FORMULATION FOR TOPICAL APPLICATION TO THE SKIN OR MUCOUS MEMBRANES

Abstract

The invention relates to a formulation for topical application to the skin or mucous membranes. The formulation has both a pulverulent composition with an enzymatic complex as active substance, and a liquid composition intended to be mixed with the pulverulent composition so as to obtain the formulation to be applied. The liquid composition comprises a solvent and in addition, an agent for dispersing the pulverulent composition in the liquid composition. The invention also relates to a system for packaging and dispensing the formulation.

Claims

1. A formulation for topical application to the skin or mucous membranes, the formulation comprising, a pulverulent composition comprising an enzymatic complex as a first active substance and, a liquid composition comprising a solvent, wherein the liquid composition or the pulverulent composition comprises a dispersing agent for dispersing the pulverulent composition in the liquid composition.

2. The formulation according to claim 1, wherein the liquid composition comprises a second active substance based on an essential oil or a mixture of essential oils, the dispersing agent being arranged to improve the dispersion of the second active substance in the liquid composition.

3. The formulation according to claim 2, wherein the second active substance comprises at least one essential oil which has at least one of the following properties: healing, antiseptic, anti-oedematous, haemostatic, anti-inflammatory or analgesic.

4. The formulation according to claim 2, comprising between 1% and 5% by weight of a complex of essential oils.

5. The formulation according to claim 1, comprising between 2% and 40% by weight of the dispersing agent.

6. The formulation according to claim 1, wherein the liquid composition comprises a second active substance which has at least one of the following properties: moisturising, soothing, anti-inflammatory, anti-oedematous, healing, restorative, antioxidant, anti-cellulite and/or anti-wrinkle, the active substance being in particular based on aloe vera, polysaccharide and/or glycerine.

7. The formulation according to claim 1, comprising between 0.1 and 5% by weight of an antimicrobial agent, based on sodium levulinate, sodium anisate, chlorhexidine or glyceryl caprylate.

8. The formulation according to claim 1, comprising between 0.1% and 2% by weight of a gelling agent based on vegetable gum.

9. The formulation according to claim 1, wherein the enzymatic complex contains hyaluronidase.

10. The formulation according to claim 9, wherein the enzymatic complex comprises hyaluronidase in liposomal form.

11. The formulation according to claim 1, comprising between 1% and 25% by weight of the enzymatic complex.

12. The formulation according to claim 1, wherein the enzymatic complex comprises at least one enzyme promoting tissue permeability.

13. The formulation according to claim 1, wherein the pulverulent composition comprises an anti-caking agent.

14. The formulation according to claim 1, comprising between 40% and 90% by weight of a solvent.

15. The formulation according to claim 1, wherein it comprises: between 3% and 20% by weight of the pulverulent composition; between 80% and 97% by weight of the 1 liquid composition.

16. A system for packaging and dispensing a formulation according to claim 1, the system comprising a body configured with a dispensing device topical application of the formulation.

17. The system according to claim 16, comprising a one-use patch, the dispensing device being configured to dispense the formulation onto the one-use patch for the topical application of the formulation by the patch.

18. The system according to claim 16, wherein the dispensing device is equipped with an applicator to enable the topical application of the formulation.

19. The system according to claim 17, wherein the body has a first and a second separate reservoirs, the first reservoir for packaging the pulverulent composition and the second reservoir for packaging the liquid composition, the system further comprising a wall and breaking device for obtaining the formulation by extemporaneous mixing of the compositions in the body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0123] Other particularities and advantages of the invention will appear in the following description, made with reference to the appended figures, wherein:

[0124] FIGS. 1a and 1b schematically represent in longitudinal section a system according to a first embodiment of the invention, respectively before (FIG. 1a) and after (FIG. 1b) the displacement of the breaking device on the use stroke;

[0125] FIG. 1c represents in perspective top view the breaking device of FIGS. 1a and 1b;

[0126] FIGS. 2a and 2b schematically represent in longitudinal section a system according to a second embodiment of the invention, respectively before (FIG. 2a) and after (FIG. 2b) the displacement of the breaking device on the use stroke;

[0127] FIGS. 3a, 3b and 3c schematically represent examples of applicators that could be associated with the dispensing device of the systems of the preceding figures for performing the topical application of the formulation after mixing of the compositions.

DETAILED DESCRIPTION

[0128] Referring to FIGS. 1 to 3, a system for packaging and dispensing the previously-described formulation is now described. In particular, the system may be packaged as a whole or separately, in a blister, whether sterile or not, before use thereof.

[0129] In general, the system comprises a body 3 equipped with a device 4 for carrying out the dispense of the formulation for topical application thereof.

[0130] In a particular application, the body may be in the form of a one-use patch which comprises a matrix in which the formulation is impregnated, said matrix being intended to be applied on an area to be treated to simultaneously ensure the dispense and the topical application of said formulation.

[0131] According to another particularly advantageous embodiment, represented in the figures, the body 3 has a first 5 and a second 6 separate reservoirs for respectively packaging one amongst the pulverulent composition and the liquid composition, said system further comprising means for obtaining said formulation by extemporaneous mixing of said compositions in said body. Indeed, an extemporaneous mixing of the compositions allows preserving the stability of the enzyme(s) of the complex, in particular hyaluronidase, until use thereof, and thus benefiting from a formulation with an optimum enzyme stability at the time when the desired medical and/or aesthetic treatment should be performed.

[0132] For this purpose, the reservoirs 5, 6 are separated by a frangible wall 7, the system comprising a device 8 for breaking up at least partially said frangible wall in order to set said reservoirs in communication to obtain said formulation.

[0133] In the figures, the body 3 comprises a first upstream reservoir 5 in which the pulverulent composition 1 is packaged and a second downstream reservoir 6 in which the liquid composition 2 is packaged. Alternatively, the liquid composition could be packaged in the upstream reservoir 5 and the pulverulent composition in the downstream reservoir 6.

[0134] The breaking device 8 comprises a piercing means 9 which is mounted on the body 3 in a departed position of the frangible wall 7, said breaking device being movable over a use stroke on which the piercing means 9 crosses the first reservoir 5 to come into the second reservoir 6 throughout the frangible wall 7.

[0135] In particular, the frangible wall 7 and/or the piercing means 9 are arranged so as to obtain a tearing of said frangible wall by said piercing means. In particular, the piercing means 9, and in particular its tip 9b, may be arranged so that its passage wrecks the frangible wall in order to facilitate the release of the first composition 1 into the second reservoir 6.

[0136] The frangible wall 7 may be made of an easily tearable material, in particular a waterproof sheet, based on plastic and/or aluminium, for example by having a tension facilitating tearing thereof by the piercing means 9.

[0137] Advantageously, the piercing means 9 comprises a rod 9a whose distal end is surmounted by a tip 9b, said tip being sharp enough to ensure piercing of the frangible wall 7 without the need for a significant effort from the user.

[0138] Referring to FIG. 1c, the tip 9b has a base surmounted by a head, said base having an external dimension which is larger than the external dimension of the rod 9a.

[0139] Thus, after passage of the point 9b, the frangible wall 7 has a tear with size large enough to enable the rod 9a to pass easily throughout it, and thus the piercing means 9 to continue its use stroke throughout the first reservoir 5.

[0140] Advantageously, the tip 9b has a conical shape, which enables a progressive tearing of the frangible wall 7 around said tip at the beginning of the use stroke.

[0141] Referring to the figures, the piercing means 9 in the departed position is disposed opposite an outer wall 10 of the first reservoir 5, said outer wall being arranged so as to enable the passage of said piercing means throughout it at the beginning of the use stroke.

[0142] The outer wall 10 could be pierceable by the piercing means, in particular by being made of a suitable material and/or by having a reduced thickness at least opposite the piercing means 9. The outer wall 10 may also have an orifice through which the piercing means 9 passes on its use stroke, said orifice possibly being covered with a lid before said passage to prevent leakages of the composition 1 out of the first reservoir 5.

[0143] In particular, as represented in FIGS. 1a and 1b, the outer wall 10 may have a concave central area 11 specifically arranged so as to enable the passage of the piercing means 9.

[0144] In FIGS. 1a, 1b and 1c, the system is in the form of a one-use vial, in particular arranged so as to contain a dose of formulation of less than 5 millilitres.

[0145] In particular, the body 3 of the vial may have a circular or square section, as well as the following dimensions:

[0146] a longitudinal dimension in the range of 5+/−1 centimetres;

[0147] a transverse dimension in the range of 1.5 cm.

[0148] In this embodiment, the breaking device 8 comprises a support 12 on which the piercing means 9 is associated, said support being arranged to be able to slide on the body 3 in order to move said piercing means over its use stroke.

[0149] The support 12 comprises a housing 13 at the centre of which the piercing means 9 is disposed, said housing having an inner geometry which is complementary to that of the bottom of the body 3 so as to be embedded under said body at the end of the use stroke (FIG. 1b).

[0150] In particular, given the dimensions of the body 3, the support 12 has a height in the range of 1 cm.

[0151] The support 12 could be slidably associated on the body 3, which allows improving the ergonomics of use of the system. In this case, the breaking device 8 may be equipped with a safety means to prevent any inadvertent movement of the piercing means 9 before using the system, the user deactivating said safety means when he wishes to mix the compositions 1, 2.

[0152] Alternatively, the body 3 could be mounted on a separate support for moving the piercing means 9 over its use stroke. Thus, the user should assemble the body 3 to the breaking device 8 when he wishes to perform mixing of the compositions 1, 2.

[0153] In FIGS. 2a and 2b, the system is in the form of a syringe. In particular, the body 3 of the syringe may have the following geometric arrangements:

[0154] a longitudinal dimension in the range of 6+/−0.5 centimetres;

[0155] a diameter in the range of 1+/−0.1 centimetres; and

[0156] a collar 3a for digital holding with a transverse dimension of about 4.5+/−0.5 centimetres.

[0157] In this embodiment, the breaking device 8 comprises a plunger 14 at the centre of which the piercing means 9 is associated, said plunger being arranged so as to be able to slide in the body 3 in order to move said piercing means over its use stroke.

[0158] To enable the movement of the piercing means 9, the plunger 14 is mounted on a syringe pusher 15, whose transverse dimension is about 5.5+/−0.5 centimetres.

[0159] Moreover, the body 3 has a third reservoir 16, in particular formed upstream of the first reservoir 5, in which the piercing means 9 is disposed in the departed position.

[0160] As represented in FIGS. 2a and 2b, the second reservoir 6 is in communication with an orifice 17 for dispensing the formulation, a suitable device 4 being mounted on the system to be able to dispense an amount of formulation coming from said orifice. The piercing means 9 could fit into the dispensing orifice 17 at the end of its stroke in order to promote mixing and dispensing of all of the formulation.

[0161] Advantageously, the dispensing device 4 is equipped with an applicator 18 to enable the topical application of the formulation directly to a portion of the body to be treated, in particular in the context of a medical and/or aesthetic intervention.

[0162] Referring to FIG. 3, this applicator 18 could in particular be selected from the group comprising a flat applicator 18a (FIGS. 1a, 1b, 3(a)), a drop-by-drop pipette 18b (FIGS. 2a, 2b, 3(b)) or a roll-on 18c.

[0163] In particular, as represented in FIG. 3(c), a roll-on type applicator 18c comprises a base 19 which is mounted on the dispensing orifice 17, said base comprising:

[0164] a lower wall 19a provided with orifices 20 through which an amount of formulation to be applied could pass;

[0165] an upper opening 19b in which a ball 21 is rotatably mounted to enable the application by means of said ball of an amount of formulation on an area to be treated.

[0166] Alternatively, the dispensing device 4 could be arranged so as to dispense a given amount of formulation in a one-use patch, the topical application of said formulation then being carried out by disposing said patch on the area to be treated.

[0167] For this purpose, the dispensing device 4 may for example be equipped with a drop-by-drop pipette 18b as described before.