Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-08-28
2003-04-01
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S728000, C424S730000, C424S731000
Reexamination Certificate
active
06541043
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition and method for treating Attention Deficit/Hyperactivity Disorder.
2. Description of Related Art
Attention Deficit/Hyperactivity Disorder (ADHD) is the fastest growing childhood disorder in the United States. About four million children and thirteen million adults suffer from attention deficit in the U.S. Diagnostic and Statistical Manual of Mental Disorders (DSM IV) categorization of ADHD includes terms such as “inattention, impulsiveness and hyperactivity”. Three subtypes are recognized ADHD: Combined type; ADHD, Predominately Inattentive Type; and ADHD, Predominately Hyperactive/Impulsive Type. The Predominately Inattentive Type makes careless mistakes, cannot keep focused on a task, and loses attention and interest quickly. Often the person appears not to listen as if their mind is “someplace else”. The predominately Hyperactive/Impulsive Type is characterized by fidgetiness, excessive unproductive movement, impulsiveness, inappropriate behavior, making noise, impatience, touching things or being disruptive.
Depending on age and development stage, ADHD sufferers may exhibit low frustration tolerance, temper outbursts, stubbornness, making demands, mood lability, rejection by peers and poor self-esteem.
There are no established diagnostic laboratory tests in the clinical assessment of ADHD and it is still not clear what fundamental cognitive deficit is responsible for this disorder.
The current treatment for ADHD is with central nervous stimulants (CNS) stimulants such as methylphenidate hydrochloride (Ritalin), amphetamines (Adderall) or pemoline (Cylert). Regrettably, each of these drugs has frequent and undesirable side effects. Methylphenidate HCl is associated with the following side effects: nervousness, insomnia, hypersensitivity, urticara, fever, arthralgia, anorexia, nausea, dizziness, tachycardia, angina, cardiac arrhythmia, and retarded growth and weight loss during prolonged therapy. Pemoline has been associated with life threatening hepatic failure, convulsive seizures, Gilles de la Tourette syndrome, hallucinations, dyskinetic movements, mild depression, dizziness, and insomnia. Amphetamines are associated with the following side effects: palpitations, tachycardia, elevated blood pressure, pyscotic episodes, over stimulation, restlessness, dizziness, euphoria, dyskinesia, dysphoria, tremors, exacerbation of motor tics and Tourette's syndrome. There is also potential for drug abuse and dependence with these drugs.
Bearing in mind the problems and deficiencies of the prior art, it is therefore an object of the present invention to provide a composition for treating Attention Deficit/Hyperactive Disorder.
A further object of the present invention is to provide a composition which can be used with existing compositions for treating Attention Deficit/Hyperactive Disorder, and preferably with a lower dosage of the existing composition.
It is another object of the present invention to provide a method for treating Attention Deficit/Hyperactive Disorder in a person by administering to the person a composition of the invention.
Still other objects and advantages of the invention will in part be obvious and will in part be apparent from the specification.
SUMMARY OF THE INVENTION
The above and other objects, which will be apparent to those skilled in art, are achieved in the present invention which is directed to a composition comprising a mixture of ingredients and a method for using the composition to treat Attention Deficit/Hyperactivity Disorder. The composition comprises a mixture of ingredients which act synergistically to provide the desired therapeutic effect.
In one aspect, a composition is provided for treating Attention Deficit/Hyperactivity Disorder comprising:
dimethylaminoethanol;
omega-3 fatty acid;
betaine;
Vitamins A, B
5
, B
6
, B
12
, C and E;
folic acid;
minerals including calcium, magnesium, zinc and selenium; and
oligomeric proanthocyanidins.
In another aspect of the invention the composition further contains lecithin, choline, 5-hydroxytryptophan (5HT) and/or tyrosine.
In a further aspect of the invention the composition further contains Reishi extract.
In another aspect of the invention the composition further contains Kava extract (kavalactone).
In still a further aspect of the invention the composition further contains gingko and/or ginseng.
In another aspect of the invention the composition further contains St. John's Wort.
In a further aspect of the invention the composition contains one or more of the above components, preferably all the above components.
The above compositions may also be used in combination with other known compositions used for treating ADHD including amphetamines, methylphenidate HCl, fluoxatine, sertraline, paroxetine, fluoroxamine, citralopram, venlafaxine, bupropion, nefazodone and mirtazapine. In an important feature of the invention, the known compositions will be used in an amount up to 50% of its normal dose in combination with the composition of the invention thus minimizing side effects of the known composition.
In another aspect of the invention a method is provided for treating Attention Deficit/Hyperactivity Disorder wherein the composition of the invention is administered by oral, sublingual, rapid dissolution tablets, buccal, transdermal, intramuscular and intravenous means. Oral compositions may be formed into a soft-gel article, capsule, tablets, tablets with a coating, sustained release or granular product.
REFERENCES:
patent: 3819480 (1974-06-01), Hochschild
patent: 5719178 (1998-02-01), Paul et al.
patent: 6056971 (2000-05-01), Goldman
patent: 2001/0031757 (2001-10-01), Shafer et al.
JP abstract, JP06311866A, see the entire abstract, Apr. 1993, Derwent-ACC No.: 1995-027241.
DeLio & Peterson LLC
DexGen Pharmaceuticals, Inc.
Naff David M.
Ware Deborah K.
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