Abstract:
A nasal passage cleaning composition comprises a saline base and contains non-steroidal natural ingredients at a buffeted comfortable pH. The composition cleans and clears the nasal passages and relieves pain, with limited irritation and substantially no side effects.

Description:
TECHNICAL FIELD  
       [0001]     This invention relates to a composition for cleaning the nasal passages.  
       BACKGROUND  
       [0002]     Rhinosinusitis is the most common health complaint in the United States affecting approximately one out of eight persons at some time in their lives. Many people also suffer from nasal and sinus allergies and their complications such as bronchitis, colds, ear aches, sinusitis and sinus headaches. Various medicaments have been proposed to treat the nasal passages. For example, nasal steroid sprays are available for treating allergies, but these have undesirable side-effects such as loss of smell, loss of activity of cilia, increased incident of viral infection, nose-bleeds, etc. In addition, it may take several days or weeks before a benefit is obtained using steroid.  
         [0003]     An alpha stimulant or vasoconstrictor such as ephedrine, NeoSynephrine® (phenylephrine hydrochloride) or Afrin (oxymetazoline hydrochloride) may be used as a decongestant, but these have various possible side-effects such as increased blood pressure, heart irregularities and rebound phenomenon and use beyond three days is not generally advised. While decongestants open the nose for a period of from 8-12 hours for the first time use, repeated use shortens this period to no more than 1-2 hours.  
         [0004]     It is common knowledge that the sympathomematic nasal decongestants such as ephedrine, pseudoferine, tetrahydrozoline HCL, oxyrnetazoline HCL or neosynephrine can have serious side effects, such as heart irregularity and increased blood pressure.  
         [0005]     Nasal sprays that are available include steroids, such as Flonase® (fluticasone propionate) from Glaxo-Wellcome, Inc, Rhinocort Aqua™ (budesonide) from AstraZeneca LP, Nasonex® from Schering Corp. or Nasacort® AQ (triamcinolone acetonide) from Aventis Pharmaceuticals Products, Inc. These all have significant undesirable side effects, including increasing the incidence of viral, bacterial, fungal infection, mucosal damage and loss of smell. Cases of nasal septum perforation have been reported.  
         [0006]     Seawater was traditionally used to rinse the nasal passages as part of a treatment for sinus problems but seawater alone lacks effectiveness. Significant discomfort is associated with seawater rinsing.  
         [0007]     What is needed is a composition that can be used to clean and clear the nose and sinus passages with a minimum of discomfort, and without the side effects common with existing nasal treatments.  
       SUMMARY OF THE INVENTION  
       [0008]     It is an object of the present invention to provide a nasal passage cleaning composition, which does not utilize steroids or sympathomemetic decongestants.  
         [0009]     It is another object to provide a nasal passage cleaning composition containing natural ingredients in a comfortable pH isotonic solution to avoid significant discomfort.  
         [0010]     It is further object to provide a method for cleaning the nasal passages using a composition which avoids significant side effects.  
         [0011]     These and other objects of the present invention are achieved by a nasal passage cleaning composition comprising a water and salt base, a mucolytic, an antiseptic, a non-steroidal, anti inflammatory, an astringent to act as a vasoconstrictor and optionally, a decongestant, an antipruritic and an analgesic, the composition formulated to have a comfortable pH. Other ingredients may be used in addition to those listed above such as an aroma agent and a pain reliever. Utilizing the present invention, nasal passage cleaning can be undertaken by spraying, rinsing or douching, with minimized discomfort, additionally avoiding the significant side effects associated with steroidal nasal sprays, or vasoconstrictors like ephedrine and NeoSynephrine sprays or drops. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0012]     The invention is a nasal passage cleaning system for individual use. Generally, the nasal organ functions as a filter, capturing and preventing particulates and other material from entering the lungs. The nose also acts as a detector by utilizing the sense of smell. When clogged or over-burdened with particulates or when subject to disease, mucus can build up with a consequent reduction in filtering ability, loss if the sense of smell and blockage of nasal airways which forces mouth breathing and prevents the flow of sinus secretions which is critical in reducing bacterial and fungal infection.  
         [0013]     A nasal passage cleaning composition according to the invention comprises water and salt as a base, generally having from 0.5 to 8.5 g/l of salt, to make an isotonic solution. The composition also contains an astringent such as potassium alum, zinc sulfate, tannic acid or combinations thereof, at from about 0.5 to 5 g/l, though a combination of two astringents, potassium alum and zinc sulfate is preferred. These ingredients shrink the mucosa and allow sinus passage drainage, decreasing pressure in the infected sinus and alleviates sinus headache and face ache.  
         [0014]     A mucolytic agent is used, at 0.05-2.0 g/l, such as guafenasine, bromhixine, acetyl L-cystine, or mucolytic enzymes, or combinations thereof. The preferred mucolytic agent is n-acetyl-L-cysteine. This ingredient is used to dissolve or soften mucus in the nasal passages.  
         [0015]     Various non steroidal inflammatory agents may also be used, such as various salicylic acid salts or propionic acid salts, at from 0.1 to 5 g/l. In particular, methyl salicylate may assist in disintegrating crusted mucus, additionally acting as a topical anti-inflammatory agent and as a pain relieving agent to reduce pain and discomfort.  
         [0016]     Various other ingredients can be used in the inventive composition such as tea tree oil (0.1-2 ml/l), menthol (0.01-0.3 g/l), eucalyptus oil (0.01-1.0 g/l), peppermint oil, camphor (0.01-1.0 g/l), alcohol, and/or glycerine (5-50 ml/l) are also used. Tea tree oil is a preferred ingredient, though substitutes are available which could include cinnamon, aloe, pine or spearmint oil.  
         [0017]     Some of these compounds provide multiple functions. For example, camphor acts to relieve pain and discomfort and also acts as an astringent. Tea tree oil provides an aromatizing ingredient while glycerine is useful as an emollient/moisturizer which protects the mucosa of the nose and sinuses. Menthol is used as an aromatizer and as an astringent and antipruritic. Balsam tolu is a useful emollient/mucosal protectant that is also an aromatizer.  
         [0018]     Preferably, the composition is buffered with a citric or phosphate compound to achieve a comfortable pH of the composition. A comfortable pH is in the range of 4.0 to 8.0, preferably about 5.5 to about 7.0, or about 6.0 to 6.7.  
         [0019]     Various optional or substitute ingredients could include gum benzoin, thymol, various antipruritics, etc.  
         [0020]     A more preferred composition would include zinc sulfate between 0.1 and 3 grams per liter, glycerine at 5 to 50 ml per liter, (gum benzoin, balsam tolu,) camphor or menthol between 0.01 and 0.1 grams per liter, aloe between 0.4 and 4 grams per liter, a solvent such as alcohol between 0.25 and 3 milliliters per liter, and tea tree oil and methyl salicylate between 0.1 and 2 milliliters per liter.  
         [0021]     Two hundred fourteen persons who had sinus trouble and who had taken the inventive composition provided the following feedback, in percent:  
                                                                       Better   Worse   Same   N/A                       Sinus discomfort   90.00   0.50   3.00   6.50           Pain in nose   66.90   0.43   5.10   27.57           Breathing at night   80.83   0.46   13.10   5.61           Opens the nose   91.50   0.00   3.00   5.50           Snoring   35.50   0.00   15.50   49.00                           None   Little   A lot                       Use Causes Pain   85.10   14.50   0.40           Use Causes   74.30   24.30   1.40           Stinging Sensation                      
 
         [0022]     The invention thus comprises a non-steroidal nasal passage cleaning composition having a salt and water solution as a base, containing an antiseptic component selected from the group consisting of tea tree oil, camphor, glycerine, alcohol, zinc sulfate and combinations thereof, present at from 0.1 to 2 grams per liter, an analgesic component selected from the group consisting of methyl salicylate, camphor and combinations thereof, present at from 0.01 to 0.1 grams per liter, a mucolytic component selected from the group consisting of n-acetyl L-cystine, potassium alum, zinc sulfate, bromhexine, guaifenesin, mucolytic enzymes, and combinations thereof, present at from 0.1 to 3 grams per liter, a moisturizing component selected from the group consisting of glycerin, balsam tolu (gum benzoin), tea tree oil, and combinations thereof, present at from at least 0.01 to 0.1 grams per liter, a non-steroidal anti-inflammatory from the group consisting of a salicylic acid salt present at from 0.1 to 2 ml. per liter. The composition is preferably a sprayable liquid having a near neutral pH for rinsing the nasal passages.  
         [0023]     It is preferred that the composition contain zinc sulfate between 0.1 and 3 grams per liter, glycerin at 5 to 50 grams per liter, gum benzoin, at least 0.1 to 3 g/liter camphor between 0.1 and 3 grams per liter. It may also contain, as an optional ingredient, aloe at between 0.4 and 4 grams per liter, alcohol between 0.5 and 3 ml per liter and tea tree oil and methyl salicylate between 0.1 and 2 ml. per liter.  
         [0024]     One composition contains per 1000 ml. of water, 7.1 grams sodium chloride, 0.5 ml. methyl salicylate, 0.8 ml tea tree oil, 0.023 grams gum benzoin or balsam tolu, 0.25 grams camphor, 0.03 grams menthol or peppermint oil, 20 ml. glycerin, 1.6 grams potassium alum, 1 gram zinc sulfate, 0.1 grams n-acetyl L-cystine and 1 gram of alcohol.  
         [0025]     The non-steroidal nasal passage cleaning composition may additionally include peppermint oil, thymol, eucolyptol, cinnamon, aloe, pine oil or spearmint oil.  
         [0026]     The inventive composition may be used in a method for cleaning the nasal passages, which comprises providing a non-steroidal nasal passage cleaning composition consisting of a salt and water base and containing an antiseptic selected from the group consisting of tea tree oil, camphor, glycerine, alcohol, zinc sulfate and combinations thereof, present at from 0.1 to 2 grams per liter, an analgesic selected from the group consisting of methyl salicylate, camphor and combinations thereof, present at from 0.01 to 0.1 grams per liter, a mucolytic selected from the group consisting of n-acetyl L-cystine, potassium alum, zinc sulfate, mucolytic enzlmes, bromhexine, guaifenesin and combinations thereof, present at from 0.1 to 3 grams per liter, a moisturizer selected from the group consisting of glycerin, balsam tolu (gum benzoin), tea tree oil, and combinations thereof, present at from 0.01 to 0.1 grams per liter, a non-steroidal anti-inflammatory from the group consisting of zinc sulfate present at from 0.1 to 3 grams per liter, methyl salicylate present at from 0.1 to 2 ml per liter, and combinations thereof, the composition being a sprayable liquid having a near neutral pH for rinsing the nasal passage; and, spraying the nasal passages with the liquid composition.  
         [0027]     Utilizing the present invention, cleaning of the nasal passages is accomplished with less discomfort than associated with other nasal cleaning products and without using steroids with their associated side-effects. By spraying, rinsing or douching the nasal passages with the invention composition, the result is dissolution and removal of pollen, smog, dust and other pollutants which cause allergies and decongestion of the nose, opening the sinus orifices for better drainage and a decrease in intra-sinus pressure to relieve sinus headaches.  
         [0028]     By dissolving the mucus and the crusted phlegm in the nose, the orifices of the sinus cavities are opened, which reduces the inter sinus passage pressure and reduces sinus headache. In addition, this opens the lachrymal ducts which connect the eyes to the nose and the Eustachian tube which connects the ears to the nose, relieving as well eye and ear symptoms associated with blockage of the lachrymal duct and/or Eustachian tube.  
         [0029]     A preferred composition according to the invention is illustrated in Table 1, though the invention is not limited to these particular ingredients or amounts, as discussed previously:  
                           TABLE 1                                        1000 ml (range)   Water            7.1 grams (0.5-8.5)   Sodium Chloride            0.5 ml (0.1-5.0)   Methyl Salicylate            0.8 ml (0-2.0)   Tea Tree Oil           0.023 grams (0-0.10)   Gum Benzoin or Balsam Tolu           0.025 grams (0-0.10)   Camphor            0.03 grams (0-0.10)   Menthol or Peppermint Oil             20 ml (5-50)   Glycerine            1.6 grams (0.5-5.0)   Potassium Alum              1 gram (0.1-3.0)   Zinc Sulfate            0.1 grams (0.05-2.00)   n-acetyl-L-cystine              1 ml (0-3.0)   Alcohol*                         *Alcohol could be substituted by adding a solvent for camphor and menthol or removed by using a surfactant such as polysorbate 80, also known as Tween 80, chlorobutanol or sodium lauryl sulphate.             
 
         [0030]     Once formulated, the composition may be applied using an applicator commonly used for nasal passage irrigation, or using a spray bottle or other like apparatus. As the composition enters the nasal passages, mucus and other residue in the nasal passage is softened and removed, the nasal passages once rinsed, are decongested and generally the user is able to breath more freely, and has a refreshing feeling. Depending on the user&#39;s condition, application a few times per day, once per day, once per week or once every two weeks can assure optimum relief for the user.  
         [0031]     While preferred embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various modifications can be made without varying from the scope of the invention.