FR3053244A1 - DEVICE FOR DELIVERY OF AT LEAST ONE ACTIVE PRINCIPLE BY PERMUCOSAL MOUTH. - Google Patents

Abstract

Device for administering at least one active principle per oral mucosa, comprising: - a body (10), - a bulb (2) inserted into said body (10), said ampoule (2) preferably containing a solution hydro-alcoholic being able to dispose of an active ingredient already dissolved therein in a solution, preferably an aqueous-alcoholic solution, said ampoule (2) having on one side a single opening closed by a perforable lid (20), said ampoule (2) being provided with the side at its end (21) opposite said opening of a shank, - a cannula (11) provided with a dispensing orifice (110) for dispensing said at least one active principle on the oral mucosa, in particular the gingivo-jugal mucosa, said cannula being provided with a deformation at its base in the form of a lower reservoir called a "kangaroo pouch", said cannula (11) being able to conceal within it one or more active principle (s) (s) likely to be dissolved s by the solution issuing from the ampoule (2), - a perforator (12) for perforating said seal (20) and connecting the inside of said ampoule (2) with said cannula (11), - said body (10) having breaking means (31, 32) for breaking said tail formed at the opposite end (21) of the ampoule (2) simultaneously and / or after perforation of said seal (20) by said perforator (12).

Description

® FRENCH REPUBLIC

NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY © Publication number:

(only to be used for reproduction orders) © National registration number

053 244

56302

COURBEVOIE © Int Cl ⁸ : A 61 J 7/00 (2017.01)

PATENT INVENTION APPLICATION

A1

©) Date of filing: 01.07.16. © Applicant (s): PEROVITCH PHILIPPE— FR and (© Priority: STICKDOSE — FR. @ Inventor (s): PEROVITCH PHILIPPE and NAVE JULIAN. (43) Date of public availability of the request: 05.01.18 Bulletin 18/01. ©) List of documents cited in the report preliminary research: Refer to end of present booklet (© References to other national documents ® Holder (s): PEROVITCH PHILIPPE, STICKDOSE. related: ©) Extension request (s): (© Agent (s): CAPRI.

DEVICE FOR ADMINISTERING AT LEAST ONE ACTIVE PRINCIPLE BY MOUTH PERUUSCOUS.

FR 3 053 244 - A1

Device for administering at least one active principle by buccal per-mucosa, comprising:

- a body (10),

- an ampoule (2) inserted into said body (10), said ampoule (2) preferably containing a hydro-alcoholic solution which may have an active principle therein already dissolved in a solution, preferably a hydro-alcoholic solution , said bulb (2) comprising on one side a single opening closed by a perforable cover (20), said bulb (2) being provided on the side at its end (21) opposite to said opening of a tail,

- A cannula (11) provided with a dispensing orifice (110) for dispensing said at least one active principle on the oral mucous membranes, in particular the gingivojugal mucosa, said cannula being provided with a deformation at its base in the form of a lower reservoir said “kangaroo pocket”, said cannula (11) being able to harbor within it one or more active principle (s) capable of being dissolved by the solution originating from the ampoule (2),

- a perforator (12) for perforating said cover (20) and connecting the interior of said bulb (2) with said cannula (11) =

- said body (10) comprising breaking means (31, 32) for breaking said tail formed at the opposite end (21) of the bulb (2) simultaneously and / or after perforation of said cover (20) by said perforator (12).

Λ —--- 122

The present invention relates to devices for administering at least one active principle by buccal per-mucosa, in particular at least one lipophilic active principle dissolved in a hydroalcoholic solution consisting of water and ethanol.

The administration by buccal per-mucosa route of active principles of lipophilic nature, put in hydroalcoholic solution with high degree of ethanol, has been described in the documents W02008035020, W02008087323, W02009095621, WO2010072950, WO2010081984, WO2010070236,

WO2011004117 or also WO2014108657. Appropriate devices for dispensing these active ingredients have been described in documents W02009016309, W02009138644, WO2010063978 or WO2012072934, allowing the administration of such hydroalcoholic solutions which must be precisely deposited in full and in a single gesture, preferably in the gutter anatomical gingivo-jugale, in order to allow the absorption of these solutions in a few seconds by this surface and mucous cavity. Such devices also allow the extemporaneous preparation and the immediate dissolution of active ingredients known to be unstable when put in hydro-alcoholic solution.

However, these devices are adapted to active principles of a certain added value, which must be put into solution at the time of their per-mucous administration. The functions of these devices being relatively complex, their industrial cost prices may not be in line with current active principles which remain stable in these same hydro-alcoholic solutions, active principles which must be economically delivered for the use of patients at a cost corresponding to the usual levels of drugs on the market, whether they are prescribed or over the counter (OTC), such as those administered orally.

The constraint of operating these hydroalcoholic therapeutic formulations at acceptable manufacturing and sales costs is compounded by the need to protect them from degradation phenomena, whether due to light, oxidation or the like. packaging of these solutions must expressly be of pharmaceutical quality.

On the other hand, the use of these solutions and their potent application, must be carried out with the greatest simplicity of preparation and application for the patient user of average competence, who most often self-administers them.

The document W02007014955 describes a bulb with a single opening provided with a seal sealed on a circular rim, which seal can be removed by pulling on an external tab, said seal can also be pierced by a straw, which then makes it possible to extract easily all the liquid by sucking it up, like a drink.

The hydro-alcoholic solutions to be administered by buccal per-mucosa, vectors of lipophilic active principles dissolved, have a very small volume, preferably less than or equal to 1 ml. For such low volumes, if we take the case of a 2 ml sealed ampoule containing 1 ml of useful hydro-alcoholic solution, the precise and complete deposition in the gingival-jugal groove of the user patient is difficult to obtain from the mere manipulation of such a small bulb. Indeed, the liquid remains retained at the level of the neck of the bulb which supports the sealing of the seal. Being a very small volume of liquid (less than 2ml) and a very small opening (less than 4mm in diameter) the weight of this liquid is not enough to evacuate it from the ampoule. There is indeed a single opening at the level of the bulb on which the liquid is retained by capillary action thus creating a surface tension at the level of this opening which prevents any air from entering the bulb and expelling the liquid. Even if the cover is completely detached from the orifice, the surface tension exerted by the hydro-alcoholic solution at the level of the glass rim of the circular neck of this small bulb remains an obstacle to the complete, easy and instantaneous delivery of the hydroalcoholic drug solution as desired. The weight is indeed not enough to break this same surface tension which retains the flow. Under these conditions, it is difficult or even impossible to pour the entire content of such a vial precisely into the anatomical gingival-jugular area, facing the premolars and molars of the lower jaw, while holding said small vial at the fingertips . And given the small volume of solution present in this same ampoule, it is essential to ensure complete and precise administration of this solution in order to have the right medically useful dose actually delivered.

The present invention aims to provide an operating device which can be reusable, bulb after bulb, to overcome the aforementioned drawbacks.

The object of the present invention is in particular to allow the easy operation of small volume sealed ampoules, in order to deliver medicinal alcoholic solutions to be administered by oral mucous membrane, preferably in the "gingivojugale" groove.

The present invention also aims to provide a device for administering at least one active principle by buccal per-mucosa which is both the support of the ampoule-container in which it is engaged and maintained but also, which allows instantly by a means of rupture associated with said support, to break the tail of the glass bulb in the best conditions of ease and safety, in order to obtain the instantaneous availability of the liquid volume inside the canal / cannula administration of this same device.

The present invention also relates to a device which limits or even prevents the risks of loss or leakage of the liquid at the time of its administration.

The present invention also relates to a simple and inexpensive device to manufacture and assemble, and reliable in use.

The present invention therefore relates to a device for administering at least one active principle by buccal per-mucosa, comprising:

- a body,

- an ampoule inserted into said body, said ampoule containing a solution, preferably a hydro-alcoholic solution, said ampoule comprising on one side an opening closed by a perforable cover, said ampoule being provided at its end opposite to said opening a tail,

a cannula provided with a liquid channel and a dispensing orifice for dispensing said at least one active principle on the oral mucous membranes, in particular the gingival-jugal mucous membranes,

a perforator for perforating said cover and connecting the interior of said ampoule with said cannula,

- Said body comprising breaking means for breaking said tail formed at the opposite end of the bulb simultaneously and / or after the perforation of said cover by said perforator.

Advantageously, said perforator has a pointed and / or cutting end.

According to a first variant, said body and said cannula are formed in a single piece.

According to a second variant, said cannula and said perforator are formed in one piece.

According to a third variant, said body and said perforator are formed in one piece.

According to a fourth variant, said body, said cannula and said perforator are formed in one piece.

Advantageously, said dispensing orifice of said cannula is provided with a removable plug.

Advantageously, the device comprises a pivoting and / or sliding support on said body, said support receiving said bulb.

Advantageously, said ampoule contains a hydroalcoholic solution consisting solely of water and ethanol, preferably with 40% to 60% ethanol and 60% to 40% water.

Advantageously, said ampoule contains an active principle dissolved in said hydro-alcoholic solution.

Advantageously, an active principle in the form of powder or liquid is contained in said cannula, said active principle being dissolved by the liquid contained in said ampoule before distribution of the assembly on the oral mucous membranes.

Advantageously, said cannula is closed by a membrane, said perforator comprising a second pointed and / or cutting end for opening said membrane.

Advantageously, the volume of said ampoule is between 0.5 ml and

2ml.

Advantageously, said cannula comprises a pocket or cavity adapted to contain substantially the entire volume of fluid from the ampoule.

Advantageously, said pocket or cavity has a volume greater than the volume of the liquid contained in said ampoule, in particular approximately 30% greater.

Advantageously, the walls of said pocket or cavity form an angle, in particular about 45 °, relative to the central space of said cannula.

Advantageously, said pocket or cavity is located in the part of the cannula which is proximal to said body.

According to a first advantageous embodiment, the device comprises a rupture device comprising a pivoting member pivotally mounted on said body, said pivoting member receiving said opposite end of the bulb.

Advantageously, said pivoting member is provided with a blind longitudinal slot forming rupture means, said blind slot allowing the insertion of the opposite end of the bulb into said pivoting member when said bulb is inserted into said body, while blocking said opposite end when said pivoting member is pivoted, causing said opposite end to break.

According to a second advantageous embodiment, the device comprises a rupture device comprising a sliding member, situated at the rear of said body, said sliding member receiving said opposite end of the bulb and moving on an inclined axis, in particular substantially perpendicular , relative to the central longitudinal axis of said bulb.

Advantageously, said sliding member comprises an inclined plane which, during the movement of said sliding member, cooperates with the bulb to move it against the perforator and causes the rupture of said opposite end of the bulb at the end of its stroke.

According to a third advantageous embodiment, said support is mounted to pivot and slide relative to said body, said support, when it slides, displacing the bulb against the perforator, said support îo comprising an inclined plane causing the rupture of said opposite end of the bulb at the end of the slide.

These characteristics and advantages, and others, of the present invention will become more clearly apparent from the following detailed description, made with reference to the accompanying drawings, given by way of nonlimiting examples, and in which,

- Figure 1 is a front view of the sealed bulb alone,

FIG. 2 is a front view of a device for administering an active ingredient by buccal per-mucosa according to a first advantageous embodiment of the invention,

FIG. 3 is a partial view in cross section of the device in FIG. 2,

FIGS. 4 to 8 are different views, in perspective, in cross section or from the side, describing the operation of the device in FIG. 2,

FIGS. 9 to 15 illustrate various alternative embodiments of removable plugs for the dispensing orifice,

FIG. 16 is a side view showing an advantageous alternative embodiment of the device of FIGS. 2 to 8,

FIGS. 17 to 19 illustrate another advantageous alternative embodiment,

FIGS. 20 to 23 illustrate yet another advantageous variant,

FIGS. 24 to 26 also illustrate another advantageous alternative embodiment,

FIGS. 27 to 30 illustrate yet another advantageous embodiment, and

- Figures 31 to 33 also illustrate yet another advantageous embodiment.

In order to make the drawings explicit, the proportion of the scales is not necessarily respected.

The present invention applies more particularly to one or more active principle (s) dissolved in a hydro-alcoholic solution. This hydro-alcoholic solution preferably consists only of water and ethanol, preferably with 40% to 60% by volume of ethanol and 60% to 40% by volume of water.

This hydro-alcoholic solution is packaged in a sealed ampoule 2, the available volume of which is preferably between 0.5 ml and 2 ml and which can be seen in FIG. 1. This ampoule 2 has an end 20 having an opening sealed with a seal and an opposite end 21 structurally closed in the shape of a point. Typically, this bulb 2 is made of glass, but other materials could be considered.

In a first advantageous embodiment of the invention, shown in FIGS. 2 to 8, the device can be broken down into three sub-assemblies, namely a cannula 11 allowing the administration of the liquid into the gingival-jugular channel through a dispensing orifice 122, a body 10 advantageously provided with a receptacle channel, preferably semi-cylindrical, receiving the bulb 2, and a perforator 12 making it possible to perforate the sealed end 20 of the bulb 2. In this first embodiment, the user firstly introduces the bulb 2 into the receptacle channel of the body 10. When the bulb is pushed against the perforator 12, the latter will then pierce the cover 20. The hydro- alcoholic is then kept inside the bulb by capillary action creating a surface tension at the interface. As it is, air cannot enter the bulb and therefore cannot evacuate the liquid it contains towards the cannula, which constitutes a stationary state. When the opposite end 21 of the bulb is broken manually, an air intake is immediately created, the air entering the bulb and spontaneously evacuating the liquid that it contains towards the cannula 11 of the device, which will then make it possible to administer the solution in the gingival-jugual gutter.

Advantageously, said perforator 12 has a pointed and / or cutting end 120 connected to said dispensing orifice 122 via a liquid channel 110. This perforator 12 can be pointed, cylindrical, conical or of any other shape as long as it makes it possible to perforate the sealed end of the bulb correctly. Advantageously, the end 120 of the perforator 12 makes it possible to remove any flap of the cover in order to ensure passage without discomfort or loss of the liquid from the bulb 2 towards the cannula 11.

According to the invention, the device comprises means 31, 32 for breaking the tail formed by the opposite end 21 of the bulb 2.

FIGS. 4 to 8 describe a breaking device 3 making it possible to carry out the breaking operation of the opposite end 21 of the bulb 2. In this example, the breaking device 3 proceeds like a guillotine or a mechanical breaking support. by pressing force on the glass tail of the bulb (end 21). In particular, the rupture device 3 may comprise a member 30 pivotally mounted on the body 10, said member 30 receiving said opposite end 21 of the bulb. Thus, when the bulb 2 is positioned in the body 10 with the cover 20 pierced by the perforator 12, the pivoting of said pivoting member 30 causes said opposite end 21 to break. Advantageously, said pivoting member 30 is provided with a longitudinal slot 31 blind allowing insertion into said member 30 of the opposite end 21 of the bulb 2 when the latter is inserted in the body 10, while blocking said opposite end 21 during pivoting, thereby causing its rupture .

Of course, any other system making it possible to cause the tail formed at the opposite end to rupture, it can be envisaged, it being understood that said tail can be provided with a circular precut which weakens it and facilitates this rupture.

Figure 8 shows a variant with spout. In order to facilitate the positioning of the end of the cannula 11 in the gingivojugale groove, that is to say behind the row of lower molars, this can be oblique with the advantage of allowing said gingivo cavity to be opened -jugal by the only physical volume of its soft, non-annoying and rounded end. Thus, when the device is held in the hand, the end of the cannula can easily be placed behind the teeth between the gum and the cheek. Any other solution making it possible to facilitate precise administration into the gingival-jugular groove can be considered such as a hemispherical shape at the end of the cannula 11.

A removable plug 5 may also be desirable at the level of the dispensing orifice 110 of the cannula 11, whatever the shape of its end. Various variants are proposed in FIGS. 9 to 15. The plug 5 can, for example, be conical and simply fit into the cannula 11, be screwable, bayonet or in any other way making it possible to ensure a seal. Other sealing solutions, such as seals, can also be considered. All versions of plugs are also applicable to each version of the device.

In a preferred embodiment, the cannula 11 is provided with a deformation of its substantially cylindrical tubing, thus producing a pocket or cavity 111 visible in FIGS. 16 and 27 to 31. This pocket 111 is able to contain substantially all of the of the liquid volume from the emptied ampoule 2, until the patient removes the obturator plug 5 from the end of the cannula 11 and applies the end of said cannula to the gingival-jugular cavity. Advantageously, said pocket 111 may contain a volume greater, for example by about 30%, than the volume of the dose of liquid to be dispensed. This allows the entire liquid volume to be retained in a stable manner in the device, before its rapid and total release by tilting the cannula in the gingival-jugular groove. To dispense the ίο dose, the user then tilts said device upwards, typically between 25 ° and 45 ° relative to the horizontal, so that the liquid volume stored in the pocket 111 of this cannula is instantly and completely delivered. by gravity in the gingival-gutter.

Said pocket 111 can be constituted by a collection cavity whose proximal and distal walls are both of angulation around 45 °. This cavity 111 is preferably located in the part of the cannula 11 which is proximal to the body 10.

Figures 17 to 19 illustrate an embodiment facilitating the positioning of the bulb 2 and its perforation. Said bulb 2 is mounted in a support 100 pivoting and sliding relative to said body

10. The body 10 may comprise two lugs 15 cooperating with two grooves 105 formed in the pivoting support 100. This pivoting support 100 comprises the receptacle channel receiving and retaining the bulb 2.

This implementation facilitates the positioning of the bulb by the user, this being done by inserting the bulb in the pivoting support 100 when the latter is in a loading position, with said pivoted support, for example 45 °, relative to the body 10, as illustrated in FIG. 17. Once the bulb is inserted in the support 100, the latter is pivoted in the other direction to return to the position parallel to said body 10, and during the sliding of said support 100 relative to the body 10 in the direction of the perforator 12, the bulb will be pierced by the perforator 12. The user then actuates the rupture device 3, as described above.

Figures 20 to 23 illustrate another embodiment in which the body 10 is no longer made in one piece. The cannula 11 and / or the perforator 12 can indeed be produced in a dissociated manner from the body 10, and this in particular to simplify manufacture. There can thus be three parts, namely the cannula 11, the perforator 12 and the body 10; or two pieces, with the cannula 11 forming only one piece with the perforator 12 but separated from the body 10; or the body 10 forming only one piece with the perforator 12 but dissociated from the cannula 11. These pieces can be assembled by screwing, welding, gluing or any other way so as to form only one sealed piece. Optionally, provision may be made for the addition of sealing solutions such as seals.

In the embodiment of Figures 24 to 26, said cannula 11 may contain an active ingredient, whether in dry or liquid form. Thus, said active ingredient will be in a situation of being dissolved as soon as it is brought into contact with the hydro-alcoholic solution from said ampoule 2, the mixing and dissolution being carried out by simple stirring before the distribution of the liquid assembly. on the gingival-jugal mucosa.

îo To this end, advantageously, said cannula 11 is closed by a membrane 4, said perforator 12 comprising a second pointed and / or cutting end 18 for opening said membrane 4.

In this variant, the cannula 11 can be pre-engaged and partially screwed onto the thread of the body 10 and stopped by a ring 6 preventing any additional screwing. This screwable base of the cannula may include grips, extra thicknesses or even lateral grooves facilitating the grip of the fingers for its screwing or unscrewing.

Here, said cannula 11 may itself contain the dosage which a patient may have to administer at regular intervals or in case of therapeutic necessity. The cannula 11 thus becomes the independent container of an active principle which will be used in due time by the support device of the invention as soon as it is loaded with an ampoule carrying the hydroalcoholic solution at the adequate volume for said active principle and its instant dissolution. Thus, the device comprises a body 10 which can successively receive a new liquid solution contained in a new ampoule 2 and successively also a new active principle carried by a new cannula 11 specific to said active principle and to its dosage. Said cannula 11 then forms the unit dosage to be applied and can be supplied commercially separately and independently of the body 10.

If the cannula 11 containing the active ingredient is delivered separately, it is preferably provided with a rigid capsule protecting its perforable membrane 4, said rigid capsule having necessarily to be removed, for example by pulling on a tongue, before undertaking to fix the thread of the cannula 11 on that of the body 10.

The screwable base of the cannula 11 may include a seal which is constrained at the end of complete screwing of the cannula after perforation of the sealed membrane 4. Advantageously, the pocket 111 is located close to said screwable base.

The sealed membrane 4 provides sealing to preserve the active principle placed inside the cannula 11. The second pointed and / or cutting end 18 is therefore provided to open the access of the hydroalcoholic solution contained in the ampoule 2 at channel 110 of cannula 11.

If the hydro-alcoholic solution is itself already carrying an active principle, there is thus a possibility of associating extemporaneously two or more active principles, one of which is already stabilized in hydroalcoholic solution. But still, if the hydro-alcoholic solution does not contain active principle, then this hydro-alcoholic solution will act as extemporaneous solvent for the active principle (s) contained (s) together or separately in the cannula , which ensures the operation and administration of certain active ingredients known to be unstable in hydro-alcoholic solutions.

The operating principle is similar to the first embodiment, with two additional steps of screwing the cannula 11 and mixing the active ingredients.

The cannula 11 half engaged on its thread, is initially retained, for example by a detachable locking ring which prevents any screwing operation and perforation of the obturator membrane 4 without any therapeutic preparation. Thus, the cannula 11 remains partly screwed in the intermediate position awaiting use.

For an implementation, it is therefore necessary to detach the locking ring, and screw the cannula 11 fully onto its thread, which will cause the membrane 4 to be perforated by the second perforator 18.

Then, by pushing the ampoule 2 into its housing, the cover 20 of the ampoule 2 containing the hydro-alcoholic solution is punctured with the perforator 12. The rupture of the tail of the ampoule with the rupture device 3 allows for the hydro-alcoholic solution to immediately meet the active principle (s) contained in the cannula and to achieve / their dissolution.

The cannula 11 always remaining plugged at its end, preferably holding the device with the dispensing orifice 122 of the cannula 11 pointing towards the ground, the device is then shaken to mix the active principle with the hydro-alcoholic solution, then the device being returned to the horizontal pre-administration position, the user removes the removable plug 5 from the cannula 11, places the end of the latter in the gingival-jug groove while tilting the body 10 of the device towards the top in order to run the hydro-alcoholic solution retained by the bag 111 and thus deliver all of the solution.

As a variant, it is possible to carry out an assembly in stages in place of the screw threads, in which case the cannula 11 should be clipped into a first bearing of the body 10, there again with a locking ring to prevent any undesired perforation. of the membrane 4 of the cannula 11.11 would then have to detach the locking ring, clip the cannula 11 on a second bearing of the body 10, which will cause the perforation of the membrane 4 by the second perforator 18. The device is then shaken to mix the active ingredient with the hydro-alcoholic solution, then the user removes the removable plug 5 from the dispensing orifice 122 of the cannula 11, and places the latter in the gingival-gutter.

Figures 27 to 30 illustrate another advantageous embodiment.

Here, the rupture device 3 is formed by a sliding member 30 ′, similar to a guillotine, located at the rear of the body 10 in which a bulb 2 containing the hydro-alcoholic solution is introduced. The sliding member 30 'moves on an inclined axis, in particular substantially perpendicular, relative to the central longitudinal axis of said bulb 2, preferably a vertical axis (in the orientation of Figures 27 to 30). It has an inclined plane

32, forming means of rupture.

With the sliding member 30 'in the high position (cf. FIGS. 27 and 29), the user introduces the bulb 2 into the receptacle channel of the body 10. By actuating the sliding member 30' downwards, the plane inclined 32 will first push the bulb 2 into the body 10 in the direction of the perforator 12, to perforate the cover 20. At the end of the race, the inclined plane 32 of the sliding member 30 'breaks the tail 21 of the bulb, as shown in Figures 28 and 30.

After use, the user raises the sliding member to its upper position and removes the empty bulb from its receptacle channel of the body 10.

FIGS. 31 to 33 illustrate another advantageous embodiment.

Here, the device comprises a support 100 pivoting and sliding relative to the body 10, said support 100 receiving the bulb 2, as visible in FIG. 31. The translation of this support 100 towards the perforator 12 allows the perforation of the seal. 20 closing the bulb and also the simultaneous rupture of the tail 21 of the bulb at the rear, by means of an inclined plane 32 disposed in the bottom of said support 100. Preferably, this rupture occurs at the end of sliding of the support 100 towards the perforator 12, so that the cover 20 of the bulb is first perforated, before the break of the tail formed at its opposite end. This is visible in Figures 32 and

33.

Various modifications are possible for a person skilled in the art without departing from the scope of the present invention as defined by the appended claims. In particular, the various characteristics and functionalities of the device described in the different embodiments and variants and can be combined with one another in an appropriate manner.

Claims (20)

Claims 1Device for administering at least one active principle via the oral mucosa, characterized in that it comprises: - a body (10), - an ampoule (2) inserted into said body (10), said ampoule (2) containing a solution, preferably a hydro-alcoholic solution, said ampoule (2) comprising on one side an opening closed by a cover (20 ) perforable, said bulb (2) being provided at its end (21) opposite to said opening with a tail, a cannula (11) provided with a liquid channel (110) and a dispensing orifice (122) for dispensing said at least one active principle on the oral mucous membranes, in particular the gingival-jugal mucous membranes, a perforator (12) for perforating said cover (20) and connecting the interior of said ampoule (2) with said cannula (11), - said body (10) comprising breaking means (31, 32) for breaking said tail formed at the opposite end (21) of the bulb (2) simultaneously and / or after perforation of said cover (20) by said perforator (12). 2, - Device according to claim 1, wherein said perforator (12) 20 has a pointed and / or cutting end (120). 3. - Device according to claim 1 or 2, wherein said body (10) and said cannula (11) are formed in one piece. 25 4, - Device according to claim 1 or 2, wherein said cannula (11) and said perforator (12) are formed in one piece. 5.- Device according to claim 1 or 2, wherein said body (10) and said perforator (12) are formed in one piece. 6. - Device according to claim 1 or 2, wherein said body (10), said cannula (11) and said perforator (12) are formed in one piece. 7. - Device according to any one of the preceding claims, 5 in which said dispensing orifice (122) of said cannula (11) is provided with a removable plug (5). 8. - Device according to any one of the preceding claims, comprising a support (100) pivoting and / or sliding on said body (10), îo said support (100) receiving said bulb (2). 9. - Device according to any one of the preceding claims, in which said ampoule (2) contains a hydro-alcoholic solution consisting solely of water and ethanol, preferably with 40% to 60% 15 ethanol and 60% to 40% water. 10. - Device according to any one of the preceding claims, wherein said ampoule (2) contains an active ingredient dissolved in said hydro-alcoholic solution. 11. - Device according to any one of the preceding claims, in which an active principle in the form of powder or liquid is contained in said cannula (11), said active principle being dissolved by the liquid contained in said ampoule (2) before distribution of the whole on the mucous membranes 25 mouths. 12. - Device according to claim 11, wherein said cannula (11) is closed by a membrane (4), said perforator (12) having a second end (18) pointed and / or cutting to open said membrane 30 (4). 13. - Device according to any one of the preceding claims, in which the volume of said ampoule is between 0.5 ml and 2 ml. 14. - Device according to any one of the preceding claims, 5 wherein said cannula (11) comprises a pocket or cavity (111) adapted to contain substantially the entire liquid volume from the bulb (2). 15. - Device according to claim 14, wherein said pocket or cavity (111) has a volume greater than the volume of the liquid contained in said ampoule (2), in particular approximately 30% greater. 16. - Device according to claim 14 or 15, wherein the walls of said pocket or cavity (111) form an angle, in particular about 45 °, relative to the central space of said cannula (11). 17. - Device according to any one of claims 14 to 16, wherein said pocket or cavity (111) is located in the part of the cannula (11) which is proximal of said body (10). 18.- Device according to any one of the preceding claims, comprising a rupture device (3) comprising a pivoting member (30) pivotally mounted on said body (10), said pivoting member (30) receiving said opposite end (21 ) of the bulb (2). 19. Device according to claim 18, in which said pivoting member (30) is provided with a blind longitudinal slot (31) forming breaking means, said blind slot (31) allowing the insertion of the opposite end ( 21) of the bulb (2) in said pivoting member (30) when said bulb (2) is inserted into said body (10), while blocking said Opposite end (21) when said pivoting member (30) is pivoted, causing said opposite end (21) to break. 20, - Device according to any one of claims 1 to 17, comprising a rupture device (3) comprising a sliding member (30j, located at the rear of said body (10), said sliding member (30j receiving said opposite end (21) of the bulb and moving on an axis 5 inclined, in particular substantially perpendicular, relative to the central longitudinal axis of said bulb (2). 21, - Device according to claim 20, wherein said sliding member (30j has an inclined plane (32) which, during the movement of said iso sliding member (30j, cooperates with the bulb (2) to move it against the perforator ( 12) and causes the rupture of said opposite end (21) of the bulb (2) at the end of the stroke. 22, - Device according to claim 8 and any one of 15 claims 10 to 17, wherein said support (100) is pivotally mounted and sliding relative to said body (10), said support (100), when sliding, moving the bulb (2) against the perforator (12) , said support (100) comprising an inclined plane (32) causing the rupture of said opposite end (21) of the bulb (2) at the end of sliding.