AEROSOL NASAL A BASE DE SELS DE LA MER MORTE

NASAL SPRAY HAVING DEAD SEA SALTS

Abrégé français

L'invention concerne une formulation d'aérosol nasal destinée à être utilisée pour le traitement de la rhinite, de la sinusite, de l'épistaxis et de l'irrigation post-chirurgicale. Cette formulation d'aérosol nasal renferme du sel de la Mer morte ou son équivalent. La composition du mélange de sels de la Mer morte comprend 31-35 % environ d'halogénure de magnésium, 24-26 % environ d'halogénure de potassium, 4-8 % environ d'halogénure de sodium, 0,4-0,6 % environ d'halogénure de calcium, l'halogénure renfermant 0,3-0,6 % environ de bromure, et 99,4-99,7 % environ de chlorure. Ladite composition peut également contenir 0,05-0,2 % environ de sulfates, et 0,5-0,2 % de matières insolubles. Ces sels comprennent 34-38 % environ d'eau de cristallisation. La formulation d'aérosol selon l'invention, qui comprend de 0,5 environ à 5 environ grammes par litre d'une solution aqueuse stérile, ainsi qu'un tampon, est sensiblement exempte d'impuretés organiques nocives.

Abrégé anglais

A nasal spray formulation for use with the treatment of rhinitis, sinusitis,
epistaxis and post-surgical irrigation. The nasal spray formulation includes
the Dead Sea salt or its equivalent. The composition of the Dead Sea salt
mixture includes about 31-35 % magnesium halide, about 24-26 % potassium
halide, about 4-8 % sodium halide, about 0.4-0.6 % calcium halide, the halide
being about 0.3-0.6 % bromide, about 99.4-99.7 % chloride, and may also
include about 0.05-0.2 % sulphates, about 0.5-0.2 % insolubles. The salts may
comprise about 34-38 % water of crystallization. The spray formulation is
about 0.5 to about 5 grams per liter of sterile aqueous solution, contains a
buffer, and is essentially free of noxious, organic impurities.

Revendications

8
WHAT IS CLAIMED IS:
1. A nasal spray formulation comprising:
a Dead Sea salt and mineral composition in aqueous solution.
2. The formulation of claim 1 where the aqueous solution is sterile.
3. The formulation of claim 1 defined further as containing a buffer.
4. The formulation of claim 3 where the buffer is to maintain a pH of from
about 6.5
to about 7.5.
5. The formulation of claim 1 where the composition is from about 0.5 to about
5
grams per liter of aqueous solution.
6. The formulation of claim 1 where the composition is about 2.5 grams per
liter of
aqueous solution.
7. The formulation of claim 1 where the composition is essentially free of
noxious
organic impurities.
8. The formulation of claim 1 wherein said Dead Sea salt and mineral
composition is
further defined as including about 31-35% magnesium halide, about 24-26%
potassium
halide, about 4-8% sodium halide, about 0.4-0.6% calcium halide, the halide
being about
0.3 -0.6% bromide and about 99.4-99.7% chloride.

9
9. A method of treating symptoms of adverse conditions affecting the nasal
cavity and
passageway, the method comprising the steps of identifying patient with an
adverse nasal
cavity conditions;
a. obtaining a premixed formulation containing a Dead Sea salt and mineral
composition in aqueous solution; and
b. administering an aerosol formed from the formulation at least 1 time a day
as symptoms of the patient persist.
10. The method of claim 9 wherein said conditions include rhinitis, sinusitis,
epistaxis
and post-surgical irritation.
11. The method of claim 9 wherein said Dead Sea salt and mineral composition
is in
sterile aqueous solution.
12. The method of claim 9 wherein said Dead Sea salt and mineral composition
in
aqueous solution contains a buffer.
13. The method of claim 12 wherein the buffer is to maintain a pH from about
6.5 to
about 7.5.
14. The method of claim 9 wherein said Dead Sea salt and mineral composition
in
aqueous solution is from about 0.5 to about 5 grams of salt per liter of said
aqueous solution.

10
15. The method of claim 9 wherein said Dead Sea salt and mineral composition
in
aqueous solution is about 2.5 grams of salt per liter of said aqueous
solution.
16. The method of claim 9 wherein said Dead Sea salt and mineral composition
is
further defined as including about 31-35% magnesium halide, about 24-26%
potassium
halide, about 4-8% sodium halide, about 0.4-0.6% calcium halide, the halide
being about
0.3 -0.6% bromide and about 99.4-99.7% chloride.
17. The method of claim 9 wherein said Dead Sea salt and mineral composition
in
aqueous solution is essentially free of organic impurities.
18. A method for treating symptoms of adverse conditions of the nasal cavity
and
passageway with a Dead Sea salt and mineral composition in aqueous solution,
the method
comprising the steps of obtaining a premixed formulation containing a Dead Sea
salt
mineral composition in aqueous solution; and self administering an aerosol
formed from
said formulations nasally at least 1 time a day as symptoms persist.
19. The method for claim 18 wherein said conditions include rhinitis,
sinusitis, epistaxis
and post-surgical irritation.
20. The method of claim 18 wherein a Dead Sea salt mineral composition in
aqueous
solution is from about 0.5 to about 5 grams per liter of said aqueous
solution.

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21. The method of claim 18 wherein a Dead Sea salt mineral composition is in
sterile
aqueous solution.
22. The method of claim 18 wherein a Dead Sea salt mineral composition in
aqueous
solution contains a buffer.
23. The method of claim 22 wherein the buffer is to maintain a pH of from
about 6.5 to
about 7.5.
24. The method of claim 18 wherein a Dead Sea salt mineral composition in
aqueous
solution is about 2.5 grams per liter of said aqueous solution.
25. The method of claim 18 wherein said Dead Sea salt and mineral composition
is
further defined as including about 31-35% magnesium halide, about 24-26%
potassium
halide, about 4-8% sodium halide, about 0.4-0.6% calcium halide, the halide
being about
0.3 -0.6% bromide and about 99.4-99.7% chloride.
26. The method of claim 18 wherein a Dead Sea salt mineral composition in
aqueous
solution is essentially free of noxious, organic impurities.
27. A method of producing a nasal spray formulation comprising Dead Sea salt
in
aqueous solution, the method comprising dissolving Dead Sea salt in aqueous
solution and
storing this premixed formulation in a container suitable for aerosol nasal
administration.
28. The method of claim 27 wherein a Dead Sea salt mineral composition in
aqueous

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solution is from about 0.5 to about 5 grams per liter of said aqueous
solution.
29. The method of claim 27 wherein Dead Sea salt mineral composition in
aqueous
solution is about 2.5 grams per liter of said aqueous solution.
30. The method of claim 27 wherein Dead Sea salt mineral composition is in
sterile
aqueous solution.
31. The method of claim 27 wherein Dead Sea salt mineral composition in
sterile
aqueous solution contains a buffer.
32. The method of claim 31 wherein the buffer is to maintain a pH of from
about 6.5 to
about 7.5.
33. The method of claim 27 wherein said Dead Sea salt and mineral composition
is
further defined as including about 31-35% magnesium halide, about 24-26%
potassium
halide, about 4-8% sodium halide, about 0.4-0.6% calcium halide, and halide
being about
0.3 -0.6% bromide and about 99.4-99.7% chloride.
34. The method of claim 27 wherein a Dead Sea salt mineral composition in
aqueous
solution is essentially free of noxious, organic impurities.
35. A nasal spray formulation comprising a Dead Sea salt and mineral
composition
having about 31-35% magnesium halide, about 24-26% potassium halide, about 4-
8%

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sodium halide, about 0.4-0.6% calcium halide, the halide being about 0.3 -0.6%
bromide
and about 99.4-99.7% chloride, where said Dead Sea salt and mineral
composition contains
a buffer maintaining a pH from about 6.5 to 7.5 and is from about 0.5 to about
5 grams per
liter of sterile aqueous solution and is essentially free of noxious, organic
impurities.

Description

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NASAL SPRAY HAVING DEAD SEA SALTS
BACKGROUND OF THE INVENTION
This is a continuation-in-part application of co-pending serial number
09/345,043,
filed June 30, 1999. The present invention relates to a nasal spray
formulation used in the
treatment of conditions involving the nasal cavity and related passageways.
Specifically,
the formulation utilizes Dead Sea salts or analogous combinations to assist in
the treatment
of rhinitis, sinusitis, epistaxis, post-surgical irrigation and the like.
The Dead Sea is one of the most saline lakes in the world. It lies between the
hills
of Judaea to the west and the Transjordanian plateaus to the east. The Jordan
River flows
from the north into the Dead Sea. About 2.5 million years ago, heavy stream
flow into the
lake deposited thick sediments containing shale, clay, sandstone, rock salt,
and gypsum.
After this, strata of clay, marl, soft chalk, and gypsum fell upon layers of
sand and gravel.
Having no outlet, the Dead Sea is a "terminal lake" which loses huge amounts
of water by
evaporation in the hot dry air. The water has evaporated faster than it has
been replenished
by precipitation over the last 10,000 years, which has resulted in the lake
gradually shrinking
to its present form. Because of this, bare deposits cover the Dead Sea valley
to a thickness
of 1 to 4 miles (1.6 to 6.4 km). This water evaporation has also resulted in
high
concentrations of salts and minerals in a unique composition that is
particularly rich in
magnesium, sodium, potassium, calcium, bromide and various other minor anions
such as,
e.g., sulfate. The concentration of salt increases toward the Dead Sea bottom.
Down to 130
feet (40m), the temperature varies from 66 ° to 98 ° F
(19° to 37° C), and the salinity is
slightly less than 300 parts per thousand. At this depth, the water is
particularly rich in
sulfates and in bicarbonates. There is a transition zone located between 130
and 330 feet
(40 and 100 m). The lower waters below 330 ft ( 1 OOm) have a uniform
temperature of about

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72 °F (22 ° C) and a higher degree of salinity (approximately
332 parts per thousand). This
lower water contains hydrogen sulfide and strong concentrations of magnesium,
potassium,
chlorine, and bromine. Below this, the deepest waters are saturated with
sodium chloride,
which is precipitated to the bottom. The lower waters are fossilized--they
remain
S permanently on the bottom because they are very salty and dense. The upper
waters date
from a few centuries A.D.
Certain references describe the use of the Dead Sea salts, but not in
connection with
the treatment ofnasal conditions. See U.S. Pat. 4,943,432 issued to Biener on
July 24, 1990
which mentions the use of Dead Sea salts for use with psoriasis, atopic
dermatitis and other
skin diseases. See also, U.S. Pat. 5,707,631 issued to Lieberman on January
13, 1998 which
describes the use of Dead Sea salts in connection with a herbal composition
for use with the
treatment of arthritis, blood pressure and Alzheimer's disease.
Further, earlier references list nasal sprays but none which utilizes the Dead
Sea salts
in the treatment of rhinitis, sinusitis, epistaxis and post-surgical
irngation. See U.S. Pat.
5,840,278 issued to Coleman on November 24, 1998 which indicates use of a
nasal spray
having a mineral component, a vitamin component and aloe vera for a cold virus
remedy.
Due to unknown and unexpected complications caused by aloe vera in the
treatment of
rhinitis, sinusitis, epistaxis and post-surgical irrigation, this formulation
may not be best
suited for such treatment.
Accordingly, an important object of the invention is to create a formulation
in the
treatment of conditions of the nasal cavity and passageway.
Another object of the invention is to create a formulation for the treatment
of
rhinitis, sinusitis, epistaxis and post-surgical irrigation.

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Another object of the invention is to create a formulation utilizing the Dead
Sea salts
for the treatment of rhinitis, sinusitis, epistaxis and post-surgical
irrigation.

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SUMMARY OF THE INVENTION
In accordance with the above and related obj ects, the present invention
provides a
nasal spray formulation for use with the treatment of rhinitis, sinusitis,
epistaxis, post-
surgical irrigation and the like. The nasal spray formulation includes about 1-
5% Dead Sea
salt or its equivalent. The composition of the Dead Sea salt mixture includes
about 31-35%
magnesium halide, about 24-26% potassium halide, about 4-8% sodium halide,
about 0.4-
0.6% calcium halide, the halide being about 0.3 -0.6% bromide, about 99.4-
99.7% chloride.
The salt may also include about 0.05-0.2% sulphates, and about 0.5-0.2%
insolubles, the
latter of which is preferably removed by appropriate filtrations or other
means. The salts
may comprise about 34-38% water of crystallization. The spray formulation is
about 0.5
to about 5.0 grams per liter of aqueous solution. Preferably, the aqueous
solution is sterile
and contains a buffer, which maintains the pH between 6.5 and 7.5. The spray
formulation
is preferably also essentially free of noxious organic impurities. "About" in
this application
means + 20%.
Methods for treatment are included in the present invention. In one particular
1 S embodiment, the claimed method involves treating symptoms of adverse
conditions
effecting the nasal cavity and related passageways, which involves identifying
a patient
with an adverse nasal cavity condition and obtaining a premixed formulation
containing a
Dead Sea salt or the equivalent formulation and mineral composition in aqueous
solution
and administering or self administering an aerosol formed from the formulation
at least 1
time a day as symptoms of the patient or individual persist.
A method of producing is also part of the present invention and the
formulations
which includes dissolving the Dead sea salt in aqueous solution and storing
this premixed
formulation in a container suitable for nasal aerosol administration.

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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention relates to a nasal spray formulation used in the
treatment of
conditions involving the nasal passageway. Specifically, the formulation
utilizes the Dead
Sea salts to assist in the treatment of rhinitis, sinusitis, epistaxis, and
post-surgical irngation.
5 Rhinitis is the inflamation of the mucous membranes of the nose. Sinusitis
is the
inflamation of the sinus. Epistaxis is nose bleed or hemorrahage from the
nose.
In a preferred embodiment of the present invention, the Dead Sea salt solution
comprises about 0.5 to about 5.0 grams per liter of sterile aqueous solution.
Said aqueous
solution may be or include a buffer, water, or any other pharmacologically
acceptable
aqueous mixture. The buffer is to maintain the pH between about 6.5 and 7.5. A
buffer is
Sodium Phosphate, Potassium Phosphate, Sodium Carbonate, or such other as
would be
used by those skilled in the art to maintain the pH between 6.5 and 7.5. The
composition
of the Dead Sea salt mixture includes about 31-35% magnesium halide, about 24-
26%
potassium halide, about 4-8% sodium halide, about 0.4-0.6% calcium halide. The
halide are
preferably about 0.3 -0.6% bromide, 99.4-99.7% chloride, and the mixture may
also include
about 0.05-0.2% sulphates, about 0.5-0.2% insolubles, the later of which are
preferably
removed by filtrates. The salts may comprise about 34-38% water of
crystallization. The
formulation is essentially free of noxious organic impurities, such as human
waste, dead
marine animals, and fossil fuel spillage. "Essentially Free" is defined as no
more than
harmless, trace quantities.
Although the preferred embodiment of this invention is the use of Dead Sea
salt from
the Dead Sea, it is understood that one skilled in the art would be able to
artificially create
a Dead Sea salt. It is also apparent to anyone skilled in the art, that
certain
pharmacologically accepted ingredients normally found in nasal spray could be
added to the

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instant nasal spray formulation. However, both of these circumstances are
claimed within
this application. The claimed invention includes both the use of actual Dead
Sea salt and
artificially created salt with the same or similar salt and mineral components
as Dead Sea
salt. Also, the addition of other pharmacologically acceptable nasal spray
ingredients does
not change the invention claimed in this application.
EXAMPLE
A pilot study has been performed on the Dead Sea salt nasal irrigation.
Patients were
given verbal and written instructions to use the Dead Sea salt nasal spray
formulation for
seven days, the first two days were used as a baseline with no treatment, and
the patients
were to evaluate their nasal stuffiness, watery, itchy eyes, runny nose,
sneezing, itchy troat
and cough as well as postnasal drainage. On the last five days, they also were
instructed to
evaluate the Dead Sea salt nasal spray's global efficacy and personal
satisfaction. They
utilized this medicine through a four ounce nasal squeeze bottle three to four
times per day.
Instructions were given to mix one teaspoon of Dead Sea salt with two cups of
water and
then subsequently boil this mixture for five minutes. The mixture used as a
nasal spray
with two sprays up each nostril three to four times per day was a 2.5%
solution with 12 g
of the salt crystal in two cups, or 480cc, of water.
Nasal stuffiness was improved by 42%. Watery, itchy eyes were improved by
55.5%. Runny nose was improved by 44%. Global efficacy and personal
satisfaction were
rated 62.5%. A few patients reported an increase of postnasal drainage by 60-
70%. This
is thought to be secondary to mobilization of the mucus in sinus cavities. All
patients
requested that they stay on Dead Sea salt formulation. One patient in
particular previously
had two endoscopic sinus surgeries and had been placed on IV antibiotics two
times. One
patient who rated the overall global efficacy as 40% and personal satisfaction
as 40% stated

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that after desisting use of the Dead Sea salt for five days that it was
obvious that it had a
greater impact as a treatment than she originally thought. This patient stated
that after five
days without use of the Dead Sea salt formulation that her hoarseness was
back, her ears and
throat were bothering her again, her mucous secretions were thicker, and she
had sinus pain
on the left, all of which had diminished greatly while on the Dead Sea salt
irngation.
One patient tested who had not tried other medical treatment reported the
following
results: nasal stuffiness-100% improved; eyes-50% improved; runny nose -100%
improved;
sneezing-82% improved; throat-100% improved; post nasal drainage-100%
improved;
global efficacy-90% improved; and personal satisfaction-100% improved.
While the invention has been described with a certain degree of particularity,
it is
manifest that many changes may be made in the arrangement of components
without
departing from the spirit and scope of this disclosure. It is understood that
the invention is
not limited to the embodiments set forth herein for purposes of
exemplification, but is to be
limited only by the scope of the attached claim or claims, including the full
range of
equivalency to which each element thereof is entitled.
It is understood that the sprit and scope of the present invention is embodied
in the
following claims.