WO2025101436A1

WO2025101436A1 - Edible ink compositions suitable for screen printing systems to produce edible graphic sublingual and buccal devices

Info

Publication number: WO2025101436A1
Application number: PCT/US2024/054170
Authority: WO
Inventors: Bryan Daniel Haynes
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-11-06
Filing date: 2024-11-01
Publication date: 2025-05-15
Anticipated expiration: 2026-05-06

Abstract

The present disclosure relates generally to oral delivery of active ingredients and, more specifically, to sublingual and buccal delivery devices that may be produced, at least in part, by screen printing. Such films may have a colorful graphic display infused with flavoring, colorings, and/or active ingredients that dissolve in the mouth. Such films may be fabricated by printing thin layers of edible inks, which may contain flavoring and colors specific to each layer. The present disclosure further relates to screen printing systems capable of producing such sublingual and buccal delivery devices.

Description

EDIBLE INK COMPOSITIONS SUITABLE FOR SCREEN PRINTING SYSTEMS TO PRODUCE EDIBLE GRAPHIC SUBLINGUAL AND BUCCAL DEVICES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application Nos. 63/596,424, filed November 6, 2023, which is incorporated herein by reference in its entirety.

FIELD

[0002] The present disclosure relates generally to oral delivery of active ingredients and, more specifically, to sublingual and buccal dissolvable films that may be produced, at least in part, by screen printing. Such films may have a colorful graphic display infused with flavoring and active ingredients that dissolves in the mouth. Such films may be fabricated by printing thin layers of edible inks, which may contain flavoring and colors specific to each layer. The present disclosure further relates to screen printing systems capable of producing such sublingual and buccal delivery devices.

BACKGROUND

[0003] Conventional sublingual dissolvable strips have remained relatively unchanged since their creation. Primarily used as a breath freshening device, conventional sublingual dissolvable strips are manufactured as single layer, single flavor, single color, and single medicine, and are limited to a square or rectangular shape that does not offer a means of graphical display. More recently, an array of additives to the sublingual strip have advanced the technology, providing for medicinal use beyond freshening breath.

[0004] With the addition of medicinal ingredients to the sublingual film industry, there has been little development or technological advancement to the sublingual strips’ appearance. Without any textual or graphical markings indicating dosage, ingredients, or warnings, all sublingual strips look identical to one another. Two potential sublingual strip identification methods, such as printing onto or die cutting shapes out of sublingual film, may be employed. However, the application of such methods would require additional equipment beyond the formation of the sublingual film. Unfortunately, the inclusion of either method would incur significant costs or waste.

[0005] Thus, what is desired in the art are alternative methods and systems to produce sublingual and buccal dissolvable films that are capable of delivering a therapeutically effective dose of one or more active ingredients.

BRIEF SUMMARY

[0006] In some aspects, provided are edible ink compositions that have been optimized for producing sublingual and buccal dissolvable films by, at least in part, screen printing.

[0007] In one aspect, provided is an edible ink composition formulated for screen printing a sublingual or buccal device. In some embodiments, the composition comprises water, pullulan, corn syrup, and alkylene glycol; and optionally at least one active ingredient.

[0008] In other embodiments, the composition comprises: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as a brightener or an opacifier; a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and one or more additional components comprising a flavoring agent, a sweetener, and/or a coloring agent; and water.

[0009] In another aspect, provided is a multi-layered sublingual or buccal device that is configured to be peeled off a substrate for consumption by a human. In some embodiments, the device comprises: (i) an edible base layer screen printed onto the substrate; (ii) one or more edible intermediate layers printed onto the edible base layer, wherein the perimeter of the one or more edible intermediate layers lies within the perimeter of the edible base layer; and (iii) an edible top layer screen printed onto the edible base layer and the one or more edible intermediate layers, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the one or more edible intermediate layers. In certain embodiments of the foregoing, each layer independently comprises variations of the edible ink compositions described herein. [0010] In another aspect, provided is a multi-layered sublingual or buccal device having one or more visual effects, such as 3-D, animation, flips, morph, and/or zoom. In some embodiments, the device comprises: a lenticular array formed by screen printing a series of layers with transparent ink onto a lenticular substrate. In some variations, the series of layers comprises: a first screen printed layer comprising a lower viscosity transparent ink; a second layer screen printed onto the first layer, wherein the second layer comprises a higher viscosity transparent ink that fills the remaining space of the lenticular array; a third layer screen printed onto the second layer, wherein the third layer comprises a graphic or color printed in alignment with one half of the lenticules of the lenticular array; and a fourth layer screen printed onto the third layer, wherein the fourth layer comprises graphic or color printed in alignment with the other half of the lenticules of the lenticular array, thereby creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array. In one variation, the device further comprises an additional layer printed onto the fourth layer, wherein the additional layer comprises a higher viscosity ink, and flavoring and/or at least one active ingredient. In another variation, the device further comprises an additional layer screen printed onto the lenticular substrate, adjacent to the first screen printed layer, wherein the additional layer comprises a higher viscosity ink, and flavoring and/or at least one active ingredient.

[0011] In another aspect, provided is a multi-layered sublingual or buccal device having a braille effect. In some embodiments, the device comprises: a substrate; one or more layers screen printed onto the substrate, wherein the one or more layers comprise graphic design; and a top layer screen printed onto the one or more layers to from a braille effect on the top layer without obstructing the graphic design, wherein the top layer comprises a higher viscosity transparent ink.

[0012] In yet another aspect, provided is a multi-layered sublingual or buccal device having a transparent or translucent window. In some embodiments, the device comprises: a substrate; a first layer screen printed onto the substrate, wherein the first layer comprises a higher viscosity opaque ink that contains one or more openings; one or more additional layers screen printed onto the first layer, wherein the one or more additional layers comprise transparent or translucent ink, optionally containing flavoring and/or at least one active ingredient, forming one or more windows through the sublingual or buccal device. [0013] In some variations, the ink used in the foregoing multi-layered sublingual or buccal devices is formulated using certain of the edible ink compositions described herein, so as to achieve the transparent, translucent or opaque effects, as the case may be.

[0014] In some variations of the foregoing, the device is configured to deliver a therapeutically effective dose of at least one active ingredient to a human in need thereof, and wherein one or more layers of the device independently further comprise at least one active ingredient. In certain variations, the device, when consumed by a human, dissolves between about 5 seconds and 40 seconds.

[0015] In another aspect, provided is a screen printing system configured to manufacture a multi-layered sublingual or buccal device with a therapeutically effective dose of at least one active ingredient. In some embodiments, the system comprises: a plurality of mesh screens having different screen mesh counts; and a plurality of edible ink compositions having different viscosities.

[0016] In some variations, when the edible ink composition has a viscosity between about 50 cps and about 100 cps, a mesh screen with a screen mesh count between 230 and about 320 is used to deliver between about 1 mg and about 5 mg of the at least one active ingredient in one printed layer of the multi-layered sublingual or buccal device. In other variations, when the edible ink composition has a viscosity between about 5,000 cps and about 10,000 cps, a mesh screen with a screen mesh count between 90 and about 230 is used to deliver between about 5 mg and about 10 mg of the at least one active ingredient in one printed layer of the multi-layered sublingual or buccal device. In yet other variations, when the edible ink composition has a viscosity between about 100,000 cps and about 200,000 cps, a mesh screen with a screen mesh count between 60 and about 90 is used to deliver at least 10 mg of the at least one active ingredient in one printed layer of the graphical sublingual device.

DESCRIPTION OF THE FIGURES

[0017] The present application can be understood by reference to the following description taken in conjunction with the accompanying figures. [0018] FIG. 1 is a cross section of an exemplary printed sublingual delivery device within an array of printed sublingual delivery devices constructed in accordance with the systems provided herein.

[0019] FIG. 2 is a top view of a printed sublingual delivery device within an array of printed exemplary sublingual delivery devices of FIG. 1.

[0020] FIG. 3 is a side view cutaway of an exemplary printed three-layer sublingual delivery device deposited on a substrate.

[0021] FIG. 4 is a top view of an exemplary printed sublingual delivery device that illustrates text and graphics deposited onto a previous printed layer.

[0022] FIG. 5 is a cross section of an exemplary printed sublingual delivery device deposited on a substrate that enables the release of active ingredients or flavors in sequence that illustrates two layers of encapsulation.

[0023] FIG. 6 is a cross section of an exemplary printed sublingual delivery device printed on a substrate that illustrates two layers side by side for simultaneous release of flavors or active ingredients encapsulated by two printed layers.

[0024] FIG. 7 is a top view of an exemplary printed sublingual delivery device that illustrates the difference in perimeter size required for encapsulation.

[0025] FIG. 8 is a cross section of an exemplary printed sublingual delivery device that illustrates the application of layers deposited to fabricate a three-layer encapsulated sublingual delivery device deposited on a substrate.

[0026] FIG. 9 is a cross section of an exemplary printed sublingual delivery device that illustrates the sequential release of encapsulated flavors and active ingredients and deposited on a substrate.

[0027] FIGS. 10A-10D is a sequence of fragmentary, top plan views of the exemplary printed sublingual delivery device of FIG. 1 , illustrating the layered fabrication. [0028] FIG. 11 is a top view of an exemplary array of printed sublingual delivery devices that illustrates a printed sublingual delivery device and the use of printed perforations to establish dosage.

[0029] FIG. 12 is a cross section of an exemplary printed sublingual device using a reverse build construction in which a lenticular array is formed by printing layers of transparent ink onto a lenticular array as a substrate.

[0030] FIG.13 is a cross section of an exemplary printed sublingual device using a forward build construction in which a lenticular array is formed by printing a series of transparent ink to form the lenticular array.

[0031] FIG. 14. is a cross section of an exemplary printed sublingual device using a reverse build construction in which a lenticular array is formed by printing layers of transparent ink to form the lenticular array onto a concave lenticular array as a substrate.

[0032] FIG. 15. is a cross section of an exemplary printed sublingual device using a forward build construction in which a lenticular array is formed by printing a series of transparent ink to form the convex lenticular array.

[0033] FIG. 16. is a cross section of an exemplary printed sublingual device using a forward build construction in which a transparent ink is printed to form braille without obstructing the graphic design of the sublingual.

[0034] FIG. 17. is a top view of an exemplary printed sublingual device using a forward build construction in which a transparent ink is printed to form braille without obstructing the graphic design of the sublingual.

[0035] FIG. 18. is a top view of an exemplary printed sublingual device using a forward build construction in which portions of the sublingual are transparent forming windows through the sublingual device. DETAILED DESCRIPTION

[0036] The following description sets forth exemplary compositions, systems, methods, parameters and the like. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure but is instead provided as a description of exemplary embodiments.

[0037] In some aspects, provided are edible ink compositions that have been optimized for screen printing techniques to produce sublingual and buccal dissolvable films. Sublingual administration generally refers to placing a drug under the tongue, whereas buccal administration generally refers to placing a drug between the gums and cheek.

[0038] In certain aspects, provided herein are edible ink compositions suitable for use with various screen printing techniques that, when combined, create an edible graphic image with multiple infusions, including flavoring, medicinal, and nutraceutical ingredients. The edible ink compositions described herein can be used with screen printing techniques to incorporate various effects for the consumer, such as detailed graphic imagery, anti-counterfeiting, product identification, three-dimensional texturing, including optical effects such as holograms, and lenticular arrays. The edible ink compositions described herein are optimized for screen print manufacturing, which uses multiple size mesh screens and requires different ink viscosities to create the desired printing effect. Conventional ink printing formulas are typically toxic, are not intended for human consumption, and do not offer the ability to dissolve orally, as required for sublingual and buccal delivery of active ingredients. Provided herein are edible inkjet ink compositions that are non-toxic, and which can be used to deliver the required levels of active ingredients to produce an oral dissolvable graphic sublingual or buccal delivery device.

Edible Ink Compositions

[0039] In some aspects, provided is an ink composition that has been optimized for screen printing sublingual or buccal devices as described herein. The ink compositions provided herein are edible and non-toxic for consumption by humans and/or other animals (e.g., non-humans, or specifically pets). The ink compositions are also optimized for use as ink in screen printing so that the resultant sublingual or buccal devices are able to remain flat (rather than curling up at the edges), are flexible (non-brittle), and have a homogeneous distribution of active ingredients (when present).

[0040] In some embodiments, the edible ink composition comprises or consists essentially of: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as a brightener or an opacifier; a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and one or more additional components comprising a flavoring agent, a sweetener, and/or a coloring agent; and water.

[0041] In certain embodiments, the first component comprises pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof. In some variations, the first component is present in the composition at between about 20% and about 25% by weight.

[0042] In certain embodiments, the second component comprises corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof. In some variations, the second component is present in the composition at between about 1% and about 10% of by weight.

[0043] In certain embodiments, the third component comprises citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof. In some variations, the third component is present in the composition at between about 1% and about 5% by weight.

[0044] In certain embodiments, the fourth component comprises a titanium oxide (e.g., titanium dioxide), calcium carbonate, kaolin clay, powdered sugar, corn starch, or a whitener, or any combination thereof. In some variations, the fourth component is present in the composition at between about 0.5% and about 5% by weight. [0045] In certain embodiments, the fifth component comprises a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof. In some variations, the fifth component is present in the composition at between about 1% and about 5% by weight.

[0046] In some variations, the one or more additional components are present in the composition at between about 0.5% and about 3% by weight. In certain embodiments, the flavoring agent comprises natural flavor. In certain embodiments, the sweetener comprises aspartame, sucralose, saccharin, stevia, acesulfame potassium, monk fruit extract, neotame, erythritol, allulose, aspartame-acesulfame salt, xylitol, or yacon syrup, or any combination thereof.

[0047] In certain embodiments, the water is purified water. In one embodiment, the water does not contain any detectable amount of impurities, minerals and/or contaminants. In some variations, water is present in the edible ink composition at between about 60% and about 70% by weight of the composition.

[0048] In some embodiments of the foregoing, the composition consists essentially of the five components, as well as the flavoring agent, the sweetener, and/or the coloring agent as set forth above.

[0049] In some embodiments, the edible ink composition comprises water, pullulan, corn syrup, and alkylene glycol. In some variations, the alkylene glycol is propylene glycol. In certain embodiments, the composition further comprises sorbitol. The relative amounts of these components may be varied to achieve different printing effects by screen printing. In some variations, the relative amounts of these components are varied to achieve different viscosities in order to achieve certain printing effects. In some embodiments, water is present in the edible ink composition at between about 60% and about 70% by weight of the edible ink composition. In some embodiments, pullulan is present in the edible ink composition at between about 20% and about 25% by weight. In some embodiments, corn syrup is present in the edible ink composition at between about 1% and about 10% of by weight. In some embodiments, alkylene glycol is present in the edible ink composition at between about 1% and about 5% by weight. [0050] For example, in an edible ink composition that has a relatively low viscosity, the edible ink composition may have a higher amount of water and lower amount of pullulan. In an edible ink that has a relatively higher viscosity, the edible ink composition may have a higher amount of pullulan and lower amount of water. In some variations, the edible ink composition has a viscosity between about 50 cps and about 100 cps, or between about 5,000 cps and about 10,000 cps, or between about 100,000 cps and about 200,000 cps.

[0051] The edible sublingual or buccal devices provided herein may, in some embodiments, include a graphical image in one or more of the layers in the multi-layered device. In some variations, this base ink composition can be modified to include one or more additional components that impact the color of the layers and the flavor of the overall device. For example, in certain embodiments, the composition further includes citric acid, titanium dioxide, sweetener(s), coloring agents(s) and/or flavoring agent(s).

[0052] The particular combinations of components in the base formulation of the edible ink composition were surprisingly identified to produce sublingual or buccal devices that are able to remain flat (rather than curling up at the edges), are flexible and not brittle, and have a homogeneous distribution of active ingredients (when present).

[0053] In one variation, the composition consists essentially of water, pullulan, corn syrup, and alkylene glycol. In another variation, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, and sorbitol. In another variation, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and citric acid. In another variation, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and titanium dioxide.

[0054] In some embodiments of the foregoing, the edible ink composition may further comprise one or more active ingredients. In some variations, active ingredients may include any suitable drug or active pharmaceutical ingredient. In certain variations, the active ingredients may include antibiotics, antiseptics, antifungals, antipyretics, antidiabetic agents, antivirals, analgesics, anti-inflammatory agents, antioxidants, antihistamines, antineoplastic Agents (e.g., cancer drugs), antihypertensives, cardiovascular drugs, psychotropic drugs, anticonvulsants, sedatives or hypnotics, muscle relaxants, antiparasitic drugs, vitamins, minerals, hormones, immunosuppressants, immunomodulators, bronchodilators, antifungals, analgesics, antiemetics, respiratory drugs, gastrointestinal drugs, dermatological drugs, ophthalmic drugs, diuretics, and bone health drugs.

[0055] In some embodiments, at least one active ingredient comprises cannabinoid(s). In one embodiment, at least one active ingredient comprises a cannabis extract or at least one cannabinoid. In one variation, the cannabis extract is a cannabis oil.

[0056] In some embodiments of the foregoing, a combination of any of the active ingredients described herein may be incorporated into the edible ink compositions. In some embodiments of the foregoing, the edible ink composition may further comprise caffeine, vitamin B6, vitamin Bl 2, vitamin C, nicotine, epinephrine, sildenafil citrate, magnesium, potassium, psilocybin, aspirin, ibuprofen, nitroglycerin, buprenorphine-with-naloxone cannabinoids, vitamins, pharmaceuticals, antioxidants, or THC, or any combination thereof.

[0057] In one variation, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, and at least one active ingredient. In yet another variation, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and at least one active ingredient. In yet other variations, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, citric acid, and at least one active ingredient. In other variations, the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, titanium dioxide, and at least one active ingredient. In one variation, the composition consists essentially of pullulan, corn syrup, citric acid, titanium dioxide, propylene glycol, natural flavor, aspartame, coloring agent, water, and at least one active ingredient. In one embodiment of the foregoing, the at least one active ingredient comprises cannabis oil.

[0058] In one variation, the composition consists essentially of pullulan, corn syrup, and alkylene glycol. In one variation, the composition consists essentially of pullulan, corn syrup, alkylene glycol, and at least one active ingredient. In yet another variation, the composition consists essentially of pullulan, corn syrup, alkylene glycol, sorbitol, and at least one active ingredient. In yet other variations, the composition consists essentially of pullulan, corn syrup, alkylene glycol, sorbitol, citric acid, and at least one active ingredient. In other variations, the composition consists essentially of pullulan, corn syrup, alkylene glycol, sorbitol, titanium dioxide, and at least one active ingredient. In one variation, the composition consists essentially of pullulan, corn syrup, citric acid, titanium dioxide, propylene glycol, natural flavor, aspartame, and coloring agent. In one variation, the composition consists essentially of pullulan, corn syrup, citric acid, titanium dioxide, propylene glycol, natural flavor, aspartame, coloring agent, and at least one active ingredient. In one embodiment of the foregoing, the at least one active ingredient comprises cannabis oil.

Sublingual or Buccal Devices

[0059] In some aspects, provided herein is a sublingual or buccal device that incorporates any of the edible ink compositions described herein. In some embodiments, the device is a multi-layered sublingual or buccal device. In some variations, the multi-layered devices are produced, at least in part, using screen printing and the edible ink compositions described herein to achieve a high enough amount of the at least one active ingredient so as to deliver a therapeutically effective dose when administered to a subject.

[0060] In one aspect, provided is a multi-layered sublingual or buccal device that is configured to be peeled off a substrate when consumed by a subject. In some embodiments, the device comprises: (i) an edible base layer screen printed onto the substrate; (ii) one or more edible intermediate layers printed onto the edible base layer, wherein the perimeter of the one or more edible intermediate layers lies within the perimeter of the edible base layer; and (iii) an edible top layer screen printed onto the edible base layer and the one or more edible intermediate layers, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the one or more edible intermediate layers.

[0061] In some embodiments, each layer independently comprises or consists essentially of: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as a brightener or an opacifier; a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and one or more additional components comprising a flavoring agent, a sweetener, and/or a coloring agent; and water.

[0062] In certain embodiments, the first component comprises pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof. In another embodiment, the first component is other than xanthan gum, or the composition does not contain any detectable amount of xanthan gum.

[0063] In certain embodiments, the second component comprises corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof.

[0064] In certain embodiments, the third component comprises citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof.

[0065] In certain embodiments, the fourth component comprises a titanium oxide (e.g., titanium dioxide), calcium carbonate, kaolin clay, powdered sugar, corn starch, or a whitener, or any combination thereof.

[0066] In certain embodiments, the fifth component comprises a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof.

[0067] In certain embodiments, the flavoring agent comprises natural flavor.

[0068] In certain embodiments, the sweetener comprises aspartame, sucralose, saccharin, stevia, acesulfame potassium, monk fruit extract, neotame, erythritol, allulose, aspartameacesulfame salt, xylitol, or yacon syrup, or any combination thereof.

[0069] In certain embodiments, the water is purified water. In one embodiment, the water does not contain any detectable amount of impurities, minerals and/or contaminants.

[0070] In some embodiments of the foregoing, each layer consists essentially of the five components, the flavoring agent, the sweetener, and the coloring agent as set forth above. [0071] In other embodiments, each layer independently comprises pullulan, corn syrup, and alkylene glycol. In other variations, each layer independently comprises pullulan, corn syrup, alkylene glycol, and sorbitol.

[0072] In some embodiments, the device is configured to deliver a therapeutically effective dose of at least one active ingredient to the human. In such embodiments, one or more layers of the device independently further comprises at least one active ingredient.

[0073] In some variations, one or more layers of the device further comprises one or more additional components, such as citric acid, titanium dioxide at least one sweetener, and/or at least one flavoring agent.

[0074] It should be understood that the different layers in the multi-layered sublingual or buccal device may share a similar base ink composition, but may also include one or more additional components, for example, depending on the desired printing effect to be achieved for a given layer. In some variations, the edible base layer comprises water, pullulan, corn syrup, alkylene glycol, and sorbitol. In some variations, the one or more edible intermediate layers independently comprises water, pullulan, corn syrup, alkylene glycol, sorbitol, and optionally citric acid and/or at least one active ingredient. In one variation of the foregoing, citric acid is not present in a layer that comes into contact with ink from an edible inkjet printer. In some variations, the edible top layer comprises water, pullulan, corn syrup, alkylene glycol, sorbitol, titanium dioxide, and optionally at least one active ingredient. In certain variations, once all the layers in the sublingual or buccal device are cured, the sublingual or buccal device has a moisture level between 5% and 20% by weight of the device.

[0075] In some variations of the foregoing, one or more of the layers further comprise a flavoring agent, a sweetener, and/or a coloring agent as described herein.

[0076] In one embodiment of the foregoing, any of the active ingredients described herein may be combined with the devices described above. For example, in one variation, at least one active ingredient comprises cannabis oil.

[0077] In one variation, the device comprises pullulan, corn syrup, citric acid, titanium dioxide, propylene glycol, natural flavor, aspartame, coloring agent, and cannabis oil. In some embodiments of the foregoing, the device consists essentially of the components as set forth above. In one variation, the device consists essentially of pullulan, corn syrup, citric acid, titanium dioxide, propylene glycol, natural flavor, aspartame, coloring agent, and cannabis oil.

[0078] Although the edible ink compositions described herein are optimized for screen printing to produce the sublingual or buccal devices, other additional techniques may be employed to construct the device. For example, one or more layers may be inkjet printed. In other words, in some variations, the device may include both screen printed and inkjet printed layers.

[0079] In certain aspects, provided is a multi-layered sublingual or buccal device that comprises: (i) an edible base layer screen printed onto the substrate; (ii) an edible intermediate layer inkjet printed onto the edible base layer, wherein the edible intermediate inkjet printed layer provides a graphical image; (iii) one or more edible intermediate layers screen printed on the edible intermediate inkjet printed layer, wherein the one or more edible intermediate screen printed layers comprises at least one active ingredient, and wherein the perimeter of the edible intermediate layers lies within the perimeter of the edible base layer; and (iv) an edible top layer screen printed onto the edible base layer and the edible intermediate layers, wherein the edible top layer optionally comprises at least one active ingredient. The perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the edible intermediate layers. The device provides a therapeutically effective dose of the at least one active ingredients to the human.

[0080] In one embodiment of the foregoing, the edible base layer, the one or more edible intermediate screen printed layers, and the edible top layer are as described herein.

[0081] In some variations, the device, when consumed by the human, dissolves at a rate of at least 1 second, or between about 5 seconds and 40 seconds.

[0082] In other embodiments, the edible ink compositions described herein may be incorporated in any suitable devices, including the following exemplary sublingual or buccal devices. [0083] In one embodiment, provided herein is a sublingual or buccal delivery device, comprising: (i) an edible base layer printed onto a substrate; (ii) a first edible intermediate layer printed onto the edible base layer, wherein the perimeter of the first intermediate layer lies within the perimeter of the edible base layer; (iii) a second edible intermediate layer printed onto the first edible intermediate layer, wherein the perimeter of the second edible intermediate layer lies within the perimeter of the first edible intermediate layer; (iv) a third edible intermediate layer printed onto the second edible intermediate layer and the first edible intermediate layer, wherein the perimeter of the third edible intermediate layer is equal to the perimeter of the first edible intermediate layer; and (v) an edible top layer printed onto the third intermediate layer and the edible base layer, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, wherein a plurality of active ingredients is present in the sublingual or buccal delivery device, wherein the plurality of active ingredients is printed into sequential edible layers, such that the release of active ingredients occurs in sequence.

[0084] In one embodiment, provided herein is a sublingual or buccal delivery device, comprising: (i) an edible base layer printed onto a substrate; (ii) a first edible intermediate layer printed onto the edible base layer, wherein the perimeter of the first intermediate layer lies within the perimeter of the edible base layer; (iii) a second edible intermediate layer and a third edible intermediate layer printed onto the first edible intermediate layer, wherein the perimeters of the second edible intermediate layer and the third edible intermediate layer lie within the perimeter of the first edible intermediate layer, and wherein the second intermediate layer and the third edible intermediate layer are deposited onto the first edible intermediate layer; and (iv) an edible top layer printed onto the second intermediate edible layer, the third intermediate layer, and the edible base layer, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, wherein a plurality of active ingredients is present in the sublingual or buccal delivery device, wherein the plurality of active ingredients is printed into sequential edible layers, such that the release of active ingredients occurs in sequence, with the release of the active ingredients present in the second edible intermediate layer and the third edible intermediate layer occurring simultaneously.

[0085] In one embodiment, provided herein is a sublingual or buccal delivery device, comprising (i) an edible base layer printed onto a substrate; (ii) a first edible intermediate layer printed onto the edible base layer, wherein the perimeter of the first intermediate layer lies within the perimeter of the edible base layer; (iii) a second edible intermediate layer printed onto the first edible intermediate layer, wherein the perimeter of the second edible intermediate layer lies within the perimeter of the first edible intermediate layer; (iv) a third edible intermediate layer printed onto the second edible intermediate layer, wherein the perimeter of the third edible intermediate layer lies within the perimeter of the second edible intermediate layer; (v) a fourth edible intermediate layer printed onto the third edible intermediate layer and the second edible intermediate layer, wherein the perimeter of the fourth edible intermediate layer is equal to the perimeter of the second edible intermediate layer; (vi) a fifth edible intermediate layer printed onto the fourth edible intermediate layer and the first edible intermediate layer, wherein the perimeter of the fifth edible intermediate layer is equal to the perimeter of the first edible intermediate layer; and (vii) an edible top layer printed onto the fifth edible intermediate layer and the edible base layer, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, wherein a plurality of active ingredients is present in the sublingual or buccal delivery device, wherein the plurality of active ingredients is printed into sequential edible layers, such that the release of active ingredients occurs in sequence.

[0086] In one embodiment, provided herein is a sublingual or buccal delivery device, comprising (i) an edible base layer printed onto a substrate; (ii) a first edible intermediate layer printed onto the edible base layer, wherein the perimeter of the first intermediate layer lies within the perimeter of the edible base layer; (iii) a second edible intermediate layer printed onto the first edible intermediate layer, wherein the perimeter of the second edible intermediate layer is equal to the perimeter of the first edible intermediate layer; and (iv) an edible top layer printed onto the second edible intermediate layer and the edible base layer, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, wherein a plurality of active ingredients is present in the sublingual or buccal delivery device, wherein the plurality of active ingredients is printed into sequential edible layers, such that the release of active ingredients occurs in sequence.

[0087] In one embodiment, as shown in FIG. 1 , a sublingual or buccal delivery device, generally designated 7, is formed by the application of first print layer 2 consisting of an edible ink compositions wherein colors, flavoring, and active ingredients are infused and deposited onto a substrate 1. This configuration of the sublingual or buccal delivery device 7 is fabricated using various conventional techniques, and is particularly suitable for printed fabrication. That is, most if not all of the subsequent material layers, atop one another, can be applied using printing techniques. Such techniques include, but are not limited to, offset printing, flexo-graphic printing, roto gravure, inkjet deposition, screen-printing and pad printing.

[0088] Referring now to FIGS. 1 and 2, a printed graphic sublingual or buccal delivery device 7, within an array of printed sublingual or buccal strips 8, is deposited by printing first print layer 2, which may or may not include graphics and text, to represent the overall scope of the invention by printing a specified shape onto a flexible substrate 1 , which additionally may be followed by a second print layer 3 which may be provided as a purely graphical indicia in order to convey the perceived visual subject matter as demonstrated in FIG. 4 of a specific sublingual or buccal device 7.

[0089] A significant advantage of printing a sublingual or buccal device 7 is print manufacturing eliminates the need for die-cutting to achieve a specified shape and therefore eliminating the waste associated to die-cutting where the space in between the specified shapes would be discarded thereby losing active ingredients as waste.

[0090] The viscosity of the ink is selected to enable optimal print fabrication, while at the same time being sufficiently viscous to allow the infused active ingredients to be uniformly suspended within the ink.

[0091] Another advantage of screen printing a sublingual or buccal delivery device 7 is that depositing layers by printing allows for multiple prints for depositing a specified amount of ink to achieve a desired thickness of ink. The composition and forward build printing sequence of the sublingual or buccal delivery device 7 is demonstrated in FIGS. 1, 2, and 4. It will be appreciated, however, that the thickness of each layer shown is not proportional, and merely shown as being equal for illustrative purposes.

[0092] In one embodiment, the sublingual or buccal delivery device 7 is formed by depositing first print layer 2, which may also be referred to as base layer, which may include multiple prints for depositing a specified amount or achieve a desired thickness. First, print layer 2 is deposited on substrate 1 , which may be described as a transparent sheet or film such as MYLAR Polyester film, polyethylene terephthalate (PET), or vacuum-deposited or sputtered indium tin oxide (ITO), and may or may not be removed from the finished sublingual or buccal delivery device 7.

[0093] In another embodiment, a second print layer 3 is deposited by printing onto first print layer 2, as shown in FIGS. 1, 2, and 4, which may be comprised of multiple prints for depositing a specified amount or achieve a desired thickness and may also include text and graphics as shown in FIG. 4. Second print layer 3 may or may not be infused with flavoring or active ingredients and may only serve as a layer that depicts text and imagery.

[0094] In another embodiment, text and imagery may be included in first print layer 2, as depicted in FIG. 3, which shows first print layer 2 is obscured or hidden by second print layer 3. Hence, the lack of ability to view the text and graphics of first print layer 2 is deposited in reverse or mirrored in relation to the overall sublingual or buccal delivery device 7. Therefore, first print layer 2 is readable to the viewer on the reverse side or bottom of the sublingual or buccal delivery device 7 before and/or after it is removed from the substrate 1.

[0095] In another embodiment, a sublingual or buccal delivery device 7 may be peeled off substrate 1 for use where substrate 1 represents a release liner intended for ease of packaging. Increased adhesion to substrate 1 may be increased by modifying the adhesion within printed ink of first print layer 2. Increased adhesion may be the only objective of first print layer 2 wherein no color, flavor, or active ingredient is used in the adhesion layer.

[0096] As demonstrated in FIG. 4, in one embodiment, second print layer 3 conveys a textual and graphic message within a single layer and represents a layer that may or may not be infused with active ingredients, wherein the layer containing active ingredients within the sublingual or buccal delivery device 7 may be within first print layer 2.

[0097] As demonstrated in FIG. 5, in another embodiment, third print layer 4 is encapsulated by second print layer 3, fourth print layer 5, first print layer 2 and fifth print layer 6. This print construction allows for the sequential release of active ingredients or flavorings where first print layer 2 and fifth print layer 6 share corresponding flavor or active ingredients and second print layer 3 and fourth print layer 5 share corresponding flavor or active ingredients which demonstrates two encapsulating layers that must dissolve before the release of flavor or active ingredients of third print layer 4.

[0098] As demonstrated in FIG. 6, in another embodiment of a sublingual or buccal delivery device 7, there is a simultaneous release of flavors and active ingredients contained within second print layer 3 and third print layer 4. This is accomplished by means of encapsulation, wherein first print layer 2 represents the first encapsulant layer and fourth print layer 5 represents the second encapsulant layer.

[0099] In another specific embodiment of FIG. 6, encapsulated layers may offer a duration of disintegration or a variable dissolving rate that enables the ability to calculate time between release of flavors and active ingredients in sublingual or buccal delivery device 7.

[0100] In one embodiment, as demonstrated in FIG. 7, the printing of concentric layers provides as a method of encapsulation wherein the top view clearly shows defined perimeters of each printed layer of sublingual or buccal delivery device 7, wherein first print layer 2 represents the first layer to dissolve in sequence, followed by second print layer 3, third print layer 4, fourth print layer 5 which represents the final layer containing active ingredients or flavoring dissolves. Each printed layer has a corresponding opposing layer as demonstrated in FIG. 8.

[0101] FIG. 8 illustrates a side view and completed construction of FIG. 7 by demonstrating additional layers that enable encapsulation and the sequential release of flavoring and active ingredients. This is accomplished by depositing first print layer 2, second print layer 3, third print layer 4, and fourth print layer 5, the innermost print layer of the final construction, followed by what is considered the corresponding opposing layers print layer 4a, print layer 3a, and print layer 2a. In this view the corresponding opposing layers are represented as being of the same composition as its opposing layer. For example, first print layer 2 and eighth print layer 2a are represented as the same material.

[0102] In another embodiment, as shown in FIG. 9, there is the sequential release of flavors and/or active ingredients contained within second print layer 3 and third print layer 4. This is accomplished by means of encapsulation where first print layer 2 represents the first encapsulant layer and fourth print layer 5 represents the second encapsulant layer.

[0103] In one embodiment, as demonstrated in FIG. 10 A, first print layer 2 is the first layer deposited onto substrate 1 and represents the first of four print layers in sequence required to form a combined graphic image within an array of sublingual or buccal delivery devices 8. Here, first print layer 2 incorporates text and graphics printed in reverse in relation to the forward build of the overall sublingual or buccal delivery device 7. Alignments or registration marks 9 are incorporated into FIGS. 10A-10D to demonstrate the alignment and registration required for the optimal outcome of the finished sublingual or buccal delivery device 7. FIG. 10B illustrates how the second print layer 3 is then disposed atop first print layer 2 (FIG. 10A), which is also referred to as base layer, which includes multiple prints for depositing a specified volume or achieve a desired thickness necessary to achieve a specified amount of flavoring or active ingredients. FIG. 10C illustrates how third print layer 4 is then disposed atop second print layer 3 (FIG. 10B), in the overall image formed by the four sequential prints of FIG. 10A-10D. Third print layer 4 represents the shadow print of the overall graphic image. FIG. 10D illustrates fourth print layer 5 is then disposed atop third print layer 4 (FIG. 10C), in the overall image formed by the four sequential prints of FIGS. 10A-10D. Fourth print layer 5 represents the highlight print of the overall graphic image.

[0104] FIG. 11 illustrates the use of printed vertical perforations 10 and printed horizontal perforations 11 that are formed by printing ink and leaving openings within the printed area to form a pattern wherein said openings in such pattern will cause an ease of separation of materials along such patterned line of openings within first printed layer 2 disposed on substrate 1 followed by second print layer 3 to fabricate an array of printed sublingual or buccal delivery devices 8 to establish dosage.

Screen Printing Systems

[0105] In one aspect, provided herein is a screen printing system configured to manufacture a multi-layered sublingual or buccal device with a therapeutically effective dose of at least one active ingredient, the system comprising: a plurality of mesh screens having different screen mesh counts; and a plurality of edible ink compositions having different viscosities, wherein: (i) when the edible ink composition has a viscosity between about 50 cps and about 100 cps, a mesh screen with a screen mesh count between about 230 and about 320 is used to deliver between about 1 mg and about 5 mg of the at least one active ingredient in one printed layer of the multilayered sublingual or buccal device; (ii) when the edible ink composition has a viscosity between about 5,000 cps and about 10,000 cps, a mesh screen with a screen mesh count between 90 and about 230 is used to deliver between about 5 mg and about 10 mg of the at least one active ingredient in one printed layer of the multi-layered sublingual or buccal device; and (iii) when the edible ink composition has a viscosity between about 100,000 cps and about 200,000 cps, a mesh screen with a screen mesh count between about 60 and about 90 is used to deliver at least about 10 mg of the at least one active ingredient in one printed layer of the graphical sublingual device.

Screen Printing Effects

[0106] The edible ink compositions provided herein may be used to produce various screen printing effects, suitable for incorporating into the sublingual and buccal devices described herein. Suitable screen printing effects may involve printing multiple layers to form a lenticular array, or printing braille texture on the top layer of the device without obstructing the graphic design present in the lower layers of the device, or forming transparent windows through the device. In some variations, these effects are achieved using a transparent ink that comprises water, pullulan, corn syrup, alkylene glycol, and citric acid, and optionally at least one active ingredient.

[0107] The effects described herein may be achieved by a reverse build construction or a forward build construction may be employed. For a forward build construction, the final graphic print is the last print furthest from the substrate so it is viewable without peeling off the substrate. For a reverse build construction, the first printed layers are viewable once peeled from the substrate for an animated sublingual display.

Lenticular Array

[0108] In general, lenticular arrays can create visual effects, such as 3-D, animation, flips, morph, zoom, or various combinations thereof, using interlaced printed images. FIGS. 12-15 provide cross sections of exemplary screen-printed devices that involve the formation of a lenticular array, e.g., using edible ink compositions as provided herein.

[0109] With reference to FIG. 12, provided is an exemplary screen printed device using a reverse build construction. In this figure, a lenticular array is formed by printing layers of transparent ink onto a lenticular substrate. This may be accomplished by providing a lenticular substrate 12 followed by a lower viscosity first print of transparent ink 2. The lower viscosity eliminates gaps within first print layer 2 caused by air bubbles. This is followed by second print layer 3 of a higher viscosity transparent ink that fills the remaining space of the lenticular array 12, followed by a third print layer 4 including graphic or color printed in alignment with one half of the lenticules of the printed array. This is followed by a fourth print 5 including graphic or color printed on the same third print layer as print layer 4 in alignment with one half of the lenticules of the printed array creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array. This is followed by a fifth print layer 6 of a higher viscosity ink that may contain flavoring and or infusion of active ingredients.

[0110] With reference to FIG. 13, provided is an exemplary screen printed device using a forward build construction. In this figure, a lenticular array is formed by printing a series of layers with transparent ink onto a lenticular substrate. This may be accomplished by providing a substrate 1 followed by first print layer 2 of a higher viscosity ink that may contain flavoring and or infusion of active ingredients, followed by second print layer 3 including graphic or color printed in alignment with one half of the lenticules of the printed array, followed by a third print 4 including graphic or color printed on the same second print layer as print 3 in alignment with one half of the lenticules of the printed array creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array. This is followed by a series of print layers 13 of transparent ink that decrease in width of each lenticule of the array forming the overall lenticular array.

[0111] With reference to FIG. 14, provided is an exemplary screen printed device using a reverse build construction. In this figure, a lenticular array is formed by printing layers of transparent ink onto a concave lenticular substrate. This may be accomplished by providing a concave lenticular substrate 17 followed by a lower viscosity first print of transparent ink 2. The lower viscosity eliminates gaps within first print layer 2 caused by air bubbles. This is followed by second print layer 3 of a higher viscosity transparent ink that fills the remaining space of the lenticular array 17, followed by a third print layer 4 including graphic or color printed in alignment with one half of the lenticules of the printed array. This is followed by a fourth print 5 including graphic or color printed on the same third print layer as print layer 4 in alignment with one half of the lenticules of the printed array creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array. This is followed by fourth print layer 6 of a higher viscosity ink that may contain flavoring and or infusion of active ingredients.

[0112] With reference to FIG. 15, provided is an exemplary screen printed device using a forward build construction. In this figure, a lenticular array is formed by printing a series of transparent ink onto a convex lenticular substrate. This may be accomplished by providing a substrate 1 followed by first print layer 2 of a higher viscosity ink that may contain flavoring and or infusion of active ingredients, followed by second print layer 3 including graphic or color printed in alignment with one half of the lenticules of the printed array, followed by a third print 4 including graphic or color printed on the same second print layer as print 3 in alignment with one half of the lenticules of the printed array creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array. This is followed by a series of print layers 14 of transparent ink that decrease in width of each convex lenticule of the array forming the overall lenticular array.

Braille

[0113] A braille effect may be achieved by screen printing a top layer of the device to form a 3D texture, without obstructing the graphic design present in the lower layers of the device. With reference to FIGS. 16 and 17, provided are an exemplary screen printed devices using a forward build construction. In this figure, a higher viscosity transparent ink is printed to form braille 14 on the top layer, without obstructing the graphic design present in first print layer 2 and second print layer 3, which are printed onto substrate 1 of the device. Transparent or Translucent Window

[0114] A transparent or translucent window may also be achieved by screen printing transparent or translucent layers of ink surrounded by opaque boarders. With reference to FIG. 18, provided is an exemplary screen printed device using a forward build construction. In this figure, a transparent or translucent ink is printed to form one or more transparent or translucent windows 15 through the overall sublingual or buccal device. This is accomplished by providing a substrate 1 , depositing first print layer 2 of a higher viscosity opaque ink that contains one or more openings, followed by one or more transparent or translucent ink prints 15 that may contain flavoring and or infusion of active ingredients forming one or more windows through the sublingual or buccal device. In other variations, the entire device may be transparent or translucent including multiple colors utilizing multiple printed regions of the sublingual or buccal device.

[0115] It should be understood that in the multiplayer sublingual or buccal device, the viscosity of one screen printed layer may be different than the viscosity of other screen printed layers in the device, thereby creating one or more of the effects described herein. In other words, a lower or higher viscosity of a layer is compared to other layers in the device. In some variations of the foregoing, a lower viscosity print is produced using an edible ink composition as described herein that has a viscosity of less than 10,000 cps, or between about 50 cps and about 100 cps, or between about 5,000 cps and about 10,000 cps. In other variations of the foregoing, a higher viscosity print is produced using an edible composition as described herein that has a viscosity of greater than 10,000 cps, or between about 100,000 cps and about 200,000 cps.

[0116] It is to be understood that, while the disclosure has been described in conjunction with the above embodiments, the foregoing description and examples are intended to illustrate and not limit the scope of the disclosure. Other aspects, advantages, and modifications within the scope of the disclosure will be apparent to those skilled in the art to which the disclosure pertains.

Claims

CLAIMS What is claimed is:

1. An edible ink composition formulated for screen printing a sublingual or buccal device, the composition comprising water, pullulan, corn syrup, and alkylene glycol.

2. The composition of claim 1 , further comprising at least one active ingredient.

3. The composition of claim 1 or 2, further comprising sorbitol.

4. The composition of any one of claims 1 to 3, further comprising: citric acid; or titanium dioxide; or at least one sweetener; or at least one flavoring agent; or at least one coloring agent; or any combination thereof.

5. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, and alkylene glycol.

6. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, and sorbitol.

7. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and citric acid.

8. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and titanium dioxide.

9. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, and at least one active ingredient.

10. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and at least one active ingredient.

11. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, citric acid, and at least one active ingredient.

12. The composition of claim 1, wherein the composition consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, titanium dioxide, and at least one active ingredient.

13. The composition of any one of claims 2-4 or 9-12, wherein at least one active ingredient comprises a cannabis extract (e.g., cannabis oil) or at least one cannabinoid.

14. The composition of any one of claims 1 to 13, wherein the alkylene glycol is propylene glycol.

15. The composition of any one of claims 1 to 14, wherein the composition has: a viscosity between about 50 cps and about 100 cps; or a viscosity between about 5,000 cps and about 10,000 cps; or a viscosity between about 100,000 cps and about 200,000 cps.

16. An edible ink composition formulated for screen printing a sublingual or buccal device, wherein the composition comprises or consists essentially of: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as a brightener or an opacifier; a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); one or more additional components comprising a flavoring agent, a sweetener, and/or a coloring agent; and water.

17. The composition of claim 16, wherein the first component comprises pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof.

18. The composition of claim 16 or 17, wherein the second component comprises corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof.

19. The composition of any one of claims 16 to 18, wherein the third component comprises citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof.

20. The composition of any one of claims 16 to 19, wherein the fourth component comprises a titanium oxide (e.g., titanium dioxide), calcium carbonate, kaolin clay, powdered sugar, corn starch, or a whitener, or any combination thereof.

21. The composition of any one of claims 16 to 20, wherein the fifth component comprises a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof.

22. The composition of any one of claims 16 to 21, wherein: the flavoring agent comprises natural flavor; and the sweetener comprises aspartame, sucralose, saccharin, stevia, acesulfame potassium, monk fruit extract, neotame, erythritol, allulose, aspartame-acesulfame salt, xylitol, or yacon syrup, or any combination thereof.

23. The composition of any one of claims 16 to 22, wherein the water is purified water.

24. The composition of any one of claims 16 to 22, wherein the water does not contain any detectable amount of impurities, minerals and/or contaminants.

25. The composition of any one of claims 16 to 24, wherein the at least one active ingredient comprises a cannabis extract (e.g., cannabis oil) or at least one cannabinoid.

26. A multi-layered sublingual or buccal device, wherein the sublingual or buccal device is peeled off a substrate for consumption by a human, the device comprising:

(i) an edible base layer screen printed onto the substrate;

(ii) one or more edible intermediate layers printed onto the edible base layer, wherein the perimeter of the one or more edible intermediate layers lies within the perimeter of the edible base layer; and

(iii) an edible top layer screen printed onto the edible base layer and the one or more edible intermediate layers, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the one or more edible intermediate layers, wherein each layer independently comprises pullulan, corn syrup, and alkylene glycol.

27. The device of claim 26, configured to deliver a therapeutically effective dose of at least one active ingredient to a human in need thereof, and wherein one or more layers independently further comprise at least one active ingredient.

28. The device of claim 27, wherein one or more layers independently further comprise sorbitol.

29. The device of any one of claims 26 to 28, wherein one or more layers further comprises: citric acid; or titanium dioxide; or at least one sweetener; or at least one flavoring agent; or at least one coloring agent; or any combination thereof.

30. The device of any one of claims 16 to 29, wherein the edible base layer comprises or consists essentially of water, pullulan, corn syrup, alkylene glycol, and sorbitol.

31. The device of any one of claims 16 to 29, wherein the one or more edible intermediate layers independently comprise or consist essentially of water, pullulan, corn syrup, alkylene glycol, and sorbitol.

32. The device of any one of claims 16 to 29, wherein the one or more edible intermediate layers independently comprise or consist essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and citric acid.

33. The device of any one of claims 16 to 29, wherein the one or more edible intermediate layers independently comprise or consist essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and at least one active ingredient.

34. The device of any one of claims 16 to 29, wherein the one or more edible intermediate layers independently comprise or consist essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, citric acid, and at least one active ingredient.

35. The device of any one of claims 16 to 34, wherein the edible top layer comprises or consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, and titanium dioxide.

36. The device of any one of claims 16 to 34, wherein the edible top layer comprises or consists essentially of water, pullulan, corn syrup, alkylene glycol, sorbitol, titanium dioxide, and at least one active ingredient.

37. The device of any one of claims 26 to 36, wherein one or more edible intermediate layers are inkjet printed or screen printed onto the edible base layer.

38. The device of claim 16, comprising:

(i) an edible base layer screen printed onto the substrate;

(ii) an edible intermediate layer inkjet printed onto the edible base layer, wherein the edible intermediate inkjet printed layer provides a graphical image;

(iii) one or more edible intermediate layers screen printed on the edible intermediate inkjet printed layer, wherein the one or more edible intermediate screen printed layers comprise at least one active ingredient, and wherein the perimeter of each of the edible intermediate layers lies within the perimeter of the edible base layer; and

(iv) an edible top layer screen printed onto the edible base layer and the one or more edible intermediate layers, wherein the edible top layer optionally comprises at least one active ingredient, and wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the one or more edible intermediate layers, and wherein the device provides a therapeutically effective dose of the at least one active ingredients to a human in need thereof.

39. The device of claim 3, wherein: the edible base layer comprises or consists essentially of water, pullulan, corn syrup, and alkylene glycol; the one or more edible intermediate screen printed layers independently comprise or consist essentially of water, pullulan, corn syrup, alkylene glycol, and optionally at least one active ingredient; and the edible top layer comprises or consists essentially of water, pullulan, corn syrup, alkylene glycol, citric acid, titanium dioxide, and optionally at least one active ingredient.

40. The device of any one of claims 27 to 30, wherein at least one active ingredient comprises a cannabis extract or at least one cannabinoid.

41. The device of any one of claims 26 to 40, wherein the alkylene glycol is propylene glycol.

42. The device of any one of claims 26 to 41 , wherein the device, when consumed by a human, dissolves between about 5 seconds and 40 seconds.

43. A multi-layered sublingual or buccal device, wherein the sublingual or buccal device is peeled off a substrate for consumption by a human, the device comprising:

(i) an edible base layer screen printed onto the substrate;

(iii) an edible top layer screen printed onto the edible base layer and the one or more edible intermediate layers, wherein the perimeter of the edible top layer is equal to the perimeter of the edible base layer, such that the edible top layer and the edible base layer together encapsulate the one or more edible intermediate layers, wherein each layer independently comprises: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as a brightener or an opacifier; a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and one or more additional components comprising a flavoring agent, a sweetener, and/or a coloring agent.

44. The device of claim 43, wherein the first component comprises pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof.

45. The device of claim 43 or 44, wherein the second component comprises corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof.

46. The device of any one of claims 43 to 45, wherein the third component comprises citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof.

47. The device of any one of claims 43 to 46, wherein the fourth component comprises a titanium oxide (e.g., titanium dioxide), calcium carbonate, kaolin clay, powdered sugar, corn starch, or a whitener, or any combination thereof.

48. The device of any one of claims 43 to 47, wherein the fifth component comprises a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof.

49. The device of any one of claims 43 to 48, wherein: the flavoring agent comprises natural flavor; and the sweetener comprises aspartame, sucralose, saccharin, stevia, acesulfame potassium, monk fruit extract, neotame, erythritol, allulose, aspartame-acesulfame salt, xylitol, or yacon syrup, or any combination thereof.

50. The device of claim 43, configured to deliver a therapeutically effective dose of at least one active ingredient to a human in need thereof, and wherein one or more layers independently further comprise at least one active ingredient.

51. The device of any one of claims 43 to 50, wherein the at least one active ingredient comprises a cannabis extract or at least one cannabinoid.

52. The device of any one of claims 43 to 51 , wherein the device, when consumed by a human, dissolves between about 5 seconds and 40 seconds.

53. A screen printing system configured to manufacture a multi-layered sublingual or buccal device with a therapeutically effective dose of at least one active ingredient, the system comprising: a plurality of mesh screens having different screen mesh counts; and a plurality of edible ink compositions having different viscosities, wherein:

(i) when the edible ink composition has a viscosity between about 50 cps and about 100 cps, a mesh screen with a screen mesh count between 230 and about 320 is used to deliver between about 1 mg and about 5 mg of the at least one active ingredient in one printed layer of the multi-layered sublingual or buccal device; (ii) when the edible ink composition has a viscosity between about 5,000 cps and about 10,000 cps, a mesh screen with a screen mesh count between 90 and about 230 is used to deliver between about 5 mg and about 10 mg of the at least one active ingredient in one printed layer of the multi-layered sublingual or buccal device; and

(iii) when the edible ink composition has a viscosity between about 100,000 cps and about 200,000 cps, a mesh screen with a screen mesh count between 60 and about 90 is used to deliver at least 10 mg of the at least one active ingredient in one printed layer of the graphical sublingual device.

54. A multi-layered sublingual or buccal device having one or more visual effects, wherein the one or more visual effects comprise 3-D, animation, flips, morph, zoom, or any combination thereof, the device comprising: a lenticular array formed by screen printing a series of layers with transparent ink onto a lenticular substrate, wherein the series of layers comprises: a first screen printed layer comprising a lower viscosity transparent ink; a second layer screen printed onto the first layer, wherein the second layer comprises a higher viscosity transparent ink that fills the remaining space of the lenticular array; a third layer screen printed onto the second layer, wherein the third layer comprises a graphic or color printed in alignment with one half of the lenticules of the lenticular array; and a fourth layer screen printed onto the third layer, wherein the fourth layer comprises graphic or color printed in alignment with the other half of the lenticules of the lenticular array, thereby creating a pattern of two or more colors or interlaced graphics in alignment with the lenticular array.

55. The device of claim 54, further comprising: an additional layer printed onto the fourth layer, wherein the additional layer comprises a higher viscosity ink, and flavoring and/or at least one active ingredient.

56. The device of claim 54, further comprising: an additional layer screen printed onto the lenticular substrate, adj acent to the first screen printed layer, wherein the additional layer comprises a higher viscosity ink, and flavoring and/or at least one active ingredient.

57. The device of any one of claims 54 to 56, wherein the lenticular substrate is a concave lenticular substrate.

58. The device of any one of claims 54 to 56, wherein the lenticular substrate is a convex lenticular substrate.

59. A multi-layered sublingual or buccal device having a braille effect, the device comprising: a substrate; one or more layers screen printed onto the substrate, wherein the one or more layers comprise graphic design; and a top layer screen printed onto the one or more layers to from a braille effect on the top layer without obstructing the graphic design, wherein the top layer comprises a higher viscosity transparent ink.

60. A multi-layered sublingual or buccal device having a transparent or translucent window, the device comprising: a substrate; a first layer screen printed onto the substrate, wherein the first layer comprises a higher viscosity opaque ink that contains one or more openings; one or more additional layers screen printed onto the first layer, wherein the one or more additional layers comprise transparent or translucent ink, optionally containing flavoring and/or at least one active ingredient, forming one or more windows through the sublingual or buccal device.

61. The device of any one of claims 54 to 60, wherein the sublingual or buccal device is peeled off the substrate for consumption by a human.

62. The device of any one of claims 54 to 61, wherein the ink is an edible ink.

63. The device of any one of claims 54 to 62, wherein the transparent ink comprises water, pullulan, corn syrup, alkylene glycol, and citric acid; and optionally sorbitol; and optionally at least one active ingredient.

64. The device of any one of claims 54 to 62, wherein the transparent ink comprises: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; and a fourth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and optionally at least one active ingredient.

65. The device of any one of claims 54 to 62, wherein the transparent ink comprises: water, a first component comprising pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof; a second component comprising corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof; a third component comprising citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof; and a fourth component comprising a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof; and optionally at least one active ingredient.

66. The device of any one of claims 60 to 62, wherein the opaque ink comprises water, pullulan, corn syrup, alkylene glycol, citric acid, and an opacifier; and optionally sorbitol; and optionally at least one active ingredient.

67. The device of any one of claims 54 to 62, wherein the opaque ink comprises: a first component serving as a thickener, stabilizer and film-forming agent; a second component comprising a liquid glucose syrup; a third component comprising weak organic acid; a fourth component serving as an opacifier; and a fifth component serving as a humectant and/or solvent for at least one active agent (optionally if present); and optionally at least one active ingredient.

68. The device of any one of claims 54 to 62, wherein the transparent ink comprises: water, a first component comprising pullulan, corn starch, tapioca starch, potato starch, agar, xanthan gum, guar gum, carrageenan, pectin, methylcellulose, or carboxymethyl cellulose, or any combination thereof; a second component comprising corn syrup, honey, agave nectar, molasses, maple syrup, or simple syrup, or any combination thereof; a third component comprising citric acid, lemon juice, vinegar, or tartaric acid, or any combination thereof; a fourth component comprising a titanium oxide (e.g., titanium dioxide), calcium carbonate, kaolin clay, powdered sugar, corn starch, or a whitener, or any combination thereof; and a fifth component comprising a glycol (e.g., propylene glycol or propanediol), or glycerin (e.g., vegetable glycerin), or any combination thereof; and optionally at least one active ingredient.

69. The device of any one of claims 64 to 68, wherein the ink further comprises a flavoring agent and/or a sweetener.