Personalized Medicament Delivery Product
20220401303 · 2022-12-22
Inventors
- Chu-Heng Liu (Penfield, NY)
- Jason M. LeFevre (Penfield, NY)
- Paul J. McConville (Webster, NY)
- Seemit Praharaj (Webster, NY)
- Douglas K. Herrmann (Webster, NY)
Cpc classification
A23P20/20
HUMAN NECESSITIES
A23P20/18
HUMAN NECESSITIES
A23P2020/253
HUMAN NECESSITIES
A61J3/07
HUMAN NECESSITIES
International classification
A61J3/07
HUMAN NECESSITIES
A23P20/18
HUMAN NECESSITIES
A23P20/20
HUMAN NECESSITIES
A61J3/00
HUMAN NECESSITIES
Abstract
A medicament delivery product is provided in which one or more medicaments are fixed on a sheet according to a patient-specific pre-defined pattern. The sheet is formed into a three-dimensional or non-planar shape to facilitate ingestion by the patient. The pre-defined patterns for the medicaments are configured for controlled release or absorption of the corresponding medicament after ingestion by the patient. The medicaments can be in a liquid or a powder form and applied to the surface of the sheet in an appropriate manner. The one or more medicaments can be any combination of drugs, medicines, vitamins, nutritional supplements and the like.
Claims
1. A method for producing a medicament delivery product ingestible by a patient, comprising the steps of: providing a sheet composed of an edible and/or pharmaceutically-compatible material; providing a plurality of medicaments; applying each of said plurality of medicaments onto a first surface of said sheet according to a patient-specific pre-defined pattern for each of said plurality of medicaments; and fixing each of said plurality of medicaments on the first surface of said sheet.
2. The method of claim 1, said plurality of medicaments are different from each other.
3. The method of claim 1, further comprising, after the step of fixing the last one of said plurality of medicaments, subsequently manipulating said sheet into a non-planar shape suitable for ingestion by the patient.
4. The method of claim 3, wherein: said sheet includes a second surface opposite said first surface; said step of subsequently manipulating said sheet includes rolling said sheet into a cylinder shape with said opposite second sheet exposed; and then fixing the sheet in said cylinder shape.
5. The method of claim 3, wherein the step of subsequently manipulating said sheet into a non-planar shape includes folding said sheet.
6. The method of claim 1, wherein: the step of providing a sheet includes providing a continuous sheet; and said applying step includes continuously conveying said sheet as each of said plurality of medicaments is applied onto said first surface.
7. The method of claim 6, further comprising, after the step of fixing the last one of said plurality of medicaments, subsequently cutting said continuous sheet to form a discrete delivery product.
8. The method of claim 1, wherein: at least one medicament of said plurality of medicaments is provided in a liquid form; and said applying step for said at least one medicament includes applying the liquid form using a plurality of nozzles, said nozzles controllable to eject said liquid form of said at least one medicament in said pre-defined pattern for said at least one medicament.
9. The method of claim 1, wherein: at least one medicament of said plurality of medicaments is provided in a powder form; and said applying step for said at least one medicament includes applying the powder form onto said sheet in said pre-defined pattern for said at least one medicament.
10. The method of claim 10, wherein said powder form is applied electrostatically to said sheet.
11. The method of claim 10, wherein said applying step for said at least one medicament includes: applying a liquid agent onto said first surface in said pre-defined pattern for said at least one medicament, said liquid agent adapted to attach or fix said powder form of said at least one medicament onto said sheet; and then applying the powder form onto said sheet so that said powder form is attached or fixed to said sheet only in said pre-defined pattern for said at least one medicament.
12. The method of claim 1, wherein the pre-determined pattern for two or more of said plurality of medicaments include a portion where one medicament at least partially overlaps another medicament.
13. The method of claim 1, wherein: said sheet includes a second surface opposite said first surface; and the method further comprises the step of printing information on said second surface of said sheet.
14. The method of claim 13, wherein said information includes one or more of medicament specific information and patient specific information.
15. The method of claim 1, wherein each of said plurality of medicaments is selected from the group consisting of a drug, a medicine, a vitamin and a nutritional supplement.
16. A method for producing a medicament delivery product ingestible by a patient, comprising the steps of: providing a sheet composed of an edible and/or pharmaceutically-compatible material; providing a medicament; applying the medicament onto a first surface of said sheet according to a patient-specific pre-defined pattern that is less than the entirety of said first surface; and then fixing the medicament on the first surface of said sheet.
17. The method of claim 16, further comprising, after the step of fixing the medicament, subsequently manipulating said sheet into a non-planar shape suitable for ingestion by the patient.
18. A medicament delivery product comprising: a sheet composed of an edible and/or pharmaceutically-compatible material; and one or more medicaments fixed to a first surface of said sheet, each of said one or more medicaments fixed in a patient-specific pre-defined pattern that is less than the entirety of said first surface.
19. The medicament delivery product of claim 18, wherein said sheet is formed into a non-planar configuration.
20. The medicament delivery product of claim 19, wherein said non-planar configuration is a cylinder shape with a surface opposite said first surface exposed.
Description
DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0020] For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the disclosure is thereby intended. It is further understood that the present disclosure includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles disclosed herein as would normally occur to one skilled in the art to which this disclosure pertains.
[0021] A medicament delivery system 1 is shown in
[0022] In accordance with the present disclosure, one or more medicaments are applied to or “printed” on the substrate 10. In certain embodiments, the one or more medicaments can be applied in a pre-defined pattern on the substrate that is personalized to the particular patient. Thus, in the example shown in
[0023] It can be appreciated that the entire surface of the substrate 10 can be covered with one medicament, such as medicament 12, or with multiple medicaments provide side-by-side along the length or width of the entire substrate 10. However, in the illustrated embodiment, the medicaments are provided in a pattern of segments 11a -11f configured to control the timing and sequence of release of the medicaments in each segment. In one embodiment, the substrate 10 is rolled into a cylindrical configuration, as shown in the top view of
[0024] In one embodiment, the delivery product 1 can be rolled or wound into a cylindrical configuration as shown in
[0025] In an alternative embodiment, a delivery product 2 is configured to be, in essence, self-contained. Thus, the device 2 includes a substrate 20 that can be formed of the edible or pharmaceutically-compatible materials described above with respect to substrate 10. The medicaments 22, 23 can be applied in essentially the same pattern of segments 21a -21f as the segments 11a -11f. In one modification, best shown in
[0026] The delivery product 2 includes a segment 21g at one end of the substrate 20 that does not include any medicament. The bottom surface 20b of the substrate 20, opposite the upper surface 20a with the segments 21a -21f, is provided with an adhesive layer 25. The adhesive layer covers substantially the entire bottom surface 20b of the substrate 20. The adhesive layer 25 comprises an adhesive capable of adhering to the upper surface 20a so that the substrate 20 can be rolled up as shown in
[0027] The segment 21g of the pattern on the substrate 20 does not include any medicament.
[0028] The segment 21g has a length sufficient to completely encircle or encase the medicament-bearing segments of the substrate when the substrate is rolled or wound into the cylindrical configuration shown in
[0029] The adhesive layer 25 offers a convenient way to roll or pack the medication delivery product 2. In addition, the adhesive or glue can be selected so that it is not readily dissolvable when ingested. This characteristic of the adhesive can prevent the quick un-winding of the packed/rolled medication structure, thereby providing a precision-controlled release of the medications originally printed on the planner substrate. Once the patient ingests the device 1, wound as shown in
[0030] It can be appreciated that the pattern segments of medicaments 11a -11f, 21a -21f described above can be for one or more medicaments, such as medicines and drugs. For instance, a particular pattern of a single medicament can be provided on the delivery product 1, 2 to establish a pre-determined release and absorption sequence, such as a time-release feature for the medicament. It is contemplated that the substrate 10, 20 dissolves at a known rate to expose the medicament deposited on the substrate, and this known rate can be used to provide for precision delivery of the medicament to the patient. The rate of delivery can be adjusted by rolling the product 1, 2, as illustrated in
[0031] The patterns of medicaments 11a -11f, 21a -21f are deposited on the substrate 10, 20 in a manner suitable to the particular medicament(s).
[0032] The deposition station 30 is configured to and capable of uniformly depositing the first liquid medicament in a pre-determined pattern across the width and along the length of the substrate as it passes beneath the device. In certain embodiments, the first liquid medication is applied at a substantially uniform thickness on the surface of the substrate. The pre-determined pattern can be unique to a particular patient, as described above. Thus, in one embodiment, the deposition station 30 includes a plurality of controllable jets or nozzles connected to a reservoir 31 containing the first liquid medicament. In specific embodiments, the deposition station can be a device used for depositing phase-change compositions onto a print substrate, in the nature of an ink-jet printer. For example, medications can be dissolved or dispersed in a phase-change carrier, such as a wax, at the deposition station, or can be dissolved or dispersed in the phase change wax that is provided to the deposition station in solid form. In embodiments utilizing a phase-change carrier, the phase change composition or wax can have a phase-change temperature between, for example, but not limited to, 40 and 200° C., or more particularly a phase-change temperature between 60 and 120° C. In some aspects, the phase change carrier can be solid at room temperature and fluid at temperatures above the phase change temperature. In some aspects, the phase change carriers can have a viscosity at jetting temperature between, for example, but not limited to, 0.5 to 50 cps, or more particularly 5 to 20 cps.
[0033] It can be appreciated that a similar ink-jet printer device can be used to deposit a medicament in liquid form without the phase-change ink. The deposition station can include a plurality of jets or nozzles extending across the width of the substrate 10, 20 and arranged to ensure that a substantially uniform layer of the first liquid medicament is applied to the substrate. The nozzles can be individually controlled to be activated to dispense the liquid medicament in a pre-determined pattern, such as the patterns described above. The nozzles can also be controlled to control the thickness of the liquid medicament layer on the substrate.
[0034] After deposition of the first medicament, the substrate 10, 20 is conveyed by rollers to a conditioning station 35 where the layer of the first liquid medicament is fixed on the substrate. In particular, the medicament can be dried and/or compacted on the substrate. The station 35 can comprise heated rollers or other components suitable to condition the medicament layer without compromising the medicament. The conditioning station 35 can also be configured to ensure that the medicament has a uniform thickness across the substrate.
[0035] If a second medicament is to be incorporated into the delivery product 1, 2, the substrate advances to a second deposition station 40 that is configured to deposit a second liquid medicament onto the substrate 10, 20 as it passes. The second deposition station 40 can be configured similar to the first deposition station 30, including nozzles or jets to direct the second liquid medicament form a second reservoir 41 onto the substrate in a controlled manner according to the pre-determined pattern. The second liquid medicament can be applied as segments separate from the first liquid medicament, as reflected in the pattern shown in
[0036] After exiting the last conditioning station, such as station 45, the substrate 10, 20 carries the full complement of medicaments in the pre-determined pattern prescribed for the particular patient. The substrate advances to a post-processing station 50. The station 50 can include a cutting element configured to cut the substrate to form the final individual delivery products 1, 2. Alternatively, the cutting element of the post-processing station 50 can be configured to form perforations along the width of the substrate 10, 20 for a certain number of delivery products 1, 2 that can be subsequently separated by the patient. Post-processing can also include printing information on the non-medicament side of the substrate 10, 20. That information can include information regarding the medicaments in the delivery product, instructions for taking the medicaments and patient specific information. The post-processing station 50 can include a packaging element configured to package the delivery product products in sheet form or to further process the delivery products into a 3D shape, as described above. The re-formed 3D delivery product can be held or fixed in the 3D configuration by insertion into a capsule or by the introduction of a fixing element, such as a band or an adhesive. In some cases, timed-release is not required so the 3D configuration of the delivery product 1, 2 can be adapted to unroll or unfold very soon after ingestion, exposing all of the medicaments on the substrates 10, 20. In these cases, the fixing element can be configured to dissolve more quickly than the delivery product 1, 2.
[0037] The system shown in
[0038] In some cases, the medicament is provided in a powder or granular form that is not susceptible to dissolved or dispersed in a liquid for nozzle deposition.
[0039] The substrate 10, 20 then passes to a powder coating station 65 that exposes the substrate, and particularly the pattern of the liquid agent, to the medicament, which is in powder or granular form and stored in a reservoir 66. The medicament will only adhere to the substrate in the pre-determined pattern and will not interact with the “un-treated” surfaces of the substrate. The powder coating station 65 is configured to apply the powder medicament in any suitable manner, with provisions to capture and/or recycle medicament that is not captured on the treated pattern. Thus, the powder medicament can be applied by direct contact between the treated pattern and the powder in the reservoir. In another embodiment, the powder can be applied by a dusting device that floods the substrate with the medication in powder form. Alternatively, the powder can be applied by a nozzle or electrostatically, as is known in the printing art. After the first powder medicament has been applied in coating station 65, the substrate passes to a conditioning station 70, which can be similar to the conditioning stations 35, 45 described above. The primary goal of the conditioning station 70 is to fix or stabilize the powder medicament on the substrate. It is contemplated that the system of
[0040] If a second medicament is required for the particular delivery product 1, 2, a subsequent second deposition station 75, second reservoir 76, second powder coating station 80, second powder reservoir 81 and second conditioning station 85 can be provided that operates in the same manner as the deposition station 60 and powder coating station 65 just described. In this instance, the second medicament is also provided in powder or granular form. The system of
[0041] The system shown in
[0042] For either system and method shown in
[0043] The systems shown in
[0044] The controller 55, 95 is thus configured and operable to first advance an edible or pharmaceutically-compatible substrate to a deposition station, as in step 100 of the flowchart in
[0045] It is contemplated that the medicament(s) are “printed” on a substrate according to the pre-defined patient-specific pattern. This “printing” can be performed using an ink jet printer or similar device for the fluid-based medicaments discussed above. Examples of suitable ink jet devices and methods are described in U.S. Pat. No. 6,779,861, issued on Aug. 24, 2004, in U.S. Pat. No. 7,828,423, which issued on Nov. 10, 2010, and in U.S. Pat. No. 9,381,154, which issued on Jul. 5, 2016, the entire disclosures of which are incorporated herein by reference. It is known that some ink jet printers are thermal printers in which the print medium is provided in solid form and then melted prior to being dispersed by the nozzles or jets. In the present disclosure, the liquid medicament is not necessarily provided in a solid form, but is typically provided in liquid form so that there is no need to melt a solid medium. For medicaments provided in powder form, the “printing” can be performed with an electrostatic printer. Examples of a suitable electrostatic printer are described in U.S. Pat. No. 6,611,665, which issued on Aug. 26, 2003, and in U.S. Pat. No. 8,840,241, issued on Sep. 23, 2014, the entire disclosures of which are incorporated herein by reference.
[0046] The present disclosure should be considered as illustrative and not restrictive in character. It is understood that only certain embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the disclosure are desired to be protected.