The present invention refers to a soft gel capsule suitable for containing and storing volatile substances, releasing them when needed. A further object of the present invention is a kit which comprises said capsule.

In a further embodiment, a device is described, suitable to be applied to a mask, characterized by the fact that it comprises:

- at least one base body, suitable for absorbing essential oils and / or volatile substances;

- optionally, means to allow the application of the device to the mask.

Said kit or said device, applied on masks, confers antimicrobial, balsamic, mucolytic and / or aromatherapy activities for the user.

Background art

Antimicrobial resistance poses a serious threat to the effective treatment of an ever-growing range of infections caused by bacteria, fungi and viruses. Around the world, antibiotic resistance is increasing. For example, reduced antibiotic sensitivity of Escherichia coli, Klebsiella pneumoniae, Streptococcus pneumoniae, a reduction that exceeded 50% in most of the countries covered by the WHO Global Report on Antimicrobial Resistance (WHO, 2014). Candidiasis has also become problematic, with Candida albicans showing increased resistance to common antifungal agents (Goncalves, SS et al. 2016 Mycoses, 59,198-219). Recent epidemics and pandemics caused by Coronaviruses such as MERS-CoV, responsible for Middle East respiratory syndrome (MERS), SARS-CoV and SARS-CoV-2, responsible for COVID-19, as well as emergent strains resistant to anti herpes simplex drugs stresses the need to identify effective approaches to prevent and treat viral infections (Boivin, G 2013 Respiratory Viruses, 7,18-23).

Essential oils and their components, including terpenes and terpenoids (1 ,8-cineole, carvacrol) and aromatic compounds (cinnamaldehyde and eugenol) have been shown to possess antimicrobial activity against a wide range of pathogens, with various spectra of activity (Bassole, IH, Juliani, HR 2012 Molecules, 17.3989-4006).

Protective face masks are devices that are widely used in containing the spread of infections.

CN108720127 describes multi-layered protective facial masks, where one of the layers is soaked in essential oils.

WO9410842 describes a container at least partially permeable to gases which contains a plurality of pressure break microcapsules containing a mixture of active ingredients which exert their action when they evaporate.

EP2734242B11 describes a device suitable for the evaporation of volatile substances which is a blister, closed by a double laminated layer, which includes a gas permeable membrane and a laminate in thermoplastic material with a porous structure.

The purpose of the present invention is to make available a device and a kit comprising the same, capable of containing and storing volatile substances and / or essential oils and releasing them if necessary in a prolonged manner, to be used in environments or as a wearable. Description Figure description

Figure 1: An embodiment of the device according to the present invention, disposable, shown applied to a mask.

Figure 2: An embodiment of the device according to the present invention, reusable, shown applied to a mask, internal face (A) and external face (B). Figure 3: Schematic diagram of the water vapor flows that are created in the circumscribed area of the mask, in the presence (A) or in the absence (comparative, B) of the device according to the present invention.

Figure 4: geometry of the soft gel capsule according to the present invention.

Figure 5: (A) vertical section and (B) top view of an embodiment of the kit according to the present invention.

Figure 6: (A) vertical section and (B) top view of an embodiment of the kit according to the present invention.

By mask we refer here to a small mask that covers the nose and mouth to protect against dust and / or possible bacterial and / or viral infections, made of canvas, non-woven fabric or other suitable material. Said masks can be of the disposable type or reusable, for example washable.

A first object of the present invention is a soft gel capsule which contains volatile substances and / or essential oils. Said soft gel capsule has a lenticular shape, with a diameter of about 9 mm or less in length and with a height of about 6.5 mm or less and it is a gelatine capsule. Preferably, the shell of said capsule comprises:

- gelatine 15-45% (w/V)

- organic starch 15-45% (w / V)

- glycerine 0-35% (w / V)

- water q.s.

Preferably, said shell is obtained from a gelatinous membrane having a thickness of between 0.6 and 0.7 mm.

With reference to Figure 4, said soft gel capsule 401 is an ellipsoid cut by the x, y and z planes. This ellipsoid is enclosed in the rectangular parallelepiped of edges 2a, 2b, 2c, defining the axes 402, 403 and 404, respectively, of said ellipsoid. In a preferred form, said axis 402 has a length comprised between 6 and 9 mm, preferably between 6.5 and 8 mm, even more preferably between 6.9 and 7.5 mm, said axis 403 has a length comprised between 5.8 and 8.8 mm, preferably between 6.3 and 7.8 mm, even more preferably between 6.5 and 7.3 mm, said axis 404 has a length of between 3.5 and 6.5 mm, preferably between 4.3 and 6 mm, even more preferably between 4.5 and 5.5 mm.

Said soft gel capsule is suitable for containing said volatile substances and / or essential oils. In a preferred form, said capsule contains a volume comprised between 40 and 100 pi, preferably about 30, or about 35 or about 40 mI, or about 60 mI in a preferred form, about 70 mI.

In a preferred form, said content loaded in said soft gel capsule has a density between 0.800 and 1.000 g / ml, preferably between 0.850 and 0.920 g / ml.

The authors of the present invention have surprisingly made a soft gel capsule with the geometry and materials described here so that it can contain an adequate volume content and the release of said content can be obtained following a slight pressure exerted on it, which is the pressure exerted by a user's fingers. By light pressure, it is meant here that the breaking of the soft gel capsule is obtained in the range 30 - 80 N, preferably 40-70 N. The release of the content is therefore obtainable at the desired moment by the user himself, by exerting said light pressure.

Soft gel capsules made with the same materials but with standard geometries, typically used in the soft gel capsules sector, for example spherical or oblong, have not been shown to be able to release the content in an equally efficient manner following pressure in the indicated ranges, or they arrive too easily to unwanted breakages, even if subjected to pressures lower than those exerted deliberately by the user's fingers, and therefore lower than 30 N.

Said volatile substances are conveniently loaded into said soft gel capsule with methods known to those skilled in the art.

A further object of the present invention is a device, suitable for being applied to a mask, characterized in that it comprises:

- at least one base body, suitable for absorbing essential oils and / or volatile substances;

- optionally, means to allow the application of the device to the mask.

The device according to the present invention is conveniently applied to any type of mask.

In one embodiment, said device is applied inside the mask, i.e. between the user's face and the mask itself. In a further embodiment, said device is applied to the outside of said mask. In an alternative form, said device comprises a portion internal to the mask and a portion external to the same. In the latter form, preferably said internal portion comprises said base body and said external portion comprises said means for allowing its application.

Said base body is, for example, a sponge, or a rubber, or an element made of any material suitable for absorbing essential oils and / or volatile substances, for example natural fibers such as paper, wood, wool, cotton, cellulose absorbent, or hydrogels, polymers, adhesive glues. Said materials are optionally loaded with silver, for example colloidal silver, or silver nanoparticles, or are fabrics comprising silver threads.

Said base body is disposable. In one embodiment, said base body is conveniently supplied individually packaged, already loaded with the mixture of one or more essential oils and / or volatile substances. In an alternative form, said base body is supplied unloaded, and is loaded at the time of use with the mixture of one or more essential oils and / or volatile substances.

In one embodiment, said device is housed in a pocket or in a fold present on the mask.

In one embodiment, said device comprises means for allowing the application of the device to the mask which are selected from permanent means and removable means.

When said means are permanent, they are conveniently selected from the adhesive glues. In this embodiment, said glues are conveniently applied to said base body which, at the time of use, is applied to said mask.

In one embodiment, with reference to Figure 1, the base body 11 of said device 10 is applied to the mask with an adhesive 12, applied to the rear of said base body. In this embodiment, said device 11 is disposable, where said base body has an adhesive on the back. By removing the film that covers said adhesive, the adhesive is uncovered and applied by the user to the mask. In a preferred form, it is applied inside the mask, interposed between the user's face and the mask itself. In one embodiment, said base body is made of adhesive glue on which said essential oils and / or volatile substances are absorbed. Preferably, in this embodiment, said application means are permanent means, so that said base body and said application means consist of a single material which is adhesive glue on which said essential oils and / or volatile substances are absorbed.

When said means are removable, they are selected from the group which includes magnets and interference coupling systems. In this embodiment, said means are reusable. Said removable means conveniently house said base body, for example, they have suitable coupling systems for receiving said base body.

By way of example, the base body according to the present invention is suitably housed in a removable means which is a support made of ferromagnetic material and which is positioned on the mask. On the opposite side of the mask, a magnet is positioned which holds said support in place. With reference to Figure 2, the device 20 is applied on the internal side of the mask, towards the user, and comprises a base body 21 which is housed in the removable means 22. Said removable means 22 is made of ferromagnetic material and comprises tabs 24 in which said base body 21 is housed and held in place (Figure 2A). On the external side of the mask, a magnet 23 is applied which couples to said removable means 22 holding them in place (Figure 2B). Alternatively, said removable means is a male element which, positioned on the template, is coupled by interference to a female element positioned on the opposite side of the template.

Alternatively, said interference coupling system is a velcro system. In one embodiment, said device loaded with essential oils and / or volatile substances gives the mask on which it is applied antimicrobial activity.

In one embodiment, a kit 500 is claimed which comprises, with reference to Figure 5:

- A support sheet, or tray 530, provided with a plurality of cavities or pockets 550, arranged to contain products, made of formable material;

- A covering film 540 at least in part gas-permeable which covers and closes said cavities;

- A plurality of soft gel capsules 510 loaded with volatile substances housed in said cavities; where said plurality of cavities are conveniently separable from each other without causing the opening of the same; characterized by the fact that each of said soft gel capsules can be individually fractured by compression within said cavities.

According to a preferred embodiment, said soft gel capsules are the soft gel capsules according to the present invention.

According to an embodiment, said support sheet 530 is a multilayer and has an external face 531, facing the external environment, and an internal face 532, facing the cavity.

Preferably, said multilayer comprises 4 layers which, from said external face, are:

- layer in APET, amorphous polyethylene terephthalate;

- polyethylene layer;

- layer in EVOH, ethylene vinyl alcohol;

- low melting polyethylene layer for welding.

Said 4 layers are laminated and glued.

Advantageously, said multilayer support sheet which comprises said 4 layers allows the covering film to adhere to said low melting polyethylene layer. The presence of the EVOH layer guarantees the desired gas barrier effect.

According to a preferred embodiment, said covering film is a single layer.

Preferably, said covering film is made of a polyolefin-based microporous synthetic material, which preferably comprises up to 50%, or up to 55%, preferably up to 60%, or up to 70% by weight of a inorganic non-abrasive filler. By way of example, said inorganic filler is silica.

Alternatively, said covering film is a polypropylene film, preferably having a thickness of about 75 pm and a weight of about 36 g / m ² Conveniently, it is possible to isolate said cavities. For example, said cavities are separated from each other in said support sheet by a fold line 590.

Each one of the cavities can then be removed from the blister, without breaking the soft gel capsule contained in them, and used independently of each other. For the purpose of the present invention, a single cavities, isolated from the kit according to the present invention, closed by sadi covering film and containing said soft gel capsules is therefore defined as "loaded pocket".

Said "loaded pocket" is the at least one base body comprised in the device according to this description.

By exerting pressure on said covering film , said soft gel capsule contained in said cavities closed by said covering film fractures and releases the volatile substances contained therein.

Advantageously, the porous and uncoated nature of the covering film absorbs in its structure the substances released by said soft gel capsule, guaranteeing a controlled and prolonged release over time. Advantageously, said covering film has characteristics of sealability which allow it to adhere to the tray, of elasticity and mechanical resistance, which allow the user to exert the pressure required for breaking the soft gel capsule without compromising the integrity of said covering film , of permeability, such as to allow the passage of the substances released following breaking of said soft gel capsule and absorption such as to guarantee a reservoir for the substances released by said soft gel capsules which remain absorbed in the structure of said covering film .

In one embodiment, said kit also comprises fixing means of the self- adhesive type. In a preferred form, said fixing means comprises a support, an adhesive and a liner. Preferably, said support is made of polyethylene foam. Preferably, said liner is made of silicone paper.

In a preferred form, with reference to Figure 6, said fixing mean 680 is of an almost circular and perforated shape. In this embodiment, said fixing means are conveniently applied under said base tray, in proximity to each one of said pockets, thus placing itself on the perimeter portion of said pocket, allowing the central portion of the pocket to emerge from said hole.

In one embodiment, said kit finds application in the diffusion in environments of the substances contained in the soft gel capsules. Conveniently, at least one loaded pocket according to the present invention is positioned or applied on any type of surface, preferably near heat sources, so as to maximize the evaporation of the contents of the soft gel capsules.

In a preferred embodiment, at least one loaded pocket is applied to a mask.

In one embodiment, said essential oils and / or volatile substances are selected for their activity stimulating the immune defences. For this purpose, essential oils are used that belong to the group that comprises: Thyme ( Thymus serpyllum L, Thymus vulgaris L), Oregano ( Origanum vulgare L.), Savory ( Satureja hortensis L, Satureja montana L, Satureja thymbra L.), Rosemary ( Rosmarinus officinalis L), Cinnamon ( Cinnamomum zeylanicum), Tea tree ( Melaleuca Alternifolia), Cajeput ( Melaleuca cajuputi), Chinese Cinnamon ( Cinnamomum cassia), Melaleuca leucadendra (L.), Frankincense ( Boswellia carteri), Myrrh ( Commiphora myrrha), Carrot ( Daucus carota), False flax ( Camelina sativa).

In one embodiment, said essential oils and / or volatile substances are selected for their antiviral activity. For this purpose, essential oils are used preferably selected from the group that comprises: Thyme ( Thymus serpyllum L, Thymus vulgaris L.), Oregano ( Origanum vulgare L), Savory ( Satureja hortensis L, Satureja montana L, Satureja thymbra L), Rosemary ( Rosmarinus officinalis L.), Cinnamon ( _' Cinnamomum zeylanicum), Tea tree ( Melaleuca Alternifolia), Cajeput ( Melaleuca cajuputi), Chinese Cinnamon ( Cinnamomum cassia).

In one embodiment, said device and / or said soft gel capsule are conveniently loaded with a blend of essential oils which have demonstrated antimicrobial synergic activity. This blend comprises essential oils selected from the group that comprises Thyme ( Thymus serpyllum L, Thymus vulgaris L.), Oregano ( Origanum vulgare L), Savory ( Satureja hortensis L, Satureja montana L, Satureja thymbra L), Rosemary ( Rosmarinus officinalis L.), Cinnamon ( Cinnamomum zeylanicum), Tea tree ( Melaleuca Alternifolia), Cajeput ( Melaleuca cajuputi), Chinese cinnamon ( Cinnamomum cassia).

In one embodiment, said device and / or said soft gel capsule are conveniently loaded with a mixture of essential oils which promote bronchial fluidity. This blend comprises essential oils selected from the group that comprises: Cypress ( Cupressus sempervirens L), Cardamom ( Elettaria cardamomum L.), Fennel ( Foeniculum vulgare), Star anise ( lllicium verum), Chamomile ( Matricaria chamomilla L.), Marjoram ( Origanum majorana L.), Anise ( Pimpinella anisum L).

In one embodiment, said device and / or said soft gel capsule are conveniently loaded with a mixture of essential oils with balsamic activity. This blend comprises essential oils selected from the group that comprsies Thyme Camphor ( Cinnamomum camphora L), Eucalyptus ( Eucalyptus globulus Labill.), Mint ( Mentha arvensis L), Pine ( Pinus mugo, Pinus sylvestris L.), Carnation ( Syzygium aromaticum L.).

In a further embodiment, said device and / or said soft gel capsule loaded with essential oils makes the mask on which they are applied suitable for aromatherapy. In this regard, essential oils are selected in the group that comprises Camphor ( Cinnamomum camphora L), Eucalyptus ( Eucalyptus globulus Labill.), Mint ( Mentha arvensis L), Pine {Pinus mugo, Pinus sylvestris L.), Carnation ( Syzygium aromaticum L.). Said volatile substances are preferably the volatile compounds contained in the above oils, obtained naturally or synthetically. In one embodiment, said volatile substances are selected from the group comprising: thymol, carvacrol, cineol, methyl eugenol, E-methyl isoeugenol, eucalyptol, geraniol, limonene, menthol.

In one embodiment, it is claimed the device and / or said soft gel capsule according to the present invention loaded with antibacterial and / or antiviral essential oils for use in enhancing the barrier effect of masks.

In a further embodiment, the use of the device according to the present invention is claimed, loaded with balsamic, analeptic / respiratory essential oils in the purification of the air breathed through a mask.

In a preferred embodiment, it is here claimed the device according to the present invention loaded with a blend of antibacterial, antiviral, balsamic, analeptic / respiratory essential oils for use in enhancing the barrier effect of masks and in purifying the air breathed through the same.

Essential oils have demonstrated the ability to purify and disinfect the air. The device according to the present invention, favouring in an advantageous manner the flow of the same in the water vapour of respiration in the circumscribed area between the nose and mouth of the user and the mask, improves the quality of the air contained in said circumscribed area, with clear advantages for the 'user.

The authors of the present invention have surprisingly demonstrated that the device according to the present invention, positioned on a mask, favours the diffusion of the essential oils contained therein, thanks to the water vapour which forms in proximity of the mask due to the effect of breathing. The water vapour at body temperature that is created around the support has in fact been shown to favour the evaporation of the essential oils contained therein.

The device, when placed between face and mask, leads to a high density of vapours from essential oils and / or volatile substances in a physically limited area, such as to offer proven antimicrobial activity. The device according to the present invention is therefore capable of exerting an active protective barrier effect. The device according to the present invention exploits the natural evaporative tendency of the active ingredients contained in the volatile substances and essential oils which, thanks to the water vapour at 37 ° C produced by breathing in the vicinity of the device itself, generates flow areas that occupy the area circumscribed around the user's nose and mouth. Said flow, passing through the interstices of said base body, favours the evaporation of essential oils and / or volatile substances loaded into it, thus making them free to move and act in said circumscribed area. Essential oils with a balsamic, aromatic, respiratory analeptic effect improve the quality of breathing, which is typically not easy for the user wearing a mask. The essential oils released by the device according to the present invention advantageously purify the air that is found in the circumscribed space between the nose and mouth of the user and the mask, improving compliance in the user with the use of the mask.

Where said essential oils loaded on said device have an antimicrobial effect, the same will be able to enhance the barrier effect of the mask, as shown in Figure 3.

Advantageously, said device is loaded with essential oils with an antimicrobial effect and with a balsamic, analeptic / respiratory effect, so as to obtain two effects simultaneously.

With reference to Figure 3A, a device 30 according to the present invention is shown, loaded with antimicrobial essential oils, applied to a mask, interposed between the user's face and the mask. Bacteria and / or viruses in the external environment 31 are rejected 32 by the physical barrier constituted by the mask. However, some bacteria and / or viruses, represented by the spheres 33, are not blocked by the physical barrier and pass through the mask. The flows of water vapour enriched with the vapours from said essential oils and / or volatile substances that are generated in the circumscribed area 34 around the user's nose and mouth, conveniently cancel said microbial load in said circumscribed area, favouring the user's inhalation of clean air 35. Figure 3B, for comparison, shows the situation that arises when a user wears a mask without the device according to the present invention. Bacteria and / or viruses in the external environment 31 are rejected 32 by the physical barrier constituted by the mask. However, some bacteria and / or viruses, represented by the spheres 33, are not blocked by the physical barrier and pass through the mask. In the absence of the flows of water vapour enriched with the vapours of said essential oils and / or volatile substances in the circumscribed area 34 around the nose and mouth of the user, said microbial load that has passed the physical barrier constituted by the mask is inhaled by the user, flow 36.

Merely by way of non-exhaustive example, some compositions of essential oils are reported here which, loaded on the support according to the present invention, play a bacteriostatic role.

Bacteriostatic composition A:

Eucalyptus globulus CT cineole (leaves) 3.52%

Cinnamomum zeylanicum CT cinnamaldehyde (cortex) 3.52% Rosmarinus officinalis CT cineole (leaf) 3.00 Daucus carota CT carotolo (seeds) 1.04% Camelina sativa oil (seeds) 88.90%

Bacteriostatic composition B:

Cinnamomum zeylanicum CT cinnamaldehyde (cortex) 3,53% Syzygium aromaticum CT eugenol (cloves) 3,53%

Origanum vulgare CT carvacle (aerial parts) 3,53%

Daucus carota CT carotolo (seeds) 1,04%

Camelina sativa oil (seeds) 88.35%

Bacteriostatic composition C:

Mentha arvensis oil 98,00%

Pinus sylvestris oil 0,50%

Melaleuca leucadendra 0,50%

Boswelia carterii 0,50%

Commiphora myrrha 0,50%

Bacteriostatic composition D:

Majoram ( Origanum majorana L.) 33%

Anise ( Pimpinella anisum L.) 33%

Cypress ( Cupressus sempervirens L.) 33%

By way of non-exhaustive example, we report here compositions of essential oils, used for their antiviral activity.

Composition vir. A:

Thymus serpyllum L. 20%

Thymus vulgaris L. 20%

Oregano ( Origanum vulgare L.) 30%

Satureja hortensis L. 10%

Satureja montana L. 10%

Satureja thymbra L. 10%

Composition vir. B:

Rosmarino ( Rosmarinus officinalis L.) 20%

Cannella cinese ( Cinnamomum cassia) 60% Incenso ( Boswellia carteri) 10%

Mirra ( Commiphora myrrha) 10%

By way of non-exhaustive example, we report here compositions of essential oils, used for aromatherapy. Composition aro. A

Star anise ( lllicium verum ) 60%

Camphor ( Cinnamomum camphora L.) 20%

Carnation ( Syzygium aromaticum L.) 20%

Composition aro. B: Eucalyptus ( Eucalyptus globulus Labill.) 45%

Field mint ( Mentha arvensis L) 35%

Pinus mugo 10%

Pinus sylvestris L. 10%