WO2018185694A1

WO2018185694A1 - Device for the administration of substances

Info

Publication number: WO2018185694A1
Application number: PCT/IB2018/052353
Authority: WO
Inventors: Alberto Luigi RIVETTI; Luigi TETI
Original assignee: ZODIAK S.r.l.
Priority date: 2017-04-06
Filing date: 2018-04-05
Publication date: 2018-10-11
Also published as: IT201700038005A1

Abstract

A device for administering substances to be administered comprises a vibrating element containing at least one dispensing duct, a vibration generator configured to vibrate the vibrating element, and an outlet element, comprising a plurality of holes, arranged for the passage of the substance to be administered during administration. The dispensing duct defines a tank adapted to completely contain the substance to be administered, and is configured to let it escape from an opening facing said outlet element.

Description

DESCRIPTION

"DEVICE FOR THE ADMINISTRATION OF SUBSTANCES "

FIELD OF APPLICATION OF THE INVENTION

[001] The present invention relates to the field of application of devices for the administration of drugs, therapeutic agents or any other suitable substance in the form of aerosol or inhaled powder or ocular powder.

PRIOR ART

[002]A drug, in order to show its effectiveness, must be put in contact with the target organ: the way this happens is just as important as the chemical nature of the drug itself. In many cases, the selected route varies the therapeutic efficacy and/or toxicity thereof. It is known that a drug, such as insulin, can be positively effective subcutaneously, toxic intravenously and useless by the oral route.

[003] Other drugs, like many antibiotics for example, are much more 'tolerated' and can be administered in various ways: in this case, doctors and especially those who produce the drugs choose the most suitable to regulate the amount of product absorbed, the maximum amount in the blood (blood peak) and the elimination time.

[004 ] The intravenous route, for example, is the one that by immediately injecting the drug into the bloodstream immediately determines a blood peak and immediately reaching the target organ. In contrast, the oral route is a generally slow path and subject to various unknown factors, such as the amount of food present in the stomach. Furthermore, the absorbed drug is immediately brought to the liver which starts the metabolization thereof .

[005] In addition to the intravenous and oral route, the intramuscular, subcutaneous, percutaneous, rectal, trans- ocular and inhalation routes exist.

[006] The inhalation route is an elective route for 'topical' treatments, i.e. where the drug has the same contact surface/absorption as its target, in this case the nose, the bronchi and the alveoli. Those suffering from bronchial asthma or allergic rhinitis use, for example, drugs that act directly on the bronchi or in the nose, that is, by direct contact.

[007] In the last 20 years, scientific research has produced numerous drugs that use the airways also for therapies defined as 'systemic', where the airways are used to get the medication more directly into the blood and target organ. For example, the growth hormone, once inhaled through the bronchioles, reaches the blood and with blood the pineal gland, which is its true target organ. There are many advantages in using the inhalation route: the mucosa of the airways is very extensive and very permeable, moreover the therapy is not invasive, is easy to practice and the patients prefer it to other more painful ones .

[008] For the administration of inhaled medicaments, three categories of instruments are mainly used: aerosol dispensers, pre-dosed spray inhalers for liquids (known by the acronym of MDI, 'Metered Dose Inhaler') and powder inhalers (known with the acronym of DPI "Dry Powder Inhaler" ) .

[009]Aerosol devices are instruments that, by exploiting the Venturi effect or the vibration of a piezoelectric (which can be combined with a suitably microperforated membrane, called mesh) , create a fog of minute particles that are inhaled during the patient's respiratory actions. The diameter of these particles (typically described by the Mass Median Aerodynamic Diameter, known by the acronym MMAD) causes the drug to reach one or more parts of the respiratory system. Typically, the very small particles, below 1/2 micron in diameter, reach the alveoli, while those with a diameter of 10/15 microns stop at the nasal cavities.

[0010] The quality of an aerosol system is mainly measured by the constancy of producing particles of a given diameter, by the dispensing rate, by the accuracy of the dispensed dose. [0011] Among the aerosol devices, used in their simplest technical form since the nineteenth century, the latest generation system is that which uses the vibration of a piezoelectric combined with a micro-perforated membrane called 'aerosol mesh' . In one of its technical variants, a shaped element (called pump body or horn) is vibrated and cooperates appropriately with a mesh that sucks the liquid from a container and nebulizes it through the micro-holes of the membrane itself, in turn put in vibration by the pump body. The container can be found both above the pump body and below it.

[0012] This system is very reliable, not bulky, easy to use and allows generating nebulized particles having a defined diameter, different according to the specific use and action envisaged for the device itself. This system can therefore be used both to reach the upper areas and the nasal cavities.

[0013] Among the mesh nebulizers which use a vibrating pump body cooperating with a mesh and which withdraw the liquid from a container is that described in document US- A-4, 850,534.

[0014] Said device comprises an elongated main body having a central hole for the passage of the liquid, and comprises vibrating piezoelectric elements and suitable electrodes to excite them. [0015] At the moment of the vibrations, the liquid, withdrawn from the container, rises through the inlet hole of the main body and is nebulized near the outlet hole of the main body.

[0016] The inlet and outlet are preferably removable from the main body and the outlet is in contact with an appropriately shaped element or with a micro-perforated membrane .

[0017] Other similar devices are described in documents EP-A-0933138 , EP-A-0635312 and US-A-4 , 796 , 807.

[0018] Of the main qualities required for an apparatus for administering inhaled medications, the Mesh nebulizer described certainly has one: the good consistency in producing a fog with particles of a defined diameter. However, among its limitations are the low dispensing rate and the impossibility of guaranteeing an always precise and repeatable dosage. In fact, the system feeds from a container through discreetly long ducts and the same container is typically large. Thus, a part of the drug is not dispensed and remains either in the ducts or on the walls of the container as a residue. This 'lost' quantity is typically inconstant and subject to variations that are not always predictable.

[0019] This is not a big problem if low toxicity and/or great tolerance drugs are dispensed. Instead, it would become a possible problem if potentially toxic drugs are used, where even minor changes in the administered dose can be lethal, such as insulin.

[0020] The second system for dispensing drugs by inhalation is the pre-dosed spray inhaler for liquids. Introduced on the market in the fifties, it replaces some of the limits of 'aerosol appliances' but potentially determines others. The pre-dosed spray inhaler for liquids, in brief, consists of a can in which the drug is in suspension or in solution with surfactants, lubricants and with a propellant, generally chlorofluorocarbons (CFC) or hydrofluoroalkanes (HFA) : when a specific pressure is applied, dedicated holes are opened and a spray is generated. It is an easy to use and very popular system, although it requires a good coordination between the aerosol delivery and the inspiratory action, which must take place at the same time. However, the particles produced have a very large and varied diameter (immediately after the output from the device, also equal to 30-40 micron) . In addition, the 'spray' fog speed is very high (even over 20m/s immediately after the outlet from the device) and therefore the mixture is 'printed' mainly on the surfaces of the nose or pharynx. All this can make it difficult to achieve the posterior nasal cavities or the bronchi at full dosage. [0021] Finally, there are powder inhalers, also introduced on the market in the fifties. These devices are directly activated by the patient's breath: the drug is inhaled at the same time as the patient inhales, are easy to use and do not require propellants and surfactants. However, the powder contained inside them, while ensuring a constant dosage, is typically highly hygroscopic, so that the particles easily tend to aggregate with consequent variation and increase of their diameter. Moreover, in some cases they may require the application of much higher inspiratory flows compared to aerosol devices and pre-dosed sprays for liquids, making their use not always simple.

[0022] The limits described make it potentially problematic to use the pre-dosed spray inhaler for liquids and powder inhalers with drugs that require certain dosages and with a precise and constant diameter of the drug particles.

[0023] The ideal system would therefore be the one that combines the advantages of mesh aerosol devices, i.e. the fog with particles having a constant diameter and with a velocity appropriate to the inspiratory force with the dosage precision of the powder inhalers and with the manageability and dispensing speed and the ease of use of pre-dosed spray inhalers for liquids. [ 0024 ] Such a system would also be suitable for the administration of drugs via the transocular route. The eye is very permeable and is an open door to the Central Nervous System: the delivery of small amounts of medicament at an adequate speed in the form of minute particles with a constant diameter would allow an easier absorption and avoid the typical corneal enlargement which instead occurs with the application of normal liquid eye drops.

[ 0025 ] As shown above, in the case of the mesh aerosol the inconstant dosage of the drug depends mainly on the length of the supply ducts and on the size of the container that is external to the suction system.

DECRIPTION AND ADVANTAGES OF THE INVENTION

[ 0026] The technical problem underlying the present invention is that of providing a device for the administration of drugs, therapeutic agents or any other appropriate substance in the form of aerosol or inhaled and ocular powder (defined substances to be administered) structurally and functionally designed to overcome one or more of the limits set forth above with reference to the prior art cited.

[ 0027 ] Within the scope of the above problem, a main object of the invention is to provide a device for administering substances to be administered that allows the administration of a sufficiently precise dose of said substances to be administered. A further scope of the invention is to provide a device for administering substances to be administered in the context of a simple, rational and rather cost-effective solution.

[0028] It is also a scope of the present invention to allow the administration of substances to be administered with the aim of performing systemic and topical therapies in an adequate and effective manner.

[0029] These and other scopes are achieved by the features of the invention set forth in the independent claim 1. The dependent claims outline preferred and/or particularly advantageous aspects of the invention.

[0030] In particular, the present invention provides a device capable of administering a predefined, measured and exact amount of substance to be administered entirely contained in the dispensing duct in the form of particles with a predefined diameter and in a constant size range.

[0031] The dispensing duct has neither upstream nor anywhere else any contact with the containers of substance to be administered, the substance is contained in the dispensing duct only. The dispensing duct may also have various shapes and dimensions both in the longitudinal and transverse plane and may have multiple openings . [ 0032 ] The dispensing duct, which may contain one or more predefined doses of the substance to be administered, can be single-use or multi-use and can also be replaced by disposable systems: once the administration is carried out, it is replaced.

[ 0033 ] With this solution, there is a total reduction of the losses of substances to be administered that normally occur during transit between the container of the substances to be administered and the dispensing duct, due to the presence of residues of substances to be administered that can remain in the container itself.

[ 0034 ] In a preferred embodiment, the delivery duct has both the function of containing the substance to be administered and of transferring it.

[ 0035 ] Furthermore, the open end of the dispensing duct interfaces with an outlet element, preferably a micro-perforated metal or plastic membrane, kept in contact (or at least in close proximity) with the surface of the open end of the dispensing duct through a resilient element (for example an elastic element or a compression spring) . By means of the vibrations in the axial direction to which the dispensing duct is subjected, the substance to be administered is brought to the surface of the open end of the dispensing duct. Since the outlet element is kept in contact with the surface of the open end of the dispensing duct by the resilient element, the same outlet element is vibrated following the movement of the open end of the dispensing duct. This configuration allows the outlet element to operate as a type of valve that opens and closes the open end of the dispensing duct: the substance to be administered is pumped when the valve is open while when it is closed, the substance to be administered crosses the openings of the outlet element and is therefore released.

[ 0036] Said administration technique allows generating particles with a predefined diameter and in a constant size range.

[ 0037 ] This configuration of the device allows both dispensing the correct dose of substance to be administered and concentrating it in the area involved in the treatment.

[ 0038 ] Due to the synergy of the dispensing duct /container with the outlet element it is possible to reduce the dose of the substance to be administered while ensuring the correct clinical amount.

[ 0039] With this solution, it is also possible to administer very small amounts of substance to be administered, for example 0.2 ml or less.

[ 0040 ] Another aspect of the invention is that of providing a device that does not need periodically neither cleaning nor replacement of the main and critical parts of its structure, in order to ensure its efficiency and constant performance, which could be complex for the user .

[0041] With this invention, the end user has a device for administering a defined dose of substance to be administered which is easy to use and maintain, compact, silent and easily transportable.

[0042] The usefulness of such a device is evident, for example, for vaccines and new drugs having a topical or systemic action, where the possibility of having an easy- to-use device capable of providing a predefined and precisely measured amount of substance to be administered, characterized by a specific dimension of the released particles, is a key element for their therapeutic efficacy. In addition, the shape of the dispensing duct /container and of the outlet element can direct the substances to be administered in specific target areas.

[0043] Preferably, the device is specifically adapted to perform a precise, localized and quantitative administration of the substance to be administered: the device dispenses a certain predefined amount of substance to be administered by projecting it in a preferential direction. [0044] Preferably, with the present device administration through the nasal cavity is possible, succeeding for example in effectively reaching the olfactory nerve.

[0045] Said objects and advantages are all achieved by the device object of the present invention, which is characterized by the following claims.

BRIEF DESCRIPTION OF THE FIGURES

[0046] This and other features will become more apparent from the following description of some of the configurations, illustrated purely by way of example in the accompanying drawings .

[0047] - Figure 1: shows a sectional view of the device for administering substances to be administered according to the present invention.

[0048] - Figure 2: shows a sectional view of an embodiment variant of the vibrating element comprising a dispensing duct and a transverse duct.

[0049] - Figure 3: shows a sectional view of a preferred embodiment comprising an abutment element of the vibrating element.

[0050] - Figure 4: shows a sectional view of a preferred embodiment of the vibrating element comprising a dispensing duct with enlargement.

[0051] - Figure 5 shows a sectional view of a preferred embodiment of the vibrating element comprising a plurality of parallel dispensing ducts.

[ 0052 ] - Figure 6: shows a sectional view of a preferred embodiment of the vibrating element in which the plurality of parallel dispensing ducts comprise a respective enlargement.

[ 0053 ] - Figure 7: shows a plan view of a preferred embodiment of an outlet element comprising a micro- perforated membrane.

DESCRIPTION OF THE INVENTION

[ 0054 ] With particular reference to figure 1, a device 10 according to the present invention is shown for the administration of drugs, therapeutic agents or any other appropriate substance in the form of aerosol or powder (defined as substances to be administered) by inhalation or by ocular route. The operation of said device 10 is substantially linked to two principles:

- ascent of the substance to be administered in a suitably sized duct subjected to vibrations,

- release of the substance to be administered in the passage through an outlet element (for example a micro- perforated membrane, called mesh in the technical jargon) also put into vibration once in contact with the vibrating element.

[ 0055 ] The device 10 comprises a main body 9 on which the following are installed:

- a vibrating element 1, defined as a pump body, configured to contain the substance to be administered;

- a vibration generator 2, generally a piezoelectric actuator, configured to vibrate the vibrating element 1;

- an outlet element 3, illustrated in detail in figure 7, comprising at least one hole (preferably a plurality of holes) 30 and cooperating with the vibrating element 1 in order to release the substance to be administered.

[0056] The vibrating element 1 comprises at least one dispensing duct 4 which defines at least one tank 40 adapted to completely contain the substance to be administered. In other words, the dispensing duct 4 defines a volumetric space corresponding to the tank 40. Preferably, the dispensing duct 4 develops axially in an axial direction X. In other words, as widely described below, the dispensing duct 4 is blind, so as to contain internally the whole amount of substance from administered. Preferably, blind dispensing duct means that the dispensing duct 4 has a shape such as to prevent the substance stowed therein from coming out spontaneously. In other words, the dispensing duct 4 does not have a plurality of openings through which the substance is free to exit (preferably having as the only opening for the substance, the described opening 5) . However, in some preferred embodiments, openings are provided which act as air outlets of the dispensing duct 4: from said openings, the substance to be administered is not allowed to flow freely, for example due to the force due to the surface tension of the same substance.

[0057] In a preferred embodiment, duct 4 has an opening 5 which is orthogonal to the axial direction X and faces towards the outlet element 3. Preferably, the opening 5 is single, that is, it represents the only opening through which the product can exit the tank 40 to be administered.

[0058] Preferably, the opening 5 is defined at an end 11 of the vibrating element 1.

[0059] Optionally, as already mentioned, the vibrating element 1 can have a transverse duct 41, illustrated in the embodiment in figure 2, which extends transversely to the dispensing duct 4 (or to the tank 40) and communicating with the atmosphere. In other words, the blind dispensing duct 4, with reference to the portion containing the substance to be administered, has an air inlet opening. Preferably, the transverse duct 41 has a smaller section, or at most equal, with respect to the dispensing duct 4. This transverse duct 41 has the task of allowing the inlet of air into the dispensing duct 4 (or of the tank 40) to prevent any occurrence of negative pressure produced within the dispensing duct 4 (or within the tank 40) during the operation of the device. According to a preferred embodiment, the transverse duct 41 is configured to open outwardly of the vibrating element in a position that is vertically higher than the dispensing duct 4. In this way, it is possible to prevent the liquid from escaping through the transverse duct 41.

[0060] In one embodiment, the dispensing duct 4 is circular in shape with a sufficiently small passage diameter, preferably less than 5mm or even more preferably less than 2mm.

[0061] The outlet element 3 is preferably operatively connected to an elastic/resilient portion 8 which develops peripherally thereto. The elastic portion 8 is mounted on a flange 93 of the main body 9; said elastic portion 8 operates and is elastically deformable along the propagation direction p of the vibrations and allows maintaining a constant and adequate contact between the outlet element 3 and the end 11 of the vibrating element 1. Preferably, the elastic portion 8 has a behavior similar to that of a compression spring. In particular, the retention of the contact between the outlet element 3 and the end 11 of the vibrating element 1 is important for maintaining a balance between the substance to be administered in ascent in the dispensing duct 4 and that released by the outlet element 3. The absence of this balance could indeed generate an unstable operation of the device.

[0062] In one embodiment, the main body 9 is provided with an abutment element 94, shown schematically in figure 3, where a waterproof resilient element 95 (e.g. an 0-ring) is housed, which surrounds the vibrating element 1. Preferably, the abutment element 94 extends from an inner wall of the main body so as to reach, at the waterproof resilient element, an enlarged portion of the vibrating element 1. This allows the substance to be administered to be isolated with the other components of the device, in case of accidental leakage thereof.

[0063] Optionally, the end 11 of the vibrating element 1 is characterized by an enlargement of its diameter with respect to the segment just preceding it, to emphasize and facilitate its vibratory effect.

[0064] According to a preferred embodiment, the vibration generator 2 vibrates vertically (up-and-down) the vibrating element 1 and in particular its end 11 which is kept in contact with the outlet element 3 by the thrust of the elastic portion 8. By virtue of such contact, the outlet element 3 is itself vibrated in the same vibration direction as the end 11 of the vibrating element 1. The outlet element 3, provided with a series of holes 30, acts as a valve which, due to its vibration, opens and closes the opening 5 of the dispensing duct 4. When the outlet element 3 does not close the opening 5, the substance to be administered is pumped - i.e. aspirated - up to the vicinity of the opening 5, then proceeding to deposit as a thin film on an outer surface of the end 11 of the vibrating element 1. On the other hand, when the outlet element 3 closes the opening 5, the pumping action is suspended and the substance to be administered is projected externally through the holes 30 of the outlet element 3, transforming into an administered substance whose particles have dimensions determined by the section of the micro holes themselves.

[0065] In other words, the vibration generator 2 supports and moves the vibrating element 1 (inside which the substance to be dispensed is completely stored) . This vibrating element 1 transmits the vibratory action to the outlet element 3 which, in turn, is vibrated by performing the above dispensing of the substance. In yet other words, the vibrating element 1 is a Sonotrode which acts as an ultrasonic pump, being commanded in its vibratory action by the vibration generator 2, and commanding the vibratory movement of the outlet element 3.

[0066] Preferably, the outlet element 3 is vibrated in a counter-phase with respect to the vibrating element 1.

[0067] The reciprocal counter-phase movement of the vibrating element 1 and of the outlet element 3 involves the described "suction pump effect" of the substance to be administered from duct 4, as well as the described "spray effect" which projects the substance to be administered (aspirated and brought at the outer surface of the end 11) outside.

[0068] In this way, the device is adapted to operate effectively succeeding in dispensing the substance, projecting it in the direction of the vibration, and then projecting it also vertically. In other words, in any position the device operates and achieves its purpose, unlike some prior art devices which instead operate effectively in a single specific position, for example, in which the gravitational action on the substance to be administered is exploited.

[0069] It is to be noted that, in order to achieve the above effect, the holes 30 preferably have a smaller size than the opening 5. Preferably, the spray effect is improved and obtained also due to a specific shape of the holes 30: in a preferred embodiment, the holes 30 extend in height with a section having a substantially conical shape, so as to make the extrusion of the substance to be administered more effective. [0070] The dispensed substance leaves the main body 9 passing through a chamber 91 comprised between the outlet element 3 and an outlet section 92.

[0071] The flange 93 is preferably dismountable from the main body 9. In order to ensure a drastic reduction of drug losses, all the liquid to be administered is completely contained in the tank 40 of the vibrating element 1.

[0072] In this way a device is provided which is capable of administering a predefined and precisely measured amount of the substance to be administered, allowing the administration of even very small amounts of substance to be administered, even below 0.2 ml.

[0073] In fact, upstream of the tank 40 there are no further containers of the substance to be administered and therefore the vibrating element 1 has both the function of containing the substance to be administered and of transferring it, when subjected to vibrations, towards the outlet element 3 for administration. In other words, the dispensing duct 4 has an open end at an end 11 of the vibrating element 1 and preferably a closed bottom at the opposite end (analogously to the above definition in which reference is made to a blind conduit) .

[0074] For this reason, the vibrating element 1 is removably connected to the vibration generator 2 so that it can be replaced once the administration of the substance to be administered has been carried out. In a preferred embodiment, the vibrating element has a flask shape, with an enlarged body at the opposite end of the opening 5. This allows a better handling of the vibrating element. In one embodiment, the surface of the end 11 surrounding the opening 5 may be curved in shape, with a convexity facing the outlet element 3 in order to further ensure contact between the two elements.

[0075] In order to facilitate the replacement of the vibrating element 1, the main body 9 further preferably comprises a connection element 7 rigidly connected to the vibration generator 2 and wherein a recess 71 is defined for the removable housing of the vibrating element 1.

[0076] Said recess 71 has a preferably flat surface 72 towards which an end 13 of the vibrating element 1 faces, opposite to the end 11. At least two abutment portions 73 are preferably defined, which can also be defined by a single ring, as in the example shown, which are configured to embrace a portion of the vibrating element 1 near the end 13, holding it in position during the operation .

[0077] On the main body 9 the vibration generator 2 is installed, preferably on the opposite side with respect to the outlet section 92; said vibration generator 2 comprises an electronic unit 21 which commands and manages the generation of vibrations in particular by means of start and stop signals. Said electronic unit 21 preferably comprises an oscillator and a vibration transmitter configured to generate a signal preferably at high frequency and preferably included in a range from 20 to 350 kHz.

[0078] Preferably, the generator 2 comprises a battery 22 configured to supply the electrical energy necessary for generating the vibrations and at least one on/off button 23 for activating or switching off the vibration signal .

[0079] Figure 5 shows a preferred embodiment of the present invention which provides a device 10 in which the vibrating element 1 comprises a plurality of dispensing ducts 4, preferably parallel to one another.

[0080] A further embodiment of the present invention is shown in figure 4 and provides that the dispensing duct 4 further comprises at least one enlargement 6 which extends transversely to the dispensing duct 4 and narrows towards the dispensing duct 4, in order to facilitate the emptying thereof. Even if a plurality of dispensing ducts are present, it may be provided that one or more of these are associated with an enlargement 6, as illustrated in figure 6. [0081] The above embodiments in figures 4 and 6 are preferably used when doses of substance to be administered are necessary which could not be contained in a single dispensing duct 4 and therefore in the relative tank 40. With these solutions, the vibrating element 1 is able to completely contain the dose to be administered .

[0082] It is understood, however, that the above description is a non-limiting example, therefore possible variants of detail that may be necessary for technical and/or functional reasons are deemed as falling within the same protection scope defined by the following claims .

[0083] That is to say, the device according to the forms of application for which it is provided is specially designed and produced. For example, in its "nasal" application it has the described end portion through which the substance is projected, of dimensions such as to allow insertion into a nostril.

Claims

1. Device (10) for administering substances to be administered comprising:

- a vibrating element (1) ;

- a vibration generator (2) configured to vibrate said vibrating element (1);

- an outlet element (3), comprising a plurality of holes (30) arranged for the passage of the substance to be administered during administration, wherein said outlet element (3) is operatively connected to an elastic portion (8) and is deformable elastically, in turn vibratingly, by the vibrating element (1) commanded in vibratory motion by the vibration generator (2);

wherein the vibrating element (1) has a dispensing duct (4) therein, wherein said dispensing duct (4) defines a tank (40) adapted to completely contain the substance to be administered, wherein the duct (4) extends from an opening (5) facing said outlet element (3) through which the substance to be administered by the vibrating action of the outlet element (3) is pumped.

2. Device (10) according to claim 1, wherein the vibration generator (2) vibrates, along the main propagation direction of the vibrations, preferably vertically, i.e. up-and-down, the vibrating element (1) and then the outlet element (3), wherein the outlet element (3) acts as a valve which, due to its vibration, opens and closes the opening (5) of the dispensing duct (4) , in such a way that in a configuration in which the outlet element (3) does not close the opening (5) , the substance to be administered is pumped up close to the opening (5) while in a configuration in which the outlet element (3) closes the opening (5), the pumping action is suspended and the substance to be administered is projected externally through the holes (30) of the outlet element (3) .

3. Device (10) according to claim 2, wherein the substance once projected to the outside through the holes (30) of the outlet element (3) corresponds to the administered substance whose particles have dimensions determined by the cross-section of the micro-holes themselves .

4. Device (10) according to any one of the preceding claims, wherein said vibrating element (1) is removably connected to said vibration generator (2), so that itis replaceable once the administration of the substance to be administered has been carried out.

5. Device (10) according to one of the preceding claims, wherein the dispensing duct (4) extends axially in an axial direction (X) parallel to the main propagation direction of the vibrations emitted by the vibration generator (2) .

6. Device (10) according to one of the preceding claims, wherein the dispensing duct (4) is blind, so as to contain the entire amount of substance to be administered at its interior.

7. Device (10) according to one of the preceding claims, further comprising a connection element (7) rigidly connected to the vibration generator (2) and wherein a recess (71) is defined for the removable housing of the vibrating element (1) .

8. Device (10) according to one of the preceding claims, wherein the dispensing duct (4) has a circular cross-section with a passage diameter of less than 5 mm, preferably less than 2 mm, wherein the holes (30) have a smaller size than the opening (5) .

9. Device (10) according to one of the preceding claims, wherein the vibrating element (1) comprises, at its interior, a plurality of dispensing ducts (4) .

10. Device (10) according to one of the preceding claims, wherein the dispensing duct (4) further comprises at least one enlargement (6) .

11. Device (10) according to claim 10, wherein the enlargement (6) extends transversely to the dispensing duct (4) and narrows towards the dispensing duct (4) .

12. Device (10) according to one of the preceding claims, wherein said vibrating element (1) comprises, at its interior, a transverse duct (41) which puts the dispensing duct (4) in communication with a region at atmospheric pressure.

13. Device (10) according to claim 12, wherein said transverse duct (41) has a cross-section equal to or less than said dispensing duct (4) .

14. Device (10) according to one of the preceding claims, wherein the opening (5) is defined at one end

(11) of the vibrating element (1), wherein the vibration generator (2) is adapted to oscillate the vibrating element (1) which abuts the outlet element (3) in such a way as to cause it to vibrate.