Patent Application
20220401303
This disclosure relates to the field of drug or medicine delivery in the form of capsules or pills. The disclosure further relates to controlled release of the drug or medicine in the capsule or pill.
Many drugs, medicaments, such as drugs, nutritional supplements, vitamins or other medicines, are provided to patients in the form of fixed dosage carriers, such as capsules, caplets, tablets or pills. For instance, over-the-counter pain relievers are often provided in fixed dosage caplets with instructions to take one or more caplets depending on the patient's age, weight and medical condition. A similar approach is often taken with respect to prescription medicaments in which a number of fixed dosage medicament carriers are prescribed to come as close to an optimal dosage as possible for the patient. In some cases, it is necessary for the patient to break apart a fixed dosage pill in order to obtain the prescribed dosage.
The use of fixed dosage medicament carriers generally only allows for an approximation of an optimal dosage of a medicament for a particular patient. Various factors go into determining an optimal dosage, including the age and physical characteristics of the patient, as well as the nature of other medicaments being taken by the patient. In addition, the assimilation characteristics of the medicament after ingestion by the patient and the potential interaction of multiple medicaments being taken by the patient are considerations in determining an optimal dosage and ingestion plan.
For many patients, the optimal dosage of a particular medicament is not a multiple of the available fixed dosage carriers. For example, a particular drug may be provided in 5 mg pills, whereas the optimal dosage for a particular patient may be 11 mg of the drug. Two 5 mg pills provide less than optimal dosage, while three of the 5 mg pills are too much.
Some medications need to be absorbed quickly or all at once to achieve the desired function. On the other hand, many other medications require slower introduction into the patient's circulatory system. This enables a sustained or delayed action within the body, making sure that the patient does not get too much of the medicament at once or does not get a sufficient quantity of the medication right away. Timed-release of medications allow medication to provide a uniform effect on the patient ntil the last amount of medication has been absorbed and processed by the body.
Consequently, there is a need for a method and medicament delivery product that allows for precision dosage and controlled release of the medicament. The dosage can be personalized to a particular patient and can be readily adjusted as needed for precise dosage control.
A personalized dosage medicament product comprises a sheet composed of an edible and/or pharmaceutically-compatible material, and one or more medicaments fixed to a first surface of said substrate or sheet, each of said one or more medicaments fixed in a patient-specific pre-defined pattern. The medicaments can be different drugs, medicines, vitamins, nutritional supplements and the like. The pre-determined pattern for each medicament is patient-specific according to a prescription for the patient, taking into account dosage and absorption rates for the particular medicament.
In one feature of the present disclosure, a method for producing a medicament delivery product ingestible by a patient is provided that comprises the steps of providing a sheet composed of an edible and/or pharmaceutically-compatible material, providing a plurality of medicaments, and applying each of the plurality of medicaments onto a first surface of the sheet according to a patient-specific pre-defined pattern for each of the plurality of medicaments. The medicaments are fixed on the first surface of the sheet for subsequent absorption by the patient when the medicament is ingested.
The method can further include the step of manipulating the medicament product into a non-planar or three-dimensional form to facilitate ingestion by the patient. The three-dimensional form in combination with the pre-defined patterns of the medicaments provides a controlled release or absorption of the corresponding medicament as the underlying substrate or sheet dissolves.
The method of the present disclosure further contemplates applying a medicament in a liquid form or a powder form onto the sheet. The sheet can be a continuous sheet fed through a series of stations in which the medicament is deposited on the substrate or sheet and subsequently fixed on the sheet. In a post-processing station, the continuous sheet can be cut into a plurality of discrete medicament delivery products according to the prescription of a particular patient. According to this method, the pattern of medicaments can be designed according to a patient-specific prescription, which prescription can be stored in a memory for use by a controller to control the stations configured to feed the substrate, deposit the medicaments fix the medicaments on the substrate and post-process the sheet or substrate.
The method and product of the present disclosure provides a medicament delivery product that is tailored to a specific patient. The method and process allows for any quantity of finished delivery product to be produced according to the patient prescription and for ready change from the prescription for one patient to the prescription for a different patient. Any number of medicaments can be fixed to the substrate and manipulated into a form that is readily ingestible by the patient. The method and product further allow for pre-determined timing and sequence of release of one or more medications in a single ingestible product.
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.
A medicament delivery system 1 is shown in
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
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
In one embodiment, the delivery product 1 can be rolled or wound into a cylindrical configuration as shown in
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
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
The segment 21g of the pattern on the substrate 20 does not include any medicament.
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
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
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
The patterns of medicaments 11a -11f, 21a -21f are deposited on the substrate 10, 20 in a manner suitable to the particular medicament(s).
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.
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.
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.
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
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.
The system shown in
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.
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
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
The system shown in
For either system and method shown in
The systems shown in
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
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.
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.
