Layered edible products for multi-step administration of multifunctional active pharmaceutical ingredients - Patents.com

Abstract

The layered edible product includes a core and at least one active layer supported by the core. The at least one active layer can include a respective API. The edible product is configured to be placed against a mucosal surface of the oral cavity, such that the respective API of the at least one active layer enters the bloodstream through the mucosal surface. The core can be ingested gastrointestinal or can be dissolvable against the mucosal surface, or both. The core can include a core API, or optionally the core can be free of an API.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 63 / 311,893, filed February 18, 2022, the disclosure of which is incorporated by reference herein as if set forth in its entirety. [Background technology]

[0002] Conventional cannabis edible products contain cannabis active pharmaceutical ingredients (APIs), including one or more cannabinoids (primarily cannabidiol (CBD) and tetrahydrocannabinol (THC), terpenes, and flavonoids. Edible products are typically designed to be consumed orally and digested in the gastrointestinal tract after undergoing chewing and swallowing. However, it has been found that only a small portion of orally ingested cannabis actives, such as THC, are absorbed into the bloodstream, and only a small portion of the absorbed cannabis reaches the brain. In some cases, it has been found that as little as 20% of the cannabis in an edible is absorbed into the body, and as little as 10% of the cannabis in an edible reaches the brain. The actual amount absorbed into the body may depend on the amount and type of food recently consumed. Foods with a high fat content may allow higher levels of cannabis to reach the liver, but this does not necessarily equate to higher levels of cannabis reaching the brain. Thus, although cannabis potency may be enhanced in the liver, overall it is the relatively small and unpredictable doses of cannabis digested in the gastrointestinal tract that contribute to the desired therapeutic effect.

[0003] Additionally, APIs are typically incorporated into edible products prior to cooking. For example, APIs are often added to a batter or other ingredient mixture that is then baked to produce an edible product. However, the high temperatures involved in cooking can evaporate terpenes and thermally degrade additives such as vitamins or supplements, thus compromising the desired therapeutic profile of the edible product. Additionally, the healthy acidic forms of CBD and THC or other acidic cannabinoids are partially or completely removed during the cooking process. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, what is needed are improved API-containing edible products and improved methods of consuming the improved API-containing edible products. [Means for solving the problem]

[0005] According to certain aspects of the present disclosure, the layered edible product can include a core and at least one active layer disposed on the core. The core can include a core API and the at least one active layer can include an inner API. The at least one active layer can be dissolvable in contact with the sublingual and buccal mucosa.

[0006] According to another aspect of the present disclosure, at least one active layer is purposefully dissolvable in contact with the sublingual and buccal mucosa and can achieve a fast onset effect followed by a longer-duration set of independent effects determined by the core API. [Brief description of the drawings]

[0007] [Figure 1A] FIG. 1 is a perspective view of a layered edible product dissolving against the sublingual mucosa. [Figure 1B] FIG. 1 is a perspective view of a layered edible product dissolving against the buccal mucosa. [Figure 2A] FIG. 1 is a perspective view of a layered edible product constructed in one embodiment having a substantially planar shape. [Figure 2B] FIG. 2B is a schematic cross-sectional side elevation view of the layered edible product of FIG. 2A showing a core, an inner active layer comprising at least one inner API disposed over the core, an outer active layer comprising at least one outer API disposed over the inner active layer, a divider layer disposed between the inner and outer active layers, and a wrapper covering the outer active layer. [Figure 2C]FIG. 2C is a schematic side elevation view of a layered edible product similar to FIG. 2B, but with the active layer disposed directly on the core. [Figure 3A] FIG. 1 is a schematic cross-sectional side elevation view of a spherical layered edible product having a substantially encapsulated shape according to another embodiment, with a portion cut away to show a core, an inner active layer disposed about the core, a partition layer disposed about the inner active layer, an outer active layer disposed about the inner active layer, and a wrapper disposed about the outer active layer. [Figure 3B] FIG. 3B is a schematic cross-sectional side elevation view of the edible product shown in FIG. 3A. [Figure 3C] FIG. 3C is a schematic cross-sectional side elevation view of a layered edible product similar to FIG. 3B, but with the inner active layer disposed directly on the core. [Figure 4A] 1 is a schematic chart showing the dosage of API in minutes that enters the bloodstream as a function of time from a layered edible product comprising a core and a single active layer. [Figure 4B] 1 is a schematic chart showing the dosage of API in minutes that enters the bloodstream as a function of time from a layered edible product that includes a core and both an inner and outer active layer. [Figure 4C] 4B, but over a 10-fold longer span of time (in hours), including short API delivery from the two layers and a much longer duration of delivery from the core. [Figure 5A] FIG. 1 is a perspective view of an inner carrier configured to receive an API to define an active layer in one embodiment. [Figure 5B] FIG. 2 is a perspective view of an outer carrier member configured to receive an API to define an active layer in one embodiment. [Figure 5C] FIG. 1 illustrates a perspective view of an outer carrier member configured to receive an API to define a core in one embodiment. [Figure 6A] FIG. 1 is a schematic side elevation view of the addition station showing delivery of core API to the core. [Figure 6B]FIG. 6B is a schematic side elevation view of an addition station illustrating delivery of an inner API to the core of FIG. 6A to define an inner active layer disposed over the core. [Figure 6C] FIG. 1 is a schematic side elevation view of an addition station illustrating delivery of an outer API to a partition disposed above an inner active layer to define an outer active layer disposed above the partition, thereby, the outer active layer being disposed above the inner active layer. [Figure 6D] FIG. 1 is a schematic side elevation view of an addition station illustrating delivery of an outer API directly to an inner active layer to define an outer active layer disposed on the inner active layer. [Figure 7A] FIG. 2 is a schematic top plan view showing a pattern of deposited API lines in one embodiment. [Figure 7B] FIG. 2 is a schematic top plan view illustrating a square pixel pattern of an API in another embodiment. [Figure 7C] FIG. 13 is a schematic top plan view showing a pattern of an API in yet another embodiment. [Figure 7D] FIG. 13 is a schematic top plan view showing a pattern of an API in yet another embodiment. [Figure 8A] FIG. 1 is a schematic side elevation view of an application system in which the application head moves in x or y to form a desired pattern of API on the edible product. [Figure 8B] FIG. 1 is a schematic side elevation view of an addition system in which the addition head is fixed in position, but the edible product is moved in x or y by a translation system to form a desired pattern of API on the edible product. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Disclosed is a layered edible product comprising a core and at least one active layer. The at least one active layer, including at least one active pharmaceutical ingredient (API), may be configured to undergo transmucosal absorption into the bloodstream through a mucous membrane in the oral cavity, such as the sublingual or buccal mucosa. Thus, the API of the at least one active layer may enter the bloodstream and provide its intended therapeutic effect with little delay. The core may be configured to be chewed and swallowed. Thus, when the core includes at least one core API, the therapeutic effect of the core API is delayed relative to the API of the at least one active layer. Thus, the user experiences the therapeutic effect of the core API after experiencing the therapeutic effect of the API of the at least one active layer. The API of the at least one layer may be configured to provide its therapeutic effect for a duration sufficient to last substantially until the core API exerts its therapeutic effect. Alternatively, the API of the at least one layer may be configured to have a therapeutic effect that is terminated before the therapeutic effect of the core API is exerted. Alternatively, the API of the at least one layer may be configured to have a duration sufficient to overlap the therapeutic effect of the core API. As will be understood from the following description, the at least one active layer may include a single active layer, an inner active layer and an outer active layer, or any number of active layers as desired. The layered edible product allows the end user to select from among the kit of available layered edible products the layered edible product of choice for consumption that best corresponds to the end user's desired therapeutic effect, which may best be optimized by selecting a layered edible product that has the desired API chemistry of the inner layer, core (if present), and outer layer (if present) in addition to the desired duration of each. The API of the outer layer (if present) and inner layer may provide a therapeutic effect over a relatively short duration that may be optimized based on the consumer's needs, such as short-term or immediate calm or other therapeutic effect as desired, while the core may provide a therapeutic effect of longer duration and may be optimized for overnight sleep quality or other therapeutic effect as desired.

[0009] One or more various aspects may be described in this application. Furthermore, for one or more of the aspects described herein, numerous alternative structures may be described; it should be understood that these are presented for illustrative purposes only and do not limit the aspects contained herein or the claims presented herein in any way. One or more of those structures may be broadly applicable to numerous aspects, as may be readily apparent from this disclosure. In general, the structures are described in sufficient detail to enable one skilled in the art to practice one or more of the aspects, and it should be understood that other structures may be utilized, and that structural, logical, software, electrical, and other changes may be made without departing from the scope of a particular aspect. Specific features of one or more of the aspects described herein may be described with reference to one or more specific aspects or figures that form part of this disclosure and in which specific structures of one or more of the aspects are shown as examples. However, it should be understood that such features are not limited to being used in the specific aspects or figures referenced in the description. This disclosure is not a literal description of all structures of one or more of the aspects, nor a list of features of one or more of the aspects that must be present in all structures.

[0010] The section headings and titles provided herein are for convenience only and are not to be construed as limiting the disclosure in any way.

[0011] Devices that are in communication with each other need not be in continuous communication with each other unless explicitly specified otherwise. Furthermore, devices that are in communication with each other may communicate directly or indirectly through one or more communication means or intermediaries, either logical or physical.

[0012] The description of an embodiment having several components in communication with each other does not imply that all such components are required. Rather, various optional components may be described to illustrate a wide variety of possible embodiments and to more fully describe one or more embodiments. Similarly, although process steps, method steps, algorithms, and the like may be described in sequence, such processes, methods, and algorithms may generally be configured to operate in alternative orders unless specifically described to the contrary. In other words, any sequence or order of steps that may be described in this patent application does not, in itself, indicate a requirement that the steps be performed in that order. Steps of a described process may be performed in any order that is practical. Furthermore, some steps may be performed simultaneously, even though they are described or implied as occurring non-concurrently (e.g., because one step is described after the other). Furthermore, the illustration of a process by depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary for one or more of the embodiments, and does not imply that the illustrated process is preferred. Also, although steps are generally described once per embodiment, this does not imply that they must be performed once or that they may be performed only once each time a process, method, or algorithm is performed or executed. Some steps may be omitted in some embodiments or occurrences, or some steps may be performed multiple times in a given embodiment or occurrence.

[0013] It will be readily apparent that where a single device is described herein, a plurality of devices may be used in place of the single device. Similarly, it will be readily apparent that where a plurality of devices is described herein, a single device or article may be used in place of the plurality of devices, and vice versa. Thus, any description herein using the singular "a" also applies with full force to "at least one" and "a plurality," unless otherwise indicated. Additionally, any description herein using the plural term "plural" also applies with equal force to the singular "a" and "at least one," unless otherwise indicated.

[0014] The functionality or features of a device may alternatively be embodied by one or more other devices not explicitly described as having such functionality or features, and thus other aspects need not include the device itself.

[0015] Techniques and mechanisms described or referenced herein may be described in the singular for clarity. However, it should be understood that a particular aspect may include multiple iterations of a technique or multiple instantiations of a mechanism unless otherwise stated. Descriptions of processes should be understood as representing modules, segments, or portions of a methodology that may include one or more steps for implementing a portion or the entire process. Alternative embodiments are included within the scope of various aspects in which functions may be performed in a different order than that shown or discussed, including substantially simultaneously or in reverse order, depending on the functionality involved, as will be appreciated by those skilled in the art.

[0016] 1A-1B, the layered edible product 20 can include at least one active layer 22 containing at least one active pharmaceutical ingredient (API). The at least one active layer 22 can be dissolvable by saliva in contact with the sublingual mucosa 24 shown in FIG. 1A to deliver the API directly into the bloodstream. The at least one active layer 22 can also be dissolvable by saliva in contact with the buccal mucosa 26 shown in FIG. 1B to deliver the API directly through the mucosa into the bloodstream. The at least one active layer 22 can include a single active layer, an inner active layer and an outer active layer, or any number of active layers as desired. Thus, the user can decide whether to apply the layered edible product 20 to the sublingual mucosa 24 or the buccal mucosa 26. Regardless of whether the product 20 is applied to the sublingual mucosa 24 or the buccal mucosa 26, the bioavailability of the API is greater than that due to gastrointestinal digestion. Furthermore, the API reaches the brain much faster than that due to gastrointestinal digestion. Thus, uptake through each mucosa allows the API to have a greater therapeutic effect in a shorter period of time compared to gastrointestinal digestion.

[0017] As described in more detail below, the layered edible product 20 can further include a core that can be chewed and swallowed, and thus undergo gastrointestinal digestion. Gastrointestinal digestion can allow a user to experience a time-delayed therapeutic effect of the core API, as compared to mucosal ingestion of the at least one active layer 22. Thus, the API from the at least one active layer 22 can provide a more immediate therapeutic effect, and the core API of the core can provide a therapeutic effect that is time-delayed relative to the effect of the API from the at least one active layer 22. Additionally, as described in more detail below, the API of the at least one layer and the core API can have different components, or different ratios of the same components, as desired, depending on the desired effect.

[0018] A layered edible product 20 according to one embodiment will now be described with reference to FIGS. 2A-2B. In particular, in one embodiment, the layered edible product 20 can define a laminated edible body 54 having a core 30 that defines a base of the edible product 20. The core 30 can be defined by any suitable edible food product as desired. The edible food products can include, by way of example and without limitation, hard candy, chocolate, brownies, cookies, soft candies such as gummy candies, savories such as trail mix bars or dried meat pieces, and the like. Thus, in some embodiments, the edible food products can be prepared foods. In some specific embodiments, the edible food products can be baked foods. The edible food products can be bite-sized, such as M&M candies, gummy candies, chocolate kisses, and the like, or can be designed to require more than one bite to be consumed completely, such as a cookie or a large brownie. It should be understood that in some embodiments, the edible food products can include multiple ingredients that can be mixed and baked or otherwise cooked during preparation.

[0019] In some examples, the core 30 may be intentionally free of APIs and is referred to herein as inactive. In other examples, the core 30 may include a core API to define an active core. In some examples, the core API may include one or more of a core non-psychoactive cannabinoid, a core psychoactive cannabinoid, a core flavonoid, and a core terpene. The core 30 may be of any composition as desired. In some examples, the core API may be incorporated into the core 30 during preparation of the food product. For example, the core API may be added to the mixture before cooking. Alternatively, the core API may be added to the edible food product after cooking and before final preparation of the food product. For example, it may be desirable to add one or more supplemental edible products to the prepared edible product before or after delivery of the core API to the edible food product. Examples include adding icing to cookies or frosting to brownies or cakes. However, in these examples, the cookies and brownies may be fully cooked or otherwise prepared before adding the core API. In yet other embodiments, the core API may be added to the core 30 after preparation of the food product. In other embodiments, the edible food may be a dry food such as dried fruit or jerky. In other embodiments, the edible product may be freeze-dried. In still other embodiments, the edible product may be a raw food such as nuts or fruit. In some embodiments, the nuts are cooked, e.g., roasted. In other embodiments, the nuts may be raw. In some cases, the nuts may be prepared with salt, sugar, honey, or any suitable alternative ingredient, thereby making the nuts sweet. Similarly, the fruit may be a raw fruit. In other embodiments, the fruit may be dried. In still other embodiments, the fruit may be prepared with salt, sugar, honey, or any suitable alternative ingredient, thereby making the nuts sweet. In other embodiments, the core 30 may be a commercially available edible product containing the respective core API. Thus, the core 30 may be procured and at least one active layer may be applied to the core 30 in any suitable manner, as described herein.Alternatively, the core 30 may be configured as an edible non-food product, such as a product that is not designed to be consumed, but may be safely consumed with no or negligible nutritional benefit, or alternatively, the core 30 may be configured as any other non-edible substrate, such as a tongue depressor.

[0020] The core 30 can define at least one or more core outer surfaces 33, which in one embodiment can include a core inner surface 32 and a core outer surface 34 opposite the core inner surface 32 along the longitudinal direction L. The core 30 can have and define any suitable shape as desired. For example, either or both of the core inner surface 32 and the core outer surface 34 can be substantially planar, curved, or can have any suitable alternative shape as desired. The core 30 can further define at least one core side surface 36 extending from the core inner surface 32 to the core outer surface 34. The at least one core side surface 36 can include a single side surface 36 that defines a substantially cylinder. Alternatively, the at least one core side surface 36 can be square or rectangular or ellipsoid-like, or can define any suitable alternative shape in cross-section as desired. In still other embodiments, the core 30 can lack a core side surface 36, for example when the core 30 is spherical, as described below with reference to Figures 3A-3C. In this regard, it should be understood that core 30 may define any regular or irregular shape as desired.

[0021] The terms "substantially," "approximately," and derivatives thereof, and words of similar import, when used to describe size, shape, spatial relationships, distance, orientation, extent, and other similar parameters, include the stated parameter, in addition to ranges including up to 1% more and up to 1% less than the stated parameter, including ranges of up to 3% more and up to 3% less than the stated parameter, including ranges of up to 5% more and up to 5% less than the stated parameter, including ranges of up to 10% more and up to 10% less than the stated parameter, and up to 20% more and up to 20% less than the stated parameter.

[0022] The layered edible product 20 may further include at least one active layer 22 disposed on the core. Each at least one active layer 22 may include an API as described in further detail below. In one configuration, the at least one active layer 22 may include an inner active layer 40 and an outer active layer 42. The inner active layer 40 and the outer active layer 42 may be arranged such that the inner active layer 40 is disposed between the core 30 and the outer active layer 42 along the longitudinal direction L. The at least one active layer 22 may include any number of active layers as desired, including one active layer or two or more active layers. The inner active layer 40 may define an inner surface 44, an outer surface 46 opposite the inner surface 44 along the longitudinal direction L, and a first at least one side surface 45 extending from the inner surface 44 to the outer surface 46. The first at least one side surface 45 may include a single side surface that defines a substantially cylinder. Alternatively, the first at least one side 45 can be square or rectangular or ellipsoid-like, or can define any suitable alternative shape in cross section as desired. Alternatively, the inner active layer 40 can lack at least one side 45, for example where the inner active layer 40 is spherical, as described below with reference to Figures 3A-3C. In this regard, it should be understood that the inner active layer 40 can define any regular or irregular shape as desired. The outer surface 46 can face in a direction towards the outer active layer 42. The inner surface 44 can face in a direction away from the outer active layer 42, and thus can face the core 30, and in particular can face the core outer surface 34. In one embodiment, the inner surface 44 can be disposed on the core outer surface 34. The outer core surface 34 can face the inner active layer 40, and the core inner surface 32 can face away from the inner active layer 40.

[0023] The outer active layer 42 can define an inner surface 48, an outer surface 50 opposite the inner surface 48 along the longitudinal direction L, and a second at least one second side surface 49 extending from the inner surface 48 to the outer surface 50. The second at least one side surface 49 can include a single side surface that defines a substantially cylinder. Alternatively, the second at least one side surface 49 can be square or rectangular or ellipsoid-like, or can define any suitable alternative shape in cross section as desired. In yet other embodiments, the outer active layer 42 can lack the second at least one side surface 49, for example, when the outer active layer 40 is spherical, as described below with reference to Figures 3A-3C. The inner surface 48 can face the inner active layer 40, and in particular, can face the outer surface 46. In one embodiment, the at least one core side surface 36, the first at least one side surface 45, and the second at least one side surface 49 can be substantially aligned with one another along the longitudinal direction L. Alternatively, one or more of the at least one core side 36, the first at least one side 45, and the second at least one side 49 may not be aligned with at most all of the other one or more of the at least one core side 36, the first at least one side 45, and the second at least one side 49 along the longitudinal direction L.

[0024] The layered edible product 20 can include at least one partition layer 52 disposed between adjacent ones of the at least one active layer 22. Thus, the partition layer 52 can be disposed between the inner active layer 40 and the outer active layer 42. The partition layer 52 can be inert and thus devoid of API. The partition layer 52 can be disposed between the entire outer surface 46 of the inner active layer 40 and the inner surface 48 of the outer active layer 42. In particular, the partition layer 52 can define an inner partition surface 53, an outer partition surface 56 opposite the inner partition surface 53 along the longitudinal direction L, and at least one partition side 58 extending from the inner partition surface 53 to the outer partition surface 56. The at least one partition side 58 can be substantially aligned with the first at least one side 45 and the second at least one side 49 along the longitudinal direction L. The barrier layer 52 may be dissolvable in contact with mucous membranes, including the buccal and sublingual mucosa, as described above. In one aspect, the barrier layer 52 may aid in adhesion of the outer active layer 42 to the inner active layer 40. The barrier layer 52 may also provide taste separation between the outer active layer 42 and the inner active layer 40, where the active layers have different taste profiles.

[0025] The barrier layer 52 can also provide a delay time between the absorption of the outer active layer 42 into the bloodstream and the absorption of the inner active layer 40 into the bloodstream. In particular, the barrier layer 52 can have a thickness sufficient to separate the inner active layer 40 from the outer active layer 42 such that at least a majority to substantially the entirety of the inner active layer 40 can be dissolved in the oral cavity before the inner active layer 40 is dissolved in the oral cavity. Thus, when the barrier layer 52 is disposed between two different API-containing structures (which can be active layers or cores 30), a majority to substantially the entirety of the outer one of the two different API-containing structures can be absorbed in the oral cavity before the inner one of the two different API-containing structures is ingested, either by contacting the mucous membrane of the oral cavity or by being chewed and swallowed. As a result, when the API of the inner active layer 40 (also referred to herein as the inner API) and the API of the outer active layer 42 (also referred to herein as the outer API) have different constituents as described in more detail below, the barrier layer 52 prevents ingestion of the inner API until at least a substantial portion of the outer API has been ingested in its entirety. The barrier layer 52 can also reduce or prevent undesirable chemical interference between non-API components of the separated layers, such as solvents or adhesives. The thicknesses of the inner active layer 40 and the outer active layer 42 can each range from sub-nanometer to nanometers up to millimeters, as desired. The thickness of the core 30 can be greater than the thicknesses of the inner active layer 40 and the outer active layer 42 to provide structural rigidity to the layered edible product 20.

[0026] While the inner surface 44, in one embodiment, may be disposed directly on the core outer surface 34, the layered edible product 20 may alternatively include a barrier layer 52 disposed between the inner surface 44 and the core outer surface 34 in the manner described above with respect to the inner active layer 40 and the outer active layer 42. The core 30, the at least one active layer 22, and the at least one barrier layer 52, as well as any other layers to be consumed, may be combined to define an edible body 54, which may be covered or surrounded by a wrapper 60. Thus, the layered edible product 20 may include an edible body 54 and a wrapper 60, which may cover or surround the edible body 54. In one embodiment, the wrapper 60 may completely encapsulate the edible body 54. In other embodiments, the wrapper 60 may cover at least the outermost surface 55 of the edible body 54. For example, the wrapper 60 may cover all but the core 30 and may be adhered to the core 30 or otherwise secured to the core 30 as desired. The outermost surface 55 of the edible body 54 may be defined by the outer active layer 42 or another outermost active layer of the at least one active layer 22. The wrapper 60 may be dissolvable against the sublingual and buccal mucosa in some embodiments. In other embodiments, the wrapper 60 is inedible and designed to be manually removed from the edible body 54 without being ingested prior to ingestion of the edible body 54. In yet other embodiments, the layered edible product 20 may include a first wrapper layer dissolvable against the sublingual and buccal mucosa and a second wrapper layer that is inedible and designed to be manually removed. The wrapper 60 may be inert and thus devoid of API. In some applications, the wrapper 60 may be configured to retain volatile components, such as terpenes or flavonoids, in the layered edible product 20 until the wrapper 60 is removed and the edible body 54 is placed in the mouth. The wrapper 60, if dissolvable, may be applied in any suitable manner known to one of ordinary skill in the art of food science, including, but not limited to, powder deposition, baths, droplets, sprays, etc. In yet other examples, the layered edible product 20 may lack a wrapper 60. For example, multiple layered edible products 20 may be placed within a common package.

[0027] 2C, as described above, the layered edible product 20 may include any number of active layers, as desired. For example, the at least one active layer 22 of the edible body 54 may include only a single active layer defined by the inner active layer 40. The inner surface 44 may face the core 30, and in particular the core outer surface 34. In one embodiment, the inner surface 44 may be disposed on the core outer surface 34. In another embodiment, a partition layer 52 (see FIG. 2B) may be disposed between the inner surface 44 and the core outer surface 34. Thus, the outermost surface 55 of the edible body 54 may be defined by the inner active layer 40, and in particular the outer surface 46. Thus, the wrapper 60 may cover at least the outer surface 46. It should be understood that in the embodiment of FIG. 2C, the inner active layer 40 defines both the outermost active layer of the edible body 54 and the innermost active layer of the edible body 54, and no active layer is disposed between the inner active layer 40 and the core 30. Stated otherwise, the inner active layer 40 can define the only active layer of the edible body 54. In the embodiment of FIG. 2B, the inner active layer 40 defines the innermost active layer of the layered edible product 20 and the outer active layer 42 defines the outermost active layer of the layered edible product 20.

[0028] 2A-2C, the core inner surface 32 can define an innermost surface 61 of the edible body 54. In some embodiments, the wrapper 60 covers the outermost surface 55 but not the innermost surface 61. Thus, the core inner surface may not be covered by any other portion of the edible body 54. As a result, the core inner surface 32 can also define an innermost surface of the layered edible product 20, and the wrapper 60 defines an outermost surface of the layered edible product 20. In other embodiments, the wrapper 60 can surround the entire edible body 48 such that it defines the outermost and innermost surfaces of the layered edible product 20.

[0029] Although the core 30 and the at least one active layer 22 can define a laminated edible body 54 in which the at least one active layer is laminated on one surface of the core 30 but not on an opposing surface of the core 30 as described above, it should be understood that the core 30 and the at least one active layer 22 can define any suitable geometric configuration as desired. For example, referring now to Figures 3A-3C, the edible body 54 can define an enclosure 57. Additionally, the edible body 54 can be substantially concentrically arranged. That is, the core 30, the at least one active layer 22, and the at least one partition layer 52 can be substantially concentrically arranged with respect to one another.

[0030] As shown, the inner active layer 40 can at least partially surround or encapsulate the core 30. In particular, the inner surface 44 can face toward at least one core outer surface 33. For example, the inner surface 44 can face toward the core outer surface 34. Depending on the shape of the core 30, the inner surface 44 can further face each of at least one core side surface 36, if present. Thus, the inner surface 44 of the inner active layer 40 can face toward all of the outer surfaces 33 of the core 30. In some embodiments, the inner active layer 40 can completely surround the core 30. In other embodiments, the inner active layer 40 can include one or more openings extending from the outer surface 46 to the inner surface 44, as desired. In any case, the inner active layer 40 can be said to substantially encapsulate the core 30. Because the inner active layer 40 can extend continuously around the core 30, the inner active layer 40 can lack the first at least one side surface 45 described above with respect to FIGS. 2A-2C.

[0031] In one embodiment, the inner surface 44 can contact at least one of the core outer surfaces 33. Thus, the inner active layer 40 can conform to the shape of the outer surface 33 of the core 30. In another embodiment, the edible body 54 can include a barrier layer 52 of the type described herein disposed between the core 30 and the inner active layer 40. The inner active layer 40 can be said to substantially encapsulate the core 30, regardless of whether the inner active layer 40 directly contacts the core 30 or contacts a barrier layer disposed between the inner active layer 40 and the core 30. Furthermore, the barrier layer, if present, can conform to the shape of the outer surface 33 of the core 30, and the inner active layer 40 can conform to the shape of the barrier layer, so that the inner active layer 40 can conform to the shape of the outer surface of the core 30, if a barrier layer is present. Furthermore, when a barrier layer is disposed between the core 30 and the inner active layer 40, the inner active layer 30 can also be said to substantially encapsulate each of the barrier layer and the core 30.

[0032] At least one core outer surface 33 can define any suitable size and shape as desired, such as ovoid, spherical, cylindrical, or any suitable alternative shape as desired. Thus, the core inner surface 32 (see FIGS. 2B-2C), the core outer surface 34, and the core side surface 36 can be contiguous with one another or can define respective intersections as desired. In other embodiments, the core 30 can lack the core side surface 36. The thickness of the inner active layer 40 from the inner surface 44 to the outer surface 46 can be substantially constant along the entirety of the inner active layer 40. Alternatively, portions of the inner active layer 40 can be thicker or thinner than other portions of the inner active layer 40, if desired.

[0033] 3A-3B, the outer active layer 42 can at least partially surround or encapsulate the inner active layer 40. In particular, the inner surface 48 can face toward the outer surface 46. Thus, the inner surface 48 of the outer active layer 42 can face toward the inner active layer 40 and all of the outer surfaces of the core 30. In some embodiments, the outer active layer 42 can completely surround the inner active layer 40. In other embodiments, the outer active layer 42 can include one or more openings, as desired, that extend from the outer surface 50 to the inner surface 48. In either case, the outer active layer 42 can be said to substantially encapsulate the inner active layer 40. Because the outer active layer 42 can extend continuously around the inner active layer 40, the outer active layer 42 can lack at least one second side surface 49 as described above with respect to FIG. 2B.

[0034] In one embodiment, the edible body 54 can include a barrier layer 52 of the type described herein disposed between the inner active layer 40 and the outer active layer 42. The barrier layer 52 can thus contact and extend around the outer surface 46. The barrier layer 52 can thus substantially encapsulate the inner active layer 40. The outer active layer 42 can contact and extend around the barrier layer 52. The outer active layer 42 can thus substantially encapsulate the barrier layer 52. The outer active layer 42 can also be said to substantially encapsulate the inner active layer 40 and the core 30. The barrier layer 52 can conform to the shape of the outer surface 46 of the inner active layer 40. The outer active layer 42 can conform to the shape of the barrier layer 52, and thus the shape of the inner active layer 40, and thus the shape of the core 30. Thus, the core 30, all of the barrier layers 52, and each of the at least one active layers 22 can have the same shape.

[0035] In other examples, the edible body 54 may lack a barrier layer 52 between the inner active layer 40 and the outer active layer 42, and the inner surface 48 may contact the outer surface 46. In the absence of a barrier layer between the inner active layer 40 and the outer active layer 42, the outer active layer 42 may still be said to conform to the shape of the outer surface 46 of the inner active layer 40. Regardless of whether the outer active layer 42 directly contacts the inner active layer 40 or whether a barrier layer 52 is disposed between the inner active layer 40 and the outer active layer 42, the outer active layer 42 may be said to substantially encapsulate the inner active layer 40 and the core 30. Additionally, all of the outer surfaces of the inner active layer 40 face toward the outer active layer 42.

[0036] As discussed above, the edible body 54, including the core 30, the at least one active layer 22, and the optional partition layer 52, can define any suitable shape. In one embodiment, the shape can be substantially spherical, and thus does not include separate sides extending from their respective inner surfaces to their respective outer surfaces. In another embodiment, the shape can be substantially ellipsoid-like. In yet another embodiment, the shape can be substantially cylindrical or disc-shaped. In other embodiments, the shape can be irregular, i.e., does not exhibit perfect symmetry about any axis. Thus, the core and at least one active layer can include respective sides extending from their respective inner surfaces to their respective outer surfaces, as discussed above.

[0037] As mentioned above, the layered edible product 20 can include a wrapper 60 that can surround the edible body 54. In particular, the wrapper 60 can cover or surround the entire outermost surface 55 of the edible body 54. The outermost surface 55 can be completely defined by an outermost one of the at least one active layers 22. In one embodiment, the wrapper 60 can surround the outer active layer 42 that defines the outermost one of the at least one active layers 22. As mentioned above, the wrapper 60 can be dissolvable against the sublingual and buccal mucosa in some embodiments. In other embodiments, the wrapper 60 is inedible and designed to be manually removed from the edible body 54 prior to ingestion of the edible body 54. In yet other embodiments, the layered edible product 20 can include a first wrapper layer that is dissolvable against the sublingual and buccal mucosa and a second wrapper layer that is external to the first wrapper layer, inedible, and designed to be manually removed. The wrapper 60 may be inert and thus lack an API.

[0038] 3C, as described above, the encapsulation body 57 can include any number of active layers as desired. For example, the at least one active layer 22 of the encapsulation body 57 can include only a single active layer defined by the inner active layer 40. The inner surface 44 can substantially encapsulate the core 30. In particular, the inner surface 44 can face the core outer surface 34. In one embodiment, the inner surface 44 can be disposed on the core outer surface 34. In another embodiment, a partition layer 52 (see FIG. 3B) can be disposed between the inner surface 44 and the core outer surface 34. Thus, the outermost surface 55 of the edible body 54 can be completely defined by the inner active layer 40, in particular by the outer surface 46. Thus, the wrapper 60 can cover the outer surface 46. It should be understood that in the embodiment of FIG. 3C, the inner active layer 40 defines both the outermost active layer of the encapsulation body 57 and the innermost active layer of the encapsulation body 57, and no active layer is disposed between the inner active layer 40 and the core 30. Stated otherwise, the inner active layer 40 is the only active layer of the encapsulation body 57. In the embodiment of FIG.

[0039] In all of the embodiments described above with respect to Figures 1-3C, the core 30, and each of the at least one active layer 22, may include at least one active pharmaceutical ingredient (API). The at least one API may include cannabis, including cannabis in acidic, neutral, and / or emulsified form, or other non-cannabis substances. The term "cannabis" as used herein refers to any extract from the marijuana plant or hemp plant, such as CBD, THC, any alternative cannabinoid, or any chemically synthesized cannabis substance, alone or in combination with any one or more of flavonoids or terpenes. The terpenes and / or flavonoids may be extracts extracted from cannabis or hemp, or may be provided as pure substances commercially obtained or synthesized from other sources. The extract may be in its pure form or may be processed as desired, including, as an example, an emulsified form of cannabis fluid. The cannabinoids may be provided as a neutral cannabinoid form or an acid cannabinoid form, as desired. The API may be provided in liquid form or any suitable alternative form as desired. Additionally, the API may be provided in a form comprised of micro- or nano-droplets, each of which is substantially encapsulated by the inclusion of a film of molecules that may be hydrophilic and / or lipophilic, as desired. The inclusion may be structured as any one of a liposome, an emulsion, a solid lipid nanoparticle, a self-nanoemulsifying drug delivery system (SNEDDS) particle, and the like. The present disclosure provides for the addition of at least one cannabis to an edible or non-edible substrate defining a core 30, and thus cannabis is contemplated as a market for the end product, although applications of the systems and methods disclosed herein without cannabis, including but not limited to other APIs, are also possible and contemplated.For example, applications of the edible products and methods disclosed herein can include and are contemplated to include APIs, including cannabinoids, any alternative one or more over-the-counter (OTC) or prescription drugs, including those that provide one or both of a health benefit or a recreational drug experience, any other controlled ingestible substance, and any one or more botanical drugs, supplements, etc. Thus, references herein to APIs can include any one or more up to all of the following: cannabis and cannabis plant-derived compounds or synthetically produced compounds, including one or more cannabinoids, either in natural oil form or in emulsified form, one or more over-the-counter drugs, one or more prescription drugs, one or more flavonoids, one or more terpenes, and one or more botanical drugs or supplements. References herein to APIs include prescription and over-the-counter drugs, and may further include any one or more active ingredients with medicinal properties, including vitamins, dietary supplements and longevity supplements, as well as nootropics or so-called "smart drugs", as desired. References to active pharmaceutical ingredients herein may alternatively or additionally include one or more up to all of the following: psychedelic or hallucinogenic ingredients, such as psilocybin and psilocin; synthetic opioids may be substituted for more dangerous ingredients, such as fentanyl; and it should be understood that the API may alternatively or additionally include fentanyl, recognizing that accurate dosing of the type described herein may be important when administering an API where an incorrect dose may have serious consequences. Similarly, references to one or more of the active pharmaceutical ingredients identified above may equally apply to any other of the active pharmaceutical ingredients identified above. According to one aspect of the present disclosure, the method of delivering cannabis or conventional drugs may also be used to deliver homeopathic remedies, herbal supplements with flavoring odors, and the like, to an edible matrix. The resulting edible matrix may be referred to as a "nutraceutical" since the definition is "food containing health-imparting additives or having medicinal properties."

[0040] At least one API of the core 30 can be referred to as the core API. At least one API of the inner active layer 40 can be referred to as the inner API. At least one API of the outer active layer 42 can be referred to as the outer API. The inner API, the outer API, and the core API can be different from each other. In one embodiment, the difference can be a difference in the chemical nature of the components or a difference in the concentration of one or more of the components. That is, the inner API can include at least one component that is not included in the core API and the outer API. Alternatively or additionally, the core API can include at least one component that is not included in the inner API and the outer API. Further alternatively or additionally, the outer API can include at least one component that is not included in the inner API and the core API. The component can be a component of the cannabis family. Alternatively, the component can be a prescription or over-the-counter drug or a therapeutic product. In one example, one of the inner API, outer API, or core API may contain high concentrations of terpenes or terpenes and THC, another of the inner API, outer API, and core API may have high concentrations of the acidic and / or neutral forms of THC and CBD, and another of the inner API, outer API, and core API may contain high concentrations of other API components. It should be understood that all permutations of cannabinoids, terpenes, flavonoids, and other API components are contemplated.

[0041] The components of the common core API, inner API, and outer API (if the edible body 54 includes the outer active layer 42) can be present in different ratios. In another embodiment, the core API, inner API, and outer API (if the edible body 54 includes the outer active layer 42) can have the same components in different ratios. As an example, ingestion of THC can provide a psychedelic high, and ingestion of CBD can provide a sedative effect. Thus, if it is desired to provide a psychedelic high, at least one API can include a high ratio of THC to CBD or no CBD. If it is desired to provide a sedative effect, at least one API can include a high ratio of CBD to THC or no THC. Thus, if it is desired to provide a more immediate psychedelic high and a delayed sedative effect, at least one of the active layers can have a high amount of THC relative to CBD. If it is desired to provide a delayed sedative effect, the core 30 can include a high amount of CBD relative to THC. Conversely, if it is desired to provide an immediate sedative effect, at least one of the active layers can have a high amount of CBD relative to THC. If it is desired to provide a delayed psychedelic effect, the core can include a high amount of THC relative to CBD.

[0042] In another example, the core API, the inner API, and the outer API (if the edible body 54 includes an outer active layer 42) may have different sensory profiles, which may be defined by either or both of a flavor profile and an aroma profile. For example, the core API may have a different sensory profile from the at least one inner API and each of the at least one outer API. Further, the inner API may have a different sensory profile from the at least one core API and each of the outer API. Furthermore, the outer API may have a different sensory profile from the at least one core API and each of the inner API. The different sensory profiles may be defined by different flavonoids and / or terpenes, or the absence thereof.

[0043] 1-3C, during use, if the wrapper 60 is present and not configured to be ingested, the user can remove the wrapper 60 and the edible body 54 can be placed in the oral cavity 63 against a selected mucous membrane. The selected mucous membrane can be defined by the sublingual mucosa 24 or the buccal mucosa 26. If the wrapper 60 is configured to be ingested, the user can place the layered edible product 20 in the oral cavity 63 against the selected mucous membrane. The selected mucous membrane can dissolve the wrapper 60 and the edible body 54 remains in the oral cavity 63 against the sublingual mucosa 24. When the edible body 54 is in contact with the selected mucous membrane, an outermost active layer of the at least one active layer 22 is disposed in contact with the selected mucous membrane and is configured to dissolve in contact with the mucous membrane. Thus, the at least one API of the outermost active layer can undergo transmucosal absorption and thus be delivered directly through the mucosa to the bloodstream. Once the outermost active layer is dissolved, the subsequently inner active layer, if present, is then exposed to the selected mucous membrane. In one embodiment, the outermost active layer may be defined by the outer active layer 42, as shown in Figures 2B and 3B. In another embodiment, the outermost active layer may be defined by the inner active layer shown in Figures 2C and 3C. In yet other embodiments, the outermost active layer may be defined by the third, fourth, or other numbered active layer, depending on the number of active layers in the at least one active layer 22.

[0044] Once the outermost active layer has dissolved against the mucosa, the active layers located within may then dissolve in sequence against the mucosa until the innermost active layer has dissolved against the mucosa. The innermost active layer may be defined by the inner active layer 40, as shown in Figures 2A-3C. It should be understood that any inactive partition layers 52 disposed between each adjacent inner and outer active layer (such as the inner active layer 40 and the outer active layer 42) also dissolve. For example, each outer active layer may dissolve against the mucosa, then the partition layer 52 may dissolve against the mucosa, then each inner active layer may dissolve against the mucosa. The partition layers 52 help ensure that each outer active layer is completely or nearly completely dissolved before the exposure of each inner active layer is placed against the mucosa. For example, it is recognized that certain regions of the outer active layer 42 may dissolve against the mucosa at a faster rate than other regions of the outer active layer 42. Thus, the barrier layer 52 aligned with a particular region can be exposed while other regions of the outer active layer 42 dissolve against the mucosa. Once the barrier layer 52 is dissolved, the inner active layer 40 is then exposed to the mucosa and can dissolve against the mucosa. Thus, the inner at least one API can be absorbed through the mucosa into the bloodstream. If an inert barrier layer is disposed between the inner active layer 40 and the core 30, the inert barrier layer dissolves before the core 30 is exposed.

[0045] Once the core 30 is exposed, it may be digested in the manner indicated. In one embodiment, the core 30 may be chewed and swallowed. For example, as described above, the core 30 may be defined by a food product intended for gastrointestinal digestion. Thus, the core API is also subject to gastrointestinal digestion. In other embodiments, the core 30 may be configured to dissolve upon contact with a mucosa as desired. In some embodiments, the edible body 54 may be configured to provide an indication to the user that the active layer(s) have dissolved and the edible body 54 is ready to be chewed and swallowed. In this regard, the core 30 may have a different flavor profile from at least one or more up to all of the active layers. The active layers may have the same flavor profile or different flavor profiles. The user may know the flavor profile of each of the at least one active layer 22 and the flavor profile of the core 30. Thus, if the user can taste the flavor of the core and cannot taste any of the flavors of the at least one active layer 22, the user may conclude that the core 30 is ready to be chewed and swallowed. Alternatively or additionally, sensory indicia may be incorporated into the partition layer rather than the active layer.

[0046] Such a structure of sequential layers and signaling properties represents a new generation of "functional or configurable edibles." In other words, the layered edible products can be configured to provide the desired effect of the API at a given time. Thus, a kit of layered edible products can include different inner APIs, different core APIs, if present, and different outer layers, if present, in any combination as desired, as described herein. From among the kits of layered edible products available, an end user can select a layered edible product for consumption that best corresponds to the end user's desired therapeutic effect, which may be best optimized by selecting a layered edible product that has the desired API chemistry of the inner layer, core (if present), and outer layer (if present) in addition to the desired duration of each. The layered edible products 20 can be substantially identical (within manufacturing tolerances) to one another in size and shape.

[0047] Referring now also to FIG. 4A, as described above with respect to FIGS. 1A-3B, the layered edible product 20 may be configured to release the API of at least one active layer 22 prior to releasing the API of the core 30. In particular, if the inner active layer 40 is the only active layer of the layered edible product, the inner API may be absorbed into the bloodstream through the mucosa, thereby resulting in a rapid response. In some embodiments, the therapeutic effect of the inner API begins to build up in the body within minutes, such as 5-10 minutes. Of course, the therapeutic effect will continue if transmucosal absorption of the inner API continues. The therapeutic effect of the inner API may persist beyond the point at which the inner active layer 40 is fully absorbed until the inner API concentration in the bloodstream is cleared by the consumer's metabolism. Once the inner active layer 40 is fully absorbed, the core 30 may be exposed and consumed. If a transition layer is disposed between the inner active layer 40 and the core 30, the transition layer is ingested prior to ingesting the core 30.

[0048] It is understood that once the inner active layer 40 has completely dissolved, the therapeutic effect provided by the inner API in the bloodstream continues for a period of time before decreasing. The inner active layer 40 and the core 30 may be configured such that the core API begins to enhance its therapeutic effect while the therapeutic effect of the inner API is decreasing. This is accomplished if the user elects to begin chewing the entire remaining edible item (which is primarily the core) when the effect of the inner API is decreasing, leaving the chewed core material in the mouth before swallowing and allowing it to be partially absorbed through the sublingual mucosa. This initial sublingual absorption of the core API allows for an early onset of the overall effect of the core API prior to gastrointestinal digestion. Without the initial sublingual absorption of the core API, the substantial entire therapeutic effect of the core API would be achieved solely by the normal gastrointestinal digestion pathway. Alternatively, the inner active layer 40 and the core 30 may be configured such that the core API begins to enhance its therapeutic effect after the therapeutic effect of the inner API has substantially ceased. In any event, it should be understood that the layered edible product 20 is configured to allow the body to experience the therapeutic effect of the inner API, followed by the therapeutic effect of the core API. Furthermore, the gastrointestinal ingested core API may provide its therapeutic effect for a longer duration than the mucosally ingested inner API, hi one embodiment, the therapeutic effect of the core API may last many times longer than the duration of the therapeutic effect of the inner API.

[0049] Referring now to FIG. 4B, when the layered edible product 20 includes an inner active layer 40 and an outer active layer 42, the outer API can be absorbed into the bloodstream through the mucosa, thereby resulting in a rapid response as described in the previous paragraph. In some embodiments (see curve 1 in FIG. 4B), the therapeutic effect of the outer API can begin to build up in the body within minutes, such as 5-10 minutes. Of course, the therapeutic effect will continue as transmucosal absorption of the outer API continues. Once the outer active layer 42 is substantially absorbed (as in the peak of curve 1 in FIG. 4B), the barrier layer 52 disposed between the outer active layer 42 and the inner active layer 40 can begin to dissolve, and the inner active layer 40 can be exposed and absorbed (curve 2 in FIG. 4B). Thus, the layered edible product 20 can be designed such that the inner active layer 40 is absorbed while the therapeutic effect of the API of the outer layer 42 still remains in the bloodstream, as depicted in FIG. 4B by the overlapping curves 1 and 2.

[0050] Alternatively, the layered edible product 20 may be configured such that the inner API begins to enhance its therapeutic effect after the therapeutic effect of the outer API has substantially ceased. Alternatively, if it is desired to stack the effects of the inner and outer APIs, the layered edible product 20 may be configured such that the inner API begins to enhance its therapeutic effect before the therapeutic effect of the outer API has terminated. In either case, it should be understood that the layered edible product 20 is configured to allow the body to experience the therapeutic effect of the outer API first, and then the therapeutic effect of the inner API. Of course, it should be understood that the therapeutic effects of the inner and outer APIs may last for different durations, as desired. Once the inner active layer 40 has been absorbed, the core 30 may be consumed in the manner described above.

[0051] It should be understood that either or both of the duration of therapeutic effect of any of the APIs described herein and the dose entering the bloodstream of any of the APIs described herein can be adjusted as desired. As shown in Figures 4B-4C, the dose of the inner API entering the bloodstream can be greater than the dose of the outer API entering the bloodstream. Alternatively, the dose of the inner API entering the bloodstream can be less than or substantially equal to the dose of the outer API entering the bloodstream. Similarly, the API of each active layer can have a greater dose, a lesser dose, or a substantially equal dose compared to the core API. As shown in Figure 4C, the duration of therapeutic effect of the core API can be longer than each of the outer and inner APIs, either alone or in combination, due to the much larger physical range of the digestive pathway in the body.

[0052] It is recognized that when the active layer and optionally the core are sequentially placed against a selected mucous membrane to undergo transmucosal absorption, a portion of each API is likely to be swallowed with saliva. However, it is also understood that a portion of each API, which may be a majority of each API to substantially all of each API, undergoes transmucosal absorption, thereby providing a more immediate therapeutic effect than if the entire layered edible product were chewed and swallowed. Furthermore, the form of the API employed in the active layer and optionally the core can be any of a variety of cannabis forms (liposomes, emulsions, solid lipid nanoparticles, self-nanoemulsifying drug delivery system (SNEDDS) particles, etc.).

[0053] Now referring generally to Figures 6A-6D, one method and apparatus for delivering at least one API in the form of microdroplets to each of the core and active layer is described. It should be understood that this is just one example showing the delivery of at least one API, and all other methods for loading the API to the core 30 and creating each active layer are contemplated herein. As shown in Figures 6A-6D, the loading system 62 can include at least one reservoir 73 containing a respective API, at least one loading station 64 receiving at least one API from the at least one reservoir 73 and delivering the API to the underlying substrate, and at least one conveyor 70 aligning the substrate with the loading head 68 of the loading station 64. One or more loading stations 64 can be used to load the core API to the core 30, load an inner API to the inner active layer 40 or to create the inner active layer 40 with an inner API, and / or load an outer API to the outer active layer 42. For example, a single dosing station 64 can selectively deliver multiple APIs from each of the reservoirs 73. The reservoirs 73 can each include a core API, an inner API, and an outer API. Alternatively, multiple dosing stations 64 can be arranged to communicate with each of the dedicated ones of the reservoirs 73, with different dosing stations 64 delivering the core API, the inner API, and the outer API. The dosing stations 64 can be configured as described in U.S. Patent Application No. 16 / 865,094, filed May 1, 2020, the disclosure of which is incorporated herein by reference as if set forth in its entirety.

[0054] 6A, the dosing station 64 is shown delivering the core API 66 from at least one dosing head 68 to the core 30. In particular, the core 30 can be aligned with the dosing head 68 by moving the core 30 into alignment with the dosing head 68 and / or moving the dosing head 68 into alignment with the core 30. In one embodiment, the core 30 can be placed on a conveyor 70 that delivers the core 30 to a position aligned with the at least one dosing head 68. The core API 66 can then be delivered from the dosing head 68 to the core 30 under gravity to define the core API. In one embodiment, the core API 66 can include any number of components of the cannabis group listed above. Alternatively or additionally, the core API 66 can include any suitable prescription or over-the-counter drug or dietary supplement, as desired. In some embodiments, once the core API 66 is delivered to one surface of the core 30, the core can be inverted such that the core API 66 is then delivered to the opposite surface of the core 30. The one surface and the opposing surface may be defined by the core inner surface 32 and the core outer surface 34, respectively. In some embodiments, at least a portion to substantially all of the core API 66 may be disposed on the core outer surface 33. Alternatively or additionally, at least a portion to substantially all of the core API 66 may be absorbed by the core 30.

[0055] In one example, the core API 66 can be delivered to the core 30 as a series of microdroplets 69 in the manner described in Appendix A. The microdroplets 69 can be delivered from the dosing head 68 under gravity along the dosing API axis 79. Alternatively, the core API 66 can be delivered as a stream, as a spray, as traditional droplets, as an emulsion, or in any suitable alternative form as desired. For example, the API can be delivered to the substrate as a powder. Alternatively, the API can be delivered as an injectable solution into the core 30.

[0056] As mentioned above, the core API 66 may be delivered to the substrate 30 according to any suitable alternative method. As mentioned above, in some examples, the substrate 30 may be a prepared food product. In particular, a mixture of ingredients, optionally including an API, may be cooked and singulated (or singulated and then cooked) to define a corresponding plurality of substrates. In one example, the core API 66 may be added as part of the substrate preparation process. For example, the core API 66 may be delivered to the ingredients, or to the mixture, optionally prior to cooking the mixture, to define the substrate 30 having at least one substrate API. Alternatively, the core 30 having the core API 66 may be procured from any suitable manufacturer or retailer.

[0057] 6B, the inner API 67 of the inner active layer 40 can be applied to the first underlying outer surface 72. Thus, the inner active layer 40 can be disposed directly on the first underlying outer surface 72. In one embodiment, the first underlying outer surface 72 can be defined by the core 30. In embodiments where the core API 66 is delivered to the core 30, the inner active layer 40 can be delivered to the core 30 after the core API 66 is delivered to the core 30 or after the API-containing core 30 is procured. Alternatively, the inner active layer 40 can be delivered to an inert, and thus non-API-containing, core 30. In other embodiments, a barrier layer of the type described above can be applied over, for example, the substrate 30, such that the first underlying surface 72 can be defined by the barrier layer. Thus, the inner active layer 40 can be applied to the first underlying surface 72 as defined by the barrier layer.

[0058] In particular, the core 30 may be aligned with the dosing head 68 by moving the core 30 into alignment with the dosing head 68 and / or moving the dosing head 68 into alignment with the core 30. In one embodiment, the core 30 may be placed on a conveyor 70 that delivers the core 30 to a position aligned with at least one dosing head 68. The inner API 67 may then be delivered from the dosing head 68 under gravity to the core 30 (or a partition layer disposed above the core 30) to define the inner active layer 40. In some embodiments, once the inner API 67 is delivered to the core 30 or the partition layer, the core may be inverted such that the inner API 67 is then delivered to the opposite surface of the core 30 or the partition. The one surface and the opposite surface may be defined by the core inner surface 32 to the core outer surface 34, respectively. Alternatively, the one surface and the opposite surface may be defined by the partition. Alternatively, one of the surfaces may be defined by the core and the other of the surfaces may be defined by the partition.

[0059] In one embodiment, the inner API 67 can include any number of components of the cannabis group listed above. Alternatively or additionally, the inner API 67 can include any suitable prescription or over-the-counter drug or dietary supplement, as desired. As described above, at least one of the components of the inner API 67 can be different from the core API 66. Alternatively or additionally, at least one of the components of the core API 66 can be different from the inner API 67. It is further understood that at least one common component can be included in both the core API 66 and the inner API 67. However, at least one of the common components can be included in the inner API 67 in a different amount relative to the core API 66. For example, as described above, the at least one common component can be THC, CBD, and / or any suitable alternative component, as desired.

[0060] In one embodiment, the inner API 67 can be delivered as a continuous series of microdroplets 69 in the manner described in Appendix A. The microdroplets 69 can be delivered from the dosing head 68 under gravity. Alternatively, the inner API 67 can be delivered as a stream, as a spray, as traditional droplets, as an emulsion, or in any suitable alternative form as desired. The inner API 67 can define a layer that extends over the first underlying surface 72. Of course, it should be understood that the inner active layer 40 can be alternatively configured as desired. For example, the core 30 can be immersed in or otherwise exposed to a bath of the inner API 76 to produce the inner active layer 40 on the core 30 or a partition layer disposed on the core 30. For example, the API can be delivered as a powder.

[0061] 5A, it should be understood that while the inner API 67 may be applied directly to the first underlying surface 72 in the manner described above, in other embodiments, the inner active layer 40 may include an inner carrier member 80 that is applied to or otherwise supported by the first underlying surface 72. The inner carrier member 80 may carry the inner API 67. In one embodiment, the inner API 67 may be delivered to the inner carrier member 80. The inner carrier member 80 may be configured as a mat, slip, strip, or other suitable structure configured to be supported by the underlying surface 72. In some embodiments, the inner carrier member 80 may be separate and adhered or otherwise joined to the first underlying surface 72. In other embodiments, the inner carrier member 80 may be 3D printed on the first underlying surface 72. The inner carrier member 80 may define an inner material matrix 82 that may be configured to absorb the inner API 67. Alternatively or additionally, the inner API 67 may coat the inner material matrix 82. Further alternatively or additionally, the inner material matrix 82 can define a plurality of pores 84 sized and configured to receive the inner API 67. For example, the inner material matrix 82 can be defined by a plurality of filaments 83 that can define the pores 84. In one embodiment, the filaments 83 can be defined by one or more layers of polymeric proteins networked to define the pores 84. The inner material matrix 82 can be defined by any suitable material that can dissolve in contact with a mucosal surface when the inner API 67 is configured to be delivered transmucosally to the bloodstream. The mucosal surface can be defined by the sublingual mucosa 24 or the buccal mucosa 26 (see FIGS. 1A-1B). For example, the material matrix 82 can include any one or more of sugar, salt, a dissolvable strip including a water-soluble polymer, and the like. In some embodiments, the material matrix 82 can be a dissolvable strip that dissolves in the oral cavity. The inner API 67 can be delivered or otherwise applied to the inner carrier member 80 in any manner described herein to define the inner active layer 40.

[0062] 6C, the barrier layer 52 may be disposed on the inner active layer 40. The barrier layer 52 may be applied in any suitable manner known to one of ordinary skill in the art of food science, including, but not limited to, powder deposition, solution, droplets, sprays, and the like. Thus, the barrier layer 52, and in particular the outer barrier surface 56, may define a second underlying outer surface 74. The outer active layer 42, in one embodiment, may be delivered to the second underlying outer surface 74 as defined by the outer barrier layer 52. Alternatively, the second underlying outer surface 74 may be defined by the inner active layer 40, as described in more detail below. In one example, the composite structure 78 including the core 30, the inner active layer 40, and the divider 52 (if present) disposed on the inner active layer 40 (with or without a divider layer between the core 30 and the inner active layer 40) can be aligned with the addition head 68 by moving the composite structure 78 into alignment with the addition head 68 and / or moving the addition head 68 into alignment with the composite structure 78. In one example, the composite structure 78 can be placed on a conveyor 70 that delivers the composite structure 78 to a position aligned with at least one addition head 68. The outer API 76 can then be delivered under gravity from the addition head 68 to the composite structure 78, specifically to the second underlying outer surface 74, to define the outer active layer 42. In some examples, once the outer API 76 is delivered to the second underlying outer surface 74, the composite structure 78 can be inverted such that the outer API 76 is then delivered to an opposing surface of the composite structure 78. The opposing surface can be defined by the divider layer 52 in one example. Alternatively, the opposing surface may be defined by the inner active layer 40. Alternatively, the opposing surface may be defined by the core 30.

[0063] In one embodiment, the outer API 76 can include any number of components of the cannabis group listed above. Alternatively or additionally, the outer API 76 can include any suitable prescription or over-the-counter drug or dietary supplement, as desired. As described above, at least one of the components of the outer API 76 can be different from either or both of the core API 66 and the inner API 67. Alternatively or additionally, at least one of the components of either or both of the core API 66 and the inner API 67 can be different from the outer API 76. It should be further understood that at least one common component can be included in either or both of the inner API 67 and the core API 66, and in the outer API 76. However, at least one of the common components can be included in the outer API 76 in a different amount relative to either or both of the inner API 67 and the core API 66. For example, as described above, the at least one common component can be THC, CBD, and / or any suitable alternative component, as desired.

[0064] In one embodiment, the outer API 76 can be delivered as a continuous series of microdroplets 69 in the manner described in Appendix A. The microdroplets 69 can be delivered from the dosing head 68 under gravity. Alternatively, the outer API 76 can be delivered as a stream, as a spray, as traditional droplets, as an emulsion, or in any suitable alternative form as desired. The outer API 76 can define a layer that extends over the first underlying surface 72. Alternatively, the composite structure 78 can be immersed in or otherwise exposed to a bath of the outer API 76 to generate the outer active layer 42 on the partition layer 52. Of course, it should be understood that the outer active layer 42 can be alternatively configured as desired. For example, the outer API 76 can be delivered as a powder. In other embodiments, the outer API 76 can be delivered in a separate layer or can form a separate layer that is later adhered or otherwise bonded to the first underlying surface 72.

[0065] 6D, as described above, the composite structure 78, and thus the resulting edible body 54, may lack a barrier layer 52 between the inner active layer 40 and the outer active layer 42. Thus, the inner active layer 40, and in particular the outer surface 46, may define a second underlying outer surface 74. The outer API 76 may be delivered directly to the second underlying outer surface 74 as defined by the inner active layer 40 to define the outer active layer 42. In one embodiment, the composite structure 78 including the core 30 and the inner active layer 40, respectively, without a barrier layer disposed between the inner active layer 40 and the outer active layer 42 (with or without a barrier layer between the core 30 and the inner active layer 40) may be aligned with the dosing head 68 by moving the composite structure 78 into alignment with the dosing head 68 and / or moving the dosing head 68 into alignment with the composite structure 78. In one embodiment, the composite structure 78 can be placed on a conveyor 70 that delivers the composite structure 78 to a position aligned with at least one dosing head 68. The outer API 76 can then be delivered under gravity from the dosing head 68 to the composite structure 78, and in particular to the inner active layer 40, to define the outer active layer 42. In some embodiments, once the outer API 76 is delivered to the inner active layer 40, the composite structure 78 can be inverted such that the outer API 76 is then delivered to an opposing surface of the composite structure 78. The one surface and the opposing surface can be defined by the inner active layer 40 in one embodiment.

[0066] In one embodiment, the outer API 76 can be delivered as a continuous series of microdroplets 69 in the manner described in Appendix A. The microdroplets 69 can be delivered from the dosing head 68 under gravity. Alternatively, the outer API 76 can be delivered as a stream, as a spray, as traditional droplets, as an emulsion, or in any suitable alternative form as desired. Alternatively, the composite structure 78 can be immersed in or otherwise exposed to a bath of the outer API 76 to produce the outer active layer 42 on the inner active layer 40. Of course, it should be understood that the outer active layer 42 can be alternatively configured as desired. For example, the outer API 76 can be delivered as a powder. In other embodiments, the outer API 76 can be delivered in a separate layer or can form a separate layer that is later adhered or otherwise bonded to the first underlying surface 72.

[0067] 5B, it should be understood that while the outer API 76 may be applied directly to the second underlying surface 74 in the manner described above, in other embodiments, the outer active layer 42 may include an outer carrier member 86 that is applied to or otherwise supported by the second underlying surface 74. The outer carrier member 86 may then carry the outer API 76. In one embodiment, the outer API 76 may be delivered to the outer carrier member 86. The outer carrier member 86 may be configured as a mat, slip, strip, or other suitable structure configured to be supported by the second underlying surface 74. In some embodiments, the outer carrier member 86 may be separate and adhered or otherwise joined to the second underlying surface 74. In other embodiments, the outer carrier member 86 may be 3D printed on the second underlying surface 74. The outer carrier member 86 may define an outer material matrix 88 that may be configured to absorb the inner API 67. Alternatively or additionally, the inner API 67 may coat the outer material matrix 88. Further alternatively or additionally, the outer material matrix 88 can define a plurality of pores 90 sized and configured to receive the outer API 76. For example, the outer material matrix 88 can be defined by a plurality of filaments 91 that can define the pores 90. In one embodiment, the filaments 91 can be defined by one or more layers of polymeric proteins networked to define the pores 90. The outer material matrix 88 can be defined by any suitable material that can dissolve in contact with a mucosal surface when the outer API 76 is configured to be delivered transmucosally to the bloodstream. For example, the outer material matrix 88 can include any one or more of sugars, salts, water-soluble polymers, and the like. In some embodiments, the outer material matrix 88 can be a dissolvable strip that dissolves in the oral cavity. The outer API 76 can be delivered or otherwise applied to the outer carrier member 86 in any manner described herein to define the outer active layer 42.

[0068] 5C, in some embodiments, the core 30 may be dissolvable against a mucosal surface in the oral cavity. Thus, the core 30 may be configured according to any of the embodiments described herein with respect to the inner active layer 40 and the outer active layer 42. For example, the core may include a core carrier member 92 capable of carrying the core API 66, if present. The core carrier member 92 may be configured as a mat, slip, strip, or other suitable structure capable of defining an underlying surface 72 (see FIG. 6B) for the inner core layer 40. The core carrier member 92 may define a core material matrix 94 that may be configured to absorb the core API 66. Alternatively or additionally, the core API 66 may coat the core material matrix 94. Further alternatively or additionally, the core material matrix 94 may define a plurality of pores 96 having a size and configuration to receive the core API 66. For example, the core material matrix 94 may be defined by a plurality of filaments 95 that may define the pores 96. In one example, the filaments 95 may be defined by one or more layers of polymeric proteins networked to define the pores 96. The core material matrix 94 may be defined by any suitable material that may dissolve in contact with a mucosal surface when the core API 66 is configured to be delivered transmucosally to the bloodstream. The mucosal surface may be defined by the sublingual mucosa 24 or the buccal mucosa 26 (see Figures 1A-1B). For example, the core material matrix 94 may include any one or more of sugars, salts, dissolvable strips including water soluble polymers, and the like. When the core material matrix 94 is dissolvable in contact with a mucosal surface, the core API 66 may undergo transmucosal absorption into the bloodstream.

[0069] In other embodiments, the core carrier member 92 may be gastrointestinal digestible. For example, the core 30 may be placed against a mucosal surface such that at least a portion, up to the entirety, of the core API 66 may undergo transmucosal absorption into the bloodstream. The core 30 may then be chewed and swallowed. Alternatively, if the carrier member of the core 30 is gastrointestinal digestible, the core 30 may be chewed and swallowed such that the core API undergoes gastrointestinal digestion in the manner described above. In still other embodiments, the core carrier member 92 may be configured to not dissolve against a mucosal surface and may further be configured to not be swallowed. In such embodiments, the core carrier member 92 may be placed against a mucosal surface such that the core API may undergo transmucosal absorption into the bloodstream in the oral cavity. Once the core API is absorbed, the core carrier member 92 may be expelled from the oral cavity.

[0070] Any number of additional intermediate active layers may be added to the composite structure as desired, between the inner active layer 40 and the outer active layer 42 as desired. The intermediate active layers may be configured according to any of the active layers described herein. The intermediate active layers may be separated from one another by respective partition layers as described herein, or may be in direct contact with one another. An innermost one of the intermediate active layers may be disposed adjacent to the inner active layer 40, with or without a partition layer disposed therebetween, and an outermost one of the intermediate active layers may be disposed adjacent to the outer active layer 42, with or without a partition layer disposed therebetween.

[0071] As discussed above with respect to Figures 1-6D, any API-containing portion of the layered edible product 20, such as the core 30, the inner active layer 40, and at least one active layer 22, including the outer active layer 42, if present, may be configured as a continuum in one embodiment. Alternatively, referring now to Figures 7A-7D, an API 98 is shown patterned on the underlying surface 103 of the carrier member 100. It should be understood that any one or more of the core API 66, inner API 67, and outer API 76 may be configured as shown by the API 98. Similarly, the underlying surface defined by any one or more of the inner carrier member 80, outer carrier member 86, and core carrier member 92 may be configured as the underlying surface 103 of the carrier member 100. Alternatively, any one or both of the first underlying surface 72 and the second underlying surface 74 may be defined by the carrier member 100.

[0072] As shown in FIG. 7A, API 98 may be disposed on an underlying surface 103 defined by a carrier member 100 in any predetermined pattern as desired. The predetermined pattern may be applied to an outermost active surface of the layered edible product 20 described above, which may be defined by a wrapper or outer active layer (which may be the only active layer or the outermost one of multiple active layers). The predetermined pattern may define any suitable shape or design. For example, the pattern 99 of API 98 may include a plurality of alternating structures 101, such as alternating lines 102 separated by gaps 104. Thus, the pattern 99 of API 98 may define a plurality of lines 102 and a plurality of gaps 104 extending between and interleaved with the lines 102. The gaps 104 may be devoid of API 98 or may include less API 98 than the lines 102. The lines 102 may be straight, curved, or otherwise shaped as desired. In other embodiments, such as that shown in FIG. 7B, the lines 102 can define a grid 106, whereby perpendicular lines 102 are arranged to intersect each row and column defined by API 98. The lines 102 can define right angles or any alternate angle as desired. The lines 102 can be individual, separate lines or can be adjacent to each other, for example, at their ends. In some embodiments, the pattern 99 can be defined such that the API 98 is positioned to match the average distance between a particular type of taste bud on a mucosal surface. In another embodiment, the pattern 99 of API 98 can define any suitable shape, such as a concentric ring pattern, a horseshoe pattern, etc., to substantially match the shape of the taste sensors and absorption zones of the sublingual or buccal mucosa.

[0073] 7C-7D, the API pattern 99 described above with respect to FIGS. 7A-7B, and any suitable alternative pattern 99, may be created lithographically, defined by patterning where small elements of the deposition size may be extended in a lithographic patterning manner. For example, the node of API deposition is defined by the finest detail along the underlying surface. This node may have a size that is the smallest size of API that can be deposited by the dosing station during use, or may have any suitable size as desired. Any image as desired by constructing a collage of nodes such that the overall appearance provides the desired pattern 99 may be defined, such as the lines and grid of FIGS. 7A-7B, an image of a rose flower 108 shown in FIG. 7C, an image of a cannabis leaf governmental symbol 110 shown in FIG. 7D, or any suitable alternative image as desired. In this manner, the API may be 3D printed on any substrate as desired. Depending on the size of the node and the limitations of the deposition equipment, the image produced may approach the detail of a high resolution black and white photograph. The desired pattern 99 may be a graphical representation, such as symbol 110, indicating that the layered edible product 20 contains cannabis, and may further include a numerical or graphical representation of the dosage of cannabis. It is understood that the pattern 99 may alternatively be a graphical representation of any other API of the layered edible product 20 in addition to the indication of the dosage of the API.

[0074] It is also contemplated that the patterning of the API may be accomplished in two different approaches. With reference to FIG. 8A, the first approach employs imaging capabilities in the API deposition assembly so that a portion of the desired image (including multiple elements) can be deposited on the stationary underlying surface 103 at a time. The dosing head 68 then moves relative to the underlying surface 103 along a plane 112 perpendicular to the dosing axis 79 to deliver the API at the desired location on the underlying surface 103. With reference to FIG. 8B, in the second approach, the transport system is configured to move each edible item to nominally position the underlying surface 103 to align with the dosing head 68 that delivers the API along the dosing axis 79. The underlying surface 103 may be placed on a moving platen 114 that may be moved along the plane 112 under computer control while the API is deposited from the dosing head along the dosing axis until the desired pattern is deposited. This approach may have the advantage that all of the patterning operations are accomplished by a moving stage and computer control without the need for movement of the dosing head. In yet other embodiments, both the application head and the underlying stage can be movable to form a desired pattern during delivery of the API from the application head.

[0075] It should be noted that the illustration and description of the embodiments and examples shown in the figures are for illustrative purposes only and should not be construed as limiting the disclosure. Those skilled in the art will understand that the present disclosure contemplates various possible modifications of the various aspects, embodiments and examples described herein. Furthermore, it should be understood that the concepts described herein may be used alone or in combination with any of the other embodiments and examples described herein. It should be further understood that the various alternatives described above with respect to one illustrated embodiment may be applied to all other embodiments and examples described herein, unless otherwise indicated. Accordingly, reference is made to the claims.

[0076] [Embodiment] (1) A layered edible product comprising: a core comprising a core active pharmaceutical ingredient (API); an inner active layer disposed over the core, the inner active layer comprising an inner API, the inner active layer being dissolvable in contact with the sublingual and buccal mucosa; 1. A layered edible product comprising: (2) The layered edible product of claim 1, wherein the inner API is different from the core API. (3) The layered edible product of embodiment 2, wherein the core API comprises at least one of a core non-psychoactive cannabinoid, a core psychoactive cannabinoid, a core terpene, and a core flavonoid. (4) The layered edible product of any of embodiments 2 to 3, wherein the inner API comprises at least one of an inner non-psychoactive cannabinoid, an inner psychoactive cannabinoid, an inner terpene, and an inner flavonoid. (5) The layered edible product of embodiment 1, wherein the core API and the inner API comprise the same components but in different proportions.

[0077] (6) The layered edible product of any one of the preceding claims, wherein the inner API comprises more psychoactive cannabinoid than the core API. (7) The layered edible product of any of claims 5 to 6, wherein the core API comprises more non-psychoactive cannabinoids than the inner API. (8) The layered edible product of any one of claims 5 to 6, wherein the core does not contain cannabis. (9) The layered edible product of any one of the preceding claims, wherein the core and the inner active layer define an edible body, and the layered edible product further comprises a wrapper covering at least an outermost surface of the edible body. (10) The layered edible product of embodiment 9, wherein the wrapper is dissolvable by saliva in contact with the sublingual and buccal mucosa.

[0078] (11) The layered edible product of claim 9, wherein the wrapper is configured to be removed from the edible body prior to placing the edible body in a mouth. 12. The layered edible product of any one of claims 9 to 11, wherein the wrapper is inert. 13. The layered edible product of any one of claims 1 to 12, wherein the inner active layer defines an outermost active layer of the layered edible product. (14) The layered edible product of claim 13, wherein the inner active layer also defines an innermost active layer such that no active layer is disposed between the inner active layer and the core. 15. The layered edible product of any one of claims 13 to 14, wherein the inner active layer is the only active layer of the layered edible product.

[0079] 16. The layered edible product of any one of claims 1 to 15, wherein the core and the inner active layer have different flavor profiles. (17) The layered edible product of any of the preceding claims, wherein the inner API has a therapeutic effect configured to last for a shorter duration than the core active pharmaceutical ingredient. (18) The layered edible product of embodiment 17, wherein the core API is configured to increase in the bloodstream after the inner API has begun to decrease in the bloodstream. (19) The layered edible product of any of claims 3 to 12, further comprising an outer active layer disposed on the inner active layer, the inner active layer being disposed between the core and the outer active layer, the inner active layer comprising the inner API, and the outer active layer comprising the outer API. (20) The multi-layered edible product of embodiment 19, wherein the inner and outer active layers are configured to dissolve in contact with the sublingual and buccal mucosa, respectively.

[0080] (21) The multi-layered edible product of embodiment 20, wherein the outer API comprises at least one of an outer non-psychoactive cannabinoid, an outer psychoactive cannabinoid, an outer terpene, and an outer flavonoid. (22) The layered edible product of embodiment 21, wherein the outer API and the inner API comprise the same components but in different proportions. (23) The layered edible product of embodiment 22, wherein the inner API comprises a different amount of a psychoactive cannabinoid than the outer API. (24) The layered edible product of embodiment 22, wherein the inner API comprises a different amount of a non-psychoactive cannabinoid than the outer API. (25) The layered edible product of any one of embodiments 22 to 24, wherein the inner API has a different component than the outer API.

[0081] 26. The layered edible product of any one of claims 19 to 25, further comprising a partition layer disposed between the inner active layer and the outer active layer. 27. The layered edible product of claim 26, wherein the divider layer is inert. 28. The layered edible product of any one of claims 19 to 27, further comprising a partition layer disposed between the core and the inner active layer. 29. The layered edible product of claim 28, wherein the partition layer disposed between the core and the inner active layer is inert. 30. The layered edible product of any one of claims 28 to 29, wherein all of the outer surfaces of the inner active layer face toward the outer active layer.

[0082] 31. The layered edible product of any one of claims 19 to 30, wherein the outer active layer substantially completely encapsulates the inner active layer. 32. The layered edible product of any one of claims 19 to 29, wherein an outer surface of the inner active layer faces toward the outer active layer and an inner surface of the inner active layer opposite the outer surface of the inner active layer faces away from the outer active layer. (33) The layered edible product of any one of the preceding claims, wherein at least a portion of the active pharmaceutical ingredients comprise microdroplets. (34) The layered edible product of any one of the preceding claims, wherein the core comprises a gummy candy. 35. The layered edible product of any one of claims 1 to 33, wherein the core comprises a hard candy.

[0083] (36) The layered edible product of any one of the preceding claims, wherein the core comprises a chocolate candy. 37. The layered edible product of any one of claims 1 to 33, wherein the core comprises dried fruit. 38. The layered edible product of any one of claims 1 to 33, wherein the core comprises nuts. (39) The layered edible product of any of embodiments 19 to 38, wherein the inner API and the outer API are configured to persist in the bloodstream for a shorter duration than the core active pharmaceutical ingredient. (40) The layered edible product of any of embodiments 19 to 38, wherein the core API is configured to increase in the bloodstream after the inner API and the outer API have begun to decrease in the bloodstream.

[0084] 41. The layered edible product of any one of claims 1 to 40, wherein the entire core faces toward the inner active layer. 42. The layered edible product of any one of claims 1 to 41, wherein the inner active layer substantially completely encapsulates the core. (43) The layered edible product of any one of the preceding claims, wherein an outer core surface of the core faces the inner active layer and an inner core surface of the core opposite the outer core surface of the core faces away from the inner active layer. (44) The layered edible product of embodiment 43, wherein the core inner surface is uncovered and defines an innermost and outermost surface of the layered edible product. (45) The layered edible product of any of the preceding claims, wherein the core comprises a core matrix and the core API is supported by the core matrix.

[0085] 46) The layered edible product of any one of the preceding claims, wherein an outermost active surface of the layered edible product comprises a predetermined pattern of the API. (47) The layered edible product of any of the preceding claims, wherein the core API and the inner API each comprise cannabis. (48) A method for sublingually incorporating ingredients of a layered edible product according to any one of embodiments 1 to 47, comprising the steps of: The method includes placing the layered edible product in the oral cavity such that an outermost one of the at least one active layer is placed against a mucous membrane defined by the buccal or sublingual mucosa, thereby allowing saliva to promote absorption of any of the active ingredients into the capillaries of the mucosa. 49. The method of claim 48, further comprising absorbing the API of an innermost one of the at least one active layers through the mucosa into the bloodstream. (50) The method of embodiment 48, further comprising the steps of exposing the core and chewing and swallowing the core to allow gastrointestinal digestion of the active pharmaceutical ingredient in the core.

[0086] (51) A method for consuming a layered edible product according to any one of embodiments 1 to 11 and 15, comprising: placing said layered edible product in the user's oral cavity against one of the selected mucous membranes selected from the group of sublingual mucosa and buccal mucosa; dissolving the inner active layer against the selected mucous membrane to receive transmucosal absorption of the inner API through the selected mucous membrane into the user's bloodstream, the dissolving exposing the core; ingesting the core; A method comprising: (52) The method of embodiment 51, wherein the step of ingesting the core comprises chewing and swallowing the core to subject the core API to gastrointestinal digestion. (53) The method of any one of embodiments 51 to 52, further comprising, prior to ingesting the core, sequentially dissolving multiple active layers in contact with the selected mucosa to absorb the different respective APIs. (54) The method of embodiment 53, further comprising dissolving an inert but dissolvable partition layer between adjacent active layers. (55) The method of any one of embodiments 51 to 54, further comprising removing the wrapper from the composite structure including the core and all active layers.

[0087] (56) The method of any one of embodiments 51 to 54, further comprising the step of dissolving a dissolvable wrapper against the selected mucous membrane. (57) The method of any one of embodiments 51 to 56, wherein the core and the inner active layer have different flavor profiles. (58) A layered edible product comprising: A core, an inner active layer disposed over the core, the inner active layer comprising an inner API, the inner active layer being dissolvable in contact with the sublingual and buccal mucosa; 1. A layered edible product comprising: (59) The layered edible product of embodiment 58, wherein the inner API comprises at least one of an inner cannabinoid, an inner tetrahydrocannabinol, an inner terpene, and an inner flavonoid. (60) The layered edible product of embodiment 59, wherein the core does not contain cannabis.

[0088] 61. The layered edible product of any of claims 58 to 59, wherein the core and the inner active layer define an edible body, and the layered edible product further comprises a wrapper covering at least an outermost surface of the edible body. (62) The layered edible product of embodiment 61, wherein the wrapper is dissolvable in contact with the sublingual mucosa and the buccal mucosa. 63. The layered edible product of claim 61, wherein the wrapper is configured to be removed from the edible body prior to consumption of the edible body. 64. The layered edible product of any one of embodiments 61 to 63, wherein the wrapper is inert. 65. The layered edible product of any one of claims 58 to 64, wherein the inner active layer defines an outermost active layer of the layered edible product.

[0089] (66) The layered edible product of embodiment 65, wherein the inner active layer also defines an innermost active layer such that no active layer is disposed between the inner active layer and the core. 67. The layered edible product of any one of embodiments 65 to 66, wherein the inner active layer is the only active layer of the layered edible product. (68) The layered edible product of any of embodiments 58 to 67, wherein the core and the inner active layer have different flavor profiles. (69) The layered edible product of any of embodiments 59 to 64, wherein the at least one active layer comprises an inner active layer disposed over the core and an outer active layer disposed over the inner active layer, the inner active layer being disposed between the core and the outer active layer, the inner active layer comprising the inner API, and the outer active layer comprising the outer API. (70) The multi-layered edible product of embodiment 69, wherein the inner and outer active layers are configured to dissolve in contact with the sublingual and buccal mucosa, respectively.

[0090] (71) The multi-layered edible product of embodiment 70, wherein the outer active pharmaceutical ingredient comprises at least one of an outer cannabinoid, an outer tetrahydrocannabinol, an outer terpene, and an outer flavonoid. (72) The layered edible product of embodiment 71, wherein the outer API and the inner API comprise the same components but in different proportions. (73) The layered edible product of embodiment 72, wherein the inner API comprises a different amount of THC than the outer API. (74) The layered edible product of embodiment 72, wherein the inner API comprises a different amount of CBD than the outer API. (75) The layered edible product of any of embodiments 72 to 74, wherein the inner API has a different component than the outer API.

[0091] (76) The layered edible product of any of embodiments 68 to 75, further comprising a partition layer disposed between the inner active layer and the outer active layer. 77. The layered edible product of embodiment 76, wherein the divider layer is inert. (78) The layered edible product of any of embodiments 68 to 77, further comprising a partition layer disposed between the core and the inner active layer. 79. The layered edible product of claim 78, wherein the partition layer disposed between the core and the inner active layer is inert. 80. The layered edible product of any one of embodiments 68 to 79, wherein all of the outer surfaces of the inner active layer face toward the outer active layer.

[0092] 81. The layered edible product of any one of embodiments 68 to 80, wherein the outer active layer substantially completely encapsulates the inner active layer. (82) The layered edible product of any of embodiments 68 to 79, wherein an outer surface of the inner active layer faces toward the outer active layer and an inner surface of the inner active layer opposite the outer surface of the inner active layer faces away from the outer active layer. (83) The layered edible product of any one of embodiments 58 to 82, wherein at least a portion of the API comprises microdroplets. (84) The layered edible product of any one of embodiments 58 to 83, wherein the core comprises a gummy candy. (85) The layered edible product of any of embodiments 58 to 83, wherein the core comprises a hard candy.

[0093] (86) The layered edible product of any of embodiments 58 to 83, wherein the core comprises a chocolate candy. (87) The layered edible product of any one of embodiments 58 to 83, wherein the core comprises dried fruit. (88) The layered edible product of any one of embodiments 58 to 83, wherein the core comprises nuts. (89) The layered edible product of any of embodiments 58 to 83, wherein the entire core faces toward the inner active layer. 90. The layered edible product of any one of embodiments 58 to 83, wherein the inner active layer substantially completely encapsulates the core.

[0094] (91) The layered edible product of any of embodiments 58 to 83, wherein an outer core surface of the core faces the inner active layer and an inner core surface of the core opposite the outer core surface of the core faces away from the inner active layer. 92. The layered edible product of embodiment 91, wherein the core inner surface is uncovered and defines an innermost and outermost surface of the layered edible product. (93) The layered edible product of any of embodiments 58 to 92, wherein an outermost active surface of the layered edible product comprises a predetermined pattern of an API. (94) The layered edible product of any of embodiments 58 to 93, wherein the core API and the inner API each comprise cannabis. (95) The layered edible product of embodiment 94, wherein the cannabis comprises chemically synthesized cannabis material.

[0095] (96) A method for sublingually incorporating ingredients of a layered edible product according to any one of embodiments 58 to 94, comprising the steps of: The method includes placing the layered edible product in the oral cavity such that an outermost one of the at least one active layer is placed against a mucous membrane defined by the buccal or sublingual mucosa, thereby allowing saliva to promote absorption of any of the active ingredients into the capillaries of the mucosa. (97) The method of embodiment 96, further comprising absorbing the API of an innermost one of the at least one active layer through the mucosa into the bloodstream. (98) The method of embodiment 97, further comprising exposing the core and chewing and swallowing the core to allow gastrointestinal digestion of the API in the core. (99) A method for consuming a layered edible product according to any one of embodiments 58 to 63 and 67, comprising: placing said layered edible product in the user's oral cavity against one of the selected mucous membranes selected from the group of sublingual mucosa and buccal mucosa; dissolving the inner active layer against the selected mucosa to receive transmucosal uptake of the inner API through the selected mucosa into the user's bloodstream, the dissolving exposing the core; ingesting the core; A method comprising: (100) The method of embodiment 99, wherein the step of ingesting the core comprises chewing and swallowing the core to subject the core API to gastrointestinal digestion.

[0096] (101) The method of any one of embodiments 99 to 100, further comprising, prior to ingesting the core, sequentially dissolving multiple active layers in contact with the selected mucosa to absorb the different respective APIs. (102) The method of embodiment 101, further comprising dissolving an inactive partition layer between adjacent active layers. (103) The method of any one of embodiments 99 to 102, further comprising removing the wrapper from the composite structure including the core and all active layers. (104) The method of any one of embodiments 99 to 102, further comprising the step of dissolving the wrapper in contact with the selected mucous membrane. (105) The method of any one of embodiments 99 to 104, wherein the core and the inner active layer have different flavor profiles.

[0097] (106) The layered edible product or method of any one of the preceding claims, wherein the core is defined by an existing edible product. (107) A kit of layered edible products comprising: a plurality of layered edible products, each having a core and an inner active layer containing an inner API and supported by said core, each substantially structurally identical to one another, but wherein the inner API of at least one of said layered edible products has at least one of a different chemical composition and a different duration of therapeutic effect compared to at least one other of said layered edible products; Including the kit. (108) The kit of embodiment 107, wherein the cores of at least some of the layered edible products are active cores containing a core API, and the core API of at least one of the layered edible products has at least one of a different chemical composition and a different duration of therapeutic effect compared to at least one other of the layered edible products. (109) The kit of any of embodiments 107 to 108, wherein at least some of the layered edible products comprise an outer active layer containing an outer API, and the outer API of at least one of the layered edible products has at least one of a different chemical composition and a different duration of therapeutic effect compared to at least one other of the layered edible products.

Claims

1. 1. A layered edible product comprising: Gumicore and an inner active layer comprising an inner API; an outer active layer comprising an outer API; Including, A layered edible product, wherein the inner API has a different constituent than the outer API.

2. The layered edible product of claim 1, further comprising a partition layer disposed between the gummy core and the inner active layer.

3. The layered edible product of claim 2, further comprising a second partition layer disposed on top of the inner active layer.

4. The layered edible product of claim 1, further comprising a partition layer disposed between the inner active layer and the outer active layer.

5. A layered edible product as described in any one of claims 2 to 4, wherein the partition layer contains a respective API.

6. A layered edible product as described in any one of claims 2 to 4, wherein the partition layer is inert.

7. The layered edible product of claim 1, wherein the gummy core comprises a core API and the inner API is different from the core API.

8. The layered edible product of claim 7, wherein the core API comprises one of a prescription drug and an over-the-counter drug.

9. The layered edible product of claim 7, wherein the inner API comprises one of a prescription drug and an over-the-counter drug.

10. 10. The layered edible product of claim 1, wherein the gummy core comprises a core API and the inner API comprises the same components as the core API but in different proportions.

11. A layered edible product as described in any one of claims 7 to 10, wherein the inner API has a therapeutic effect configured to last for a shorter duration than the core API.

12. The layered edible product of claim 11, wherein the core API is configured to increase in the bloodstream after the inner API has begun to decrease in the bloodstream.

13. A layered edible product as described in any one of claims 7 to 10, wherein the gummy core comprises a core matrix, and the core API is supported by the core matrix.

14. The layered edible product of claim 1, further comprising an outermost edible wrapper.

15. 15. The layered edible product of claim 14, wherein the outermost edible wrapper is dissolvable by saliva in contact with the sublingual and buccal mucosa.

16. 15. The layered edible product of claim 14, wherein the outermost edible wrapper is configured to be removed from the edible body prior to placing the edible body in a mouth.

17. 17. The layered edible product of any one of claims 14 to 16, wherein the outermost edible wrapper is inert.

18. 10. The layered edible product of claim 1, wherein the outer active layer defines the outermost active layer of the layered edible product.

19. 10. The layered edible product of claim 1, wherein the inner active layer also defines an innermost active layer such that no active layer is disposed between the inner active layer and the gummy core.

20. 10. The layered edible product of claim 1, wherein the gummy core and the inner active layer have different flavor profiles.

21. 10. The layered edible product of claim 1, wherein the outer API and the inner API comprise the same components in different proportions.

22. 10. The layered edible product of claim 1, wherein the inner API has a different composition than the outer API.

23. 10. The layered edible product of claim 1, wherein not all of the outer surface of the inner active layer faces toward the gummy core.

24. The layered edible product of claim 1, wherein the inner active layer substantially completely encapsulates the gummy core.

25. 10. The layered edible product of claim 1, wherein an outer surface of the inner active layer faces toward the outer active layer and an inner surface of the inner active layer opposite the outer surface of the inner active layer faces toward the gummy core.

26. The layered edible product of claim 1, wherein at least a portion of the active pharmaceutical ingredient comprises microdroplets delivered to the gummy core.

27. 10. The layered edible product of claim 1, wherein the entire gummy core faces toward the inner active layer.

28. A layered edible product comprising: Gumicore and at least one active layer disposed on the gummy core, the at least one active layer comprising a respective at least one API; a barrier layer disposed between the gummy core and the at least one active layer; 1. A layered edible product comprising:

29. The layered edible product of claim 28, wherein the at least one API comprises one of a prescription drug and an over-the-counter drug.

30. The layered edible product of claim 28, wherein the gummy core does not contain an API.

31. The layered edible product of claim 29 or 30, wherein the gummy core comprises a core API.

32. The layered edible product of claim 29 or 30, further comprising a wrapper surrounding the at least one active layer.

33. The layered edible product of claim 32, wherein the wrapper comprises a respective API.

34. 33. The layered edible product of claim 32, wherein the wrapper is inert.

35. 30. The layered edible product of claim 28, wherein the at least one active layer also defines an innermost active layer such that no active layer is disposed between the at least one active layer and the gummy core.

36. 30. The layered edible product of claim 28, wherein the gummy core and the at least one active layer have different flavor profiles.

37. The layered edible product of claim 28, wherein the partition layer is an active partition layer containing the respective API.

38. 30. The layered edible product of claim 28, wherein the divider layer is inert.

39. The layered edible product of claim 28, wherein the partition layer is a first partition layer, and the layered edible product further comprises a second partition layer on the at least one active layer, and the at least one active layer is disposed between the first partition layer and the second partition layer.

40. A layered edible product comprising: An edible body, Gumicore and an active pharmaceutical ingredient (API); and an edible body comprising: an edible wrapper surrounding the edible body; 1. A layered edible product comprising:

41. The layered edible product of claim 40, wherein the gummy core defines the API.

42. The layered edible product of claim 40, wherein the API comprises one of a pharmaceutical drug and an over-the-counter drug.

43. The layered edible product of claim 40, wherein the gummy core is inert.

44. The layered edible product of claim 40, further comprising at least one active layer between the gummy core and the edible wrapper, the at least one active layer comprising at least one respective API.

45. The layered edible product of claim 44, wherein the at least one API comprises one of a pharmaceutical drug and an over-the-counter drug.

46. 41. The layered edible product of claim 40, further comprising a divider layer disposed over the gummy core.

47. The layered edible product of claim 46, wherein the partition layer is active.

48. The layered edible product of claim 46, wherein the partition layer is inert.

49. The layered edible product of any one of claims 46 to 48, further comprising at least one active layer containing the at least one API, wherein the partition layer is disposed between the gummy core and the at least one active layer.

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