WO2002009807A1

WO2002009807A1 - Iontophoresis fluid container with dispenser and electrode

Info

Publication number: WO2002009807A1
Application number: PCT/IT2001/000421
Authority: WO
Inventors: Elisabetta Rossi
Original assignee: Elisabetta Rossi
Priority date: 2000-08-02
Filing date: 2001-07-31
Publication date: 2002-02-07
Also published as: ITFI20000173A0; AU2001284399A1; IT1316594B1; ITFI20000173A1

Abstract

An electrode (1) and a container (15) for the trascutaneous administration of molecules contained in a carrier product (V). The electrode comprises: - a conductive element (3); - a protective cage (9) around said conductive element; - a member (7) for reversibly connecting said electrode to a container (15) containing the carrier (V) and the active principle.

Description

IONTOPHORESIS FLUID CONTAINER WITH DISPENSER AND ELECTRODE

DESCRIPTION Technical field The present invention relates to a container and an electrode for a gel or liquid suspension or other type of carrier, for drug molecules, phytotherapic, homeopathic or cosmetic products, for carbon dioxide, oxygen, nitrogen, or other substances, for an active principle to be delivered via ionophoresis or other techniques involving the application of an electric field, which favours the penetration of the molecules to be delivered through the epidermis and beyond the dermic barrier. State of the art Ionophoresis is a known technique for transdermal delivery of drugs or other products, for various purposes. This technique provides for disposing the ionisable molecules of a substance to be delivered, within a container and then bringing a portion of the container in contact with the skin of the patient to whom the substance is to be administered.

In correspondence of the portion to be brought in contact with the skin, the container is closed by an osmotic or partially permeable membrane. The patient and the container with the molecules to be delivered, are located within an electric circuit having a voltage and/or frequency source whose output can be varied in a controllable manner, which causes the ionisation of the molecules and the migration of the ions through the osmotic membrane and patient's skin, thereby entering within the tissues beneath the epidermis down to a depth depending on the applied frequency. The electrical circuit is closed by one or more electrodes applied at suitable body positions on the patient under treatment.

Various apparatuses for ionophoresis are disclosed in the literature. For instance, EP-A-0292930 discloses an apparatus wherein the container for the solution with the molecules to be delivered, has an osmotic membrane through which the ions generated by the electric field produced by a suitable apparatus, migrate. The molecules are in a liquid solution within the container sealed by the osmotic membrane.

US-A-5084008 describes a different container for the drug to be administered by ionophoresis. In this case the container is specially fit for using with molecules contained in a gel, and the same container is closed by a permeable layer having the function of leaving the ions to pass through and, at the same time, of preventing the gel from drying during the time the container is stored. The container is characterized by a particular configuration of the means for distributing the current inside the drug.

WO-8808729 discloses an electrode for ionophoresis consisting of a plate of conducting material to which a porous membrane is applied, having therein the molecules to be delivered. The membrane is protected by a removable protecting sheet which is removed when applying the electrode on the patient. WO-9622810 describes a container for a drug to be delivered by ionophoresis, after having frozen the solution containing said drug.

In this case the container is made up of two portions reversibly joined to each other and defining an inner volume which is intended to hold the solution containing the drug to be administered.

Subsequently, the container with the relevant content is frozen and, when used, the upper section of the container is removed to expose the block formed by the frozen solution. The latter is put in contact with the patient's epidermis. The portion of the container which is not removed, and within which the base of the block of frozen solution is housed, contains the electrode suitably shaped to ensure the electric contact with the block of frozen solution. This container has remarkable drawbacks which are due to: the lack of devices for reliably stabilizing one upon the other the two portions of the container, when the latter is to be filled with the solution containing the medicine; the lack of a suitable closure ensuring the hygiene of the product, as the container is open on top to allow the filling thereof; the impossibility of ensuring that the container will be used only once, for the sake of hygiene. Moreover, this container is suited only and exclusively for the application of solutions frozen beforehand.

The electrode is unstable and is likely to get drenched because of the melting of the ice block, with the risk of electric discharges.

Throughout the present description, reference will be made specifically to ionophoresis as a particularly advantageous administration technique. This, however, should be considered as a preferred but not exclusive way of using the present invention.

Objects and summary of the invention

The object of the present invention is that of providing and electrode for delivering an active e principle dispersed in a liquid, gel or other similar carrier, by ionophoresis or other similar technique, which overcomes the drawbacks and limits of the currently known systems .

More generally, the object of the present invention is to provide a storing and delivering device suitable for the administration by means of an electric field, of principles dispersed in said carrier.

According to the invention, an electrode is provided for transdermal administration of an active principle contained in a carrier, characterized in that it comprises an elongated conductive element; a supporting member for reversible connection of said electrode to a container containing the carrier and the active principle .

According to a preferred embodiment, around the conductive element there is arranged a protection cage structure made of electrically insulating material. In a possible embodiment the conductive element is advantageously an extended lamina or a conductive bar.

The connection member may be provided with a thread, a bayonet joint, a fixed joint or other suitable systems for connecting the electrode to the container and removing the electrode, even by damaging the container, the latter being preferably of disposable type.

Further advantageous features and embodiments of the electrode according to the invention are set forth in the appended claims.

The invention relates also to a device for transdermal delivery of an active principle contained in a carrier, by the application of an electric field, characterized in that it comprises an electrode as defined above and a container reversibly engaged with said electrode, said container having at least a wall portion permeable to the ionised molecules of said active principle . This wall portion may be simply perforated to allow the molecules, and possibly part of the carrier, to pass through .

Further advantageous features and embodiments of the device according to the invention are set forth in the other appended claims.

Brief description of the drawings

The invention will be better understood in the light of the following description concerning a few, non- limiting examples thereof, shown in the annexed drawings wherein:

Fig. 1 is a longitudinal sectional view of an electrode according to the invention;

Fig. 2 shows a flask to which the electrode of Fig. 1 can be associated; Fig. 3 to 6 show further possible embodiments of the present invention.

Detailed description of the preferred embodiments of the invention

With reference to what is disclosed in figures 1 and 2, the embodiment of electrode shown therein generally indicated by 1, comprises a conductive bar 3 which forms the proper electrode, electrically linked to a cable 5 for connection with a voltage-generating machine, such as a machine for ionophoresis of a type known per se . The conductive bar 3 is supported by a bush 7 of insulating material passed through by the conductive element of the connecting cable 5, which is thus electrically linked to the bar 3.

The bush 7 carries in an axial position with respect to the conductive bar 3, a protection cage 9 of insulating material, for instance of a sufficiently rigid plastics .

The bush 7 is also provided with an external thread 11. The latter makes if possible to screw down the electrode 1 in the mouth 13 of a flask generally indicated by 15, in which a carrier is disposed such as a gel or a liquid that can contain the active principle or wherein the latter and/or the carrier can be added at the time of use. The flask 15 may be of disposable type with a closure 17 consisting, for example, of a film heat-sealed or glued on the mouth 13 of the flask. For use, the film making up the closure 17 is removed and to this purpose it may be provided with a handgrip appendix 17A. At this point the active principle my be added to the carrier V, if it is not already disposed in the flask 15, or if it is necessary to add a further active principles to the one already present therein.

The bottom 19 of the flask 15 has a wall permeable to the molecules of the active principle, that is, a wall through which it is possible to establish a flow of ions formed by the ionised molecules of the active principle contained in the carrier V. The bottom of the flask may be simply provided with holes having a dimension sufficiently small to avoid an excessive dispersion of the carrier.

The bottom of the container 15 may in turn be protected by a second film 21, possibly having an appendix 21A which makes it easy to remove said film. In use, after having removed the closing film 17, the electrode 1 is inserted into the flask 15 and blocked therein by screwing the bush 7 in the thread of the mouth 13 of flask 15. The removal of the film 21 exposes the osmotic wall, which defines the bottom 19 of the flask, to allow the ionophoresis treatment. To this end, between the electrode 1 and a counter-electrode not shown (the latter being usually made in the form of a flexible metal lamina) both connected to the ionophoresis machine or other generator (not shown) , a voltage difference is applied in a variable manner with time according to a predetermined law. The counter-electrode is applied to a suitable portion of the patient's body, while the bottom 19 of the flask 15 (into which the electrode 1 has been introduced) is applied in correspondence of the region of the patient's body where the active principle, contained in the carrier V inside the flask, is to be administered.

Upon completion of the treatment, the flask 15 may be unscrewed from the bush 11 and disposed of, while the electrode 1 can be cleaned for using again in further treatments with a new flask.

The flask 15 may also be empty and be filled before use thereof, with the carrier and active principle as necessary. In this case, the protection formed by the films 17 and 21 can be omitted. Although the presence thereof is to be preferred for the sake of hygiene.

In the illustrated example the electrode includes a conductive bar having elongated cylindrical or prismatic shape .

This corresponds to the particular shape of the flask associated to the electrode. However, different conformations of the electrode as well as of the container are possible.

For example, the electrode may be a relatively thin and long lamina, or a lamina with rectangular or square configuration. The shape of the container will be compatible with that of the electrode.

Similarly, the protective cage will have a shape correspondingly suited for protecting the conductive element . The term cage refers to any structure having a consistence sufficient to form a protection around the conductive element and to allow the flow of the carrier.

Other embodiments of the invention, shown in Figures 3 to 6, will now be described.

In particular, the first two embodiments show a device for transdermal delivery of substances contained in a carrier fluid, denoted in its entirety by 30.

This device comprises a plastic or glass flask 31, containing a carrier fluid for the substances to be delivered and having at its bottom 32 a rubber, plastic or other similar material, socket 33; in its initial condition, i.e. in the condition where the flask is produced ready for distribution, this socket is sealed with a layer 34 of tin foil or other material which can be removed by means of tearing, likewise it occurs for ordinary drug packagings . The flask 31 is provided with a threaded mouth 35 suitable for the application of a normal screw-cap (not shown in the drawings) in the initial condition already mentioned above, or with a dispensing head 37 for performing a treatment involving transcutaneous administration of the substances .

The dispensing head 37 has a threaded ring 38 for screwing it onto the mouth 35 of the flask and terminates in a hemispherical cap provided with small holes 40. The device of this example of the invention also comprises an electrode 41 consisting of a bar-shaped conductive element 42, connected to an electric power supply line 43 and mounted on an insulating support 44.

In order to perform treatment, the electrode 41 is inserted into the flask 31 via the socket 33 after removal of the sealing foil 34, until the support 44 engages the bush 33.

In this condition, the conductive bar 42 extends along the flask as far as the dispensing head 37 and allows the movement of the ions of the substances to be delivered, contained in the carrier fluid, likewise it has already been described for the preceding example.

Unlike the first example, however, in this case there is a perforated cap 39 instead of the osmotic membrane through which the substances pass. Indeed, if the flask is handled with the head 37 directed downwards (i.e. as shown in the Figures) and is passed over the zone of the body to be treated, the holes 40 of the cap allows the carrier fluid to flow thereby forming a film on the skin which allows the transdermal administration of the substances.

On the basis of this delivery device, it is also possible to devise other variations of the invention simply by changing the type of dispensing head; indeed, it can be understood that the dispensing head may be designed with forms different from that described above, as shown in Figures 5 and 6.

In the first of these figures the dispensing head 37 screwed onto the bottle terminates, instead of the perforated cap, with a roller supported in a freely rotatable manner; for this purpose a space is left between the surface of the roller and the bottom edge of the head 37, sufficient to allow rotation of the roller about its axis when it is covered with a film of carrier fluid.

The device according to this example is used in a manner similar to that of the preceding one, causing the roller 50 to roll over the part of the body to be treated, with the flask kept in the overturned condition shown in Fig. 5. In this way when the roller performs its rolling movement, a film of carrier fluid is deposited on the portion of its surface which is located inside the dispensing head and is then spread onto the skin when this portion turns outside.

It is also obvious that a solution equivalent to that described above would be obtained by replacing the roller with a ball.

A further possible embodiment of the administration delivery device is shown in Figure 6, wherein the dispensing head has been replaced with a pad 60 of sponge or other similar material, which is impregnated with the carrier fluid contained in the flask so as to spread it over the zone of the body to be treated. This pad is associated (for example by means of gluing) with the threaded ring 38 so as to be fixed on the mouth of the bottle.

These embodiments of delivery devices may be used alternatively, depending on various factors such as the part of the body to be treated, the type of treatment to be performed, etc.; for example, the solution with dispensing head equipped with roller is advantageous in the case of applications over large areas, while the solution with perforated cap is suitable for carrier fluids with higher viscosity. Of course, also, the other modifications mentioned above in connection with the first example described herein, can apply to the embodiments of the invention illustrated in Figures 3 to 6. Therefore, the shape of the electrode and associated conductive element may differ from the elongated shape which, although it is undoubtedly the most suitable for insertion into a flask as seen before, could nevertheless be replaced by an electrode plate-shaped or in any case shaped differently from the conductive bar; obviously, in these circumstances, the socket for insertion of the electrode into the flask should also be replaced with an opening suitable for receiving and supporting electrodes shaped differently from those seen. In the same way it is also obvious that in these examples too, the conductive element may be protected with a cage structure made of insulating material, likewise explained above.

All these and other equivalent variations fall within the scope of the claims which follow.

Claims

1. Device for transdermal delivery of substances contained in a carrier fluid, characterized in that it comprises : - a container (15, 31) for the carrier fluid; dispensing means (19, 21; 37, 39; 50; 60) removably associated with the container, for applying the carrier fluid onto the zone of the body to be treated;

- an electrode (1, 41) provided with a conductive element (3, 42) insertable into the container for extending in the region of said dispensing means.

2. Device according to Claim 1, wherein the container (15, 31) for the carrier fluid is a flask or a bottle.

3. Device according to Claim 2, wherein the dispensing means consists of the bottom (19, 21) of the container (15) or a portion thereof, which is permeable to the substances to be delivered and wherein the electrode (1) is inserted into the container via its mouth.

4. Device according to Claim 2, wherein the dispensing means comprises a head (37) fitted onto the mouth of the container (31) outside thereof, provided with a surface portion (39) where holes (40) are provided for allowing the carrier fluid to pass through, and wherein the electrode (41) is inserted into the container via its bottom (32) .

5. Device according to Claim 2, wherein the dispensing means comprises a head (37) fitted onto the mouth of the container (31) outside thereof, open at its side farther with respect to the container where there is a rotatably supported roller (50) , and wherein the electrode (41) is inserted into the container via its bottom (32) .

6. Device according to Claim 2, wherein the dispensing means comprises a porous pad (60) fitted onto the mouth of the container outside thereof, and wherein the electrode (41) is inserted into the container via its bottom (32) .

7. Device according to any one of Claims 3 to 6 , wherein the electrode comprises a conductive element (3, 42) with an elongated shape, mounted on a support (7, 44) connectable to the mouth (13) or to the bottom (32) of the container (15, 31) .

8. Device according to any one of the preceding claims, wherein the electrode (1, 41) comprises a cage structure (9) made of insulating material for protecting the conductive element (3, 42) .

9. Electrode of a device for the transdermal of substances contained in a carrier fluid, characterized in that it comprises:

- a conductive element (3, 42);

- an insulating support (7, 44) for said conductive element, reversibly connectable to a container (15, 31) of carrier fluid so that the conductive element is inserted inside the container.

10. Electrode according to Claim 9, wherein the support (7) for said conductive element (3) comprises a threaded bush (7) fitting the mouth of a flask or bottle forming the container (15) for the carrier fluid.

11. Electrode according to Claim 9, wherein the support (44) for the conductive element (42) is insertable into an opening (33) provided on the bottom (32) of a flask or bottle (31) forming the container for the carrier fluid.

12. Electrode according to Claims 9 to 11, wherein the conductive element (3, 42) is substantially a bar with an elongated shape.

13. Electrode according to Claims 9 to 12, wherein the conductive element (3, 42) is protected by a cage structure (9) made of electrically insulating material.

14. Container for a carrier fluid for transdermal delivery of substances, characterized in that it is substantially in the form of a bottle or flask having at least one portion of the bottom wall (19) permeable to the substances to be delivered.

15. Container according to Claim 14, wherein a thread (13) is present in the mouth of said flask or container.

16. Container according to Claim 15, comprising a respective, removable, protective closure for said bottom wall and mouth.

17. Container for a carrier fluid for transdermal delivery of substances, characterized in that it is substantially in the form of a flask or bottle having an opening (33) in the bottom (32) for the introduction of an electrode (41) .

18. Container according to Claim 17, wherein said opening is delimited by a socket (33) arranged in the bottom (32) of the flask or bottle.

19. Container according to Claim 18, comprising a thread (35) at the mouth of the flask or bottle.