Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Alkali or alkaline earth chloride
Reexamination Certificate
2000-01-19
2003-11-11
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Alkali or alkaline earth chloride
C424S677000, C514S853000, C514S872000, C514S956000, C514S957000, C604S048000, C604S500000, C604S503000, C604S514000, C604S516000
Reexamination Certificate
active
06645532
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the field of hypertonic solutions for delivery as sprays to relieve or prophylax against pain and discomfort in the ears arising from congestion or obstruction of the eustachian tubes or changes in middle ear pressure relative to atmospheric pressure from environmental conditions.
BACKGROUND OF THE INVENTION
The use of saline nose drops has been known. Several nose drops containing sodium chloride and other salts are available on the market. One commonly sold saline spray/drops preparation is LITTLE NOSES™, which contains 0.65% sodium chloride in water along with disodium phosphate, sodium phosphate, benzalkonium chloride and phenyl mercuric acetate 0.002% (a preservative). Another commonly used saline spray is Baby Ayr™, which contains, in addition to 0.65% sodium chloride, monobasic potassium phosphate/sodium hydroxide buffer to prevent nasal irritation. Neither of these preparation provide the level of clearing that is provided by the product described and claimed herein.
Baxter Healthcare Corporation sells two hypertonic solutions containing 3% and 5% sodium chloride for intravenous use to restore fluid and electrolyte balance. The solutions are used for replenishing sodium in patients who suffer from severe sodium depletion. The directions for administration include instructions to give slowly because of possible damage to the veins.
Recently, a composition containing hypertonic salt solutions called ENTsol™ has been placed on the market for use in reducing edema in the nasal passages. No teaching relating to relief from discomfort arising from congestion or changes of pressure in the eustachian tubes is taught therein, and the methods of administration taught in the instructions do not provide benefits associated with the methods taught herein.
SUMMARY OF THE INVENTION
This invention provides solutions containing at least 1.5% salt of a strong acid with preferred salt content at 2% to 3.5%, preferably 2%-3%. The most preferred compositions contain about 2.4-3% sodium chloride and are delivered in the form of sprays or mists. The methods of the invention are useful for treating and preventing discomfort in the ears that results from congestion in the eustachian tubes and/or pressure changes in the environment such as those caused by changes in altitude. Solutions for use in accord with the methods of the invention usually do not contain alcohol.
REFERENCES:
patent: 5899878 (1999-05-01), Glassman
patent: 6182660 (2001-02-01), Hopper
patent: 1313142 (1993-01-01), None
patent: 97/29756 (1997-08-01), None
Anonymous, ‘ENTsol nasal lavage lets you breathe better, fast’, Executive Health's Good Health Report, Aug. 1998, vol. 34, No. 11, p. 8 [retrieved on Jul. 24, 2000]. Retrieved from PROQUEST Direct on USTPO STIC NPL Virtual Library.*
Anonymous, ‘Bradley Pharmaceuticals successively introduces ENTsol Drug-free hypertonic nasal wash: provides new therapy in fight against sinusitus’, Business Wire [online], Nov. 19, 1998. New York, NY [retrieved on Jul. 24, 2000]. Retrieved from PROQUEST.*
Talbot, A. R. et al., “Mucociliary clearance and buffered hypertonic saline solution,” The Laryngoscope, vol. 107, Apr. 1997, pp. 500-503.*
The Merck Manual of Medical Information, Home edition, Merck Research Laboratories, Whitehouse Station, NJ, 1997, pp. 1006-1007.*
MacMillan Health Encyclopedia, MacMillan Publishing Co., New York, NY, vol. 2, 1993, pp. 32-33.*
Dorland's Pocket Medical Dictionary, WB Saunder Co., Phila. (1982) pp313, 336.
Hendricks Glenna
Pak John
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