Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2002-04-03
2003-11-04
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S434000, C424S051000, C514S853000
Reexamination Certificate
active
06641799
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to therapeutic compositions for treating nasal passages. In particular, the present invention relates to decongesting and moisturizing the tissues that line nasal passages.
BACKGROUND
The nose is a very specialized and complicated structure that serves dual functions as the organ for the sense of smell and as an entry to the respiratory tract. As part of the respiratory tract, a healthy nose moisturizes and warms incoming air and filters out foreign materials.
Nasal passages and other portions of the respiratory tract are lined with specialized tissue layers. In the nose and sinus areas this tissue is often called the nasal mucosa. Like many tissues, the nasal mucosa is composed of several cell layers and cell types. Mucous cells are one type of cell found in the nasal mucosa. These cells are found throughout the nasal mucosa and are generally clustered into small glands. These glands secrete a sticky substance called mucus. Mucus is composed of water, shed epithelial (surface) cells, dead leukocytes, mucin, and inorganic salts, among other things, that are all held in suspension. Mucus functions as a trap for airborne particles (e.g., dust, bacteria, and viruses) that enter the nasal passages. Mucus also lubricates the walls of the nose, sinuses, and throat.
In a healthy nose, the mucus is cleared from the nasal passages on a regular basis by a layer of cells in the nasal mucosa called the ciliated columnar epithelium. These cells possess small hair-like projections called cilia that undulate and “sweep” mucus through the nasal passages allowing it to drain to the back of the throat where it can be swallowed or expelled. This line of defense protects the body against the bacteria and viruses that continually enter the nose and mouth.
Connected to the nose are sinuses or air-filled cavities located behind certain facial bones. There are four groups of sinuses, namely, frontal, sphenoidal, ethmoidal, and maxillary. The sinuses are also lined with mucus secreting tissue. The sinuses are normally kept clear when mucus drains through them into the nasal passages. If they are obstructed for any reason, such as from the congestion present during a cold, normal drainage may not occur and infection of the sinuses may result.
Virtually all persons are occasionally stricken with acute upper respiratory infections (common colds), acute or chronic allergy flare-ups of the nose, and/or acute or chronic non-allergic rhinosinusitis. Persons afflicted by such conditions usually incur significant discomfort and inconvenience.
All of these disorders are characterized by intense inflammation of the nasal mucosa. A number of symptoms contribute to the discomfort and inconvenience associated with the common cold or sinusitis. Symptoms often include one or more of the following: nasal congestion, post-nasal drip, decreased sense of smell, ear fullness, headache, sore throat, malaise, muscle and joint aches, fatigue, cough, chest congestion, fever, chills and gastrointestinal maladies. Considerable research has been conducted over the years aimed at reducing the incidence and duration of symptoms associated with allergies and common colds.
Perhaps the most common symptom experienced by cold and allergy sufferers is “congestion.” The term “congestion” is commonly used by the layperson and in the patent literature as catch-all term to describe a complex series of events that hinder a person's ability to breathe through the nose when they have a cold, sinusitis or an allergic reaction.
For example, “congestion” can include a physiological response to an irritant that involves increased blood flow to tissues lining the nose. This increased blood flow causes these tissues to swell and physically block the nasal passages. Alternatively, when a nose is irritated or injured, fluid can seep into the free spaces in the tissues of the nose or build up in individual cells thereby causing additional “congestion”. “Congestion” can also include the overproduction of mucus or the buildup of mucus due to increased mucus viscosity or depressed cilia activity or both. “Congestion” may also occur when a person lies on his or her side causing receptor cells in the nose to close off one nasal airway. Changes in temperature and/or humidity can alter the tissue of the nose and cause a “congested” feeling.
Current medications and treatments for “congestion” provide only minimal symptom relief and some have undesirable side effects. Over-the-counter medications containing antihistamines sometimes cause drowsiness and impair cognitive judgment so that driving an automobile or operating other power driven machinery can be dangerous. Decongestants and adrenalin derivatives can elevate blood pressure, cause heart palpitations and stimulate brain activity causing insomnia or hyperalertness.
Numerous over-the-counter sprays (e.g., Afrin®) relieve some symptoms, but contain active ingredients such as the vasoconstrictor oxymetazoline hydrochoride. These types of sprays are directed at reducing swelling caused by increased blood flow to the nasal mucosa and are quite effective. Unfortunately, they are also associated with a significant addictive, rebound phenomenon of the nasal membranes (Rhinitis Medicamentosa). As a result, over-the-counter sprays with these types of active ingredients may actually lengthen the duration of common cold or sinusitis symptoms.
Inhaled corticosteroid nasal sprays provide some relief for allergic rhinitis but do not reduce inflammation caused by acute viral infections, or inflammation associated with other forms of non-allergic rhinitis (atrophic rhinitis, vasomotor rhinitis, hormonally-induced vasomotor instability, etc.). Prolonged use of steroid sprays has also been associated with drying, cracking and bleeding of the nose.
More passive treatments such as isotonic saline mists are also widely marketed for purposes of moisturizing the nose and relieving cold and allergy symptoms. Several patents discuss herbal based mists as an alternative to over-the-counter sprays such as Afrin®.
These more passive sprays and treatments have proved to be less than satisfactory at providing the relief sought by sufferers of colds or allergies or other nasal problems. For example, isotonic saline mists add moisture to the nose but provide little overall relief for congestion.
Accordingly, a need exists for a nasal spray that provides a noticeable measure of relief for those that suffer from “congestion” of the nasal passages yet does not exhibit the harmful side effects associated with sprays that contain active ingredients such as vasoconstrictors and steroids. Such a spray should be economical to produce and safe for use by most individuals suffering from “congestion.”
OBJECT AND SUMMARY OF THE INVENTION
In view of the foregoing discussion, an object of the invention is to provide a nasal spray that eases congestion of the nasal passages, in particular, congestion due to decreased ciliary function, swelling, fluid retention, increased mucus secretion and/or mucus buildup.
A further object of the invention is to provide a method for manufacturing such a nasal spray. A still further object of the invention is to provide method of treating the nasal passages, in particular the nasal mucosa, to ease the discomfort associated with congestion due to decreased ciliary function, swelling, fluid retention, increased mucus secretion and/or mucus buildup.
The invention meets these and other objects by providing a composition for osmotic decongestion and moisturization of the nasal passages comprising water, a ciliary stimulant, a mucus thinning agent, an osmotic agent, glycerin, and a preservative. Preferably the composition is alkaline and is hypertonic with respect to the cells of the nasal mucosa.
The invention also meets the above stated objects by providing a method of preparing an alkaline, hypertonic composition for use in osmotic decongestion of the nasal passages. The method comprises obtaining a quantity of water that is between about 67% and 68% of the tota
Haghighatian Mina
Nos Spray, Inc.
Summa & Allan P.A.
LandOfFree
Nasal spray for decongesting nasal passages does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Nasal spray for decongesting nasal passages, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Nasal spray for decongesting nasal passages will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3139201