U.S. patent application number 09/785367 was filed with the patent office on 2001-07-12 for composition for freshening nostrils and sinus cavities.
Invention is credited to Fust, Charles A..
Application Number | 20010007651 09/785367 |
Document ID | / |
Family ID | 25135271 |
Filed Date | 2001-07-12 |
United States Patent
Application |
20010007651 |
Kind Code |
A1 |
Fust, Charles A. |
July 12, 2001 |
Composition for freshening nostrils and sinus cavities
Abstract
A composition is disclosed for freshening sinus cavities,
including a carrier of the ingredients and a masking agent for
concealing or eliminating odors that emanate from the sinus
cavities. The disclosure is also related to a composition for
cleansing and freshening nostrils and sinus cavities that includes
a saline solution as a moisturizing base component, a flavoring
agent, a preservative, an antiseptic and/or anti-microbial agent, a
counter-irritant, and an alcohol. The disclosure is also related to
the use of such composition to provide many unexpected benefits of
clean and healthy nasal and sinus passages.
Inventors: |
Fust, Charles A.; (Venice,
FL) |
Correspondence
Address: |
THOMAS, KAYDEN, HORSTEMEYER & RISLEY, LLP
100 GALLERIA PARKWAY, NW
STE 1750
ATLANTA
GA
30339-5948
US
|
Family ID: |
25135271 |
Appl. No.: |
09/785367 |
Filed: |
February 16, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09785367 |
Feb 16, 2001 |
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09585070 |
Jun 1, 2000 |
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09585070 |
Jun 1, 2000 |
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09152151 |
Sep 11, 1998 |
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6083525 |
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09152151 |
Sep 11, 1998 |
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09123646 |
Jul 28, 1998 |
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09123646 |
Jul 28, 1998 |
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08644225 |
May 10, 1996 |
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5785988 |
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Current U.S.
Class: |
424/49 |
Current CPC
Class: |
A61K 31/315 20130101;
A61K 45/06 20130101; A61K 31/352 20130101; A61P 31/00 20180101;
A61P 27/16 20180101; A61K 8/34 20130101; A61K 31/00 20130101; A61K
31/045 20130101; A61Q 11/00 20130101; A61K 8/37 20130101; A61K
8/4973 20130101; A61K 31/618 20130101; A61K 33/30 20130101; A61K
31/05 20130101; A61P 11/02 20180101; A61K 9/0043 20130101 |
Class at
Publication: |
424/49 |
International
Class: |
A61K 007/16 |
Claims
I claim:
1. A composition for freshening sinus cavities comprising a carrier
means and a masking agent for concealing or eliminating odors
emanating from the sinus cavities.
2. A composition as defined in claim 1 and further including a
preservative.
3. A composition as defined in claim 1 and further including a
counterirritant.
4. A composition as defined in claim 1 and further including a
solubility enhancer.
5. A composition as defined in claim 1 and further including an
antiseptic/anti-fungal means.
6. The composition of claim 5, wherein the antiseptic/anti-fungal
means is selected from the group consisting of: cetylpyridinium
chloride (CPC), chlorhexidine digluconate, hexetidine,
sanguinanine, triclosan, and benzalkonium chloride.
7. A composition as defined in claim 1 and further including an
anti-infective means.
8. A composition as defined in claim 1 and further including a
healing agent.
9. A composition as defined in claim 8, wherein the healing agent
is selected from the group consisting of: zinc acetate and zinc
chloride.
10. The composition as defined in claim 8, wherein the healing
agent has a zinc ion availability of 100.
11. A composition as defined in claim 1, wherein the composition is
dispensed through a delivery means selected from the group
consisting of: a spray bottle, a dropper, a pump bottle, and an
atomizer-type bottle.
12. The use of the composition of claim 1, wherein said use
eliminates smoker's-breath.
13. The use of the composition of claim 1, wherein said use acts as
a placebo for medicated nasal compositions.
14. The use of the composition of claim 1, wherein said use soothes
nasal and sinus passages of individuals living in harsh
climates.
15. The use of the composition of claim 1, wherein said use cleans
nasal and sinus passages of individuals living in areas with high
pollen count.
16. The use of the composition of claim 1, wherein said use cleans
nasal and sinus passages of individuals living in polluted
areas.
17. The use of the composition of claim 1, wherein said use clears
nasal and sinus passages of individuals that snore.
18. The use of the composition of claim 1, wherein said use clears
nasal and sinus passages of individuals suffering from sleep
apnea.
19. The use of the composition of claim 1, wherein said use cleans
nasal and sinus passages of individuals who have recently undergone
nasal or sinus surgery.
20. The use of the composition of claim 1, wherein said use
moisturizes nasal and sinus passages of individuals who communicate
extensively verbally.
21. A composition for freshening nostrils and sinus cavities
comprising a saline solution as a moisturizing base component, a
flavoring agent for masking or eliminating odors from the sinuses
or nostrils, a preservative means for enhancing the shelf life of
the composition, a counterirritant for facilitating acceptance of
the composition by the nostrils and sinuses, and an alcohol for
facilitating solubility of the components.
22. A composition as defined in claim 21 and further comprising a
healing means.
23. A composition as defined in claim 22, wherein the healing means
is zinc acetate or zinc chloride.
24. A composition as defined in claim 21 and further comprising an
infection preventative agent.
25. A composition comprising: an osmotic agent of approximately 0.1
to approximately 2 percent by weight of the composition; a
buffering agent of approximately 0.1 to approximately 5 percent by
weight of the composition; a solubilizing agent of approximately
0.1 to approximately 12 percent by weight of the composition; a
surfactant of approximately 0.001 to approximately 5 percent by
weight of the composition; an antiseptic of approximately 0.001 to
approximately 10 percent by weight of the composition; an
anti-infective/anti-fungal of approximately 0.001 to approximately
5 percent by weight of the composition; a sweetener of
approximately 0.1 to approximately 4 percent by weight of the
composition; an aromatic component of approximately 0.1 to
approximately 5 percent by weight of the composition; a healing
agent of approximately 0.001 to approximately 5 percent by weight
of the composition; a solvent of less than approximately 100
percent by weight of the composition.
Description
CLAIM OF PRIORITY
[0001] This Application is a continuation-in-part of co-pending
U.S. utility application entitled, "Composition for Freshening
Nostrils and Sinus Cavities," having Ser. No. 09/585,070, filed
Jun. 1, 2000, which is a continuation-in-part of U.S. utility
application having Ser. No. 09/152,151, filed Sep. 11, 1998, which
is a continuation-in-part of U.S. utility application having Ser.
No. 09/123,646, filed Jul. 28, 1998, which is a
continuation-in-part of U.S. utility application having Ser. No.
08/644,225, filed May 10, 1996, which are entirely incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to a composition that is applied to a
person's nostrils and sinus cavities, using an inhaler or other
suitable means, for cleansing, freshening and deodorizing the named
areas for controlling halitosis.
BACKGROUND OF THE INVENTION
[0003] Conventional control of halitosis or "bad breath", as it is
often termed, is presently accomplished through the use of
mouthwashes, breath mints, candy, chewing gum, brushing and
flossing teeth, and other such means that are taken by mouth.
Recent developments in this field have focused on the theory that
the digestive organs can be responsible for objectionable odors
that are produced from consuming certain foods or liquids.
[0004] Many problems have been associated with inadequate cleansing
of the nasal and sinus cavities. For examples, smokers of cigars
and cigarettes often have a particular form of fetid breath known
as "smoker's breath." Further, other individuals suffering from
problems associated with the nasal passages and sinus cavities
become addicted to over-the-counter medicated nasal and sinus
sprays. Active ingredients in these sprays alter normal body
functions in order to achieve short-term results. Prolonged use of
medicated sprays frequently results in user dependency. In many
cases this occurs long after the original symptoms for which the
sprays were intended have run their course.
[0005] Additionally, a particular type of fetid breath originates
in an area deep within the throat, near the extreme rear of the
tongue, where the sphenoid sinus drains into the throat. Bacteria
buildup in this area produces sulfurous gases which results in
accumulative fetid breath. Small plastic devices, described as
tongue scrapers, are a common method people often use in an attempt
to dislodge the bacterial build up as they attempt to combat this
type of fetid breath; however, many of the users of these devices
report vexatious retching with foreign objects placed so deeply
within the throat.
[0006] Further, some individuals living in harsh, cold climates
often associated with mountainous living, reported they frequently
experience cracking and bleeding of the nasal passages. These same
individuals reported their home interior heating is often very dry,
resulting in a mild form of sleep distress.
[0007] Individuals living in certain parts of the country such as
farm belts and urban suburbs frequently must contend with very high
pollen concentrations contaminating the atmosphere. This
environmental condition often results in distressed breathing among
a great number of people because their airways become heavily taxed
when the pollen, which resembles a very fine dust, becomes
entrapped in their nose and sinuses. The pollen also results in
sneezing and watery eyes.
[0008] Certain geographic areas, such as large, industrialized
cities have very poor air quality due to high concentrations of
airborne pollution caused by industrial and engine emissions, as
well as common mold spores, dust and other hazardous particulates.
The pollutants can lodge or even clog the nasal passages and sinus,
possibly leading to infection.
[0009] Another problem associated with the sinuses is sinusitis, an
infection of one or more of the sinus cavities caused by fungus.
Once infected, the lining of the sinus cavity becomes swollen,
causing a buildup of fluid or mucus. This buildup is responsible
for symptoms such as congestion, runny nose, headache pain and
sinus pressure.
[0010] Not to be confused with chronic sleep disorders, some
individuals snore due to obstructed nasal passages. The individuals
who exhibit this condition also frequently experience an extreme
dryness in their mouth. Much the same as with individuals seeking
relief from snoring due to obstructed nasal passages, many other
individuals have difficulty sleeping for the same reason
"obstructed nasal passages".
[0011] A further possible problem with nasal and sinus passages is
associated with the "common cold", a minor respiratory illnesses
caused by a variety of different respiratory viruses. Symptoms of
nasal discharge, nasal congestion and sneezing are usually present
from the first day and usually progress to maximum severity by the
second or third day. The cost of treatment with over-the-counter
medications and outpatient clinics is estimated at more than $6.5
billion annually, all related to the relief of symptoms. The
symptomatic treatment available often contains one or more
antihistamines, decongestants, antitussives and expectorants, as
well as other types of pharmaceutical actives. For individuals with
certain medical conditions such as heart disease, hypertension,
diabetes or thyroid disorder, these active ingredients could pose a
risk.
[0012] In a wide range of respiratory infections, increased nasal
secretion of mucus greatly reduces the efficiency of the sense of
smell and taste, and also frequently creates the sensation of
unusual taste and smell. This is sometimes reported as a "metallic
effect". A heavy cold has a similar effect of damping odor
sensitivity by the over-production of mucus and the swelling of the
nasal membranes. A specific infection of the olfactory membrane,
known as rhinitis, may result in an altered or total, temporary
loss of smell. The same effect may stem from a number of allergies,
all of which are associated with nasal congestion.
[0013] Other individuals having problems with nasal and sinus
passages are those recovering from post operative medical care that
are frequently required to visit an ear, nose and throat specialist
(ENT) for sinus and nasal irrigation procedures. In these
procedures, solutions are forced, under pressure, into the
patient's affected areas for cleansing.
[0014] Some individuals who are required to communicate
extensively, such as sales people and teachers, frequently
experience excessive dryness of the mouth and nose. This dryness
often results in unusual bad breath, as well as a soreness and
discomfort of the throat.
[0015] Further, an altered sensitivity to odors is commonly
encountered during pregnancy. Substances previously pleasant
smelling may become repugnant to expectant mothers. The exact
reason for this condition is not known, but the body's changed
hormonal state exerts an influence on the olfactory membrane,
frequently causing it to swell. Additionally, nasal blockage is
commonly associated with pregnancy.
[0016] In today's market place, one can find health care products
related to every conceivable hygienic purpose except for the nose
and sinuses. For existing oral care products, what are often
marketed as "new and improved formulas" are actually nothing more
than old concepts. Mouthwash rinses are used to flush the mouth
with bacteria killing agents and, in most cases, with additives of
various types designed to freshen the mouth and mask odors.
Bacterial elimination is normally accomplished by the use of
alcohol and/or various dilutions of saline solution. The use of
alcohol in these products often causes the intrusive effect
experienced by many persons as a burning sensation. Saline
solutions are very effective bacteria killing agents and do not
cause the burning sensation; however, the taste is not well
received by most consumers. While somewhat effective in some cases,
mouthwashes and other oral means of controlling breath odors may
not be completely effective in solving many of the problems noted
above.
SUMMARY OF THE INVENTION
[0017] It is, therefore, one of the principal objects of the
present invention to freshen breath and eliminate or mask
objectionable breath odors by introducing the composition of the
present invention into the nostrils and therethrough, into the
sinus cavities.
[0018] Another object of the present invention is to provide a
composition which may be conveniently introduced through the nose
with, for example, an inhaler or atomizer-type container and which
causes no discomfort to the user. A further object of the present
invention is to provide an effective means of breath odor control
as a substitute or supplement to conventional therapies and which
has both immediate and residual effect.
[0019] These and additional objects are attained by the present
invention which, in the broadest sense, comprises a carrier means,
such as water or a dilute saline solution, and an odor masking
agent. The odor-masking agent can be an essential oil or flavoring
means such as those used in conventional mouthwashes. Other
additives may include a small quantity of alcohol for acting on
bacteria and an adherent means such as glycerin for maintaining the
composition in place in the nostrils and sinus cavities for a
sufficient length of time to produce the desired effect. Other
means such as preserving agents and healing and soothing agents may
also be employed.
[0020] Various additional objects and advantages of the present
invention will become apparent from the following detailed
description.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0021] The present invention is a liquid composition that is
inhaled through the nostrils and into the sinus cavities. It is of
particular utility for use by persons who smoke cigarettes, cigars
and the like, as the smoke necessarily invades the nostrils and
sinus cavities when it is inhaled.
[0022] The composition includes a carrier means, which can be water
or a mild or dilute saline solution. The saline solution is
preferred and provides a mild antibacterial effect. Saline
solutions are also commonly used as moisturizers at present and are
safely used in the nasal passages and sinuses. While the
concentration may vary between approximately 50% and approximately
75%, a solution of approximately 65% saline has been found to be
effective and non-objectionable for the user.
[0023] Control and/or elimination of objectionable odors is
accomplished using masking agents in the composition, such as, for
example, but not limited to, oil of peppermint, spearmint, etc., or
agents having a fruity or citrus essence. Other agents include, but
are not limited to eucalyptol, methyl salicylate, and various other
flavoring means.
[0024] A small quantity of alcohol may be used in the composition
to provide an antibacterial effect. The alcohol is not necessary,
but may facilitate mixing of the other components. A further
component which may be added is a preserving agent such as
benzalkonium chloride, which is used to extend shelf life. The use
of the preserving agent or agents depends on whether or not some or
any of the other components are stable in storage.
[0025] It is known in the art that zinc ions are powerful and
natural antirhinoviral agents, immune system aids, interferon
inducers, cell plasma/membrane pore closing agents,
anti-inflammatory agents, antioxidants, protease inhibitors, and
strong drying agents. It has been found that zinc ion availability
(ZIA) values of approximately 100 will shorten the common cold by
an average of seven days. Prior to the composition of present
invention, ZIA 100 was only available in the form of zinc acetate
lozenges. The composition of the present invention can also
incorporate the ZIA 100 zinc acetate, or zinc chloride, thereby
providing further healing and soothing properties to the
composition. The zinc acetate or zinc chloride provided in the
composition is pleasant tasting, flavor stable and causes no
objectionable after taste.
[0026] Also included in the composition is an antiseptic and/or
anti-microbial agent. Various embodiments of the composition exist
in which various antiseptic and/or anti-microbial agents are used.
In the preferred embodiment of the composition, the antiseptic
agent used is cetylpyridinium chloride (CPC). Other antiseptic
and/or anti-microbial agents include, but are not limited to,
chlorhexidine digluconate, hexetidine, sanguinanine, triclosan, and
benzalkonium chloride. It should be understood that many other
antiseptic and/or anti-microbial agents could be used in the
present invention, as would be known to one skilled in the art.
[0027] The delivery method used for the composition can vary.
Delivery means of the composition include for example, but are not
limited to, spray bottles, droppers, and/or atomizer-type squeeze
or pump bottles. Experimentation with a one ounce (1 oz.) pump
atomizer spray bottle can be an effective delivery means of the
composition. Containers of this type are currently used by several
pharmaceutical companies for introducing sinus medication into the
nostrils and sinus cavities. The atomizer-type bottles reduce the
composition to a very fine mist, thus making the delivery of the
composition minimally intrusive.
[0028] No discomfort for the user was experienced in testing of the
composition. In addition, no harmful effects on the nostrils or
sinus cavities were caused by any of the components of the
composition. Further illustrated by clinicals entitled: "A Phase
Study to Evaluate the Safety and Efficacy of SinoFresh Nasal Care
Used Twice Daily" (the Study). The composition effectively
eliminated or masked odors associated with smoking and with eating
various foods such as onion, garlic and other spices, as well as
certain liquids, particularly alcoholic beverages, coffee, tea,
etc.
[0029] There are numerous advantages and unexpected results from
use of the composition. For example, smokers and those exposed to
second hand tobacco smoke who routinely use the composition of the
present invention have all reported the complete elimination of
smoker's breath. Many have also reported an improvement in their
sense of smell after prolonged use of the composition.
[0030] Other than being the location of the olfactory membrane, the
nasal cavity is quite unrelated to smells and smelling, but instead
acts as an air-conditioning type system to clean and treat the air
breathed before the air meets the sensitive and delicate tissues of
the lungs. As such, it has been found unexpectedly that the sense
of smell is improved by the cleansing of the olfactory hairs and
the replacement of olfactory mucosa while using the composition of
the present invention. Also, nose hairs become burdened with
nicotine, tar and other tobacco-related chemicals. Routine hygienic
cleansing of the nasal passages and sinus cavities aids the body in
ridding itself of offensive odors, especially those that have
become trapped in the middle, inferior and superior nasal concha.
Freshening ingredients of the composition of the present invention
that are left in the nose after cleansing with the composition
leaves the nose and sinuses feeling cleansed, cleared, and
refreshed with a minty aftertaste.
[0031] Many people have been able to substitute the use of the
composition of the present invention in lieu of use of the
medicated sprays, thereby relieving their dependency. Their
unexpected results can be explained in several ways. First, the
user develops a habit with regard to the sprayer itself. For
example, some reformed smokers utilize a therapeutic device
resembling a cigarette to imitate the act of placing an actual
cigarette in their mouth. The use of the present composition
fulfills a similar function for the user as use of stronger,
harsher medicated sprays. Second, by keeping nasal passages and
sinuses cleaner and therapeutically refreshed, users experience
increased breathing capacity. This is especially beneficial because
it is accomplished without the use of medicated ingredients.
Therefore, the composition can be used as often as desired with
absolutely no addictive problems.
[0032] Some individuals who use the composition have reported an
unexpected improvement in oral-related fetid breath. Prolonged use
of the composition allows for residual deposits of the cleansing
and freshening agents to pass through the nasal and sinus passage
and drain down into the described area of the mouth, thus resulting
in correlative improvements in reducing these bacteria and
deposits, and leaving behind freshening agents. The composition
offers a more user-friendly approach to this type of bad
breath.
[0033] While using the composition individuals living in harsh,
cold climates that experience cracking and bleeding of the nasal
passages reported a heretofore unprecedented tremendous improvement
in the cracking and bleeding symptoms, as well as improvements in
their sleep distress. These improvements are a result of
moisturizing agents and isotonic saline nature of the composition
ingredients. The sleep distress is relieved with a clearing of the
nasal passages, which makes breathing easier in the thin
atmosphere.
[0034] It is found unexpectedly that, with respect to those
individuals living in areas with a high pollen count, routine
hygienic cleansing of the nasal passages and sinuses with the
composition, loosens and expels much of the pollen that has become
trapped in the nasal passages and nose hairs which are acting as
the body's filtering system for the respiratory system. The more
the composition is used, the more pollen that is expelled. Because
there are no medicinal ingredients in the composition, the user can
cleanse the nose as often as necessary in order to relieve this
type of problem.
[0035] For individuals living in polluted geographic areas, routine
use of the composition can provide a previously unknown innocuous
method of expelling much airborne pollution from the nose and
sinuses. Use of the composition results in a cleansing and
freshening process that improves breathing ability.
[0036] With respect to sinusitis, clinical studies were conducted
to validate the use of the composition in the prevention and
treatment of chronic sinusitis, the basis of which is the
antifungal properties of the solution. In addition, it has been
found unexpectedly that routine use will relieve many of the
symptoms and bathe the affected area with soothing and
antibacterial, anti-fungal, and/or anti-infective ingredients.
Fetid breath is often present as an additional symptom of sinusitis
that use of the composition can, in most cases, eliminate. Further
illustrated by Clinicals entitled "Intranasal Antiseptic Effect on
Chronic Sinusitis Protocol".
[0037] Individuals who snore, that regularly maintain good hygienic
practices by utilizing the composition just prior to retiring to
bed, report an unexpected and significant change in their ability
to breathe clearly through the nose. With their change in
breathing, they reported a decrease in oral dryness, thereby
relieving the condition that is known to cause snoring.
[0038] The composition is also useful with resolving problems
associated with the common cold. While the composition is not a
cure for the common cold, many of the symptoms can be relieved
without the need for medical or pharmaceutical ingredients. While
the cold is "running its course", keeping the nose and sinuses
clean, bathed and refreshed with minty, freshening ingredients
helps the individual feel and breathe much better. Engaging in a
thorough hygienic cleansing just prior to retiring for bed and
after arising, thereby expelling excess nasal and sinus mucus that
cause a "runny nose", brings tremendous relief to the user.
Further, as noted previously, by raising the ZIA values in
individuals suffering from the outset of a cold, the composition
can shorten the duration of the cold.
[0039] For those individuals suffering from difficult breathing
during sleep, many users of the composition have reported,
unexpectedly, that they breathe much better after a thorough,
hygienic cleansing of the nose and sinuses just prior to retiring
to bed. Nasal mucus and other related foreign matter that has
accumulated in the nose hairs is easily expelled with the
therapeutic process. The user retires with clearer nasal passages
and a refreshed, minty aftertaste and is less likely to experience
sleep disorders associated with blocked nasal passages.
[0040] Further, within the scope of their ENT's complete approval,
some of the users of the composition have utilized a method of
hygienic cleansing of the nose and sinuses to compliment the care
received at the ENT's office after surgery on the nose and/or sinus
passages. The ingredients contained in the composition are
completely innocuous, i.e., there is nothing present that will
interfere with the physician's care. Unexpectedly, these users
reported their breathing became easier, their nose and sinuses felt
cleaner and very positive changes occurred in what they described
as "very fetid" breath. The composition cannot be substituted for
an ENT's care and hygienic cleansing of the nose and sinuses cannot
be compared to, nor achieve the same results, as
physician-supervised irrigation, no more than toothpaste and
mouthwash can be substituted for procedures performed by a dentist
in their office; nonetheless, the invention provides advantages to
the user that do not come without its use.
[0041] With regard to individuals whose occupations require
extensive verbal communication, unexpected results indicate that
users of the composition have been able to restore moistness to
their noses and sinuses and during routine use, residual amounts of
the ingredients pass through the nose and sinuses, leaving deposits
of the cleansing, freshening agents to soothe the throat.
[0042] With respect to pregnant women, users of the composition
with this condition described as hormonal change have reported that
routine cleansing of the nasal passage and sinuses seemed to
improve their ability to breathe, likely due to the expulsion of
the nasal blockage in the form of excess nasal mucus. The
freshening ingredients left behind results in a minty aftertaste
which can also often replace the sense of repugnant odors that may
come with pregnancy.
[0043] The composition is truly an exception since it is in fact a
new concept in the control of fetid breath. Prior to the invention,
the effect the nose and sinuses have on a person's breath was not
addressed. In addition, few people have considered the positive
health benefits that can be achieved with routine therapeutic
cleansing of the nose and sinuses.
[0044] If one examines an air filter, taken from the average home
interior heating and cooling system, the debris caught in the
filter clearly reflects samples of the many contaminants we ingest
into our noses on a daily basis. If these filters were never
cleaned, eventually the system would shut down. Because the nose
and sinuses provide a similar function for our respiratory system,
the positive benefits that can be achieved by routine cleansing is
apparent.
[0045] The routine, hygienic cleansing of the nose and sinuses,
using the composition containing isotonic saline, moisturizing,
purifying and antiseptic agents will result in cleaner, healthier
nasal and sinus passages, rewarding the user with an improved
breathing ability.
[0046] Unexpected results reveal that users of the composition have
reported relief of many types of symptoms, likely due to their
routine programs of hygienic cleansing of the nose and sinuses.
After thorough cleansing, the deposits of freshening ingredients
left behind replaces the metallic effect with a minty
aftertaste.
EXAMPLE 1
[0047] The following formula provides a representative example of
the composition.
1 Ingredient Amount Sodium chloride 0.65% Benzalkonium chloride
0.002% Thimerosal 0.001% Eucalyptol 0.03% Methyl salicylate 0.02%
Menthol 0.015 Alcohol 0.07% PEG or glycerin Trace (Optional) Zinc
acetate/zinc chloride Optional
[0048] A summary of the properties of ingredients of the
composition:
2 Ingredient Property Sodium chloride Base ingredient also acting
as a moisturizer Benzalkonium chloride Preservative Thimerosal
Preservative Eucalyptol Flavoring Agent, also containing antiseptic
effect Methyl salicylate Counterirritant, (Local Analgesic
containing flavor similar to Wintergreen) Menthol Counterirritant
Alcohol Aids in solubility effect of other ingredients also
containing antibacterial effect. Zinc acetate/zinc chloride Healing
and soothing properties
[0049] The above listed formula for the composition has undergone
testing and has proved effective for its stated purpose. The
composition was dispensed from a 1 oz. pump atomizer bottle and was
successful in eliminating and/or masking odors which could be
considered offensive in certain circumstances or by certain people,
i.e., odors from smoking, cutting, dicing, or consuming onions,
etc.
[0050] Based on experiments that have been conducted, the
eucalyptol, methyl salicylate and menthol can be replaced by other
similar acting ingredients to completely change the flavor. The
base ingredients of the composition, preservative(s) and alcohol,
are in percentage amounts that will remain relatively constant. The
solution of the invention is prepared according to known techniques
and excipients, as described in "Remington's Pharmaceutical
Sciences Handbook," 17.sup.th ed., Hack Publ. Co., N.Y., U.S.A.
[0051] It should be stated that the composition of the invention is
not limited to the ingredients stated in the original application
or an intervening continuation-in-part (CIP) formulation.
Substitution ingredients are widely available for each of the
essential components, as described in "Remington's Pharmaceutical
Sciences," 17th edition.
[0052] The first set of intrinsic ingredients of the composition is
the antiseptic and anti-infective agents. The elimination of
certain types of fungus and bacteria, which are known to cause
offensive odors, will aid in the freshening of the breath and are
selected and formulated to produce the results as described.
[0053] The second set of intrinsic ingredients of the composition
is the aromatic components which aid in the freshening and
deodorizing of the nasal and sinus cavities. These ingredients are
selected and formulated to produce the results described
herein.
[0054] The third intrinsic ingredient of the composition is the
isotonic, aqueous solution, acting as an osmotic agent. This
ingredient is selected and formulated for the isotonic value and
fully disclosed in "Remington's Pharmaceutical Sciences," 17.sup.th
edition. This ingredient is selected and formulated to produce the
results further described herein.
EXAMPLE 2
[0055] The following formula provides a second representative
example of an isotonic, sterile, aqueous solution of the
composition. In this formula, the function of the ingredients is
given under "Application".
3 RANGE INGREDIENT APPLICATION PERCENTAGE 0.1 to 2% Sodium chloride
Osmotic agent 0.650 0.1 to 5% Sodium borate Buffering agent 0.100
0.1 to 9% Alcohol SD Solubilizing agent 0.090 0.001 to 2% Edetate
disodium Preservative 0.050 0.1 to 3% Glycerin Solubilizing agent
0.001 0.001 to 5% Polysorbate 80 .TM. Surfactant 0.045 0.001 to 5%
Poloxamer 407 .TM. Antiseptic 0.030 0.001 to 5% Domiphen bromide
Antiseptic 0.030 0.001 to 5% Cetylpyridinium Anti-infective/ 0.040
chloride Anti-Fungal 0.1 to 2% Sorbitol Sweetener 0.002 0.1 to 2%
Sodium saccharin Sweetener 0.002 0.1 to 5% Aromatic Masking agent
0.005 component 0.001 to 5% Zinc acetate/ Healing agent 0.040 zinc
chloride Deionized water Solvent (vehicle) <100% (W/W %)
[0056] The examples of the composition given, both in the parent
application and the CIP filings, are representative of preferred
embodiments. However, the ranges of the composition should not be
limited to these examples in terms of ingredients and
administration.
[0057] Thus, while an embodiment and various modifications thereof
of the composition for cleansing and freshening nostrils and sinus
cavities has been described in detail herein, various additional
changes and modifications may be made without departing from the
scope of the present invention.
* * * * *