Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2000-02-16
2001-08-28
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
active
06281248
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition. More particularly, the present invention relates to a composition for treating asthma.
2. Description of the Prior Art
The frequency of occurrence of allergic diseases, particularly bronchial asthma is continuously increasing. Social-economical and environmental conditions, enhancement of affectivity of the diagnosis, and the lack of an adequate, really healing therapy provide background of this increase. Despite for or partially even due to the elevated drug consumption, the mortality ratio also shows a rising tendency.
Bronchial asthma is characterized by bronchospasm caused by contraction of the bronchial smooth muscle, increased secretion of mucus from the bronchi, and edema of the respiratory mucosa.
While the etiology of asthma is not completely known, it is believed to involve an allergic reaction. Allergic reactions occur in sensitized individuals who are exposed to the antigen to which they are sensitized. The antigen provokes the release in the body of certain chemicals (allergic mediators) which in turn produce the allergic symptoms. Allergic reactions can also produce effects in organs other than the bronchi, particularly the skin, the eyes, and nasal mucosa, and include such diseases as allergic rhinitis and urticaria.
Acute asthmatic bronchospasm has been treated with drugs which relax bronchial smooth muscle. Sympathomimetic drugs, such as epinephrine, isoproterenol, and terbutaline and xanthine drugs, such as theophylline and its salts (aminophylline, etc.) have been used for this purpose. Drugs, such as cromolyn which inhibit the release of allergic mediators, have been used prophylactically to treat bronchial asthma. Corticosteroid drugs have also been used to treat bronchial asthma and other allergy diseases.
Many of the drugs used hitherto have short comings which make them less than ideal for treatment of asthma and other bronchspastic and allergic diseases. For example, epinephrine and isoproterenol relieve the symptoms of asthma for only a relatively short period of time and are ineffective orally. Theophylline has limited efficacy and produces cardiac and gastrointestinal side effects. Cromolyn sodium is only effective by inhalation or injection and is ineffective by oral administration. The corticosteroid drugs have serious side effects which limit their chronic use.
Numerous innovations for asthma treatments have been provided in the prior art that will be described. Even though these innovations may be suitable for the specific individual purposes to which they address, however, they differ from the present invention in that they only relieve the symptoms of asthma for a relatively short period of time, are ineffective orally, have limited efficacy, produce cardiac and gastrointestinal side effects, are only effective by inhalation or injection and are ineffective by oral administration, and have serious side effects which limit their chronic use.
FOR EXAMPLE, U.S. Pat. No. 4,089,059 to Diamond teaches prolonged bronchodilation and prolonged inhibition of allergic mediator release in mammals are produced by administering an effective amount of a substituted xanthine compound having the formula: ##STR1## wherein: R.sub.1=methyl R.sub.3=c.sub.4-c.sub.7 alkyl, C.sub.4-C.sub.7 cycloalkylalkyl C,sub.4-C.sub.7 alkenyl, C.sub.4-C.sub.7 alkynyl, or C.sub.4-C.sub.7 cycloalkyl R.sun.8=c.sub.1-c.sub.2 alkyl. Those compounds are useful in the treatment of bronchial asthma and other bronchospastic and allergic diseases. The bronchodilator and antiallergy agents may be administered in the form of tablets, capsules, aerosols, solutions, suspensions or suppositories.
ANOTHER EXAMPLE, U.S. Pat. No. 4,837,203 to Adcock et al. teaches peptides of the formula X--Tyr--X.sup.2 --Gly--Phe(4NO.sub.2)--Pro--NH.sub.2 wherein X is hydrogen or an amidino group and X.sup.2 is D-S-methylmethionyl or D-arginyl, together with their pharmacologically acceptable salts, which have been described as exhibiting analgesic, antidiarrheal and antitussive activity, are effective in reversing neuronally-mediated bronchoconstriction in mammals. The said compounds have application in the palliation of conditions characterized by such a state, in particular asthma in human beings.
STILL ANOTHER EXAMPLE, U.S. Pat. No. 5,179,089 to Takacs et al. teaches compounds of the general formula (I), ##STR1## wherein R means hydrogen or a straight or branched chain C.sub.1-6 alkoxy group; P.sup.1 stands for hydrogen or a straight or branched chain C.sub.1-6 alkyl group; R.sup.2 represents hydrogen or a straight or branched chain C.sub.1-6 alkyl group; R.sup.3 means hydrogen, a straight or branched chain C.sub.1-6 alkyl group optionally substituted by one or two hydroxyl and/or one or two straight or branched chain C.sub.1-4 alkoxy group(s); or a C.sub.4-7 cycloalkyl group; R.sup.4 stands for hydrogen or a straight or branched chain C.sub.1-6 alkyl group optionally substituted by one or two hydroxyl and/or one or two straight or branched chain C.sub.1-4 alkoxy group(s); or a C.sub.4-7 cycloalkyl group; or R.sup.3 and R.sup.4 together with the nitrogen atom, to which they are attached form a 4 to 8-membered cyclic group of formula ##STR2## optionally substituted by one or two straight or branched chain C.sub.1-4 alkoxy and/or one or two straight or branched chain C.sub.1-4 alkyl group(s), where optionally an oxygen or sulfur atom or an N-R.sup.5 group may be substituted for a ring carbon atom, where R.sup.5 means hydrogen or a straight or branched chain C.sub.1-6 aliphatic alkyl group, the 4- to 8-membered cycle optionally being condensed with a benzene ring; R.sup.6 stands for hydrogen or a C.sub.1-10 acyl group and the salts and hydrates thereof as well as pharmaceutical compositions containing these compounds. The compounds of the invention antagonize the effects of constrictive mediators, e.g. histamine, acetylcholine or serotonin; they show an antiallergic action and possess an antiinflammatory effect. Thus, these compounds can therapeutically be used as bronchodilators as well as antiallergic or antiinflammatory drugs, particularly in the treatment of bronchial asthma.
STILL ANOTHER EXAMPLE, U.S. Pat. No. 5,705,505 to Shenvi et al. teaches compounds of formula I ##STR1## wherein Q.sup.1, Q.sup.2, Q.sup.3, and Q.sup.4 have any of the meanings given in the specification, their N-oxides, and their pharmaceutically acceptable salts are nonpeptide antagonists of neurokinin A and useful for the treatment of asthma, etc. Also disclosed are pharmaceutical compositions, processes for preparing the compounds of formula I and intermediates.
It is apparent that numerous innovations for asthma treatments have been provided in the prior art that are adapted to be used. Furthermore, even though these innovations may be suitable for the specific individual purposes to which they address, however, they would not be suitable for the purposes of the present invention which is to relieve the symptoms of asthma for a long period of time, is effective orally, has unlimited efficacy, produces no cardiac and gastrointestinal side effects, is effective by oral administration, and has no serious side effects which limit its chronic use.
SUMMARY OF THE INVENTION
ACCORDINGLY, AN OBJECT of the present invention is to provide a composition for treating asthma that avoids the disadvantages of the prior art.
ANOTHER OBJECT of the present invention is to provide a composition for treating asthma that is simple to use.
BRIEFLY STATED, STILL ANOTHER OBJECT of the present invention is to provide a method of treating asthma that includes the step of controlling the asthma by ingesting a composition which includes a selective serotonin reuptake inhibitor that is sertraline hydrochloride. Chronic administration of the sertraline thereof downregulates brain norepinephrine receptors. The increased output of the brain norepinephrine receptors increases the di
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