Method and system for printing personalized medication

Abstract

An exemplary method of printing medications on digestible substrates is described. Single component nonmagnetic toners with active pharmaceutical ingredients (API) embedded or dissolved in the toner are used. The binders for the toner are digestible. The printing process includes loading the single component non-magnetic toners from a sump to a donor roll and developing them either directly onto the substrate or through the use of an intermediate member. Traditional xerographic charge and exposure can be used to make the tablet imprints. Dosage is controlled through solid area or halftone development (when charge and exposure are used). The printed first layer may undergo cold or warm pressure fusing. This medicament layer is then subjected to another station to print a second layer of medical tablet. Multiple stations may be used to build up a complete personalized tablet. Optionally, a final station prints protective overcoat materials to finalize the tablet.

Claims

1. A method of printing personalized medication with a printing system, the method comprising: dissolving at least a salicylate material in binder, to create a first triboelectrically chargeable medicament toner, wherein one or more pharmaceutically inert ingredients are compounded in the binder in addition to the salicylate material; transferring the charged toner to a selectively exposed intermediate member; transferring the toner from the intermediate member to an edible substrate; fusing the transferred toner via cold pressure, warm pressure, or radiant fusing; compounding another material in binder, to create a second triboelectrically chargeable medicament toner different from the first toner; transferring the second charged toner to a second selectively exposed intermediate member; transferring the second toner from the intermediate member to form a second layer on the edible substrate; fusing the second transferred toner via cold pressure, warm pressure, or radiant fusing; and depositing one or more protective overcoat materials to finalize the personalized medication, wherein the printing system includes multiple transfer stations configured to deliver either increased doses or tablets with more than one triboelectrically chargeable medicament toner.

2. The method of claim 1, wherein the intermediate member comprises a donor roll or a web.

3. The method of claim 1, wherein at least one of the first and second toners comprises a single component toner.

4. The method of claim 1, wherein at least one of the first and second toners comprises a two-component toner and includes a carrier.

5. The method of claim 1, wherein at least one of the first and second toners comprises a single component, non-magnetic toner.

6. The method of claim 1, wherein the multiple transfer stations are further configured to deliver tablets with more than one salicylate material.

7. A method of printing personalized medication with a printing system, the method comprising: compounding a salicylate material in binder, to create at least one triboelectrically chargeable medicament toner, wherein one or more pharmaceutically inert ingredients are compounded in the binder in addition to the salicylate material; directly depositing the medicament toner onto an edible substrate; fusing the transferred toner via cold pressure, warm pressure, or radiant fusing; and further comprising compounding another material in binder, to create a second triboelectrically chargeable medicament toner different from the first toner; directly depositing the second medicament toner onto the edible substrate to form a second layer on the edible substrate; and fusing the second transferred toner via cold pressure, warm pressure, or radiant fusing and depositing one or more protective overcoat materials to finalize the personalized medication, wherein the printing system includes multiple transfer stations configured to deliver increased doses.

8. The method of claim 7, wherein the toner comprises a single component toner.

9. The method of claim 7, wherein the toner comprises a two-component toner and includes a carrier.

10. The method of claim 7, wherein the toner comprises a single component, non-magnetic toner.

11. A method of printing personalized medication, the method comprising: loading a first single component, non-magnetic toner from a first sump onto a first donor roll, wherein the first toner comprises a first salicylate material embedded or dissolved in at least one toner binder, wherein one or more pharmaceutically inert ingredients are compounded in the binder in addition to the salicylate material; transferring the first toner from the first donor roll to an edible substrate to form a first layer on the edible substrate; loading a second single component, non-magnetic toner from a second sump onto a second donor roll, wherein the second toner comprises a second salicylate material embedded or dissolved in at least one toner binder and is different from the first toner; transferring the second toner from the second donor roll to the edible substrate to form a second layer on the edible substrate and an increased dose; developing the layers of toner; and depositing one or more protective overcoat materials over the layers of toner to finalize the personalized medication, wherein the printing system includes multiple transfer stations configured to deliver increased doses.

12. The method of claim 11, wherein each printed layer undergoes cold pressure fusing, warm pressure fusing, or radiant fusing.

13. A method of printing personalized medication with a printing system, the method comprising: dissolving an active pharmaceutical ingredient (API) in binder, to create at least one triboelectrically chargeable medicament toner, wherein one or more pharmaceutically inert ingredients are compounded in the binder in addition to the API; transferring the charged toner to a selectively exposed intermediate member; transferring the toner from the intermediate member to an edible substrate; fusing the transferred toner via cold pressure, warm pressure, or radiant fusing; compounding another API in binder, to create a second triboelectrically chargeable medicament toner different from the first toner; transferring the second charged toner to a second selectively exposed intermediate member; transferring the second toner from the intermediate member to form a second layer on the edible substrate; and fusing the second transferred toner via cold pressure, warm pressure, or radiant fusing; and depositing one or more protective overcoat materials to finalize the personalized medication, wherein the printing system includes multiple transfer stations to deliver increased doses or tablets with more than one API.

14. The method of claim 13, wherein the intermediate member comprises a donor roll or a web.

15. The method of claim 14, wherein the first and second toners comprise one or more of a single component toner, a two-component toners including at least one carrier, or a single component, non-magnetic toner.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows multiple xerographic stations for depositing multiple medications on an edible substrate;

(2) FIG. 2 is a block diagram showing stations inserted between two adjacent depositions for the use of stabilizing the previous layer before the next deposition;

(3) FIG. 3 is a block diagram of an exemplary printing system suitable for implementing aspects of the exemplary embodiment; and

(4) FIG. 4 is a flow chart illustrating an exemplary method of printing personalized medication on edible substrates.

DETAILED DESCRIPTION

(5) The exemplary embodiment relates to a method of printing personalized medications (or tablets) on digestible substrates or on substrates that can be excreted from the digestive tract. The exemplary embodiment generally involves the use of toners, which have active pharmaceutical ingredients (API) embedded or dissolved in toner binders. The binders are also either digestible or can be excreted.

(6) More particularly, the exemplary embodiment generally includes compounding an active pharmaceutical ingredient (API) in binder to create at least one triboelectrically chargeable medicament toner. The medicament toner may be deposited to edible substrates through at least two ways: (1) by direct deposition onto edible substrates (as in Xerographically direct to paper) or (2) by developing the charged toner to a selectively exposed intermediate member and transferring the toner from the intermediate member to an edible substrate. The transferred toner may be fused via cold pressure, warm pressure, or radiant fusing. Optionally, one or more pharmaceutically inert ingredients are compounded in the binder in addition to the API. The system can be either two-component (i.e., include a carrier) or single component. In some embodiments, the system uses single component, non-magnetic, API-containing toners. Further, some systems may include multiple transfer stations to deliver either increased doses or tablets with more than one API. The exemplary embodiments will be described in greater detail below.

(7) In single component development systems, the toner particles are usually triboelectrically charged and generally are required to jump a gap to develop the electrostatic latent image on an image surface. Most single component development systems cause the charged toner particles to be transported to a development zone where they are caused to form a toner cloud by the action of an AC electric field. A combination of AC and DC electrical biases attract the charged toner particles in the toner cloud to the electrostatic latent image on image surface, thereby developing the image and rendering it visible. There are several reasons for selecting single component, nonmagnetic toners. For example, single component development does not need a carrier. Also, single component development does not need highly charged particles, which gives more latitude to particle designs. Typical single component toners are charged by the metering blade on the donor roll before development and have a low Q/m ratio. In addition, single component development can use either Emulsion Aggregation (EA) or conventional toners. Moreover, single component development is a relatively gentle process.

(8) There are various ways to deposit or print the medicament toners onto digestible substrates. For example, in one printing system, a donor roll is employed to load the single component non-magnetic toners from a sump whereby toners could be developed through electric bias directly onto the substrate. Alternatively, toners can be developed through electrical bias onto an intermediate member and then transferred onto the substrate.

(9) FIG. 1 illustrates an example of multi-station fabrication of medical tablets using single component non-magnetic development that directly deposits the medicament powder onto an edible substrate 1. With reference to FIG. 1, multiple stations (2, 3, and 4) may be used to build up a complete personalized tablet on the edible substrate 1, with each station depositing a different medicine. Each toner (5, 6, 7) at each station has a different active pharmaceutical ingredient (API) dispersed in the binder. Although not shown, it is to be understood that a sump is used to hold toner, which includes at least one API, along with a mechanism for automatically replenishing toner, as it is consumed.

(10) FIG. 2 depicts some optional steps in the tablet-making process. That is, one or more stations 8 can be inserted between two adjacent depositions of API on the substrate 9, e.g., between API 1 and API 2 or between API 2 and API 3, etc., for the use of stabilizing the previous layer before the next deposition. To keep each medicament layer from contaminating the next deposition station 8, a fuser (or stabilizer such as charger) may be incorporated to compact or fuse the toner (this can be cold pressure, warm pressure, or conventional toner fusing). A final station 10 overprints the medication with protective materials for tablet coating.

(11) Since high image resolution is not required, the medicament tablet shape can be formed from a mask (an insulation material with openings for toner development) or through traditional xerographic charge and exposure methods and systems. Medicament dosage can be controlled through layers of solid area in the mask development. In the case that a real latent image can be formed, dosage can also be controlled by using halftones.

(12) The receiving substrate can be edible papers or any other suitable materials that will not disintegrate in the digestive tract and can be expelled (paper itself may qualify for this requirement). The receiving substrate generally needs to be at least similar to paper in physical properties to facilitate deposition and stabilization of the toner on the edible substrate.

(13) There are various advantages to building a personalized medicament tablet through single component non-magnetic development. For example, such a process is likely to work with a high percentage of APIs used in the tablet form of medicines. Also, fabrication and characteristics of medicament powders are similar to toner and its manufacturing, in particular, is similar to the conventional toner manufacturing. Further, polymers used in current hot melt extrusion have similar glass transition temperatures as xerographic toners.

(14) Suitable materials for binders include polyesters, which are used in hot extrusions of pharmaceutical excipients. Such polyesters have similar properties as xerographic toners. Polyesters tend to be charged negatively. If charge, or Q/M, of the particles need to be enhanced, use of charge control agents are possible. For example, salicylate-type materials (i.e., the medicine used in Aspirin) have the necessary properties to serve as a charge control agent. Besides charge control agents, it is also possible to use other means to enhance particle charges. For example, US patent publication 2008/0056776, the disclosure of which is incorporated herein by reference, shows an example of using corotron to pretreat the particles.

(15) Preventing contamination of donor rolls is a consideration. Donor rolls for single component development are made of semi-conductive rubbers. They are typically polyurethane doped with ionically conductive salts. Polyurethane is chemically inert. Polyurethane is used as storage containers/foams for pharmaceutical solutions. When digested, it becomes urea (a component of animal urine). Contamination of polyurethane from donor roll wear to printed pills is very minimal. The overall effect of polyurethane on the medication is virtually none. Ionically conductive salts are also widely used in pharmaceutical industry. Any reactions between the salt leached out of the donor roll and the pharmaceutical ingredients can be minimized or eliminated, since the active pharmaceutical ingredients constitute only 0.5% of the total materials used in the tablet, which is buried in the binder or through the correct selection of the salts.

(16) The term marking engine is used herein generally to refer to a device for applying an image to print media. Print media usually refers to a physical sheet of paper, plastic, or other suitable physical print media substrate for images, whether precut or web fed. In this case, the print media includes digestible substrates or substrates that can be excreted from the digestive tract. As used herein, a printing system can be a digital copier or printer, multi-function machine, or the like and can include one or more marking engines, as well as other processing components, such as print media feeders, finishers, and the like.

(17) With reference to FIG. 3, an exemplary apparatus 10 for printing personalized medication, such as tablets, in accordance with the exemplary embodiment is schematically illustrated. Of course, it is to be understood that other types of printing systems may be utilized in accordance with aspects of the exemplary method. In this regard, reference is made to several U.S. patents and patent Publications that describe additional printing system architectures that may be suitable for implementing the exemplary embodiment, including U.S. Pat. No. 6,208,825, U.S. Patent Publication No. 2011/0008077, and U.S. Patent Publication No., 2010/0021189, the disclosures of which are incorporated herein by reference.

(18) As shown in FIG. 3, the apparatus 10 may include first and second xerographic (electrostatic) marking engines 14, 16. It is to be appreciated, however, that the apparatus 10 may include any number of marking engines, depending on the application and the number of active pharmaceutical ingredients to be deposited in each tablet.

(19) The developer generally includes only toner particles (or toner). The toner (or, in this case, API(s) and/or other materials) is consumed by the marking engines 14, 16 during the printing of tablets, for instance. By way of example, the first marking engine 14 consumes toner in the course of generating a first print (or layer) on first print media (or edible substrate) 30, while the second marking engine 16 consumes toner in generating a second print (or layer) on print media (or edible substrate) 32, which may be the same or a different sheet of print media from print media 30. Each marking engine 14, 16 may receive fresh developer 34, 36 from a respective replaceable container (or sump) 38, 40, although it is also contemplated that the marking engines could be supplied toner from a common container.

(20) With further reference to FIG. 3, each xerographic marking engine 14, 16 applies toner to print media 30, 32, such as sheets of paper, during the formation of images. The exemplary marking engines 14, 16 may include many of the hardware elements employed in the creation of desired images by electrophotographical (xerographical) processes. For example, the marking engines 14, 16 may utilize two component magnetic brush development systems, either to directly develop electrostatic images on a photoreceptor or to load a donor roll, which in turn is used to develop a photoreceptor. FIG. 1 illustrates an embodiment where images are developed directly on a photoreceptor.

(21) Since both marking engines 14, 16 may be similarly configured, only one marking engine 14 will now be described, with similar elements on the other marking engine indicated by a prime (). In particular, the marking engine 14 typically includes a charge retentive surface 80, such as a rotating photoreceptor in the form of a belt or drum. The images are created on a surface of the photoreceptor. Disposed at various points around the circumference of the photoreceptor 80 are xerographic components. The xerographic components each perform a portion of a marking operation (the formation of a layer of toner on the print media). These components may include a charging station 82 for each of the toners to be applied, such as a charging corotron, an exposure station 84, such as a raster output scanner (ROS), which forms a latent image on the photoreceptor, a developer unit 86, associated with each charging station for developing the latent image formed on the surface of the photoreceptor, a transferring unit 88, such as a transfer corotron, a fuser 90, for fusing the toner layers to the print media and a cleaning device 92, for cleaning the photoreceptor before a new toner layer is formed thereon. As will be appreciated, there may be multiple charging stations, exposure stations, and associated developer stations arranged around a single photoreceptor, one set for each toner. Alternatively, for each toner, a separate photoreceptor is provided. In this embodiment, the toner layers may be transferred from the photoreceptor to the sheet via an intermediate transfer belt. Alternatively, the photoreceptors are arranged in tandem, with the sheets being sequentially marked at a separate transfer station for each of the toners.

(22) Optionally, a charging device, such as corotron, deposits charge through pre-determined masks to the receiving substrate (that can be photoreceptor or other semi-insulating media). These masks may be in the shape of tablets. In the case that a digital charging (such as ionographic writing) or exposure (such as ROS or LED), the API from each station can be deposited either layered on top of the previously deposited particles or can be put down adjacently. Depending on the API release timing, structures can be built around each API.

(23) In operation, the photoreceptor 14 rotates and is charged at the charging station 82. The charged surface arrives at the exposure station 84, where a latent image is formed. The portion of the photoreceptor on which the latent image is formed arrives at the developer unit 86, which applies toner to the latent image to obtain a toner image. The developed image moves with the photoreceptor to the transferring unit 88, which transfers the toner image thus formed to the surface of the print media substrate 30 (or to an intermediate transfer belt), by applying a potential to the sheet. The sheet and image are conveyed away from the photoreceptor to the fuser 90, which fuses the toner image to the sheet using heat and/or pressure. Meanwhile, the photoreceptor 14 rotates to the cleaning device 92, which removes residual toner and charge from the photoreceptor, ready for beginning the process again. It is to be appreciated that the marking engine 14, 16 can include an input/output interface, a memory, a marking cartridge platform, a marking driver, a function switch, a controller and a self-diagnostic unit, all of which can be interconnected by a data/control bus.

(24) By way of example, the first sump 38 may be configured to load a first toner, such as a single component, non-magnetic toner, onto the first donor roll 80. The first single component, non-magnetic toner may include a first API embedded or dissolved in the first toner and the first donor roll may be configured to transfer the first single component, non-magnetic toner to an edible substrate 30 to form a first layer on the edible substrate 30. The second sump 40 may be configured to load a second toner, such as a single component, non-magnetic toner, onto the second donor roll 80. The second single component, non-magnetic toner may include a second API embedded or dissolved in the second toner and the second donor roll may be configured to transfer the second single component, non-magnetic toner to the edible substrate 30 to form a second layer on the edible substrate 30. The developers 86, 86 may be configured to develop the layers of toner on the edible substrate 30 and, optionally, a depositor (not shown) may be configured to deposit one or more protective overcoat materials on the layers of toner to finalize the medication.

(25) An exemplary computer-implemented method of printing personalized medication using the printing system of FIG. 3 is shown in FIG. 4. The exemplary method generally includes loading, for example, a first toner 34, such as a single component, non-magnetic toner, from a first sump 38 onto a first donor roll 80 (402). Typically, the first single component, non-magnetic toner 34 includes a first type of API embedded or dissolved in the toner 34. The first single component, non-magnetic toner 34 is then transferred from the first donor roll 80 to an edible substrate 30 to form a first layer on the edible substrate 30 (404). A second toner 36, such as a single component, non-magnetic toner, is then loaded from a second sump 40 onto a second donor roll 80 (406). The second single component, non-magnetic toner 36 generally includes a second type of API embedded or dissolved in the second toner 36. The second single component, non-magnetic toner 36 from the second donor roll 80 is transferred to the edible substrate 30 to form a second layer on the edible substrate (408). The layers of toner are developed via a developer 86, 86 (410), and, optionally, one or more protective overcoat materials are deposited over the layers of toner to finalize the medication (412).

(26) The exemplary methods described herein may be implemented in a non-transitory computer program product that may be executed on a computer or other type of computing device. The computer program product may be a tangible computer-readable recording medium (or computer-usable data carrier) on which a control program is recorded, such as a disk, hard drive, or may be a transmittable carrier wave in which the control program is embodied as a data signal. Common forms of computer-readable media (or data carriers) include, for example, flash drives, floppy disks, flexible disks, hard disks, magnetic tape, or any other magnetic storage medium, CD-ROM, DVD, or any other optical medium, a RAM, a PROM, an EPROM, a FLASH-EPROM, or other memory chip or cartridge, transmission media, such as acoustic or light waves, such as those generated during radio wave and infrared data communications, and the like, or any other medium from which a computer can read and use.

(27) It will be appreciated that variants of the above-disclosed and other features and functions, or alternatives thereof, may be 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.