Supplement, delivery method and device for said supplement

Abstract

A supplement formulation including a combination of vitamins, minerals, amino acids, and stimulants, and a delivery method and device for said supplement formulation. Caffeine is present in the supplement formulation in an amount of about 40-60 mg/ml, of which about 15-30 mg/ml is caffeine from coffee beans and about 15-30 mg/ml is caffeine from green tea extract. About 5-20 mg/ml caffeine from guarana seed extract may also be present. Such a delivery device provides the supplement to a mouth/throat area of a user where it is readily absorbed in the mouth/throat area of the user or ingested by the user.

Claims

1. A method of formulating a supplement formulation comprising steps of: 1) obtaining an extract containing caffeine from coffee beans; 2) obtaining an extract containing caffeine from green tea; 3) heating water to at least 140° F.; and 4) adding the extract containing caffeine from coffee beans and the extract containing caffeine from green tea to the water; wherein the formulation has a final concentration of caffeine between 40 and 60 mg/ml.

2. The method of claim 1, wherein the water is heated to about 160° F.

3. The method of claim 1, wherein caffeine from guarana seed extract is further added in step 4.

4. The method of claim 1, wherein no additional ingredients are added to the water before the caffeine is added, except for an optional preservative.

5. The method of claim 4, wherein additional ingredients selected from the group consisting of vitamins, minerals, flavoring agents, coloring agents, solvents, and mixtures thereof are added to the caffeine in solution under constant agitation.

6. The method of claim 1, further comprising adjusting the pH of the supplement formulation to be about 3-4.

7. The method of claim 5, further comprising adjusting the viscosity of the supplement formulation by addition of glycerin.

8. The method of claim 7, wherein the supplement formulation comprises about 15-25 mg/ml of caffeine from coffee beans, about 15-25 mg/ml of caffeine from green tea extract, and about 5-20 mg/ml of caffeine from guarana seed extract and is stable in liquid form.

9. The method of claim 7, wherein: the supplement formulation further comprises about 20-50 μg/ml of vitamin B12, about 15-20 μg/ml of vitamin B3, up to 1 μg/ml of vitamin B6, and up to 10 g/ml of taurine.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows a sprayer according to an embodiment of the present subject matter.

(2) FIG. 2 shows the mechanism of oral absorption of nutrients provided by embodiments of the present subject matter.

(3) FIGS. 3A and 3B shows the mechanism for delivery of the supplement formulation from the delivery device according to certain embodiments of the present subject matter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(4) The description of illustrative embodiments according to principles of the present subject matter is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description of embodiments of the subject matter disclosed herein, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present subject matter. Relative terms such as “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description only and do not require that the apparatus be constructed or operated in a particular orientation unless explicitly indicated as such. Terms such as “attached,” “affixed,” “connected,” “coupled,” “interconnected” and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. Moreover, the features and benefits of the subject matter are illustrated by reference to the exemplified embodiments. Accordingly, the subject matter expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features that may exist alone or in other combinations of features; the scope of the subject matter being defined by the claims appended hereto.

(5) This disclosure describes the best mode or modes of practicing the subject matter as presently contemplated. This description is not intended to be understood in a limiting sense, but provides an example of the subject matter presented solely for illustrative purposes by reference to the accompanying drawings to advise one of ordinary skill in the art of the advantages and construction of the subject matter. In the various views of the drawings, like reference characters designate like or similar parts.

(6) Throughout the application, where compositions are described as having, including, or comprising specific components, or where processes are described as having, including, or comprising specific process steps, it is contemplated that compositions of the present teachings can also consist essentially of, or consist of, the recited components, and that the processes of the present teachings can also consist essentially of, or consist of, the recited process steps.

(7) In the application, where an element or component is said to be included in and/or selected from a list of recited elements or components, it should be understood that the element or component can be any one of the recited elements or components, or the element or component can be selected from a group consisting of two or more of the recited elements or components. Further, it should be understood that elements and/or features of a composition, an apparatus, or a method described herein can be combined in a variety of ways without departing from the spirit and scope of the present teachings, whether explicit or implicit herein

(8) The use of the terms “include,” “includes”, “including,” “have,” “has,” or “having” should be generally understood as open-ended and non-limiting unless specifically stated otherwise.

(9) The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise.

(10) Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently described subject matter pertains.

(11) Where a range of values is provided, for example, concentration ranges, percentage ranges, or ratio ranges, it is understood that each intervening value, to the tenth of the unit of the lower limit, unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the described subject matter. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and such embodiments are also encompassed within the described subject matter, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the described subject matter.

(12) Throughout the application, descriptions of various embodiments use “comprising” language. However, it will be understood by one of skill in the art, that in some specific instances, an embodiment can alternatively be described using the language “consisting essentially of” or “consisting of”.

(13) For purposes of better understanding the present teachings and in no way limiting the scope of the teachings, unless otherwise indicated, all numbers expressing quantities, percentages or proportions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. In addition, where the use of the term “about” is before a quantitative value, the present teachings also include the specific quantitative value itself, unless specifically stated otherwise. As used herein, the term “about” refers to a ±10% variation from the nominal value unless otherwise indicated or inferred.

(14) Reference will now be made in detail to each embodiment of the present subject matter. Such embodiments are provided by way of explanation of the present subject matter, which is not intended to be limited thereto. In fact, those of ordinary skill in the art may appreciate upon reading the present specification and viewing the present drawings that various modifications and variations can be made thereto.

(15) In one aspect, the present subject matter relates to a portable delivery device configured to deliver a combination of stimulants, vitamins, amino acids, minerals, etc. orally. Preferably, the delivery device delivers a supplement formulation comprising a combination of caffeine, niacin (vitamin B3), vitamin B12, vitamin B6, guarana seed extract and taurine. The delivery device may further include a canister containing an amount of a supplement formulation. The supplement formulation may contain biologically active ingredients as well as additives, such as color, flavor and preservatives.

(16) Embodiments of the present subject matter have the following differentiating factors over existing energy supplements.

(17) A. Caffeine Content:

(18) Table 1 summarizes energy supplement products existing on the market in comparison to the supplemental formulation and delivery device of the present subject matter. Considering, for example, Instavit Energy Spray and Marz Reboot, both have proprietary blends of multiple ingredients that include a total of 28 mg solid blend ingredients in 1 ml of solution. It is estimated that the caffeine content in 1 ml is between 15 and 20 milligrams. In contrast, an embodiment of the present subject matter is a supplement formulation having a caffeine concentration of about 40-60 mg per 1 ml, stably in liquid solution. The stability in liquid solution of the caffeine in the supplement formulation was achieved through significant testing and experimentation to optimize solubility and stability. In attempts to achieve a desired caffeine concentration of 40-60 mg caffeine per ml using any single caffeine source, 99% of caffeine precipitated as solids out of solution in a matter of days. Surprisingly, it was found that a caffeine concentration of 40-60 mg caffeine per ml could be achieved in stable solution by using multiple sources of caffeine. An embodiment of the present subject matter is to combine caffeine from at least two sources to achieve the caffeine concentration in the desired range: i. 15-30 mg per ml of caffeine from coffee beans; and ii. 15-30 mg per ml of caffeine from green tea extract.
In this regard, the desired range of caffeine concentration can be obtained by using 20-30 mg per ml of caffeine from coffee beans and 20-30 mg/ml of caffeine from green tea extract.

(19) In another embodiment, the present supplement formulations have a combination of caffeine from at least three sources to achieve the caffeine concentration in the desired range: i. 15-25 mg per ml of caffeine from coffee beans; ii. 15-25 mg per ml of caffeine from green tea extract; and iii. 5-20 mg per ml of caffeine from guarana seed extract.
In this regard, the desired range of caffeine concentration can be obtained by using 15-25 mg per ml of caffeine from coffee beans, 15-25 mg/ml of caffeine from green tea extract, and 5-15 mg per ml of caffeine from guarana seed extract. In another embodiment, 10-20 mg per ml of caffeine from guarana seed extract can be used.

(20) In some alternative embodiments, the caffeine concentration can be about 30-45 mg of caffeine per ml, using a combination of caffeine from coffee beans and green tea extract, while maintaining the mixture in stable liquid form.

(21) In addition, it is to be noted that the amounts of caffeine present in the instant formulations represent the amount of active caffeine from each source. The amounts indicated do not include amounts of non-active caffeine from each source material. Thus, for example for guarana seed extract, a higher amount of guarana seed extract in total may be used to obtain the desired amount of the active caffeine component.

(22) Further methodological details allowing for optimal stability of the supplement formulation with a desired high caffeine concentration are as follows:

(23) Appropriate solvent, preferably water, is heated before any active ingredients are added, preferably to a temperature of at least 140° F. Caffeine from at least two different sources are added to the water in quantities to achieve a final concentration in the heated water of 30-60 mg/ml of caffeine, and preferably from 40-60 mg/ml of caffeine. The at least two different sources are preferably selected from a group of natural caffeine sources, such as of coffee beans and green tea extract. In some embodiments, the at least two different sources of caffeine can further comprise a third caffeine source, guarana seed extract. In an embodiment, caffeine from at least all three sources of caffeine may be added to achieve a final concentration of caffeine in the range of 40-60 mg/ml.

(24) In one embodiment, caffeine from coffee beans should be added to a concentration of 20-30 mg/ml and caffeine from green tea extract should be added to a concentration of 20-30 mg/ml. In another embodiment, caffeine from coffee beans should be added to a concentration of 15-25 mg/ml, caffeine from green tea extract should be added to a concentration of 15-25 mg/ml and caffeine from guarana seed extract should be added to a concentration of 5-20 mg/ml. In an embodiment, the caffeine from coffee beans can be from green coffee beans. Caffeine from other sources of caffeine, natural and synthetic, may additionally be added; however, synthetic caffeine anhydrous, for example, was found to be less soluble than the above listed natural caffeine sources.

(25) After adding caffeine, the solution is blended, which blending is preferably maintained while additional ingredients are added. Additional ingredients added may be chosen from a group of biologically active ingredients including, but not limited to, vitamins and minerals, including vitamins B3, B6 and B12, Taurine and Guarana seed extract. Additional additives may be added, such as coloring agents, flavoring agents (e.g., sweeteners) and compatible solvents. In one embodiment, a pH of the supplement formulation is adjusted to a range of pH 3-4. A viscosity of the supplement formulation may be increased by addition of glycerin. Various mixtures and combinations of any of the above may be added, as appropriate.

(26) If a preservative is to be added to the final supplement formulation, said preservative may be added before or after heating of water, but before adding caffeine.

(27) The supplement formulation may be formulated at a large scale, for example in batches of around 50 gallons, or around 6000 units, and bottled for delivery. During formulating and bottling of the supplement formulation, the supplement formulation should be continuously agitated to maintain ingredients in solution. In one embodiment, the supplement formulation has a final density of 8 lb/gallon.

(28) The supplement formulation made according to the method of the above embodiment may be delivered by a delivery device according to the present specification or by another appropriate delivery method, such as a dropper, measuring spoon or an existing cosmetic or pharmaceutical delivery container, e.g., cosmetic spray or pump bottle.

(29) In comparison, typical caffeine content of prominent existing energy drinks are: i. Red Bull: Approximately 80 mg caffeine in approximately 250 ml, equaling 0.32 mg caffeine per milliliter. ii. 5 Hour energy: Approximately 200 mg caffeine in approximately 60 ml, equaling 3.3 mg caffeine per milliliter.

(30) The caffeine content of the supplement formulation according to the above embodiments of the present subject matter is significantly higher on a per ml basis than relevant existing products, and importantly, by a factor of at least 2-3 times relative to the closest existing caffeinated concentrate (see Table 1).

(31) B. Spray Volume:

(32) Other energy sprays in the market that deliver stimulants via an oral spray form deliver insufficient caffeine content per spray for efficient and convenient effective use.

(33) For example, Marz Reboot and Instavit each requires 4-7 sprays per serving, with a volume dispersed per spray being in the range of 0.1 ml to 0.15 ml.

(34) For the supplement formulation formulated according to the methods of the above embodiments and delivered as an oral spray using the delivery device of the present subject matter, the oral spray can be delivered between about 0.4 ml and about 1.0 ml per spray, giving 3-7 times greater volume dispersed per spray. In some embodiments, the present oral spray can be delivered between about 0.4 ml and about 0.7 ml per spray. In other embodiments, the present oral spray can be delivered at about 0.5 ml per spray

(35) By providing the supplement formulation with improved stability of caffeine in solution allowing for greater caffeine concentration and with physical properties such that the delivery device delivers increased spray volume per spray, an embodiment of the present subject matter delivers approximately 6-20 times greater caffeine per spray than the closest relevant existing products.

(36) Table 1 below provides a summary of comparable features of embodiments of the present subject matter over existing products:

(37) TABLE-US-00001 TABLE 1 Feature comparison of existing energy supplement products Present 5 Hr Marz Black Bear Subject Red Bull Energy Spray Instavit Gevitta Sparx Spray Matter Year Founded 1987* 2002 2014 2015 2014 2017 2017 2017 Format: Drink Shot Spray Spray Spray Spray Spray Spray Serving Size: 8.4 oz 1.93 oz 1 ml 0.5 ml 0.5 ml 0.90 grams 0.8 ml 1.5 ml (1 oz) Per Unit 1 serving 2 servings 30 servings 28 servings 15 servings 33 servings 31 Servings 20 servings Per Serving: CAFFEINE FREE Serving unit 1 drink 2 servings 7 sprays 4 sprays 8 sprays 6 sprays 5 sprays 3 sprays in 1 shot (1 ml) bottle Caffeine 80 mg 200 mg - Undisclosed: Undisclosed undisclosed Undisclosed: 0 75 mg 240 mg <28 mg <30 mg <90 mg in extra blend blend blend strength (caffeine (caffeine (caffeine est. est. est. under 20) under 20) under 30) B3 (Niacin) 20 mg 30 mg 0 0.5 mg undisclosed 0 2.8 mg  24 mg (100%)  (150%)   (3%)     (14%)  (150%) B6 4.5 mg 40 mg 0.67 mg 0 undisclosed 0 0.9 mg 4.9 mg (250%) (2000%) (33%)     (45%)  (288%) B12 4 μg 500 μg 0 50 μg 0 500 μg 2500 μg 75 μg  (80%) (8333%) (800%) (8000%) (41,000%) (3125%) Taurine: unknown Blended, Blended None undisclosed 0 0 75 mg high mg of Caffeine N/A N/A 2.86 5 undisclosed 5 0 25 per spray (Approximates) Servings to 1 Bottle 0.4 28 16 undisclosed 16 Infinity 3.2 achieve 80 mg Caffeine (Approximates) Caffeine per extra 1 ml appx. 0.3 strength Est. Est. undisclosed Est. at 25 0.00 50 mg/ml mg/ml at 4.0 under 20 under 20 entirely mg/ml mg/ml mg/ml mg/ml

(38) In at least one embodiment of the present subject matter, the metered dose dispensed by the delivery device is as follows: Approximate dosage volume: 1 ml 40-60 mg of caffeine 20-50 μg of B12 15-20 μg of B3 Up to 1 μg of B6 Up to 10 g of Taurine 100 mg of Guarana seed extract Solvent(s) Flavoring agents Sweetener(s) pH of 3-4 Density of about 8 pounds per gallon

(39) It is intended that the spray will be absorbed by, e.g., the intestinal tract. The spray can be administered frequently throughout the day on an as-needed basis. Preferably, a user will not exceed 2-3 sprays in any 4-hour period, depending on the strength and contents of the supplement mixture.

(40) In one embodiment, the delivery device can have a housing, first end, second end, opening, canister, supplement mixture, spray mechanism/actuator, flow grate, cavity, first section and second section.

(41) In another embodiment, the delivery device may have a receptacle and a spray cap, whereby depression of the spray cap causes a metered spray (about 0.4 ml to about 0.7 ml) of the supplement formulation to be emitted onto a surface or into the surrounding environment.

(42) The housing may be a singular structure or consist of two or more sections. These sections join to form a cavity where the canister resides. A receptacle in the cavity may be used to join or couple the canister to the housing.

(43) The housing can have an opening disposed in either of the first or the second end. The opening can be shaped and configured to accommodate a mouth of a user and direct the spray into the mouth of the user. A flow grate may further serve to direct the spray to the user's mouth and to prevent the passage of any larger or undesirable materials which may be caught up in the spray to not enter the mouth of the user. In some embodiments, the housing may be separated to allow for a new canister to be inserted into the device and in other embodiments allow for the removal and refilling of the canister. The canister may then be reinserted.

(44) The canister can be in the shape of a cylinder. In some embodiments, the canister can contain about 60 sprays, or a total capacity of between about 24 ml and 42 ml. The canister can further have an actuator that, when depressed, enables the supplement mixture to be dispensed in a metered spray. The canister can further be configured to reside in a cavity of the housing as described herein.

(45) In one embodiment, a user can hold the delivery device at a distance from the user's mouth or covers the opening of the device with the user's mouth and activate the actuator of the cylinder or canister. The supplement mixture is then released in the form of a spray. The actuator may be activated by depressing the canister or a portion of the housing of the device. In other embodiments, depressible buttons may be utilized. In one embodiment, the spray has a desired average particle size greater than 10 μm, thereby preventing the spray from passing into an airway of the user.

(46) In an embodiment, the delivery device is shaken by the user immediately prior to spraying, thereby avoiding any possible sedimentation of the supplement formulation contained therein. This has the dual benefit of maximizing the uniformity of spray composition and avoiding any clogging of the delivery device.

(47) C. Delivery Device Structure and Function:

(48) Presently, existing nutraceuticals and dietary supplements delivered in a spray format utilize a standard sprayer in a standard bottle. FIG. 1 shows various views of the delivery device according to one embodiment of the present subject matter. The delivery device according to an embodiment of the present subject matter is unique at least for comprising the following three elements: i. a bottle bottom that contains the supplement formulation; ii. a sprayer comprising an accordion shaped element, referred to hereafter as an accordion, which is flexible and can be depressed; and iii. a bottle top that, with the bottle bottom, completely conceals a sprayer inside.

(49) When depressed, the bottle top pushes down on the accordion and a spray hole in the bottle top moves synchronously with the sprayer head to disperse the supplement formulation. The sprayer is screwed or crimped into the bottom of the bottle; the accordion is snapped into the bottom of the bottle and the bottle top is snapped into the accordion, making the bottle a single unit that does not come apart. The sprayer is concealed to the eye when the delivery device is assembled as described. This sprayer is designed or configured to deliver between 0.4 ml and 1.0 ml per spray, such that it is most suitable for delivering the supplement formulation in accordance with the present subject matter. In an embodiment, the sprayer is configured to deliver 0.5 ml per spray. Accordingly, the sprayer has a larger orifice size than is typical for a liquid supplement sprayer, to accommodate the larger amount of spray being delivered, as well as the particle size of the formulation being delivered. As such, sprayers typically used with, for example, lotions, can be used herein.

(50) While the present subject matter has been described at some length and with some particularity with respect to the several described embodiments, it is not intended that it should be limited to any such particulars or embodiments or any particular embodiment, but it is to be construed with references to the appended claims so as to provide the broadest possible interpretation of such claims in view of the prior art and, therefore, to effectively encompass the intended scope of the subject matter. Furthermore, the foregoing describes the subject matter in terms of embodiments foreseen by the inventor for which an enabling description was available, notwithstanding that insubstantial modifications of the subject matter, not presently foreseen, may nonetheless represent equivalents thereto.