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Title:
PRINTED DELIVERY DEVICE HAVING SUPPLEMENTS
Document Type and Number:
WIPO Patent Application WO/2021/045742
Kind Code:
A1
Abstract:
Printed delivery devices are disclosed herein. In some embodiments, a printed delivery device (100) includes a support substrate. A first printed composition (102), including a first supplement, is coated onto the support substrate (202) and a second printed composition (102) disposed on the first printed composition. A decorative film is applied to one or more of the first printed composition, second printed composition, or the support substrate (602).

Inventors:
KAISERMAN TERRANCE (US)
KHAWLY ROOSEY (US)
FERBER ANDREW (US)
GENTILE JOHN (US)
Application Number:
PCT/US2019/049517
Publication Date:
March 11, 2021
Filing Date:
September 04, 2019
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
VITIPRINTS LLC (US)
International Classes:
A61J3/06; A61K9/24; B33Y80/00
Domestic Patent References:
WO2014188079A12014-11-27
Foreign References:
US20120315333A12012-12-13
US20080260807A12008-10-23
Other References:
CADER HATIM K ET AL: "Water-based 3D inkjet printing of an oral pharmaceutical dosage form", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 564, 9 April 2019 (2019-04-09), pages 359 - 368, XP085689547, ISSN: 0378-5173, DOI: 10.1016/J.IJPHARM.2019.04.026
SCOUTARIS NICOLAOS ET AL: "Jet dispensing of multi-layered films for the co-delivery of three antihypertensive agents", DRUG DELIVERY AND TRANSLATIONAL RESEARCH, SPRINGER, GERMANY, vol. 8, no. 1, 2 October 2017 (2017-10-02), pages 32 - 42, XP036414693, ISSN: 2190-393X, [retrieved on 20171002], DOI: 10.1007/S13346-017-0430-3
Attorney, Agent or Firm:
VEZERIS, James, A. et al. (US)
Download PDF:
Claims:
IN THE CLAIMS

1. A printed delivery device, comprising: a first layer formed of a printable composition including at least one first supplement; a second layer formed of a second printable composition including at least one second supplement; and wherein the second layer is disposed on the first layer.

2. The printed delivery device of claim 1, wherein the at least one second supplement is different from the at least one first supplement.

3. The printed delivery device of claim 1, wherein the at least one second supplement is the same as the at least one first supplement.

4. The printed delivery device of claim 1, further comprising: a support substrate.

5. The printed delivery device of claim 4, wherein the support substrate encompasses the at least one of the first or second layer.

6. The printed delivery device of claim 4, wherein the first layer is disposed on the support substrate.

7. The printed delivery device of claim 1, wherein one or more of the first layer and second layer have micro-scoring or pinholes.

8. A printed delivery device, comprising: a support substrate; a first printed composition, including a first supplement, disposed onto the support substrate; a second printed composition disposed on the first printed composition; and a decorative film applied to one or more of the first printed composition, second printed composition, or the support substrate.

9. The printed delivery device of claim 8, wherein the support substrate is polyester.

10. A printed delivery device, comprising: a support substrate; a first layer printed onto a surface of the support substrate, wherein the first layer includes a supplement and/or a pharmaceutical; and a printed decorative layer, wherein the decorative layer is printed onto the first supplement.

11. The printed delivery device of claim 10, wherein the supplement includes one or more of a vitamin, a mineral, a protein, a probiotic, a fiber, an amino acid, and other dietary supplements.

12. The printed delivery device of claim 10, wherein the supplement includes one or more of CBD oil, THC oil, and Hemp oil.

13. The printed delivery device of claim 10 further comprising a second layer, wherein the second layer includes a second supplement.

14. The printed delivery device of claim 10, wherein the decorative layer is applied with ink-jet printing.

15. The printed delivery device of claim 10, wherein the decorative layer includes one or more identification codes.

16. The printed delivery device of claim 10, wherein the decorative layer is comprised of natural colorants.

17. The printed delivery device of claim 10, wherein the supplement includes one or more of a vitamin, a mineral, a protein, a probiotic, a fiber, an amino acid, and other dietary supplements.

18. The printed delivery device of claim 10, wherein the support substrate is polyester and the first layer is removable from the support substrate.

19. The printed delivery device of claim 10, wherein the supplement and the pharmaceutical are mixed together.

20. The printed delivery device of claim 10 further comprising: a second layer formed on the first layer, wherein the second layer includes a second supplement and/or a second pharmaceutical.

Description:
PRINTED DELIVERY DEVICE HAVING SUPPLEMENTS

BACKGROUND OF THE INVENTION

[0001] Conventional delivery devices for supplements, such as tablets, capsules, soft gels, pills, etc., are typically formed from, or include, a mixture of a supplement or supplements with additional materials. These additional materials, such as fillers and excipients enable the supplement within the conventional delivery devices to flow and dissolve when subjected to the appropriate conditions, such as after consumption or placement with a liquid. However, the addition of these additional materials to the conventional delivery devices detracts from the overall purity of the supplement or supplements contained therein.

[0002] The additional materials add bulk (e.g., mass, weight, length, width, and/or depth,) to the conventional delivery device, increase manufacturing time, and increase manufacturing cost. In this regard, each additional material used in manufacturing a conventional delivery device adds mass to the completed delivery device, requires additional time to incorporate into the completed delivery device, and results in additional costs to cover the additional materials as well as to cover the increase in manufacturing time.

[0003] Many supplements are incapable of being blended together within a single conventional delivery device. For instance, supplements, such as a water-soluble supplement and a non-water soluble supplement are often immiscible. In addition, interactions, such as chemical reactions, between different supplements may result in the degradation of one or more of the supplements contained therein, which in turn may result in a less efficacious dosage. As such, combinations of supplements that are incapable of being blended and/or result in the degradation of one or more of the supplements may need to be separated into distinct, conventional delivery devices.

BRIEF SUMMARY OF THE INVENTION

[0004] The technology is related to a printed delivery device. In one aspect of the technology the printed delivery device comprises a first layer formed of a printable composition including at least one first supplement; a second layer formed of a second printable composition including at least one second supplement; and wherein the second layer is disposed on the first layer. In some embodiments the printed delivery device of includes a support substrate.

[0005] In some instances the at least one second supplement is different from the at least one first supplement. In some embodiments the at least one second supplement is the same as the at least one first supplement.

[0006] In some embodiments the support substrate encompasses the at least one of the first or second layer. In some instances the first layer is disposed on the support substrate. [0007] In another aspect of the technology the printed delivery device comprises a support substrate; a first printed composition, including a first supplement, coated onto the support substrate; a second printed composition disposed on the first printed composition; and a decorative film applied to one or more of the first printed composition, second printed composition, or the support substrate.

[0008] In some instances the support substrate is polyester.

[0009] In some instances the first supplement is a probiotic. In some instances the second printed composition includes a second supplement. The second supplement is a vitamin, in some embodiments.

[0010] In some embodiments the decorative film is applied with lamination.

[0011] In some aspects of the technology the printed delivery device can include a multilayer stack, for instance, having one supplement in a first layer, and one or more additional supplements in one or more layers overlying the first layer. The layers of the multilayer stack can, in some embodiments, have layers with varied doses of a supplement. The layers, in some embodiments, can be different colors to identify an ingredient and/or dosage.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1A depicts a schematic view of a printed delivery device in accordance with some embodiments of the present application.

[0013] Figure IB depicts a schematic view of a printed delivery device having two layers of printed compositions in accordance with some embodiments of the present application.

[0014] Figure 2A depicts a schematic view of a printed delivery device having a support substrate around a layer of printed compositions in accordance with some embodiments of the present application.

[0015] Figure 2B depicts a schematic view of a printed delivery device having a support substrate around a layer of printed composition disposed on a second layer of printed compositions in accordance with some embodiments of the present application.

[0016] Figure 2C depicts a schematic view of a printed delivery device having a support substrate around multiple layers of printed compositions in accordance with some embodiments of the present application.

[0017] Figure 2D depicts a schematic view of a printed delivery device having multiple support substrates in accordance with some embodiments of the present application.

[0018] Figure 3 depicts a flow chart for a method of making a printed delivery device in accordance with some embodiments of the present application. [0019] Figures 4A-E depict stages of fabrication a printed delivery device made in accordance with the method described in FIG. 3

[0020] Figure 5 depicts a flow chart for a method of making a printed delivery device composition in accordance with some embodiments of the present application.

[0021] Figures 6A-E illustrate stages of fabrication of a printed delivery device in accordance with the method described in FIG. 5.

[0022] Figure 7 depicts a formation of an ink in accordance with some embodiments of the present application.

DETAILED DESCRIPTION

[0023] The invention relates to printed delivery devices formed of one or more layers of printed compositions, such as films, and methods of making them. As described above, conventional delivery devices, such as pills and capsules, typically require the use of additional materials which detracts from the purity of the supplement, as well as adding bulk and manufacturing costs to the conventional delivery device. Moreover, conventional delivery devices are limited as to the combinations of supplements they can offer. In this regard, certain combinations of supplements are immiscible and some combinations of supplements may result in the degradation of one or more of the supplements. This can create a situation where the efficacy of the supplements is diminished or ineffective. It may also require multiple conventional delivery devices to deliver the desired supplements.

[0024] To address these issues, printed delivery devices may be formed from one or more layers of printed composition. Each layer may contain a supplement or grouping of interacting and/or non interacting supplements. Each supplement within a layer may be of a predetermined dose. The printed delivery devices may be utilized in applications where a supplement may be desirable, for example, as an additive to a food or beverage for the purpose of nutrition, flavor, sweetening, medicinal ingestion, and the like.

[0025] The printed delivery device may be configured such that it is shelf-stable. In this regard, printed compositions may be configured with a moisture barrier, such that the printed composition, and the supplements therein, are unaffected by room humidity and moisture levels within a certain threshold. Moreover, the layers of printed composition may be arranged such that the printed delivery device is of a particular size and shape. The size and shape of each printed delivery device may be tailored depending upon its intended use, its packaging, and/or its shipping method. For instance, the layers of a printed delivery device may be printed in a rectangular shape, such that the printed delivery device is rectangular and capable of being positioned within a box for flat shipping. [0026] The dissolution or dispersal rate of each layer of printed compositions may be controlled.

In this regard, the printed compositions of a printed delivery device may be tailored to have individual time release profiles. For instance, a first layer containing a supplement can dissolve at a faster rate than a second layer containing a second supplement to allow ingestion of the first supplement prior to the second supplement. More particularly, an ingestible printed delivery device containing a first layer having a pleasant tasting supplement and a second layer having an unpleasant tasting supplement, may be configured such that the first layer dissolves prior to the second layer. As such, the pleasant tasting supplement may bind to tongue receptors prior to the unpleasant tasting supplement dissolving, thereby blocking or masking the taste of the unpleasant supplement.

[0027] A printed delivery device may include one or more layers comprised of printed compositions. FIG. 1A depicts one exemplary embodiment of a printed delivery device 100 including a first layer 102 of printed composition. FIG. IB depicts another exemplary embodiment of a printed delivery device 110 which includes two layers, including first layer 102 comprised of a printed composition and second layer 104 comprised of a printed composition, such as a film. Although only two layers are shown in FIG. IB, any number of layers may be present.

[0028] Each layer may include active or inactive ingredients. In this regard, the printed composition may be comprised of active ingredients, such as one or more supplements or pharmaceuticals. For instance, referring again to FIG. IB, first layer 102 may be comprised of a printed composition containing a first supplement and second layer 104 may be comprised of another printed composition including a second supplement. Although the first layer 102 and second layer 104 are disclosed as containing active ingredients, they may contain inactive ingredients and/or a combination of active and inactive ingredients. Moreover, each layer may contain the same or different active and inactive ingredients. Layers having active ingredients may be referred to as active layers.

[0029] The active ingredients may include supplements and the supplements may include those suitable for nutrition, flavor enhancement, and/or medicinal purposes that can be ingested. Nutritional supplements can include a vitamin, a mineral, a protein, a probiotic, a fiber, an amino acid, and other dietary supplements. For example, vitamins may include any suitable vitamin that can be ingested, such as vitamin A, B, C, D, E, B12, and the like found in a typical over the counter multivitamin. Minerals may include iron, magnesium, potassium, and the like found in a typical over the counter multivitamin. A protein may include whey protein or a plant based protein. In some instances, the active and inactive ingredients may include pharmaceuticals, such as acetylsalicylic acid, acetaminophen, ibuprofen, etc., as well as beverage and food items.

[0030] In order to incorporate active and inactive ingredients into the printed composition, the active ingredients may be microencapsulated, dispersed, suspended and/or solubilized into a printable composition, such as carrageenan, xanthum gum, guar gum, or other such material. In some instances, a small amount of preservative, such as ascorbic acid may be included in the composition.

[0031] The printable composition may include additional components to alter the properties of the printed delivery device. Such properties may include the following: Structural support of the printed composition; release control of an active ingredient, such as a supplement from the printed composition as it dissolves and/or disperses; shelf stability of the active ingredient; manipulation of the printable composition or formed printed composition during manufacture; appearance of the printed delivery device; and taste of the printed delivery device.

[0032] For instance, the printable composition may be configured such that the dissolution or dispersion of the active or inactive ingredients within the printable composition may be released over a period of time. For instance, additional components such as starches may be mixed with one or more of polyvinyl alcohol, polysaccharides (e.g., Pullulan), sodium alginate, etc., and into one or more of the materials for generating the printable composition such as, carrageenan, xanthum gum, guar gum, etc. [0033] The period of dissolution or dispersion may be adjusted based on the amount of starch, such as a slower period of dissolution or dispersion when more starch is used and quicker dissolution or dispersion when less starch is used (or vice versa). In some instances a binder may be added to the printable composition to maintain the structural integrity of the substances therein. Binders may include one or more of polysaccharides (e.g., Pullulan,) sodium alginate, etc. In some instances, the entire printed delivery device and/or individual layers of the printed delivery device may include be subjected to micro scoring and/or pinholes. By doing such, the surface area of the printed delivery device and/or layers is increased, thereby allowing for faster dissolution/dispersion.

[0034] Other additional components in the printable composition can include one or more of polymers, defoamers, flow aides, flavor enhancers, rheological modifiers, humectants, waxes, and the like and other components that are utilized to print a layer from an ink, such as dyes, pigments, etc. Exemplary polymers may be water soluble, water swellable or water insoluble. They may include but are not limited by, ethyl cellulose, polyacrylic acid, methyl cellulose, polyethylene oxide, guar gum, xanthum gum, gum Arabic, polyvinyl alcohol, sodium alginate, water-soluble hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, sodium carboxy methyl cellulose, methyl cellulose, polyvinyl alcohol, xanthum gum, various starches such as corn starch, rice starch etc.

[0035] Defoamers may include, but are not limited thereto, alcohol or polysiloxane type defoamers both in water and alcohol. Flow aids may contain food grade glycols and polyglycols, xylitol, glycerol.

[0036] Waxes may include, but are not limited thereto, paraffin or carnauba waxes. [0037] Humectants may include, but are not limited thereto, all molecular weight polyethylene glycols and propylene glycols, xylitol, glycerol sugars and starches. Rheology modifiers may include, but are not limited thereto, sodium salts of an acrylic polymer, various starches and gums.

[0038] Colorants may also be used to tint printed compositions to specific colors. In this regard, each layer may include its own color or the same color.

[0039] Each layer can be tailored to the particular needs of an application. For example, a layer that is self-supporting (e.g. as shown in FIG. 1A) may include, in addition to one or more supplements, components such as one or more high glass transition (Tg) PVOH, PVA, sodium alginate, polysaccharides, wax, or starch that is stiff but which will dissolve quickly upon contact with a predetermined amount of moisture, such as upon contact with a beverage and/or saliva.

[0040] Alternatively, a layer that is deposited or encapsulated on a support substrate (as described in further detail herein,) may have a different composition where the printed composition does not need to provide its own support. For example, such a layer having an active ingredient may include, in addition to one or more supplements, a food grade thickening system such as xanthum gum. Further, the layer could be printed on a support substrate that includes strong structural support from the inclusion of materials such as wax and/or sodium alginate, PVOH, PVA. In some instances, multiple layers of one or more of the same supplements may be used to increase the dosage of a single printed delivery device. [0041] In the preceding exemplary embodiments, each layer of the respective printed delivery devices may be sufficiently robust in terms of shelf stability and/or mechanical stability such that the layers do not require a support substrate to improve or provide these properties. In other words, layers comprised of films having sufficient rigidity and/or additional components may obviate the need for a support substrate. For example, a supplement and/or additional component in the layer that has a high glass transition can allow for a more rigid layer which has sufficient stiffness to handle and/or orally ingest and/or place in a food product, such as a beverage, without sagging to a degree that makes handling difficult.

[0042] Printed delivery devices may include a support substrate. The support substrate, also referred to as a support structure, may provide a supportive base on which one or more layers of printed composition may be positioned. In this regard, the one or more layers of the printed delivery device may not be capable of maintaining their shape and/or supporting their own weight. As such, during handling, storing, and/or transportation the one or more layers may break apart or otherwise deform, and/or sag. To prevent this from occurring, a support substrate may be used to provide structural support to layers disposed therein. For instance, FIG. 2A depicts one exemplary embodiment of a printed delivery device 200 including a support substrate 202 encompassing the first layer 201. In some instances, support substrates may be used for printed delivery devices even if they are capable of maintaining their shape and/or supporting their own weight. The substrate could be an alginate.

[0043] Another exemplary embodiment of a printed delivery device including a support structure is shown in FIG. 2B. In this embodiment the printed delivery device 210 includes a first layer 201 completely encapsulated by the support substrate 202. A second layer 204, which may be, on its own, structurally sound, is disposed on a surface of the support substrate 202, such that the second layer 204 is not encapsulated by the support substrate 202. In instances where the second layer 204 does not require structural support, a smaller support structure 202 may be used in the printed delivery device 210. As such, the amount of material to produce the support structure 202 may be reduced.

[0044] In contrast with the embodiment of FIG. 2B, FIG. 2C shows a printed delivery device

220 which has two layers 210 and 212 fully encapsulated by a support structure 202.

[0045] FIG. 2D depicts yet another exemplary embodiment of a printed delivery device 230 including the first layer 230 encapsulated by a first support substrate 242 and the second layer 232 encapsulated by a second support substrate 252. The support substrate 242 may be suitable to meet the shelf life and/or time release criteria of the first layer 230, which may include one or more active ingredients, second layer 232, which many include one or more active ingredients, and the second support substrate 252 may be suitable to meet the shelf life and/or time release criteria of the second layer 232. [0046] Although some of the support structures of the above embodiments (e.g., Figs. 2B-2D,) are shown as fully encapsulating one or more layers, a layer may be deposited or otherwise positioned on support substrate, or vice-versa. As such, only a portion or portions of a layer may be disposed on a support structure. Further, a layer may be encapsulated or disposed on more than one support substrate. For instance, a layer may be disposed between support substrates, i.e., one support substrate atop active layer, and another support substrate below the layer.

[0047] The support structure may be comprised of a printed composition and/or any of the other additional components described herein. In this regard, the support substrate may be dissolvable or non- dissolvable. In certain embodiments the support structure may be comprised of a dissolvable film, such as manufactured by Aquapak, Monosol, Nippon-gohsei, etc. A release liner or paper may be used as a support substrate. As used herein, a release paper is a paper with a release agent coated to allow a layer(s) formed thereon to be released from the paper. A release liner may be paper, polyester, plastic, or other such material with or without a release agent coating, which allows a layer(s) formed thereon to be released.

[0048] In addition to, or apart from providing structural support, the support substrate may be configured to provide a protective layer to maintain shelf stability of the printed delivery device, control release of the layers, and/or provide a packaging for the printed delivery device. In this regard, the support substrate can be tailored to the particular need of the application of the printed delivery device. For instance, when the support substrate is to function as a barrier layer to moisture and/or, in some instances as a packaging material, the support substrate may include wax, polyester, silicone, and desiccants, such as rice starch or other starches which block a predetermined amount of moisture from reaching layers encompassed by the support substrates (although such materials may be used even in other configurations of the support structure). In one exemplary embodiment, the support substrate could be two or more layers, such as a hydrophobic layer and a desiccant layer. In this regard, hydrophobic layer may overly the desiccant layer which is closed to the layer. In operation, the hydrophobic layer limits moisture vapor transmission to the layers encompassed by the support substrate. However, should there be a hole or defect in the hydrophobic layer, the desiccant layer can absorb moisture that gets through the hydrophobic layer. The support substrate, although hydrophobic, may still dissolve when immersed in a certain amount of liquid, such as a beverage or in a user’s mouth upon ingestion.

[0049] In some instances, the support substrate may be a hydrophobic coating to ensure that the surface of the active layer does not get tacky. For instance, polyvinyl alcohol (PVOH), starch, and/or other edible and safe binders can be modified to give the desired surface feel, dissolution rates and taste profiles necessary to make a stable product that can go through normal handling.

[0050] Where the printed delivery device is to be operated in certain environments, such as sub- freezing temperatures, some of the layers can be brittle. As such, the support structure, such as a release paper or release liner, may be configured to prevent the layers from breaking or otherwise becoming deformed. In some instances, where the support structure is printed, the ink used to print the support structure may be configured to withstand the extreme temperatures. For example, a release liner may be interleafed between individual printed delivery devices to form a container. In another example, ink which includes constituents which have a low glass transition (Tg) may be used to allow the ink to be able to withstand exposure to lower temperatures. In this regard, ingredients, such as powders, would not be affected by those temperatures. Other liquid ingredients, which may be free of water that would crystallize, would be of high enough purity to withstand lower temperatures. In the case of higher temperatures of below 200F, or more or less, adjustments to the we would make the same choices. Please keep in mind that we balance the ingredients to go through both extremes. Think chocolate. If it melts in high temperatures, it solidifies when the temperature drops. The disks have similar characteristics.

[0051] Similar to the controlled release of the layers, described above, the support substrate may be configured such that the dissolution or dispersion of the support substrate may be performed over a period of time. In this regard, additional components such as starches may be mixed with polyvinyl alcohol and into one of the materials for generating the printable support substrate such as carrageenan, xanthum gum, guar gum, etc. The period of dissolution or dispersion may be adjusted by adjusting the formulation of the composition. For instance, based on the ingredients contained in the composition, such as the amount starch, the dissolution or dispersion rate may be adjusted. In one such example, a slower period of dissolution or dispersion may occur when more starch is used and quicker dissolution or dispersion when less starch is used. In some instances a binder may be added to the printable composition to maintain the structural integrity of the substances therein. In some instances, the support substrate may include supplements or other active ingredients.

[0052] The printed delivery device may be arranged in various dispensing configurations. For example, one dispensing configuration may be a continuous tape with or without perforations for tearing. In some instances the continuous tape arrangement of the printed delivery device may be placed in a tape dispenser type device, where a portion of the strip may be torn off with the assistance of a cutting blade. In the continuous tape arrangement, a support substrate, such as release paper may support and or enclose one or more active layers.

[0053] In another exemplary embodiment, the printed delivery device may be printed on a release paper in the form of dots, small particles, granules, or the like. The printed delivery device may be removed from the release paper. In instances where the printed delivery device is formed on a printed support substrate, no release paper may be required. Rather, the printed delivery device may be stored in a dispenser such as a dispenser with openings similar manner to that of a salt shaker. Other dispensing configurations may include stacking the printed delivery device on top of each, such as similar to Pez from a Pez dispenser, or packaging the printed delivery device in a pouch or sealed packaging, such as like an individual Band-Aid. Packaging for dispensing may also be printed and/or individualized, for example, with a person’s name. Also, a support substrate may allow for multiple dosages (e.g., portioned layer(s) of active ingredients,) to be attached to one sheet of a support substrate to carry multiple dosages on one sheet instead of individual dosages that are packed loose.

[0054] The printed delivery devices may be used sublingually, orally, within a food or beverage item, topically, etc., depending upon their configuration. For instance, printed delivery devices which are configured to dissolve/disperse easily may be used sublingually, whereas a printed delivery device which is configured to dissolve slowly may be used within a beverage item. The foregoing examples are in no way limiting, as slow dissolving/dispersing printed delivery devices may be used in a beverage and a fast dissolving/dispersing printed delivery device may be used orally.

[0055] The printed delivery device and components thereof, such as each layer and support substrate, can be any shape suitable for a desired application. For example, a printed delivery device can be in the form of a rectangular or square strip, sheets, a cube, a sphere, a disk, oval, stars, snowflakes, decorative designs, and the like. [0056] The printed delivery device can vary in dimensions. Such variation in size may be dependent on application. In some embodiments, an individual layer may range in length or diameter from about 1mm x 1 mm to about 12 inches by 12 inches. Larger lengths or diameters are possible, for example, such as when the printed compositions are printed as sheets for large scale production, such as in food products or beverages. For instance, larger sizes for printed compositions may be utilized in large tea makers or large industrial coffee makers.

[0057] In some embodiments, an individual layer may range in thickness from about 2 microns to about 15 mils, or greater than 15 mils. For example, providing an appropriate dosage of vitamin D, such as 1,000 IU or more, an active layer may be about 3 microns in thickness and measuring about 2mm x about 2mm. In another example, Vitamin C or a protein may require a printed composition that is about 10 mils or more in thickness and measuring about 3 inches x about 3 inches in order to carry an efficacious dose, such as about 5 grams of the supplement. In some embodiments, the overall thickness of the printed composition may range from about 1 micron to about 50 mils. In some embodiments, the overall length or diameter of the printed composition may range from about 1mm x about 1mm to about 12 inches x about 12 inches. Larger lengths and diameters are also contemplated.

[0058] A printed delivery device can have multiple layers where one or more of the layers are different shapes. For example, a round support substrate may have one or more strip shaped active layers disposed thereon. In another example, the shapes of the printed delivery device may be tailored to meet a particular design need, such as a shape of the item that the printed composition will be included in, or to achieve a desired release profile.

[0059] The printed delivery device can be made using any number of printing techniques, for example, such as screening printing, rotary screen printing, flexography, offset gravure, ink jet, bubble jet, dry toner, ribbon transfer, powder coating, spray coating, roll coating, reverse roll coating, slot die coating, hot and/or cold laminating, knife coating, sintering, padding, curtain coating, and the like. In this regard, printing techniques are understood to cover coating techniques.

[0060] In some embodiments, a printing method using an ink, such as inks described herein, may be utilized to make the one or more layers of printed composition. The ink may be aqueous or solvent based. The ink may be ultraviolet (UV) curable, electron beam (EB) curable, thermally curable, cold curable, ambient catalyzed, ambient crosslinked, and the like. The ink may be edible and/or dissolvable based on the desired application. The ink may include the various components of the active layer, support substrate, and barrier layer discussed herein.

[0061] The printing method may vary depending on the type of printed delivery device being made. Figure 3 depicts a flow chart for a method 300 of making a printed composition in accordance with an embodiment of the present application. The method 300 is described concurrently with fabrication steps depicted in Figures 4A-E.

[0062] At 302, an ink 402 is deposited on a release paper 404 (shown in FIG. 4A). At 304, the ink 402 is cured to form a first layer 406 (shown in FIG. 4B). The first layer 406 may be an active layer or a support substrate, such as those described herein. Optionally, at 306, a second ink 408 is deposited atop the first layer 406 (shown in FIG. 4C). At 308, the second ink 408 is cured to form a second layer 410 (shown in FIG. 4D). The second layer may be an active layer, a barrier layer, or a support substrate, such as those described herein. Optionally, additional layers, such as active layers, inactive layers, or support substrates, may be added atop the second layer to achieve a desired printed composition. At 310, a finished printed composition 412 is removed from the release paper 404 (shown in FIG. 4E). Alternatively, the release paper 404 may itself be an exemplary support substrate and part of the printed composition.

[0063] Figure 5 depicts a flow chart for a method 500 of making a printed delivery device in accordance with an embodiment of the present application. The method is described concurrently with fabrication steps depicted in Figures 6A-E. At 502, a support substrate 602 is provided (shown in FIG. 6A). The support substrate 602 may be pre-manufactured by any suitable technique including printing and/or casting. At 504, an ink 604 is deposited on the support substrate 602 (shown in FIG. 6B). At 506, the ink 604 is cured to form a first layer 606 (shown in FIG. 6C), where the first layer may be an active layer or support substrate as discussed herein. At 508, a second ink 608 is deposited on the first layer 606 (shown in FIG. 6D). At 510, the second ink 608 is cured to form a second layer 610 (shown in FIG. 6E), where the second layer may be an active layer or a support substrate as discussed herein. Optionally, any suitable number of additional layers may be provided to form a printed composition.

[0064] In an example process of forming a printed delivery device, an ink containing a first supplement, such as a probiotic, may be knife coated onto a polyester support substrate. Additional layers, such as vitamins A and B, may each be screen printed, in a layered configuration on the first layer. [0065] A flexo printed decorative film may be applied to a polyester release coating. The polyester release coating may then be overlaid on a portion, or all of the, printed delivery device. The flexo printed decorative film may then be laminated, through hot or cold lamination, to the printed delivery device.

[0066] In some instances, decorative designs or other such indicia, such as words, pictures, etc., may be printed onto the printed delivery device. In this regard, indicia may include the identification codes, such as spatial codes, QR codes, bar codes, identification numbers, or other such indicia which can be used to identifying, track, and/or provide information. These indicia and decorative designs may be ink-jet or flexo printed directly onto the printed delivery device. [0067] A design/indicia may also be printed directly onto the support substrate or layer. For example, a decorative layer may be ink-jet printed onto the support substrate and/or layer(s) using an edible ink. Although the example provides for ink-jet printing of the design/indicia, any other printing techniques may be used, such as screening printing, rotary screen printing, flexography, offset gravure, ink jet, bubble jet, dry toner, ribbon transfer, powder coating, spray coating, roll coating, reverse roll coating, slot die coating, hot and/or cold laminating, knife coating, sintering, padding, curtain coating, and the like. In this regard, printing techniques are understood to cover coating techniques.

[0068] Each layer of the printed delivery device may have a natural colorant added, such as turmeric, beet root, etc.

[0069] The printed delivery device may be used in various applications that may benefit from a supplement. For example, the printed delivery device may be added to a food or beverage, such as a cake mix, a muffin mix, a cupcake mix, a tea bag, a coffee pod, ground coffee, coffee beans which are then ground, powdered chocolate mixes, powdered soup mixes, gelatin mixes, concentrates, such as almond milk concentrate, soybean concentrate, macadamia nut concentrate, and the like. In one example, as the tea in a tea bag and/or coffee in a coffee pod is made using water, a supplement from the printed composition within the tea bag and/or coffee pod, can be released in the tea and/or coffee. In this instance, a supplement may be a sweetener. Other supplements may include a vitamin, mineral, or the like.

[0070] In some instances, a printed delivery device can include layers which are printed from inks having various concentrations of food, cleaners, fertilizers, or other such products. For instance, the ink may include an edible concentrate such as almond milk concentrate, soybean concentrate, macadamia nut concentrate, apple juice concentrate, and the like. In some instances the inks may include cleaning concentrates such as concentrated soap. In some instances, the ink may include concentrates of fertilizer. By incorporating the concentrates into the printed delivery device, shipping costs may be saved as there may be no need for refrigeration. Additionally, absence of liquid reduces the weight of the shipped product.

[0071] In some instances, a printed composition can include multiple supplements that release at different times, such as a vitamin and a probiotic. For example, the printed composition may be tailored such that the vitamin dissolves first in the stomach, but the probiotic is slower to dissolve until it reaches the intestines.

[0072] An example method of forming an ink for printing a layer of the printed composition having oil is shown in Fig. 7. As shown in block 701, water, comprising 56% of the overall composition of the ink, or more or less, may be heated to 140 degrees Fahrenheit. Sunflower lecithin, comprising 4%, or more or less, of the overall composition of the ink, may be added to the heated water, as shown in block 702. The sunflower lecithin and water may be mixed to form an emulsification, as shown in block 703. The oil, such as THC, CBD, Hemp oil, or other oils, having 10%, or more or less of the overall composition of the ink, may be added to the emulsification, as shown in block 704. As shown in block 705, flavorings, sweeteners, viscosity modifiers, or other such fillers, such as cluster dextrin, malto dextrin, etc., comprising 27%, or more or less, of the overall composition of the ink, may be added to the emulsification. Finally, as shown in block 706, sodium alginate, comprising 3%, or more or less, of the overall composition of the ink, may be added to the emulsification.

[0073] It will be understood by those skilled in the art that, although the subject invention has been described above in relation to embodiments thereof variations and modifications can be effected in these preferred embodiments without departing from the scope and spirit of the invention.

[0074] Unless otherwise stated, the foregoing, alternative examples are not mutually exclusive, but may be implemented in various combinations to achieve unique advantages. As these and other variations and combinations of the features discussed above can be utilized without departing from the subject matter defined by the claims, the foregoing description of the embodiments should be taken by way of illustration rather than by way of limitation of the subject matter defined by the claims. In addition, the provision of the examples described herein, as well as clauses phrased as "such as," "including" and the like, should not be interpreted as limiting the subject matter of the claims to the specific examples; rather, the examples are intended to illustrate only one of many possible embodiments. Further, the same reference numbers in different drawings can identify the same or similar elements.