APPLICATOR FOR NASAL OINTMENT

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

Public health authorities advise sufferers of inhalation allergies such as hay fever to avoid as far as possible any contact with the associated allergenic substances and to use medicinal products which suppress the allergic reactions.

The invention has for its object to provide an applicator which is filled with a medically inert or medically inactive agent and with use of which the associated allergic reactions do not occur, or at least occur considerably less severely.

In this respect the invention provides an applicator, comprising: a supply container at least partially filled with an ointment for covering mucous membranes, in particular nasal mucous membranes, against direct contact with allergenic substances present in the air, such as pollen of grasses, plants, shrubs or trees, faeces of house dust mite, fine dust, for instance dust released during sanding, grinding, drilling, cutting or sawing of solid materials such as wood, plastics, metals and the like, soot, smoke or other contaminants, the ointment being a spreadable, pasty, fatty substance; and dispensing means for dispensing the ointment for use thereof such that it 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, such that after applying ointment to the mucous membranes a user is at least less susceptible to inhalation allergies such as hay fever.

The applicator can further be provided with displacement means for dispensing ointment via at least one dispensing opening when they are activated.

According to a subsequent aspect of the invention, the applicator can have the special feature that the at least one dispensing opening is situated in the peripheral wall of a tube with closed end, this tube having a diameter such that it can be inserted into the nose. In order to ease as much as possible the possibly already irritated mucous membranes of the nose, the applicator preferably has the special feature that at least the outer surface of the tube consists of a material which is to some extent soft and flexible, for instance a rubbery material such as a soft polyurethane.

The applicator can advantageously further have the special feature that the supply container has a manually compressible wall in the manner of a squeeze-bottle or tube. It is noted that use can also be made of a hypodermic syringe-like structure. A squeeze bottle-like structure or a compressible tube is however easier to operate with one hand.

Also suitable as applicator is a nasal spray bottle, the nozzle of which is inserted into the nose and whereby, as a result of compressing the bottle with a hand, a quantity of the pasty ointment according to the invention enters the nose. It is possible to envisage a modification of this known bottle for the ointment according to the invention, in the sense that there is attached to the bottle a tube with closed end and a rounded outer side, which is solid on the inside, or at least provided with a plug, and the outer wall of which consists of two layers. The inner wall is closed and the outer wall comprises openings through which the ointment can be pressed outside from the flexible container when pressure is exerted on the bottle with a hand. Dispensing openings are left clear by rotating the tube

and, after use, reclosed by rotating the tube back. In per se generally known manner a closing cap is then screwed onto the tube or snap-fixed thereon.

Once the ointment has been introduced into the nose using such an applicator, the insertion tube is preferably removed from the nostril while being rotated or moved reciprocally to some extent, whereby the distribution of the ointment in the nose takes place as homogeneously as possible. In a determined embodiment the ointment has the special feature that the ointment comprises pasty fat.

Alternatively or in combination therewith, the ointment can have the feature that the ointment comprises oil . In a combination of the two latter mentioned aspects, the ointment can have the special feature that the ointment comprises pasty or at least more or less solid fat and oil.

The ointment preferably has the feature that it is free of additives such as aromatic substances, colouring agents, gelling agents and preservatives.

According to an aspect of the invention, the ointment can have the special feature that the fat comprises a mineral fat such as vaseline and paraffin. Alternatively or in combination herewith, the ointment can have the feature that the fat comprises an animal fat such as beeswax and wool fat.

The ointment can also have special feature that the fat comprises a vegetable fat such as coconut fat, mango butter, palm fat, shea butter and cacao butter.

Said categories of fat can be applied individually or in combination with each other.

Different types of fat of the same category, thus mineral, animal or vegetable, can also be applied in combination if desired.

According to yet another aspect of the invention, the ointment has the special feature that the liquid oil comprises an animal oil.

Animal oils are known in many forms and types. They are usually readily usable as constituent in an ointment according to the invention.

An ointment is however recommended in which the animal oil is free of oil from marine animals, such as cod liver oil, whale oil or fish oil. Oil from marine animals usually emits an odour which is perceived as unpleasant by most people and is found in practice to be susceptible to decay relatively quickly. Certainly when the ointment is used on the nasal mucous membrane, it is recommended for obvious reasons that the ointment is substantially odourless, or at least does not emit any unpleasant odour.

The ointment can also have the special feature that the oil comprises a vegetable oil, such as almond oil, avocado oil, borage oil (or bernagie oil) grape seed oil, hemp oil, jathropa oil, jojoba oil, cottonseed oil, coconut oil, rapeseed oil (or canola oil), linseed oil, macadamia oil, maize oil, olive oil, palm oil, palm seed oil, peanut oil (or arachis oil), rape oil, rice germ oil or rice husk oil, safflower oil (or thistle oil), sesame oil, soya oil, wheat-germ oil, evening primrose oil, walnut oil, castor oil (or ricinus oil) , sunflower oil, salad oil, (usually a mixture of different types of vegetable oils) .

Of the stated so-called fatty oils (to distinguish them from so-called essential oil) , the following oils are primarily suitable, among other reasons because they are widely known, because of their wide distribution and many years of use in for instance cosmetic products: maize oil, olive oil, palm oil, sesame oil, soya oil, wheat-germ oil and sunflower oil.

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

In this respect an ointment preferably has the special feature that the oil is free of 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 aniseed oil and thyme oil.

According to a determined aspect of the invention, the ointment has the special feature that it comprises less than 5% by weight, preferably less than 1% by weight, of water.

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

The ointment is preferably embodied such that the ratio of fat and oil is chosen such that the ointment is persistent at a temperature of use of about 25-38 ⁰ C. The term 'persistent' is understood to mean that the ointment forms a good cover layer for a longer period of time and, other than in the case of for instance less viscous substances such as more oleaginous substances and gels, does not tend to release and migrate as a result of for instance gravitational force.

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

There are patients who are not only allergic to the stated allergenic substances present in the air, but also to determined vegetable substances, including vegetable oils. In this respect it is important that patients can be provided with an ointment in which there is no constituent present of a type to which the user is allergic. A specific embodiment of the ointment

according to the invention therefore has the special feature that the ointment is free of a constituent to which a user is allergic. It will be apparent that in this respect different types of ointment can be brought onto the market, all making use of for instance a specific type of vegetable oil or a combination of such oils. It can then be made clear with a relevant text on the packaging and in the information leaflet which oil or oils have been applied and, conversely, which oil or oils are not to be found in the ointment, so that the user can make a well-considered choice.

The stated constituents are chosen such that it appears likely that most allergy patients can make a choice of ointment which is advisable for them and to which they will not have an allergic reaction.

In respect of the desired persistent character of the ointment it is noted that attempts have been made to apply only a liquid oil or a gel to the nasal mucous membrane. This has hardly any effect however. An oil forms only a thin film on the nasal mucous membrane and disappears quickly as a result of gravitational force, as does a gel which, when the temperature increases after application, becomes more fluid.

The use of for instance only white vaseline has the drawback, certainly after a period of time, of imparting a 'dry sensation' .

As tests have meanwhile demonstrated, the ointment according to the invention does not have these adverse effects. If a hay fever reaction occurring in unprotected conditions does not occur when the ointment according to the invention is used, the associated symptoms, such as sneezing, swollen nasal mucous membranes and itching and tearing eyes, do not appear either. It is therefore possible to continue breathing through the nose, since it is not blocked by the swollen nasal mucous membranes .

Covering the nasal mucous membranes with the ointment according to the invention can thus prevent the

swelling of the mucous membranes in the nose in reaction to contact with an allergenic substance. This also makes the use of this ointment suitable for patients with bronchial disorders who have allergic reactions to the most diverse substances present in indoor- air. These include the finely distributed substances as specified above. The nose has a mechanism for purifying the air to be inhaled. When a patient is forced as a result of the swelling of the nasal mucous membranes to breathe through the mouth, contaminants and (other) allergenic substances are no longer removed from the inhaled air, which is very undesirable from the air cleaning viewpoint. Particularly for patients with allergic asthma or COPD, preventing these substances from penetrating into the bronchi via the mouth is essential in limiting allergic reactions as far as possible.

The irreversible damage which allergic reactions can cause to the pulmonary tissue can already be demonstrated at very young age. Because these patients usually begin to breathe through the mouth because breathing through the nose is made difficult by the swollen nasal mucous membranes, the allergens enter the bronchi directly. By covering the nasal mucous membrane with the ointment the nasal mucous membrane will not come into contact with, and so not be able to react to, the allergens present in the air, so that the patient can continue to breathe regularly through the nose. On their way through the nose at least a substantial part of the allergens will remain behind in the ointment. The quantity of allergens which can enter the bronchi directly will hereby decrease very considerably, and can even be reduced to completely harmless proportions .

In a survey in the Netherlands an inhalation allergy was identified in 28%-33% of children in the 7 to 12- year age group, in about 50% of the 20 to 29-year age group and in about 25% of the 60 to 69-year age group {source: RIVM, Dutch National Institute for Public Health and the Environment) . It will however be apparent

that inhalation allergies are a problem not just in the Netherlands, but worldwide.

Attention is emphatically drawn to the fact that the applicator with the ointment according to the invention and the use thereof does not qualify as a medical aid or a medical treatment. This is because there is no medical intervention in the human body. The ointment according to the invention is composed such that particularly the nasal mucous membranes are only covered, so as it were a 'mechanical' treatment, and preferably such that none of the constituents can cause an allergic reaction in a user.

On the basis of these considerations many variants of the composition are therefore possible. The composition per se is not very specific or not specific to the effect of the ointment. What is important is the 'covering' function.

In addition to the significant effect of the ointment according to the invention which is highly essential for allergy patients, it has also been determined that the effect of the applied ointment on the sense of smell is zero. This is an important observation, since the nose comprises the olfactory organ which gives a warning upon contact with odours which are out of the ordinary and can thus fulfil an important warning function. This can for instance be the smell of a combustible gas or tainted food. Tests have shown that use of the ointment according to the invention has no effect whatever on the functioning of the olfactory organ.

For use as prevention against hay fever it is sufficient to cover the nasal mucous membranes with ointment before the user goes outside, where contact with allergens can occur. For indoor use, it is recommended to apply the ointment when getting up, and the ointment is preferably removed when going to bed.

The removal of the ointment takes place in the same way for both indoor and outdoor use. The nose must first

be gently blown and thus cleaned. The residue of used, and thus contaminated, ointment must then be removed, for instance with a wad of cotton wool or a cotton swab soaked in oil. Making use of an oil-soaked cotton swab prevents the hypersensitive nasal mucous membranes becoming too dry, and therefore becoming irritated again, during the period that they do not need to be protected, such as during the night. The cleaning with the oil-soaked cotton swabs can prevent this drying-out to at least some extent. If desired, ointment can also be applied once again for the night. The application of the ointment to the mucous membranes in the nose with a cotton swab has heretofore appeared to be a practical method. Cotton swabs with a quantity of ointment thereon and ready for once-only use are, as a disposable, also practical from the viewpoint of hygiene. In order to remove the ointment from the nasal mucous membranes after a period of time, cotton swabs can be used which are for instance soaked in the same type of oil as the oil included in the ointment.

The invention is not limited to a specific composition or percentages of the solid or pasty fat relative to the oil. It is possible to envisage a proportion of about 25-30% of oil with the addition of fat to 100%.

In the case where a somewhat lower viscosity, and so a slightly more fluid and more easily spreadable character is desired, increasing the share of vegetable oil could be considered, this to for instance 50% or even 75%. This makes application of the ointment easier, but also entails the risk of a decline in the persistence of the ointment.

Pasty or at least more or less solid fats obtained from petroleum, such as vaseline and paraffin, are probably to be recommended because, in contrast to the fats of vegetable and animal origin, they are not absorbed through the skin and the mucous membranes of the nose. In addition, the solids from petroleum are

absolutely free of germs in purified form and are readily tolerated by almost everyone. A drawback is the possibility of a so-called ^λ paraffin addiction' and the tendency of the skin to become dry. The addition of a certain quantity of oil to the solid or pasty fats considerably reduces the possibility of a paraffin addiction occurring and drying of the skin or the mucous membrane. The correct spreadability, in combination with the desired persistence, can also be realized by adding oil to the fat.

Vaseline can withstand the action of chemicals and can form a barrier function relative to the skin and mucous membranes of the nose.

Patients who suffer from CARA/COPD are extra- vulnerable to air pollution, which is estimated to cause the death of 5,000 people annually in the Netherlands.

Determined solid fats, such as wool fat, coconut fat, mango butter, shea butter and cacao butter are probably not individually suitable because they have too low a melting point. Due to the increase in temperature through contact with the skin they become considerably more fluid, whereby the covering protective layer will tend to disappear under the influence of gravitational force. These fats are therefore individually less suitable due to their lack of persistence in conditions of use. Determined substances can however be added to these fats in order to increase the melting point and improve the persistence at a temperature of use of about 25-38°C. Vaseline, paraffin, beeswax and palm fat, among others, must be heated in order to cause them to melt. The melting range lies sufficiently above the temperature in the nose. It is also possible to make a combination of for instance vaseline, beeswax and sesame oil, as well as an almost unlimited number of other combinations .

It is noted that under the name "Boegem Balsem®" a company of applicant produces and sells an ointment

intended for the purpose of treating burnt skin. This ointment consists of the vegetable oils sesame oil (sesamum indicum) and sunflower oil {helianthus annuus) and a base of petrolatum {vaselinum album) . This known ointment is supplied in a tube, so not in an applicator according to the present invention.

The invention will now be elucidated with reference to the accompanying drawings. In the drawings: figure 1 shows a schematic view of the use of an applicator for the ointment according to the invention; figure 2 shows a front view of the applicator; figure 3 shows a side view of the applicator; figure 4 shows the applicator according to figure 3, indicating the manner in which ointment can be dispensed 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 to figure 5 at the stage where a number of applicators are being filled simultaneously; figure 7 shows a partially transparent front view of the stage at which the filled applicators are closed by sealing; figure 8 is a side view of the situation shown in figure 7; figure 9 shows a cotton swab serving as deplicator, of which the outer ends provided with swabs are soaked in a suitable oil; figure 10 shows a deplicator embodied as a foam swab; figure 11 shows a part of a strip package with two deplicators as according to figure 9; figure 12 shows a part of a strip package with two deplicators as 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, the tube having a closed end and consisting of a soft flexible material, for instance a rubbery material or a soft plastic, such as a suitable polyurethane. An arrow 3 indicates the manner in which tube 5 can be inserted into the nose of the user. A round arrow 4 indicates that something of a rotating movement must be made with the tube 5 inserted in the nose in order to spread the ointment effectively over the nasal mucous membrane.

The ointment present in applicator 1 must be pressed out via perforations 2 by applying a squeezing movement with the fingers 6. The manner in which applicator 1 is constructed and must be used will be further elucidated with reference to figures 2, 3 and 4.

Figure 2 shows that tube 5 of applicator 1 has a rounded top 7. Tube 5 has perforations 2, while a certain quantity of ointment 9 is present in a widened part situated under tube 5. Situated under ointment 9 is an air chamber 10 which is sealed on the underside by means of a sealing edge 11.

Figure 3 shows a side view of applicator 1.

Figure 4 shows that by squeezing air chamber 10 as according to arrows 12 ointment 9 is pressed out of the tube via perforations 8.

Figure 5 shows a number of empty applicators carried with the tube in downward direction in a blister carrier of plastic modelled by thermoforming.

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

In order to prevent unintended pressing of ointment out of the filled applicators, use is made of a closing edge 17 which effectively seals the tube with perforations 8 such that possibly exiting ointment does not tend to dry out or that there is any other undesirable effect due to exposure to the environment, such as air oxygen.

Figure 6 shows filling of the applicators, now designated 18. A filling machine 21 has a number of delivery tubes 22 which are introduced into the empty applicators. During filling the filling machine is displaced upward as according to an arrow 20 such that the bottom edges of the filling tubes are always positioned just above the ointment surface in the tube. The ointment introduced into applicators 18, and particularly into tube 5 thereof, is designated with reference numeral 19.

Figure 7 shows the filled applicators 23 which are carried by blister carrier 15 and have yet to be closed by means of a sealing machine with welding bars (see also figure 8 herefor) . Figure 8 shows a side view of sealing machine 25 with the heated sealing bars 26 to be moved toward each other as according to arrows 27. These engage the open mouth edges of the filled but not yet closed applicators 23 of figure 7, squeeze them together and thus fully seal the filled applicators 23.

Figure 8 further shows a transparent view of a recess in blister carrier 15 for deplicators in strip package to be described below.

Figure 9 shows a deplicator 30 embodied as a per se known cotton swab, of which the two tips consisting of swabs are impregnated with a suitable oil, in particular an oil which the user knows he/she can readily tolerate and to which he/she is not hypersensitive.

Figure 10 shows a functionally corresponding deplicator with a plastic rod and two tips consisting of foam material which are likewise impregnated with oil.

Figure 11 shows a part of a sealed strip package for deplicators 38 according to figure 9. Perforated tear- off edges are designated with reference numeral 35. One package at a time with a deplicator can hereby be torn from a strip 34. Sealing edges 36 are indicated with hatching.

Easy tearing is obtained in per se known manner by making use of serrated edges 37.

Figure 12 shows the same structure. Strip package 34 is however intended in this embodiment for packaging of applicators 32 according to figure 10.

Finally, figure 13 shows a complete package 40 of twenty-four applicators and twenty-four packed deplicators, wherein for the sake of clarity the filled blister carrier with applicators and deplicators is drawn above a cardboard box 42 in which it must be received in the direction of an arrow 43.

It will be apparent that, despite the fact that the ointment according to the invention is not a medicinal product, it may be desirable under certain conditions to fully guarantee hygiene during production and storage. It is thus possible to work in a clean environment in the manner usual in the pharmaceutical industry, and air chambers 10 could perhaps be filled, preferably not with air containing oxygen but with a non-oxidizing protective gas, for instance nitrogen or an inert gas.

It is further possible during the production of the applicators and deplicators and the packaging thereof to work in an environment which is not only clean but even in an environment which satisfies high sterility requirements.

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