Long lasting breath mint

Abstract

A long lasting breath mint including a carrier and a flavorant, wherein the carrier includes at least one of a high viscosity cellulose ether and a low viscosity cellulose either and an alginate. The carrier forms a gel upon contact with saliva. A tablet is placed in the mouth of user, whereupon the tablet is wetted with saliva. A surface of the tablet is converted to a gel resulting in a tablet having an outer gel layer and a core. The gel serves as an adhesive for adhering the tablet to mouth structure. The gel slows exposure of the core to moisture and also slows diffusion of flavorant into the mouth of the user with the gel resulting in a breath mint having an extremely long life prior to complete dissolution, e.g., greater than 30 minutes or longer.

Claims

1. A method of freshening breath of a user comprising the steps of: placing a tablet in the mouth of the user, said tablet comprising a carrier and a flavorant; wetting said tablet with saliva; converting a surface of said tablet to a gel resulting in an outer gel layer and a core; slowing exposure of said core to moisture with said gel; and slowing diffusion of said flavorant into the mouth of the user with said gel, wherein said step of slowing exposure comprises diffusing said flavorant through said gel for greater than 30 minutes, and wherein said gel comprises at least one of a high viscosity cellulose ether and low viscosity cellulose ether and an alginate.

2. The method according to claim 1 further comprising the step of: molding said gel layer to a mouth structure for assisting in adhering said tablet to said mouth structure with said gel.

3. The method according to claim 1 wherein said step of slowing exposure comprises: diffusing flavorant through said gel for greater than 1 hour.

4. The method according to claim 3 wherein said step of slowing exposure comprises: diffusing said flavorant through said gel for greater than 2 hours.

5. The method according to claim 1 wherein: said tablet further comprises an enhancer; and wherein said method further comprises a step of diffusing said enhancer through said gel.

6. The method according to claim 5 wherein: said enhancer is selected from a group consisting of vitamin D, chromium picolinate, Xylitol, vitamin B complex, and melatonin.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The accompanying drawings, together with the specification, illustrate exemplary embodiments, and together with the description serve to explain the principles of these embodiments.

(2) FIG. 1 schematically illustrates an embodiment of a compressed tablet of the invention.

(3) FIG. 2 schematically illustrates an embodiment of a microstructure of the compressed tablet of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(4) Particular embodiments of the invention are described below in detail for the purpose of illustrating its principles and operation. However, various modifications may be made, and the scope of the invention is not limited to the exemplary embodiments described below.

(5) As used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a flavoring agent” or “a colorant” encompasses a combination or mixture of different flavoring agents or colorants as well as a single flavoring agent or colorant.

(6) Embodiments of compositions disclosed herein provide exceptionally small oral dosage forms with long lifetimes. For example, some embodiments provide a slow-dissolving breath mint in the form of a microtablet with a diameter not greater than about 6.4 mm (0.25 inch) and a weight not greater than about 141 mg, which dissolves over at least about 2 hours when adhered to a user's gum, releasing flavor, freshening a user's breath, and moistening the user's mouth over the lifetime thereof. In contrast, typical slow release breath mints with similar lifetimes have over twice the weight. Furthermore, lifetimes of candy mints and the flavor release of chewing gums are typically measured in minutes rather than hours. Some embodiments of the microtablet further comprise enhancements, such as a nutritional supplement, a vitamin, a mineral, a coenzyme, a biologically active compound, or a combination thereof.

(7) FIG. 2 schematically illustrates a proposed structure of an embodiment of the microtablet 100. Without being bound by any theory, it is believed that each microtablet 100 comprises microscopic honeycomb-like cells 130. As illustrated in FIG. 2, each cell 130 comprises a carrier layer 132, which includes a carrier, and a nucleus 134, which includes substantially all of the one or more active ingredients. The carrier in the carrier layer 132 forms the gel layer 110 when contacted by moisture from a user's saliva. Cells 130 on the surface of the microtablet 100 protect cells 130 in the interior from the user's saliva. In FIG. 2, surface cells 130a in the process of dissolving are indicated by dashed lines. The active ingredients in the nucleus 134 remain dispersed in the gel layer 110, and become exposed to the user as the outer surface of the gel layer 110 dissolves in the user's mouth. Consequently, the microtablet 100 exhibits a slow or controlled release of the active ingredients in the nucleus 134 and a long lifetime for the microtablet 100.

(8) In some embodiments, the carrier comprises at least one cellulose ether and alginate. As discussed above, the carrier forms an adhesive gel in contact with moisture. In some embodiments, the composition comprises from about 19% to about 39% percent of the carrier by weight. In some embodiments, the composition comprises from about 16% to about 32% of the at least one cellulose ether, and from about 3% to about 7%, of the alginate.

(9) Examples of suitable cellulose ethers include, for example, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose (hypromellose, HPMC), carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose (HPC), and the like, and combinations thereof. Some embodiments, comprise hydroxypropyl methylcellulose. Some embodiments comprise hydroxypropyl methylcellulose and another cellulose ether.

(10) Examples of suitable alginates include sodium alginate, potassium alginate, alginic acid, algin, and combinations thereof. It is believed that the alginate contributes to the adhesion of the microtablet to the user's gum.

(11) In some embodiments, the active ingredient includes at least one flavorant. The at least one flavorant is of any type known in the art, for example, essential oils, natural flavorants, artificial flavorants, nature-identical flavorants, semi-synthetic flavorants, and the like. The at least one flavorant provides the composition with a desired flavor profile, for example, mint (spearmint), peppermint, cinnamon, wintergreen, licorice, citrus, lemon, orange, lime, vanilla, chocolate, strawberry, cherry, ginger, banana, and the like. Because flavor preferences vary by geography and/or culture, some embodiments of the composition comprise flavor profiles selected accordingly. Examples of suitable flavorants include menthol (peppermint) R-(−)-carvone (spearmint), methyl salicylate (wintergreen), cinnamaldehyde (cinnamon), anethole (hcorice/anise), vanillin (vanilla), and the like. In some embodiments, the at least one flavorant gives the composition breath freshening properties. In some embodiments, the at least one flavorant masks an undesired taste of another ingredient in the composition.

(12) In some embodiments, the at least one flavorant includes at least one sweetener. Suitable sweeteners include natural sweeteners and artificial sweeteners. Suitable natural sweeteners include sugars, monosaccharides, disaccharides, sugar alcohols, and other natural sweeteners, for example, glucose, fructose, sucrose, xylitol, sorbitol, and stevia. Suitable artificial sweeteners include, for example, aspartame, sucralose, neotame, acesulfame, potassium, and saccharin. In some embodiments, the at least one sweetener includes xylitol, which has a low glycemic index, is non-cariogenic (does not promote tooth decay). In some embodiments, the at least one sweetener is xylitol.

(13) In an aspect of the invention, a slow dissolving breath mint comprises (a) from about 10 to about 60 wt. % of a carrier, (b) from about to about 90 to about 40 wt. % of an active ingredient and (c) from 0 to about 20 wt. % of at least one conventional additive, based on the weight of the composition. In an aspect of the invention, the slow dissolving breath mint comprises (a) from about 20 to about 50 wt. % of the carrier, (b) from about to about 80 to about 50 wt. % of the active ingredient and (c) from 0 to about 20 wt. % of the at least one conventional additive, based on the weight of the composition. And in an aspect of the invention, the slow dissolving breath mint comprises (a) from about 30 to about 40 wt. % of the carrier, (b) from about to about 70 to about 60 wt. % of an active ingredient and (c) from 0 to about 20 wt. % of at least one conventional additive, based on the weight of the composition.

(14) In one embodiment, the mint of the invention includes an enhancement that is a sensate agent. Sensate agents provide cooling, tingling, heat or the like. Representative cooling agents include, without limitation, carboxamides, menthol and ketals, and diols. In one aspect the cooling agent is a paramenthan carboxyamide agent, such as N-ethyl-p-menthan-3-carboxamide, known commercially as “WS-3”, N,2,3-trimethyl-2-isopropylbutanamide, known as “WS-23,” and mixtures thereof. Additional cooling agents include menthol, 3-1-menthoxypropane-1,2-diol known as TK-10 manufactured by Takasago, menthone glycerol acetal known as MGA manufactured by Haarmann and Reimer, and menthyl lactate known as Frescolat® manufactured by Haarmann and Reimer. Representative heating agents include, without limitation, capsaicin. Representative tingling agents include, include without limitation, cinnammic aldehyde.

(15) The breath mint of the invention may be in the form of a microtablet (microtab), tablet, lozenge, pastille, troche, or dragee. In some embodiments, a microtablet is manufactured by directly compressing a powder form of the composition between dies. In some embodiments, the microtablet is coated, while in other embodiments the microtablet is uncoated.

(16) To provide contact for the user, the breath mint of the invention is of a small size. In one embodiment, a longest dimension of the microtablet is about 10 mm, about 9 mm, about 7 mm, about 6 mm, 5 mm, or about 4 mm. In some embodiments, the microtablet has a diameter of about 6.4 mm (0.25 in). In some embodiments, a thickness of the microtablet is about 5 mm, about 4.9 mm, about 4.8 mm, about 4.7 mm, about 4.6 mm, about 4.5 mm, about 4.4 mm, about 4.3 mm, about 4.2 mm, about 4.1 mm, or about 4 mm. The microtablet dimensions or size is preferably sufficiently small to comfortably fit entirely between a user's inner cheek and gum. Preferably, the microtablet is sized sufficiently small as to be unnoticed by the user over its lifetime when adhered to the user's gum, for example, while speaking. The adhesion of the microtablet adheres to the user's gum to reduce migration thereof.

(17) Some embodiments of the microtablet have a mass of less than about 250 mg, less than about 200 mg, less than about 190 mg, less than about 180 mg, less than about 170 mg, less than about 160 mg, less than about 155 mg, less than about 150 mg, less than about 145 mg, less than about 144 mg, less than about 143 mg, less than about 142 mg, less than about 141 mg, less than about 140 mg, less than about 139 mg, less than about 138 mg, less than about 137 mg, less than about 136 mg, less than about 135 mg, less than about 134 mg, less than about 133 mg, less than about 132 mg, less than about 131 mg, or less than about 130 mg.

(18) In some embodiments, when the microtablet is adhered to a user's gum, it dissolves over the course of at least 30 minutes, at least one hour, at least two hours, at least three hours, at least four hours, at least five hours, at least six hours, at least seven hours, at least eight hours, at least nine hours, or at least ten hours. In some embodiments, the microtablet dissolves at a faster rate when administered in a different manner, for example, in a user's mouth but not adhered to the gum, where a user is likely to suck on the microtablet. For example, some embodiments that take at least about 2 hours to dissolve when adhered to the gum dissolve over from about 30 minutes to about 90 minutes when not adhered to the gum. In some embodiments, this slow dissolution or long lifetime of the microtablet provides a slow or extended release of one or more active ingredients thereof, for example, a flavor component or enhancement. Suitable flavor components include, for example, flavorants and/or sweeteners. Other examples of suitable active ingredients include enhancements, such as nutritional supplements, vitamins, minerals, co-factors, biologically active compounds, and the like.

(19) In some embodiments, the active ingredient is a probiotic product making up 30 wt. % to 90 wt. % of the composition in addition to a minimum of 1 wt. % to 3 wt. % or greater of flavorant.

(20) In some embodiments, moisture from a user's saliva activates an adhesive that allows the microtablet to adhere to the gum and converts a surface of the microtablet 100 into a gel layer 110, as illustrated in FIG. 1, thereby generating a segmented gel comprising an outer gel layer 110 and a solid core 120. In some embodiments, the gel layer 110 forms over the course of from about 30 minutes to about 1 hour. As the microtablet 100 dissolves, the core 120 shrinks, the outer surface thereof adding to the gel layer 110 as illustrated in FIG. IB. The gel layer 110 has several functions. The gel layer 110 improves the mouth-feel of the microtablet 100, when attached to a user's gum, over the course of its several-hour lifetime compared with a completely solid formulation by cushioning the solid core 120 from the user's mouth, thereby contributing to the comfort of the microtablet. The gel layer 110 is also believed to control moisture diffusion from a user's mouth to the core 120, thereby preventing premature disintegration of the microtablet 100, and therefore is at least partially responsible for the long lifetime of the microtablet. The gel layer 110 controls diffusion of the one or more active ingredients into the user's mouth, and consequently, provides controlled release of flavor components, resulting in long-lasting flavor. In some embodiments, the gel layer 110 also adheres the microtablet to the user's mucosa and/or gum.

(21) In some embodiments of the composition, enhancements may be provided, such as at least one nutritional supplement, vitamin, mineral, coenzyme, biologically active compound, or the like. Examples include acetyl L-carnitine, boswellia serrata extract, boswellia serrate resin, astaxanthin, benfotiamine, beta glucan, bergamot, black catechu heartwood, black currant, black rice, blueberry, boron, bromelain, calcium fructoborate, caffeine, chamomile, chinese skullcap root, chromium piccolinate, chondroitin sulfate, citrulline, cocoa, coenzyme Q10, copper glycinate, cordyceps, cranberry seed oil, curcumin, dang shen, DHA (docosahexaenoic acid), eleutherococcus senticosus, EPA (eicosapentaenoic acid), boswellia serrata extract, fisetin, vitamin B9, calcium fructoborate, γ″amino butyric acid, gamma tocopherol, glucosamine sulfate, grape seed, holy basil, hops strobile, hydrolyzed milk protein, krill oil, L-carnosine, lemon balm, L-arginine, L-theanine, lutein, magnesium, marigold flower, melatonin, curcumin phospholipid (Meriva® curcurmin phytosome, Thorne Research, Dover, Id.), methylsufonylmethane, n-acetylcysteine, nattokinase, niacin, niacinamide, omega-3 fatty acids, omega-6 fatty acids, omega-7 fatty acids, omega-9 fatty acids, low molecular weight polyphenol (Oligonol®, Amino Up Chemical, Japan), Panax ginseng, phosphatidylserine complex, pomegranate seed oil, potassium, quercetin, reishi, resveratrol, Rhodiola rosea (golden root), rutin, Salvia miltiorrhiza, sea buckthorn oil, Siberian ginseng, squid oil, taurine, tocopherols, tocotrienols, trypsin, turmeric, UC-II undenatured-type 2 collagen, Scutellaria baicalensis and Acacia catechu bioflavonoid extract (Univestin®, Unigen, Seattle, Wash.), valerian root, vitamin B complex, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3, zeaxanthin, and zinc.

(22) Some embodiments comprise an agent that provides a sensation to the user's mouth, for example, heating or cooling. An example of a heating agent is capsaicin. An example of a cooling agent is N-ethyl-p-menthane-3-carboxamide.

(23) Some embodiments of the composition comprise other ingredients, for example, release agents, anti-caking agents, lubricants, and the like.

(24) In an aspect of the invention, the carrier comprises (i) from about 30 to about 60 wt. % of a high viscosity hydroxypropylmethylcellulose (HPMC), (ii) from about 10 to about 40 wt. % of a low viscosity HMPC, (iii) from about 0.5 to about 25 wt. % of hydroxypropylcellulose (HPC), and (iv) from about 5 to about 35 wt. % of an alginate based on the weight of the carrier, where the total of the wt. %'s of (i)-(iv) equals 100. In an aspect of the invention, the carrier comprises (i) from about 35 to about 55 wt. % of the high viscosity HMPC, (ii) from about 15 to about 35 wt. % of the low viscosity HMPC, (iii) from about 1 to about 20 wt. % of the HPC and (iv) from about 10 to about 30 wt. % of the alginate where the total of the wt. %'s of (i)-(iv) equals 100. And in an aspect of the invention, the carrier comprises (i) from about 40 to about 50 wt. % of the high viscosity HMPC, (ii) from about 20 to about 30 wt % of the low viscosity HMPC, (iii) from about 5 to about 15 wt. % of the HPC and (iv) from about 15 to about 25 wt. % of the alginate, where the total of the wt. %'s of (i)-(iv) equals 100.

(25) In an aspect of the invention, the high viscosity HPMC is defined as one having a molecular weight of 60,000 or greater. Suitable high viscosity HPMC's include, without limitation, Dow Methocel® cellulose ethers E4M CR, E10M CR, K4M, K15M, and K100M. In another aspect of the invention, a low viscosity HPMC is defined as one having a molecular weight of 50,000 or less. Suitable low viscosity HPMC's include, without limitation, Dow Methocel® cellulose ethers E5, E15LV, E50LV, AND K100LV.

(26) In an aspect of the invention suitable HPC's include Ashland Klucel Nutra D®. Examples of suitable alginates include sodium alginate, potassium alginate, alginic acid, algin, and combinations thereof.

(27) In some embodiments, the formulation is manufactured by blending the components to provide a powder, which is converted into microtablets, for example, by direct compression. In some embodiments, the tableting is performed under a relatively high pressure. Consequently, in those embodiments, the ingredients of the composition are selected for compatibility with the tableting conditions.

(28) In one aspect of the invention, the breath mint additionally contains a colorant and/or other conventional additives. Suitable colorants include natural colorants, e.g., pigments and dyes obtained from mineral, plant, and/or animal sources. Examples of natural colorants include red ferric oxide, yellow ferric oxide, annattenes, alizarin, indigo, rutin, and quercetin. Synthetic colorants may also be used and may include an FD&C or D&C dye, e.g., an approved dye selected from the so-called “coal-tar” dyes, such as a nitroso dye, a nitro dye, an azo dye, an oxazine, a thiazine, a pyrazolone, a xanthene, an indigoid, an anthraquinone, an acridine, a rosaniline, a phthalein, a quinoline, or a “lake” thereof, i.e., an aluminum or calcium salt thereof. Useful colorants may be food colorants in the “GRAS” (Generally Regarded As Safe) category.

(29) Some embodiments of the composition comprise other conventional additives, for example, release agents, such as magnesium stearate, anti-caking agents, lubricants, and the like.

(30) In an aspect of the invention, the breath mint is formulated as a tablet, lozenge, pastille, troche, or dragee.

(31) It is another distinct advantage of the invention, that in one aspect, the dimensions or size of the compressed tablet is sufficiently small so that it comfortably fit entirely between a user's inner cheek and gum. And in some aspects, the compressed tablet is sized sufficiently small as to be unnoticed by the user over its lifetime when adhered to the user's gum, for example, while speaking.

(32) In an aspect of the invention, the breath mint is slow dissolving as measured by a paddle test. By paddle test is meant the following protocol:

(33) Paddle Test

(34) Fill a 250 ml beaker containing a stir bar with 200 ml of deionized water at pH 6.4.

(35) Place the beaker inside a water bath (for example, inside a 600 ml beaker filled with ca. 50 ml of water) equipped with a temperature measuring device) (for example, a thermometer taped to the inside of the 600 ml beaker).

(36) Place the entire apparatus on a hot plate stirrer (for example, a Corning Hot Plate Stirrer (Model PC--−220)) and stir at 60 cycles per minute until the temperature of the water bath is equilibrated to 37 C.

(37) Once these conditions are stable (60 cycles/min, 37 C), place 40 mg of the sample and measure the time it takes for the sample to dissolve.

(38) In some embodiments, the compressed tablet dissolves in more than 30 minutes, as measured by the paddle test; in some embodiments, the compressed tablet dissolves in more than one hour, as measured by the paddle test, in some embodiments, the compressed tablet dissolves in more than three hours, as measured by the paddle test, in some embodiments, the compressed tablet dissolves in more than four hours, as measured by the paddle test, in some embodiments, the compressed tablet dissolves in more than five hours, as measured by the paddle test, in some embodiments, the compressed tablet dissolves in more than six hours, as measured by the paddle test; in some embodiments, the compressed tablet dissolves in more than seven hours, as measured by the paddle test; in some embodiments, the compressed tablet dissolves in more than eight hours, as measured by the paddle test; in some embodiments, the compressed tablet dissolves in more than nine hours, as measured by the paddle test; and in some embodiments, the compressed tablet dissolves in more than five hours, as measured by the paddle test.

(39) In an aspect of the invention, moisture from a user's saliva may cause the compressed tablet to adhere to the user's gum. Without wishing to be bound by a theory of the invention, as illustrated in FIG. 1, it is believed that the saliva converts the surface of the compressed tablet 100 into a gel layer 110, thereby generating a segmented gel comprising an outer gel layer 110 and a solid core 120. In some embodiments, the gel layer 110 forms over the course of from about 30 minutes to about 1 hour. As the compressed tablet 100 dissolves, the core 120 shrinks, the outer surface thereof adding to the gel layer 110 as illustrated in FIG. 2. The gel layer 110 has several functions. The gel layer 110 improves the mouth-feel of the compressed tablet 100, when attached to a user's gum, over the course of its several-hour lifetime compared with a completely solid formulation by cushioning the solid core 120 from the user's mouth, thereby contributing to the comfort of the compressed tablet. The gel layer 110 is also believed to control moisture diffusion from a user's mouth to the core 120, thereby preventing premature disintegration of the compressed tablet 100, and therefore is at least partially responsible for the long lifetime of the compressed tablet. The gel layer 110 controls diffusion of the one or more active ingredients into the user's mouth, and consequently, provides controlled release of flavor components, resulting in long-lasting flavor. In some embodiments, the gel layer 110 also adheres the compressed tablet to the user's mucosa and/or gum.

(40) FIG. 2 schematically illustrates a proposed structure of an embodiment of the compressed tablet 100. Without being bound by any theory, it is believed that each compressed tablet 100 comprises microscopic honeycomb-like cells 130. As illustrated in FIG. 2, each cell 130 comprises a carrier layer 132, which includes a carrier, and a nucleus 134, which includes substantially all of the one or more active ingredients. The carrier in the carrier layer 132 forms the gel layer 110 when contacted by moisture from a user's saliva. Cells 130 on the surface of the compressed tablet 100 protect cells 130 in the interior from the user's saliva. In FIG. 2, surface cells 130a in the process of dissolving are indicated by dashed lines. The active ingredients in the nucleus 134 remain dispersed in the gel layer 110, and become exposed to the user as the outer surface of the gel layer 110 dissolves in the user's mouth. Consequently, the compressed tablet 100 exhibits a slow or controlled release of the active ingredients in the nucleus 134 and a long lifetime for the compressed tablet

(41) It is another distinct advantage of the compositions disclosed herein that they provide exceptionally small oral dosage forms with long lifetimes. For example, some embodiments provide a slow-dissolving breath mint in the form of a compressed tablet with a diameter not greater than about 6.4 mm (0.25 inch) and a weight not greater than about 141 mg, which dissolves over at least about 2 hours when adhered to a user's gum, releasing flavor, freshening a user's breath, and moistening the user's mouth over the lifetime thereof. In contrast, typical slow release breath mints with similar lifetimes have over twice the weight. Furthermore, lifetimes of candy mints and the flavor release of chewing gums are typically measured in minutes rather than hours.

(42) In some embodiments, the compressed tablet dissolves at a faster rate when administered in a different manner, for example, in a user's mouth but not adhered to the gum, where a user is likely to suck on the compressed tablet. For example, some embodiments that take at least about 2 hours to dissolve when adhered to the gum dissolve over from about 30 minutes to about 90 minutes when not adhered to the gum. In some embodiments, this slow dissolution or long lifetime of the compressed tablet provides a slow or extended release of one or more active ingredients thereof, for example, a flavor components or a nutritional supplement. In some embodiments, a compressed tablet is manufactured by directly compressing a powder form of the composition between dies. In one aspect, the compressed tablet is coated, while in another aspect the compressed tablet is uncoated.

(43) In an aspect of the invention, the compressed tablet is manufactured by blending the components in a suitable blender, such as a high intensity ribbon blender to provide a homogeneous powder. The resulting powder is allowed to set for a period of time sufficient to permit entrapped air to escape. The deareated power is then pelletize in a conventional pelleting machine. In an aspect of the invention, the deaerated powder is compressed at a pressure of from about 1,000 to about 7,500 psi and in an aspect of the invention, the deaerated powder is compressed at a pressure of from about 2,000 to about 4,000 psi.

(44) In some embodiments, the compressed tablet is coated, while in other embodiments the compressed tablet is uncoated.

Example 1

Breath Mint

(45) TABLE-US-00001 Ingredient Wt % Natural peppermint powder 35.7 N-Ethyl-p-menthane-3-carboxamide 4.8 Xylitol 11.4 Sucralose 2.1 High viscosity hydroxypropyl methylcellulose 17.6 (Methocel 100K) Low viscosity hydroxypropyl methylcellulose 8.8 (Methocel K4M) Hydroxypropylcellulose 5.3 (Klucel Nutra D) Sodium alginate 7.3 (Keltrone HVCR, NF) Magnesium stearate 2.3

(46) The ingredients were blended and tableted into 6.4 mm (0.25 in) diameter by 4.4 mm thick, 141 mg tablets. The tablets took at least about 2 hours to dissolve when attached to a user's gum.

(47) A breath mint was prepared by blending the all the ingredients in a high intensity ribbon blender to provide a homogeneous powder. The resulting powder was allowed to set for twelve hours until the entrapped air escapes. The deareated powder was then pelletized in a pelleting machine at a pressure of from about 4,000 psi to produce a breath mint weighing 141 mg and having circular cross section with a diameter of 6.4 mm.

Example 2

Breath Mint

(48) TABLE-US-00002 Ingredient Wt % Peppermint flavor 35.7 N-Ethyl-p-menthane-3-carboxamide 4.8 Xylitol 11.4 Sucralose 2.1 Hypromellose 26.6 Hydroxypropylcellulose 5.3 Sodium alginate 7.3 Magnesium stearate 2.3

(49) Paddle Test

(50) A paddle test was conducted to quantify the slow dissolution of the breath mint of the invention. A 250 ml beaker containing a stir bar and 200 ml of deionized water at pH 6.4 was placed inside a water bath (600 ml beaker filled with ˜150 ml of H2O). A thermometer was taped to the inside of the 600 ml beaker to monitor the temperature of the water bath. The entire apparatus was placed on a Corning Hot Plate Stirrer (Model PC--−220). Stirring was set to 60 cycles per minute and the temperature of the water bath was equilibrated to 37 C. Once these conditions were stable (60 cycles/min, 37 C), the breath mint was placed in the 250 ml beaker as a timer was started and the start time was recorded in a lab notebook. It took over 18 hours for the breath mint to dissolve.

(51) As a comparison, existing mints available on the market were also analyzed using a dissolution test. As can be seen from the test results below, the mints of the invention had a much greater life.

(52) TABLE-US-00003 ANALYSIS METHOD MDL Dissolution ARL 2.27* 1.0 ARL ID Description RESULT UOM 106017 Mints of the 240 Minutes invention 106012 Tic Tac Freshmints 26 Minutes 106016 Mintos 18 Minutes 106014 Altoids Wintegreen 17.75 Minutes Small 106015 Breath Savers 16.5 Minutes Peppermint 106013 Icebreakers 9.75 Minutes Notes: *60 cycles per minute, 37.4C, pH 6.44.

(53) Thus, the present invention is well adapted to carry out the objectives and attain the ends and advantages mentioned above as well as those inherent therein. While presently preferred embodiments have been described for purposes of this disclosure, numerous changes and modifications will be apparent to those of ordinary skill in the art. Such changes and modifications are encompassed within the spirit of this invention as defined by the claims.