Abstract:
A method for producing edible medications comprises providing a three-dimensional (3D) model of the edible medication including an internal cavity sized and shaped for receipt of a medicament therein, printing an edible media to form a portion of the 3D shell corresponding to the model for introduction of the medicament, and then printing the edible media to form the remainder of the 3D shell to completely enclose the medicament within the edible media.

Description:
TECHNICAL FIELD 
     The present disclosure relates to medicaments for consumption by humans and animals. In particular, the disclosure relates to the introduction of medicaments into an ingestible media. 
     BACKGROUND 
     Getting pets to take medicaments in pill or liquid form is difficult and frustrating. A limited number of pet medications are available in flavored chewable formats. However, most pet medicaments are not provided in this manner due to cost and shelf-life concerns. Thus, the pet owner or veterinarian is left with the uncomfortable task of cajoling or forcing an animal to ingest an undesirable medication. One traditional technique is to hold the pet&#39;s mouth open and introduce the medicament into the back of the throat of the animal. Of course, this is uncomfortable and distressing to the pet and not always successful. 
     Another approach is to embed a pill medicament in some food item that is desirable to the pet, such as butter, cheese, a hot dog, or commercially available pet treats such as Greenies® brand Pill Pockets®. While this approach is less invasive, it can be equally frustrating as the intelligent pet manages to enjoy the tasty food while somehow spitting out the medicament. Moreover, this approach is not well-suited to liquid medicaments. 
     The same issues arise with children, particularly with children that are too young to be “bribed” to swallow the medicine. Consequently, there is a need for a way to provide a medicament in a format that is easily and willingly ingested by pet or person. It is further desirable that a process for providing the medicament in this format be readily tailored to the form of the medication as well as the tastes of the recipient. 
     SUMMARY OF THE DISCLOSURE 
     A method is provided for producing edible medications based on three-dimensional printing of an edible media to form a shell for receiving a medicament. The method includes providing a three-dimensional (3D) model of the edible medication including an internal cavity sized and shaped for receipt of a medicament therein and then providing that model to a 3D printing machine. An edible media is fed to the 3D printing machine for printing a first portion of the 3D model. In one aspect, the first portion is configured to provide access to at least a portion of the cavity for introduction of the medicament. After the medicament is introduced into the partially formed cavity, the remaining portion of the 3D model is printed with the edible media to completely enclose the cavity and the medicament within the cavity. 
     In one aspect, the medicament may be a solid medicament, in which case the 3D model is printed leaving a bottom half of the cavity exposed for placement of the solid medicament. In a further aspect, the medicament may be a liquid medicament, in which case the 3D model is printed so that substantially the entire cavity is formed, leaving an opening at the top of the cavity for injection of the liquid medicament. The medicament may be introduced into the partially formed edible shell robotically or manually. In another aspect, the 3D model may include a plurality of edible medications formed in an array and configured for easy removal of the edible shells from the array. 
    
    
     
       DESCRIPTION OF THE FIGURES 
         FIG. 1  is a top view of medicaments contained within an edible shell for ingestion by an animal. 
         FIG. 2  is a plan view of an array of edible shells having a different configuration than the shells shown in  FIG. 1 . 
         FIG. 3  is a plan view of an array of edible shells of the configuration shown in  FIG. 1 . 
         FIG. 4  is a side view of the array of edible shells shown in  FIG. 4 . 
         FIG. 5  is a block diagram showing components in the production of the edible shells shown in the prior figures. 
         FIG. 6  is a flowchart of process steps in the production of the edible shells shown in the prior figures. 
     
    
    
     DETAILED DESCRIPTION 
     For a general understanding of the present embodiments, reference is made to the drawings. In the drawings, like reference numerals have been used throughout to designate like elements. As used herein, the terms “3D printing” or a “3D printer” refer to processes and machines capable of forming three-dimensional shapes from a model by the sequential application of successive layers of a media. The 3D printing process is performed under computer control based on a model of the desired 3D shape stored in a memory. As used herein, the 3D printer includes a computer controller with a memory, and components for applying jettable media in thin layer under computer control. As used herein, a “jettable media” can be a settable composition that can be provided in an initial form that has a viscosity sufficiently low to be readily ejected from jets mounted on a movable carriage in the 3D printing machine or a solid media that changes to a low viscosity when heated so it can be ejected from jets then harden as it cools. 
     One example of a suitable 3D printer is the “CubeX™” 3D printer sold by 3D Systems, Inc. The CubeX™ 3D printer is configured to create 3D models from PLA or ABS plastic in layer thicknesses of 0.1-0.5 mm. The plastic material is heated within reservoirs in the printer and heated to achieve a viscosity that allows the material to be fed under pressure to one or more jets and discharged from the jets in a controlled pattern on a printing surface to form a discrete thin layer of material. The carriage supporting the jets is raised at each printing step to apply a new layer onto an existing layer that has at least partially cured. It is understood that certain modifications to the 3D printer may be necessary to accommodate the use of edible material as the jettable media. At a minimum, the working components will be cleanable and sterilizable to meet food handling regulations. Modifications to the heating protocol, reservoir, flow to the jets, and the jets themselves may also be warranted to handle the food grade media. 
     The embodiments disclosed herein relate to the preparation of medicaments for ingestion by an animal, and to a system and method for use by a veterinarian in dispensing medicaments to be administered by veterinary personnel or the pet owner. However, it is understood that the systems and methods disclosed herein may find application in other arenas, such as in the preparation of medicaments for human consumption and use by a pediatrician or pharmacist. 
     The present disclosure provides a system and method for “building” a flavored shell around a medicament, whether in pill or liquid form, using a 3D printer and 3D printing process. In particular, a model corresponding to a particular edible shell configuration is generated according to the nature, size and shape of the medicament and other parameters. The additional parameters may include positioning of the medicament within the shell, the exterior configuration of the shell, the fluid properties of the media, etc. By way of example, different configurations of medicaments and edible shells are shown in  FIG. 1 . In one example, the edible shell  12  is produced to define an interior cavity  14  that is sized to receive a generally spherical medicament  20 . The shell  12 ′ is provided with two interior cavities  14 ′ to receive two of the spherical medicaments  20 . An oblong medicament  22  is received within an appropriately configure cavity  14 ″ in the edible shell  12 ″. In the illustrated examples, the shells  12 ,  12 ′,  12 ″ have the shape of a dog bone. Other shell shapes are possible, such as the goldfish shape of the shells  32  in the array  30  shown in  FIG. 2 . Moreover, other medicament shapes are possible, such as a disc shape, although most pill-type medication is provided in one of these three shapes. The medicament may be provided in other sizes as well, which require adjustment of the dimensions of the interior cavities. 
     The 3D printer is configured to produce an array of the edible shells, such as the array  10  shown in  FIGS. 3-4 . The array  10  includes a plurality of shells  12  in a support structure including an outer frame  16  and supporting spars  18 . The spars  18  are integrally printed with the shells but have a reduced cross-section so that the shells  12  can be readily severed from the spars  18 . The spars  18  are arranged to adequately support the plurality of shells in the array for removal from the 3D printing machine and to maintain the integrity of the array as it is being formed layer-by-layer by the 3D printing machine. It is contemplated that the operator may cut the shells from the spars using a knife. Alternatively, the shells may be pressed from the array so that the shells mechanically separate from the spars without the use of a knife. 
     As is known, a 3D model is derived to control the operation of the 3D printing machine. The control software reads the model and directs the movement and operation of the jets accordingly layer by layer. In accordance with the present disclosure, a data base of 3D models may be accessed by the 3d printing software or a data base of design parameters may be accessed by software that then creates the 3D model. In the former case, the data base would include 3D models corresponding to particular medicament configurations and particular edible shell configurations. For example, the three configurations shown in  FIG. 1  could be standard 3D models retained in the data base. In the later alternative, the model generation software utilizes information regarding the shape and dimensions of the medicament and the shape and dimensions of the edible shell to generate a 3D model of the shell, including the cavity configured to hold the medicament. The user, such as the veterinarian, supplies the requisite information to the 3D modeling software, which generates the model and conveys the model to the 3D printing software to control the operation of the 3D printing machine. It can be appreciated that the model produced by the modeling software can include the support structure  16 ,  18  according to a predetermined protocol to produce an array of shells, such as the array  10  shown in  FIGS. 2-3 . 
     It is further contemplated that a more sophisticated 3D modeling software may draw on a data base of medications which includes the volumetric properties of the medicaments. In this case, the user or veterinarian need only identify the medication, rather than provide the dimensions of the medicament. A data base may also be maintained for animal species to determine the appropriate configurations and dimensions for the edible shell. For instance, an edible shell intended for a Chihuahua is necessarily smaller than a shell intended to be consumed by a horse. The 3D modeling software may also access a personalization data base in which pet owner or veterinarian preferences can be stored, such as shell shapes or edible composition (i.e., flavoring, texture, etc.). 
     A system for producing an edible 3D printed medication is depicted in  FIG. 5 . The heart of the system is the 3D printing machine  50  that is adapted to produce 3D products from an edible jettable media. The media is contained in a reservoir  54  that may be separate from or part of the printing machine  50 . In one embodiment, the reservoir  54  is configured to contain a plurality of different edible jettable media, with a fluid transfer mechanism configured to convey a selected one of the media to the jets of the 3D printing machine  50 . For instance, the jettable media can be a form of gelatin that hardens or sets with or without the application of heat. The plurality of media contained within the reservoir  54  may be the same gelatin composition with different flavoring, or may be different types of gelatin. It is contemplated that the array of edible media can encompass a wide range of media that are capable of use in a 3D printing procedure. 
     The 3D printing machine  50  may incorporate its own internal processor operable to execute software commands for controlling the components of the 3D printing machine, as is known in the art. In the system shown in  FIG. 5 , the printing machine may communicate with a computer and interface  52  that allows the user, such as a veterinarian, to tailor the finished product produced by the printing machine. In one aspect, the computer  52  may communicate with a data base  53  stored in a memory that may be part of the computer and interface  52 , may be contained with a separate storage device, or may be accessible in the “cloud” or offsite storage using cloud computing or internet access schemes. The computer may execute software that allows the user to select among information stored in the data base  53 , such as types of medicaments, types of edible media, configurations of the final product, customer/client preferences and the like. The software may also provide an avenue for the user to directly generate the data required by the 3D printing machine  50  to produce the 3D product, by way of the computer and interface  52 . For instance, the use may desire to encapsulate a medicament that is not available in the data base  53 , in which case the software executed by the computer would allow the user to enter dimensional properties of the medicament. 
     The 3D printing machine  50  may also integrate with a source of the medicament  56 . In one embodiment, the medicament is provided separately by the user, as described below. In another embodiment, the medicament is contained within a container  56  that is accessed by the 3D printing machine  50  for introduction into a cavity formed in the 3D printed media. In one example, a solid pill or tablet form medicament may be extracted by a robotic arm associated with the printing machine and placed within a newly formed cavity, as described herein. For a liquid medicament in container  56  the medicament may be introduced into the newly formed cavity by a robotic nozzle, or may be treated by the 3D printing machine as another jettable media in which case the medicament is jetted into the newly formed cavity. Alternatively, the medicament, whether solid or liquid, may be manually introduced into the cavity by a technician. 
     In the case of an array, such as the array  10  shown in  FIG. 3 , the medicament may be introduced into multiple cavities in multiple shells  12 . It can be appreciated that the 3D printing machine may be controlled so that all of the shells  12  in the array include the same edible media and the same medicament. However, the printing machine may also be controlled to allow for variation among any and all of the shells  12  of the array  10 , such as different edible media for the same medicament and even different outer configurations for the end products. 
     A flowchart of the process steps disclosed herein is shown in  FIG. 6 . In the first step  60 , the user, such as the veterinarian, selects the edible jettable media. This selection can be made using the computer and interface  52  and can be obtained from the data base  53  or separately entered by the user, as discussed above. In the next step  62 , the user selects the medicament, which again may be by way of the data base or by separate data entry. The dosage of the medicament may be selected in step  64 , provided that the medicament is not already supplied in a fixe dosage. It is understood that the media and medicament selection process may be very limited, such as with only one available media and one available medicament, may be heavily data base oriented in which very specific media and medicaments are provided, and even specific limited combinations of media and medicament. 
     The software executed by the computer  52  may also permit user selection of the shell configuration in step  66 . Thus, the user may again select from a data base of shape, such as the dog bone or goldfish configurations shown in  FIGS. 2-3 , as well as other standard shapes. Alternatively, the user may provide data for the configuration of the shell by entry through the computer interface. 
     The selection steps  60 - 66  all lead to step  68  in which the computer software generates a 3D model of the shell to be printed by the 3D printing machine  50 . As is known, the 3D printing machine applies successive thin layers of the jettable media to form the 3D shape, complete with internal features such as the cavity  14 . Each of the features and components selected in steps  60 - 66  imparts some definition to the 3D shape to be printed and the manner in which it is printed. For instance, the selection of media may determine the thickness of the layers, the duration of the jetting process or the delay before a subsequent layer is applied. The selection of medicament and dosage may determine the dimensions of the cavity  14  defined in the edible media. It is contemplated that the cavity dimensions are adapted for a close fit with the medicament in the case of a solid medicament or for a substantially identical volume for a liquid medicament dosage. The shell configuration selection obviously determines the outer dimensions and shape of the final product  10 ,  30  for instance. All of this data is used by the software to generate a 3D model in step  68  to be used by the 3D printing machine. 
     The final product is produced in the ensuing steps  72 - 80 . In one aspect, the medication preparation process contemplates a final product with either a solid or a liquid medicament. The 3D printing process is modified according to the state of the medicament. Thus, in step  70  a determination is made as to whether the medicament is solid or liquid. In the case of a solid medicament, the control software directs the 3D printing machine to print the 3D shape, or apply the successive media layers, only until the bottom half of the cavity  14  is formed in step  72 . At this point, the medicament is introduced in step  78  by placing the solid medicament obtained from the container  56  within the partially formed cavity. In one embodiment the medicament is placed robotically by a machine associated with the printing machine  50 . In another embodiment, the computer and/or printing machine may alert a technician to manually place the medicament in the cavity. Once the medicament has been placed, the 3D printing process continues to complete the formation of the shell around the medicament in step  80 , leading to removal of the final product in step  82 . 
     If the medicament is a liquid, the control passes from step  70  to step  74  in which the 3d model is modified to add an internal hole at the top of the cavity  14 . This hole is sized for introduction of the liquid medicament, such as through a nozzle or syringe. Once the model is modified, the 3D printing machine applies the layers of the selected media in step  76  according to the revised model up to the printing of the hole. At that point, the entire cavity and surrounding media has been formed so that only a hole is visible that communicates with the interior of the cavity  14 . At this point, the liquid medicament is introduced through the hole into the cavity in step  78 . As with the solid medicament, the liquid medicament may be robotically or manually introduced as described above. Once the cavity  14  has been filled with the liquid medicament, the 3D printing machine is directed to complete the formation of the shell in step  80  in which the internal hole is covered with media so that the final product removed in step  82  is complete and fully contained. 
     It will be appreciated that variants of the above-disclosed and other features, and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art, which are also intended to be encompassed by the following claims.