Systems and methods for producing API-containing edible products and resulting edible products

Abstract

The present disclosure provides a reliable method and apparatus for delivering a pharmaceutical active ingredient to food products produced in a batch process. In one embodiment, the pharmaceutical active ingredient is added after the batch food product is cooked and cooled. The food product may be a candy, baked food, or any alternative food product that is mixed as a batch and then cooked and cooled.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 63 / 197,189, filed June 4, 2021, and to U.S. Patent Application No. 63 / 328,306, filed April 7, 2022, the disclosures of each of which are incorporated by reference herein as if set forth in their entirety.

[0002] [Technical field] The present disclosure relates to the field of cannabis products, and more specifically to the field of cannabis-containing edible products, and methods and systems for producing the same. [Background technology]

[0003] [Current situation] The legal cannabis industry is growing rapidly in the United States, Canada, and around the world. Traditionally, cannabis, or other active pharmaceutical ingredients (APIs), included in batch-produced prepared foods are typically added during the batch stage of production. In particular, as shown in FIG. 1, a method 100 for batch production of prepared foods includes step 101 of providing ingredients for the food to be prepared. For example, the providing step can include step 102 of mixing multiple edible ingredients together to produce a mixture of the batch food. In some examples, a quantity of food can be removed from the mixture to produce a desired amount of the batch food. The batch food is then cooked at a desired temperature for a desired time in step 103 and then cooled in step 104. The batch food is then apportioned into individualized food products in step 106 and then packaged as desired in step 108. In some examples, the individualized food products are subjected to a final cooling step 107 before packaging.

[0004] A conventional API addition process includes adding an API to a batch food product and performing one or more mixing operations in an attempt to obtain a homogenous mixture of the API. Thus, the final personalized food product contains a certain amount of API. However, the inventors have discovered that a conventional addition sequence can cause substantial variations in the dosage of API in the produced food product. As a result, the medicinal effect experienced when consuming one of the personalized foods is substantially different from the medicinal effect experienced when consuming another of the personalized foods. This difference can have a significant impact when the food product is bite-sized. When the food product is larger than bite-sized, the variation in API addition can further cause a first region of the food product to contain substantially more or less API than a second region of the food product. Thus, the medicinal effect experienced when consuming the first region of the food product is substantially different from the medicinal effect experienced when consuming the second region of the food product. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, what is needed are improved batch produced ready-to-eat meals in which the added API is more consistent between produced personalized foods than has been previously achieved. [Means for solving the problem]

[0006] In one embodiment, a method of preparing a food product may include providing a batch food mixture, cooking the batch food mixture such that the food product defines a cooked batch food product, and cooling the cooked batch food product such that the cooked batch food product defines a cooled food product. The method may further include, after the cooling step, adding a cannabinoid to the cooled food product.

[0007] The following detailed description will be better understood when read in conjunction with the accompanying drawings, in which there is shown by way of illustration example embodiments, it being understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown. [Brief description of the drawings]

[0008] [Figure 1] 1 is a flow chart showing the steps associated with a conventional method for batch preparation of cooked food products. [Figure 2A] FIG. 1 is a schematic perspective view of a system for delivering an active pharmaceutical ingredient to an edible product. [Figure 2B] FIG. 2B is an enlarged schematic perspective view of a portion of the edible product shown in FIG. 2A. [Figure 3A] FIG. 2B is a schematic diagram of the addition zone of the system shown in FIG. 2A. [Figure 3B] FIG. 2 is a perspective view of a microdroplet in one embodiment. [Figure 3C] FIG. 13 is a side view of a microdroplet in another embodiment. [Figure 4] FIG. 2B is a top view of the edible product shown in FIG. 2A showing the delivery zone. [Figure 5A] FIG. 1 is a perspective view of mixed nuts loaded with active pharmaceutical ingredients according to an embodiment of the present disclosure. [Figure 5B] FIG. 1 is a perspective view of a dried fruit loaded with an active pharmaceutical ingredient according to an embodiment of the present disclosure. [Figure 5C] FIG. 1 is a perspective view of a baked good to which has been added an active pharmaceutical ingredient according to an embodiment of the present disclosure. [Figure 5D] FIG. 1 is a side view of a gummy loaded with an active pharmaceutical ingredient according to an embodiment of the present disclosure. [Figure 5E] FIG. 1 is a perspective view of a tongue depressor loaded with an active pharmaceutical ingredient according to an embodiment of the present disclosure. [Figure 6A] FIG. 2 is a perspective view of an adder constructed in accordance with one embodiment. [Figure 6B] FIG. 6B is a schematic diagram of a method of dosing using the dosing machine shown in FIG. 6A. [Figure 7]1 is a flow chart illustrating steps associated with a method for batch preparation of cooked food according to one embodiment. [Figure 8] 4 is a flow chart illustrating steps associated with a method for batch preparation of cooked food products according to another embodiment. [Figure 9A] 4 is a flow chart illustrating steps associated with a method for batch preparation of cooked food products according to yet another embodiment. [Figure 9B] FIG. 2 is a schematic diagram of a mold cavity for receiving a food product in one embodiment. [Figure 10] 4 is a flow chart illustrating steps associated with a method for batch preparation of cooked food products according to yet another embodiment. [Figure 11] 4 is a flow chart illustrating steps associated with a method for batch preparation of cooked food products according to yet another embodiment. [Figure 12] FIG. 1 is a schematic diagram of a mixing device according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] One or more different aspects may be described in this application. Moreover, for one or more of the aspects described herein, numerous alternative configurations may be described; it should be understood that these are presented for illustrative purposes only and in no way limit the scope of the aspects contained herein or the claims presented herein. One or more of the configurations may be broadly applicable to numerous aspects, as is readily apparent from the disclosure. In general, the configurations have been 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 configurations 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 forming a part of this disclosure, in which specific configurations of one or more of the aspects are shown by way of example. However, it should be understood that such features are not limited to use in one or more specific aspects or figures in conjunction with which they are described. This disclosure is not a literal description of all configurations of one or more of the aspects, nor a list of one or more features of the aspects that must be present in all configurations.

[0010] The section headings provided in this patent application and the title of this patent application 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 otherwise specified. In addition, devices that are in communication with each other may communicate directly or indirectly through one or more communication means or intermediaries, whether logical or physical.

[0012] A description of an aspect in which multiple components are in communication with one another does not imply that all such components are required. Conversely, a variety of optional components may be described to illustrate a wide range of possible aspects and to more fully illustrate one or more aspects. Similarly, although process steps, method steps, algorithms, and the like may be described in a sequential order, such processes, methods, and algorithms may generally be configured to operate in alternative orders unless specifically stated otherwise. In other words, any sequence or order of steps that may be described in this patent application does not, in and of itself, indicate a requirement that the steps be performed in that order. The steps of a described process may be performed in any practical order. 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 its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, nor does it imply that the illustrated process, or any of its steps, are required for one or more of the aspects, nor does it imply that the illustrated process is preferred. Also, although steps are generally described once per embodiment, this does not imply that they must occur once or that they may occur 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 or article is described herein, multiple devices or articles may be used in place of the single device or article. Similarly, it will be readily apparent that where multiple devices or articles are described herein, a single device or article may be used in place of the multiple devices or articles.

[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 are sometimes 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 specified. Process descriptions or blocks in the figures should be understood as representing modules, segments, or portions of code that include one or more executable instructions for performing specific logical functions or steps in the process. Alternative embodiments are within the scope of various aspects that may perform functions in different orders than those shown or described, including substantially simultaneously or in reverse order, depending on the functionality involved, for example, as will be appreciated by those skilled in the art.

[0016] As described below with reference to Figures 7-11, methods are described for preparing foods with a desired dose of API by adding the API at one or more stages of the food preparation process to reduce the chance of error in the final dose in personalized foods. First, systems and methods for producing cannabis edibles, and the resulting edible products, are provided, as will now be generally described with reference to Figures 2-6.

[0017] Method and system for adding cannabis to edible products According to an embodiment, a method of converting an edible product or other substrate into a cannabis or other API-containing product is disclosed. The method can include a step of delivering an API, such as a cannabinoid, to a substrate, which may be an edible product or a non-edible product. The step of delivering can be performed using any suitable one or more applicators that deliver a predetermined dosage of the cannabinoid. The term "cannabinoid" as used herein refers to any extract from a marijuana plant or hemp plant, such as CBD, THC, or any alternative cannabinoid, alone or in combination with any one or more of flavonoids and terpenes. The extract may be in its pure form or may be processed as desired, including, for example, an emulsified form of cannabinoid liquid. The present disclosure provides for the addition of at least one cannabinoid to a substrate, and thus the cannabinoid is contemplated as a market for the final product, although applications of the systems and methods disclosed herein without cannabis, including, but not limited to, other active pharmaceutical ingredients (APIs), are also possible and contemplated. For example, applications of the systems and methods disclosed herein can include, and are contemplated to include, active pharmaceutical ingredients (APIs) including one or more cannabinoids, any alternative one or more over-the-counter (OTC) or prescription drugs, including those that provide either or both of a health benefit or a recreational drug experience, or any other controlled ingestible substance. Thus, references to active pharmaceutical ingredients herein can include any one of the following: cannabis, one or more cannabinoids in either natural oil form or emulsified form, one or more over-the-counter drugs, one or more prescription drugs, one or more flavonoids, one or more terpenes, and any desired behavior-modifying consumables. Thus, references to one or more active pharmaceutical ingredients herein can be equally applied to any other of the active pharmaceutical ingredients identified herein. According to aspects of the present disclosure, methods of delivering cannabinoids or traditional drugs can also be used to deliver homeopathic remedies, herbal supplements with flavors or odors, and the like, which are also APIs, to edible products.The resulting edible product can be called a "nutraceutical" because the definition is "a food that contains a health-imparting additive or has medicinal properties. All APIs described herein can be provided as natural or synthetic compounds, as desired.

[0018] The active pharmaceutical ingredient can be added to a substrate to produce an active-containing substrate, which may include edible foods, edible non-food products, or other non-edible substrates. Edible foods can include, by way of example and not limitation, hard candy, chocolate brownies, cookies, soft candies such as gummies, savories such as trail mix bars or dried meat pieces, and the like. Thus, in some embodiments, the edible food can be a prepared food. In some specific embodiments, the edible food can be a baked food. The edible food can be bite-sized, such as M&M candies, gummies, chocolate kisses, and the like, or designed to require more than one bite to be consumed completely, such as cookies. Thus, in some embodiments, the edible food can include multiple mixed ingredients. As will be appreciated from the following description, the food can be fully prepared before adding the API to the food. In other embodiments, the API can be added during the preparation of the food. In some embodiments, the food can be a dehydrated food, such as dried fruit or jerky. In other embodiments, the edible product can be freeze-dried. In yet other examples, the edible product may be a raw food product such as nuts or fruit.

[0019] It will be appreciated that the application of active pharmaceutical ingredients to food products allows a wider range of foods to be produced with the active pharmaceutical ingredients. Furthermore, the API can be added more precisely compared to traditional methods. When applying active pharmaceutical ingredients to pre-prepared foods, APIs with a short shelf life can be applied to the substrate and consumed in a shorter period of time, with the active pharmaceutical ingredients being combined with raw ingredients that are subsequently processed to prepare the food product. When the API is added during the food preparation process, the API can be added more precisely compared to traditional methods where the API is included in bulk ingredients that are mixed prior to cooking or baking.

[0020] In yet another embodiment, as described above, the substrate to which the API is added can be an edible non-food product. The primary purpose of a food product is to deliver nutrients, whereas the primary purpose of a non-food product is to deliver the API, either alone or with a carrier. Examples of edible non-food products can include dissolvable materials such as slips, or can be capsules, pills, tablets, nuggets, and the like. Alternatively, as described above, the substrate can be a non-edible product 33. That is, the substrate is not designed for human consumption, but is designed to be placed in the mouth. One such non-limiting example is a tongue depressor 35 (see FIG. 5E).

[0021] In one embodiment, multiple active-containing substrates can be provided as a set, with some of the substrates having different doses of active pharmaceutical ingredients and designed to be taken at different times during a period, such as different days of the week. Thus, a desired dose profile can be delivered to the patient over that period. Alternatively or additionally, one of the active-containing substrates can contain at least one different active pharmaceutical ingredient. Thus, a set of active-containing substrates can be designed to be taken sequentially (i.e., one after the other) over that period, thereby delivering a desired predetermined sequence of active pharmaceutical ingredients to the patient.

[0022] The active pharmaceutical ingredient, including one or more cannabinoids, may be delivered to the substrate in liquid form as an API-containing liquid or in granular solid form as an API-containing solid. The API-containing liquid may be in the form of a pure API, such as a resin, or in the form of a concentration of the API in a liquid carrier, such as a solvent. The API-containing solid may be in the form of a pure API, such as a powder, or may be a mixture of the API and any other suitable material. The API-containing liquid and API-containing powder delivered to the substrate may be referred to as the API-containing material. In some examples, the applicator may deliver a small amount of the active pharmaceutical ingredient to the substrate. For example, the small amount may be delivered by the applicator as microdroplets carried by the solvent, each having a volume ranging from about 2 nanoliters to about 10 microliters, such as about 25 nanoliters to about 2 microliters. For example, the microdroplets may have a volume ranging from about 25 nanoliters to about 1 microliter. The microdroplets may have a concentration of the API as desired. For example, the concentration of the API can range from about 50 micrograms per microliter of solution to about 1 milligram per microliter of solution. In other examples, the liquid can be a pure resin of the API.

[0023] In one embodiment, it is envisioned that applicators that deliver similar doses of API to similar substrates can deliver microdroplets of approximately the same size to the similar substrates. Thus, for example, when delivering API to dried fruits and / or nuts designed to have the same dose of API, the applicator can deliver approximately the same volume and number of microdroplets to each dried fruit and / or nut, or to a group, such as a serving, of dried fruits and / or nuts.

[0024] As described in further detail below, a dosing head can be provided that is configured to deliver any suitable volume of microdroplets, such as the volumes described above. Thus, each microdroplet can contain a minute amount of API, ranging from about 0.1 micrograms to about 10 milligrams, for example, from about 1 milligram to about 2 milligrams. However, it is recognized that the microdroplets can have any volume as desired. It is further recognized that each microdroplet can contain a different amount of API, for example, depending on the volume of the microdroplet. The minute amount of API in the microdroplets allows precise control of the dose of API delivered to the substrate. For example, each volume of microdroplets can be delivered to the substrate within a range of about 1% to about 10%, for example, about 5%, from the target volume of the microdroplets at 3 sigma. Thus, the dose of API in each microdroplet can be delivered to the substrate within a range of about 1% to about 10%, for example, about 5%, from the target dose at 3 sigma. The target volume of the microdroplets can vary based on the surface area or volume of the substrate to which the microdroplets are applied. Similarly, the dose of API delivered to the substrate can similarly be within the range of about 1% to about 10%, e.g., about 5%, at three sigma, from the target dose of API to the substrate, or to a packaged portion of substrate, such as dried fruits or nuts. The target volume of the microdroplets can vary based on the surface area or volume of the substrate to which the microdroplets are applied.

[0025] Thus, in one embodiment, minute amounts can be delivered to a substrate in the form of successive individualized (e.g., one at a time) microdroplets. The use of microdroplets can aid in precise dosing of active pharmaceutical ingredients compared to conventional techniques. The microdroplets can be delivered to the outer surface of the substrate by a 3D printer, an inkjet printer, or other suitable printing process. Alternatively or additionally, the microdroplets can be delivered to the outer surface of the substrate by precision spraying. Still alternatively or additionally, the microdroplets can be delivered to an internal location of the substrate surrounded by the outer surface. For example, the microdroplets can be mechanically injected or delivered using an air gun that fires the microdroplets at the substrate with a blast of high-pressure air (this is a similar method to how some vaccines and other drugs can be administered subcutaneously without the use of injection with a needle). Without being bound by theory, it is believed that microdroplets to an internal location of the substrate can also help facilitate administration or ingestion of potentially bitter-tasting (or strong cannabis-tasting) formulations by providing a means to add small amounts of such substances to a much larger amount of edible product.

[0026] Microdroplets containing the API can be delivered to the substrate. The microdroplets can include a solution containing at least one cannabinoid in liquid form as a solute mixed with any suitable solvent. The at least one cannabinoid can be substantially homogeneously mixed with the solute to help achieve a predictable dosage of the at least one cannabinoid. Alternatively, the microdroplets can consist of, or consist essentially of, a purified, partially purified, or unpurified cannabinoid extract in liquid form with a desired viscosity that allows the cannabinoid extract to be reliably dispensed. In some examples, the liquid can be heated to achieve the desired viscosity without mixing the cannabinoid extract in the solute. In some examples, the microdroplets can be oily or hydrophilic in nature. For example, the microdroplets can be multi-layered with a protein or other protective coating surrounding a precise dose of an oil-based or water-based formulation. Since the concentration of the cannabinoid in the liquid can be known, a volume of liquid can be predetermined and delivered to the substrate to achieve the desired, predetermined approximate dosage of the cannabinoid. In some other examples, the microdroplets can be of an emulsified cannabinoid liquid.

[0027] In other embodiments, the active pharmaceutical ingredient, which may include one or more cannabinoids, may be added to the substrate in granular form.For example, cannabinoid extracts, which may be purified, partially purified, or unpurified, may be delivered to the substrate as a powder.In some embodiments, cannabinoids may be crystallized and milled to produce a powder.Since the concentration of cannabinoids in the powder is known, the mass of powder may be predetermined and delivered to the substrate to achieve the desired dosage of cannabinoids.

[0028] The liquid or powder delivered to the substrate can contain a single desired cannabinoid. Thus, a single desired cannabinoid can be delivered to the substrate. Alternatively, multiple different liquids or powders can be delivered to the substrate, each containing their own different cannabinoid or cannabinoids. Thus, multiple desired cannabinoids can be delivered to the substrate by delivering multiple different liquids and powders. The liquids and powders can be delivered in equal or different amounts. Thus, the ratio of one or more cannabinoids to one or more other cannabinoids can be controlled. In other examples, the liquid or powder delivered to the substrate can contain multiple cannabinoids in equal or desired proportions. Thus, a single liquid or powder can be delivered to the substrate to deliver either a single cannabinoid or multiple cannabinoids. Multiple cannabinoids delivered to the food product using one or more powders or liquids can contain two or more cannabinoids up to the full range of cannabinoids, for example, about 113 cannabinoids.

[0029] It should be appreciated that the cannabinoids are not subjected to the food preparation process since they are added to the edible product after the edible product is prepared. Thus, the cannabinoids are not subjected to mixing of the food ingredients, cooking of the food, freeze-drying of the food, dehydration of the food, etc. As a result, the active pharmaceutical ingredient is not subject to processes that may otherwise reduce the potency of the active pharmaceutical ingredient. However, the present disclosure recognizes that the method of delivering cannabinoids to prepared foods can also be applied to raw foods, such as raw fruits and nuts, edible non-foods, and other non-edible substrates.

[0030] According to another embodiment, the API, such as cannabis or other formulations, can be applied via any suitable printing process, including 3D, inkjet printing, or any suitable alternative printing process. In some cases, such printing can be used to apply any suitable label, such as, for example, a cannabis warning symbol or warning, and the ink dots used for printing can be composed of the target formulation, primarily derived from cannabis or hemp. In some embodiments, the formulation used for precise addition to the edible product can include a substantial fraction of one or more of any suitable cannabinoids. Non-limiting examples of such cannabinoids include THC, CBD, or a combination of one or both of these with other cannabinoids. In some embodiments, the mixture of cannabinoids can be supplemented by one or more terpenes or flavonoids, which can be extracted from cannabis or hemp, or can be provided as pure substances commercially obtained or synthesized from other sources. Furthermore, bitter or strong cannabis flavors can be hidden within the much more dominant flavors of the "host" edible product. Alternatively or additionally, at least one cannabinoid can be deposited in a location of the product that is not designed to be in direct initial contact with the tongue during ingestion, thereby further masking the taste of at least one cannabinoid.For example, at least one cannabinoid can be applied to the top round surface of a cookie, recognizing that the cookie is designed to be placed in the mouth with the bottom flat surface in contact with the tongue.Alternatively or additionally, the microdroplets can be coated with sugar or other suitable taste masking agents as desired.

[0031] In some embodiments, soft edible products such as chocolate, gummies, licorice, etc., can be used as a "carrier" or "host" for an amount of cannabinoid that can be injected (by air gun, needle, or other suitable method known in the art) into the soft edible product, forcing the added material into the bulk of the soft edible product. The flavor of cannabis can be masked by such an approach. In some embodiments, energy such as infrared, forced air, or microwaves can be applied to the surface of the edible product to soften (or further soften) the material in small areas, allowing the cannabis or hemp-derived material to be more easily injected (or to a greater depth into the host edible product) into the infrared pre-treated areas. Energy can be applied before injection, after injection, or both before and after injection. In other examples, at least one cannabinoid can be applied to multiple surfaces of the edible product up to the entire surface of the edible product.

[0032] For edible products, such as hard or soft candies, or any other suitable edible substrate, a visible design can be printed on the item with CBD, THC, or other cannabinoid compound acting as an ink. Microdots with indication of the dose of the cannabinoid compound can be printed as desired. The dose can also be sprayed or added as an additional layer, such as a candy or chocolate layer. In some embodiments, the at least one cannabinoid can be mixed with a food ingredient just before packaging or delivering the prepared edible product (e.g., as an ingredient in an icing or other coating, or as part of a sugar coating applied to a gummy candy), especially if such an ingredient is suitable for addition.

[0033] In some embodiments, the edible product can be coated with a coating of small oil globules or solid powders, each containing at least one cannabinoid, to block the taste or mask the flavor of cannabis. In some embodiments, a colorant can be added to the at least one cannabinoid prior to delivery to the edible product in order to blend the formulation blend with the color of the edible product.

[0034] According to one embodiment, the applicator sprays the API onto the surface of the edible product; the cannabis or hemp-derived material diffuses into or remains on the surface of the cannabis or hemp-derived material.

[0035] According to one embodiment, the applicator projects an API-containing liquid into the edible product.

[0036] According to one embodiment, the applicator sprays the API-containing liquid into the edible product.

[0037] According to one embodiment, the applicator sprays the API-containing liquid onto the surface of the edible product.

[0038] According to one embodiment, the applicator stamps the API-containing material onto the surface of the edible product.

[0039] According to one embodiment, the applicator prints the API-containing material onto the surface of the edible product.

[0040] According to one embodiment, the applicator distributes the API-containing material onto the surface of the edible product.

[0041] According to one embodiment, the applicator establishes one or more API-containing micro-pills on the surface of the edible product.

[0042] According to one embodiment, the applicator applies a conformal coating of an API-containing material to an edible product.

[0043] According to certain embodiments, the applicator encapsulates or mixes the API-containing material with one or more modifiers configured to modify at least one or more of the flavor, mechanical properties, or aesthetics of the applied cannabis or hemp material prior to addition to the edible product.

[0044] According to certain embodiments, the applicator controls the size, location, or distribution of API-containing materials on an edible product to modify flavor or aesthetics.

[0045] According to certain embodiments, the applicator regulates one or both of the concentration of the API in the solution or a component of the solution.

[0046] According to an embodiment, energy is applied to the surface of the edible product to enhance the adhesion of the API-containing material to the edible product. According to an embodiment, energy is applied to increase the temperature of the surface. In one embodiment, the temperature can be increased by directing at least one of forced air, microwaves, and light, such as infrared light, at the surface. Energy can be applied before the API-containing material is delivered to the edible product, after the API-containing material is delivered to the edible product, or both before and after the API-containing material is delivered to the edible product.

[0047] 2A-3, all of the above method steps and apparatus described herein, including the active-containing matrix, can be incorporated into or provided by any suitable system. One such system 20 is illustrated and described herein, however, as noted above, it is recognized that numerous alternatives are available for dispensing an approximate dose of active pharmaceutical ingredient onto or into a desired matrix. In one embodiment, the system 20 is configured to deliver the active pharmaceutical ingredient 22 to a matrix 23, which may be configured as an edible product 24, thereby producing an active-containing matrix. When the matrix is ​​an edible product, the active-containing matrix can be referred to as an active-containing edible product. As noted above, the edible product 24 can be any suitable fully prepared food product. Alternatively, as described in more detail below, the edible product 24 can be dosed with the API at one or more steps of the food manufacturing process, which reduces the chance of dose inconsistencies that are common using conventional dosing techniques. Further, as noted above, the active pharmaceutical ingredient may include at least one cannabinoid, at least one alternative drug or substance that provides a health benefit or recreational drug experience, or any desired alternative ingestible controlled substance as specified by law. It will be appreciated that the system 20 may provide a cost-effective and efficient method for providing a product line of substrates having desired amounts and types of active pharmaceutical ingredients.

[0048] In some cases, it may be desirable to add one or more supplemental edible products to the prepared edible product 24 before or after the active pharmaceutical ingredient 22 is delivered to the edible product 24. 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 pharmaceutical ingredient. The system 20 may include up to one or more of a delivery station 28 configured to receive one or more edible products, an addition station 36 configured to deliver an approximate dose of the active pharmaceutical ingredient (API) 22 to one or more edible products, a post-processing station 40, and a packaging station 42 that may be configured to package the edible product 24 carrying the approximate dose of the active pharmaceutical ingredient 22. In some examples, the approximate dose may be an exact dose as described herein. The post-processing station 40 can be configured to at least one of: 1) dry out the solvent, for example if the API is delivered as a solution; 2) change, for example increase, the viscosity of the API; 3) further adhere the API to the substrate; 4) distribute the API along the substrate; 5) increase the absorption or diffusion of the API into the substrate. Operation of the system can be controlled by any suitable controller, such as the Champion 3700 Digital Dispensing Benchtop System, available from Creative Automation Company, having offices in Sun Valley, Calif.

[0049] The terms "substantially," "approximately," "about," and words of similar import, when used in reference to an amount, volume, mass, weight, dose, size, shape, orientation, or other parameter, specifically include the stated parameter within plus or minus 20% of the stated parameter, including, for example, within plus or minus 5% of the stated parameter, including, for example, within plus or minus 10% of the stated parameter, including, for example, within plus or minus 1% of the stated parameter, along with ranges within plus or minus 2% of the stated parameter.

[0050] In the case where the at least one active pharmaceutical ingredient is delivered as an API-containing liquid 25, which may be a solution of the type described above, or a pure API, for example as an oil, the system 20 may include a holding tank 26 configured to hold the liquid 25. Thus, the liquid 25 may be a pure cannabis extract in one example, but in other examples, the cannabis extract may be mixed or otherwise combined with one or more other substances, such as a solvent, as desired. In one example, the liquid is a solution having an approximate concentration of the cannabinoids or other active pharmaceutical ingredients 22 described above. The approximate concentration of the active pharmaceutical ingredient in the API-containing substance may be a known concentration as described above. Thus, the active pharmaceutical ingredient 22 may define the solute of the solution, and the solution may define any suitable solvent. In one example, the solvent may be an alcohol, such as ethanol or any alternative alcohol, as desired, or any other viscosity reducing agent, as desired. In one example, the liquid 25 may contain the active pharmaceutical ingredient in a concentration ranging from about 40% to about 90%, such as from about 50% to about 70% by volume in solution with the solvent. It will be appreciated that the solvent may be removed substantially in its entirety during a subsequent drying step, e.g., the solvent may readily evaporate after being applied to the edible product 24. Nonetheless, it would be desirable for the solvent to be one that is safe for consumption in small amounts.

[0051] Alternatively, the cannabinoid or other active API-containing liquid 25 may be a free-standing extract, meaning that it is not mixed with a carrier designed to be burned or otherwise vaporized. The extract may be purified, partially purified, or unpurified as desired. Such a free-standing extract may be in the form of a resin having a relatively high viscosity, which may prevent the extract from flowing freely enough to be easily delivered to the substrate 23. Thus, as described in more detail below, the system 20 may include one or more heaters configured to increase the temperature of the extract, thereby reducing the viscosity of the API-containing liquid. Alternatively or additionally, an additive, such as alcohol, may be added to the liquid 25, which reduces the viscosity of the liquid. The alcohol is easily evaporated after the liquid 25 is applied to the substrate 23. It is recognized that an extract having a suitably low viscosity may be easily delivered to the substrate in any manner described herein. For example, it may be desirable to maintain the extract at a heated temperature while applying the extract to the substrate 23. The heating temperature may range from about 100°F to about 200°F, such as at least about 100°F or at least about 150°F. In one embodiment, the heating temperature may range from about 150°F to about 180°F. It is contemplated that the extract will have a sufficiently low viscosity at room temperature, but nevertheless, in some cases, it may be desirable to maintain the solution at the heating temperature. Since the approximate dosage of at least one cannabinoid in the liquid 25 is known, the predetermined approximate volume of liquid 25 delivered from the holding tank 26 to the dosing station 36, and thus to the edible item 24, can contain approximately the predetermined approximate dosage of the pharmaceutical ingredient 22.

[0052] The delivery station 28 can be configured to receive a plurality of substrates 23, such as a plurality of edible products 24. Although the substrate is shown as an edible product 24, it is recognized that the substrate can be configured as any suitable alternative substrate as described above. In one embodiment, the system 20 includes one or more support surfaces 30 of at least one support member 32, which are configured to receive and support a respective one or more edible products 24. The support surfaces 30 can be defined by respective predefined locations of the support members 32. The predefined locations can be defined by geometric markings. Alternatively or additionally, the predefined locations can be defined by pockets 34 defined by the support members 32. At least one or both of the support members 32 and the dosing station 36 can be movable to align the dosing station 36 with the edible products 24. The dosing station 36 can be configured to deliver an approximate volume of liquid 25 to one edible food product at a time, or can be configured to deliver multiple approximate volumes of liquid 25 to respective multiple edible food products simultaneously. In this regard, the description of a singular element herein applies with equal force to the plural singular elements and at least one of the singular elements. Thus, the terms "a", "an", and "the" used in connection with a singular device or method step herein include a plurality of devices or method steps, and at least one of the devices or method steps. Conversely, the description of a plural element herein applies with equal force to the singular element, or at least one of the singular elements. Thus, the plural devices or method steps described herein include the singular "a", "an", "the", as well as "at least one". The dosing station 36 can be configured as an ultra-low volume liquid handling machine commercially available from Biofluidix, which has a place of business in Freiburg, Germany.

[0053] In one embodiment, the support member 32 can be configured as any suitable delivery member, such as a conveyor 38 or other suitable support member designed to support and transport the edible product to be operatively aligned with the application station 36. The conveyor 38 can be correspondingly movable to transport the edible product 24 from the delivery station 28 to the application station 36. Alternatively, the support surface 30 can be stationary and the application station 36, including applicators that can be configured as one or more application heads as described below, can be movable to be aligned with the substrate 23. Further alternatively, both the support surface 30 and the application station can be movable to align the application head with the substrate 23. It can thus be said that at least one of the support surface 30 and the application station 36 can be movable relative to the other of the support surface 30 and the application station 36 to align the substrate 23 with the application head of the application station 36.

[0054] Further alternatively, system 20 may be configured for self-service, whereby it is recognized that a user places a substrate on support surface 30 at addition station 36. Alternatively, a user may place substrate 23 on support surface 30 and manually move substrate 23, for example along support surface 30, to addition station 36. In this example, support surface 30 may be a stationary support surface. Additionally, the addition station may be stationary.

[0055] After the active pharmaceutical ingredient is delivered from the dosing station 36 to the substrate 23, the active-containing substrate 23 can be moved from the dosing station 36 to a post-treatment station 40. The active-containing substrate 23 can be moved from the dosing station 36 to a post-treatment station 40 using the support surface 30 or any suitable alternative equipment. In this regard, the post-treatment station 40 can be positioned in-line with the dosing station 36 along the support surface 30 in some examples. Alternatively, the post-treatment station 40 can be offline relative to the support surface 30. Thus, the active-containing substrate can remain at the post-treatment station 40 for a desired amount of time until the active-containing substrate is suitable for packaging. At this point, the active-containing substrate can be moved from the post-treatment station 40 to a packaging station 42. The support surface 30 or any suitable alternative equipment can move the active-containing substrate from the post-treatment station to the packaging station 42. In this regard, the post-treatment station 40 can be positioned in-line with the dosing station 36 along the support surface 30 or can be offline relative to the support surface 30.

[0056] Once the edible product 24 is aligned with the dosing station 36, the dosing station 36 is configured to deliver a predetermined approximate volume of an active pharmaceutical ingredient, such as at least one cannabinoid, to the edible product. In some examples, the active pharmaceutical ingredient may be presented as a liquid 25. Since the concentration of the active pharmaceutical ingredient in the liquid 25 is known and the desired dosage of the active pharmaceutical ingredient to be delivered to the substrate 23 is known, the approximate volume of the liquid 25 to be delivered to the substrate 23 can be determined. In some examples, an electrostatic force can be generated that drives the active pharmaceutical ingredient into the substrate 23, thereby causing the active pharmaceutical ingredient and the substrate to be oppositely charged. For example, the substrate 23 can be given a negative charge and a positive charge can be added to the liquid or powder to be delivered, thereby generating the electrostatic charge.

[0057] It will be appreciated that in other examples, the active pharmaceutical ingredient may be delivered to the substrate 23 as a powder. For example, the liquid 25 containing at least one cannabinoid may be an initial form of a resin that can be dried and crystallized. The resulting crystals can be ground into a powder having a desired dosage of the active pharmaceutical ingredient. Since the density of the active pharmaceutical ingredient in the powder is known and the desired dosage of the active pharmaceutical ingredient to be delivered to the substrate 23 is known, an approximate mass of powder to be delivered to the substrate 23 by the dosing station 36 can be determined.

[0058] The dosing station 36 may include at least one applicator of the type described above, such as a plurality of applicators. Each applicator may define a dosing head 46 configured to dispense a respective approximate amount of an approximate volume of liquid 25 delivered from the holding tank 26. Thus, the dosing station 36 may include at least one dosing head 46, such as a plurality of dosing heads 46. The dosing station 36, particularly the applicators, and thus the dosing heads 46, are in fluid communication with the holding tank 26. Thus, the dosing heads 46 are configured to receive a respective amount of the volume of liquid 25 delivered from the holding tank 26 and dispense the respective amount to the edible product 24. The respective amounts dispensed by the dosing heads 46 cumulatively define an approximate volume of liquid 25 received from the holding tank 26.

[0059] As will be described, the dosing head 46 can be configured to deliver a precise amount of volume of the liquid 25 to the edible product 24. In some embodiments, the precise amount can be a minute amount applied to the edible product 24. Thus, the edible product 24 can receive a predictable dose of the active pharmaceutical ingredient within the bounds of federal regulations. Furthermore, this dose of the active pharmaceutical ingredient can be applied at a specific location of the edible product as desired. For example, in certain embodiments, it may be desirable to deliver the active pharmaceutical ingredient such that the active pharmaceutical ingredient is substantially uniformly distributed on or within the edible product 24. As a result, for example, if the edible product is a large baked food, consuming different areas of the edible product with equal volumes will result in the intake of substantially the same amount of the active pharmaceutical ingredient. One non-limiting example of a large baked food can be a brownie. Furthermore, if the edible product 24 is a bite-sized food that is a product of batch ingredients that are mixed and / or cooked and then singulated, consumption of different bite-sized food items having equal volumes will result in the intake of substantially the same amount of the active pharmaceutical ingredient. One non-limiting example of such a bite-sized food can be a gummy candy. In one embodiment, the additive head 46 may be defined by a True Volume™ Piston Positive Displacement Pump available from Creative Automation Company having a place of business in Sun Valley, Calif. In another embodiment, the additive head 46 may be defined by a Pipetman M P10M device available from Gilson Inc. having a place of business in Middleton, Wisconsin.

[0060] 3, the dosing station 36 can include an injection reservoir 49 disposed between the holding tank 26 and the dosing head 46. The dosing station 36 can include a first conduit 51 extending from the holding tank 26 to the reservoir 49 and a second conduit 53 extending from the reservoir 49 toward the dosing head 46. Thus, the reservoir 49 can receive a volume of liquid 25 from the holding tank 26. The dosing station 36 can further include a second conduit 53 extending from the reservoir 49. The second conduit 53 can extend to a manifold 55. Thus, the reservoir 49 can deliver the volume of liquid 25 to the manifold 55 under a pressure differential provided by the pump, which can distribute the volume of liquid 25 to the dosing head 46. In this regard, it should be understood that the second conduit 53 is in fluid communication with the dosing head 46. The pump can be a positive pump that defines a positive pressure differential. The holding tank 25 can be under positive pressure to provide a positive force urging the liquid 25 from the holding tank 26 towards the addition head 46. Alternatively, the holding tank 25 can be under negative pressure to draw the liquid 25 from the holding tank 26 towards the addition head 46. In other embodiments, the system 20 can include multiple pumps, each configured to provide a respective pressure differential to a respective one or more of the addition heads 46.

[0061] The pumps can, for example, define respective pistons movable within corresponding cylinders to eject a precise predetermined volume of liquid 25. In this regard, a stroke length of the pistons that deliver liquid 25 to the first at least one dosing head 46 can be different from a stroke length of the pistons that deliver liquid 25 to the second at least one dosing head 46. Alternatively, the pumps can include an elastic micropipe having an inner diameter that is partially squeezed by a piezo stack actuator to drive liquid 25 from the dosing heads 46.

[0062] In some examples, the different dosing heads 46 can be configured to deliver different amounts of respective volumes of liquid 25 to the edible product 24 (see FIG. 2). Additionally, the liquid 25 delivered by the first at least one dosing head 46 can include a different active pharmaceutical agent than the liquid 25 delivered by the second at least one dosing head 46. Additionally, the system 20 can be configured to deliver any number of API-containing liquids 25, each containing a different pharmaceutical agent, to each of the at least one dosing heads 46. Thus, the dosing heads 46 can be combined to deliver active pharmaceutical agents from different liquid extracts in different amounts onto a common substrate 23. Alternatively or additionally, the different liquids can have different concentrations of their respective active pharmaceutical agents. Thus, the system 20 can include any number of holding tanks 26 as desired, each tank containing a different liquid extract containing at least one different pharmacoactive ingredient. The different liquid extracts can be delivered to different ones of the dosing heads 46. Thus, the different dosing heads can be configured to deliver different cannabinoids to the substrate.

[0063] As an example, the first group of dosing heads 46 can be configured to deliver a dosage of a first active pharmaceutical, and the second group of dosing heads 46 can be configured to deliver a dosage of a second active pharmaceutical, the second active pharmaceutical being different from the first active pharmaceutical. For example, the first active pharmaceutical can be THC and the second active pharmaceutical can be CBD. Furthermore, the first active pharmaceutical can be delivered at a different predetermined approximate dosage than the second active pharmaceutical. Furthermore, the tank containing the first active pharmaceutical can be maintained at a different temperature than the second tank. This allows the viscosity of each of the API-containing liquids 25 to be individually controlled. Additionally, the temperature from one or more of each of the conduits 51, 53 and at each of the dosing heads 46 can be different to individually control the viscosity of each liquid extract as it travels from each of the tanks to each of the one or more dosing heads 46.

[0064] The system 20 can include any suitable feedback mechanism to provide an indication that the at least one dosing head 46 has delivered the at least one active pharmaceutical ingredient to the substrate 23. The feedback mechanism can be a closed feedback loop in some examples. For example, a pressure sensor can be disposed in the conduit 53 to measure the back pressure in the conduit 53. For example, a decrease in back pressure can indicate that each of the at least one dosing heads 46 has delivered each of the at least one active pharmaceutical ingredient to the substrate 23. Alternatively, the system 20 can include a load cell that determines that the substrate 23 is aligned with the dosing head 46 by sensing weight. Additionally alternatively, the system 20 can include a visual recognition system that includes a visual sensor to visually identify that the substrate 23 is aligned with the dosing head 46. Thus, it is understood that in some examples, the substrate 23 can be disposed anywhere on the support surface, not necessarily at a predetermined location on the support surface.

[0065] Additionally, system 20 can include a camera designed to measure a quantification of the microdroplets delivered from addition head 46. For example, the camera can measure the cross-sectional dimension of the microdroplets as they move from addition head 46 to substrate 23. It is recognized that the microdroplets may be elongated as they move from addition head. However, the surface tension of the microdroplets may cause the microdroplets to become more spherical as they move from addition head 46 to substrate 23. Thus, in one embodiment, the cross-sectional dimension may be a maximum cross-sectional dimension that approximates the diameter of a sphere, and an estimate of the volume of the microdroplets may be calculated as desired. However, the cross-sectional dimension may be any suitable alternative cross-sectional dimension that relates to the volume of the microdroplets. The cross-sectional dimensions of the microdroplets or the calculated volume estimates can be compared to one another to ensure consistency in the volume of the microdroplets being delivered to substrate 23 or to verify desired variations in the volume of the microdroplets. The cross-sectional dimensions or the calculated estimates can then be integrated into a feedback loop to ensure proper operation of system 20. In one embodiment, the camera may be a SmartDrop system available from Biofluidix, having offices in Freiburg, Germany.

[0066] As mentioned above, the system 20 can be configured to deliver heat to the liquid 25 either in one or more of the conduits and / or in the dosing head 46 prior to or during dispensing of the API-containing liquid to the substrate 23. The heat can be sufficient to reduce the viscosity of the API-containing liquid 25. In some examples, for example, if the API-containing liquid 25 includes a solvent, the step of delivering heat to the liquid 25 can evaporate the solvent such that a pure API having a sufficiently low viscosity is dispensed from the dosing head 46. Thus, in one example, the API-containing liquid 25 can include an API and a solvent and can travel from the holding tank 26 to the dosing head 46. The API-containing liquid 25 can be heated between the holding tank 26 and the dosing head 46 to reduce the viscosity of the liquid 25 and, in some cases, evaporate some or all of the solvent. Alternatively or additionally, the API-containing liquid 25 can be heated at the dosing head 46 to reduce the viscosity of the liquid 25 and, in some cases, evaporate some or all of the solvent. In one embodiment, the system 20 can include at least one heater that delivers heat from one or more of the first conduit 51, the second conduit 53, the injection reservoir 49, the manifold 55, and the dosing head 46 up to all of them to reduce the viscosity of the API-containing liquid and, in some cases, evaporate the solvent. In one embodiment, the liquid 25 can be maintained at a temperature ranging from about 100°F to about 200°F, such as from about 140°F to about 200°F, in one embodiment, from about 150°F to about 180°F. Alternatively, in some embodiments, such as when the liquid 25 is a solution, the liquid 25 can be maintained at room temperature.

[0067] Although the dosing head 46 can be configured to deliver a liquid 25 containing at least one active pharmaceutical ingredient to the substrate 23 in one embodiment, the dosing head 46 can alternatively be configured to deliver at least one active pharmaceutical ingredient in solid or powder form to the substrate 23 in the manner described herein with respect to the liquid 25. Thus, the above examples of applying an active pharmaceutical ingredient in the form of a liquid can apply with equal force to a powder containing at least one active pharmaceutical ingredient, unless otherwise indicated. Each dosing head 46 can be configured to deliver microdroplets of the API, as described above. Thus, it should be understood that the powder can be delivered to the substrate 23 as a micro-amount. The powder can be stored in the holding tank 26 and can be directed to the dosing head 46 through the first conduit 51 and the second conduit 53, either directly or through the manifold 55. Thus, it can be said that a quantity of API-containing material can be applied to the substrate 23. The API-containing material can be in the form of a powder or liquid. Thus, the API-containing material can include a desired concentration of the active pharmaceutical ingredient, as described above. In other embodiments, the API-containing material may contain only active pharmaceutical ingredients.

[0068] Additionally, each of the dosing heads 46 can be configured to dispense the API-containing liquid 25 received from the holding tank 26, although it will be appreciated that the API-containing liquid 25 can be delivered using other methods. For example, the system 20 can include a first holding tank containing the API in liquid or solid form and a second holding tank containing the solvent. The API and the solvent can be mixed at the dosing station 36. For example, the API and the solvent can be mixed at the dosing head 46. In one example, the dosing head can include a first chamber that receives the API and a second chamber that receives the solvent. The API and the solvent can be mixed in the dosing head 46 to generate a solution having a predetermined concentration of the API. The solution generated in the dosing head 46 can then be dispensed as one or more microdroplets in the manner described herein. In some examples, this concentration can be varied in the dosing head 46. That is, the respective ratios of API and solvent mixed in the dosing head 46 can be changed. Additionally, the API or solution may be mixed with at least one other ingestible conditioning agent configured to modify at least one of the flavor, one or more mechanical properties, or one or more aesthetic properties of the cannabis or hemp material. Mixing may occur within the dosing head 46 or at any other location as desired. For example, in some embodiments, at least one other edible product may be mixed into the liquid 25 in the holding tank 26.

[0069] 2A-3B, in one embodiment, the dosing heads 46 can be arranged in an array 48 including at least one row 50 of dosing heads 46. The dosing heads 46 in each row 50 can be spaced substantially equally apart along their respective rows 50. Alternatively, the dosing heads 46 can be variably spaced along their respective rows 50. The array 48 can further include a plurality of columns 52 that space the rows 50 from one another. The dosing heads 46 can be spaced equally apart along their respective columns 52. Alternatively, the dosing heads 46 can be variably spaced along their respective columns 52. In one embodiment, all of the dosing heads 46 can be configured to deliver the same at least one active pharmaceutical ingredient. Alternatively, as described above, different groups of dosing heads 46 can be configured to deliver respective different active pharmaceutical ingredients. Each group can include at least one dosing head 46 up to a plurality of dosing heads 46. Each group can be defined by a respective one or more of the rows 50. Alternatively, each group can be defined by a respective one of the columns.

[0070] 2A-4, the addition heads 46 can be aligned with different respective locations of the addition zone 54 of the edible product 24. Thus, the addition heads 46 can be positioned to deliver their respective amounts of volume of the liquid 25 to the different respective locations of the addition zone 54. Additionally, the system 20 can be configured to deactivate selected addition heads 46 that are not aligned with the addition zone 54 and therefore do not receive their respective portions of the volume of the liquid 25, and activate selected addition heads 46 that are aligned with the addition zone 54 and therefore receive their respective portions of the volume of the liquid 25. In some embodiments, the system 20 can include a sensor that identifies the addition zone 54 of the edible product 24. The sensor can be a camera, a weight sensor that measures the weight of the substrate 23 on the support surface and determines the addition zone based on the weight and / or size, or any suitable alternative sensor. The addition zone 54 can be at least partially defined by the perimeter 56 of the edible product 24. For example, the addition zone 54 can be defined in its entirety by the perimeter 56 of the edible product 24. Thus, the entire outer surface of the edible product 24 can define the addition zone 54. In some examples, the addition zone 54 can be located entirely within the perimeter 56. For example, the addition zone 54 can be greater than half, such as greater than 75%, of the footprint defined by the perimeter. In any event, it can be said that the addition zone 54 can be substantially a predetermined location relative to the perimeter 56 of the edible product 24. Thus, the addition zone 54 can be consistent among a number of different sizes of edible products 24, such as cookies or brownies, which can have similar, but not identical, sizes and shapes.

[0071] The addition heads 46 may be spaced apart from one another as desired to deliver a desired distribution of the active pharmaceutical ingredient to the edible product 24 within the addition zone 54. Alternatively, one or more of the addition heads 46 may be movable to deliver the active pharmaceutical ingredient to multiple locations on the edible product 24. In one embodiment, the addition heads 46 are configured to deliver a substantially uniform distribution of the volume of liquid 25 to the edible product 24 within the addition zone 54. For example, each amount of the volume of suspension dispensed by each of the addition heads 46, or each of the plurality of addition heads, may be substantially equal to each amount of suspension dispensed by the other addition heads 46 or the other plurality of addition heads 46.

[0072] In another embodiment, the system 20 can divide the dosing zone 54 into a plurality of subzones. Each subzone can be configured to receive a different at least one active pharmaceutical ingredient. Thus, at least one dosing head 46 of the first group can deliver a first at least one active pharmaceutical ingredient to a first subzone of the subzones, and at least one dosing head 46 of the second group can deliver a second at least one active pharmaceutical ingredient different from the first at least one active pharmaceutical ingredient to a second subzone of the subzones. Alternatively or additionally, at least one dosing head 46 of the first group can be configured to deliver a first dosage amount of the first at least one active pharmaceutical ingredient, and at least one dosing head 46 of the second group can be configured to deliver a second dosage amount of the second at least one active pharmaceutical ingredient different from the first dosage amount. In yet another embodiment, at least one dosing head 46 of the first and second groups can be configured to deliver different dosage amounts of the same at least one active pharmaceutical ingredient. The active pharmaceutical ingredient may be substantially evenly distributed in each of the subzones.

[0073] In some examples, at least one dosing head 46, such as a plurality of dosing heads 46, can be movable along the substrate 23 to deliver each of the at least one active pharmaceutical ingredient at different locations of the edible product 24. Additionally, the dosing heads 46 can be configured to deliver different active pharmaceutical ingredients to the substrate 23. For example, the dosing heads 46 can be configured to deliver different combinations of liquids and / or powders. In one example, the dosing head 46 can deliver a first liquid or powder containing a first active pharmaceutical ingredient to the substrate 23. The dosing head 46 can then deliver a second active pharmaceutical ingredient, different from the first active pharmaceutical ingredient, to the substrate 23. The dosing head 46 can then deliver a third active pharmaceutical ingredient, different from each of the first and second active pharmaceutical ingredients, and so on, to the substrate 23 until all desired active pharmaceutical ingredients have been delivered to the substrate 23.

[0074] When the dosing heads 46 are arranged as a group of dosing heads 46 each delivering a respective different at least one active pharmaceutical ingredient, the different active pharmaceutical ingredients can be delivered to respective different locations of the substrate 20. For example, the dosing heads 46 can remain stationary relative to the substrate 23 as the active pharmaceutical ingredients are delivered to the substrate 23. Alternatively, the dosing heads 46 can be movable along the substrate 23, and a combination of active pharmaceutical ingredients as delivered by at least one dosing head 46 of different groups can be delivered to the same respective location of the substrate 20. The heads 46 can be movable such that the dosing heads 46 can deliver respective active pharmaceutical ingredients to respective locations of the substrate 23 that are different from the other dosing heads. The active pharmaceutical ingredients at the respective different locations can be substantially uniformly distributed in at least one direction along the substrate 23. For example, the active pharmaceutical ingredients at the different locations can be substantially uniformly distributed in two perpendicular directions along the substrate 23.

[0075] The substrate 23 includes an outer surface defining an inner surface 60 facing the support surface 30 and an outer surface 58 opposite the inner surface 60. The dosing head can deliver the active pharmaceutical ingredient to the outer surface 58 of the substrate 23. The edible product 24 defines a thickness extending from the inner surface 60 to the outer surface 58. The delivered volume of the active pharmaceutical ingredient can remain substantially on the outer surface 58. By delivering a volume of liquid to the outer surface 58, the liquid can be exposed to oral receptors, thereby increasing the rate of uptake of the active pharmaceutical ingredient. Alternatively or additionally, the delivered volume of liquid 25 can permeate the outer surface 58 to soak into at least a volume of the thickness of the edible product extending from the outer surface 58 to the opposite inner surface 60. Alternatively, the active pharmaceutical ingredient can be infused into the substrate 23 between the inner surface 60 and the outer surface 58. For example, at least 20% of the active pharmaceutical ingredient can be located in the central 75% of the thickness. The central 75% of the thickness can be spaced equidistant from each of the inner surface 60 and the outer surface 58. For example, at least 20% of the active pharmaceutical ingredient can be disposed in the central 50% of the thickness. The central 50% of the thickness can be spaced equidistant from each of the inner surface 60 and the outer surface 58. In some examples, the distribution along the outer surface of the substrate 23 can be different than the distribution along the thickness of the substrate 23 from the outer surface to the inner surface.

[0076] In one example, the dosing head 46 can be configured to deliver respective amounts of the active pharmaceutical ingredient in the form of microdroplets 62 to respective locations on the outer surface 58 of the edible product 24. The microdroplets 62 can have any suitable size and shape as desired. In one example, the microdroplets 62 can include minute amounts of the active pharmaceutical ingredient. For example, the microdroplets 62 can define a maximum cross-sectional dimension along a horizontal direction that is within a range of about 5 millionths of an inch to about 100 thousandths of an inch, for example, when printed. For example, the range can be about 5 thousandths of an inch to about 50 thousandths of an inch. In one example, the maximum cross-sectional dimension along a selected direction can be within a range of about 20 thousandths of an inch to about 40 thousandths of an inch. The dosing head 46 can be spaced apart from the edible product 24 along a direction of movement of the active pharmaceutical ingredient from the dosing head 46 to the edible product 24. Thus, the active pharmaceutical ingredient is delivered to the substrate along the direction of movement. The selected direction may be substantially perpendicular to the direction of movement. In one embodiment, the dosing head 46 is spaced above the edible product 24 along a vertical direction. This allows the selected direction to be substantially horizontal. For example, the dosing head 46 may be spaced any suitable distance from the edible product 24 when delivering the active pharmaceutical ingredient to the edible product 24, such as from about 2 mm to about 25 mm. As shown in FIG. 3B, at least some of, up to all of the microdroplets 62 may be substantially spherical. Alternatively or additionally, as shown in FIG. 3C, at least some of, up to all of the microdroplets 62 may be elongated, e.g., substantially teardrop-shaped, or alternatively shaped as desired.

[0077] In one embodiment, the microdroplets 62 are delivered from the dosing head 46 to the respective locations of the edible product 24 under any suitable force, such as gravity, electrostatic force, etc. In another embodiment, the microdroplets 62 are delivered from the dosing head 46 to the respective locations of the edible product under positive pressure. In this regard, the dosing station 36 can control whether the microdroplets 62 remain on the outer surface 58 of the edible product 24 and whether the microdroplets 62 penetrate the thickness of the edible product 24 through the outer surface 58 in the manner described above. In yet another embodiment, one or more of the dosing heads 46 can be coupled to respective needles that can be driven into the edible product 24 to deliver respective amounts of volumes of the liquid 25 to locations between the outer surface 58 and the inner surface 60 within the edible product 24. In some cases, the needles can be heated at a suitable temperature to soften or melt locations of the substrate contacted by the needles to aid in injection of the needles into the substrate. The heated needles can also maintain a desired viscosity of at least one active pharmaceutical ingredient as the active pharmaceutical ingredient is being delivered through the needles into the substrate. Whether the active pharmaceutical ingredient is delivered to the edible product 24 as microdroplets or as an injectable, the active pharmaceutical ingredient can be delivered to the edible product in minute amounts.

[0078] As mentioned above, the system 20 can include a post-processing station 40 configured to process the edible product 24 after the liquid 25 is delivered thereto. The post-processing station 40 can be configured to dry the solvent, for example, when the API is delivered as a solution. In this regard, the post-processing station 40 can include any suitable drying member, such as a plurality of drying heads 70 or at least one drying head 70 configured to deliver a desiccant to respective locations of the edible product 24 to dry the liquid 25. It is understood that as the liquid 25 dries, the solvent of the delivered volume of liquid 25 carrying the active pharmaceutical ingredient can also dry and evaporate, leaving the active pharmaceutical ingredient on the substrate 23. In this regard, the drying heads 70 can be arranged in an array having the same number of rows and columns as the array of the dosing heads 46. Furthermore, the relative position of the drying heads 70 with respect to the other drying heads 70 can be the same as the relative position of the dosing heads 46 with respect to the other dosing heads 46. Thus, the drying head 70 can be aligned with the active pharmaceutical ingredient delivered to the edible product 24 by the addition head 46 .

[0079] The desiccant may be configured as any suitable light, including ultraviolet, laser, infrared, and the like. Alternatively, the desiccant may be a forced gas delivered to the exterior surface of the edible product 24. The forced gas may be any suitable alternative gas, such as air, nitrogen, or an inert gas. The forced gas may be heated, and may have a temperature, for example, in the range of about 100°F to about 250°F. Alternatively, the forced gas may be substantially unheated and thus at ambient temperature. Alternatively, the forced gas may be cooled, and thus at a temperature below ambient temperature. In this regard, the cooled forced gas may freeze the cannabinoids on the surface of the substrate, or slow the evaporation of the solvent so that the cannabis-containing solution penetrates further into the thickness of the substrate 23. Alternatively, the post-treatment station 40 may expose the loaded substrate to ambient air or a controlled environment to dry the volume of liquid 25. It is recognized that the desiccant applied to the API may increase the viscosity of the API. The post-treatment station can further adhere the API to the substrate 23. For example, by increasing the viscosity, the API can be further adhered to the substrate 23. Additionally, applying forced air to the substrate 23 can disperse the API along the substrate as it moves along the outer surface of the substrate 23, thereby facilitating absorption of the API into the substrate 23. For example, it is recognized that the API can be saturated in the portion of the substrate 23 that is beneath the delivered microdroplets. Then, by moving the API along the outer surface of the substrate 23, the API can be absorbed into the substrate 23 at locations of the substrate 23 that are not saturated with the API. The post-treatment station 40 can further solidify the API on or within the substrate 23. In some examples, the API can crystallize on or within the substrate 23. Alternatively, the API can remain as an oil on or within the substrate 23. If the at least one cannabinoid is applied as a powder, the post-treatment step can apply heat to the powder, thereby liquefying the at least one cannabinoid on the substrate 23.The liquefied powder may then be cooled, causing the liquid to solidify, crystallize, or otherwise be deposited on or within the substrate 23.

[0080] It is understood that energy can be applied to the substrate 23 to improve diffusion or absorption of the API into the substrate 23. For example, when heat is applied to the surface of certain substrates 23, particularly certain edible products, such as chocolates, baked goods, gummies, lollipops, etc., the temperature of the surface of the edible product increases to a level at which the edible product melts, moistens, or otherwise assumes a form configured to encapsulate the API. The temperature can be increased, for example, by directing at least one of heated forced air and light at the surface.

[0081] Once the substrate 23 has been post-processed, the active-containing edible product 24 may be transferred from the post-processing station 40 to a packaging station 42. At the packaging station 42, the dry edible products 24 may be individually packaged in any suitable package 73. Alternatively or additionally, multiple active-containing edible products 24 may be packaged in a common package. The active-containing edible product 24 may include a cooked edible product and a dose of an active pharmaceutical ingredient carried by the cooked edible product within an application zone of the cooked edible product. The dose of the active pharmaceutical ingredient may be substantially uniformly distributed in the application zone. Because the edible product is fully cooked prior to the addition of the active pharmaceutical ingredient, there is no need to cook the active pharmaceutical ingredient after the active pharmaceutical ingredient is added.

[0082] In some examples, the edible product 24 can be configured as a plurality of nuts 37 (FIG. 4A) and / or fruits 39 (FIG. 4B), and / or a mixture of dried fruits and nuts, and possibly other additional food products. It is understood that the API is not visible in FIGS. 5A-5E due to the nature of the figures. The active pharmaceutical ingredient can be applied to the nuts and fruits in any suitable manner as disclosed herein. In some examples, the nuts are cooked, e.g., roasted. In other examples, the nuts may be raw. In some cases, the nuts or fruits can be prepared with salt, sugar, honey, or any suitable alternative ingredients. This can sweeten the nuts. In some examples, the fruits can be raw fruits. In other examples, the fruits can be dried. In still other examples, the fruits can be sweetened. It is understood that the fruits and nuts can have a relatively low surface area and volume. Thus, variation in the dose of active pharmaceutical ingredient applied to the fruits and nuts can have a significant effect on the ratio of active pharmaceutical ingredient per volume of the edible product when compared to edible products having a larger surface area and volume.

[0083] Thus, it may be particularly advantageous to precisely control the dose of active pharmaceutical ingredient applied to the fruits and nuts. The active pharmaceutical ingredient may be applied to the fruits and nuts in a minute amount in the manner described above, thereby allowing precise control of the dose of active pharmaceutical ingredient applied to the fruits and nuts. It is recognized that microdroplets having respective volumes ranging from about 5 nanoliters to about 20 microliters may be delivered to individual fruits or nuts, depending on the size of the fruit or nut. Thus, each fruit or nut may contain an amount or dose of API ranging from about 2.5 micrograms to about 20 milligrams. Thus, each microdroplet may contain a minute amount of API ranging from about 0.5 micrograms to about 1 milligram. Of course, it is recognized that the dose of API per dried fruit or nut may vary as desired. For example, other amounts of microdroplets may be delivered to the fruits and nuts, depending, for example, on the size of the fruit and nut, the size of the microdroplets, and the concentration of the API in the microdroplets. The minute amount of API in the microdroplets allows the dose of API delivered to the substrate to be precisely controlled as described above. Additionally, the dosage of API per dried fruit or nut can be precisely controlled, even for multiple servings of dried fruit and / or nuts. For larger edible products such as baked foods41 (see Figure 5C), microdroplets can be applied in the range of about 5 nanoliters to about 20 microliters across the entire surface, greatly increasing the total API delivered to the substrate up to 100 milligrams or more.

[0084] It should be appreciated that several advantages can be achieved using the system 20. In one embodiment, the substrate 23 can include multiple active pharmaceutical ingredients, thereby eliminating the traditional need to consume multiple medications, each having a single active pharmaceutical ingredient. Additionally, minute amounts of active pharmaceutical ingredients can be applied to the substrate. Thus, the dose of at least one active pharmaceutical ingredient carried by the substrate can be better controlled relative to traditional application processes. Additionally, the at least one active pharmaceutical ingredient can be substantially uniformly distributed along the addition zone. Additionally, individual addition of active pharmaceutical ingredients on the substrate can allow for the use of locally manufactured active pharmaceutical ingredients that are applied after the substrate is prepared, thereby avoiding the need to transport the applied active pharmaceutical ingredients across jurisdictional lines, which may be illegal or subject to additional taxes in some jurisdictions. Additionally, adding to the substrate after the substrate has crossed jurisdictional lines can reduce or eliminate degradation of the active pharmaceutical ingredients during transport across jurisdictional lines, which may sometimes include long distance transportation. In some embodiments, a dye can be used with the active pharmaceutical ingredient, if desired, to verify that the active pharmaceutical ingredient has been delivered to the substrate.

[0085] 6A-6B, it is recognized that in some embodiments, the system 20 described above can be configured as a single integrated, separate dosing machine 72. The dosing machine 74 can include the conveyor 38, the holding tank 26, the delivery station 28, the dosing station 36, the post-processing station 40, and the packaging station 42. The dosing machine 74 can further include a support structure 76 that supports the conveyor 38, the holding tank 26, the delivery station 28, the dosing station 36, the post-processing station 40, and the packaging station 42. Thus, the conveyor 38, the holding tank 26, the delivery station 28, the dosing station 36, the post-processing station 40, and the packaging station 42 can be said to be integrated into a single, separate dosing machine and supported by the common support structure 76. The dosing machine 72 can further include a camera that measures the maximum cross-sectional dimension of the microdroplets in the manner described above. Additionally, the system 20 and the dosing machine 74 can include a washer configured to remove loose particulates from the substrate 23 prior to delivery of the API to the substrate 23. For example, in the case of salted nuts, the loose salt can be removed from the nuts while the salt that has a strong adhesion to the nuts remains. In one embodiment, the washer can be configured to deliver forced air to the substrate to remove loose debris from the substrate. Thus, when the API is delivered to the substrate, the API can have a strong adhesion to the substrate 23. In some embodiments, the forced air can be heated to increase the temperature of the substrate to improve the absorption or diffusion of the API into the substrate in the manner described herein.

[0086] The delivery station 28 may include a hopper 76 or other storage member that houses one or more of the substrates 23. The delivery station 28 may further include a delivery member 78 configured to receive the substrates from the hopper 76 and deliver the substrates 23 from the hopper 76 to the addition station 36. For example, the delivery member 78 may transport the substrates 23 from the hopper 76 to the addition station 36 and further to a third location aligned with the delivery location where the added substrate is delivered to the conveyor 38. The delivery member 78 may include and define any suitable material that may have at least one elongated groove 80 or other suitable structure that directs the substrates 23 along a respective path 81 from the hopper 76 to the addition station 36. For example, the delivery member 78 may include a plurality of grooves 80 that define a plurality of paths 81 from the hopper 76 to the respective addition stations 36. Alternatively, the plurality of delivery members 78 may define respective grooves 80 that extend along respective paths from the hopper 76 to the respective addition stations 36.

[0087] In one embodiment, the delivery member 78 can be tilted downward along a direction from a first location aligned with the hopper 76 to a second location aligned with the addition station 36 to a third location aligned with the delivery location where the added substrate is delivered to the conveyor 38. Additionally, the delivery member 78 can be configured to vibrate, rock, or otherwise move the substrate 23 along the delivery member 78 from the first location to the second location and from the second location to the third location. Alternatively, the delivery member 78 can be configured as a conveyor to move the substrate 23 from the first location to the second location and from the second location to the third location. Alternatively, as described above, a user can manually move the substrate 23 along the delivery member 78 or otherwise move the substrate 23 to a position aligned with the addition station 36.

[0088] In operation, the substrates 23 are loaded into the hopper 76. The substrates 23 are then delivered from the hopper 76 to a first location on the delivery member 78. This delivery can be under gravity or any suitable alternative structure and method. In particular, the substrates 23 can be delivered to the delivery member 78 to be arranged along the respective paths 81. The substrates 23 can be individualized and arranged as a single file on the respective delivery member 78, and thus along the respective paths 81. Alternatively, a group of substrates 23 may be arranged on one or more of the delivery members 78. The substrates 23 moving along the respective paths 81 can define the same type of substrate, such as fruits or nuts, or baked foods, etc. Alternatively, substrates 23 of different types can move along the respective paths 81. For example, the substrates 23 moving along one path can include dried fruits. The substrates 23 moving along another path or the same path can include raw or roasted nuts. The substrates 23 moving along yet another path can include baked foods.

[0089] The substrate 23 moves along the delivery member 78 to a second location whereby the substrate 23 is aligned with at least one respective dosing station 36. The dosing machine 72 can include a plurality of dosing stations 36 whereby each of the dosing stations 36 is aligned with each of the delivery members 78. As described above, each of the delivery members 78 extends along a respective path 81. Thus, each of the dosing stations 36 is aligned with one of the respective paths 81 and configured to deliver the API to the substrate 23 moving along the respective path 81. In one embodiment, the substrate 23 can be positioned on the delivery member 78 such that one or more dosing heads 46 of the dosing stations 36 aligned with the respective paths are configured to deliver the API to only one substrate 23 at a time as the substrate 23 moves along the respective path 81. Specifically, the dosing heads 46 can be configured to deliver microdroplets to each individual substrate 23 in a manner described herein. Because the API is delivered in microdroplets, a precise, predetermined dose of the API is delivered to each of the substrates 23.

[0090] In one embodiment, the same API-containing liquid can be delivered to the multiple substrates 23. Alternatively, API-containing liquids having different API properties can be delivered to the different substrates 23. The different substrates 23 can define respective substrates. The substrates can move along different respective paths 81 to different dosing stations 36 operatively aligned with the respective paths 81. The dosing stations 36 can deliver respective APIs to the aligned substrates 23, either individually or as groups of substrates 23, each API having at least one API property different from the other APIs. Alternatively, the substrates 23 can move along the same path 81 to the same dosing station 36. Alternatively, the substrates 23 can move along different paths 81 to the same dosing station 36. The same dosing station can deliver a first API-containing liquid to the first at least one substrate 23, e.g., the first substrates 23. The same dosing station can deliver a second API-containing liquid to the second at least one substrate 23, e.g., the second substrates 23. The first and second APIs can have at least one API characteristic that differs from each other. The different API characteristics can include at least one of: 1) the concentration of the API; 2) the volume of the API delivered to the substrate during the delivery step, which can include at least one of different numbers of microdroplets and microdroplets having different volumes; 3) the composition of the API; 4) a modifier mixed with the API, configured to modify at least one of the flavor, mechanical properties, and aesthetics of the delivered API; and 5) the location of at least one dosing zone on the substrate 23 that defines the location on the substrate 23 where the API-containing liquid is to be deposited. The mechanical characteristics can include the viscosity of the API-containing liquid in some examples. The mechanical characteristics can further include the surface tension of the API-containing liquid delivered from the dosing station. It is further understood that the different API characteristics can include different predetermined doses delivered to the different substrates 23. In one example, the doses can be predetermined to correspond to a dosing regimen over a period of time.Thus, one or more groups of substrates can have doses that are different and designed to be consumed at predetermined times during the dosing regimen. For example, the doses can decrease over a period of time defined by the dosing regimen. Alternatively, each substrate 23 can receive an API-containing liquid 25 having the same API characteristic. Additionally, substrates in different groups can receive an API-containing liquid 25 having at least one different API characteristic, with all substrates within each group receiving the same API-containing liquid 25.

[0091] Alternatively, it is envisioned that a predetermined amount of substrate 23, or a plurality of substrates 23, such as dried fruits and / or nuts, can be grouped together on the delivery member 78 along respective paths 81. Thus, the dosing station 36 can be aligned with a group of substrates 23. Thus, the dosing head 46 can deliver a predetermined or targeted amount of API-containing microdroplets to the group as a whole, as opposed to each individual dried fruit or nut. Because the API is delivered in microdroplets, a precise, predetermined dose of API is delivered to the group of substrates 23. The group of substrates 23 can be intended to be consumed in a single serving. Thus, when the substrates 23 of the group are consumed, a precise, predetermined dose is consumed. It is recognized that the predetermined amount of substrates 23 to be dosed in a group is not limited to fruits and nuts, but to any type of edible product 24 designed to be consumed in large quantities, such as chips, popcorn, pretzels, candies such as gummies 45 (FIG. 4D), and the like. It should be understood, therefore, that the addition station can be configured to deliver the API to at least one substrate 23 at a time, which can include a single substrate 23 or a group of substrates 23.

[0092] Each dosing station 36 may include at least one dosing head 46, such as an array of dosing heads 46, and one or more holding tanks 26 capable of housing a respective API-containing liquid 25 as described above. It is recognized that the multiple dosing stations 36 may receive the API-containing liquid 25 from a common one of the holding tanks. Alternatively, the dosing stations 36 may receive the API-containing liquid 25 from different holding tanks 26. The API-containing liquids 25 in the different holding tanks 26 may have different APIs from each other or may have the same API. Thus, the API may be a cannabinoid or any suitable alternative active pharmaceutical ingredient. Each of the at least one dosing heads 46 of the dosing stations 36 may be operatively aligned with each of the pathways 81 to deliver an active pharmaceutical ingredient to the at least one substrate 23 moving along each of the pathways 81. Thus, as the at least one substrate 23 moves along the respective pathway to a second location, the dosing station 36 delivers a predetermined amount of the API-containing liquid 25 from the at least one dosing head 46 to the respective aligned at least one substrate 23. The addition head 46 ceases delivery of the API-containing liquid 25 when the at least one substrate 23 has received a predetermined amount of liquid 25. The addition heads 46 of the array of addition heads 46 can be combined to deliver a predetermined amount of liquid 25 to respective different locations of the at least one substrate 23. That is, the locations of the at least one substrate 23 can be aligned with various addition heads 46 of the array of addition heads 46 that are aligned with respective pathways 81.

[0093] After each at least one substrate 23 has received a predetermined amount of liquid 25, the substrate 23 moves along the delivery member 78 past the second location. The dosing station 36 resumes delivery of liquid 25 when another at least one substrate 23 moves to the second location into a position aligned with the at least one dosing head 46. In this regard, each at least one substrate 23 disposed sequentially along the respective path 81 receives a predetermined amount of liquid 25 from the aligned one of the dosing stations 36. The predetermined amounts can be equal to each other or different from each other as desired, depending on the at least one substrate 23 and the desired dose of active pharmaceutical ingredient to be delivered to the at least one substrate 23. The dosing machine 72 can include a processor programmed with a dose to be applied to the substrate 23 moving along the at least one delivery member 78. The processor can control the operation of the delivery member 78 and each of the stations of the dosing machine 72 described above. For example, the addition station 36 may include any suitable instrument or sensor, as described above, to identify when one of the substrates 23 has moved into alignment with the addition head 46 and when a substrate 23 requiring delivery of liquid 25 is not aligned with the addition head 46 and communicate the alignment information to the processor. The processor then controls the operation of the addition head 48.

[0094] Once the substrates 23 are loaded with the active pharmaceutical ingredient-containing liquid 25, the substrates 23 move along the delivery member 78 to a third location where they are delivered to the conveyor 38. In this regard, the delivery member 78 can be disposed in a spatial relationship with respect to the conveyor, and the substrates 23 can move from the delivery member 78 to the conveyor 38. In one embodiment, the delivery member 78 is supported by a delivery support member 82 of the adder 72. Thus, the support structure 76 can include a base 77 that supports the conveyor 38 and the packaging station 42, and a delivery support member 82 that supports the delivery member 78, in addition to the addition station 36, at least one holding tank 26, at least one hopper 76, and the post-processing station 40. The substrates 23 can be dried as they move from the second location to the third location. Thus, the adder 72 can include a post-processing station 40 between the second and third locations. The post-processing station can be configured as described above. Thus, the API can attach to the substrate 23 once the substrate 23 has been treated during the processing step.

[0095] The delivery support member 82 can support the delivery member 78 at a location above the conveyor 38, and the loaded substrate 23 can move downward from the support structure 78 towards the conveyor 38. In one embodiment, the loaded substrate 23 can move under gravity from the support structure 78 towards the conveyor 38. For example, the delivery member 78 can transport the substrate 23 to a third location defined by an opening 83 in the delivery support member 82. The substrate 23 can then move through the opening 83 towards the conveyor 38. Alternatively, the third location can be configured as a conveyor or other suitable transport member configured to transport the substrate 23 towards the conveyor. The third location can be configured as a single opening or conveyor that receives loaded substrate 23 from all or multiple pathways 81. Alternatively, each pathway 81 can have its own dedicated third location.

[0096] The adder 72 may include a packaging station 42 that delivers a plurality of packages 86 to the conveyor 38. In one embodiment, the packages 86 are placed on the conveyor 38 upstream of the third location. The adder 72 may include a reservoir that contains a plurality of packages and may deliver the packages sequentially onto the conveyor 38. Alternatively, a separate machine may deliver the packages to the conveyor 38. The conveyor 38 moves the packages 86 to a position aligned with each of the third locations. This causes at least one of the substrates 23 moving from the delivery member 78 toward the conveyor 38 to be delivered into each package 86. In some embodiments, it is contemplated that a single added substrate, such as a baked food, is delivered into each package 86. In other embodiments, it is contemplated that multiple added substrates, such as dried fruits and / or nuts, are delivered into each package 82. For example, the multiple substrates 23 may be delivered from multiple paths 81 up to all paths 81 into a single respective container 82. Alternatively, one or more conveyors 38 can deliver packages to respective locations such that packages 82 receive their respective at least one substrate 23 from each of the multiple paths 81 via a dedicated third location. Thus, packages 86 can receive their respective at least one substrate 23 simultaneously.

[0097] The packaging station 42 may further include a sealing station 88 configured to enclose the packages 86 after they receive their respective at least one substrate 23. In particular, the conveyor 38 delivers the packages 86 to the sealing station 88 after they receive their respective at least one substrate 23. The sealing station seals the packages 86 and may attach the packages 86 to themselves, for example, if the packages 86 are plastic bags or alternatively configured plastic packages. Alternatively, the sealing station 88 may deliver and fasten a cap onto the packages 86, for example, if the packages are configured as jars or other appropriately configured packages. The sealed packages may then be delivered to customers.

[0098] Referring again to FIG. 1, as described above, the API can be delivered to the food product at any appropriate stage during the batch food production process, which reduces the chance of dose inconsistencies that are common using conventional dosing techniques, thus producing a more consistent API dosage in the resulting individualized food product. The inventors have identified many opportunities for error in conventional API dosing during the method 100 for batch production of prepared food products, which results in inconsistent API dosing in the final food product. To begin with, it is recognized that the batch mixing step 102 may include a step 102a of mixing dry ingredients of the batch food product and a step 102b of mixing liquid ingredients of the batch food product, combining the dry mixed ingredients and the liquid mixed ingredients in step 102. It is recognized that steps 102a and 102b are performed separately as shown, but may instead be alternatively combined into a single mixing step, as desired.

[0099] As shown in FIG. 1, the mixing step 102 can include mixing together 102a only ingredients that are in dry form. For a successful product batch, a precise amount (by volume or weight) of each dry ingredient (including the API if present in the dry ingredient) that is mixed is usually desired. Deviations from the specified volume or weight of each dry ingredient will cause an error in the resulting food product. The sum of these individual errors constitutes a complete deviation of the dry ingredient volume or weight from the specified amount. This error affects the final API concentration of the product batch. In particular, this can shift the API concentration of the entire batch higher or lower relative to the desired concentration.

[0100] The mixing step 102 in FIG. 1 may further include a step 102b of mixing together only ingredients that are liquids. For a successful product batch, a precise amount (volume or weight) of each liquid ingredient (including API if present in the liquid ingredient) to be mixed is usually desired, and deviations from the specified volume or weight of each liquid ingredient may cause errors in the resulting food product. The sum of these individual errors constitutes a complete deviation of the liquid ingredient volume or weight from the specified amount. This error affects the final API concentration of this product batch. In particular, this may shift the API concentration of the entire batch higher or lower relative to the desired concentration.

[0101] The inventors recognize that errors in the volume of API in either the dry or liquid mix or both can also linearly affect the resulting API concentration of the resulting food product by appearing in the numerator of the concentration calculation: API concentration = API amount (by weight or volume) / total amount (by weight or volume) of all ingredients in each mix. Because there may be several ingredients in the batch formula, some high deviations may offset other low deviations, thereby reducing the deviation in the resulting denominator. However, deviations in the amount of API are not offset by other ingredients, since they are the only amount in the numerator of the API concentration calculation. Thus, errors in the amount of API directly contribute to the resulting error in the API concentration of the batch product and therefore the resulting food product.

[0102] It is therefore recognized that potential sources of error in the concentration of the API in the food product may result from deviations in the amount of each component mixed. Yet another source of error may result from incomplete mixing of any one to all of: (a) incomplete mixing of all dry components in step 102a, (b) incomplete mixing of all liquid components in step 102b, and (c) incomplete mixing of the dry and liquid component mixtures. If steps 102a and 102b are combined into a single step, the source or error may result from incomplete mixing of the combination of dry and liquid components. Incomplete mixing may have a direct effect on the concentration of the API in the individual food products produced from the mixture, because consistency of the amount of API across the various individual portions of the product provides the consumer with a consistent dose of API in the resulting individual spiked food products. If the API is incompletely combined with the other components of the mixture, the concentration of the API in the resulting individual food products may vary significantly, thereby providing the consumer with a dosage of API that is too high or too low.

[0103] The above-identified errors during the mixing step can result in deviations in API dosage per portion of the resulting food product prior to the cooking step 103. However, there are additional opportunities for errors in the consistency of the API in the resulting food product. For example, non-uniformity in the dry ingredient mix can cause nodules (also called "rocks") of concentrated solid ingredients when mixed with liquid, which persist through the final overall mixing step and absorb above or below average API.

[0104] Additionally, non-uniformity can result from insufficient mixing time in any one or all of the above mentioned mixing steps. Mixing can be considered part art and part technique since feedback regarding the degree of mixing completion is often not readily available. Thus, the decision of when to terminate a mixing step can be difficult to pinpoint, and unless mixing is extensive, non-uniformity will remain, especially in parts of the mixed volume that experience corner or other shape effects or lack of uniform folding action. These issues can directly impact the final concentration of the API in the resulting personalized food product.

[0105] Once the mixing step is complete, a step 103 of cooking the batch food mixture is then performed, the food defining a cooked batch food. The cooking step 103 can bring the batch food to a temperature of at least about 150°F, such as about 200°F, such as about 150°F to about 500°F or higher, including a range of about 250°F to about 350°F. However, temperature variations throughout the food can result in varying degrees of decarboxylation of the API. Additionally, in some cases, the temperature and time required to cook the food in step 103 can cause the active ingredient of the API to degrade.

[0106] Continuing to refer to FIG. 1, step 103 represents a high temperature cooking process (boiling, baking, etc.). In this step, the components of the batch mixture respond to a significant temperature increase by undergoing an amount of evaporation. Different components undergo different amounts of evaporation, and the same is true for the components of the API, such as CBD, THC, terpenes, and flavonoids. Thus, the ratio of these API components (known as the "profile" of the API) changes during high temperature cooking. This change in profile and the reduction in the overall amount of API are the two main effects of high temperature processing on the potency of the final edible product. Furthermore, this individual variation in potency reduction arises from temperature non-uniformity throughout the volume of the batch during cooking. Thus, the overall reduction in API, the modification of the profile, and the spatial temperature non-uniformity can all be expected to exacerbate (a) the inaccuracy of the average API content of the cooked batch (deviation from the target dosage), and (b) the inconsistency or variation in the API dosage per portion experienced by the consumer.

[0107] The food product is cooled in step 104, and the cooked batch food product defines the cooled food product. The cooling step 104 can reduce the temperature of the cooked batch food product by at least 10% of the temperature of the cooked food product, for example, by at least 20% of the temperature of the cooked food product, including at least 30% of the temperature of the cooked food product. However, there can be inconsistencies in the temperature of the cooled food product over time. Because cooling can cause the food product to shrink, certain areas of the food product can have a higher concentration of API than other areas when the food product is apportioned to individual molds or otherwise individualized in the apportionment step 106, which can be another source of error in the amount of API present in the resulting individualized food product. It is understood that in some embodiments, the apportionment step 106 can be performed before any cooling sequence. Thus, step 104 can be performed after step 106.

[0108] Once the food product is packaged, it may be shipped as desired. As mentioned above, the personalized food product may be further cooled in step 107 before packaging. The further cooling step 107 may further reduce the temperature of the food product by at least 10% of the temperature of the cooled food product, for example, by at least 20% of the temperature of the cooled food product, including at least 30% of the temperature of the cooled food product. It is recognized that the food product may also be passively cooled by exposure to ambient temperature during the apportionment step 106. Thus, the temperature reduction described above with respect to the further cooling step 107 may also be applied to the temperature of the food product after the apportionment step 106. However, as described above with respect to the cooling step 104, the further cooling step 107 may cause further variation in temperature throughout the food product. As a result, if the resulting food product is larger than a bite-sized edible product, the food product will suffer from variation in API concentration. In particular, a first region of the personalized food product may have a substantially different API concentration than a second region of the personalized food product. Of course, it will be appreciated that in some embodiments, if the initial cooling step 104 alone sufficiently cools the food product, the further cooling step 107 may be omitted. While Figure 1 shows one example of a conventional food preparation process, it will be appreciated that numerous other processes exist depending on the added food product being prepared. However, because the food product is added prior to the cooking step 103, the resulting food product may be subject to inaccuracies and inconsistencies in addition as discussed above.

[0109] 7-9, it will be appreciated that by performing step 110 of adding the API to the food product at a distinct step during method 100' for batch production of cooked food products, as compared to conventional addition techniques, at least one or more, and even all of the above-mentioned potential causes of API addition errors can be reduced or avoided entirely. Method 100' can include at least a portion of the food preparation steps of method 100. Thus, the cooking step 103, cooling step 104, portioning or individualizing step 106, final cooling step 107, and packaging step 108 of method 100' can be performed as described above with respect to method 100, except for the step of adding the API, unless otherwise indicated.

[0110] As shown in FIG. 7, the method 100' may include at least a mixing step 102, a cooking step 103, a cooling step 104, and a packaging step 108. As mentioned above, a step 102 of creating a batch food mixture provided in step 101 may include dry ingredients, e.g., mixed in step 102a, and wet ingredients, e.g., mixed in step 102b. It is understood that step 102 may alternatively include a solely wet mixture without dry ingredients, or alternatively include a solely dry mixture without wet ingredients. Thus, it should be understood that in step 102, the batch food mixture may be provided by mixing the batch food ingredients. In other examples, the batch food may be delivered premixed for use in a subsequent method step. In step 103, the mixture is cooked (such as by baking, broiling, boiling, steaming, frying, baking, or using any suitable alternative cooking method) to produce a food product that may define a cooked food product. As discussed above, the cooking step 103 of the method 100' may raise the temperature of the batch of food product to at least about 200°F, for example, from about 200°F to about 500°F or more, including in the range of about 250°F to about 350°F.

[0111] In step 104, the food product may be cooled, defining the food product as cooled. As discussed above, the cooling step 104 of method 100' may reduce the temperature of the cooked batch food product by at least 10% of the temperature of the cooked food product, for example, at least 20% of the temperature of the cooked food product, including at least 30% of the temperature of the cooked food product. Eventually, the cooling step 104 or a combination of cooling step 104 and one or more other cooling steps may allow the temperature of the food product to reach approximately room temperature. The cooling step 104 or any cooling step described herein may be an active cooling step, in which the temperature of the food product is reduced by actively exposing the food product to a cooling element, such as cooling air, having a temperature below room temperature. Alternatively, the cooling step cooling step 104 or any cooling step described herein may be a passive cooling step, in which the temperature of the food product is reduced by exposing the food product to an ambient temperature, which in some examples may be room temperature. Finally, in step 108, the food product may be packaged and shipped.

[0112] As shown in FIG. 7, the method 100′ can include an addition step 110 that includes delivering the API to the food product after the cooking step 103. For example, the addition step 110 can be performed after the cooking step 103 and before the optional cooling step 104. Alternatively, the addition step 110 can be applied after the cooking step 103 and after the cooling step 104. Thus, the API can be added to the entire batch of food product. Because the API is delivered to the food product after the mixing step 102, the API is not subject to variability throughout the mixture due to imperfections during the mixing process, as is the case with the conventional method 100 of FIG. 1. Furthermore, because the API can also be delivered to the food product in one embodiment after the cooking step 103, the API is not subject to degradation during the cooking step 103, as is the case with the conventional method 100 of FIG. 1. It should be understood that in all of the embodiments of FIG. 7-FIG. 11 described herein, the API delivered to the food product in step 110 can be disposed in the resulting final cooled food product, unless otherwise indicated.

[0113] It is further recognized that if an API, such as a cannabinoid, is not decarboxylated and thus is in an acidic form, it will remain in the acidic form when added after the cooking step 103. In contrast, in the conventional method 100, the API component that is not initially decarboxylated may be decarboxylated during the cooking step 103. Thus, in the method 100', the API may be added in its acidic form (i.e., not decarboxylated) and may remain in the acidic form if desired. Without being bound by theory, it is believed that the acidic form of the API may have certain medical benefits if added, maintained, and consumed in its acidic form. Of course, it is understood that the added API may be provided in its decarboxylated (e.g., non-acidic or neutral) form if desired and then delivered to the food product in its decarboxylated form. It is understood that in some examples, the API may be partially decarboxylated when delivered to the food product. However, in these examples, the API is not fully decarboxylated. Thus, the API is more acidic than an API that is fully decarboxylated using the conventional batch addition method.

[0114] Alternatively or additionally, the API may be delivered to the food in the addition step 110 after cooking step 103 and after some cooling of the food (or no cooling depending on the cooking temperature) such that the temperature of the food does not completely decarboxylate the API during the addition step 110. Thus, the API may be at least partially non-decarboxylated. As mentioned above, the API may be a cannabinoid in one embodiment. During the method, the API may be added to be up to about 80% decarboxylated, and therefore at least about 20% may be non-decarboxylated. For example, the API may be up to about 70% decarboxylated, and therefore at least about 30% may be non-decarboxylated. For example, the API may be up to about 60% decarboxylated, and therefore at least about 40% may be non-decarboxylated. For example, the API may be up to about 50% decarboxylated, and therefore at least about 50% may be non-decarboxylated. For example, the API may be up to about 40% decarboxylated, and therefore at least about 60% may be non-decarboxylated. For example, the API may be up to about 30% decarboxylated, and therefore at least about 70% non-carboxylated. For example, the API may be up to about 20% decarboxylated, and therefore at least about 80% non-carboxylated. For example, the API may be up to about 10% decarboxylated, and therefore at least about 90% non-carboxylated. In yet other examples, the API may remain completely non-carboxylated. Once the API is delivered to the food product in the addition step 110, the food product may have sufficient viscosity to be deliverable to an individual mold, as discussed in more detail below.

[0115] In some embodiments, the API may be delivered to the food product in the addition step 110 after cooking step 103 and after some cooling of the food product (or no cooling by the cooking temperature) such that the temperature of the food product does not completely evaporate the API. If necessary, the amount of API to add to the food product may be determined in part based on the amount of API that evaporates due to the temperature of the food product during the addition step 110. In one embodiment, up to about 80% by weight of the API may be evaporated. For example, up to about 70% by weight of the API may be evaporated. For example, up to about 60% by weight of the API may be evaporated. For example, up to about 50% by weight of the API may be evaporated. For example, up to about 40% by weight of the API may be evaporated. For example, up to about 30% by weight of the API may be evaporated. For example, up to about 20% by weight of the API may be evaporated. For example, up to about 10% by weight of the API may be evaporated. In yet other embodiments, the API may not evaporate at all. As discussed above, once the API is delivered to the food product in the addition step 110, the food product may have sufficient viscosity to be deliverable to individual molds, as discussed in more detail below.

[0116] As will now be described with respect to FIG. 8, the method 100′ can include a step of delivering an API to the individualized food products. In particular, the batch food products can be apportioned to the individualized food products. Thus, after the individualization step, the food products can be said to define the individualized food products. The API can then be delivered to the individualized food products according to any suitable delivery method described herein, including delivery of microdroplets. In one embodiment, the individualization step can be performed in step 106, whereby the food products are apportioned to individual molds and the cooled food products are apportioned to the individualized food products. For example, the adding step 110 can be performed after the cooled food products are delivered to the respective molds in step 106. As a result, the substrate that is added in the above-described method can be configured as one or more individualized food products produced in step 106. Thus, the adding step 110 can be performed before the steps of removing the individualized food products from the respective molds in step 108 and packaging the individualized food products.

[0117] The dosing step 110 may include one or more to all of: 1) delivering an API such as a cannabinoid to the mould prior to the step of delivering the food to the respective mould, such that the cooled food contacts the delivered cannabinoid in the respective mould during the step of delivering the food to the respective mould, 2) delivering the cannabinoid directly to the individualised food whilst it is being placed in the respective mould, and 3) delivering the cannabinoid directly to the cooled food whilst the food is being delivered to the respective mould. In one example, delivering the cannabinoid and food to the respective moulds may include adding alternating layers of edible food and cannabinoid such that the cannabinoid is disposed between adjacent layers of the food.

[0118] The food products can be considered individualized food products once they are delivered to the respective molds. In some examples, such as when the food products are configured as gummies, the cooled food products can be viscous and flowable and can be driven to flow into the respective molds. The individualized food products can define cooled individualized food products when they are delivered to the molds after the cooling step 104. It is recognized that in some examples, cooked food products can be delivered to the molds at step 106 after the cooking step 103 and before the cooling step 104, if desired. Thus, the step 110 of adding to the individualized food products allocated to the molds can be performed after the cooking step 103 and before the cooling step 104. Thus, the individualized food products can define cooked individualized food products after the cooking step 103 and before the cooling step 104.

[0119] It will be appreciated that the API may therefore be delivered to the individualized food products after they have been cooked in step 103 in the manner described above with respect to Figures 7-8. In one embodiment, the API may be delivered to the individualized cooked food products in their respective molds. In another embodiment, the cooked food products may be non-viscous, for example if the food products are configured as baked foods, and the individualized food products may be physically divided or apportioned from the remainder of the cooked food product, for example during a cutting operation. Thus, the API may be delivered to the batch food product after the cooking step (and before or after the cooling step 104) and before the food products are divided or apportioned into the individualized food products. Alternatively, the API may be delivered to the batch food product after the cooking step (and before or after the cooling step 104) and after the food products are divided or apportioned into the individualized food products.

[0120] Alternatively, referring now to FIG. 9A, it will be appreciated that the method 100' can achieve certain advantages with respect to the conventional method 100 of FIG. 1 if the food product is individualized prior to the cooking step 103. In particular, by adding to the individualized food product prior to the cooking step 103, the individualized food product is less subject to variability due to potentially imperfect mixing than would be the case with a batch mixture. Moreover, regardless of whether the individualized food product is incompletely mixed at step 102 of FIG. 9A, the API can still be accurately delivered to the food product as microdroplets. Thus, imperfect mixing has minimal or no effect on the dosage of the API delivered to the individualized food product. The API can be delivered to the individualized food product either before or after the cooking step 103, as described above.

[0121] Thus, in one embodiment shown in FIG. 9A, the food product may be individualized in step 101, which provides the ingredients of the food product to be prepared. In particular, these ingredients may be apportioned into individual molds before being mixed in step 102 to produce an individualized food mixture. An API may be delivered in step 110 to each of the individualized food mixtures as described above to define an individualized food mixture containing or spiked with the API. In some embodiments, an API, such as a cannabinoid, may be delivered to the mold prior to the step of delivering the food ingredients to the respective molds. Alternatively, the food ingredients may be delivered to the molds and the API may then be delivered to the individualized food components while the individualized food mixture is being placed in the respective molds. Alternatively, the API may be delivered to the molds while the food ingredients are being delivered to the molds.

[0122] In another embodiment shown in FIG. 9A, after the completion of step 102 of mixing the food products, the food products can be individualized. In particular, ingredients can be provided in step 101 and mixed as a batch in step 102. The mixed batch food products prepared in step 102 can then be individualized to produce individualized food mixtures. The API can be delivered to each of the individualized food mixtures as described above (again as step 110 in FIG. 9A) to define individualized food mixtures to which the food products have been added. In some embodiments, the API, such as a cannabinoid, can be delivered to the mold prior to the step of delivering the food mixtures to the respective molds. Alternatively, the food mixtures can be delivered to the molds and the API can then be delivered to the individualized food mixtures while the individualized food mixtures are being placed in the respective molds. Alternatively, the API can be delivered to the mold while the food mixture is being delivered to the mold. For example, the API can be delivered to the mold between successive layers of the mixture that are added to the mold. Thus, the API can be placed between successive layers of the mixture.

[0123] 9B, each mold 109 can define a base 111 and at least one sidewall 113 supported by the base 111 to define an interior mold cavity 117 that receives the food mixture 119. Some of the molds 109 can share a common sidewall 113. The base 111 can define a closed lower end of the mold cavity 117, and the at least one sidewall 113 can define an open end 115 configured to receive the food product. The base 111 and the at least one sidewall 113 can define any suitable size and shape as desired. In some embodiments, the sidewall 113 can be rigid. In other embodiments, the sidewall 113 can be flexible to pulse, thereby further mixing the food mixture 119 with or without the API disposed in the mold cavity 117. Alternatively or additionally, the mold 109 may be disposed on a support surface 121 that may be configured to vibrate, thereby agitating and further mixing the food mixture 119 disposed within the mold cavity 117. Alternatively or additionally, an air flow 123 may be directed across an exposed surface of the food mixture 119 to stimulate agitation of the food mixture 119. Alternatively or additionally, energy 125 may be directed into the food mixture 119. The energy may be configured as propagating electromagnetic waves or illumination (infrared, ultrasonic, microwave) pulses.

[0124] The spiked individualized food mix can then be cooked at step 103, cooled at step 104, and packaged at step 108, if desired. It is further understood that the API can also be delivered to the food product after the cooking step, if desired, in the manner described herein. Alternatively, the individualized food mix can be cooked without the API added first, and then the API can be added after the cooking step 103 and / or cooling step 104, but before the packaging step 108, in the manner described above.

[0125] The step of delivering the API can be accomplished by delivering microdroplets of the API in the manner described above. Thus, the dosing step 110 may include one or more to all of: 1) delivering microdroplets of the API to the molds prior to the step of delivering the food to the respective molds, such that the food contacts the delivered cannabinoids in the respective molds during the step of delivering the food to the respective molds; 2) delivering microdroplets of the cannabinoid directly to the food as the food is delivered to the respective molds; and 3) delivering microdroplets of the cannabinoid directly to the individualized food while the individualized food is placed in the respective molds. The microdroplets may be delivered according to any of the embodiments described herein.

[0126] Thus, the dosing step 110 can include delivering at least one microdroplet of API-containing liquid from the dosing station to the individualized food product in the manner described above. Similarly, the dosing step can include aligning the individualized food product with a dosing head of the dosing station, and the step of delivering at least one microdroplet includes delivering at least one microdroplet from the dosing head to the individualized food product. In this regard, the dosing step can include delivering a respective API to different ones of the individualized food products, each API having at least one API characteristic that differs from each other. The different API characteristics include at least one of: 1) concentration of the API, 2) volume of API delivered to the individualized food product during the dosing step, 3) composition of the API, 4) modifier mixed with the API, the modifier configured to modify at least one of flavor, mechanical properties, and aesthetics of the delivered API, and 5) location of at least one dosing zone of the individualized food product. Alternatively or additionally, the step of delivering at least one microdroplet of API-containing liquid can include delivering different APIs to different subzones within the delivery zone of the personalized food product. Furthermore, the method 100' can include a step of post-treating the personalized food product after the addition. As described above, the post-treatment can do at least one of: 1) drying the solvent; 2) increasing the viscosity of the API; 3) further adhering the API to the personalized food product; 4) dispersing the API along the personalized food product; 5) increasing the absorption of the API into the personalized food product.

[0127] Referring now to FIG. 10, it is recognized that in some methods 100′, it may be desirable to divide the batch food into more manageable sub-batches having a quantity of food less than the quantity of the batch food but greater than the quantity of the individualized food. One or more of the sub-batches may then be doped with an API in step 110. The step 105 of dividing the cooked batch food to produce at least one sub-batch, such as a plurality of sub-batches, may be performed before the cooling step 104. Alternatively, the step of dividing the cooked batch food to produce at least one sub-batch, such as a plurality of sub-batches, may also be performed after the cooling step 104. The step 105 of producing the sub-batch may be performed before the dosing step 110. The step of dividing the cooked batch food to produce at least one sub-batch may include delivering the cooked product to at least one container to produce at least one sub-batch. For example, each sub-batch may be delivered to a different separate container. Alternatively, the multiple sub-batches may be delivered to a single container having separate compartments. It should be appreciated that the cooked batch food that is divided into sub-batches may also be configured as a cooled batch food that has been subjected to a cooling step 104 before being divided into sub-batches.

[0128] The sub-batches may be added in any manner as described above with respect to the individualized food products. Thus, in one embodiment, the adding step may include one or more up to all of: 1) delivering an API to the at least one container prior to the step of dividing the cooked food product into the respective at least one container to define the at least one sub-batch, such that the at least one sub-batch contacts the delivered API in the at least one container during the step of dividing the cooked batch food product to produce the at least one sub-batch; 2) delivering an API directly to the cooked food product during the step of dividing the cooked batch food product to produce the at least one sub-batch (i.e., when delivering the cooked food product to the respective at least one container); and 3) delivering an API directly to the at least one sub-batch after dividing the cooked batch food product into sub-batches (i.e., after delivering the cooked food product to the at least one container). In this regard, it is understood that the cooked food product may be considered a sub-batch once it is delivered to the respective mold. Because the sub-batches contain a larger amount of food than is intended in the personalized food product, after the sub-batches have had the API added, they can be apportioned into the personalized food products in any manner desired in an apportionment step 106. A final cooling step can be performed in step 107, if desired, as described above, and the personalized food products can be packaged in step 108. The final cooling step 107 can be performed before or after the apportionment step 106.

[0129] In another example, referring now to FIG. 11, it is understood that if the mixed food product is divided into mixed sub-batches prior to the cooking step 103 and the API is delivered to the mixed sub-batches, the method 100' can achieve certain advantages over the conventional method 100 of FIG. 1. In particular, by adding to the mixed sub-batches prior to the cooking step 103, the food product in the sub-batches is less subject to variability due to potentially imperfect mixing than would be the case with a batch mixture. Furthermore, even if the sub-batches are imperfectly mixed, the API can be delivered to the sub-batches as microdroplets. Thus, imperfect mixing has minimal or no effect on the dosage of the API delivered to the individualized food product. It is understood that the API can be delivered to the sub-batches either before or after the cooking step 103.

[0130] Thus, in one embodiment shown in FIG. 11, sub-batches may be provided after step 101 of providing ingredients of the food product to be prepared. In particular, these ingredients may be provided in batch amounts, combined and mixed in step 102. The mixed food product prepared in step 102 may then be divided into sub-batches in step 105. The API may then be delivered to each of the sub-batches as described above such that the mixed sub-batches define pre-dosed mixed sub-batches. The pre-dosed mixed sub-batches may then be cooked and cooled as desired. Alternatively, the mixed sub-batches may be cooked in step 103 to produce cooked sub-batches, and then the API may be delivered to the cooked sub-batches after the cooking step 103. For example, the API may be delivered to the cooked sub-batches after the optional cooling step 104 and before the packaging step. As described above, the sub-batches of food products may be apportioned to individualized food products in step 106. The individualized food products may optionally undergo a final cooling sequence 107, and the individualized food products may be packaged in step 108.

[0131] The step of delivering the API to the sub-batches can be accomplished by delivering micro-droplets of the API in the manner described above. Thus, the adding step 110 can include one or more up to all of: 1) delivering micro-droplets of the API to at least one container prior to the step of dividing the food into respective containers to define the sub-batches. Thus, the sub-batches contact and adhere to the delivered API in the at least one container during the step of dividing the cooked batch food to produce the at least one sub-batch; 2) delivering micro-droplets of the API directly to the food during the step of dividing the cooked batch food to produce the sub-batches (i.e., as the cooked food is delivered to each of the at least one container); and 3) delivering micro-droplets of the API directly to the at least one sub-batch after dividing the food into sub-batches (i.e., after the food is delivered to the at least one container). The micro-droplets can be delivered according to any embodiment described herein.

[0132] Thus, the dosing step 110 may include delivering at least one microdroplet of API-containing liquid from the dosing station to the sub-batch of food product in the manner described above. Similarly, the dosing step may include aligning the sub-batch to be added with the dosing head of the dosing station, and the delivering at least one microdroplet may include delivering at least one microdroplet from the dosing head to the sub-batch. In this regard, the dosing step may include delivering a respective API to different ones of the sub-batches, each API having at least one API characteristic that differs from the others. The different API characteristics include at least one of: 1) concentration of API, 2) volume of API delivered to the sub-batch during the dosing step, 3) composition of API, 4) modifier mixed with API, configured to modify at least one of flavor, mechanical properties, and aesthetics of the delivered API, and 5) location of at least one dosing zone of the sub-batch. Alternatively or additionally, the step of delivering at least one microdroplet of API-containing liquid can include delivering different APIs to different sub-zones of the delivery zone of the sub-batch. Furthermore, the method 100' can include a step of post-treating the dosing sub-batch after dosing. As described above, the post-treating can include at least one of: 1) drying the solvent; 2) increasing the viscosity of the API; 3) further adhering the API to the sub-batch; 4) dispersing the API along the sub-batch; and 5) increasing the absorption of the API into the sub-batch. In some examples, such as when the food product is configured as a gummy candy, the cooked food product can be viscous and can flow into the respective at least one container to produce the sub-batch. In other examples, such as when the food product is configured as a baked food, the cooked food product can be non-viscous and can be physically divided, such as cut from the remainder of the cooked food product, and delivered to the container.

[0133] It should further be appreciated that the sub-batches of food may be further individualized as desired, as described above with respect to step 106. Additionally, the individualized food may be doped with an API as desired, in the manner described above. Thus, if the food is divided into sub-batches, the food may be doped with an API as described above either or both: 1) when the food is divided into sub-batches, and 2) when the food is individualized. Thus, in one embodiment, a first portion of the desired dosage of the API may be delivered to the sub-batch, and a second portion of the desired dosage of the API may be delivered to the individualized food. Thus, by dividing the food into sub-batches, a two-stage API delivery system may be provided, in which a first amount of API is added, and then, in a post-apportionment step, a second amount of API is added. The second amount of API may be configured to be taken up sublingually immediately upon ingestion of the food. The first amount of API may enter the bloodstream upon digestion of the food. In some embodiments, the first amount of API may be greater than the second amount of API.

[0134] 9 and 11-12, an embodiment is provided that discloses a method of adding an API to a food product prior to the cooking step 103. Although a particular embodiment of a method of mixing an API with ingredients prior to the cooking step 103 is disclosed, it should be understood that the API can be mixed with the ingredients according to any suitable alternative embodiment as desired. For example, at least one mixing device 120 can be configured to mix the API with the ingredients. In one embodiment, the mixing device 120 can be configured as a mixing tube 122. The mixing device 120 can define an elongated body 124 that defines a mixing chamber 126, and at least one mixing element 128 within the mixing chamber that is configured to mix the food ingredients and the API disposed in the mixing chamber 126. The body 124, and thus the mixing chamber 126, can be substantially cylindrical in shape, substantially conical in shape, or can define any suitable alternative shape as desired. The mixing element 128 may be configured as an auger, one or more mixing blades, etc., that may be actuated to operate by rotating within the mixing chamber 126 to mix ingredients disposed within the mixing chamber 126. The mixing device 120 may include at least one food input conduit 130 extending through the body 124 and configured to deliver one or more ingredients of a batch food product to the mixing chamber 126, and at least one API input conduit 132 extending through the body 124 and configured to deliver at least one API to the mixing chamber 126.

[0135] For example, at least one dry component of a food product and at least one wet component of a food product may be delivered to the mixing chamber 126 through at least one food input conduit 130. In one embodiment, the dry and wet components of a food product may be delivered to the mixing chamber 126 through the same product input conduit 130. Alternatively, different groups of one or more dry components may be introduced to the mixing chamber through respective different dry food input conduits 130. Similarly, different groups of one or more wet components may be introduced to the mixing chamber through respective different wet food input conduits 130. It should be understood that some or all of the food components may be premixed, for example in a mixing tube, before being introduced to the mixing chamber 126 through the respective product input conduits 130. Alternatively,

[0136] The API may be delivered to the mixing chamber 126 and mixed with the food ingredient. In one embodiment, the API is delivered to the mixing chamber 126, for example, through an API input conduit 132. For example, a predetermined amount of the API may be poured, pipetted, delivered as discrete microdroplets as described herein, or delivered to the mixing chamber 126 in any manner desired. One or more APIs may be delivered through a single API input conduit 132. Alternatively, multiple APIs may be delivered through respective different API input conduits 132. Thus, it may be said that at least one API may be delivered to the mixing chamber 126 through at least one API input conduit 132. In one embodiment, the API may be delivered to the mixing chamber 126 prior to the delivery of the food ingredient to the mixing chamber 126. Alternatively, the API may be delivered to the mixing chamber 126 after the delivery of the food ingredient to the mixing chamber 126. Alternatively, the API may be delivered into the mixing chamber 126 during the delivery of the food ingredient into the mixing chamber 126.

[0137] The spiked food mixture can then be heated as step 103. For example, the mixing device 120 can define an outlet 134 configured to deliver the mixture from the mixing device 120 to any suitable carrier for delivering the mixture to an oven that performs the cooking step 103. The cooked food can then be divided into individualized food products and packaged in the manner described above, or delivered to individual molds in step 106 as described above. In other examples, the API-containing mixture can be delivered from the mixing device 120 directly to the singulation molds or to an intermediate carrier that delivers the API-containing mixture to the singulation molds. The molds can then be optionally heated in step 103 and cooled before being packaged.

[0138] As mentioned above, the mixing device 120 can include at least one mixing element 128 configured to mix the food ingredients and APIs disposed in the mixing chamber 126 to generate an API-containing mixture. The mixing element 128 can be actuated as and / or after the ingredients and APIs are introduced into the mixing chamber 126, thereby generating an API-containing mixture. As mentioned above, the body 124, and thus the mixing chamber 126, can be substantially conical in shape. Thus, the mixing chamber 126 can define a vortex during operation of the mixing element 128, which mixes the food ingredients and APIs and further drives the resulting mixture through the outlet 134.

[0139] As discussed above, the method 100' for batch production of cooked food products may be applied to any food product that is a product of mixing ingredients and heat, as desired. By way of example and not limitation, the food product may be a candy or baked food, or any alternative food product as desired. In one embodiment, the candy may be a gummy or hard candy, as desired. The individual candies may be individually wrapped. Alternatively, the candies may be unwrapped in a package. Alternatively, the individually wrapped candies may be in a package. The candies may be bite-sized, that is, sized to be placed entirely in the consumer's mouth, or sized to be consumed by repeated chewing. If the food product is a baked food product, the baked food product may be individually wrapped. Alternatively, multiple brownies may be placed in a common container. Alternatively, the individually wrapped baked food products may be placed in a common container. The baked food product may be sized to be placed entirely in the consumer's mouth, or sized to be consumed by repeated chewing.

[0140] 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 appreciate 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 above with the above-mentioned embodiments and examples can be used alone or in combination with any of the other embodiments and examples described above. Furthermore, it should be understood that the various alternatives described above with respect to one illustrated embodiment can be applied to all other embodiments and examples described herein, unless otherwise indicated. Accordingly, reference is made to the claims.

[0141] [Embodiment] (1) A method for preparing a food product, comprising: providing a food mixture to define a batch food mixture; cooking the batch food mixture such that the food product defines a cooked food product; cooling the cooked food product such that the food product defines a cooled food product; adding an active pharmaceutical ingredient (API) to the food product after the providing step; A method comprising: (2) The method of claim 1, wherein the cooling step comprises actively cooling the cooked food. (3) The method of claim 1, wherein the cooling step comprises passively cooling the cooked food. (4) The method of claim 1, wherein the providing step includes mixing a plurality of edible ingredients to produce the batch food mixture. (5) The method of claim 1, wherein the providing step includes mixing a plurality of edible ingredients and then removing a quantity of food from the plurality of edible ingredients to produce the batch food mixture.

[0142] (6) The method of any one of claims 1 to 5, wherein the adding step is performed after the cooking step. (7) The method of any one of the preceding claims, wherein the adding step is carried out after the cooling step. (8) The method of any one of the preceding claims, wherein the adding step is carried out before the cooling step. (9) The method of any one of the preceding claims, wherein the API comprises a cannabinoid. (10) The method of any one of embodiments 9, wherein the cannabinoid is not fully decarboxylated.

[0143] 11. The method of claim 9, wherein the cannabinoid is not decarboxylated. (12) The method of embodiment 9, wherein the cannabinoid is fully decarboxylated. (13) The method of any one of the preceding claims, wherein the dosing step comprises delivering at least one microdroplet of an API-containing liquid comprising the API from a dosing station to the food product. (14) The method of claim 13, wherein the adding step includes aligning the food to be added with an adding head of the adding station, and the delivering step includes delivering the at least one microdroplet from the adding head to the food. (15) The method of any one of embodiments 13 to 14, wherein the at least one microdroplet contains the API at a concentration ranging from about 50 micrograms per microliter of solution to about 1 milligram per microliter of solution.

[0144] (16) The method of any one of claims 13 to 15, wherein the at least one microdroplet comprises a plurality of microdroplets. (17) The method of any one of claims 13 to 16, wherein the addition station includes an array of addition heads, and the step of delivering at least one microdroplet includes delivering a plurality of microdroplets from the array of addition heads. 18. The method of claim 17, wherein a first one of the addition heads delivers a first API-containing liquid and a second one of the addition heads delivers a second API-containing liquid that is different from the first API-containing liquid. 19. The method of any one of claims 13 to 18, wherein the API-containing liquid comprises a solution of the API and a solvent. (20) The method of any one of embodiments 13 to 19, wherein each microdroplet contains a minute amount of the API, ranging from about 0.1 micrograms to about 10 milligrams.

[0145] (21) The method of any one of embodiments 13 to 19, wherein each microdroplet has a volume ranging from about 2 nanoliters to about 10 microliters. (22) The method of embodiment 21, wherein the volume is in the range of 25 nanoliters to about 2 microliters. (23) The method of embodiment 22, wherein the volume is in the range of about 50 nanoliters to about 1 microliter. (24) The method of claim 21, wherein the volume is within about 1% to about 5% of the predetermined target volume of the microdroplet at 3 sigma. 25. The method of any one of claims 13 to 24, wherein the API-containing liquid comprises a pure API.

[0146] (26) The method of any one of embodiments 13 to 25, wherein the doping step comprises delivering respective APIs to different ones of the foods, wherein the respective APIs have at least one API characteristic that differs from one another. (27) The method of embodiment 26, wherein the different API characteristics include at least one of: 1) a concentration of the API; 2) a volume of API delivered to the food product during the dosing step; 3) a composition of the API; 4) a modifier mixed with the API, the modifier being configured to modify at least one of a flavor, a mechanical property, and an aesthetics of the delivered API; and 5) a location of at least one dosing zone of the food product. (28) The method of any one of claims 13 to 27, wherein the step of delivering at least one microdroplet of API-containing liquid comprises delivering different APIs to different subzones within a delivery zone of the food product. 29. The method of any one of claims 13 to 28, further comprising increasing the temperature of the API during the adding step to reduce the viscosity of the API. (30) The method of any of claims 13 to 29, further comprising post-treating the food product after the adding, the post-treating comprising at least one of: 1) drying the solvent; 2) changing the viscosity of the API; 3) further adhering the API to the food product; 4) dispersing the API along the food product; and 5) increasing absorption of the API into the food product.

[0147] (31) The method of any one of embodiments 1 to 12, further comprising personalizing the food product to define a personalized food product. 32. The method of claim 31, wherein the individualizing step is performed after the cooking step and before the cooling step. 33. The method of claim 31, wherein the individualizing step is performed after the cooling step. 34. The method of claim 31, wherein the individualizing step is performed after the mixing step and before the cooking step. (35) The method of any one of embodiments 31 to 34, wherein the individualizing step includes severing the individualized food products from the remainder of the food product.

[0148] (36) The method of any one of embodiments 31 to 34, wherein the individualizing step includes delivering the food products to respective molds such that the food products are apportioned into individualized food products. (37) The method of any one of embodiments 31 to 34, wherein the adding step comprises adding the API to the personalized food product. 38. The method of claim 37, wherein the individualizing step includes severing the individualized food products from the remainder of the food product. (39) The method of any one of embodiments 31 to 37, wherein the individualizing step includes delivering the food products to respective molds such that the food products are apportioned into individualized food products. 40. The method of claim 39, further comprising removing the individualized food products from their respective molds.

[0149] 41. The method of claim 40, wherein the adding step is performed prior to removing a quantity of food from a plurality of edible ingredients to produce the batch food mixture. (42) The method of any one of embodiments 39 to 41, wherein the doping step comprises delivering the API to the molds prior to the step of delivering the cooled food products to their respective molds, and the cooled food products contact the delivered API in the respective molds during the step of delivering the cooled food products to their respective molds. (43) The method of any one of embodiments 39 to 42, wherein the adding step comprises delivering the API directly to the cooled food product as it is delivered to the respective mold. (44) The method of embodiment 42, wherein the adding step comprises delivering the API directly to the personalized food product while the personalized food product is disposed within the respective mold. 45. The method of claim 44, wherein the API is disposed between successive layers of the personalized food product within each mold.

[0150] (46) The method of any one of embodiments 31 to 45, further comprising packaging the personalized food product. (47) The method of any one of embodiments 31 to 46, further comprising a step of cooling the personalized food product after the cooling step is performed. 48. The method of claim 47, wherein the further cooling step is carried out after the adding step. (49) The method of claim 48, wherein the further cooling step comprises cooling the individualized food product by at least 10% of the temperature of the cooked food product after the cooking step is completed. 50. The method of any one of claims 31 to 49, wherein the cooking step includes bringing the food to a temperature of at least about 200°F.

[0151] 51. The method of claim 50, wherein the temperature is in the range of about 200°F to about 500°F. (52) The method of any one of claims 50 to 51, wherein the cooling step reduces the temperature by at least 10% to produce the cooled food product. (53) The method of any of embodiments 37 to 52, wherein the dosing step comprises delivering at least one microdroplet of an API-containing liquid comprising the API from a dosing station to the individualized food product. (54) The method of embodiment 53, wherein the adding step includes aligning the individualized food product with an addition head of the addition station, and the delivering step includes delivering the at least one microdroplet from the addition head to the individualized food product. (55) The method of any one of embodiments 53 to 54, wherein the at least one microdroplet contains the API at a concentration ranging from about 50 micrograms per microliter of solution to about 1 milligram per microliter of solution.

[0152] (56) The method of any one of embodiments 53 to 55, wherein the at least one microdroplet comprises a plurality of microdroplets. (57) A method according to any of embodiments 53 to 55, wherein the addition station includes an array of addition heads, and the step of delivering at least one microdroplet includes delivering a plurality of microdroplets from the array of addition heads. 58. The method of embodiment 57, wherein a first one of the addition heads delivers a first API-containing liquid and a second one of the addition heads delivers a second API-containing liquid that is different from the first API-containing liquid. 59. The method of any one of claims 53 to 58, wherein the API-containing liquid comprises a solution of the API and a solvent. (60) The method of any one of embodiments 53 to 59, wherein each microdroplet contains a minute amount of the API in the range of about 0.1 micrograms to about 10 milligrams.

[0153] (61) The method of any one of embodiments 53 to 59, wherein each microdroplet has a volume ranging from about 2 nanoliters to about 10 microliters. (62) The method of embodiment 61, wherein the volume is in the range of 25 nanoliters to about 2 microliters. (63) The method of embodiment 62, wherein the volume is in the range of about 50 nanoliters to about 1 microliter. (64) The method of embodiment 60, wherein the volume is within about 1% to about 5% of the predetermined target volume of the microdroplet at 3 sigma. 65) The method of any one of embodiments 53 to 64, wherein the API-containing liquid comprises a pure API.

[0154] (66) The method of any of embodiments 54 to 65, wherein the adding step comprises delivering at least one microdroplet of the API-containing liquid to each of the plurality of individualized food products. (67) The method of any of embodiments 53 to 66, wherein the dosing step comprises delivering respective APIs to different ones of the personalized foods, wherein the respective APIs have at least one API characteristic that differs from one another. (68) The method of embodiment 67, wherein the different API characteristics include at least one of: 1) a concentration of the API; 2) a volume of API delivered to the personalized food product during the dosing step; 3) a composition of the API; 4) a modifier mixed with the API, the modifier being configured to modify at least one of a flavor, a mechanical property, and an aesthetic of the delivered API; and 5) a location of at least one dosing zone of the personalized food product. (69) The method of any of embodiments 53 to 68, wherein the step of delivering at least one microdroplet of API-containing liquid comprises delivering different APIs to different subzones within a delivery zone of the personalized food product. (70) The method of any of embodiments 53 to 69, further comprising increasing the temperature of the API during the adding step to reduce the viscosity of the API.

[0155] (71) The method of any of embodiments 53 to 70, further comprising post-treating the personalized food product after the adding, the post-treating comprising at least one of: 1) drying the solvent; 2) increasing the viscosity of the API; 3) further adhering the API to the personalized food product; 4) dispersing the API along the personalized food product; and 5) increasing absorption of the API into the personalized food product. (72) The method of any one of the preceding claims, further comprising delivering the mixture to a plurality of molds. 73. The method of claim 71, wherein the adding step comprises delivering the API to the mold prior to the step of delivering the mixture to each mold, and the mixture contacts the delivered API in the each mold during the step of delivering the mixture to each mold. (74) The method of embodiment 72, wherein the adding step comprises delivering the API directly to the mixture after the mixture is delivered to the respective mold. (75) The method of embodiment 74, wherein the adding step comprises delivering the API directly to the individualized food products while the individualized food products are disposed within their respective molds.

[0156] 76. The method of claim 75, wherein the API is disposed between successive layers of the mixture within each of the molds. (77) The method of any one of embodiments 72 to 76, further comprising mixing the mixture and the API in the mold. 78. The method of claim 77, wherein each of the molds defines a base and at least one sidewall supported by the base to define an interior mold cavity for receiving the mixture, the at least one sidewall configured to pulse to mix the mixture and the API within the mold. (79) The method of any one of embodiments 77 to 78, wherein the mold is disposed on a support surface configured to vibrate to mix the mixture and the API within the mold. (80) The method of any one of embodiments 77 to 79, further comprising stimulating agitation of the mixture.

[0157] 81. The method of claim 81, wherein the stimulating step includes directing an air flow across an exposed surface of the mixture. (82) The method of any one of embodiments 80 to 81, wherein the stimulating step includes directing energy to the mixture in the mold. (83) The method of embodiment 82, wherein the energy is configured as at least one of a propagating electromagnetic wave and an illumination pulse. (84) The method of any one of the preceding claims, wherein the providing step comprises delivering components of the mixture to a mixing chamber of an apparatus, the adding step comprises delivering an API to the mixing chamber, and the method further comprises mixing the components and the API to define an added mixture. 85. The method of claim 84, wherein the providing step includes delivering dry and wet components of the mixture to the mixing chamber.

[0158] 86. The method of claim 85, wherein the dry ingredients and the wet ingredients are delivered to the mixing chamber through a single input conduit. 87. The method of claim 85, wherein the dry and wet components are delivered to the mixing chamber through respective multiple input conduits. (88) The method of any of embodiments 85 to 87, comprising delivering the API to the mixing chamber before, during, or after delivery of the component to the mixing chamber. (89) The method of any one of embodiments 84 to 88, comprising delivering the mixture from an outlet of the mixing device to a plurality of molds. (90) The method of any of embodiments 84 to 89, wherein the mixing chamber defines a vortex to force the mixture out of an outlet of the mixing chamber as the component and the API are mixed.

[0159] (91) The method of any one of the preceding claims, further comprising dividing the food product into at least one sub-batch, and wherein the adding step comprises adding the API to the at least one sub-batch. (92) The method of embodiment 91, wherein the step of dividing the food into at least one sub-batch is performed after the step of serving and before the step of cooking. 93. The method of claim 92, wherein the at least one sub-batch is dosed with the API prior to the cooking step. (94) The method of embodiment 92, wherein the at least one sub-batch has the API added after the cooking step. 95. The method of claim 94, wherein the at least one sub-batch is added with the API after the cooling step.

[0160] (96) The method of embodiment 91, wherein the step of dividing the food product into at least one sub-batch is performed after the step of cooking and before the step of cooling. (97) The method of embodiment 96, wherein the at least one sub-batch is added with the API prior to the cooling step. (98) The method of embodiment 96, wherein the at least one sub-batch is added with the API after the cooling step. (99) The method of embodiment 91, wherein the step of dividing the batch food into at least one sub-batch is performed after the step of cooling. (100) The method of any one of claims 91 to 99, wherein the cooking step includes bringing the food to a temperature of at least 150°F.

[0161] (101) The method of embodiment 100, wherein the temperature is in the range of about 150°F to about 500°F. (102) The method of any one of embodiments 91 to 101, wherein the cooling step reduces the temperature of the cooked food by at least 10% of the temperature of the cooked food after the cooking step is completed. (103) The method of any of embodiments 91 to 102, wherein dividing the food product to produce at least one sub-batch comprises delivering the food product to at least one container to produce the at least one sub-batch, and the adding step comprises delivering the API to the container prior to dividing the cooked food product to produce at least one sub-batch, and the at least one sub-batch contacts the delivered API in the container during dividing the cooked food product to produce at least one sub-batch. (104) The method of any of embodiments 91 to 103, wherein the adding step comprises delivering the API directly to the sub-batch during a step of dividing the cooked batch food to produce at least one sub-batch. (105) The method of any of embodiments 91 to 104, wherein the adding step comprises delivering the API directly to the sub-batch after dividing the cooked batch food to produce at least one sub-batch.

[0162] (106) The method of any one of embodiments 91 to 105, wherein the adding step comprises delivering at least one microdroplet of an API-containing liquid containing the API from an adding station to the at least one sub-batch. (107) The method of embodiment 106, wherein the adding step includes aligning the at least one sub-batch with an addition head of the addition station, and the delivering step includes delivering the at least one microdroplet from the addition head to the at least one sub-batch. (108) The method of any one of embodiments 106 to 107, wherein the at least one microdroplet contains the API at a concentration ranging from about 50 micrograms per microliter of solution to about 1 milligram per microliter of solution. (109) The method of any one of embodiments 106 to 108, wherein the at least one microdroplet comprises a plurality of microdroplets. (110) A method according to any one of embodiments 106 to 109, wherein the addition station includes an array of addition heads, and the step of delivering at least one microdroplet includes delivering a plurality of microdroplets from the array of addition heads.

[0163] (111) The method of embodiment 110, wherein a first one of the addition heads delivers a first API-containing liquid and a second one of the addition heads delivers a second API-containing liquid that is different from the first API-containing liquid. (112) The method of any one of embodiments 106 to 111, wherein the API-containing liquid comprises a solution of the API and a solvent. (113) The method of any one of embodiments 106 to 112, wherein each microdroplet contains a minute amount of the API in the range of about 0.1 micrograms to about 10 milligrams. (114) The method of any one of embodiments 106 to 112, wherein each microdroplet has a volume ranging from about 2 nanoliters to about 10 microliters. (115) The method of embodiment 114, wherein the volume is in the range of 25 nanoliters to about 2 microliters.

[0164] (116) The method of embodiment 115, wherein the volume is in the range of about 50 nanoliters to about 1 microliter. (117) The method of embodiment 114, wherein the volume is within about 1% to about 5% of the predetermined target volume of the microdroplet at 3 sigma. (118) The method of any one of embodiments 106 to 117, wherein the API-containing liquid comprises a pure API. (119) The method of any of embodiments 106 to 117, wherein the at least one sub-batch comprises a plurality of sub-batches, and the adding step comprises delivering at least one microdroplet of the API-containing liquid to each of the plurality of sub-batches. (120) The method of any one of embodiments 106 to 119, wherein the adding step comprises delivering a respective API to the at least one sub-batch, the respective APIs having at least one API characteristic that differs from one another.

[0165] (121) The method of embodiment 120, wherein dividing the food product to produce at least one sub-batch further comprises producing a plurality of sub-batches, and the adding step comprises delivering respective APIs to different ones of the sub-batches. (122) The method of any of embodiments 120 to 121, wherein the different API characteristics include at least one of: 1) a concentration of the API; 2) a volume of API delivered to the at least one sub-batch during the adding step; 3) a composition of the API; 4) a modifier mixed with the API, the modifier being configured to modify at least one of a flavor, a mechanical property, and an aesthetics of the delivered API; and 5) a location of at least one addition zone of the at least one sub-batch. (123) The method of any of embodiments 116 to 122, wherein the step of delivering at least one microdroplet of API-containing liquid comprises delivering different APIs to different subzones within the at least one sub-batch delivery zone. (124) The method of any of embodiments 116 to 123, further comprising increasing the temperature of the API during the adding step to reduce the viscosity of the API. (125) The method of any of embodiments 116 to 124, further comprising post-treating the at least one sub-batch after the adding, the post-treating comprising at least one of: 1) drying off the solvent; 2) increasing the viscosity of the API; 3) further adhering the API to the at least one sub-batch; 4) dispersing the API along the at least one sub-batch; and 5) increasing absorption of the API into the at least one sub-batch.

[0166] (126) The method of any one of the preceding claims, wherein the cooking step is performed on a first side of a jurisdictional boundary line and the adding step is performed on a second side of the jurisdictional boundary line. (127) The method of any one of the preceding embodiments, wherein the API is an extract from a marijuana plant, a hemp plant, or any alternative API, alone or in combination with one or more of a flavonoid and a terpene. (128) The method of any one of the preceding embodiments, wherein the API comprises a dietary supplement. (129) The method of any one of the preceding claims, wherein the food product is a baked food. (130) The method of any one of the preceding claims, wherein the food product comprises a gummy candy.

[0167] (131) The method of any one of embodiments 1 to 129, wherein the food is a fruit or a nut.

Claims

1. A method for preparing food, comprising: providing a mixture of food to define a batch of food mixture; cooking the batch of food mixture so that the batch of food mixture defines a cooked food; after the cooking step, delivering the food to respective molds so as to distribute the food into individualized foods; cooling the cooked food so that the food defines a cooled food; adding an active pharmaceutical ingredient (API) that has not undergone the providing step to the individualized foods; A method comprising the above steps.

2. The method according to claim 1, wherein the adding step is performed after the cooking step so that the API does not undergo the cooking step.

3. The method according to claim 2, wherein the API comprises a cannabinoid.

4. The method according to claim 2, wherein the adding step is performed before the cooling step.

5. The method according to claim 1, wherein the adding step is performed after the cooling step.

6. The method according to claim 1, wherein the API comprises an undecarboxylated cannabinoid.

7. The method according to claim 1, wherein the delivering step is performed before the cooling step.

8. The method according to claim 1, wherein the delivering step is performed after the cooling step.

9. The method according to claim 1, wherein the adding step includes delivering the API to the mold before delivering the food to respective molds, and the food contacts the API delivered to the respective molds during the delivering step of delivering the food to the respective molds.

10. The method according to claim 1, wherein the adding step includes directly delivering the API to the food when the food is delivered to the respective molds.

11. The method according to claim 10, wherein the adding step includes directly delivering the API to the individualized food after the individualized food is delivered into the respective molds.

12. The method according to claim 1, wherein the API is disposed between consecutive layers of the individualized food within the respective molds.

13. The method according to claim 1, further comprising delivering at least one of the individualized foods to a package and then sealing the package.

14. The method according to claim 1, wherein the cooling step is performed after the adding step.

15. The method according to claim 1, further comprising stimulating the stirring of the mixture after the step of adding the API to the food.

16. The providing step includes delivering the components of the mixture to a mixing chamber of an apparatus, the adding step includes delivering the API to the mixing chamber, and the method further includes mixing the components and the API to define the added mixture. The method according to claim 1.

17. The method according to claim 1, further comprising dividing the food into at least one sub-batch, and the adding step includes adding the API to the at least one sub-batch.

18. The method according to claim 1, wherein the API includes an extract from a marijuana plant or a hemp plant.

19. The method according to claim 18, wherein the API includes one or both of flavonoids and terpenes.

20. The method according to claim 1, wherein the API includes one or both of flavonoids and terpenes.

21. The method according to claim 1, wherein the API includes a dietary supplement.

22. The method according to claim 1, wherein the food is a baked food.

23. The method according to claim 1, wherein the food is a gummy.

24. The adding step includes injecting the API into the food either 1) during the step of delivering the food to respective molds and 2) after the step of delivering the food to respective molds is completed. The method according to claim 1.

25. The method according to claim 24, wherein the cooling step is performed after the injecting step.

26. The method according to claim 24, wherein the cooling step is performed before the injecting step.

27. The method according to claim 1, wherein the API includes cannabinoids.

28. The method according to claim 1, wherein the API includes an extract from a marijuana plant or a hemp plant. **Claim 29**: The method according to claim 1, wherein the API comprises one or both of flavonoids and terpenes. **Claim 30**: The method according to claim 1, wherein the API comprises dietary supplements. **Claim 31**: The method according to claim 1, wherein the API comprises over-the-counter (OTC) drugs. **Claim 32**: The method according to claim 1, wherein the API comprises prescription drugs. **Claim 33**: The method according to claim 17, wherein the step of packaging is carried out after the step of cooling. **Claim 34**: The method according to claim 13, wherein the step of packaging comprises delivering one of the individualized foods into a package. **Claim 35**: The method according to claim 13, wherein the step of packaging comprises delivering a plurality of the individualized foods into a package. **Claim 36**: The method according to claim 13, wherein the API comprises a powder. **Claim 37**: The method according to claim 36, further comprising the step of encapsulating the API by the surface of the individualized food. **Claim 38**: The method according to claim 37, further comprising raising the temperature of the surface of the individualized food, thereby encapsulating the API on the surface. **Claim 39**: The method according to claim 37, wherein the individualized food is of bite size. **Claim 40**: The method according to claim 37, wherein the individualized food comprises gummies. **Claim 41**: The method according to claim 37, wherein the individualized food comprises chocolate. **Claim 42**: The method according to claim 37, wherein the individualized food comprises hard candy. **Claim 43**: The method according to claim 36, wherein the API comprises one of over-the-counter drugs and prescription drugs. **Claim 44**: The method according to claim 36, wherein the API comprises dietary supplements. **Claim 45**: The method according to claim 36, wherein the API comprises cannabinoids.

Images