, VII, VIII, IX, X, and XI). In some cases, the Bacopa extract can include at least 30% by weight of Bacopasides (e.g., about 40% by weight of Bacopasides, about 45% by weight of Bacopasides, about 50% by weight of Bacopasides, about 55% by weight of Bacopasides, or about 60% by weight of Bacopasides).

[0019] The brain health supplement composition provided herein also includes ginkgo extract. Ginkgo extract can be obtained using any suitable process and can be from any suitable source. In some cases, ginkgo extract can be obtained from ginkgo leaves. In some cases, ginkgo extract can be commercially available. For example, ginkgo extract can be obtained from Dongling Health Food Co., Ltd. (Zhejiang, PRC). The brain health supplement composition provided herein can include any suitable amount of ginkgo extract. For example, at least 5% by weight (e.g., at least 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30 or 40% by weight) of the brain health supplement composition provided herein can be ginkgo extract. In some cases, the brain health supplement composition can include about 5% by weight to about 30% by weight of ginkgo extract. For example, the brain health supplement composition can include about 5% to about 25% by weight of Ginkgo extract, about 5% to about 20% by weight of Ginkgo extract, about 9% to about 20% by weight of Ginkgo extract, about 11% to 17% by weight of Ginkgo extract, or about 14% by weight of Ginkgo extract.

[0020] In some cases, the brain health supplement compositions provided herein can include about 40 mg to about 800 mg (e.g., about 40 mg to about 600 mg, about 40 mg to about 400 mg, about 120 mg to about 400 mg, about 150 mg to about 400 mg, about 200 mg to about 400 mg, about 200 mg to about 350 mg, about 200 mg to about 300 mg, or about 225 mg to about 275 mg) of Ginkgo extract. In some cases, the brain health supplement compositions provided herein can be formulated to include an amount of Ginkgo extract such that a daily dose of about 40 mg to about 800 mg (e.g., about 40 mg to about 600 mg, about 40 mg to about 400 mg, about 40 mg to about 400 mg, about 150 mg to about 400 mg, about 200 mg to about 400 mg, about 200 mg to about 350 mg, about 200 mg to about 300 mg, or about 225 mg to about 275 mg) of Ginkgo extract can be conveniently administered. For example, the brain health supplement compositions provided herein can be formulated to contain an amount of Ginkgo extract such that the daily dose is from about 120 mg to about 400 mg (eg, from about 200 mg to about 300 mg).

[0021] Ginkgo extracts may include one or more flavonoid glycosides (e.g., quercetin, kaempferol, and isorhamnetin). Ginkgo extracts may include one or more terpene lactones (e.g., ginkgolide A, ginkgolide B, ginkgolide C, bilobalide, and other ginkgolides). In some cases, ginkgo extracts may include one or more terpene lactones and one or more flavonoid glycosides. Ginkgo extracts may include one or more flavonoid glycosides in an amount of at least about 10% by weight (e.g., 10%, 20%, 30%, 35%, 40%, 45%, 50%, 10 to 20%, 20 to 30%, 30 to 40%, or 40 to 50%). In some cases, the ginkgo extract may include at least about 1% by weight (e.g., 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 1% to 5%, 5% to 10%, or 10% to 15%) of one or more terpene lactones. In some cases, the ginkgo extract may include at least about 10% by weight of one or more flavonoid glycosides and at least about 1% by weight of one or more terpene lactones. For example, the ginkgo extract may include at least about 20% by weight of one or more flavonoid glycosides and at least about 4% by weight of one or more terpene lactones. In some cases, the ginkgo extract may include about 24% by weight of one or more flavonoid glycosides and about 6% by weight of one or more terpene lactones.

[0022] In some cases, provided herein is a brain health supplement that can include phosphatidylserine, ginkgo extract and bacopa extract, wherein the composition is formulated into tablets, capsules or soft gels. In some cases, provided herein is a brain health supplement that can include about 8% by weight to about 14% by weight of phosphatidylserine, about 9% by weight to about 20% by weight of ginkgo extract and about 11% by weight to about 23% by weight of bacopa extract. In some cases, provided herein is a brain health supplement that can include about 8% by weight to about 10% by weight of phosphatidylserine, about 11% by weight to about 17% by weight of ginkgo extract and about 13% by weight to about 19% by weight of bacopa extract. In some cases, provided herein is a brain health supplement that can include about 8.25% by weight of phosphatidylserine, about 14% by weight of ginkgo extract and about 16% by weight of bacopa extract.

[0023] The brain health supplement compositions provided herein can be formulated so that a daily dose comprises about 25 mg to about 1200 mg of phosphatidylserine, about 40 mg to about 400 mg of Ginkgo extract, and about 100 mg to about 800 mg of Bacopa monnieri extract. For example, the brain health supplement compositions provided herein can be formulated so that a daily dose comprises about 50 mg to about 500 mg of phosphatidylserine, about 150 mg to about 400 mg of Ginkgo extract, and about 150 mg to about 450 mg of Bacopa monnieri extract, or about 50 mg to about 200 mg of phosphatidylserine, about 200 mg to about 300 mg of Ginkgo extract, and about 200 mg to about 350 mg of Bacopa monnieri extract.

[0024] The brain health supplement compositions provided herein can be formulated to include one or more additional active ingredients. For example, the brain health supplement compositions can include phosphatidylserine, ginkgo extract, Bacopa monnieri extract, and one or more additional active ingredients, such as acetyl-L-carnitine, acetyl coenzyme A, vitamin B12, huperzine A, vitamin E, and pyridoxine, etc. One or more. In some cases, the additional active ingredients can include one or more acetylcholinesterase inhibitors. Examples of acetylcholinesterase inhibitors that can be included in the brain health supplement compositions provided herein include, but are not limited to, huperzine A, carbamates (e.g., physostigmine, neostigmine, pyridostigmine, ambenonium, demarcarium, and rivastigmine), caffeine, piperidines (e.g., donepezil), xanthostigmine, aminobenzoic acid, flavonoids, pyrroloisoxazoles, edrophonium, ladostinigil, ungeremine, lactucopicrin, coumarin, donepezil, galantamine, rivastigmine, and tacrine. Acetylcholinesterase inhibitors can be obtained, for example, as described elsewhere (see, e.g., Chinese Patent No. CN103951618).

[0025] In some cases, the brain health supplement compositions provided herein can include one or more of the following additional active ingredients: carotenoids (e.g., alpha-carotene, beta-carotene, lycopene, lutein, zeaxanthin and / or cryptoxanthin), phenolic compounds (e.g., flavonoids, flavonols, flavanones, catechins, anthocyanins, isoflavones, dihydroflavonols and / or chalcones), phenolic acids (e.g., ellagic acid, tannic acid and / or vanillin), hydroxycinnamic acid derivatives (e.g., caffeic acid, chlorogenic acid, ferulic acid, curcumin and / or coumarin), lignans, allyl sulfide from onion or garlic, and essential oils (e.g., melaleuca oil, clove oil, cinnamon bark oil, thyme oil, oregano oil, mountain savory oil, cistus oil, eucalyptus oil globulus oil), orange oil, lemongrass oil, helichrysum oil, ravensara oil, lemon oil, spearmint oil, and / or lavender oil).

[0026] In some cases, the brain health supplement composition provided herein may further include one or more of vitamin E, tocopherol, tocotrienol, vitamin A, carotene, lutein, astaxanthin, CoQ10, vitamin C, folate, uric acid, vitamin B12, and folic acid.

[0027] The brain health supplement compositions provided herein can be formulated for oral administration and can include one or more suitable excipients, flavoring agents, coloring agents and / or other ingredients. When intended for oral use, tablets, troches, lozenges, aqueous or oily suspensions, non-aqueous solutions, dispersible powders or granules (including micronized granules or nanoparticles), emulsions, hard capsules or soft capsules, syrups or elixirs can be prepared. Compositions intended for oral use can be prepared according to any suitable method, including standard methods for making pharmaceutical compositions. Such compositions can include one or more agents such as, but not limited to, sweeteners, flavoring agents, coloring agents and preservatives to provide a palatable preparation. For oral administration, tablets, capsules or soft gels can be prepared with one or more pharmaceutically acceptable excipients such as adhesives, fillers, lubricants, disintegrants and / or wetting agents. In some cases, tablets can have coatings (e.g., coatings based on polymers or polysaccharides with or without plasticizers and / or pigments). Liquid preparations for oral administration can take the form of, for example, solutions, syrups or suspensions, or they can exist as dry products for reconstitution with saline or other suitable liquid vehicles before use. In some cases, liquid preparations can appropriately contain pharmaceutically acceptable additives such as suspending agents, emulsifiers, non-aqueous solvents, preservatives, buffer salts, flavoring agents, coloring agents and sweeteners. Preparations for oral administration can be appropriately formulated to provide controlled release of one or more compounds. In some cases, tablets, capsules or soft gels can be prepared with methacrylic acid copolymers (e.g., L100-55 or S100) for release outside the stomach (e.g., in the intestines, colon, or both).

[0028] In some cases, the brain health supplement compositions provided herein may include a pharmaceutically acceptable carrier for administration to a mammal. Suitable carriers include, but are not limited to, sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents include, but are not limited to, propylene glycol, polyethylene glycol, vegetable oils, and organic esters. Suitable aqueous carriers include, for example, water, alcohol, saline, and buffered solutions. Pharmaceutically acceptable carriers may also include physiologically acceptable aqueous vehicles (e.g., physiological saline) or other carriers suitable for oral administration.

[0029] In some cases, the brain health supplement composition provided herein can be in the form of capsules, tablets or soft gels, which are formulated as unit doses equal to the daily required dose for a specific mammal as an example only. For example, if a mammal needs 100 mg of a specific medicament, each piece can contain about 100 mg of the medicament by weight. As used herein, mammals generally refer to people, but can also include domestic mammals (e.g., dogs, cats and livestock such as cattle, horses, pigs or sheep). The dosage of the specific brain health supplement composition provided herein will depend on many factors, including the overall health of the mammal. In some cases, the total daily dose (e.g., a full portion) can be prepared and administered in the form of one or more dosage units (e.g., one tablet, capsule or soft gel, two tablets, capsules or soft gels, three tablets, capsules or soft gels, four tablets, capsules or soft gels, five tablets, capsules or soft gels, or six tablets, capsules or soft gels). For example, in some cases, one tablet, one capsule, or one soft gel can contain a full portion (e.g., daily dose) of the composition. In some cases, two tablets, two capsules, or two soft gels combined can contain a full portion (e.g., daily dose) of the composition. In some cases, three tablets, three capsules, or three soft gels combined can contain a full portion (e.g., daily dose) of the composition.

[0030] In some cases, when the brain health supplement composition provided herein is in the form of a capsule, tablet or soft gel, the composition may further comprise one or more pharmaceutically acceptable excipients, such as calcium powder (e.g., calcium carbonate powder), microcrystalline cellulose (MCC) (e.g., MCC 101), cross-linked carboxymethyl cellulose sodium, stearic acid, silicon dioxide (e.g., In some cases, the capsule, tablet or soft gel form of the brain health supplement composition provided herein further comprises calcium powder (e.g., calcium carbonate powder), MCC (e.g., MCC 101), cross-linked sodium carboxymethylcellulose, stearic acid, silicon dioxide (e.g., In some cases, the capsule, tablet, or soft gel form of the brain health supplement composition provided herein further comprises one or more of the following: about 10 wt % to about 50 wt % calcium powder (e.g., calcium carbonate powder), about 5 wt % to about 15 wt % MCC (e.g., MCC 101), about 1 wt % to about 10 wt % cross-linked sodium carboxymethylcellulose, about 0.1 wt % to about 3 wt % stearic acid, about 0.1 wt % to about 3 wt % silicon dioxide (e.g., In some cases, the capsule, tablet or soft gel form of the brain health supplement composition provided herein further comprises one or more of the following: about 25 wt % to about 37 wt % calcium powder (e.g., calcium carbonate powder), about 7 wt % to about 10 wt % MCC (e.g., MCC 101), about 3.5 wt % to about 5.5 wt % cross-linked carboxymethyl cellulose sodium, about 1 wt % to about 2 wt % stearic acid, about 1 wt % to about 2 wt % silicon dioxide (e.g.,

[0031] Silicon dioxide) and from about 0.5 wt % to about 1 wt % magnesium stearate.

[0032] In some cases, a full serving of a brain health supplement composition provided herein in the form of one or more tablets, one or more capsules, or one or more soft gels comprises about 300 mg to about 500 mg of calcium carbonate powder, about 50 mg to about 200 mg of MCC (e.g., MCC 101), about 25 mg to about 100 mg of croscarmellose sodium, about 10 mg to about 50 mg of stearic acid, about 10 mg to about 50 mg of silicon dioxide (e.g., In some cases, a full serving of the brain health supplement composition provided herein in the form of one or more tablets, one or more capsules, or one or more soft gels may include about 350 mg to about 450 mg of calcium carbonate powder, about 50 mg to about 150 mg of MCC (e.g., MCC 101), about 45 mg to about 75 mg of croscarmellose sodium, about 17.5 mg to about 30 mg of stearic acid, about 20 mg to about 30 mg of silicon dioxide (e.g., silicon dioxide) and from about 10 mg to about 15 mg magnesium stearate.

[0033] In some cases, the brain health supplement composition in the form of tablets, capsules or soft gels can be coated with a suitable coating. For example, the coating can include one or more of cellulose, calcium carbonate powder and carnauba wax. In some cases, the coating can include cellulose, calcium carbonate powder and carnauba wax. In some cases, the brain health supplement composition in the form of tablets, capsules or soft gels includes an amount of coating of about 1% by weight to about 5% by weight based on the total weight of the composition. In some cases, the brain health supplement composition includes about 1% by weight to about 3% by weight of cellulose, about 0.1% by weight to about 1.5% by weight of calcium carbonate powder in the coating, and about 0.001% by weight to about 0.05% by weight of carnauba wax. In some cases, the brain health supplement composition includes about 1.6% by weight to about 2.4% by weight of cellulose, about 0.5% by weight to about 1.3% by weight of calcium carbonate powder in the coating, and about 0.008% by weight to about 0.012% by weight of carnauba wax. In some cases, a brain health supplement composition comprises about 2.2 wt% cellulose, about 0.8 wt% calcium carbonate powder in a coating, and about 0.01 wt% carnauba wax.

[0034] In some cases, a brain health supplement composition in the form of a tablet, capsule, or soft gel can be formulated to release the active ingredient (e.g., phosphatidylserine, ginkgo extract, and Bacopa monnieri extract) in water at a temperature of about 37°C in less than 60 minutes (e.g., an immediate release formulation). The brain health supplement composition provided herein can release the active ingredient in water at a temperature of about 37°C in less than 45 minutes. In some cases, the tablet, capsule, or soft gel is formulated to have a coating that dissolves at the pH of gastric fluid. In some cases, the coating of the tablet, capsule, or soft gel exhibits an in vitro dissolution profile in artificial gastric fluid, including at least about 95% of the absorption window active ingredient release after 1 hour.

[0035] In some cases, the brain health supplement composition in the form of tablets, capsules or soft gels is formulated into a controlled release formulation. The controlled release formulation may include a pH-dependent coating on a tablet, capsule or soft gel, and the release of the active ingredient from the coating depends on the pH of the surrounding environment. The pH-dependent coating material can be dispersed or dissolved in water or a suitable organic solvent. The pH-dependent coating exhibits pH-dependent solubility, making it insoluble in acidic media (e.g., acidic gastric juice) but soluble in intestinal fluid (e.g., small intestine or colon). In some cases, the pH-dependent coating will cause degradation of the coating and release of the active ingredient when exposed to the pH environment of the small intestine. In some cases, the pH-dependent coating will not cause significant degradation of the coating when exposed to the pH environment of the small intestine and will not release the active ingredient. In some cases, the pH-dependent coating will cause degradation of the coating and release of the active ingredient when exposed to the pH environment of the colon. In some cases, the pH-dependent coating delays the release of the absorption window of the active ingredient until the composition passes through the stomach and reaches the higher pH environment of the small intestine. In some cases, the pH-dependent coating will dissolve at a pH of about 5, about 5.5, about 6, or about 6.5, or the pH-dependent coating will dissolve at a pH of about 5.5, about 6.0, about 6.5, or about 7.

[0036] The pH-dependent coating may comprise one or more enteric coating polymers. Typical examples include one or more of the following, alone or in combination: methacrylic acid copolymers, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethyl ethylcellulose, shellac, zein or other suitable enteric coating polymer solutions or dispersions. Specific enteric polymers that may be used are those that preferentially dissolve in the more alkaline pH of the intestine. L and / or S, or a polymer that dissolves slowly at a predetermined rate in the digestive tract, e.g. RL (e.g. RL 100), RS (e.g. R100) and / or such Blends of polymers.

[0037] Exemplary embodiments

[0038] Embodiment 1 is a composition comprising phosphatidylserine, Ginkgo biloba extract and Bacopa monnieri extract, wherein the composition is formulated into a tablet, a capsule or a soft gel.

[0039] Embodiment 2 is the composition of embodiment 1, wherein the composition comprises: about 8 wt % to about 14 wt % of phosphatidylserine, about 9 wt % to about 20 wt % of Ginkgo biloba extract, and about 11 wt % to about 23 wt % of Bacopa monnieri extract.

[0040] Embodiment 3 is the composition of embodiment 1, wherein the composition comprises: about 8 wt % to about 10 wt % of phosphatidylserine, about 11 wt % to about 17 wt % of Ginkgo biloba extract, and about 13 wt % to about 19 wt % of Bacopa monnieri extract.

[0041] Embodiment 4 is the composition of embodiment 1, wherein the composition comprises: about 8.75 wt % of phosphatidylserine, about 14 wt % of Ginkgo biloba extract, and about 16 wt % of Bacopa monnieri extract.

[0042] Embodiment 5 is the composition of any one of embodiments 1 to 4, wherein one tablet, capsule or soft gel comprises one entire portion of the composition.

[0043] Embodiment 6 is the composition of any one of embodiments 1 to 4, wherein the two tablets combined, the two capsules combined, or the two soft gels combined comprise one complete portion of the composition.

[0044] Embodiment 7 is the composition of any one of embodiments 1 to 4, wherein the three tablets combined, the three capsules combined, or the three softgels combined comprise one complete serving of the composition.

[0045] Embodiment 8 is the composition of any one of embodiments 5 to 7, wherein a full serving of the composition comprises: about 25 mg to about 1200 mg of phosphatidylserine, about 40 mg to about 400 mg of Ginkgo biloba extract, and about 100 mg to about 800 mg of Bacopa monnieri extract.

[0046] Embodiment 9 is the composition of any one of embodiments 1 to 8, further comprising one or more additional active ingredients.

[0047] Embodiment 10 is the composition of embodiment 9, wherein the additional active ingredient comprises one or more of L-carnitine, vitamin B12, huperzine A, vitamin E, and pyridoxine.

[0048] Embodiment 11 is the composition of any one of embodiments 1 to 10, further comprising: calcium carbonate powder, microcrystalline cellulose (MCC), croscarmellose sodium, stearic acid, silicon dioxide, and magnesium stearate.

[0049] Embodiment 12 is the composition of embodiment 11, wherein the composition comprises: about 25 wt % to about 37 wt % calcium carbonate powder, about 7 wt % to about 10 wt % MCC, about 3.5 wt % to about 5.5 wt % croscarmellose sodium, about 1 wt % to about 2 wt % stearic acid, about 1 wt % to about 2 wt % silicon dioxide, and about 0.5 wt % to about 1 wt % magnesium stearate.

[0050] Embodiment 13 is the composition of embodiment 11 or embodiment 12, wherein one tablet, capsule or soft gel contains one entire portion of the composition.

[0051] Embodiment 14 is the composition of any one of embodiments 11 to 13, wherein the two tablets combined, the two capsules combined, or the two softgels combined comprise one complete serving of the composition.

[0052] Embodiment 15 is the composition of any one of embodiments 11 to 13, wherein the three tablets combined, the three capsules combined, or the three softgels combined comprise one complete serving of the composition.

[0053] Embodiment 16 is the composition of any one of embodiments 13 to 15, wherein one full serving of the composition comprises: about 350 mg to about 450 mg of calcium carbonate powder, about 50 mg to about 150 mg of MCC, about 45 mg to about 75 mg of croscarmellose sodium, about 17.5 mg to about 30 mg of stearic acid, about 20 mg to about 30 mg of silicon dioxide, and about 10 mg to about 15 mg of magnesium stearate.

[0054] Embodiment 17 is the composition of any one of embodiments 1 to 16, wherein the tablet, capsule or softgel comprises a coating, and wherein the coating comprises: cellulose, calcium carbonate powder, and carnauba wax.

[0055] Embodiment 18 is the composition of embodiment 17, wherein the composition comprises: about 1.6 wt % to about 2.4 wt % cellulose, about 0.7 wt % to about 1.3 wt % calcium carbonate powder in the coating, and about 0.008 wt % to about 0.012 wt % carnauba wax.

[0056] Embodiment 19 is the composition of embodiment 17, wherein the composition comprises: about 2.2 weight percent cellulose, about 0.8 weight percent calcium carbonate powder in a coating, and about 0.01 weight percent carnauba wax.

[0057] Embodiment 20 is the composition of any one of embodiments 1 to 19, wherein the tablet, capsule or soft gel is formulated to release the phosphatidylserine, the Ginkgo extract and the Bacopa monnieri extract in water at a temperature of about 37°C in less than 60 minutes.

[0058] Embodiment 21 is the composition of any one of embodiments 1 to 19, wherein the tablet, capsule or soft gel is formulated to release the phosphatidylserine, the Ginkgo extract and the Bacopa monnieri extract in water at a temperature of about 37°C over 60 minutes.

[0059] Embodiment 22 is the composition of any one of embodiments 1 to 21, wherein the tablet, capsule or soft gel comprises a pH dependent coating thereon.

[0060] Embodiment 23 is the composition of embodiment 22, wherein the pH-dependent coating is insoluble at a pH of less than about 5, less than about 4.5, less than about 4, or less than about 3.5.

[0061] Embodiment 24 is the composition of embodiment 22 or 23, wherein the pH-dependent coating dissolves at a pH of about 5 or above, about 5.5 or above, about 6 or above, about 6.5 or above, or about 7 or above.

[0062] Embodiment 25 is the composition of any one of embodiments 22 to 24, wherein the pH-dependent coating comprises one or more of methacrylic acid copolymer, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethyl ethyl cellulose, shellac and zein.

[0063] The present invention will be further described in the following examples, which do not limit the scope of the invention described in the claims.

[0064] Example

[0065] Example 1 - Brain Health Supplement Composition

[0066] A brain health supplement composition was prepared according to the composition shown in Table 1 below.

[0067] Table 1. Supplements for brain health.

[0068] Bacopa (Bacopa monnieri) leaf extract (50 wt% Bacopa saponins) 275mg Ginkgo (Ginkgo) Leaf Extract 240mg Phosphatidylserine (70 wt%) 100mg

[0069] Example 2 - Brain Health Supplement Tablets

[0070] The brain health supplement composition was prepared as tablets with the composition shown in Table 2 below. The tablets were prepared with calcium carbonate powder, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide and magnesium stearate. The tablets were coated with a coating containing a mixture of cellulose, calcium carbonate powder and carnauba wax.

[0071] Table 2. Brain health supplement tablets.

[0072] Bacopa monnieri (Bacopa monnieri) leaf extract (50 wt.% Bacopa saponins) 275mg Ginkgo (Ginkgo) Leaf Extract 240mg Phosphatidylserine (70 wt%) 100mg

[0073] Example 3 - Brain Health Supplement Composition

[0074] A brain health supplement was prepared according to the composition shown in Table 3 below.

[0075] Table 3. Brain health supplement composition.

[0076] Bacopa monnieri (Bacopa monnieri) leaf extract 350mg Ginkgo (Ginkgo) Leaf Extract 120mg Phosphatidylserine (70 wt%) 150mg

[0077] Example 4 - Brain Health Supplement Composition

[0078] A brain health supplement was prepared according to the composition shown in Table 4 below.

[0079] Table 4. Brain health supplement composition.

[0080] Bacopa monnieri (Bacopa monnieri) leaf extract 300mg Ginkgo (Ginkgo) Leaf Extract 150mg Phosphatidylserine (50 wt%) 125mg

[0081] Example 5 - Brain Health Supplement Tablets

[0082] The brain health supplement composition was prepared into tablets with the composition shown in the following Table 5. The tablets were prepared with calcium carbonate powder, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide and magnesium stearate. The tablets were coated with a coating, wherein the coating was a mixture comprising cellulose, calcium carbonate powder and carnauba wax.

[0083] Table 5. Brain health supplement tablets.

[0084] Bacopa monnieri (Bacopa monnieri) leaf extract (50 wt.% Bacopa saponins) 350mg Ginkgo (Ginkgo) Leaf Extract 120mg Phosphatidylserine (70 wt%) 150mg

[0085] Other Implementations

[0086] It should be understood that although the invention has been described in conjunction with its detailed description, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages and modifications are within the scope of the appended claims.

Claims

1. A composition comprising phosphatidylserine, Ginkgo biloba extract and Bacopa monnieri extract, wherein the composition is formulated into a tablet, a capsule or a soft gel.

2. The composition according to claim 1, wherein the composition comprises: about 8% to about 14% by weight of said phosphatidylserine, about 9% to about 20% by weight of said Ginkgo extract, and About 11 wt % to about 23 wt % of the Bacopa monnieri extract.

3. The composition according to claim 1, wherein the composition comprises: about 8% to about 10% by weight of said phosphatidylserine, about 11% to about 17% by weight of said Ginkgo extract, and About 13 wt % to about 19 wt % of the Bacopa monnieri extract.

4. The composition according to claim 1, wherein the composition comprises: about 8.75% by weight of said phosphatidylserine, about 14% by weight of said Ginkgo extract, and About 16% by weight of the Bacopa monnieri extract.

5. The composition of claim 1, wherein one tablet, capsule or soft gel contains one entire portion of the composition.

6. The composition of claim 1, wherein two tablets combined, two capsules combined, or two soft gels combined comprise one complete serving of the composition.

7. The composition of claim 1, wherein three tablets combined, three capsules combined, or three soft gels combined comprise one complete serving of the composition.

8. The composition according to claim 5, wherein one serving of the composition comprises: about 25 mg to about 1200 mg of said phosphatidylserine, about 40 mg to about 400 mg of said Ginkgo extract, and About 100 mg to about 800 mg of the Bacopa monnieri extract.

9. The composition of claim 1, further comprising one or more additional active ingredients.

10. The composition of claim 9, wherein the additional active ingredient comprises one or more of L-carnitine, vitamin B12, huperzine A, vitamin E and pyridoxine.

11. The composition according to claim 1, further comprising: Calcium carbonate powder, Microcrystalline cellulose (MCC), Croscarmellose sodium, Stearic acid, Silicon dioxide, and Magnesium stearate.

12. The composition according to claim 11, wherein the composition comprises: about 25% to about 37% by weight of said calcium carbonate powder, about 7 wt % to about 10 wt % of said MCC, from about 3.5% to about 5.5% by weight of said croscarmellose sodium, from about 1 wt % to about 2 wt % of said stearic acid, from about 1 wt % to about 2 wt % of said silicon dioxide, and From about 0.5 wt % to about 1 wt % of said magnesium stearate.

13. The composition of claim 11, wherein one tablet, capsule or soft gel contains a complete serving of the composition.

14. The composition of claim 11, wherein two tablets combined, two capsules combined, or two soft gels combined comprise one complete serving of the composition.

15. The composition of claim 11, wherein three tablets combined, three capsules combined, or three soft gels combined comprise one complete serving of the composition.

16. The composition of claim 13, wherein a full serving of the composition comprises: about 350 mg to about 450 mg of said calcium carbonate powder, about 50 mg to about 150 mg of said MCC, about 45 mg to about 75 mg of said croscarmellose sodium, from about 17.5 mg to about 30 mg of said stearic acid, from about 20 mg to about 30 mg of said silicon dioxide, and From about 10 mg to about 15 mg of said magnesium stearate.

17. The composition of claim 1, wherein the tablet, capsule or soft gel comprises a coating, and wherein the coating comprises: cellulose, Calcium carbonate powder, and Carnauba wax.

18. The composition according to claim 17, wherein the composition comprises: from about 1.6% to about 2.4% by weight of said cellulose, about 0.7 wt % to about 1.3 wt % of said calcium carbonate powder in said coating, and From about 0.008 wt. % to about 0.012 wt. % of the carnauba wax.

19. The composition of claim 17, wherein the composition comprises: about 2.2% by weight of said cellulose, about 0.8% by weight of said calcium carbonate powder in said coating, and About 0.01% by weight of said carnauba wax.

20. The composition of claim 1, wherein the tablet, capsule or soft gel is formulated to release the phosphatidylserine, Ginkgo biloba extract and Bacopa monnieri extract in water at a temperature of about 37°C in less than 60 minutes.

21. The composition of claim 1, wherein the tablet, capsule or soft gel is formulated to release the phosphatidylserine, the Ginkgo extract and the Bacopa monnieri extract in water at a temperature of about 37°C over 60 minutes.

22. The composition of claim 1, wherein the tablet, capsule or soft gel comprises a pH dependent coating thereon.

23. The composition of claim 22, wherein the pH-dependent coating is insoluble at a pH of less than about 5, less than about 4.5, less than about 4, or less than about 3.

5.

24. The composition of claim 22, wherein the pH-dependent coating dissolves at a pH of about 5 or above, about 5.5 or above, about 6 or above, about 6.5 or above, or about 7 or above.

25. The composition of claim 22, wherein the pH-dependent coating comprises one or more of methacrylic acid copolymer, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethyl ethyl cellulose, shellac, and zein.