Organic compounds -- part of the class 532-570 series – Organic compounds – Carboxylic acid esters
Reexamination Certificate
2001-09-14
2003-01-21
Killos, Paul J. (Department: 1625)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carboxylic acid esters
C514S226500, C514S277000, C514S290000, C514S325000, C514S568000, C514S653000
Reexamination Certificate
active
06509492
ABSTRACT:
TECHNICAL FIELD
The present invention is directed to methods and compositions for the treatment of symptoms of upper respiratory conditions, including allergic rhinitis, coryza, influenza, rhinovirus and other viral infections. More particularly the invention relates to tannate compositions comprising at least two or more agents for the treatment of upper respiratory indications, wherein the agents are provided in a single administrative dose.
BACKGROUND OF THE INVENTION
Upper respiratory symptoms, resulting from a cold or influenza infection or allergic reactions, though not generally life threatening are some of the most annoying symptoms to have. Work days and hours are lost when employees are debilitated by these symptoms. The symptoms include nasal congestion, cough, sinusitis, cough, cold, cold-like symptoms, influenza symptoms and allergic rhinitis. Additionally other symptoms of upper respiratory mucosal congestions such as those seen in perennial and rhinnitis and Eustachian tube congestion.
These symptoms are treated with a variety of therapeutic agents. For example, antihistamines interact with histamine released in the body in an allergic reaction by competing for the histamine H
1
-receptor. Antihistamines reduce the effects of histamine in allergic reactions and tissue injury response. Antihistamines offset the histamine effects of increased capillary permeability and edema formation, particularly in the nasal mucosa where vascular engorgement, mucosa edema, irritation, sneezing and watery secretions result from histamine release.
Nasal decongestants act by release of adrenergic mediators from postganglionic nerve terminals. Ideally, nasal dcongestants are not given in amounts that cause other sympathomimetic effects such as pressor activity and central nervous system stimulation. The relief of symptoms of upper respiratory symptoms is achieved by the vasoconstriction and shrinkage of the nasal mucosa. Use of vasoconstriction produces a sustained, gradual decongestant effect with little if any return to congested levels seen prior to administration of the decongestant. Orally administered decongestants can reach mucosa that is not accessible by topical agents and allows for shrinkage of swollen tissues in the upper respiratory tract.
What is needed are methods and compositions comprising effective amounts of compositions of one or more therapeutic agents that are used for treatment of upper respiratory symptoms.
SUMMARY OF THE INVENTION
The present invention is directed to methods and compositions for treating upper respiratory indications in humans and animals, both adult and juvenile, comprising administration of compositions comprising one or more therapeutic agents. Such therapeutic agents include, but are not limited to, therapeutically effective amounts of tannate compositions, preferably antihistamines, cough suppressants or antitussives, decongestants and expectorants. Preferably the combinations are in single compositions comprising at least one or more agents, in pharmaceutical formulations. Methods and compositions are provided for the treatment of upper respiratory indications. The compositions are preferably formulated in the form of tablets, capsules, sterile solutions or suspensions, compounded in a conventional manner with physiologically acceptable vehicles or carriers, recipients, binders, preservatives, stabilizers, flavorings, or the like, as called for by accepted pharmaceutical practice.
Preferably, tannate compositions of the present invention comprise antihistamines, decongestants, cough suppressants or antitussives and expectorants. Such compositions can be used in combination with compounds from the same pharmacological class that do not contain tannates. Additionally, the compositions may comprise other therapeutic agents, for example, analgesics, narcotics, antibiotics, antivirals and antifungals.
The present invention is directed to compositions comprising tannate compounds and methods of use of such compositions. The present invention comprises pharmaceutical compositions comprising one or more of the following therapeutic agents in combination. Therapeutic agents of the present invention comprise antihistamines, sympathomimetic drugs such as nasal decongestants, bronchodilators, cough suppressants or antitussives and expectorants. Such therapeutic agents are administered for the treatment, management or mitigation of cough, cold, cold-like symptoms, symptoms related to upper respiratory infections, influenza symptoms and allergic rhinitis. Additionally other symptoms of upper respiratory mucosal congestions are included, such as those seen in perennial rhinitis, and for the relief of nasal congestion and Eustachian tube congestion. The compositions of the present invention may also be administered concurrently or sequentially with antibiotics, antiviral agents and analgesic compositions.
The present invention comprises injectable and noninvasive routes for delivery, including but not limited to, the oral, nasal, pulmonary, rectal, buccal, vaginal, transdermal and ocular routes. Compositions comprising combinations of at least two or more therapeutic agents may be administered through these routes of administration in compositions that allow for immediate or sustained release, controlled release or time-release dosing to the patient. The release profile of the compositions of the present invention allows for greater safety in administration of multiple agents, reduces the number of factors a physician must consider in treating upper respiratory indications with a multiple agent regimen, provides for greater compliance in patients, and results in fewer side effects for patients.
While studies have demonstrated a benefit of multi-drug therapy, the tasks of administering several different agents proves to be a challenge for the physician, patients, and caregivers. The present invention provides compositions and methods for treatment of upper respiratory indications by the administration of compositions comprising a combination of at least one or more therapeutic agents in an effective amount to treat the symptoms of upper respiratory indications.
The present invention provides compositions and methods for administering compositions comprising combinations of two or more therapeutic agents in compositions that are easily administered to persons having upper respiratory indications including but not limited to viral infection symptoms, cold symptoms, allergic rhinitis or other allergic reactions, runny nose, cough, post-nasal drip, nasal congestion and sinusitis. The present invention also provides compositions and methods for administering compositions comprising combinations of two or more therapeutic agents that promote high patient acceptance and compliance in persons with upper respiratory indications. The present invention provides compositions and methods for administering compositions comprising combinations of two or more therapeutic agents that maximize agent absorption in persons having upper respiratory indications.
These and other features and advantages of the present invention will become apparent after a review of the following detailed description of the disclosed embodiments and the appended claims.
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First Horizon Pharmaceutical Corporation
Killos Paul J.
Leydig , Voit & Mayer, Ltd.
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