COMPOSITION FOR IMPROVED ENERGY, FOCUS AND CLARITY
20230039272 · 2023-02-09
Inventors
Cpc classification
A61K31/522
HUMAN NECESSITIES
A61K31/7076
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K36/48
HUMAN NECESSITIES
A61K31/197
HUMAN NECESSITIES
A61K31/522
HUMAN NECESSITIES
A61K31/4015
HUMAN NECESSITIES
A61K31/675
HUMAN NECESSITIES
A61K36/48
HUMAN NECESSITIES
A61K31/7076
HUMAN NECESSITIES
A61K31/4045
HUMAN NECESSITIES
A61K31/4045
HUMAN NECESSITIES
International classification
A61K36/48
HUMAN NECESSITIES
A61K31/197
HUMAN NECESSITIES
A61K31/4015
HUMAN NECESSITIES
A61K31/522
HUMAN NECESSITIES
A61K31/675
HUMAN NECESSITIES
A61K31/7076
HUMAN NECESSITIES
Abstract
A composition comprising: a racetam; an extract of Mucuna Pruriens; S-Adenosyl methionine; and caffeine; useful for improvement of alertness, physical endurance, sleep patterns, memory, perceptual acuity, and/or for increasing energy.
Claims
1. A composition comprising: a racetam; an extract of Mucuna Pruriens; S-Adenosyl methionine; and caffeine.
2. The composition claim 1 further comprising a second racetam.
3. The composition of claim 1 further comprising N-phenylacetyl-L-prolylglycine ethyl ester.
4. The composition of claim 1 further comprising any one or more of: Panax ginseng; Ginkgo biloba; ginger root; Cordyceps militaris; Lion's Mane; L-Theanine; and Cordyceps Sinesis.
5. The composition of claim 1 wherein the racetam is aniracetam, piracetam, oxiracetam, pramiracetam, or phenylpiracetam.
6. The composition of claim 1 wherein the racetam is oxiracetam.
7. The composition of claim 2 wherein the second racetam is piracetam.
8. The composition of claim 1 further comprising psilocin or psilocybin.
9. The composition of claim 1 comprising: oxiracetam, N-phenylacetyl-L-prolylglycine ethyl ester, Panax ginseng, ginger root, Mucuna Pruriens Extract, S-adenosyl methionine, Cordyceps Militaris, Lion's Mane, L-theanine, caffeine, and Cordyceps Sinesis.
10. The composition of claim 9 comprising, as a weight percentage of active ingredients: 20-30% oxiracetam, 0.4-0.8% Noopept, 2-4% Panax ginseng, 6-8% ginger root, 10-15% Mucuna Pruriens extract, 2-5% Sam-E, 8-12% Cordyceps Militaris, 12-18% Lion's Mane, 3-5% L-theanine, 6-10% delayed release caffeine, and 8-12% Cordyceps Sinensis.
11. The composition of claim 10 comprising, as a weight percentage of active ingredients: about 25% oxiracetam, about 0.6% Noopept, about 3% Panax ginseng, about 7% ginger root, about 13% Mucuna Pruriens extract, about 3.5% Sam-E, about 10% Cordyceps Militaris, about 15% Lion's Mane, about 4% L-theanine, about 8% delayed release caffeine, and about 10% Cordyceps Sinensis.
12. The composition of claim 10 comprising, per dose: 37.5-375 mg of oxiracetam; 0.9-9 mg of N-phenylacetyl-L-prolylglycine ethyl ester; 4.3-44 mg of panax ginseng; 10.5-105 mg of ginger root; 18-190 mg of Mucuna Pruriens extract; 5-53 mg of Sam-E; 14-145 mg of Cordyceps Militaris; 22-225 mg of Lion's Mane; 6-60 mg of L-theanine; 12-120 mg of caffeine; 14-25-150 mg of Cordyceps Sinesis.
13. The composition of claim 12 comprising, per dose: 50-187.5 mg of oxiracetam; 1.2-4.5 mg of N-Phenylacetyl-L-prolylglycine ethyl ester; 5.8-22 mg of panax ginseng; 14-52.5 mg of ginger root; 25-94 mg of Mucuna Pruriens extract; 7-25 mg of Sam-E; 19-72 mg of Cordyceps Militaris; 30-112 mg of Lion's Mane; 8-30 mg of L-theanine; 16-60 mg of caffeine; and 20-72 mg of Cordyceps Sinesis.
14. The composition of claim 13 comprising, per dose: about 62.5 mg of oxiracetam; about 1.5 mg of N-phenylacetyl-L-prolylglycine ethyl ester; about 7.3 mg of panax ginseng; about 17.5 mg of ginger root; about 31.25 mg of Mucuna Pruriens extract; about 8.75 mg of Sam-E; about 23.75 mg of Cordyceps Militaris; about 37.5 mg of Lion's Mane; about 10 mg of L-theanine; about 20 mg of caffeine; and about 23.75 mg of Cordyceps Sinesis.
15. The composition of claim 1 wherein the caffeine is a delayed release caffeine.
16. The composition of claim 15 wherein the delayed release caffeine is a delayed release caffeine 60 or a delayed release caffeine 80.
17. The composition of claim 1 further comprising non-medicinally active ingredients selected from fillers, flavors, preservatives, dyes, excipients, stabilizers, sweeteners, compacting agents, solubilizing agents, anti-flocculants, and gelling agents.
18. The composition of claim 1 in the form of a gummy, a capsule, or a tablet.
19. Method of improving alertness, physical endurance, sleep patterns, memory, perceptual acuity, and/or increasing energy in an individual in need thereof, comprising administering an effective amount of a compound of claim 1 to said individual.
20. Use of a compound of claim 1 for improvement of alertness, physical endurance, sleep patterns, memory, perceptual acuity, and/or for increasing energy.
Description
BRIEF DESCRIPTION OF FIGURES
[0050]
DETAILED DESCRIPTION
[0051] Unless otherwise explained, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Patent applications, patents, and publications referred to herein to assist in the understanding of the aspects described are herewith incorporated by reference in their entirety.
[0052] In understanding the scope of the present application, the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements. Additionally, the term “comprising” and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and/or steps. The foregoing also applies to words having similar meanings such as the terms “including”, “having” and their derivatives.
[0053] It will be understood that any aspects describing as “comprising” certain components may also “consist of” or “consist essentially of”, wherein “consisting of” has a closed-ended or restrictive meaning and “consisting essentially of” means including the components specified but excluding other components except for materials present as impurities, unavoidable materials present as a result of processes used to provide the components, and components added for a purpose other than achieving the technical effect of the invention.
[0054] All ranges given herein include the end of the ranges and also any intermediate range points, whether explicitly stated or not.
[0055] Terms of degree such as “substantially”, “about” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree should be construed as including a deviation of at least +/−5% of the modified term if the deviation would not negate the meaning of the word it modifies.
[0056] Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below. The abbreviation “e.g.” is used herein to indicate a non-limiting example. The word “or” is intended to include “and” unless the context clearly indicates otherwise.
[0057] Described is a composition comprising a unique formulation of ingredients, in specific ratio ranges. The composition is useful as a dietary supplement and/or a nutraceutical.
[0058] When taken, the composition provides a variety of advantageous effects, which may simulate the neurological experience of the microdosing of a psychedelic drug, such as psilocybin. The composition is safe for human consumption, preferably avoids the use of controlled or illegal substances (such as psilocybin) and may provide many beneficial effects. These effects may include: an energy boost, which may be a sustained energy boost lasting up to 6-8 hours; an enhancement of physical focus, clarity and precision; improved physical performance including for aerobic and non-aerobic exercise and competition, such as squash, racquetball, tennis, hockey, basketball, and other sports involving either or preferably both physical performance and mental acuity; improve overall performance baseline; improved mental acuity; improved visual acuity; improved auditory acuity; improved empathy and “connection” with other individuals; decreased anxiety; improved mental focus, including concentration, conscious awareness, mindfulness, and increased engagement and attentiveness; improved hand-eye co-ordination; better sleep; better focus; heightened flow state activation; improved mood state, including happiness, well-being, peace, calm, optimism, and reductions in depressive symptoms; improved health behaviours; improved creativity, including divergent thinking, curiosity, shifting perspectives, and openness; improved self-efficacy, including motivation, ambition, productivity, confidence, sense of agency; improved self-care, including introspection, meditation, and other behaviours facilitating mental health; improved energy, including alertness, wakefulness, and stimulation; social benefits, including extraversion, empathy, sense of connection, and verbal fluency; cognitive benefits, including cognitive enhancement, clarity of thought, and memory; reduced anxiety including social-anxiety; enhanced senses; improved cardiovascular endurance; reduced migraines and/or headaches; stress reduction; reduced sensitivity to trauma; reduced substance dependence; improved mood; and better short term memory. The effects may be felt without the typical side effects of stimulants, such as the “jitters” or a “crash”.
[0059] The composition may be taken orally, as a pill, powder, extract, or in a “gummy” form. It may be incorporated into a food or drink, or a lozenge or lollipop. In the form of a lozenge or lollipop, it may be administered orally, interbucally, or sublingually. In the form of a powder, it may be taken orally, or by means of internasal administration. The composition may be vaporized and inhaled.
[0060] The composition comprises: a racetam, for example, aniracetam, piracetam, oxiracetam, pramiracetam, and/or phenylpiracetam; N-phenylacetyl-L-prolylglycine ethyl ester; extract of Mucuna Pruriens; S-Adenosyl methionine; and caffeine. Optionally, the composition may further comprise any one or more of: Panax ginseng; Ginkgo biloba; ginger root; Cordyceps militaris; Lion's Mane; L-Theanine; and Cordyceps Sinesis. In some embodiments, the N-phenylacetyl-L-prolylglycine ethyl ester may be substituted with a second racetam. In some embodiments, the caffeine is a delayed release caffeine, such as delayed release caffeine 60 or delayed release caffeine 80.
[0061] In certain embodiments, the composition comprises, per dosage: 37.5-375 mg, for example, 50-187.5 mg, for example about 62.5 mg of oxiracetam; 0.9-9 mg, for example 1.2-4.5 mg, for example about 1.5 mg of N-Phenylacetyl-L-prolylglycine ethyl ester; 4.3-44 mg, for example, 5.84-22 mg, for example about 7.3 mg of panax ginseng; 10.5-105 mg, for example, 14-52.5 mg, for example, about 17.5 mg of ginger root; 18-190 mg, for example 25-94 mg, for example about 31.25 mg of Mucuna Pruriens extract; 5-53 mg, for example 7-25 mg, for example about 8.75 mg of Sam-E; 14-145 mg, for example 19-72 mg, for example about 23.75 mg of Cordyceps Militaris; 22-225 mg, for example, 30-112 mg, for example about 37.5 mg of Lion's Mane; 6-60 mg, for example 8-30 mg, for example about 10 mg of L-theanine; 12-120 mg, for example, 16-60 mg, for example 20 mg of Delayed Release Caffeine 60; and 14.25-150 mg, for example 20-72 mg, for example, 23.75 mg of Cordyceps Sinesis.
[0062] In certain embodiments, the composition comprises, as weight percent of active ingredients: 20-30%, preferably about 25% oxiracetam, 0.4-0.8, preferably about 0.6% Noopept, 2-4%, preferably about 3% Panax ginseng, 6-8%, preferably about 7% ginger root, 10-15, preferably about 13% Mucuna Pruriens Extract, 2-5%, preferably about 3.5% Sam-E, 8-12%, preferably about 10% Cordyceps Militaris, 12-18%, preferably about 15% Lion's Mane, 3-5%, preferably about 4% L-theanine, 6-10%, preferably about 8% delayed release caffeine, and 8-12, preferably about 10% Cordyceps Sinensis.
[0063] The combination of ingredients in the composition may provide unexpected effects that are enhanced over what would be expected from the ingredients acting alone or in combination. The effects may be additive, or synergistic. The specific ratio of ingredients is also tailored such that it may provide unexpected additional benefits. For example, the ingredients may act in concert with one another, or complement one another, in a herebefore unexpected manner.
[0064] The composition may also comprise non-medicinal ingredients, such as fillers, excipients, stabilizers, sweeteners, compacting agents, solubilizing agents, anti-flocculants, gelling agents, and the like.
EXAMPLES
Example 1: Manufacture of Gummy Dosages
[0065] Gummy dosages are increasingly popular. Typically, these are gelatin-based gels or gums, which are in the form of a teddy bear or other shape. These are often referred to as “gummy bears” or the like, and are of similar consistency and density as the popular children's candies.
[0066] 12 Compositions of the invention are manufactured utilizing the ingredients and quantities as described in Table 1, and the methodology described in below. Briefly, water is heated to 70 degrees C. and a suitable amount unflavored gelatin is added and mixed until dissolved. Corn syrup, pre-heated to 110 degrees C., is added to the gelatin mixture. The active ingredients as described in Table 1, in fine powder form, are then added and solubilized. Any desired wet ingredients, for example, flavors, preservatives, and dyes, or fillers, excipients, stabilizers are then added and the resulting solution is mixed until completely dissolved. The solution is decanted into 100 silicone gelatin molds and the gelatin allowed to cure at room temperature or light refrigeration for 12 to 18 hours or until set. The resultant gummies are removed from the molds and optionally tossed in sugar and/or another desired outer coating, such as citric acid or tartaric acid (for “sours”).
TABLE-US-00001 TABLE 1 1 2 3 4 5 6 7 8 9 10 11 12 Ingredient (g) Oxiracetam 6.2 6.2 6.2 5.0 3.7 37.5 18.8 10.3 5.7 6.5 Pramiracetam 0 0 6.2 0 0 0 0 0 15 0 0 0 Piracetam 0 6.2 0 0 0 0 0 10 0 0 0 Noopept 0.15 0 0.15 0.15 0.12 0.09 0.9 0.5 0 0.21 0.11 0.3 Panax 0 0 0.73 0.73 0.584 0.44 4.4 2.2 0 0.54 2.00 1.5 Ginseng Ginkgo 0 0 0 0 1.5 0 0 0 .8 0.53 0 0.2 Biloba Ginger Root 0 0 0 1.75 0 1.0 10.5 5.3 2 2.0 4.3 1.3 Mucuna 3.125 3.125 3.125 3.125 2.5 1.9 19.0 9.4 3 4.0 7.1 3.7 Pruriens Extract Sam-E 0.875 0.875 0.875 0.875 0.7 0.55 5.3 2.6 1 2.0 1.4 0.7 Cordyceps 0 0 0 2.375 1.9 1.40 14.3 7.1 2.5 4.0 1.0 5.4 Militaris Lion's Mane 0 0 0 3.75 3.0 2.20 22.5 11.2 4 5.0 10.3 3.7 L-theanine 0 0 0 1.0 0.8 0.6 6 3 1 0 1.5 3.0 Delayed 0 2.0 2.0 2.0 1.6 0.6 12 6 1 1 4.0 7.0 Release Caffeine 60 Delayed 2.0 0 0 0 0 0.6 0 0 1 1 0 0 Release Caffeine 80 Cordyceps 0 0 2.375 2.375 1.9 1.40 14.3 7.2 2 3.0 5.2 2.1 Sinesis
Example 2: Manufacture of Capsules
[0067] 12 compositions of the invention are manufactured utilizing the active ingredients and quantities as described in Table 1. Briefly, the active ingredients as described in Table 1 are obtained as or rendered into fine powders, and mixed in a blender to homogeneity. Methylcellulose fiber is added as required, to decrease “deadspace” and to harbor a consistent capsule. A powder mixer is used to homogenize the powder, which is then transferred to a capsule filling unit. 100 hard capsules are filled, then tumble coated, using conventional methods.
Example 3: Administration of Compound
[0068] The compounds made in Examples 1 and 2 are administered, daily to individuals, for one month. Individuals self-report various beneficial effects, including a decrease in challenging experiences associated with ADHD, improved energy, alertness, calmness, improved physical endurance, improved sleep, cognitive enhancement, improved mood, creativity, balanced energy without jitters or a crash, increased focus and achieving a flow state-like experience significantly more than placebo controls.
[0069] In product testing and customer feedback involving 22 participants (including both men and women and individuals between the ages of 18-55 in both the United States and Canada), individuals were asked to rate on a scale of 1-10, how much the administration of compound 4 of Table 1 improved their focus, mood, reaction speed, mental clarity, creativity, and reduced anxiety. The scores were tabulated and shown in
[0070] The above disclosure generally describes the present invention. Although specific terms have been used herein, such terms are intended in a descriptive sense and not for purposes of limitation.
[0071] All publications, patents and patent applications cited above are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety.
[0072] Although preferable embodiments of the invention have been described herein in detail, it will be understood to those skilled in the art that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.