MOISTURIZING NASAL GEL AND APPLICATOR DEVICE DESCRIPTION OF THE INVENTION During disease, or when the local environment has a low humidity, the tissues of the inner part of the nose may dry out. This nasal dryness can cause discomfort, burning, congested breathing or even bleeding and the associated possibility of nasal infections. The present invention seeks to alleviate the dryness of the nasal tissues within the nasal cavity, and particularly seeks that said relief extend over a prolonged period of time. The present invention is capable of providing such relief without the need for pharmacological ingredients. The present invention is directed to solving the problems associated with dry nasal tissues by slowly releasing moisture or water directly into the internal nasal tissues and the microenvironment of the nasal cavity. The present invention solves these problems by providing a nasal gel that is applied to the nasal tissue and remains within the nose for a substantial period of time, and which can release water or moisture to the nasal tissues or cavity during this time. By doing this, the user feels relieved and the nasal tissues are healthier, without the need to rely on pharmacological ingredients. As used in the present, the expression
"Pharmacological ingredients" refer to ingredients classified as drugs by the United States Federal Drug Administration (U.S.FDA), with the ingredients being present in which such ingredients function as drugs as determined by the U.S.FDA. The present invention solves these problems by providing a moisturizing nasal gel comprising: water in an amount preferably ranging from 50% by weight to about 99% by weight; a controlled release agent in an amount effective to provide water to a nasal tissue at a rate preferably between 1% by weight to 50% by weight per hour at about 38 ° C; and a gel-forming agent in an amount effective to provide a viscosity to the moisturizing nasal gel, preferably from about 5000 centipoise to 300,000 centipoise at about 25 ° C. The present invention is also directed to a method for applying a moisturizing nasal gel on the nasal tissues using a device comprising a dispenser and an applicator. The applicator comprises a tip having side wall openings and which preferably has a sealed end opposite a second end, which is in communication with the dispenser reservoir. BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 is a diagram showing the loss
percent by weight over time of a nasal gel embodiment of the present invention. FIGURE 2 is a side view of one embodiment of the nasal gel applicator of the present invention. FIGURE 3 is another side view of the applicator embodiment shown in FIGURE 2. FIGURE 3A is a cross-sectional view of the embodiment of the applicator shown in FIGURE 3, taken along line A-A. FIGURE 3B is a top view of the embodiment of the applicator shown in FIGURE 3. FIGURE 3C is a bottom view of the applicator embodiment shown in FIGURE 3. FIGURE 4 is a perspective view of the embodiment of the applicator shown in FIGURE 2. FIGURE 5 is a perspective view of an alternative embodiment of the nasal gene applicator of the present invention. FIGURE 6 is a perspective view of another embodiment of the nasal gel applicator of the present invention. To provide moisture to the nasal tissues for a prolonged period of time, it is necessary to solve the natural biological actions, such as sneezing, that work to clean or remove the
foreign materials of the nasal cavity. It is also necessary to provide moisture in a form that can retain water in the nasal tissue and simply does not drain out of the nose. The present invention achieves these objectives by providing a product in gel form in the nasal cavity, which resists both cleansing and draining the nose, and therefore remains in the nasal cavity and in contact with the nasal tissues for a substantial period of time. To provide a product in the form of a gel, a gelling or gel-forming agent is used in the present invention. A wide variety of materials are available, which can turn an aqueous solution into gel. The gel-forming agent must be safe to use in nasal teats, non-irrigating, and capable of forming a gel that is stable over time. Preferably, the gel-forming agent must form a gel having a viscosity sufficient to remain adhered to the nasal tissues after application, but which is not so viscous, to be uncomfortable for the user, difficult to stock or apply , or interfere with the release of water in the nasal tissues and nasal cavity. More preferably, the gel forming agent should form a thixotropic gel that is easy to apply in a thin layer and regain
a significant viscosity after its application to remain on the nasal tissues for a prolonged period of time. The moisturizing nasal gels of the present invention are effective with the viscosity varying preferably from about 5,000 centipoise to about 300,000 centipoise at room temperature, or about 25 ° C. More preferably, the viscosity of the moisturizing nasal gel of the present invention is between about 100,000 centipoise to about 300,000 centipoise at about 25 ° C, and particularly preferred is a moisturizing gel having a viscosity of about 100,000 centipoise at about 25 ° C. The viscosity ranges described herein are measured using a Brookfield viscometer at room temperature. At the lower end of the viscosity ranges, the Brookfield viscometer is fitted with a number 4 spindle operating at 10 rpm, and at the upper end of the range, the Brookfield viscometer is adjusted with a helio-static TE spindle operating at 0.3 rpm. In addition, the moisturizing nasal gel of the present invention includes a controlled release agent that physically or chemically traps, retains or contains water, so that moisture is progressively released over a substantial period of time. If the water is released
too fast, the product will be deficient. If the water is released too slowly, the moisturizing nasal gel will be effective in providing the necessary moisture to the nasal tissues. The water should preferably be released from the water binder or entrap the water at a rate that can maintain moisture in the environment of the nasal cavity and / or nasal tissues for a substantial period of time. The controlled release agent used in the present invention should be safe for use in nasal, non-irritating tissues, and should not interfere with the gelling action of the gel-forming agent. Preferably, the controlled release agent should be capable of containing large amounts of water and releasing it at a relatively uniform rate for a substantial period of time. In general, the nasal gel should release at least 0.1 grams of water per hour, for approximately 2 to 4 hours after its application on the nasal tissue. Preferably, the nasal gel of the present invention releases water at a rate between about 1% by weight to about 50% by weight per hour at body temperature, or about 38 ° C, based on the total weight of the gel. More preferably, the nasal gel of the present invention releases water at a rate between about 1% by weight to 10% by weight per hour at
body temperature . It was surprisingly discovered that the nasal gel having a viscosity within the ranges described above was not substantially cleaned out of the nose by natural logic functions, and remained within the nose for a substantial period of time without causing discomfort or unpleasant feeling to the nose. user. In a preferred embodiment, the gel-forming function and the controlled-release function are provided by a single component or ingredient of the moisturizing nasal gel. This component preferably has all the properties described above for each function. Examples of materials that can be used to perform both functions in a single component include, but are not limited to: hydrogel-forming agents, such as hydroxyethylcellulose; silica; bar; a carbomer; and similar. A material that produces a gel and then releases water for a period of minutes to hours would be effective for the moisturizing nasal gel of the present invention. A preferred component of nasal gel that can perform both the gel-forming function and the controlled-release function is glyceryl polymethacrylate. Useful formations of the moisturizing nasal gel of the present invention comprising glyceryl polymethacrylate are summarized in Table I.
Table I
A preferred formulation of the present invention comprises about 65% by weight of water, 25% by weight of glyceryl polymethacrylate, and 10% by weight of other ingredients. Other ingredients or components in the nasal gel may include, but are not limited to: humectants; conservatives; shock absorbers; coloring agents; fragrances; solubilizing agents; stabilizing agents; gel modifiers; herbal materials; and vitamins. Each of these ingredients may be present in any amount, so long as it does not substantially interfere with gel formation and controlled release functions of the gel, preferably between about 0 wt% to 10 wt%. The preservatives, if used, can preferably be present in amounts ranging from 0.1% by weight to 1.0% by weight, depending on the preservative.
If water-insoluble ingredients are used in the gel of the present invention, it might be useful or necessary to trap such ingredients of microvesicles such as
liquid crystals, miscels, liposomes, encapsulation and the like. If a fragrance is used, it should preferably be one that provides relief from cold symptoms, such as camphor, menthol or eucalyptus. Example I A moisturizing nasal gel was prepared according to the formula shown in Table II.
Table II Ingredient Registered Trademark Function% Proved Weight Water Medium; 34.955% provides moisture Polymetacrilate Lubrajel MS1 Forming agent 59.00% [29.5% - of gel glyceryl; agent 36.58% water liberator of 22.42% -29.5% water glyceryl polymethacrylate]
Fragrance in Fragrance 2.25% oil Polysorbate 20 Liposorb L-20 Solubilizer 2.00%
Conservative Germaben II3 Conservative 0.80%
Prope1englicol Moisturizer 0.50%
Glycerin Moisturizer 0.50%
1Lubrajel® S is a product of International Specialty Products, Wayne, J. 2 Liposorb® L-20 is a product of Lipo Chemicals, Inc., Patterson, NJ. 3Germaben® II is a product of Sutton Laboratories, Inc., Chantham, NJ. Ten 0.2 gram dose units of the gel released an average of 0.2 grams of water per hour for six hours. The water release rate of the moisturizing nasal gel of the present invention was measured by applying 100 grams of the gel to the 2 mm thick layer on a metal surface. The metal surface was then subjected to a temperature close to body temperature, or about 100 ° F or about 38 ° C, and the weight loss of the gel was measured over time. FIGURE 1 shows the weight loss weight velocity over time. Weight loss is attributed to the moisture-releasing gel to the surrounding environment, such as a nasal cavity. As can be seen in FIGURE 1, the rate of weight loss during the first two hours was approximately 1 grams every 10 minutes, or approximately 0.1% per minute, or approximately 6% per hour. After the first two hours, the weight loss rate of the gel of the present invention decreased, but still continued to
a slower speed. This non-linear weight loss rate of the moisturizing gel of the present invention was unexpected, since in general, the diffusion of water is a linear phenomenon. The advantage of the non-linear weight loss rate is that although the speed of weight loss becomes slower over time, the gel still remains on the surface and releases moisture for a longer period of time than it would if the Weight loss speed will remain linear over time. Although the primary function of the moisturizing nasal gel of the present invention is to deliver water to tissues or nasal membranes for a substantial period of time, the gel can also be used to simultaneously release other beneficial materials such as vitamins, herbal extracts, pharmaceutical materials, materials homeopathic, and similar. The gel of the present invention can also be used to deliver water-insoluble agents to nasal membranes on a time-release basis, although the water in the gel evaporates, and any insoluble component in water is also released on the nasal tissue. The moisturizing nasal gel of the present invention is preferably applied in such a way as to provide a relatively uniform layer of gel on the inner nasal tissues, and more preferably, in such a way as to substantially prevent it from being inserted directly into the inner nasal tissues.
nasal passage, where the gel can not function to hydrate the nasal membranes. This can be achieved in several ways, such as using a cotton swab, fingertip, or other type of applicator. Preferably, a clamping bottle adjusted with the applicator tip of the present invention is used to apply the gel to the nasal tissues.
FIGURE 2 shows an embodiment of the applicator tip 10 of the present invention. The applicator tip 10 includes a base 11, side walls 12, a closed end 14, an open end 16 of the base 11, and a side wall hole 18. The applicator tip 10 generally has a length and diameter that are appropriate for the geometry of the nasal cavity, and preferably is inclined to fit comfortably within the nasal cavity. The open end 16 is preferably flared to prevent insertion of the tip 10 too deep into the nasal cavity. The side wall orifices 18 are preferably arranged to deliver the gel to an appropriate depth within the nasal cavity, with the holes preferably longitudinally positioned along the length of the tip to deliver the gel comfortably and evenly over the nose. the length of the nasal cavity, substanty without delivering the gel too far within the nasal length of the nasal cavity, substanty without
spreading the gel too far into the nasal cavity, where the gel can be delivered directly onto the nasal passages, or too little into the nasal cavity where the gel would not remain in the nasal cavity for a sufficient period of time to provide relief to the dryness. The side wall orifices 18 are preferably positioned rady to deliver the gel substanty and evenly over the perimeter of the nasal cavity. The holes 18 preferably have relatively restricted openings to retard the flow of the gel to allow consistent dose application amounts. Preferably, the applicator tip 10 has a length ranging from about 0.5 inches to 1.5 inches. In a particularly preferred embodiment, the applicator tip 10 has a length between about 0.75 inches and 0.85 inches. The open end 16 of the base 11 is preferably in communication with a reservoir, not shown, containing the moisturizing nasal gel of the present invention. The applicator tip 10 and the reservoir together comprise the spout for dispensing the moisturizing nasal gel. The side wall 12 includes at least one hole 18, and preferably includes a plurality of such holes to facilitate the gel assortment of the side wall holes on the nasal tissues. FIGURES 3A, 3B and 3C
show a cross-sectional view, top view, and bottom view, respectively, of the embodiment of the applicator tip shown in FIGURE 3. As can be seen in FIGURE 3B, the side wall holes 18 can be positioned generally and uniformly around of the side wall 12 to provide a relatively uniform application of the gel within the nasal cavity on the nasal tissues. In the preferred embodiment shown in FIGURE 3B, the side wall holes 18 are positioned 120 degrees apart from one another. Other positions of the side wall holes 18 can be used to properly deliver the gel into the nasal cavity. FIGURE 3A is a cross-sectional view of the embodiment of the applicator tip shown in FIGURE 3, taken along line AA of FIGURE 3. In this preferred embodiment, the applicator tip 10 has a total length of approximately 0.8 inches, a sidewall length 12 of approximately 0.54 inches, and a base width 11 of approximately 0.37 inches. As previously mentioned, the dimensions of the applicator tip 10 are selected to fit comfortably within the nasal cavity to apply the nasal gel of the present invention. FIGURE 4 is a perspective view of the embodiment of the applicator tip shown in FIGURE 1.
Other embodiments of the applicator tip of the present invention are shown in FIGURES 5 and 6. As can be seen, the number and dimensions of the holes 18 may vary depending on the viscosity of the gel being applied and the amount of gel that is applied. will apply per application. FIGURE 6 shows an embodiment in which the side wall hole 18 has different dimensions depending on the location of each hole 18 along the side wall 12. The applicator tip 10 can be made of any material suitable for use with the gel moisturizing nasal of the present invention. Such materials may be compatible with the moisturizing nasal gel, safe for the intended use and should be suitable for use in conjunction with the nasal gel-containing spout, such as a tube, bottle, sprayer and the like. Such materials include, but are not limited to, polyethylene, polypropylene, polyurethane, ABS, and the like. Preferably, injection molded polyethylene is used to make the applicator tip 10 of the present invention. The applicator tip of the present invention is suitable for dispensing gels having a viscosity ranging from about 5,000 CPS to 300,000 CPS at room temperature using a Brookfield viscometer. Particularly preferred for use with the tip
Applicators of the present invention are gels that are thixotropic and have a significant yield point, although fluid gels can also be dispensed through this applicator tip. Although the applicator tip has been described for use in the nasal cavity, it can be used to apply a gel in any cavity that has the geometry and requirements similar to those of the nasal cavity. Also, although the applicator tip has been described for dispensing a gel-shaped product, a similar dispenser can be used to supply a solid or liquid product. Industrial Application Example II A study was carried out using the moisturizing nasal gel prepared according to the formula shown in Table II. The gel was placed in a dispensing tube to which the applicator tip shown in FITURES 2-4 was fixed. 115 study participants were asked to use the gel for a period of 3 to 5 days. The results are shown below. Satisfaction regarding the time for the gel to take effect: Extremely satisfied 17% Very satisfied 42% Fairly satisfied 29%
Not very satisfied 5% Not at all satisfied 7% Did the product provide relief / improvement? Yes 91% No 9% Duration of relief effect (in those who said that it did provide relief): Less than one hour 11% One to two hours 22% Two to three hours 15% More than three hours 44% Average duration of effect of relief: 3.6 hours As can be seen, the moisturizing nasal gel in the present invention, applied with the applicator of the present invention, provided significant relief to individuals suffering from nasal discomfort without the need for pharmacological ingredients. Although the foregoing is intended to describe the present invention, it does not mean that it limits the total scope of the invention, which is set forth in the following claims.