CA2561340A1 - Electrically assisted delivery system for administration of ionized active agents - Google Patents
Electrically assisted delivery system for administration of ionized active agents Download PDFInfo
- Publication number
- CA2561340A1 CA2561340A1 CA 2561340 CA2561340A CA2561340A1 CA 2561340 A1 CA2561340 A1 CA 2561340A1 CA 2561340 CA2561340 CA 2561340 CA 2561340 A CA2561340 A CA 2561340A CA 2561340 A1 CA2561340 A1 CA 2561340A1
- Authority
- CA
- Canada
- Prior art keywords
- skin
- administration
- active agents
- delivery system
- tip
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
Abstract
The present invention consists of a compact cylindrical device fitted with a disposable tip for the transdermal delivery of ionized active ingredients with the assistance of an electrical field. The device can be maneuvered with one hand while the tip is applied to the localized area needing treatment. The tip has been so designed obtain direct skin contact with both the electrode containing the active ingredient and the counterelectrode.
The device is particularly suited for the delivery of medicaments useful for the treatment of various skin conditions.
The device is particularly suited for the delivery of medicaments useful for the treatment of various skin conditions.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates generally to the transdermal delivery of active agents underneath the surface of the skin for treating lesions, diseased tissue or damaged skin.
More specifically, it relates to a portable device for the iontophoretic delivery of active agents into the epidermis and dermis so as to obtain efficient penetration at the delivery site in a targeted manner.
1. Field of the Invention This invention relates generally to the transdermal delivery of active agents underneath the surface of the skin for treating lesions, diseased tissue or damaged skin.
More specifically, it relates to a portable device for the iontophoretic delivery of active agents into the epidermis and dermis so as to obtain efficient penetration at the delivery site in a targeted manner.
2. Prior Art Iontophoresis has been employed for several decades as a means for applying medication through a patient's skin. The application of an electric field to the skin is known to greatly enhance the transport of various ionic agents especially through the most external layers of the skin, i.e., stratum corneum and the epidermis, to reach ultimately small capillary vessels located in the dermis. Based on this principle, iontophoretic transdermal delivery techniques have been proposed as a substitute to hypodermic injection for many medicaments, thereby eliminating the concomitant problems of trauma, pain and risk of infection to the patient.
In iontophoresis, the application of an electrical field drives charged ions through dermal layers into a target tissue. This technique enables the non-invasive, controlled administration of therapeutic agents for either local or systemic action.
Recently, a device has been launched for administering lidocaine for local anesthesia in infants prior to superficial dermatological procedures (LidoSiteTM, Vyteris, Inc., Fair Lawn, NJ) (Kalia et al., 2004). This device, in which the positively-charged lidocaine is transported from the anodal compartment into the skin, results in local anaesthesia within 10 minutes - within which period the drug reaches the nerves located in the dermis and epidermis.
For dermatological applications, one targets tissues adjacent to the delivery site in order to effect a localized treatment. So far, the technique of iontophoresis has been used only rarely for the topical administration of agents to treat various dermatological conditions.
One may explain that the use of iontophoretic patches usually fitted with an adhesive to hold the patch in place is not appropriate for treating various skin conditions, even more so in the case of apparent skin lesions requiring the local administration of medicated agents.
US Patent 5,676,648 describes a device for administering anti-virals for example to localized lesions in the face: the apparatus, designed to be hand-held, employs a detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The second electrode, also called the counter-electrode, is a circumferential tactile band made of conductive material located on the base assembly.
The electrical circuit is completed by the electrical connection between the skin of the user's hand and the device, implying the passage of an electrical current through the arm and other parts of the body forming a path to the site of application. US
Patents 6,148,231 and 6,735,470 provide additional improvements of that invention in that the counter-electrode is in the form of a thimble fitted to the user's finger; the user can apply the medication loaded electrode for the desired period of time by exerting pressure on the lesion with the finger covered with a complicated device which appears very uncomfortable for the user.
The present invention consists of a compact cylindrical device fitted with a disposable tip containing the active ingredient. The device can be easily maneuvered with one hand and its tip precisely applied to the treatment site without recourse to the user's arm and body to conduct electricity for the iontophoretic process. The compact design combined with the establishment of an electrical circuit loop limited to the treatment site enables an efficient treatment in a short period of time. Furthermore, the device can be used by a health professional to treat areas of the skin not readily accessible to the user.
SUMMARY OF THE INVENTION
The present invention discloses a portable iontophoretic device made up of two parts: a reusable cylindrical holder containing two contact pads, the power supply and the electronic controller required to create the electrical field in the skin and a disposable tip assembly made up of two compartments, one for each electrode.
In the disposable tip assembly (See Drawing entitled "DISPOSABLE APPLICATOR
A"), the central compartment of cylindrical shape contains the active agent lodged within a porous polymeric matrix or within a firm hydrogel allowing the flow of current.
Delivery of the active agent is obtained by applying the distal end of the disposable tip assembly to the area of skin to be treated and activating the electronic controller. The peripheral compartment, isolated from the central compartment, contains a certain amount of the counter-ion also in a porous matrix or in a hydrogel and serves to complete the circuit loop in the skin tissue touching the distal end of the disposable tip assembly. In this invention, the two compartments are so designed to offer a compact configuration allowing the application of the device specifically to the treatment site without recourse to the user's finger, arm and body to conduct the current necessary to establish the current loop.
If the active ingredient is positively charged at physiological pH, the central electrode becomes the anode and the peripheral electrode the cathode. The peripheral compartment contains a negative counter-ion. If the active ingredient is negative, the central compartment becomes the cathode, the peripheral compartment contains a positive counter-ion and the peripheral electrode becomes the anode.
The cylindrical holder is so designed to present at its upper extremity two axi-symmetrical planar contact pads made of a good metal conductor (See Drawing entitled "REUSABLE CONTROLLER A"). The outer surface of these two contact pads have the same dimensions as the external surface of the two compartments on the proximal end of the disposable tip assembly. The two contact pads are separated by a gap allowing the insertion of a cylindrical wall made of non-conducting material around the central electrode when the disposable tip assembly is fitted to the top of the cylindrical holder.
This cylindrical wall contributes to eliminate short circuiting between the two electrodes and to position precisely the disposable tip assembly onto the upper extremity of the cylindrical holder.
In one embodiment of this invention (See Drawing entitled "DISPOSABLE
APPLICATOR
B"), the central compartment is so designed to protrude from the distal end of the disposable assembly tip so that this compartment loaded with the drug exerts a somewhat larger pressure onto the skin, thereby facilitating the establishment of a three dimensional electrical field at the treatment site.
In another embodiment of this invention, the peripheral compartment can be so designed to protrude from the distal end of the disposable tip assembly so as to increase its surface area in contact with the external skin layer and to exert a light pressure on it, thereby facilitating the establishment of a three-dimensional electrical field at the treatment site.
One novel aspect of this invention consists of making the peripheral compartment out of a porous polymeric matrix resilient enough to effect pressure around the skin area to be treated in order to obtain a good electrical contact between the skin and the cathode, and yet permeable enough to permit the flow of counterions towards the skin.
This particular invention allows the delivery of the active agent by exerting a gentle pressure with the portable iontophoretic device to a lozalized portion of the skin. The desired pharmacological action is obtained by combining the appropriate quantity of active agent in the central compartment and by selecting the required current and voltage condition for the electrical controller located in the cylindrical holder. In optimal conditions, the delivery is efficient enough to take place in a reasonably short period of time during which the user applies the iontophoretic device to the portion of the skin to be treated.
In iontophoresis, the application of an electrical field drives charged ions through dermal layers into a target tissue. This technique enables the non-invasive, controlled administration of therapeutic agents for either local or systemic action.
Recently, a device has been launched for administering lidocaine for local anesthesia in infants prior to superficial dermatological procedures (LidoSiteTM, Vyteris, Inc., Fair Lawn, NJ) (Kalia et al., 2004). This device, in which the positively-charged lidocaine is transported from the anodal compartment into the skin, results in local anaesthesia within 10 minutes - within which period the drug reaches the nerves located in the dermis and epidermis.
For dermatological applications, one targets tissues adjacent to the delivery site in order to effect a localized treatment. So far, the technique of iontophoresis has been used only rarely for the topical administration of agents to treat various dermatological conditions.
One may explain that the use of iontophoretic patches usually fitted with an adhesive to hold the patch in place is not appropriate for treating various skin conditions, even more so in the case of apparent skin lesions requiring the local administration of medicated agents.
US Patent 5,676,648 describes a device for administering anti-virals for example to localized lesions in the face: the apparatus, designed to be hand-held, employs a detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The second electrode, also called the counter-electrode, is a circumferential tactile band made of conductive material located on the base assembly.
The electrical circuit is completed by the electrical connection between the skin of the user's hand and the device, implying the passage of an electrical current through the arm and other parts of the body forming a path to the site of application. US
Patents 6,148,231 and 6,735,470 provide additional improvements of that invention in that the counter-electrode is in the form of a thimble fitted to the user's finger; the user can apply the medication loaded electrode for the desired period of time by exerting pressure on the lesion with the finger covered with a complicated device which appears very uncomfortable for the user.
The present invention consists of a compact cylindrical device fitted with a disposable tip containing the active ingredient. The device can be easily maneuvered with one hand and its tip precisely applied to the treatment site without recourse to the user's arm and body to conduct electricity for the iontophoretic process. The compact design combined with the establishment of an electrical circuit loop limited to the treatment site enables an efficient treatment in a short period of time. Furthermore, the device can be used by a health professional to treat areas of the skin not readily accessible to the user.
SUMMARY OF THE INVENTION
The present invention discloses a portable iontophoretic device made up of two parts: a reusable cylindrical holder containing two contact pads, the power supply and the electronic controller required to create the electrical field in the skin and a disposable tip assembly made up of two compartments, one for each electrode.
In the disposable tip assembly (See Drawing entitled "DISPOSABLE APPLICATOR
A"), the central compartment of cylindrical shape contains the active agent lodged within a porous polymeric matrix or within a firm hydrogel allowing the flow of current.
Delivery of the active agent is obtained by applying the distal end of the disposable tip assembly to the area of skin to be treated and activating the electronic controller. The peripheral compartment, isolated from the central compartment, contains a certain amount of the counter-ion also in a porous matrix or in a hydrogel and serves to complete the circuit loop in the skin tissue touching the distal end of the disposable tip assembly. In this invention, the two compartments are so designed to offer a compact configuration allowing the application of the device specifically to the treatment site without recourse to the user's finger, arm and body to conduct the current necessary to establish the current loop.
If the active ingredient is positively charged at physiological pH, the central electrode becomes the anode and the peripheral electrode the cathode. The peripheral compartment contains a negative counter-ion. If the active ingredient is negative, the central compartment becomes the cathode, the peripheral compartment contains a positive counter-ion and the peripheral electrode becomes the anode.
The cylindrical holder is so designed to present at its upper extremity two axi-symmetrical planar contact pads made of a good metal conductor (See Drawing entitled "REUSABLE CONTROLLER A"). The outer surface of these two contact pads have the same dimensions as the external surface of the two compartments on the proximal end of the disposable tip assembly. The two contact pads are separated by a gap allowing the insertion of a cylindrical wall made of non-conducting material around the central electrode when the disposable tip assembly is fitted to the top of the cylindrical holder.
This cylindrical wall contributes to eliminate short circuiting between the two electrodes and to position precisely the disposable tip assembly onto the upper extremity of the cylindrical holder.
In one embodiment of this invention (See Drawing entitled "DISPOSABLE
APPLICATOR
B"), the central compartment is so designed to protrude from the distal end of the disposable assembly tip so that this compartment loaded with the drug exerts a somewhat larger pressure onto the skin, thereby facilitating the establishment of a three dimensional electrical field at the treatment site.
In another embodiment of this invention, the peripheral compartment can be so designed to protrude from the distal end of the disposable tip assembly so as to increase its surface area in contact with the external skin layer and to exert a light pressure on it, thereby facilitating the establishment of a three-dimensional electrical field at the treatment site.
One novel aspect of this invention consists of making the peripheral compartment out of a porous polymeric matrix resilient enough to effect pressure around the skin area to be treated in order to obtain a good electrical contact between the skin and the cathode, and yet permeable enough to permit the flow of counterions towards the skin.
This particular invention allows the delivery of the active agent by exerting a gentle pressure with the portable iontophoretic device to a lozalized portion of the skin. The desired pharmacological action is obtained by combining the appropriate quantity of active agent in the central compartment and by selecting the required current and voltage condition for the electrical controller located in the cylindrical holder. In optimal conditions, the delivery is efficient enough to take place in a reasonably short period of time during which the user applies the iontophoretic device to the portion of the skin to be treated.
Claims
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2561340 CA2561340A1 (en) | 2006-09-20 | 2006-09-20 | Electrically assisted delivery system for administration of ionized active agents |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2561340 CA2561340A1 (en) | 2006-09-20 | 2006-09-20 | Electrically assisted delivery system for administration of ionized active agents |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2561340A1 true CA2561340A1 (en) | 2008-03-20 |
Family
ID=39190402
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2561340 Abandoned CA2561340A1 (en) | 2006-09-20 | 2006-09-20 | Electrically assisted delivery system for administration of ionized active agents |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2561340A1 (en) |
-
2006
- 2006-09-20 CA CA 2561340 patent/CA2561340A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |