CN110860029B - Transdermal drug delivery patch and transdermal drug delivery method - Google Patents
Transdermal drug delivery patch and transdermal drug delivery method Download PDFInfo
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- CN110860029B CN110860029B CN201910955861.8A CN201910955861A CN110860029B CN 110860029 B CN110860029 B CN 110860029B CN 201910955861 A CN201910955861 A CN 201910955861A CN 110860029 B CN110860029 B CN 110860029B
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
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Abstract
The invention discloses a transdermal drug delivery patch and a transdermal drug delivery method, which comprise the following steps: the drug delivery device comprises a drug supply structure, a control device, an electric power drug delivery module, a microneedle array driving module, a first drug storage pool and a second drug storage pool; the first medicine storage pool is positioned between the medicine supply structure and the electrodynamic force medicine feeding module, and the second medicine storage pool is positioned between the electrodynamic force medicine feeding module and the microneedle array driving module; the control device is respectively connected with the electric power drug delivery module and the micro-needle array driving module. An electric field is applied between the electric power dosing module and the micro-needle array driving module through the control device, so that the medicines can penetrate through the skin cuticle through the micro-needle array driving module while being transmitted from the first medicine storage pool to the second medicine storage pool, and the speed of the medicines penetrating through the skin cuticle can be realized by adjusting the size of the electric field, so that the actual application requirements are met.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a transdermal drug delivery patch and a transdermal drug delivery method.
Background
The medicine can be slowly released in the human body and can be kept in an effective concentration range by adopting a transdermal administration technology. However, transdermal drug delivery is often prevented from entering the human body well by the stratum corneum of human skin.
In the prior art, transdermal drug delivery is generally realized by using techniques such as microneedle arrays, ultrasonic introduction, electroporation, ion introduction or laser micropore and the like, so as to promote the drugs to penetrate through the stratum corneum into the human body. However, in practical applications, the dosage of the patient needs to be adjusted according to the change of the disease condition, and the administration rate of these techniques is often difficult to adjust on a single transdermal patch, which causes a gap between the current transdermal administration mode and the practical application requirement.
Disclosure of Invention
The object of the present invention is to provide a transdermal patch and a transdermal administration method, which are directed to the above-mentioned disadvantages of the prior art, and the object is achieved by the following means.
In a first aspect the present invention provides a transdermal patch comprising: the drug delivery device comprises a drug supply structure, a control device, an electric power drug delivery module, a microneedle array driving module, a first drug storage pool and a second drug storage pool;
the first medicine storage pool is positioned between the medicine supply structure and the electrodynamic force medicine feeding module, and the second medicine storage pool is positioned between the electrodynamic force medicine feeding module and the microneedle array driving module;
the control device is respectively connected with the electric power drug delivery module and the microneedle array driving module.
A second aspect of the present invention provides a method of transdermal drug delivery using a control device in a transdermal drug delivery patch as described in the first aspect above, the method comprising:
receiving a first control instruction;
and applying an electric field to the electrodynamic force drug delivery module and the microneedle array driving module based on the first control instruction so that the drugs in the first drug storage pool are pumped into the second drug storage pool under the action of the electric field force and pass through the skin stratum corneum by the microneedle array driving module.
In the embodiment of the application, the electric field is applied by the control device on the electric power drug delivery module and the micro-needle array driving module, so that the drug is promoted to be transferred from the first drug storage pool to the second drug storage pool, and simultaneously, the micro-needle array driving module penetrates through the stratum corneum, and the speed of the drug penetrating through the stratum corneum can be adjusted by controlling the size of the electric field, so as to meet the requirements of practical application.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention and not to limit the invention. In the drawings:
FIG. 1 is a schematic diagram illustrating the construction of a transdermal patch in accordance with an exemplary embodiment of the present invention;
FIG. 2 is a schematic structural view of another transdermal patch according to an exemplary embodiment of the present invention;
FIG. 3 is a schematic structural view of yet another transdermal patch according to an exemplary embodiment of the present invention;
fig. 4 is a flow chart illustrating an embodiment of a method of transdermal drug delivery according to an exemplary embodiment of the present invention.
Detailed Description
Reference will now be made in detail to the exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, like numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatus and methods consistent with certain aspects of the invention, as detailed in the appended claims.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in this specification and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.
It is to be understood that although the terms first, second, third, etc. may be used herein to describe various information, these information should not be limited to these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present invention. The word "if" as used herein may be interpreted as "at … …" or "when … …" or "in response to a determination", depending on the context.
For some chronic diseases, long-term oral administration or injection of drugs is required to control the progress of the disease, and the transdermal administration technology can solve the inconvenience of long-term oral administration or injection of drugs for patients with chronic diseases. However, the transdermal administration mode adopted at present has a constant administration rate, which is not consistent with the actual situation that the dosage of the patient needs to be adjusted according to the change of the disease condition.
In order to solve the above technical problems, the present invention provides a novel transdermal drug delivery technology, and fig. 1 is a cross-sectional view of a transdermal drug delivery patch, including: the drug replenishing structure 10, the control device 20, the electrodynamic force drug delivery module 30, the microneedle array driving module 40, the first drug storage tank 50 and the second drug storage tank 60; the control device 20 is connected with the electrodynamic force drug delivery module 30 and the microneedle array driving module 40 respectively;
the first drug reservoir 50 is located between the drug supply structure 10 and the electromotive force drug delivery module 30, and the second drug reservoir 60 is located between the electromotive force drug delivery module 30 and the microneedle array driving module 40.
The medicine supply structure 10, the control device 20, the electromotive force drug delivery module 30, the microneedle array driving module 40, the first drug reservoir 50, and the second drug reservoir 60 may be combined together by using a medical epoxy resin adhesive to form a patch.
Illustratively, as shown in fig. 1, the control device 20 may be disposed above the electrodynamic drug delivery module 30, and the control device 20 may be located in a region isolated from the first drug reservoir 50, respectively, the control device 20 may include a control chip and a micro battery, and the control device 20 may wirelessly communicate with an external wireless control panel for user operation.
Wherein the control device 20 is reusable and the micro battery is replaceable.
In the invention, the first medicine storage tank 50 is made of medical materials and can be prepared by one or more methods of plastic injection, wet etching, dry etching, hot embossing, 3D printing and the like; the second drug reservoir 60 may be composed of an area enclosed between the electrodynamic drug delivery module 30 and the microneedle array drive module 40.
In this embodiment, an electric field is applied to the electrodynamic force drug delivery module and the micro-needle array driving module through the control device, so that the drug can pass through the skin cuticle through the micro-needle array driving module while being transferred from the first drug storage tank to the second drug storage tank, and the rate of the drug passing through the skin cuticle can be changed by adjusting the size of the electric field, so as to meet the requirements of practical application.
In one embodiment, the transdermal patch shown in FIG. 1 may further include a thermal assist device 70 surrounding the periphery of the transdermal patch, and the thermal assist device 70 may be connected to the control device 20 via a lead 701.
Illustratively, during administration, the thermal aid 70 may heat the skin by means of a magnetic field, infrared, electric current, etc., to promote blood circulation to further increase the rate of diffusion of the drug in the body, and control of the temperature and duration of heating of the thermal aid 70 may be achieved by the control device 20.
In one embodiment, as shown in fig. 1, the medication supply structure 10 may include an exhaust port 101 and a medication supply inlet port 102.
Wherein, the exhaust port 101 is composed of a biocompatible spacer and a cap provided with a thread; the drug replenishment inlet 102 is made of biocompatible artificial silicone rubber material.
Illustratively, when the drug supply is performed, the cover of the exhaust port 101 is opened by rotation, and the syringe is used to inject the drug into the first drug reservoir 50 to the drug supply injection port, so as to ensure that the transdermal drug delivery of different drug delivery doses for a longer time can be realized without replacing the drug delivery device.
In another embodiment, the medication supply structure 10 may also include only the medication supply inlet 102.
In an embodiment, the electrokinetic administration module 30 may include a porous membrane drive electrode 301 and a porous membrane drive unit 302. Wherein the porous membrane driving electrode 301 is attached to the porous membrane driving unit 302, and the porous membrane driving electrode 301 is connected to the control device 20 through a lead 3011 and is in direct contact with the drug in the first drug reservoir 50.
The porous membrane drive unit 302 serves as a microstructure of the electrokinetic drug delivery module 30, which can drive the drug from the first drug reservoir 50 to the second drug reservoir 60 together with the electric field between the porous membrane drive electrode 301 and the microneedle array drive module 40.
Illustratively, the porous membrane driving electrode 301 may be made by modifying a layer of metal on the upper surface, the lower surface and the inside of the pore channels of the porous membrane with biocompatibility; the porous membrane driving unit 302 may also be made of a porous membrane material having biocompatibility.
In one example, the porous membrane driving electrode 301 may be fabricated by using a Micro-Electro-Mechanical System (MEMS) technique. For example, the upper and lower surfaces and the interior of the pore channels of the porous thin film may be modified with a metal material by using a Chemical Vapor Deposition (CVD), a Plasma Enhanced Chemical Vapor Deposition (PECVD), an electron beam evaporation deposition, a magnetron sputtering technique, or a chemical modification, and since the modified metal is in direct contact with the drug, the metal material having biocompatibility, such as gold, platinum iridium, tantalum, or nickel, needs to be selected.
In another example, the porous membrane material may be polyurethane, polyimide, polyethylene terephthalate, polycarbonate, silicon-based materials, glass, organic glass, etc., which have vertically ordered channels with pore sizes on the order of micron, submicron, or submillimeter.
In the presence of an electric field, in order to enhance the effect of pumping the drug from the first drug reservoir 50 into the second drug reservoir 60, the pore size of the porous membrane driving electrode 301 is larger than that of the porous membrane driving unit 302.
In one embodiment, as further shown in fig. 1, the microneedle array driver module 40 can include a non-metallic microneedle array 401, a first drive electrode 402, and a second drive electrode 403; the first driving electrode 402 and the second driving electrode 403 are respectively modified on the upper surface and the lower surface of the non-metallic microneedle array 401.
Wherein there is no connection between the first driving electrode 402 and the second driving electrode 403. The first driving electrode 402 is connected to the control device 20 through a wire 4021, and the second driving electrode 403 is connected to the control device 20 together with the wire 4031 after passing through the substrate of the non-metal microneedle array through a metal wire 4032.
By applying an electric field between the first driving electrode 402 and the porous membrane driving electrode 301 for a certain time period through the control device 20, the drug in the first drug reservoir 50 can be pumped into the second drug reservoir 60, and the drug can also pass through the stratum corneum of the skin through the microneedle array driving module 40. In addition, the rate of the drug passing through the stratum corneum by the microneedle array can be further accelerated by the control device 20 applying an electric field between the first drive electrode 402 and the second drive electrode 403 for a certain time.
Illustratively, the non-metallic microneedle array 401 may be a hollow cone (the microneedle array shown in fig. 1 is a hollow cone), and the drug passes through the skin stratum corneum through the through hole (the diameter of the needle tip may be between 2nm and 1000 μm) of the microneedle array needle body, or may be a solid cone, and the microneedle array in the transdermal drug delivery patch shown in fig. 2 is a solid cone, and the drug passes through the skin stratum corneum along the outer wall of the microneedle array through the through hole (the diameter may be between 2nm and 1000 μm) on the microneedle array substrate. The nonmetal microneedle array 401 can be made of silicon, silicon-based materials, glass, organic glass and other materials; since the first driving electrode 402 and the second driving electrode 403 are both in direct contact with the drug, they may be made of a biocompatible metal material, such as platinum, gold, platinum iridium, tantalum, nickel, etc.
Wherein, the length of the needle body can be between 20 and 2000 mu m no matter the needle body is a solid conical needle body or a hollow conical needle body.
Illustratively, the first driving electrode 402 and the second driving electrode 403 can be prepared by MEMS technology.
In one embodiment, as shown in fig. 3, the microneedle array driver module 40 may also include only a metallic microneedle array 404, where the metallic microneedle array 404 is used as a driving electrode in addition to passing the drug through the stratum corneum layer of the skin.
The metal microneedle array 404 is connected to the control device 20 through a lead 4041. An electric field may be applied between the porous membrane drive electrode 301 and the metallic microneedle array 404 for a duration of time by the control device 20 to cause the drug in the first reservoir 50 to be pumped into the second reservoir 60 and pass through the stratum corneum via the metallic microneedle array 404.
Illustratively, since the metallic microneedle array 404 is in direct contact with the drug, it needs to be made of a biocompatible metallic material. The metallic microneedle array may also be hollow conical or solid conical.
Fig. 4 is a flowchart illustrating an embodiment of a transdermal drug delivery method according to an exemplary embodiment of the present invention, which may be applied to a control device in the transdermal drug delivery patch shown in fig. 1, as shown in fig. 4, the transdermal drug delivery method includes the following steps:
step 410: a first control instruction is received.
Illustratively, when the user uses the transdermal patch to administer the drug, the user can select the required dosage and the administration time length by operating the operation panel, and then the control device can receive a first control instruction carrying the required dosage and the administration time length.
Step 420: and applying an electric field to the electrodynamic force drug delivery module and the microneedle array driving module based on the first control instruction so that the drugs in the first drug storage pool are pumped into the second drug storage pool under the action of the electric field force and pass through the skin stratum corneum by the microneedle array driving module.
In an embodiment, when the microneedle array driving module includes a non-metal microneedle array, a first driving electrode and a second driving electrode, in step 420, a first electric field value between the first driving electrode and the second driving electrode and a second electric field value between the first driving electrode and the electromotive force drug delivery module may be determined according to the first control instruction, and an electric field is applied between the first driving electrode and the second driving electrode by using the first electric field value for a first preset time period, so that the drug in the second drug reservoir passes through the stratum corneum of the skin through the non-metal microneedle array, and an electric field is applied between the first driving electrode and the electromotive force drug delivery module by using the second electric field value for a second preset time period, so that the drug in the first drug reservoir is pumped into the second drug reservoir.
The electrokinetic drug delivery module comprises a porous membrane driving electrode and a porous membrane driving unit, so that an electric field with a second electric field value is applied to the first driving electrode and the porous membrane driving electrode. The control device may be provided with a first relational expression between an electric field applied between the first drive electrode and the second drive electrode and a second relational expression between an electric field applied between the first drive electrode and the porous membrane drive electrode and a rate, in advance.
Based on the above, the control device can calculate the administration rate according to the administration time length and the required dose carried by the first control instruction, then determine the first electric field value according to the administration rate and the first relational expression, determine the second electric field value according to the administration rate and the second relational expression, and then determine the cycle number according to the administration time length, the first preset time length and the second preset time length carried by the first control instruction.
For example, the first relational expression and the second relational expression may be obtained in advance according to experimental means, and the first preset time period and the second preset time period may be set according to practical experience.
It should be noted that the main function of the electric field between the first driving electrode and the porous membrane driving electrode is to drive the drug from the first reservoir into the second reservoir, during which period the drug will pass through the stratum corneum via the microneedle array module. The electric field between the first drive electrode and the second drive electrode acts to further accelerate the rate at which the drug passes through the stratum corneum by the microneedle array module.
In one embodiment, when the microneedle array driving module includes a metal microneedle array, in step 420, a third electric field value between the electromotive force drug delivery module and the metal microneedle array may be determined according to the first control instruction, and a drug delivery duration may be determined, and then an electric field may be applied between the electromotive force drug delivery module and the metal microneedle array using the third electric field value for the drug delivery duration, so that the drug in the first drug reservoir is pumped into the second drug reservoir and passes through the metal microneedle array through the stratum corneum.
The electrokinetic drug delivery module comprises a porous membrane driving electrode and a porous membrane driving unit, so that an electric field with a third electric field value is applied to the metal microneedle array and the porous membrane driving electrode. The control device may be provided with a third relationship between the electric field applied between the porous membrane drive electrode and the metal microneedle array and the rate.
Based on this, the control device may calculate the administration rate based on the administration duration and the required dose carried by the first control instruction, and then determine the third electric field value based on the administration rate and the third relation.
Illustratively, the third relation may also be obtained in advance according to experimental means.
It should be further noted that the electric field between the metal microneedle array and the electrodynamic drug delivery module is used for driving the drug from the first drug storage pool to the second drug storage pool and simultaneously driving the drug to pass through the stratum corneum through the microneedle array module.
It should be further noted that after applying an electric field between the electrodynamic force drug delivery module and the microneedle array driving module based on the received first control instruction, a second control instruction may be further received, and a heating time duration and a heating temperature may be determined based on the second control instruction, and a heating time duration required for the thermal assist module to continuously or intermittently heat may be controlled according to the heating temperature.
To this end, the flow shown in fig. 4 is completed, and the administration rate can be adjusted according to different medication requirements of the user through the flow.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. This invention is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (3)
1. A transdermal patch, comprising: the drug delivery device comprises a drug supply structure, a control device, an electric power drug delivery module, a microneedle array driving module, a first drug storage pool and a second drug storage pool;
the first medicine storage pool is positioned between the medicine supply structure and the electrodynamic force medicine feeding module, and the second medicine storage pool is positioned between the electrodynamic force medicine feeding module and the microneedle array driving module;
the control device is respectively connected with the electric power drug delivery module and the microneedle array driving module;
wherein the microneedle array driving module comprises: the array comprises a nonmetal microneedle array, a first driving electrode and a second driving electrode; the first driving electrode and the second driving electrode are respectively modified on the upper surface and the lower surface of the nonmetal microneedle array;
the electrokinetic dosing module comprises: a porous membrane drive electrode and a porous membrane drive unit;
the porous membrane driving electrode is attached to the porous membrane driving unit and is in direct contact with the medicine in the first medicine storage pool;
the porous membrane driving electrode is made by modifying a layer of metal on the upper surface, the lower surface and in the pore canal of the porous membrane with biocompatibility;
the porous membrane driving unit is made of a porous membrane material with biocompatibility;
wherein the pore diameter of the porous membrane driving electrode is larger than the pore diameter of the porous membrane driving unit.
2. The transdermal patch of claim 1, further comprising: a heat assist device surrounding the periphery of the transdermal patch;
the heat assist device is connected to the control device.
3. The transdermal patch of claim 1, wherein the drug supply structure comprises: an exhaust port and a drug supply sample inlet;
the air vent consists of a gasket with biocompatibility and a cover provided with threads;
the medicine supply injection port is made of an artificial silicone rubber material with biocompatibility.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910955861.8A CN110860029B (en) | 2019-10-09 | 2019-10-09 | Transdermal drug delivery patch and transdermal drug delivery method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910955861.8A CN110860029B (en) | 2019-10-09 | 2019-10-09 | Transdermal drug delivery patch and transdermal drug delivery method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN110860029A CN110860029A (en) | 2020-03-06 |
| CN110860029B true CN110860029B (en) | 2022-04-22 |
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| ATE532553T1 (en) * | 2006-02-10 | 2011-11-15 | Hisamitsu Pharmaceutical Co | TRANSDERMAL DRUG ADMINISTRATION DEVICE WITH MICRONEEDLES |
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