Edible transmucosal drug delivery method using an intermediate capsule as a temporary vessel

Abstract

The present invention relates to a method for making an edible composition (e.g., a gummy or chocolate) for delivering a transmucosal formulation having at least one active ingredient, wherein the edible composition comprises an outer shell made from an edible material surrounding a center or pocket containing the transmucosal formulation. The method utilizes a capsule as a temporary carrier of the transmucosal formulation. During the manufacturing process and while encased in the outer shell made from the edible material, a control led-degradi ng formulation present in the fill formulation along with the transmucosal formulation gradually degrades the capsule leaving an edible composition with a pocket of liquid or semi-liquid transmucosal formulation. The controlled degrading formulation degrades the capsule so that its hardness is about equal to or less than that of the edible material hardness. The outer shell retains the transmucosal formulation in the pocket without leakage through the edible material.

Description

APPLICATION November 10, 2025 DocketNo.: 0318.0017002 -1- Edible Transmucosal Drug Delivery Method Using An Intermediate Capsule As A Temporary VesselRELATED APPLICATION(S)100011 This application claims the benefit of U.S. Provisional Application No. 63719762, entitled, “Edible Transmucosal Drug Delivery Method Using An Intermediate Capsule As A Temporary Vessel” by Mark C. Thompson et al., filed November 13, 2024.The entire teachings of the above application(s) are incorporated herein by reference.BACKGROUND OF THE INVENTION[00021 Chewable tablets and gums can be used for delivering active agents. Chewable tablets and gums often do not have liquid centers containing the active agent to be delivered transmucosally through the oral mucosa. Several active ingredients cannot be reliably delivered through oral mucosa in solid or powdered form.

[0003] As such, a need exists for an edible composition having a liquid or semi-liquid center with a transmucosal formulation through the oral mucosa. A further need exists to do so without leakage of the transmucosal formulation through the outer shell. Yet, a further need exists to have an edible composition that has a consistent hardness throughout the composition to make chewing it a more pleasant experience.SUMMARY OF THE INVENTION

[0004] The present invention relates to methods for making an edible composition for delivering a transmucosal formulation having an active ingredient. The transmucosal formulation product has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP. The edible composition has an outer shell made from an edible material surrounding the center having the transmucosal formulation. The method includes the step of filling a capsule with a fill formulation that includes the transmucosal formulation (having at least one active ingredient) and a controlled degrading formulation. This capsule serves as a temporary carrier to place the transmucosal formulation in the center and does so without leakage. The capsule is degraded or dissolved during the methodology of making the edible composition after the capsule is surrounded by the edible material. The temporary capsule is filled at a first temperature rangingDocket No. 0318.0017002-2- from about 32°F to about 90 °F. The capsule is degraded by the fill formulation at a second temperature ranging from about 91 °F to about 350 °F. The method includes the step of forming the outer shell from the edible material at the second temperature, wherein the edible material is in a liquid state, semi-liquid, or semi-solid state at the second temperature. During the method, the first temperature is less than the second temperature. The method further includes positioning the filled capsule in the edible material while the edible material is in the liquid state, semi-liquid, or semi-solid state, such that edible material encases the filled capsule, to thereby obtain an edible composition having an outer shell and an intact filled capsule. The method next includes allowing the edible composition having the outer shell and the intact filled capsule to sit for a time period (e.g., about 1 minute to about 48 hours) wherein the capsule is degraded such that the capsule hardness is about equal to or less than that of the edible material hardness, to thereby obtain the edible composition having the outer shell made from the edible material surrounding the center having the transmucosal formulation. The fill formulation does not degrade the edible material such that the outer shell is maintained; and the outer shell retains all or most of the transmucosal formulation in the center. In an embodiment, the capsule is degraded such that the capsule can no longer house the fill formulation. In an aspect, the capsule is degraded by a percentage ranging from about 30% to about 100%.[00051 In an embodiment, the method further includes a step of increasing the temperature of the edible composition having the outer shell and the intact filled capsule to a third temperature that ranges e.g., from about 91 °F to about 350 °F. In an embodiment the second temperature is less than the third temperature.[00061 Additionally, in an embodiment, the step of forming the outer shell from the edible material occurs in two or more stages, wherein a portion of the edible material is poured in each stage and wherein the filled capsule is repositioned to remain centered.[00071 In one aspect, the method can further include a step prior to filling the capsule that includes bathing the capsule in a solution to improve a mechanical barrier of the capsule. For example, if the capsule is a gelatin capsule, the solution can be a conditioning solvent that temporarily hardens or seals the capsule surface (e.g., ethanol, isopropyl alcohol, propylene glycol, glycerin, vegetable oil, or medium chain triglyceride oil). In certain manufacturing embodiments, non- ingestive processing solvents such as acetone or benzyl alcohol can be used and substantially removed prior to consumption.Docket No. 0318.0017002-3- [00081 In an embodiment, the edible material is present in the edible composition in an amount ranging from about 20% w / w to about 99% w / w of total weight of the edible composition. The transmucosal formulation is present in the edible composition in an amount ranging from, for example, about 1% w / w to about 80% w / w of the total weight of the edible composition. In another example, the active ingredient is present in an amount ranging from 0.001% w / w to 50% w / w of total weight of the edible composition. In one aspect, the fdl formulation includes a degrading agent in an amount ranging from about 0.5% w / w to about 99% w / w of the total weight of the fill formulation. In yet another aspect, the transmucosal formulation has a moisture content ranging from about 0% to about 60%.[00091 With respect to hardness, in an aspect, the capsule hardness before being bathed in an edible solvent, has a capsule hardness rating from about Shore A 10 to about Shore A 90, and after the capsule dissolves, the capsule has a hardness rating from about Shore 00 1 to about Shore 0085 or a hardness rating from about Shore A 0 to Shore A 50. In an embodiment, the edible material hardness has a hardness ranging from about Shore 00 1 to about Shore 0080 or a hardness rating from about Shore A from about 0 to about 40. In an aspect, once the capsule is degraded during the method of making the edible composition, the degraded capsule has a hardness that is similar to or less than that of the edible material.[00101 The outer shell of the edible composition is made from the edible material such as soft candy, gummies, chocolate, marshmallow, caramels, marzipan, toffees, fudges, jellybeans, or combination thereof. The transmucosal formulation of the edible composition is present as a liquid, emulsion, or gel. The capsule, in an embodiment, is made from a capsule material comprising gelatin, cellulose, starch, pullulan, Hydroxypropyl methylcellulose (HPMC), cellulose acetate phthalate (CAP), Polyvinyl acetate (PVA), or a combination thereof.[00111 The filled capsule, in one aspect, has a filled capsule density equal to or less than the edible material density. The filled capsule density, in an embodiment, ranges from about 0.3 g / cm3to about 1.5 g / cm3and the edible material density ranges, e.g., from about 0.7 g / cm3to about 1.8 g / cm3.[00121 In an embodiment, the controlled degrading formulation has two or more of an agent type wherein the agent type is a surfactant / emulsifier, a solvent, or a sugar. The solvent for use herein can include non-oil based solvents (e.g., water, glycerin, propylene glycol, isopropyl alcohol, ethyl alcohol, tetraglycol, diethylene glycol monoethyl ether, Polyethylene Glycol (PEG) 200, PEG-300, PEG-400, PEG-600, diethyl glycol, ethylene glycol, triethylene glycol,Docket No. 0318.0017002-4- butylene glycol, pentylene glycol, hexylene glycol, sorbitol, maltitol, xylitol, sucralose, sodium hyaluronate, sodium pyrrolidone carboxylic acid (PCA) or a combination thereof) and the like, and oil based solvents (e.g., oils, oleic acid, wax, fats, palm oil, beeswax, medium chain monoglyceride, coconut oil, medium chain triglycerides, vegetable oil, olive oil, grape seed oil, safflower oil, soy oil, castor oil, almond oil, avocado oil, sunflower oil, canola oil, flaxseed oil, hemp oil, pumpkin seed oil, sesame oil, jojoba oil, borage oil, evening primrose oil, poppy seed oil, marula oil, argan oil, rosehip oil, tamanu oil, kukui nut oil, moringa oil, pecan oil, walnut oil, cumin oil, caprylyl glycol) and the like. The surfactant or emulsifier, for use herein, can include Lecithin, Soy Lecithin, Sunflower Lecithin, Egg Lecithin, Polysorbate 80, Polysorbate 85, Polysorbate 65, Polysorbate 60, Polysorbate 40, Polysorbate 25, Polysorbate 20, Polysorbate 10, PEG-20 Elydrogenated Castor Oil, PEG-40 Elydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, PEG-30 Dipolyhydroxy stearate, PEG-7 Glyceryl Cocoate, PEG-8 Stearate, Disodium Sulfosuccinate, Sodium Lauryl Sulfate, Sodium Coco-Sulfate, Ammonium Lauryl Sulfate, Triethyl Citrate, Tributyl Citrate, Acetyl Tributyl Citrate, Triethyl Citrate, Sodium Stearoyl Lactylate, Calcium Stearoyl Lactylate, Glyceryl Stearate, Glyceryl Stearate SE, Glyceryl Stearate Citrate, Glyceryl Oleate, Polyglyceryl-4 Oleate, Polyglyceryl- 10 Oleate, Sorbitan Monostearate, Sorbitan Monooleate, Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Polyglyceryl-3 Polyricinoleate (PGPR), Steareth-20, Sodium Lauroyl Lactylate, Sorbitan Laurate, Sodium Methyl Cocoyl Taurate or a combination thereof.Additionally, the sugar for use as an agent type in the degrading formulation includes e.g., mannitol, sorbitol, corn syrup, fructose, sucrose, sucralose, xylitol, glucose, sugar alcohol, maltitol, erythritol, lactose, maltose, dextrose, agave syrup, maple syrup, honey, trehalose, isomalt, ribose, inulin, coconut sugar, date sugar, brown rice syrup, yacon syrup, barley malt syrup, molasses, sorghum syrup, apple juice concentrate, cane sugar, turbinado sugar, muscovado sugar, palm sugar, lucuma powder, monk fruit extract, stevia, blackstrap molasses, caramel syrup, golden syrup, fruit syrup, grapefruit juice concentrate, pear juice concentrate, cherry juice concentrate, pomegranate juice concentrate.[00131 The edible composition delivers an (e.g., one or more) active ingredient that is part of the transmucosal formulation and includes, for example, acetaminophen, acetohydoxamic acid, acetophenazine, acyclovir, albuterol, allopurinol, amiloride, amoxicillin, amphetamine, ampicillin, antisense polymers, atenolol, baclofen, beclomethasone, benfotiamine, betamethasone, budesonide, bumetanide, butorphanol, carbamazepine, carphenazine, celecoxib,Docket No. 0318.0017002-5- cefuroxime, cephradine, chloramphenicol, chlorothiazide, chlorzoxazone, cinoxacin, clorazepate, cioxacillin, cyclacillin, dapsone, dicloxacillin, diethylstilbestrol, dopamine, doxorubicin, erythropoietin, estradiol, fenoprofen, gabapentin, human growth hormone, hydralazine, hydrochlorothiazide, ibuprofen, indomethacin, insulin, isoproterenol, ketoprofen, levodopa, levothyroxine, meclofenamate, melphalan, metformin, methyl salicylate, metronidazole, minoxidil, morphine, nadolol, nalidixic acid, naproxen, nomifensine, norfloxacin, oxaprozin, oxycodone, paramethasone, peptide fragments, perphenazine, phenylpropanolamine, pregabalin, probenecid, quinethazone, ritodrine, scopolamine, serotonin, sildenafil, tadalafil, terbutaline, terfenadine, tocainide, terbinafine, triamterene, trimethoprim, valacyclovir, sirtuin inhibitors, nicotinamide, AIII, coumarin, sirtinol, alpha-NAD, carbamido- NAD, trichostatin A, suramin sodium, apicidin, BML-210, BML-266, depudecin, HC Toxin, ITSA1, nullscript, phenylbutyrate, sodium, scriptaid, splitomicin, suberoyl bis-hydroxamic acid, sirtuin activators, resveratrol, isonicotinamide, butein, luteolin, plant extracts, cannabidiol, cannabinoids, hemp, nicotine, hemp derived compounds, terpenes, or a combination thereof.[00141 In addition to the method, the present invention relates to an edible composition for delivering a transmucosal formulation having an active ingredient. The edible composition includes, in an example, an outer shell from the edible material having an edible material hardness, a center of the transmucosal formulation having the active ingredient, wherein the center is formed by a degraded capsule, wherein the outer shell surrounds the center; and a controlled degrading formulation. In an embodiment, the transmucosal formulation of the edible composition has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP, and the viscosity of the edible material of the edible composition at the second temperatures ranges from about 1500 cP to about 25,000 cP. In an aspect, the degraded capsule has a capsule hardness about equal to or less than that of the edible material hardness. In an aspect, the fill formulation does not degrade the edible material such that the outer shell is maintained; and the outer shell retains all or most of the transmucosal formulation in the center.[00151 In yet another embodiment the invention pertains to an edible composition for delivering a transmucosal formulation made as using the method described herein. The edible composition has an active ingredient wherein the transmucosal formulation has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP and the viscosity of the edible material of the edible composition at the second temperatures ranges from about 1500 cP to about 25,000 cP, wherein the edible composition comprises an outer shell made from an edible materialDocket No. 0318.0017002-6- surrounding a center having the transmucosal formulation. The fill formulation does not degrade the edible material such that the outer shell is maintained, and the outer shell retains all or most of the transmucosal formulation in the center.[00161 The edible composition can use any transmucosal formulation for delivering an active. In an embodiment, the transmucosal formulation has at least one mucolytic agent for thinning or decreasing viscosity of mucus, wherein the at least one mucolytic agent is present in an amount between 0.01% w / w and 2.0% w / w of the transmucosal formulation; at least one transmucosal formulation solvent; at least one proteolytic agent that cleaves or fragments long chain proteins to create cellular spacing of the stratified squamous epithelial layer, basement membrane, or a combination thereof, to allow passage of at least one vasodilatory agent and at least one active ingredient, wherein the at least one proteolytic agent is present in an amount ranging between 0.01% w / w to 10% w / w of the transmucosal formulation; at least one vasodilatory agent present in an amount ranging between 0.001% w / w to 15% w / w of the transmucosal formulation; and the active ingredient. In this embodiment, the transmucosal formulation allows for penetration of the active ingredient at the mucosal surface to the smooth muscle. Also in this embodiment, the transmucosal formulation has a pH of between about 4.5 and about 8. pH regulating agent include e.g., citric acid, hydrochloric acid, potassium hydroxide, sodium hydroxide, sodium carbonate, sodium bicarbonate, or any combination thereof. At least one transmucosal formulation solvent include, for example, at least one nonpolar solvent (e.g., carbon tetrachloride, benzene , diethyl ether , hexane , methylene chloride , toluene or a combination thereof), at least one polar aprotic solvent (e.g., is propylene carbonate, acetone, ethyl acetate , dimethyl sulfoxide, acetonitrile , dimethylformamide, or combination thereof), at least one polar protic solvent (e.g., water, methanol, isopropanol, acetic acid methanol, ethyl alcohol, n- propanol , n-butanol , or a combination thereof), at least one fatty acid (e.g., linoleic acids, linolenic acids, oleic acids, stearic acids, myristic acids, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, or a combination thereof), at least one limonene (e.g., D-limonene, L-Limonene, or a combination thereof), or combination thereof. In an alternative embodiment, the nonpolar solvent can be selected from edible or pharmaceutically acceptable nonpolar solvents and oils including MCT, edible vegetable oils (e.g., safflower, sunflower, olive), and limonene, or combinations thereof; non-ingestive processing solvents (e.g., acetone, methylene chloride) can be used only during manufacturing and are substantially removed prior to consumption as verified by residual-solvent testing compliant with applicableDocket No. 0318.0017002-7- pharmacopeial limits. Similarly, in an alternative embodiment, the at least one polar aprotic solvent is selected from edible or pharmaceutically acceptable polar aprotic solvents including propylene carbonate and ethyl acetate, or non-ingestive processing solvents including acetone, dimethyl sulfoxide, acetonitrile, and dimethylformamide, or combinations thereof; non-ingestive processing solvents may be used only during manufacturing and are substantially removed prior to consumption as verified by residual-solvent testing compliant with applicable pharmacopeial limits. In an embodiment, the transmucosal formulation includes a vasodilator that allows for the active ingredient to be delivered systemically or to local tissue. In an embodiment, the vasodilator is amrinone, arginine, bamethan sulphate, bencyclane fumarate, benfurodil hemi succinate, benzyl nicotinate, buflomedil hydrochloride, buphenine hydrochloride, butalamine hydrochloride, cetiedil citrate, ciclonicate, cinepazide maleate, cyclandelate, di isopropylammonium dichloroacetate, ethyl nicotinate, hepronicate, hexyl nicotinate, ifenprodil tartrate, inositol nicotinate, isoxsuprine hydrochloride, kallidinogenase, methyl nicotinate, naftidrofuryl oxalate, nicametate citrate, niceritrol, nicoboxil, nicofuranose, nicotinyl alcohol, nicotinyl alcohol tartrate, nitric oxide, nonivamide, oxpentifylline, papaverine, papaveroline, pentoxifylline, peroxynitrite, pinacidil, pipratecol, propentofylline, raubasine, suloctidil, teasuprine, thymoxamine hydrochloride, tocopherol nicotinate, tolazoline, xanthinol nicotinate, diazoxide, hydralazine, minoxidil, and sodium nitroprusside, clonidine, guanabenz, methyl dopa, alpha adrenoceptor, indoramin, phenoxybenzamine, phentolamine, prazosin, PDE-5 inhibitors, sildenafd, tadalafil, adrenergic neuron blocking agents, bedmidine, debrisoquine, guanethidine, ACE inhibitors, benazepril, captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, ganglion blocking agents, pentolinium, trimetaphan, calcium channel blockers, amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, verapamil, prostaglandins, prostacyclin, thrombuxane A2, leukotrienes, PGA, PGA1, PGA2, PGE1, PGE2, PGD, PGG, PGH, angiotensin II analogs, saralasin, nitroglycerin, labetalol, thiazide, isosorbide dinitrate, pentaerythritol tetranitrate, digitalis, hydralazine, diazoxide, sodium nitroprusside, or a combination thereof.

[0017] Unexpectedly, the present invention yields an edible composition that maintains a discrete liquid or semi-liquid transmucosal pocket without leakage, while simultaneously providing a uniform, chewable texture — a combination not achieved in conventional filled gummies or encapsulated confections. This dual outcome is achieved by using the temporary capsule as a transient scaffold — initially leak-proof during molding, then controllably softened or dissolvedDocket No. 0318.0017002-8- so its hardness becomes equal to or less than that of the surrounding shell. The result is a stable, homogeneous chew experience that conventional filled gummies or encapsulated candies do not provide.BRIEF DESCRIPTION OF THE DRAWINGS[00181 The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.[00191 Fig. l is a schematic showing the methodology of the present invention.DETAILED DESCRIPTION OF THE INVENTION[00201 A description of preferred embodiments of the invention follows.[00211 The present invention provides for an edible composition with a liquid or semi-liquid center having the transmucosal formulation that delivers an active agent or ingredient. The inventive method allows for the liquid or semi-liquid center to be housed by the edible outer shell without leakage. At the same time, the hardness of the capsule carrier is reduced during inventive manufacturing methodology 100 so that it is about equal to or less than that of the outer shell, which makes consuming the edible composition more pleasant (e.g., there is not a hard center shell to bite through). As described in the Summary, this process unexpectedly yields an edible composition that exhibits both a uniform chew texture and stable containment of a liquid or semi-liquid transmucosal core without leakage.[00221 There were several barriers that were overcome to arrive at the inventive manufacturing methodology 100. One barrier was that the transmucosal formulation which is in a liquid, semiliquid state was interacting with the edible material that makes the outer shell, such as com syrup and gelatin material of a gummy. Creating a “pocket” while pouring the edible material often led to leakages. Leakage or seepage impacts the dosage of the active in the transmucosal formulation, which should be precise. Further, using a traditional pill capsule to hold the transmucosal formulation was found to be an unpleasant experience when biting through a soft outer shell to then hit the hard shell of the traditional capsule since the hardness of the traditional capsule is greater than that of the outer shell.Docket No. 0318.0017002-9- [00231 The inventive manufacturing methodology 100 utilizes a capsule that temporarily holds the transmucosal formulation, which is degraded or dissolved during the manufacturing process, to leave the liquid center and soft outer shell without leakage.[00241 Referring to Fig. 1, the inventive manufacture methodology 100 makes an edible composition for delivering a transmucosal formulation having an active ingredient. The edible composition has an outer shell made from an edible material surrounding the center having the transmucosal formulation.[00251 The transmucosal formulation is described herein as being in liquid, semi-liquid, semi-solid state. Described in another way, the transmucosal formulation product has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP (e.g., about 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 1,000, 2,000, 3,000, 4,000, 5,000, 6,000, 7,000, 8,000, 9,000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000, 200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000, 1,000,000, cP). This range covers substances that are liquid to those that are soft. For example, this viscosity range covers substances such as water to pastes to shortening. In an instance, viscosity can be measured with a rotational viscometer (e.g., Brookfield LV) at 25 °C using spindle LV-1 to LV-4 at 10 rpm, or according to manufacturer’s instructions. Equivalent rotational methods may be used if they yield substantially the same value. Viscosity meters are commercially available from e g., AMETEK Brookfield (Middleboro, MA, USA). The transmucosal formulation of the edible composition is present as a liquid, emulsion, or gel.[00261 The method includes step 102 of filling a capsule (e.g., a temporary carrier / housing) with a fill formulation that includes the transmucosal formulation and a controlled degrading formulation. The fill formulation is defined herein as including at least the transmucosal formulation and the controlled degrading formulation. The transmucosal formulation can be any formulation that delivers an active ingredient through the mucosa. The components of the transmucosal formulation, in certain embodiments, are described further herein. The controlled degrading formulation can be any formulation that allows for (e.g., aids or controls) the degradation of the temporary capsule and is edible. In an embodiment, the controlled degrading formulation has two or more agent types including a surfactant / emulsifier, a solvent, or a sugar, as further described herein.[00271 This capsule serves as a temporary carrier to place the transmucosal formulation in the center and does so without leakages. The capsule is degraded or dissolved during the methodology ofDocket No. 0318.0017002-10- making the edible composition. The degradation occurs after the filled capsule is positioned within the edible material that becomes the outer shell, as premature degradation would cause leakage in the capsule. Interestingly, the controlled degrading formulation is in the fill formulation, and not in the edible material that becomes the outer shell. As such, the conditions (e.g., temperature) and components used, as further described herein, allow for controlled degradation of the capsule from within the capsule.[00281 The terms “capsule”, “carrier”, “temporary capsule”, “temporary carrier” or “temporary carrier capsule” are used interchangeably and refer to a housing that houses the fill material and degrades during the method of making the edible composition.[00291 The temporary capsule is filled at a first temperature. The first temperature is a temperature that allows the fill formulation to be housed by the capsule with no degradation or little or slow degradation of the capsule. The first temperature range depends on components of the fill formulation and the material from which the capsule is made. Put another way, the first temperature is a temperature that allows the capsule to house the fill formulation without leakage until the method of positioning the filled capsule in the edible material of step 106 (further described herein) is complete. In an example, the period of time between filling the capsule in step 102 and positioning the filled capsule in the edible material in step 106 ranges from about 1 minute to about 1 hour (e.g., about 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes). The first temperature, in an embodiment, ranges from about 32°F to about 90 °F (e.g., about 32 °F, 35 °F, 40 °F, 45 °F, 50 °F, 55 °F, 60 °F. 65 °F, 70 °F, 75 °F, 80 °F, 85 °F, 90°F). In step 108, as further described herein, the capsule is degraded by the fill formulation at a second temperature that is greater than the first temperature (e.g., the first temperature is less than the second temperature).[00301 In step 104, the inventive methodology 100 includes the step of forming the outer shell from the edible material at the second temperature. The second temperature, in an embodiment, is the temperature at which the filled capsule having the fill formulation sits in the edible material for a time period during which the capsule is degraded. The second temperature, in an embodiment, ranges from about 91 °F to about 350 °F (e.g., about 91 °F, 95 °F, 100 °F, 110 °F, 120 °F, 130 °F, 140 °F. 150°F, 160 °F, 170°F, 180 °F, 190 °F, 200°F, 210°F, 220 °F, 230°F, 240 °F. 250°F, 260 °F, 270 °F, 280 °F, 290 °F, 300°F, 310 °F, 320 °F, 330 °F, 340 °F. 35O°F). The edible material is in a liquid state, semi-liquid, or semi-solid state at the second temperature.Docket No. 0318.0017002-11- [00311 In an embodiment, the method further includes a step of increasing the temperature of the edible composition having the outer shell and the intact filled capsule to a third temperature that ranges e.g., from about 91 °F to about 350 °F. This step is optional and sometimes not necessary depending on the controlled degrading formulation, capsule and transmucosal formulation solvents used.[00321 In the embodiment in which the filled capsule having the filled formulation sits in the edible material for a period of time at a third (e g., higher) temperature, the use of a third higher temperature will depend on the type of degrading agent used in the controlled degrading formulation, the capsule material, and the temperature at which the degrading agent catalyzes the capsule. The third temperature, in an embodiment, ranges from about 91 °F to about 350 °F (e.g., about 91 °F, 92 °F, 95 °F, 100 °F, 110°F, 120°F, 130°F, I4O°F. 150°F, 160 °F, 170°F, 180 °F, 190 °F, 200°F, 210 °F, 220 °F, 230 °F, 240 °F. 250°F, 260 °F, 270 °F, 280 °F, 290 °F, 300°F, 310 °F, 320 °F, 330 °F, 340 °F. 350°F). In an embodiment, the third temperature is greater than the second temperature.[00331 Forming the outer shell from an edible material in step 104 can be accomplished, in an aspect, by using a mold and an edible material that is in liquid form at the second temperature, and then solidifies while cooling (e.g., at room temperature). The edible material is defined as any material that can be formed into a bite-size edible composition that is in a liquid state, semiliquid, or semi-solid state at the second temperature, and solidifies when cooled. “Cooled” refers to a temperature below 91 °F. The cooling temperature at which the edible material solidifies ranges from about 0°F to about 90°F (e.g., about 0 °F, 5°F, 10 °F, 15 °F, 20 °F, 25 °F, 30 °F, 32 °F, 35 °F, 40 °F, 45 °F, 50 °F, 55 °F, 60 °F. 65 °F, 70 °F, 75 °F, 80 °F, 85 °F, 90°F). In an embodiment, the second temperature, or third temperature, as applicable, gradually cools e.g., to room temperature, to allow the outer shell to cool into a solid state.[00341 Molding techniques for making edible foods are known in the art. An example of making a gummy or chocolate candy of the present invention includes combining the ingredients (e.g., sugar, gelatin, flavoring, extracts, syrup, molasses, honey, wax, chocolate, fat, butter, milk, cream, eggs, salt, citric acid, water, etc.), heating it, pouring the combined ingredients in a mold, positioning the filled capsule, and allowing it to set. The viscosity of the edible material at the second temperature ranges from about 1500 cP to about 25,000 cP (e.g., about 1500, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 6500, 7000, 7500, 8000, 8500, 9000, 9500, 10,000,Docket No. 0318.0017002-12- 12,000, 14,000, 16,000, 18,000, 20,000, 22,000, 24,000, or 25,000 cP). In an embodiment, the viscosity of the edible material is greater than that of the fill formulation and as such the fill formulation having the transmucosal formulation remains in the center as the capsule is degraded. For example, corn syrup has a viscosity of about 2,000 cP and about 3,000 cP, molasses has a viscosity ranging from about 5,000 to about 10,000 cP, and chocolate syrup has a viscosity ranging from about 10,000 to about 25,000 cP.[00351 The molds used can create edible compositions in any shape and size. Often, the sizes are bite-size and to allow one to comfortably fit the edible composition in the mouth (e.g., 0.25 inches, 0.50 inches, 0.75 inches, 1.25 inches, 1.50 inches, 1.75 inches, 2.0 inches or 0.635 centimeters, 1.27 centimeters, 1.905 centimeters, 3.175 centimeters, 3.81 centimeters, 4.445 centimeters, and 5.08 centimeters). As such, the outer shell of the edible composition is made from the edible material comprising soft candy, gummies, chocolate, marshmallow, caramels, marzipan, toffees, fudges, jellybeans, or combination thereof. Methods for making gummies are disclosed in patent publications, including US20200138704 and US20240032562, the entire teachings of which are incorporated by reference herein.100361 The outer shell formed in step 104 is made from the edible material and houses the transmucosal formulation and does so without leakage of the transmucosal formulation e.g., at “cooled” temperatures ranging from about 0 °F to about 90 °F ( about 0 °F, 5°F, 10 °F, 15 °F, 20 °F, 25 °F, 30 °F, 32 °F, 35 °F, 40 °F, 45 °F, 50 °F, 55 °F, 60 °F. 65 °F, 70 °F, 75 °F, 80 °F, 85 °F, 90°F). As such, once formed, the transmucosal formulation does not degrade the outer shell and the outer shell is able to remain intact and house the transmucosal formulation. The outer shell can range in thickness from about 1 mm to about 2 cm (e.g., about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.5 cm, and 2 cm) or about 0.04 inches to 0.79 inches (e.g., about 0.04 in, 0.08 in, 0.12 in, 0.16 in, 0.20 in, 0.24 in, 0.28 in, 0.31 in, 0.35 in, 0.39 in, 0.59 in, and 0.79 in).[00371 In an aspect, the edible material has a density that ranges from about 0.3 g / cm3to about 1.8 g / cm3(e.g., about 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, and 1.8 g / cm3). Similarly, once formed / cooled, the edible material hardness of the outer shell has a hardness rating from about Shore 00 1 to about Shore 0080 or has a hardness rating from about Shore A 0 to Shore A 40 (e.g., about Shore 00 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80 or about Shore A 0, 1, 2, 3, 4, 5, 6, 7, 8 9 10, 15, 20, 25, 30, 35, 40). Hardness can be measured using durometers that are commercially available e.g., fromDocket No. 0318.0017002-13- Starrett Global, Athol MA USA Model No. 38O5B Electronic Durometer - Shore A Scale or from PTC instruments (Los Angeles, CA USA) Model Durometer Shore 00 Scale PTC® Instruments Ergo Style #411.[00381 In Fig. 1, methodology 100 includes step 106 which involves positioning the filled capsule in the edible material while the edible material is in the liquid state, semi-liquid or semi-solid state at the second temperature, such that edible material encases the filled capsule. The positioning step allows the edible material to encase the filled and intact capsule. This step results in an edible composition having an outer shell and an intact filled capsule.[00391 The filled capsule, in one aspect, has a filled capsule density less than or about the same as the edible material density. A filled capsule density being less than or about the same as the density as that of the edible material into which it is placed allows the user to more easily position the capsule within the edible material. In an embodiment, the filled capsule is suspended in the edible material. In an embodiment, the filled capsule density ranges from about 0.3 g / cm3to about 1.5 g / cm3(e.g., about 0.3, 0.4, 0.5, 0.6, 0.70.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 g / cm3), whereas the edible material has a density that ranges from about 0.7 g / cm3to about 1.8 g / cm3(e.g., about 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, and 1.8 g / cm3).[00401 In an embodiment, the step of forming the outer shell from the edible material occurs in two or more stages, wherein a portion of the edible material is poured in each stage and wherein the filled capsule is repositioned to remain centered. For example, a portion of the outer shell can be poured into the mold and begin to form. The filled capsule can be positioned thereon and anchored to the edible material. Then additional edible material can be poured onto the first layer having the filled capsule, wherein the additional edible material covers or partially covers the filled capsule. The user / technician can reposition the filled capsule before the edible material cools to ensure it remains centered. If the filled capsule is not fully covered, additional edible material can be poured until the filled capsule is fully encased.[00411 Step 108 of Fig. 1 relates to allowing the edible composition having the outer shell and the intact filled capsule to sit for a time period. The time period can range from about 1 minute to about 48 hours (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 minutes, or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 24, 25, 30, 35, 40, 45, or 48 hours). During this period of time, the edible material cools to the cooling temperature. The cooling temperature at which the edible material solidifies ranges from about 0°F to about 90°F (e.g., about 0°F, 5°F, 10 °F, 15 °F, 20 °F, 25 °F, 30 °F, 32 °F, 35 °F, 40 °F, 45 °F, 50 °F, 55 °F, 60 °F. 65 °F, 70 °F, 75 °F, 80 °F, 85 °F, 90°F).Docket No. 0318.0017002-14- [00421 During methodology 100, the filled capsule is degraded such that the capsule hardness is about equal to or less than that of the edible material hardness. Since the capsule hardness is degraded to less than or about the same as that of the edible material, the consistency of the edible composition allows for a better experience for the user. For example, if the capsule remained at its original hardness, when the user bites into the edible composition, the user would feel or taste the “crunch” of the hard capsule. However, with the inventive composition, the user experiences the softness of the outer shell and a soft or liquid center with no “crunch.”[00431 The resulting edible composition has an outer shell made from the edible material surrounding the center or pocket having the liquid, semi-liquid, semi-solid transmucosal formulation. Additionally, the fill formulation does not degrade the edible material so the outer shell is maintained and stays intact. The outer shell retains all or most of the transmucosal formulation in the center or pocket.[00441 In an embodiment, during methodology 100, after it is encased in the edible material, the capsule, which serves as a temporary carrier, is degraded such that the capsule can no longer house the fill formulation. The edible material which is now the outer shell of the edible composition houses the transmucosal formulation which was included in the fill formulation. In an aspect, the capsule is degraded by a percentage ranging from about 30% to about 100%. (e.g., 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95% or 100%).[00451 With respect to hardness, in an aspect, the capsule hardness before being optionally bathed or conditioned in an edible solvent, has a capsule hardness from about Shore A 10 to about Shore A 90 (e.g., about Shore A 10, 15, 20, 25, 30, 3540, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90) and after the capsule is degraded by methodology 100 has a hardness rating / amount about that of the surrounding outer shell or a hardness rating of about Shore 00 1 to about Shore 0080 or from about Shore A 0 to Shore A 40 (e.g., about Shore 00 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80 or about Shore A 0, 1, 2, 3, 4, 5, 6, 7, 8 9 10, 15, 20, 25, 30, 35, 40)[00461 In one aspect, the method can further include a step prior to filling the capsule that includes bathing the capsule in a solution to improve a mechanical barrier of the capsule. For example, if the capsule is a gelatin capsule, the solution can be a conditioning solvent that temporarily hardens or seals the capsule surface (e.g., ethanol, isopropyl alcohol, propylene glycol, glycerin, vegetable oil, or medium chain triglyceride oil). In certain manufacturing embodiments, non- ingestive processing solvents such as acetone or benzyl alcohol may be used and substantiallyDocket No. 0318.0017002-15- removed prior to consumption. After bathing the capsule, the capsule hardness maintains or is better maintained, and has a hardness from about Shore A 10 to about Shore A 90 (e.g., about Shore A 10, 15, 20, 25, 30, 35 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90). In some cases, a bathed capsule provides a better barrier to retain the transmucosal formulation until the edible material is heated to the second or third temperature, as applicable. Even when bathed, fdled capsule does degrade to a hardness amount that is equal to or less than that of the edible material.[00471 In an aspect, once the capsule is degraded during the method of making the edible composition, the degraded capsule has a hardness that is equal to or less than the hardness of the edible material.[00481 The temporary capsule is degraded by a component of the fdl formulation that interacts with the material of the capsule to break it down. This component or components will depend on material from which the capsule is made.[00491 Capsules, in one aspect, used in the inventive methodology are those “hard” capsules that can be fdled with a liquid, semi-liquid, or semi-solid transmucosal formulation including suspensions and emulsions. They are also called liquid-fdled hard capsules. The flowable fdl materials are mixed with an active pharmaceutical ingredient. The capsule can be made from any safe and edible material known in the art or later developed. Most commercially available capsules are gelatin based or vegan based. Types of capsules, in an embodiment, include gelatin capsules, a vegetable-based cellulose, starch capsules (e.g., potato starch), pullulan capsules (e.g., fermented tapioca) and Polyvinyl acetate (PVA) capsules. The capsule, in an embodiment, is made from a capsule material comprising gelatin, cellulose, starch, pullulan, Hydroxypropyl methylcellulose (HPMC), cellulose acetate phthalate (CAP), Polyvinyl acetate (PVA), or a combination thereof.[00501 The capsules can be fdled with the fdl formulation using a machine or can be done manually and then sealed. In certain embodiments, a hard capsule is made from two halves, fdled and then sealed. In one aspect, the rim of one half is smaller in diameter than the other, so the other half s larger rim fits over it and seals the capsule. The two capsule halves are manufactured separately, then fdled using machinery or by hand.[00511 The controlled degrading formulation depends on the type of capsule and the transmucosal formulation solvent. Both the gelatin capsules and vegetarian based capsules are water soluble but they degrade during the methodology at different rates and temperatures. As such, inDocket No. 0318.0017002-16- selecting the capsule, the transmucosal formulation solvent and controlled degrading formulation are done in concert. For example, if a gelatin capsule is selected and the solvent of the transmucosal formulation is oil based, then water can be used as the degrading agent solvent to degrade the gelatin capsule. Since water is an effective solubilizing agent or degrading agent, an emulsifying agent (e.g., PEG-40 Hydrogenated) can be used. The emulsifying agent slows down the degrading process until exposed to the second and / or third temperature during the process, as the case may be. Similarly, when selecting a Hydroxypropyl methylcellulose (HPMC) vegetarian capsule and the solvent of the transmucosal formulation is oil based, water and / or ethyl alcohol can again be used as the degrading agent solvent. In addition to using an emulsifying agent such as PEG-40 Hydrogenated, a water insoluble agent such as castor oil can also be used to control the degradation of the capsule until exposing it to the second and / or third temperature. In the case in which a gelatin capsule is selected along with a non-oil based transmucosal solvent, any combination of emulsifying agents, surfactants, sugars and water insoluble agents are used to slow down the capsule degradation until the capsule is exposed to the second and / or third temperature. The following table exemplifies combinations of the transmucosal formulation solvent, capsule type, degrading agents that were used with the present invention:Docket No. 0318.0017002-17-[00521 Table 1:[00531 In an embodiment, the controlled degrading formulation has two or more of an agent type wherein the agent type is a surfactant / emulsifier, a solvent, or a sugar. One or more agent types can be used, one or more of the same agent type can be used, or any combination thereof.[00541 The controlled degrading solvent for use herein can include one or more non-oil based solvents so long as the solvent is edible and allows for the controlled degradation of the capsule. Such solvents include one or more solvents such as water, glycerin, propylene glycol, isopropyl alcohol, ethyl alcohol, tetraglycol, diethylene glycol monoethyl ether, Polyethylene Glycol (PEG) 200, PEG-300, PEG-400, PEG-600, diethyl glycol, ethylene glycol, triethylene glycol, butylene glycol, pentylene glycol, hexylene glycol, sorbitol, maltitol, xylitol, sucralose, sodium hyaluronate, sodium pyrrolidone carboxylic acid (PCA) or a combination thereof) and the like.Docket No. 0318.0017002-18- Any commercially available or known solvent can be used as the controlled degrading solvent so long as it is edible and allows for the controlled degradation of the capsule, as described herein.[00551 The controlled degrading solvent for use herein can include oil based solvents (e.g., oils, oleic acid, wax, fats, palm oil, beeswax, medium chain monoglyceride, coconut oil, medium chain triglycerides, vegetable oil, olive oil, grape seed oil, safflower oil, soy oil, castor oil, almond oil, avocado oil, sunflower oil, canola oil, flaxseed oil, hemp oil, pumpkin seed oil, sesame oil, jojoba oil, borage oil, evening primrose oil, poppy seed oil, marula oil, argan oil, rosehip oil, tamanu oil, kukui nut oil, moringa oil, pecan oil, walnut oil, cumin oil, caprylyl glycol) and the like. Any commercially available or known oil-based solvent can be used as the controlled degrading solvent so long as it is edible and allows for the controlled degradation of the capsule, as described herein.[00561 The controlled degrading solvent for use herein can include one or more surfactants or emulsifiers, for use herein. Such surfactants and emulsifiers include Lecithin, Soy Lecithin, Sunflower Lecithin, Egg Lecithin, Polysorbate 80, Polysorbate 85, Polysorbate 65, Polysorbate 60, Polysorbate 40, Polysorbate 25, Polysorbate 20, Polysorbate 10, PEG-20 Hydrogenated Castor Oil, PEG-40 Hydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, PEG-30 Dipolyhydroxystearate, PEG-7 Glyceryl Cocoate, PEG-8 Stearate, Disodium Sulfosuccinate, Sodium Lauryl Sulfate, Sodium Coco-Sulfate, Ammonium Lauryl Sulfate, Triethyl Citrate, Tributyl Citrate, Acetyl Tributyl Citrate, Sodium Stearoyl Lactylate, Calcium Stearoyl Lactylate, Glyceryl Stearate, Glyceryl Stearate SE, Glyceryl Stearate Citrate, Glyceryl Oleate, Polyglyceryl-4 Oleate, Poly glyceryl- 10 Oleate, Sorbitan Monostearate, Sorbitan Monooleate, Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Polyglyceryl-3 Polyricinoleate (PGPR), Steareth-20, Sodium Lauroyl Lactylate, Sorbitan Laurate, Sodium Methyl Cocoyl Taurate or a combination thereof. Any commercially available or known surfactants or emulsifiers can be used as the controlled degrading solvent so long as it is edible and allows for the controlled degradation of the capsule, as described herein.[00571 The controlled degrading solvent for use herein can include one or more sugars for use as an agent type in the degrading formulation and include e.g., mannitol, sorbitol, com syrup, fructose, sucrose, sucralose, xylitol, glucose, sugar alcohol, maltitol, erythritol, lactose, maltose, dextrose, agave syrup, maple syrup, honey, trehalose, isomalt, ribose, inulin, coconut sugar, date sugar, brown rice syrup, yacon syrup, barley malt syrup, molasses, sorghum syrup, apple juice concentrate, cane sugar, turbinado sugar, muscovado sugar, palm sugar, lucuma powder, monkDocket No. 0318.0017002-19- fruit extract, stevia, blackstrap molasses, caramel syrup, golden syrup, fruit syrup, grapefruit juice concentrate, pear juice concentrate, cherry juice concentrate, pomegranate juice concentrate. Any commercially available or known sugars can be used as the controlled degrading solvent so long as it is edible and allows for the controlled degradation of the capsule, as described herein.[00581 An active drug or an “active ingredient” refers to any component of the transmucosal formulation that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, amelioration, or prevention of a disease, condition or disorder. Further, an active ingredient or active chemical ingredient can include any plant extract, essential oil, isolate, distillate or biologic. Examples of active ingredients that are useful in the mucosal- applied pharmaceutical formulations and methods of the present invention include: antifungal agents; anti-inflammatory agents, such as non-steroidal anti-inflammatory drugs (NSAIDS) and steroidal anti-inflammatory drugs; antibiotics; antiviral agents; anti -neoplastic agents; anesthetics; systemic drugs; steroid hormones, such as estradiol and testosterone; agents, such as protectants, emollients; nutrients, such as vitamins; and others known to those skilled in the art (e.g., those ingredients listed by the U.S. Food and Drug Agency in “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)”, available at: https: / / www.fda.gov / drugs / drug-approvals-and-databases / approved-drug-products-therapeutic- equivalence-evaluations-orange-book that are suitable by those skilled in the art). In an embodiment, the active ingredient is capable of inducing a desired physiological effect on a targeted mucosa or other tissue other than solely a vasodilatory or vasoconstrictory effect.[00591 Specific examples of active ingredients for use in the edible composition include acetaminophen, acetohydoxamic acid, acetophenazine, acyclovir, albuterol, allopurinol, amiloride, amoxicillin, amphetamine, ampicillin, antisense polymers, atenolol, baclofen, beclomethasone, benfotiamine, betamethasone, budesonide, bumetanide, butorphanol, caffeine, carbamazepine, carphenazine, celecoxib, cefuroxime, cephradine, chloramphenicol, chlorothiazide, chlorzoxazone, cinoxacin, clorazepate, cioxacillin, cyclacillin, dapsone, dicloxacillin, diethylstilbestrol, dopamine, doxorubicin, erythropoietin, estradiol, fenoprofen, gabapentin, human growth hormone, hydralazine, hydrochlorothiazide, ibuprofen, indomethacin, insulin, isoproterenol, ketoprofen, levodopa, levothyroxine, lidocaine hydrochloride, meclofenamate, melphalan, metformin, methyl salicylate, metronidazole, minoxidil, morphine, nadolol, nalidixic acid, naproxen, nomifensine, norfloxacin, oxaprozin, oxycodone,Docket No. 0318.0017002-20- paramethasone, peptide fragments, perphenazine, phenylpropanolamine, pregabalin, probenecid, quinethazone, ritodrine, scopolamine, serotonin, sildenafil, tadalafil, terbutaline, terfenadine, tocainide, terbinafine, triamterene, trimethoprim, valacyclovir and any derivatives of these and combinations of the foregoing. The active ingredient can also be a sirtuin inhibitors such as nicotinamide, AIII, coumarin, sirtinol, alpha-NAD, carbamido-NAD, trichostatin A, suramin sodium, apicidin, BML-210, BML-266, depudecin, HC Toxin, ITSA1, nullscript, phenylbutyrate, sodium, scriptaid, splitomicin, or suberoyl bis-hydroxamic acid. Further, the active ingredient can be sirtuin activators such as resveratrol, isonicotinamide, butein, or luteolin. In addition, active ingredients can also be compounds extracted from plants including hemp and cannabis in all of their forms including essential oils, extracts or isolates. Therapeutic drugs or active ingredients now known, or developed in the future, can be used in inventive edible composition so long as the therapeutic drugs or active ingredients can be delivered to the vasculature of the mucosa or tissue underlying the mucosa.[00601 In some embodiments of the invention, the active ingredient comprises a biological agent.Examples of biological agents include peptides, small proteins and protein fragments; antibody fragments; small nucleic acids and nucleic acid fragments such as aptamers and siRNA; or combinations of these.[00611 In an embodiment, the active ingredient can be included in the inventive edible composition in sufficient concentration and in effective amounts to confer the desired effect of the active ingredient. The actual effective amounts of the active agent / ingredient or drug can vary according to the specific composition being utilized, the age, weight and condition of the patient. Dosages for a particular individual patient can be determined by one of ordinary skill in the art using conventional considerations, (e.g., by means of an appropriate, conventional pharmacological protocol). In an aspect, dosing will also depend on the therapeutic effect to be achieved for the disease state. In general, the amount of active ingredient present in the inventive formulation ranges from about ,001%w / w to about 50%w / w (e.g., .001, .005, .01, .05, .1, .5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10, 15, 20, 25, 30, 35, 40, 45, 50%w / w).[00621 The present invention relates to an edible composition for delivering a transmucosal formulation having an active ingredient. As described herein, the edible composition includes, in an example, an outer shell from the edible material having an edible material hardness, a center of the transmucosal formulation having the active ingredient, wherein the center is formedDocket No. 0318.0017002-21- by a degraded capsule, wherein the outer shell surrounds the center. The center is a pocket of a liquid, semi-liquid, semi-solid transmucosal formulation. In an embodiment, the transmucosal formulation of the edible composition has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP, and the degraded capsule has a capsule hardness about the same or less than that of the edible material hardness. In an aspect, the fill formulation does not degrade the edible material such that the outer shell is maintained; and the outer shell retains all or most of the transmucosal formulation in the center.[00631 In an embodiment, the edible material is present in the edible composition in an amount ranging from about 20% w / w to about 99% w / w (e.g., about 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% w / w) of the total weight of the edible composition. The transmucosal formulation is present in the edible composition in an amount ranging from, for example, about 1% w / w to about 80% w / w (e.g., about 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% w / w) of the total weight of the edible composition. In another example, the active ingredient is present in an amount ranging from about 0.001% w / w to about 50% w / w (e.g., about 0.001%, 0.01%, 0.1%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% w / w) of total weight of the edible composition. In one aspect, the fill formulation includes a degrading agent in an amount ranging from about 0.5% w / w to about 99% w / w (e.g., about 0.05%, 0.1%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% w / w) of the total weight of the fill formulation. In yet another aspect, the transmucosal formulation has a moisture content ranging from about 0% to about 60% (e.g., about 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%).[00641 In yet another embodiment the invention pertains to an edible composition for delivering a transmucosal formulation made with the steps of the methods described herein.[00651 In another embodiment, the present invention relates to kits and systems having the temporary capsule, the controlled degrading formulation, and the edible material to form the outer shell, as described herein. The kit or system can optionally include the transmucosal formulation or the customer can use a compatible transmucosal formulation of their own. The kit or system can include any of the components described herein (e.g., molds, edible solvents, active ingredients, the fill formulation, and the like).[00661 Embodiments of the invention can be useful for medical conditions, diseases or disorders such as musculoskeletal diseases, vascular diseases, neurological diseases, viral, bacterial or parasitic diseases, blood disorders, oral-related diseases, autoimmune diseases, organ diseases,Docket No. 0318.0017002-22- pain, cosmetic purposes and others. The number of diseases is numerous, but some examples include basal cell carcinomas, melanoma, oral cancers, diabetic neuropathy, chemotherapy- derived neuropathy, general neuropathy, benign prostatic hypertrophy, solid tumors. In some embodiments, the active ingredient is a sirtuin inhibitor or sirtuin activator and the formulation is applied to the skin of a patient to treat one of these medical conditions. Oral related diseases or conditions that the edible composition can be used, in an embodiment, include abscesses, stomatitis, erythroplakia, burning mouth syndrome, leukoplakia, oral lichen planus, candidiasis, tonsillitis, xerostomia, halitosis, herpes simplex virus, aphthous stomatitis, oral cancer, periodontitis, gingivitis, and dental caries. Where accessible, the formulation can be applied to a region of the mucosa or tissue associated with the medical condition.[00671 The edible composition of the present invention is for delivering an active agent or ingredient to a “patient” or “individual” which refers to any animal, including mammals such as a human, non-human primate, mouse, rat, guinea pig, rabbit, pig, horse or dog.[00681 The edible composition of the present invention is meant to be chewed by the individual and the mucosal delivery system is administered or applied “directly” to an individual’s oral mucosa surfaces such as the mouth, tongue, cheek, buccal pouch, and sub lingual mucosa.[00691 As described herein the edible composition can use any transmucosal formulation for delivering an active. The transmucosal formulation for use with the edible composition include those formulated as a liquid, semi-liquid or semi-solid and can be present as a liquid, emulsion, or gel. Examples of transmucosal formulations can be found in the following US patent publications: US20210259951A1, US20070292387 Al, 11160753, 11331302, 9364431, and the like, the entire teachings of which are incorporated by reference herein.[00701 In an embodiment, the transmucosal formulation for use with the edible composition can include the following: at least one mucolytic agent for thinning or decreasing viscosity of mucus, wherein the at least one mucolytic agent is present in an amount between 0.01% w / w and 2.0% w / w; at least one transmucosal formulation solvent; at least one proteolytic agent that cleaves or fragments long chain proteins to create cellular spacing of the stratified squamous epithelial layer, basement membrane, or a combination thereof, to allow passage of at least one vasodilatory agent and at least one active ingredient, wherein the at least one proteolytic agent is present in an amount ranging between 0.01% w / w to 10% w / w; at least one vasodilatory agent present in an amount ranging between 0.001% w / w to 15% w / w; and the active ingredient. In this embodiment, the transmucosal formulation allows for penetration of the active ingredient atDocket No. 0318.0017002-23- the mucosal surface to the smooth muscle. Also in this embodiment, the transmucosal formulation has a pH of between about 4.5 and about 8. pH regulating agent include e.g., citric acid, hydrochloric acid, potassium hydroxide, sodium hydroxide, sodium carbonate, sodium bicarbonate, or any combination thereof. At least one transmucosal formulation solvent include, for example, at least one nonpolar solvent (e.g., carbon tetrachloride , benzene , diethyl ether , hexane , methylene chloride , toluene or a combination thereof), at least one polar aprotic solvent (e.g., propylene carbonate, acetone, ethyl acetate , dimethyl sulfoxide , acetonitrile , dimethylformamide, or combination thereof), at least one polar protic solvent (e.g., water, methanol, isopropanol, acetic acid methanol, ethyl alcohol , n-propanol , n-butanol , or a combination thereof), at least one fatty acid (e.g., linoleic acids, linolenic acids, oleic acids, stearic acids, myristic acids, phosphatidylcholine, phosphatidylethanolamine, phosphatidyl serine, or a combination thereof), at least one limonene (e.g., D-limonene, L- Limonene, or a combination thereof), or combination thereof. In an alternative embodiment, the nonpolar solvent can be selected from edible or pharmaceutically acceptable nonpolar solvents and oils including MCT, edible vegetable oils (e.g., safflower, sunflower, olive), and limonene, or combinations thereof; non-ingestive processing solvents (e.g., acetone, methylene chloride) may be used only during manufacturing and are substantially removed prior to consumption as verified by residual-solvent testing compliant with applicable pharmacopeial limits. Similarly, in an alternative embodiment, the at least one polar aprotic solvent is selected from edible or pharmaceutically acceptable polar aprotic solvents including propylene carbonate and ethyl acetate, or non-ingestive processing solvents including acetone, dimethyl sulfoxide, acetonitrile, and dimethylformamide, or combinations thereof; non-ingestive processing solvents may be used only during manufacturing and are substantially removed prior to consumption as verified by residual-solvent testing compliant with applicable pharmacopeial limits. In an embodiment, the transmucosal formulation includes a vasodilator that allows for the active ingredient to be delivered systemically or to local tissue. In an embodiment, the vasodilator is amrinone, arginine, bamethan sulphate, bencyclane fumarate, benfurodil hemi succinate, benzyl nicotinate, buflomedil hydrochloride, buphenine hydrochloride, butalamine hydrochloride, cetiedil citrate, ciclonicate, cinepazide maleate, cyclandelate, di isopropylammonium di chloroacetate, ethyl nicotinate, hepronicate, hexyl nicotinate, ifenprodil tartrate, inositol nicotinate, isoxsuprine hydrochloride, kallidinogenase, methyl nicotinate, naftidrofuryl oxalate, nicametate citrate, niceritrol, nicoboxil, nicofuranose, nicotinyl alcohol, nicotinyl alcohol tartrate, nitric oxide,Docket No. 0318.0017002-24- nonivamide, oxpentifylline, papaverine, papaveroline, pentoxifylline, peroxynitrite, pinacidil, pipratecol, propentofylline, raubasine, suloctidil, teasuprine, thymoxamine hydrochloride, tocopherol nicotinate, tolazoline, papaverine, xanthinol nicotinate, diazoxide, hydralazine, minoxidil, and sodium nitroprusside, clonidine, guanabenz, methyl dopa, alpha adrenoceptor, indoramin, phenoxybenzamine, phentolamine, prazosin, PDE-5 inhibitors, sildenafil, tadalafil, adrenergic neuron blocking agents, bedmidine, debrisoquine, guanethidine, ACE inhibitors, benazepril, captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, ganglion blocking agents, pentolinium, trimetaphan, calcium channel blockers, amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, verapamil, prostaglandins, prostacyclin, thrombuxane A2, leukotrienes, PGA, PGA1, PGA2, PGE1, PGE2, PGD, PGG, PGH, angiotensin II analogs, saralasin, nitroglycerin, labetalol, thiazide, isosorbide dinitrate, pentaerythritol tetranitrate, digitalis, hydralazine, diazoxide, sodium nitroprusside, or a combination thereof.EXEMPLIFICATIONExample 1 : Edible composition with a pocket of the transmucosal delivery formulation having an active agentIngredients / components :Example A: Oil-based transmucosal formulation and gelatin capsuleTransmucosal formulation ingredients:• 4 lOmg Safflower Oil• 140mg MCT 60 / 40 oil• 20mg Lecithin• lOmg Potassium Sorbate• 140mg Ethyl Alcohol• 50mg Active DrugControlled Degrading Agent Ingredients (per capsule)• 200mg Distilled water• 1 Omg PEG-40 Hydrogenated Castor OilDocket No. 0318.0017002-25- • 20mg Polysorbate 80Capsule Type• Size 3 Capsuline Hide Bovine Gelatin Capsule (ingredients are hide bovine gelatin and water)Edible material:• 5760mg Strawberry Gelatin Gummy Base by Melt-to-Make (ingredients are Cane Sugar, Glucose (Corn), Water, Gelatin; Less than 2% of: Tartaric Acid, Natural Flavor, Color (Elderberry Juice, Beta-Carotene)Methods:1. Combine the transmucosal formulation ingredients with the controlled degrading agent ingredients to create the fill formulation until fully mixed.2. Fill capsule with 240mg of fill formulation at 20°C.3. Combine the components for the edible material and pour into mold at 74°C.4. Position the filled capsule in the center of the edible material at 74°C.5. Allow the filled capsule to sit in the edible materials for 8 hours and allow to cool to a temperature of 20°C.6. Remove from mold.Example B: Oil-based transmucosal formulation and cellulose capsuleTransmucosal formulation ingredients:• 420mg Safflower Oil• lOOmg MCT Oil• 1 Omg Lecithin• 20mg Propylene Glycol• 1 Omg Potassium Sorbate• 5 Omg Active DrugControlled Degrading Agent Ingredients (per capsule)• 220mg distilled water• 16mg PEG-40 Hydrogenated Castor Oil• 154mg Ethyl AlcoholCapsule TypeDocket No. 0318.0017002-26- • XPRS Nutra Size 3 Empty Capsules (ingredients are vegetable cellulose)Edible material:• 5760mg Strawberry Gelatin Gummy Base by Melt-to-Make (ingredients are Cane Sugar, Glucose (Corn), Water, Gelatin; Less than 2% of: Tartaric Acid, Natural Flavor, Color (Elderberry Juice, Beta-Carotene)Methods:1. Combine the transmucosal formulation ingredients with the controlled degrading agent ingredients to create the fill formulation2. Fill capsule with 240mg of fill formulation at 20°C.3. Combine the components for the edible material and pour into mold at 70°C.4. Position the filled capsule in the center of the edible material at 70°C.5. Allow the filled capsule to sit in the edible materials for 24 hours and allow to cool to a temperature of 20°C.6. Remove from moldExample C: Water and oil-based transmucosal formulation and gelatin capsule Transmucosal formulation ingredients (per capsule):• 440mg Distilled water• 226mg Safflower Oil• 30mg Polysorbate 80• lOmg Sorbitol• 5 Omg Active DrugControlled Degrading Agent Ingredients (per capsule)• 232mg Ethyl Alcohol• 12mg PEG-60 Hydrogenated Castor OilCapsule Type• Size 4 Capsuline Hide Bovine Gelatin Capsule (ingredients are hide bovine gelatin and water)Edible material:• 5800mg Strawberry Gelatin Gummy Base by Melt-to-Make (ingredients are Cane Sugar,Docket No. 0318.0017002-27- Glucose (Corn), Water, Gelatin; Less than 2% of: Tartaric Acid, Natural Flavor, Color (Elderberry Juice, Beta-Carotene)Methods:1. Combine the transmucosal formulation ingredients with the controlled degrading agent ingredients to create the fill formulation2. Fill capsule with 200mg of fill formulation at 20°C.3. Combine the components for the edible material and pour into mold at 74°C.4. Position the filled capsule in the center of the edible material at 74°C.5. Allow the filled capsule to sit in the edible materials for 8 hours and allow to cool to a temperature of 20°C.6. Remove from mold.Example D: Water and oil-based transmucosal formulation and cellulose capsule Transmucosal formulation ingredients (per capsule):• 390mg Distilled water• 250mg Safflower Oil• 36mg Propylene glycol• 24mg Sorbitol• 50mg Active DrugControlled Degrading Agent Ingredients (per capsule)• 226mg Ethyl Alcohol• 14mg PEG-40 Hydrogenated Castor Oil• 1 Omg PEG-60 Hydrogenated Castor OilCapsule Type• XPRS Nutra Size 3 Empty Capsules (ingredients are vegetable cellulose)Edible material:5800mg Strawberry Gelatin Gummy Base by Melt-to-Make (ingredients are Cane Sugar, Glucose (Corn), Water, Gelatin; Less than 2% of: Tartaric Acid, Natural Flavor, Color (Elderberry Juice, Beta-Carotene)Docket No. 0318.0017002-28- Methods:1. Combine the transmucosal formulation ingredients with the controlled degrading agent ingredients to create the fill formulation2. Fill capsule with 200mg of fill formulation at 20°C.3. Combine the components for the edible material and pour into mold at 70°C.4. Position the filled capsule in the center of the edible material at 70°C.5. Allow the filled capsule to sit in the edible materials for 24 hours and allow to cool to a temperature of 20°C.6. Remove from mold.Docket No. 0318.0017002-29-[00711 The terms “about”, “approximately”, “substantially”, and their equivalents may be understood to include their ordinary or customary meaning. In addition, if not defined throughout the specification for the specific usage, these terms can be generally understood to represent values about but not equal to a specified value. For example, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.09% of a specified value.[00721 The terms, comprise, include, and / or plural forms of each are open ended and include the listed items and can include additional items that are not listed. The phrase “And / or” is open ended and includes one or more of the listed items and combinations of the listed items. Unless otherwise specified, the term “a” or “the” can mean “at least one” or “one or more”.[00731 The relevant teachings of all the references, patents and / or patent applications cited herein are incorporated herein by reference in their entirety. Citation of the above documents and studies is not intended as an admission that any of the foregoing is pertinent prior art. All statements as to the contents of these documents are based on the information available to the applicants and do not constitute any admission as to the correctness of the contents of these documents.[00741 While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.

Claims

Docket No. 0318.0017002-30- CLAIMSWhat is claimed is:1) A method for making an edible composition for delivering a transmucosal formulation having an active ingredient wherein the transmucosal formulation has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP, wherein the edible composition comprises an outer shell made from an edible material surrounding a center having the transmucosal formulation; the method comprises the steps of:a) Filling a capsule having a capsule hardness with a fill formulation comprising the transmucosal formulation and a controlled degrading formulation at a first temperature; wherein the capsule is degraded by the fill formulation at a second temperature, to thereby obtain a filled capsule;b) Forming the outer shell from the edible material having an edible material hardness at the second temperature, wherein the edible material is in a liquid state, semi-liquid, or semi-solid state at the second temperature, wherein the first temperature is less than the second temperature;c) Positioning the filled capsule in the edible material while in the liquid state, semi-liquid, or semi-solid state, such that edible material encases the filled capsule, to thereby obtain an edible composition having an outer shell and an intact filled capsule;d) Allowing the edible composition having the outer shell and the intact filled capsule to sit for a time period wherein the capsule is degraded such that the capsule hardness is about equal to or less than that of the edible material hardness, to thereby obtain the edible composition having the outer shell made from the edible material surrounding the center having the transmucosal formulation;wherein the fill formulation does not degrade the edible material such that the outer shell is maintained; and wherein the outer shell retains all or most of the transmucosal formulation in the center.2) The method of claim 1, wherein the capsule is degraded such that the capsule can no longer house the fill formulation.3) The method of claim 2, wherein the capsule is degraded by a percentage ranging from about 30% to about 100%.Docket No. 0318.0017002-31- 4) The method of claim 1, the first temperature having a range from about 32°F to about 90 °F. 5) The method of claim 1, the second temperature in a range from about 91 °F to about 350 °F. 6) The method of claim 1, the time period ranging from about 1 minute to about 48 hours.7) The method of claim 1, wherein the method further includes a step of increasing the temperature of the edible composition having the outer shell and the intact filled capsule to a third temperature.8) The method of claim 7, the third temperature ranges from about 91 °F to about 350 °F.9) The method of claim 1, wherein forming the outer shell from the edible material occurs in two or more stages, wherein a portion of the edible material poured in each stage and wherein the filled capsule is repositioned to remain centered.10) The method of claim 1, comprising, prior to step a), the step of bathing the capsule in a solution to improve a mechanical barrier of the capsule.11) The method of claim 10, wherein the capsule is a gelatin capsule and the solution is an edible solvent.12) The method of claim 11, wherein the edible solvent comprises Isopropyl Alcohol, Ethyl Alcohol, Acetone, Benzyl Alcohol, 1 -Butanol, Propylene Glycol, Glycerin, Vegetable Oil, MCT Oil13) The method of claim 1, wherein the edible material is present in the edible composition in an amount ranging from about 20% w / w to about 99% w / w of total weight of the edible composition.14) The method of claim 1, wherein the transmucosal formulation is present in the edible composition in an amount ranging from about 1% w / w to about 80% w / w of the total weight of the edible composition.15) The method of Claim 1, wherein the active ingredient is present in an amount ranging from 0.001% w / w to 50% w / w of total weight of the edible composition.16) The method of claim 1, wherein the fill formulation comprises a degrading agent in an amount ranging from about 0.5% w / w to about 99% w / w of the total weight of the fill formulation. 17) The method of claim 1, the transmucosal formulation comprises a moisture content ranging from about 0% to about 60%.18) The method of claim 1, wherein the capsule hardness before step a) has a hardness rating from about Shore A 10 to about Shore A 90.Docket No. 0318.0017002-32- 19) The method of claim 1, wherein the capsule hardness after step d) has a hardness rating from about Shore 00 1 to about Shore 0085 or about Shore A 0 to about Shore A 50.20) The method of claim 1, wherein the edible material hardness has a hardness rating from about Shore 00 1 to about Shore 0080 or about Shore A 0 to about Shore A 40.21) The method of claim 1, wherein the outer shell of the edible composition is made from the edible material comprising soft candy, gummies, chocolate, marshmallow, caramels, marzipan, toffees, fudges, jellybeans, or combination thereof.22) The method of claim 1, wherein the transmucosal formulation of the edible composition is present as a liquid, emulsion, or gel.23) The method of claim 1, wherein the filled capsule has a filled capsule density and the edible material has an edible material density, wherein the filled capsule density is less than or about the same as the edible material density.24) The method of claim 23, wherein the filled capsule density ranges from about 0.3 g / cm3to about 1.5 g / cm3.25) The method of claim 24, wherein the edible material density ranges from about 0.7 g / cm3to about 1.8 g / cm3.26) The method of claim 1, wherein the capsule is made from a capsule material comprising gelatin, cellulose, starch, pullulan, Hydroxypropyl methylcellulose (HPMC), cellulose acetate phthalate (CAP), Polyvinyl acetate (PVA), or a combination thereof.27) The method of claim 1, wherein the controlled degrading formulation comprises two or more of an agent type wherein the agent type comprises a surfactant / emulsifier, a solvent, or a sugar. 28) The method of claim 27, wherein the solvent comprises non-oil-based solvents and oil-based solvents.29) The method of claim 28, wherein non-oil based solvents comprise water, glycerin, propylene glycol, isopropyl alcohol, ethyl alcohol, tetraglycol, diethylene glycol monoethyl ether, Polyethylene Glycol (PEG) 200, PEG-300, PEG-400, PEG-600, diethyl glycol, ethylene glycol, triethylene glycol, butylene glycol, pentylene glycol, hexylene glycol, sorbitol, maltitol, xylitol, sucralose, sodium hyaluronate, sodium pyrrolidone carboxylic acid (PCA) or a combination thereof.30) The method of claim 28, wherein oil based solvents comprises oils, oleic acid, wax, fats, palm oil, beeswax, medium chain monoglyceride, coconut oil, medium chain triglycerides, vegetable oil, olive oil, grape seed oil, safflower oil, soy oil, castor oil, almond oil, avocado oil, sunflowerDocket No. 0318.0017002-33- oil, canola oil, flaxseed oil, hemp oil, pumpkin seed oil, sesame oil, jojoba oil, borage oil, evening primrose oil, poppy seed oil, marula oil, argan oil, rosehip oil, tamanu oil, kukui nut oil, moringa oil, pecan oil, walnut oil, cumin oil, caprylyl glycol.31) The method of claim 27, wherein the surfactant or emulsifier comprises Lecithin, Soy Lecithin, Sunflower Lecithin, Egg Lecithin, Polysorbate 80, Polysorbate 85, Polysorbate 65, Polysorbate 60, Polysorbate 40, Polysorbate 25, Polysorbate 20, Polysorbate 10, PEG-20 Hydrogenated Castor Oil, PEG-40 Hydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, PEG-30 Dipolyhydroxy stearate, PEG-7 Glyceryl Cocoate, PEG-8 Stearate, Di sodium Sulfosuccinate, Sodium Lauryl Sulfate, Sodium Coco-Sulfate, Ammonium Lauryl Sulfate, Triethyl Citrate, Tributyl Citrate, Acetyl Tributyl Citrate, Sodium Stearoyl Lactylate, Calcium Stearoyl Lactylate, Glyceryl Stearate, Glyceryl Stearate SE, Glyceryl Stearate Citrate, Glyceryl Oleate, Polyglyceryl-4 Oleate, Polyglyceryl-10 Oleate, Sorbitan Monostearate, Sorbitan Monooleate, Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Polyglyceryl-3 Polyricinoleate (PGPR), Steareth-20, Sodium Lauroyl Lactylate, Sorbitan Laurate, Sodium Methyl Cocoyl Taurate or a combination thereof.32) The method of claim 27, wherein the sugar comprises mannitol, sorbitol, com syrup, fructose, sucrose, sucralose, xylitol, glucose, sugar alcohol, maltitol, erythritol, lactose, maltose, dextrose, agave syrup, maple syrup, honey, trehalose, isomalt, ribose, inulin, coconut sugar, date sugar, brown rice syrup, yacon syrup, barley malt syrup, molasses, sorghum syrup, apple juice concentrate, cane sugar, turbinado sugar, muscovado sugar, palm sugar, lucuma powder, monk fruit extract, stevia, blackstrap molasses, caramel syrup, golden syrup, fruit syrup, grapefruit juice concentrate, pear juice concentrate, cherry juice concentrate, pomegranate juice concentrate.33) The method of Claim 1, wherein the active ingredient is acetaminophen, acetohydoxamic acid, acetophenazine, acyclovir, albuterol, allopurinol, amiloride, amoxicillin, amphetamine, ampicillin, antisense polymers, atenolol, baclofen, beclomethasone, benfotiamine, betamethasone, budesonide, bumetanide, butorphanol, carbamazepine, carphenazine, celecoxib, cefuroxime, cephradine, chloramphenicol, chlorothiazide, chlorzoxazone, cinoxacin, clorazepate, cloxacillin, cyclacillin, dapsone, dicloxacillin, diethylstilbestrol, dopamine, doxorubicin, erythropoietin, estradiol, fenoprofen, gabapentin, human growth hormone, hydralazine, hydrochlorothiazide, ibuprofen, indomethacin, insulin, isoproterenol, ketoprofen, levodopa, levothyroxine, meclofenamate, melphalan, metformin, methyl salicylate,Docket No. 0318.0017002-34- metronidazole, minoxidil, morphine, nadolol, nalidixic acid, naproxen, nomifensine, norfloxacin, oxaprozin, oxycodone, paramethasone, peptide fragments, perphenazine, phenylpropanolamine, pregabalin, probenecid, quinethazone, ritodrine, scopolamine, serotonin, sildenafil, tadalafil, terbutaline, terfenadine, tocainide, terbinafine, triamterene, trimethoprim, valacyclovir, sirtuin inhibitors, nicotinamide, AIII, coumarin, sirtinol, alpha-NAD, carbamido- NAD, trichostatin A, suramin sodium, apicidin, BML-210, BML-266, depudecin, HC Toxin, ITSA1, nullscript, phenylbutyrate, sodium, scriptaid, splitomicin, suberoyl bis-hydroxamic acid, sirtuin activators, resveratrol, isonicotinamide, butein, luteolin, plant extracts, cannabidiol, cannabinoids, hemp, nicotine, hemp derived compounds, terpenes, or a combination thereof. 34) An edible composition for delivering a transmucosal formulation having an active ingredient;wherein the edible composition comprises:a) an outer shell from the edible material having an edible material hardness;b) a center of the transmucosal formulation having the active ingredient, wherein the center is formed by a degraded capsule, wherein the outer shell surrounds the center; andc) a controlled degrading formulation;wherein the transmucosal formulation has a viscosity ranging from about 0.1 centiPoise (cP) to about 1,000,000 cP,wherein the degraded capsule has a capsule hardness, wherein the capsule hardness is about the same or less than that of the edible material hardness,wherein the fdl formulation does not degrade the edible material such that the outer shell is maintained; andwherein the outer shell retains all or most of the transmucosal formulation in the center.35) An edible composition for delivering a transmucosal formulation having an active ingredient, made by the method of Claims 1-33.36) The method of claims 1-33, wherein the transmucosal formulation comprises:a) at least one mucolytic agent for thinning or decreasing viscosity of mucus, wherein the at least one mucolytic agent is present in an amount between 0.01% w / w and 2.0% w / w; b) at least one transmucosal formulation solvent;c) at least one proteolytic agent that cleaves or fragments long chain proteins to create cellular spacing of the stratified squamous epithelial layer, basement membrane, or a combinationDocket No. 0318.0017002-35- thereof, to allow passage of at least one vasodilatory agent and at least one active ingredient, wherein the at least one proteolytic agent is present in an amount ranging between 0.01% w / w to 10% w / w;d) at least one vasodilatory agent present in an amount ranging between 0.001% w / w to 15% w / w; ande) the active ingredient;and wherein the formulation allows for penetration of the active ingredient at the mucosal surface to the smooth muscle.37) The method of claim 36, wherein the transmucosal formulation has a pH of between about 4.5 and about 8.

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