NL2001342C2 - Balm for covering mucous membranes against allergenic substances present in the air, the use of the balm and an applicator for the balm. - Google Patents

Description

Sch / svk / Boegem-4q

BALSEM FOR COVERING MUCED FLASES AGAINST ALLERGENIC SUBSTANCES AVAILABLE, THE USE OF THE BALSEM AND AN APPLICATOR FOR THE BALSEM

The invention lies in the field of preventive treatment of inhalation allergies, such as hay fever,

Health authorities advise sufferers of 5 inhalation allergies, such as hay fever, to avoid contact with the relevant allergenic substances as much as possible and to use medicines that suppress the allergic reactions.

It is an object of the invention to provide a medically inert inactive agent, in which use the relevant allergic reactions do not occur, or at least considerably less violently.

In connection with this, the invention provides a balm for covering mucous membranes, in particular nasal mucous membranes, against direct contact with allergenic substances present in the air, such as pollen from grasses, plants, shrubs, or trees, droppings of house dust mites, fine dust, for example dust released during sanding, grinding, drilling, milling, or sawing solid materials, such as wood, plastics, metals and the like, soot, smoke or other contaminants, which balm is a spreadable, pasty, greasy substance is such that after applying balm to the mucous membranes a user is at least less susceptible to inhalation allergies, such as hay fever.

In a particular embodiment, the balm has the special feature that the balm contains pasty fat.

2

Alternatively or in combination therewith, the balm may be characterized in that the balm contains oil.

In a combination of the latter two aspects, the balm can have the special feature that the balm contains pasty or at least more or less solid fat and oil.

The balm is preferably characterized in that it is free from additives, such as fragrances, colorants, gelling agents and preservatives.

According to an aspect of the invention, the balm can have the special feature that the fat contains a mineral fat, such as vaseline and paraffin.

Alternatively or in combination therewith, the balm can have the feature that the fat contains an animal fat, such as beeswax and wool fat.

The balm can also have the special feature that the fat contains a vegetable fat, such as coconut fat, mango butter, palm fat, shea butter and cocoa butter. The mentioned fat categories can be used individually or in combination with each other.

Different types of fats of this category, i.e. mineral, animal or vegetable, can also be used in combination if desired.

According to yet another aspect of the 2b invention, the balm has the special feature that the liquid oil contains an animal oil.

Animal oils are known in many forms and types. They are usually useful as a component of a balm according to the invention.

However, preference is given to a balm in which the animal oil is free from oil derived from marine animals, such as cod liver oil, whale oil or fish oil. Oil from marine animals usually spreads an odor experienced by most people as unpleasant and in practice appears to be perishable relatively quickly.

Certainly when the balm is used on the nasal mucosa, it is preferable for obvious reasons if the balm is essentially substantially odorless or at least does not spread an unpleasant odor.

The balm can also have the special feature that the oil contains a vegetable oil, such as almond oil, avocado oil, borage oil (or borage oil), grape seed oil, hemp oil, jathropa oil, jojoba oil, cottonseed oil, coconut oil, rapeseed oil (or canola oil), linseed oil (or linseed oil), macadamia oil, corn oil, olive oil, palm oil, palm kernel oil, peanut oil (or peanut oil), rapeseed oil, rice germ oil or rice husk oil, safflower oil (or thistle oil), sesame oil , soybean oil, wheat germ oil, evening primrose oil, walnut oil, castor oil (either castor oil or castor oil), sunflower oil, sia oil (usually a mixture of different types of vegetable oils).

Of the so-called fatty oils (as distinguished from so-called essential oil) the following oils are primarily eligible, inter alia in connection with their high reputation, distribution and long-term application in, for example, cosmetic products: corn oil, olive oil, palm oil, sesame oil, soy oil, wheat germ oil and sunflower oil.

The strong odor of essential oils generally makes these oils less suitable for use in the nose. There is also a greater risk of allergic reactions and hypersensitivity reactions to essential oils compared to other types of oil.

In connection therewith, a balm preferably has the special feature that the oil is free from essential oil, such as bergamot oil, lemon oil, eucalyptus oil, clove oil, lavender oil, olibanum oil, patchouli oil, peppermint oil, rosemary oil, sandalwood oil, orange oil, star anise oil and thyme oil.

According to a particular aspect of the invention, the balm has the special feature that it contains less than 5% by weight, preferably less than 1% by weight, of water.

4

A specific embodiment of the balm has the special feature that it contains aloe vera juice. Aloe vera is a plant whose juice, according to various publications, has a certain cooling and soothing effect when applied to the skin. When used in the balm according to the invention, this property could have a beneficial effect, in addition to the covering effect against contact with allergenic substances.

The balm is preferably designed in such a way that the ratio between fat and oil is chosen such that the balm is persistent at an operating temperature of approximately 25 - 38 ° C. By the term "persistent" it is meant that the balm forms a good coating over a longer period of time and, unlike, for example, less viscous substances, such as more oily substances and gels, has no tendency for release and migration due to, for example, gravity. .

It has been established that by covering the mucous membranes of the nose with a layer of the balm according to the invention, a substantial reduction of allergic reactions occurs for a longer period of time.

There are patients who are not only allergic to the allergens present in the air, but also to certain plant substances, including vegetable oils. In connection with this, it is important that patients can be offered a balm in which there is no component of a type to which the user is allergic. A specific embodiment of the balm according to the invention therefore has the special feature that the balm is free from a component to which a user is allergic. It will be clear that in this connection different types of balm can be marketed, all of which make use of, for example, a specific type of vegetable oil or a combination of such oils. On the package and in the package leaflet it can then be made clear with a relevant text which oil or oils have been used and which oil or oils are not actually present in the balm, so that the user can make a well-considered choice.

The aforementioned ingredients have been chosen such that it seems likely that most allergy sufferers can make a sensible choice of a balm to which they will not respond allergically.

With regard to the desired persistent character of the balm, it is noted that attempts have been made to apply only a thin, liquid oil to the nasal mucosa. However, this has hardly any effect. An oil only forms a thin film on the nasal mucosa and disappears quickly due to gravity. The use of, for example, exclusively white Vaseline has the disadvantage of giving a "dry feeling", certainly over time.

The balm according to the invention, as tests have already shown, does not have these adverse effects. If, for example, a hay fever reaction occurs under unprotected conditions when the balm according to the invention is used, the associated complaints such as sneezing, swollen nasal mucous membranes and itchy and watery eyes will not occur. This allows breathing to continue through the nose because it is not blocked by the swollen nasal membranes.

Thus, covering the nasal mucosa with the balm of the invention can prevent swelling of the mucous membranes in the nose in response to contact with an allergenic substance. This makes the use of this balm also suitable for patients with respiratory diseases, who have an allergic reaction to the most diverse substances in the air indoors. These include the finely divided substances as specified above. The nose has a mechanism to purify the air to be inhaled. When a patient is forced to breathe through the mouth as a result of the swelling of the nasal mucous membranes, 6 the inhaled air is no longer cleaned of impurities and (other) allergenic substances, which is highly undesirable from a cleaning point of view. In particular for patients with allergic asthma or COPD, the prevention of the penetration of these substances through the mouth into the airways is essential to minimize allergic reactions.

The irreversible damage that allergic reactions can have to the lung tissue can already be demonstrated at a very young age. Because these patients often start breathing through the mouth, because breathing through the nose is hampered by swollen nasal mucus, the allergens end up directly in the airways. By covering the nasal mucosa with the balm, the nasal mucosa will not come into contact with and therefore cannot respond to the allergens present in the air, so that the patient can continue to breathe quietly through the nose. On their way through the nose, at least a substantial part of the allergens may remain in the balm.

As a result, the amount of allergens that can enter directly into the respiratory tract will decrease very sharply and can even be reduced to completely harmless proportions.

In a Dutch study an inhalation-25 allergy has been shown in 28% - 33% of the 7 - 12 year old children, in about 50% of the 20 - 29 year olds, and in around 25% of the 60 - 69 year olds (source: RIVM). However, it is clear that inhalation allergies are not just a Dutch but a global problem.

Attention is drawn to the fact that the balm according to the invention and the use thereof does not qualify as a medical device or a medical treatment respectively. After all, no intervention takes place in the human body. The balm according to the invention is composed in such a way that in particular the nasal mucosa membranes are only covered, so as to say a "mechanical" treatment, and preferably such that none of the components can cause an allergic reaction in a user .

Many variations in the composition are therefore possible on the basis of these considerations. The composition per se is little or not specific to the efficacy of the balm. After all, it is about the "hedging" function.

In addition to the important effect of the balm according to the invention, which is very essential for allergy sufferers, it has also been established that the effect of the applied balm is nil. This is an important observation. After all, the nose contains the olfactory organ, which warns of contact with abnormal odors and can thus fulfill an important signal function. For example, this can be the smell of a combustible gas or spoiled food. When using the balm according to the invention, no influence on the functioning of the olfactory organ has been established during investigations.

The invention furthermore relates to the use of the balm according to the above specification, wherein the balm is applied to mucous membranes, in particular nasal mucous membranes and thus covers these mucous membranes against direct contact with allergenic substances present in the air.

For example, the use can take place such that the application of the balm takes place by hand, a cotton swab, a spatula, an applicator, or a spray can containing a suspension with the balm. For use as prevention against hay fever, it is sufficient to cover the nasal mucous membranes with balm before the user goes outside, where contact with the allergens can take place. For indoor use, it is recommended to apply the balm on standing up, and the balm is preferably removed when going to bed.

Removal of the balm takes place in the same way for application both indoors and outdoors. The nose must first be softly 8 stained and therefore cleaned. The residues of used and thus contaminated balm must then be removed, for example with a wad of cotton wool or a cotton swab soaked in oil. By making use of an oil-soaked cotton swab, the hypersensitive nasal mucous membranes are prevented from becoming too dry during the period that they do not need to be protected, such as during the night, and thereby becoming irritated again. Cleaning with cotton swabs soaked in oil can at least somewhat prevent this drying out. If desired, balm can also be applied again for the night. To date, applying the balm to the mucous membranes in the nose with a cotton swab seems to be a practical method.

15 cotton swabs with a quantity of balm on top and ready for one-time use are also practical from a hygienic point of view as disposable. In order to remove the balm from the nasal mucous membranes over time, cotton swabs may be used which are, for example, soaked in the same type of oil as the oil incorporated in the balm.

The use of the balm can furthermore take place such that the application of the balm takes place by hand, a cotton swab, a spatula, an applicator, or a spray can containing a suspension with the balm.

The invention furthermore relates to an applicator with a storage container for balm according to the above specification and with dispensing means for dispensing it and for thus using the balm according to the above specification.

The applicator can further be provided with displacing means for delivering balm via at least one delivery opening upon activation thereof.

According to a further aspect of the invention, the applicator can have the special feature that the at least one dispensing opening is located in the peripheral wall of a closed-end tube, which tube has a diameter such that it can be inserted into the nose to become.

In order to protect the possibly already irritated mucous membranes of the nose as much as possible, the applicator preferably has the special feature that at least the outer surface of the tube consists of a somewhat soft and flexible material.

Finally, the applicator can advantageously have the special feature that the supply container has a wall that can be pressed by hand, in the manner of a squeeze bottle 10 or tube.

It is noted that a syringe-like structure can also be used. However, a squeeze-bottle-like structure or an compressible tube is easier to operate with one hand.

Suitable applicator is a nasal spray bottle, the mouthpiece of which is inserted into the nose and as a result of which, as a result of pressing the bottle by hand, a quantity of the pasty balm according to the invention ends up in the nose . A modification of the known bottle for the balm according to the invention can be envisaged in the sense that on the bottle a tube with a closed end and a rounded outside is attached, which is solid on the inside, or at least is of a plug and whose outer wall consists of two layers. The inner wall is closed and the outer wall contains openings through which the balm can be pressed outwards from the flexible container when pressure is exerted on the bottle by hand. By rotating the tube, 30 dispensing openings are cleared and closed again after use. A closing cap is then rotated over the tube in a manner known per se or fixed by clicking.

After the balm 35 has been applied in the nose with such an applicator, the insertion tube is preferably removed from the nostril slightly rotating or reciprocating, whereby the distribution of the balm in the nose takes place as homogeneously as possible.

10

The invention is not limited to a specific composition or percentages of the solid or pasty fat relative to the oil. One can think of a share of approximately 25 - 30% oil and a supplement of 5 to 100% with fat.

In the case where a somewhat lower viscosity, i.e. a slightly smoother and more easily spreadable character, is desired, it could be considered to increase the proportion of vegetable oil, for example up to 50% or even 75%. This makes applying the balm easier, but also entails the risk that the persistence of the balm deteriorates.

Pasty obtained from petroleum or at least more or less solid fats such as vaseline and paraffin are probably preferable because, unlike the fats of vegetable and animal origin, they are not absorbed by the skin and the mucous membranes of the nose. In addition, the solids from petroleum in purified form are absolutely free of germs and are well tolerated by almost everyone. A disadvantage is the possibility of a so-called "paraffin addiction" and the tendency to dry out the skin. By adding a certain amount of oil to the solid or pasty fats, the possibility of a paraffin addiction and drying of the skin or mucosa is considerably reduced. The correct spreadability can also be achieved by adding oil to the fat, in combination with the desired persistence.

Vaseline is resistant to the effects of chemicals and can act as a barrier against the skin and mucous membranes of the nose.

Patients suffering from cara / copd are extra vulnerable to air pollution, which is estimated to kill 5,000 Dutch people every year.

Certain solid fats, such as wool fat, coconut fat, mango butter, shea butter, and cocoa butter, are individually unlikely to be suitable because they have a low melting point. As a result of contact with the skin, they become considerably more fluid, as a result of which the covering protective layer will tend to disappear under the influence of gravity. These fats are therefore individually less suitable due to their lack of persistence under conditions of use. Certain substances can, however, be added to these fats in order to increase the melting point and improve the persistence at an operating temperature of approximately 25-38 ° C.

Vaseline, paraffin, beeswax and palm fat, among other things, have to be heated to melt them.

The melting range is sufficiently above the temperature in the nose. It is also possible to make a combination of, for example, vaseline, beeswax and sesame oil, as well as a virtually unlimited number of other combinations.

The invention will now be explained with reference to the accompanying drawings. Show in the drawings:

Figure 1 shows a schematic representation of the use of an applicator for the balm according to the invention; Figure 2 is a front view of the applicator; Figure 3 is a side view of the applicator; Fig. 4 shows the applicator according to Fig. 3, in which it is indicated how balm can be delivered by squeezing; Figure 5 shows a cross-section through a number of applicators in a package, prior to filling thereof; figure 6 shows a view corresponding with figure 5 in the phase in which a number of applicators are filled simultaneously; Figure 7 shows a partly transparent front view of the phase in which the filled applicators are closed by sealing; Figure 8 shows the situation shown in Figure 7 in a side view; Figure 9 shows a cotton swab serving as a deplicator, the ends of which are provided with cotton wool soaked in a suitable oil; Figure 10 shows a deplicator designed as a foam stick; figure 11 shows a part of a strip package with two deplicators according to figure 9; figure 12 shows a part of a strip package with two deplicators according to figure 10; and Figure 13 is a perspective view of a package, comprising a cardboard box and a blister carrier to be placed therein, carrying twenty-four applicators and twenty-four deplicators.

Figure 1 shows the use of an applicator 1 with a tube 5 with perforations 2, which tube has a closed end and consists of a soft, flexible material, for example a rubber-like material or a soft plastic. The arrow 3 indicates the manner in which the tube 5 can be inserted into the nose of the user. A round arrow 4 indicates that a slightly rotating movement must be made with the tube 5 inserted in the nose in order to effectively spread the balm over the nasal mucosa.

The balm present in the applicator 1 must be expressed via the perforations 2 by exerting a pinching movement through the fingers 6. The manner in which the applicator 1 is constructed and must be used will be explained with reference to Figs. 2, 3 and 30 4.

Figure 2 shows that the tube 5 of the applicator 7 has a rounded top 7. The tube 5 has the perforations 2, while in a widened part located under the tube 5 there is a certain amount of balm 9. Below the balm 9 is an air chamber 10, which is sealed at the bottom by means of a sealing edge 11.

Figure 3 shows the applicator 1 in side view.

13

Figure 4 shows that the compressed air 12 of the air chamber 10 squeezes the balm 9 out of the tube via the perforations 8.

Figure 5 shows a number of empty applicators which are supported with the tube in a downward direction by a blister carrier of thermoformed plastic.

The tubes of the applicators fit into respective recesses 16 in the blister carrier 15.

To prevent unintentional pressing of balm from the filled applicators, a sealing edge 17 is used, which effectively seals the tube with the perforations 8, such that any emitted balm does not have a tendency to dry out or other undesired effects of exposure to the environment, such as atmospheric oxygen.

Figure 6 shows the filling of the applicators now indicated with 18. A filling machine 21 has a number of delivery tubes 22 that are inserted into the empty applicators 20. During filling, the filling machine is moved upwards according to an arrow 20, such that the lower edges of the filling tubes are always positioned just above the balm surface in the tube. The balm introduced into the applicators 18, in particular into its tube 25, is indicated by reference numeral 19.

Figure 7 shows the filled applicators 23, which are supported by the blister carrier and still have to be closed by means of a sealing machine with welding beams (see also Figure 8).

Figure 8 shows in side view the sealing machine 25 with the heated sealing bars to be moved towards each other according to arrows 27. These grip the open mouth edges of the filled but not yet closed applicators 23 according to Figure 7, pinch them together and thus seal the filled applicators completely shut.

Fig. 8 furthermore shows a cut-out in the blister carrier for deplicators in strip packaging to be described below.

Figure 9 shows a deplicator 30 which is designed as a cotton swab known per se, the tips of which are made of cotton wool impregnated with a suitable oil, in particular an oil which the user knows is well tolerated and for which he has no hypersensitivity possession.

Figure 10 shows a functionally corresponding deplicator with a plastic rod and tips made of foam material 10, which are also impregnated with oil.

Figure 11 shows a part of a sealed packaging strip for the deplicators 38 according to Figure 9. Perforated tear edges are indicated by the reference number 35. As a result, one package with a deplicator can always be torn from a strip 34. The seal edges 36 are indicated by hatching.

Easy tearability is obtained in a manner known per se by using toothed edges 37.

Figure 12 shows the same structure. However, in this embodiment the packaging strip 34 is intended for packaging the applicators 32 according to Figure 10.

Finally, Figure 13 shows a complete package 40 of twenty-four applicators and twenty-four applicators, the filled blister carrier with applicators and applicators being drawn above a cardboard box 42 for the sake of clarity, in which it must be received in the direction of an arrow. 34.

It will be clear that, despite the fact that the balm according to the invention is not a medicine, it may be desirable under certain circumstances to fully guarantee hygiene during production and storage. For example, it is possible to work in a clean environment in the manner customary in the pharmaceutical industry and the air chambers 10 may preferably not be filled with oxygen-containing air, but with a non-oxidizing protective gas, for example nitrogen or a noble gas.

15

Furthermore, during the production of the applicators 5 and the deplicators and the packaging thereof, work can be carried out in not only a clean environment, but even in an environment that satisfies high requirements of sterility.

The invention is not limited to the described and shown examples. Many changes in the composition of the balm, the method of application, that applicators and the applicators are possible within the scope of the invention.

Claims (23)

1. Balm for covering mucous membranes, in particular nasal mucous membranes, against direct contact with allergens present in the air, such as pollen from grasses, plants, shrubs, or trees, droppings of house dust mites, fine dust, for example dust released during sanding, grinding, drilling, milling, or sawing of solid materials such as wood, plastics, metals and the like, soot, smoke or other contaminants, which balm is a spreadable, pasty, greasy substance such that after applying balm to the mucous membranes, a user is at least less susceptible to inhalation allergies, such as hay fever. 15 The balm of claim 1, wherein the balm contains pasty fat. 3. Balm as claimed in any of the foregoing claims, wherein the balm contains oil. 4. Balm according to claims 2 and 3, wherein the balm contains pasty or at least more or less solid fat and oil. 25 5. Balm as claimed in any of the foregoing claims, wherein the balm is free from further additives, such as fragrances, colorants, gelling agents and preservatives. 30 The balm of claim 2, wherein the fat contains a mineral fat, such as vaseline and paraffin. The balm of claim 2, wherein the fat contains an animal fat, such as beeswax and wool fat. 5 The balm of claim 2, wherein the fat contains a vegetable fat, such as coconut fat, mango butter, palm fat, shea butter and cocoa butter. The balm of claim 3, wherein the liquid oil contains an animal oil. 10. Balm as claimed in claim 9, wherein the animal oil is free from oil derived from marine animals, such as cod liver oil, whale oil or fish oil. 11. Balm according to claim 3, wherein the liquid oil contains a vegetable oil, such as almond oil, avocado oil, borage oil (or borage oil), grape seed oil, hemp oil, jathropa oil, jojoba oil, cottonseed oil, coconut oil, rapeseed oil (or canola oil), linseed oil (or linseed oil), macadamia oil, corn oil, olive oil, palm oil, palm kernel oil, peanut oil (or peanut oil), rapeseed oil, rice germ oil or rice husk, safflower oil (or thistle oil), sesame oil , soybean oil, wheat germ oil, evening primrose oil, walnut oil, castor oil (either castor oil or castor oil), sunflower oil, lettuce oil (usually a mixture of different types of vegetable oils). 30 12. Balm as claimed in any of the foregoing claim 3, wherein the liquid oil is free from essential oil, such as bergamot oil, lemon oil, eucalyptus oil, clove oil, lavender oil, olibanurrt oil, patchouli oil, peppermint oil, rosemary oil, sandalwood oil, orange oil, star anise oil and thyme oil. A balm according to any one of the preceding claims, wherein the balm contains less than 5% by weight, preferably less than 1% by weight, of water. 14. Balm as claimed in any of the foregoing claims, wherein the balm contains juice from the aloe vera. 15. Balm as claimed in any of the foregoing claim 4, wherein the ratio between fat and oil is chosen such that the balm is persistent at an operating temperature of approximately 25 - 38 ° C. 16. Balm as claimed in any of the foregoing claims, wherein the balm is free from a component to which a user is allergic. 15 17. The use of the balm according to any one of the preceding claims, wherein the balm is applied to mucous membranes, in particular nasal mucous membranes and thus covers these mucous membranes against direct contact with allergenic substances present in the air. 18. The use according to claim 14, wherein applying the balm is by hand, a cotton swab, a spatula, an applicator or a spray can containing a suspension with the balm, 19. Applicator with a balm storage container according to one of claims 1 to 16 and with dispensing means for dispensing it for thus using the balm according to one of claims 17 and 18. 20. Applicator as claimed in claim 19, comprising displacing means for delivering balm via at least one delivery opening upon activation thereof. Applicator as claimed in any of the claims 19 and 20, wherein the at least one dispensing opening is located in the peripheral wall of a closed-end tube, which tube has a diameter such that it can be inserted into the nose. 5 Applicator as claimed in any of the claims 21, wherein at least the outer surface of the tube consists of a somewhat soft and flexible material. Applicator according to claim 29, wherein the supply container has a wall that can be pressed by hand, in the manner of a squeeze bottle or tube. 15 *****