U.S. patent application number 11/044362 was filed with the patent office on 2005-11-03 for composition to reduce or quit smoking addiction.
Invention is credited to Pera, Ivo E..
Application Number | 20050241658 11/044362 |
Document ID | / |
Family ID | 8179031 |
Filed Date | 2005-11-03 |
United States Patent
Application |
20050241658 |
Kind Code |
A1 |
Pera, Ivo E. |
November 3, 2005 |
Composition to reduce or quit smoking addiction
Abstract
A method and composition to help persons reduce or quit smoking
is disclosed, employing raw tobacco leaves, or tobacco fluid
extract, or food grade tobacco like flavor and aroma, and
Antioxidants, with or without and SAMe and caffeine. All
ingredients can be in a micro-powdered or liquid form, for buccal
administration. The composition can be in a tablet or capsule that
is intended to be slowly sucked and dissolved in the mouth, and
that delivers the nicotine, caffeine or SAMe, proved to be
effective in alleviating smoking withdrawal symptoms. The
composition can also be embedded inside a soft squeezable plastic
cigarette for simulated smoking, providing additional periodic
doses of nicotine, caffeine and SAMe to satisfy cravings for
cigarettes.
Inventors: |
Pera, Ivo E.; (Hollywood,
FL) |
Correspondence
Address: |
Daniel S. Polley, Esq.
DANIEL S. POLLEY, P.A.
1215 East Broward Boulevard
Fort Lauderdale
FL
33301
US
|
Family ID: |
8179031 |
Appl. No.: |
11/044362 |
Filed: |
January 26, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11044362 |
Jan 26, 2005 |
|
|
|
10261541 |
Sep 30, 2002 |
|
|
|
6845777 |
|
|
|
|
Current U.S.
Class: |
131/352 ;
131/270; 131/347 |
Current CPC
Class: |
A23G 3/36 20130101; A23G
3/366 20130101; A61K 9/0058 20130101; A23G 4/123 20130101; A23G
4/06 20130101; A23G 4/068 20130101; A23G 3/44 20130101; A23L 33/105
20160801; A23G 3/48 20130101; A23G 4/14 20130101; A24B 15/16
20130101; A61K 45/06 20130101 |
Class at
Publication: |
131/352 ;
131/347; 131/270 |
International
Class: |
A24F 047/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 22, 2001 |
EP |
EP 01125054.5 |
Claims
What is claimed is:
1. A composition to help a person reduce or quit tobacco smoking,
comprising the following ingredients: a tobacco element with
coffee; and at least one Antioxidant.
2. The composition of claim 1 wherein said tobacco element is
chosen from one or more of the following: raw uncured tobacco,
tobacco fluid extract or food grade tobacco like aroma and
flavors.
3. The composition of claim 1 further comprising SAMe.
4. The composition of claim 1 wherein said coffee is brewed or in
soluble form and having caffeine or is decaffeinated.
5. The composition of claim 1 wherein said at least one Antioxidant
is selected from one or more of the following: Acetyl-L-Carnitine,
Adenosine, Allicin, Aloe, Alpha Lipoic Acid, BHA, BHT, Bilirubin,
Capsaicin, Catalases, Catechin, Cysteine, Coenzyme Q10, Copper
Sebacate, Coumarin, Curcumin, Dimethylglycine, Glycine, Ferrous
Fumarate, Folic Acid, Genistein, Ginger, Ginko Biloba, Gallates,
Gluconate, Glutathione or Glutathione Peroxidase, Green Tea,
Inositol, Isoascorbic Acid, L-Glutamine, Linoleic Acid, L-Methyl
Methionine, L-Seleno Cysteine, L-Seleno Methionine or Methionate,
Lycopene, Lutein, Manganese, Melatonin, Methionine Reductase
w/(Cu--Zn or Mn), N-Acetylcysteine or L-Cysteine, N-Acyl 1-Cysteine
Esters, N-Acyl 1-Methionine Esters, Poplar Bud, Procyanidin,
Pycnogenol, Resveratrol, Rosemary, Rutin, Rutinose, Selenium-Yeast,
Seleno Cysteine, Seleno Methionine or Methionate, Silubum Marianum,
Sodium Bisulfite, Sodium Metasulfite, Sodium Sulfite, Sodium
Thiosulfite, Spirulina, Sulfuraphane, Superoxide Dismutase (SOD),
Taurine, Thioglycerol, Thiol, Thiosorbitol, Thiourea, Vitamin A
Compounds, Vitamin B2 Compounds, Vitamin B6 Compounds, Vitamin B12
Compounds, Vitamin C Compounds, Vitamin E Compounds, Wheat Grass or
Zinc Gluconate.
6. The composition of claim 1 wherein the ingredients are provided
in unit dosage form.
7. The composition of claim 1 wherein the ingredients are prepared
by employing one or more organic or inorganic additives.
8. The composition of claim 1 wherein the ingredients are prepared
by employing one or more flavors.
9. The composition of claim 7 wherein said one or more additives is
chosen from the following: an excipient, a preservative, a
stabilizer, a suspending agent, a dispensing agent, a diluent or a
base wax.
10. The composition of claim 8 wherein said one or more flavor is
tobacco.
11. The composition of claim 1 wherein said tobacco element is in a
liquid flavor form.
12. The composition of claim 1 wherein said tobacco element is in a
liquid form which is mixed with brewed or soluble caffeinated or
decaffeinated coffee.
13. The composition of claim 1 wherein said tobacco element is in a
powdered or capsule form.
14. The composition of claim 1 wherein said tobacco element
contains Nicotiana tabacum leaves reduced in a dry powdered form,
which contains between about 0.01% to about 8% of Nicotine.
15. The composition of claim 6 wherein said unit dosage form is
selected from one of the following: chewing gums, tablets,
capsules, pills, powders, granules, liquid solutions, liquid
solutions mixed with brewed or soluble caffeinated or decaffeinated
coffee, suspensions, or embedded inside a soft squeezable plastic
cigarette.
16. A composition to help a person reduce or quit tobacco smoking,
comprising the following ingredients: a tobacco element chosen from
one or more of the following: raw uncured tobacco, tobacco fluid
extract or food grade tobacco like aroma and flavors; at least one
Antioxidant; SAMe; and brewed or soluble caffeinated or
decaffeinated coffee.
17. The composition of claim 16 wherein the ingredients are
provided in unit dosage form selected from one of the following:
chewing gums, tablets, capsules, pills, powders, granules, liquid
solutions, liquid solutions mixed with brewed or soluble
caffeinated or decaffeinated coffee, suspensions, or embedded
inside a soft squeezable plastic cigarette.
18. The composition of claim 16 wherein the ingredients are
prepared by employing one or more organic or inorganic additives
and one or more flavors.
19. The composition of claim 18 wherein said one or more additives
is chosen from the following: an excipient, a preservative, a
stabilizer, a suspending agent, a dispensing agent, a diluent or a
base wax.
20. The composition of claim 18 wherein said one or more flavor is
tobacco.
21. The composition of claim 16 wherein said tobacco element is in
a liquid flavor form, a liquid form or powdered form.
22. The composition of claim 16 wherein said tobacco element
contains Nicotiana tabacum leaves reduced in a dry powdered form,
which contains between about 2% to about 8% of Nicotine.
23. The composition of claim 16 wherein each unit dosage having an
amount of said SAMe of about 200 mg or less.
24. The composition of claim 16 wherein each unit dosage having an
amount of said caffeine of about 100 mg or less.
25. The composition of claim 16 wherein said at least one
Antioxidant is selected from one or more of the following:
Acetyl-L-Carnitine, Adenosine, Allicin, Aloe, Alpha Lipoic Acid,
BHA, BHT, Bilirubin, Capsaicin, Catalases, Catechin, Cysteine,
Coenzyme Q10, Copper Sebacate, Coumarin, Curcumin, Dimethylglycine,
Glycine, Ferrous Fumarate, Folic Acid, Genistein, Ginger, Ginko
Biloba, Gallates, Gluconate, Glutathione or Glutathione Peroxidase,
Green Tea, Inositol, Isoascorbic Acid, L-Glutamine, Linoleic Acid,
L-Methyl Methionine, L-Seleno Cysteine, L-Seleno Methionine or
Methionate, Lycopene, Lutein, Manganese, Melatonin, Methionine
Reductase w/(Cu--Zn or Mn), N-Acetylcysteine or L-Cysteine, N-Acyl
1-Cysteine Esters, N-Acyl 1-Methionine Esters, Poplar Bud,
Procyanidin, Pycnogenol, Resveratrol, Rosemary, Rutin, Rutinose,
Selenium-Yeast, Seleno Cysteine, Seleno Methionine or Methionate,
Silubum Marianum, Sodium Bisulfite, Sodium Metasulfite, Sodium
Sulfite, Sodium Thiosulfite, Spirulina, Sulfuraphane, Superoxide
Dismutase (SOD), Taurine, Thioglycerol, Thiol, Thiosorbitol,
Thiourea, Vitamin A Compounds, Vitamin B2 Compounds, Vitamin B6
Compounds, Vitamin B12 Compounds, Vitamin C Compounds, Vitamin E
Compounds, Wheat Grass or Zinc Gluconate.
26. A composition to help a person reduce or quit tobacco smoking,
comprising the following ingredients: a tobacco element chosen from
one or more of the following: raw uncured tobacco, tobacco fluid
extract or food grade tobacco like aroma and flavors; at least one
Antioxidant; SAMe in an amount of about 200 mg or less; and brewed
or soluble coffee having caffeine in an amount of about 100 mg or
less.
27. The composition of claim 26 wherein the ingredients are
provided in unit dosage form selected from one of the following:
chewing gums, tablets, capsules, pills, powders, granules, liquid
solutions, liquid solutions mixed with brewed or soluble
caffeinated or decaffeinated coffee, suspensions, or embedded
inside a soft squeezable plastic cigarette.
28. The composition of claim 26 wherein the ingredients are
prepared by employing one or more organic or inorganic additives
and one or more flavors; wherein said one or more additives is
chosen from the following: an excipient, a preservative, a
stabilizer, a suspending agent, a dispensing agent, a diluent or a
base wax; wherein said one or more flavor is tobacco and
coffee.
29. The composition of claim 26 wherein said tobacco element and
coffee is in a liquid flavor form, a liquid form or powdered
form.
30. The composition of claim 26 wherein said tobacco element
contains Nicotiana tabacum leaves reduced in a dry powdered form,
which contains between about 0.01% to about 8% of Nicotine and said
coffee contains about 1% to 8% caffeine.
31. The composition of claim 26 wherein said at least one
Antioxidant is selected from one or more of the following:
Acetyl-L-Carnitine, Adenosine, Allicin, Aloe, Alpha Lipoic Acid,
BHA, BHT, Bilirubin, Capsaicin, Catalases, Catechin, Cysteine,
Coenzyme Q10, Copper Sebacate, Coumarin, Curcumin, Dimethylglycine,
Glycine, Ferrous Fumarate, Folic Acid, Genistein, Ginger, Ginko
Biloba, Gallates, Gluconate, Glutathione or Glutathione Peroxidase,
Green Tea, Inositol, Isoascorbic Acid, L-Glutamine, Linoleic Acid,
L-Methyl Methionine, L-Seleno Cysteine, L-Seleno Methionine or
Methionate, Lycopene, Lutein, Manganese, Melatonin, Methionine
Reductase w/(Cu--Zn or Mn), N-Acetylcysteine or L-Cysteine, N-Acyl
1-Cysteine Esters, N-Acyl 1-Methionine Esters, Poplar Bud,
Procyanidin, Pycnogenol, Resveratrol, Rosemary, Rutin, Rutinose,
Selenium-Yeast, Seleno Cysteine, Seleno Methionine or Methionate,
Silubum Marianum, Sodium Bisulfite, Sodium Metasulfite, Sodium
Sulfite, Sodium Thiosulfite, Spirulina, Sulfuraphane, Superoxide
Dismutase (SOD), Taurine, Thioglycerol, Thiol, Thiosorbitol,
Thiourea, Vitamin A Compounds, Vitamin B2 Compounds, Vitamin B6
Compounds, Vitamin B12 Compounds, Vitamin C Compounds, Vitamin E
Compounds, Wheat Grass or Zinc Gluconate.
Description
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 10/261,541, filed Sep. 30, 2002, which claims
the benefit of and priority to European Patent Application No. EP
01125054.5, filed in the European Patent Office on Oct. 22, 2001.
all applications are incorporated by reference.
TECHNICAL FIELD
[0002] The present invention relates to the technical sector of the
production of substances useful to help persons to reduce or quit
smoking. In particular, it concerns a novel composition containing
tobacco or tobacco fluid extract or food grade, tobacco like flavor
and aroma with antioxidants with or without caffeine and/or SAMe
and/or brewed or soluble caffeinated or decaffeinated coffee.
BACKGROUND ART
[0003] Tobacco is an annual plant with a long fibrous root, stem
erect, round, hairy and viscid. It branches near the top and is
from 3 to 6 feet high. Leaves are large, numerous, alternate,
sessile, somewhat decurrent, ovate, lanceolate, pointed, entire,
slightly viscid and hairy, pale-green color, brittle, narcotic
odor, with a bitter acrid taste. By distillation with water it
yields a concrete volatile oil termed nicotianin or tobacco
camphor, which is tasteless, crystal-line and smells of tobacco;
other constituent is the alkaloid nicotine, nicotianin, nicotinine,
nicotine, nicoteline. After leaves are smoked the nicotine
decomposes into pyridine, furfurol, collidine, hydrocyanic acid,
carbon monoxide, etc. The poisonous effects of tobacco smoke are
due to these substances of decomposed nicotine. Tobacco, if used as
snuff, causes violent sneezing and also a copious secretion of
mucous. Chewed, it increases the flow of saliva by irritating the
mucous membranes of the mouth. In large doses it produces nausea,
vomiting, sweats and great muscular weakness.
[0004] The alkaloid nicotine in high doses is a virulent poison,
producing great disturbance in the digestive and circulatory
organs. It innervates the heart, causing palpitation and cardiac
irregularities and vascular contraction, and is considered one of
the causes of arterial degeneration. Nicotine is very like coniine
and lobeline in its pharmacological action, and the pyridines in
the smoke modify very slightly its action. Tobacco was once used as
a relaxant, but is no longer employed except occasionally in
chronic asthma.
[0005] In "A modem herbal book" it is mentioned that tobacco is
used as a sedative, diuretic, expectorant, discutient, and
sialagogue, and internally only as an emetic, when all other
emetics fail. The leaves in combination with the leaves of
belladonna or stramonium make an excellent application for
obstinate ulcers, painful tremors and spasmodic affections.
[0006] Tobacco smoking has become recognized over the last few
decades as a major medical and social problem. This includes not
only cigarette smoking, but also cigar and pipe smoking and
smokeless tobacco use including chewing tobacco and snuff. Because
of the medical problems associated with its use, the majority of
tobacco users would like to stop or at least reduce the amount of
tobacco consumed each day. In addition to the medical problems,
there are also restrictions now relating to smoking in the work
place and in public areas, such as restaurants and shopping
centers, which also require smokers to exercise considerably
greater control over their smoking habits.
[0007] However, many people find it virtually impossible,
especially in the case of cigarettes, to control their tobacco
habit. Where a person, for example, has stopped smoking cigarettes
completely, there is often a continuous craving, and if that person
tries to alleviate the craving by smoking even just one cigarette,
he or she very quickly returns to his or her original level of
consumption. Similarly, if one tries to cut down on the amount of
tobacco used, such as the number of cigarettes smoked each day, the
craving increases in intensity, and the smoker soon returns to the
former level of use. Prior to this invention, tobacco users,
especially smokers, had to rely on will power and complete
abstention to manage their tobacco habit. There was no known drug
that permitted the users to control effectively their craving or
use of tobacco. By and large it is the impurities in tobacco and
its smoke, which kill, while nicotine provides most of the
pleasure, stimulation and relief from stress.
[0008] Tobacco smoking lowers the amount of oxygen that gets to the
brain. While dilation of the blood vessels in the brain occurs
immediately after cigarette smoking, chronic smoking slows the
overall reduction in cerebral blood flow. It also causes
vasoconstriction of the blood vessels in other areas of the body,
and infuses the red blood cells with carbon monoxide, greatly
reducing their oxygen-carrying capacity. In a sense, this
constitutes a slow suffocation of the cells in the body and is far
more pernicious than any possible benefit that might accrue from
nicotine, which, as some research has shown, in small quantities
may temporarily "wake up" certain aspects of memory.
[0009] Smoking also greatly increases the number of free radicals
in the blood. Eventually it affects the lungs and hinders
breathing, which depletes energy and strength. Although the effects
of cigarette smoking on a variety of diseases, including cancer and
cardiovascular illness and emphysema, have been well publicized,
the effect of smoking on nutrients in the body are less widely
known. Consider the destructive effects of cadmium, a toxic trace
element as deadly as mercury and lead, and one of the components of
tobacco. One pack of cigarettes yields 10 times the amount of
cadmium the body is capable of assimilating, thus weakening the
immune system. Cadmium get into tobacco in several ways, most
commonly from growing tobacco in cadmium polluted soil, and is
sprayed on tobacco as a fungicide. Even if you don't smoke,
environmental exposure to tobacco smoke raises your blood
concentration of cadmium. Israeli investigators found that the
blood levels of cadmium in non-smokers exposed to cigarette, smoke
was very close to the average found in smokers. Cadmium decreases
the availability of selenium and inhibits the metabolism of zinc.
Not only does smoking lower the level of Vitamin C and
beta-carotene in the blood and reduces levels of Vitamin E and
several B-complex vitamins in body tissues, but for unknown reasons
smokers also are less likely to consume fruits and vegetables,
particularly those high in Vitamin C and carotene.
[0010] Smokers all over the world are aware of the dangers they
stand by continuing to smoke the regular types of cigarettes,
cigars or the like. It has been proven that, the major damage to
smokers is caused by residues of tar transferred by the inhaled
smoke to the lungs, causing tar deposits on the lungs. These
deposits are major causes for lung cancer and other incurable
damages.
[0011] The partial oxidation that occurs during smoking to the
paper or other cellulose parts in the cigarettes results in a large
proportion of carbon monoxide in the released cigarette smoke. When
the smoke is being inhaled these quantities of carbon monoxide
enter the bloodstream, thus causing a reduction of available oxygen
in the blood, and hence great disturbances to the heart function.
It is well known that cigarette smoking is a major reason for
several heart diseases.
[0012] It has therefore been the aim of many products to attract
smokers away from smoking cigarettes, thus reducing the medical
risks, yet retaining some of the pleasures caused by the supposed
addiction to cigarettes. It has been proved that most smokers who
wish to stop smoking are addicted to several features of the
smoking procedures, namely:
[0013] The sensation of holding a mouthpiece and sucking it;
[0014] The taste of nicotine, the major aroma of tobacco;
[0015] The ritual of taking in and blowing out the smoke.
[0016] This invention is directed to help smokers reduce or quit
smoking; more specifically it concerns itself with a novel
composition which is designed to satisfy the psychogenic drives and
pharmacological needs of the smoker, without subjecting the smoke,
or other unwanted intrusions upon his person.
[0017] The potential ill-effect inherent in smoking cigarettes and
other tobacco products are well documented and need not to be
repeated here. Due to the recognized risks associated with smoking,
the tobacco industry has introduced products having low tar and
nicotine content, enhancing the efficiency of the filters on their
filtered cigarettes, and labeling the cigarette pack, as directed
by the Surgeon General of the United States Public Health service.
All of this is to provide an information message warning the
purchase of the health risks associated with smoking. All of the
measures taken by the tobacco industry, the warning of the Surgeon
General, the educational programs and messages from national
associations concerned with heart disease and lung cancer, the
incentives for medical/health insurance have done little to
dissuade the habitual smoker from continuing to smoke. The reasons
underlying his resistance to break this habit are threefold:
[0018] a) The psychological and social drives associated with
smoking, namely, an apparent need or ritual involved in the
lighting and holding of a cigarette and gratification derived by
placing it in one's mouth.
[0019] b) To stimulate the act of puffing on a cigarette, and
[0020] c) The pharmacological effects of nicotine upon the
body.
[0021] The mechanical steps involved in smoking include carrying
cigarettes, lighting them, placing them between the lips, sucking
on them, inhaling the smoke, exhaling, holding the lighted
cigarette, and repeating the maneuver. A physical need that is
satisfied by these steps is the achievement of a blood level of
nicotine and other substances. This is somewhat that habituated
smoker's body comes to sense a worthwhile goal. Psychological needs
that are satisfied by the steps involved in smoking are very basic
and infantile, including ingesting, sucking, grasping, and
repetitive hand to mouth activity.
[0022] That the psychological needs of smoking are of as great
importance as the chemical ones is amply illustrated by consistent
observations on persons who have recently tried to quit. They eat
more and gain weight, "do not know what to do" with their hands,
and experience extreme psychological discomfort manifested as
irritably. While the loss of chemical satisfaction contributed to
this by unknown and indirect mechanisms, the substitution of food
for smoking substitutes the importance of the sucking and ingestion
behavior.
[0023] Many preparations have been devised to combat tobacco
habits. These prior efforts have generally been directed to the
concurrent use of tobacco and silver salts, sulfides, sulfur,
thioglycols, lobeline, sedatives, anticonvulsant drugs, or other
substances causing nausea or ill feeling to the end of building up
to a psychological response to tobacco that make the same
undesirable. Not only have such preparations proved unpopular
because of the lack of desire on the part of the individual
deliberately to make himself ill to cure the habit, they have also
proved ineffective to many instances even when faithfully employed.
It is well known that the habit-formula and health-deterring factor
in tobacco (Nicotiana Tabacum) is the Nicotine
(C.sub.10H.sub.14N.sub.2) which is a very toxic substance, the
lethal unit dose for an average adult is about 60 mg; one cigarette
delivers about 1 mg. of nicotine. Nicotine is a volatile oil,
inflammable, powerfully alkaline, with an acrid smell and a burning
taste. Once nicotine enters the blood stream, it has been shown to
cross the blood brain barrier and bind to receptors in the brain,
resulting in the release of the neurotransmitter serotonin in the
central nervous system's neurohumoral pathways. One constituent of
tobacco smoke: nicotine, is a stimulant to the central nervous
system. Nicotine is one of the most powerful psychoactive drugs
known, with addiction occurring when doses reach high levels.
Smokers inhale approximately one milligram per cigarette, which
quickly enters the bloodstream through the lungs, going straight to
the brain. Here, it stimulates the brain, speeding up communication
between cells. But by the time a cigarette is finished, the
nicotine level in the blood begins to plunge, causing the body to
urgently signal its need for more. Smoking a cigarette every half
an hour or so keeps nicotine levels elevated, but the smoker pays a
devastating price.
[0024] Nicotine probably is the reason why many people find smoking
pleasurable and the reason many people become dependent on tobacco.
Withdrawal from nicotine brings about unpleasant sensation likened
to withdrawal from any drug. Nicotine produces widespread effects
on both the central nervous system and the cardiovascular and
peripheral systems. Nicotine addiction is established more rapidly
than addiction of heroin. Almost any smoker claims that smoking
helps him or her to calm down, to work better and to meet the daily
stress with its apparent tranquilizing effect, but that is proved
to be an illusion. Smoking doses not make a smoker less irritable
or vulnerable to annoyance. Smoking a cigarette introduces nicotine
into the system via the soft tissues of the mouth as well as
through the lungs. The body reacts violently, since nicotine is a
psychoactive drug. The reaction causes a flow of adrenaline and
other hormones, which bring us to a high alert and gives us
(briefly) increased energy in a crisis by elevating our blood-sugar
level. This causes a momentary "lift", it is followed, however, by
a too rapid movement of glucose out of the blood after the "danger"
is past, and the result is a feeling of fatigue. Fatigue causes
anxiety, self-pity, low grade dissatisfaction and general
discomfort, which, for a smoker is a signal to reach for the pickup
in a cigarette.
[0025] Consider the fact that this process is repeated twenty,
thirty or forty times a day and for however many years a person
smoke; if we could see inside our body, we will see a lot of
action. In addition to glands squirting adrenaline, the pancreas is
busily dealing with the glycogen and the blood pressure, which
increase the heartbeat rate by at least 9 beats per minute (around
1000 extra beats per day), and all that activity apparently
influences the levels of fats circulating in the bloodstream. At
the same time, the red blood cells are obstructed for their mission
of carrying oxygen to the heart and brain because of the carbon
monoxide and other gases in the cigarette smoke. In fact, "as much
as 20% of the blood pushed around by the heart of the smokers is
not working so far as carrying oxygen is concerned. Since the heart
has the highest oxygen requirement per unit weight of any tissue,
any change in the supply of oxygen could affect the heart first,
and thereby increase the risk of an attack for the smoker". Since
nicotine is addictive, since the body requires that a certain level
must be maintained in the blood-stream, the smoker becomes
uncomfortable when he or she has gone beyond the normal time for
another dose. Usually he or she reacts by reaching automatically
for another cigarette. Switching to low-nicotine cigarette supply
causes problem smokers to smoke more; zero-nicotine cigarettes are
usually rejected.
[0026] Let's consider why people continue to smoke. They don't quit
because smoking gives them certain benefits. Many campaigners for
the elimination of cigarette smoking have not realized that people
would lose these benefits, as well as the health risks. Tobacco has
significant effects on behavior and psychological state. Recent
research has shown that cigarette smokers (and others who use
tobacco) find that tobacco use makes it easier to cope with
over-stimulation like city noise and overcrowding. That's because
the nicotine in cigarette smoke is a stimulus barrier, a substance
that makes it easier for a person to function in an
over-stimulating environment. Human brain-wave activity can be
measured by putting electroencephalograph electrodes on a person's
head. When a subject is subjected to a sudden unexpected stimulus
(like a loud noise), you find out how much the brain responds to
these stimuli. The brain of a person who has used nicotine responds
less to these distracting stimuli than the brain of someone who
doesn't smoke. In this way, the nicotine makes it possible for some
people to cope with the over-stimulation found in most cites by
reducing their brain's reactions to the extraneous stimulation.
[0027] While nicotine's effect on the neurotransmission of
serotonin, and the receptors of the presynaptic membrane are poorly
understood; it is believed that the abstinence from tobacco and
nicotine results in the re-up-take and accumulation of serotonin in
these neurohumoral pathways, that when the release of which is not
stimulated by nicotine, results in the symptoms of nicotine
withdrawal. The symptoms included restlessness, irritability,
anxiety, drowsiness, increasingly frequent waking from sleep,
impatience, confusion, impaired concentration, carbohydrate craving
and weight gain, impaired reaction time and a craving for tobacco;
this craving for tobacco is the overwhelming reason why so many
individuals who try to quit smoking fail to succeed.
Pharmacological therapies are known to help, those addicted to
nicotine, but most of the therapies are unsatisfactory because they
have short term effect as well as numerous undesirable
side-effects.
[0028] Nicotine is readily absorbed by all of the body's tissues,
including the skin, the respiratory epithelium, and the mucous
membranes of the mouth, nose and intestines. The present invention
Tobacco-Antioxidants composition's absorption through the mouth,
depends too on the pH level or in effect, the acidity of the saliva
present, with a more acidic saliva changing nicotine molecules into
a ionic form that is not well absorbed. Similarly nicotine entering
the acidic medium of the stomach cannot easily move across cellular
membranes, again reducing absorption, while in the alkaline medium
of the small intestine, the molecules reverts to soluble, nonionic
state, easily passing through the intestinal wall. From there
nicotine undergoes extensive metabolism in the liver, the resulting
products, or metabolites, of this process being primarily cotinine
and nicotine n-oxide. Consequently, only about 30% of nicotine from
the intestine reaches the bloodstream in a not metabolized
form.
[0029] In contrast, inhalation of tobacco smoke allows a greater
amount of active nicotine to pass into the circulatory system. (As
much as 90% of the nicotine inhaled from a cigarette is absorbed
into the bloodstream). From the bloodstream the compound passes to
the heart, which pumps a significant portion of the nicotine
directly to the brain, the transfer is so rapid, in fact, that
nicotine in tobacco smoke reaches the brain more quickly than does
nicotine injected directly into the bloodstream through as
vein.
[0030] After a brief rise, the brain's nicotine concentration
quickly falls as the compound is speedily redistributed to the
other parts of the body. Some researchers believe that the bolus of
nicotine in each puff of tobacco inhaled from a cigarette
reinforces the nicotine habit in the brain, probably by releasing a
small amount of dopamine, so that hundreds of puffs per day
reinforces the addiction hundreds of times per day. Nicotine
readily crosses the placental barrier as well, resulting in fetal
exposure to the compound when women smoke during pregnancy.
Additionally, nicotine can pass into breast milk, albeit in very
low levels. Possessing a relatively short duration of action within
the body, nicotine has a plasma half-life of between 30 minutes and
2 hours (meaning that half of the blood's nicotine levels disappear
within this span of time). In nicotine-dependent cigarette smokers,
who typically smoke every 30 to 45 minutes, blood nicotine levels
rise cumulatively during the day before leveling off. Peak levels
in the arteries, which deliver the drug to the brain, often reach
approximately 40 micro-grams per milliliter of blood. Although most
nicotine in the body is metabolized in the liver, the compound is
also eliminated through excretion in urine, passing into it from
the bloodstream according to changes in urinary acidity. Lowering
of the pH, that is, making the urine more acids, as happens in
stressful situations or through an increased intake of vitamin C,
increases nicotine excretion, decreasing the compound's levels more
rapidly.
[0031] Since cotinine, nicotine's major metabolite, has a much
longer half-life than its parent compound, lasting from 10 to 40
hours, its presence in the body is commonly used to determine
whether an individual's smoking cessation efforts have been
successful.
[0032] As blood nicotine levels decline, the nicotine-dependent
smoker begins to experience sense of craving, this typically being
a cue to reach for another cigarette. Since inhaled nicotine is
absorbed so rapidly, smokers can adjust (titrate) their blood
nicotine levels within a satisfying range not only by controlling
the timing and number of cigarettes consumed but also by altering
the way in which each cigarette is smoked, that is, the duration of
each puffs, the depth of smoke inhalation, and the length of time
that smoke is held in the lungs.
[0033] Nicotine may be tied to the onset of cardiovascular disease,
based on the ability of sharp increases in blood nicotine levels to
encourage blood clotting, inflation of blood lipid levels, and
stimulation of a portion of the accomplishes this last action by
raising blood levels of catecholamines, comprising adrenaline and
similar compounds. Yet direct evidence association low levels of
nicotine with cardiovascular disease is weak, and when nicotine is
absorbed slowly, it does not appear to increase cardiovascular risk
or cause adverse cardiac effects, even in patients with coronary
artery disease.
[0034] During surveys conducted in industrialized nations, most
participating smokers expressed a desire to give up tobacco and in
many cases, revealed that they had tried to do so, with the first
few attempts commonly ending in relapse. This relapse can be traced
at least in part to the nicotine withdrawal syndrome, which exists
when at least four of the following signs occur within 24 hours of
an abrupt cessation of a reduction in nicotine use: (a) a dysphoric
or depressed mood; (b) insomnia; (c) irritability, frustration, or
anger; (d) anxiety; (e) difficulty in concentrating; (f)
restlessness; (g) a decreased heart rate; and (h) an increased
appetite or weight gain.
[0035] Despite this litany of adverse effects, epidemiological
studies also indicate that smoking may afford some protection
against the development of both Parkinson's disease, caused by the
death of certain dopamine containing brain cells, and Alzheimer's
disease. There is also some evidence that smoking decreases the
change of developing ulcerative colitis, an inflammatory bowel
disease.
[0036] On a more positive note, not necessarily speaking against
tobacco and according to my research for alternate use of tobacco
in agriculture, I have evaluated the potential of tobacco as a
source of leaf protein and use its protein for food plus as a safer
alternative choice to smoking, considering the yield by the hectare
of leaf proteins can be at least four times higher than that of
seed proteins and that the proteins contained in the amino acids
are circa 9% Aspartic Acid, 5.2% threonine, 3.1% serine, 11.5%
glutamic acid, 5.1% proline, 10.3% glycine, 9.4% alanine, 8%
valine, 1.2% valine, 1.2% methionine, 4.5% isoleucine, 8.9%
leucine, 4.4% tyrosine, 4.1% phenylalanine, 6% lysine, 2.8%
histidine, and 6.5arginine. Leaves contain 0.6 to 0.9% alkaloids,
including nicotine, nornicotine, anabasine and anataline; roots
also contain most of these alkaloids. Leaves also contain the
aromatic nicotianin (tobacco camphor).
[0037] By weight proteins are the major component of the dry
material of a living organism and they are among the most important
functional components of the living cells. Proteins are the
building blocks of the body and are required for the growth, repair
and maintenance of cells, which are constructed from proteins.
Proteins are needed for the manufacture of hormones, antibodies,
enzymes and tissue. The major cause of poor nutritional value is
due to a low content or unavailability of one or more of the
indispensable amino acids.
[0038] More recent study of the smoking problem has led to the
development of Nicotine gums or patches, as anti-smoking aids. As a
general practice that alternative nicotine sources are only
effective as anti-smoking aid when an individual immediately stops
smoking and substitutes the nicotine source for the cigarette. The
problem with nicotine substitution therapy involves the
administration of the psychoactive constituent of tobacco indicates
as a contributor to the diseases for which smoking is a risk
factor.
[0039] Administering just nicotine as a substitute of smoking have
not been successful because these methods do not recognize and
address the two-prong "addiction" of smoking. First, there are
social and psychological reasons for smoking that must be initially
overcome. Secondly, there is the more powerful psychological than
pharmacological reason (nicotine addiction) that must then be
conquered. Both the social and psychological causes of smoking, as
well as the pharmacological nicotine dependence must be addressed
in sequence, if a truly successful method of eliminating an
individual's tobacco smoking habit and associated nicotine
dependence is to be provided.
[0040] Caffeine--The stimulant effects that are attributed to
nicotine, including those characterizing its addictive nature, are
also attributed to caffeine, hooked. One-half of the world's
population, consumes caffeine in tea, and another one third get
their fix from coffee. Millions more find daily doses in soft
drinks. Caffeine's origin in soft drinks has a botanical basis:
caffeine is a component of the kola nut from which Coca Cola was
originally derived. However, modem beverages of many brands are
purposely spiked with the drug. Like nicotine, caffeine is found
naturally in plants, like tea, coffee, kola, nuts, and cacao beans
(from which cocoa and chocolate are made). In fact, it is even
placed in the same general chemical class as nicotine. But the
similarities do not end there. The table below compares the effects
of nicotine with those of caffeine, the similarity is self
explanatory.
[0041] 1 Nicotine Caffeine Brain: Stimulant Stimulant Enhances
concentration Enhances concentration Enhances performance Enhances
performance Sense of well being Sense of well being Mood elevation
Mood elevation Addictive: Addictive: Psychic dependence Psychic
dependence Withdrawal Withdrawal Tolerance Tolerance Stimulates
breathing Center Stimulates breathing Center Circulatory: Increases
heart rate Increases heart rate Increases blood pressure Increases
blood pressure Constricts blood vessels Constricts blood vessels
Other: Increases: Increases: Free fatty acids Free fatty acids
Catecholamine release Catecholamine release Saliva and lung
secretion Stomach acids Urine flow. Consumers of caffeine do not
suffer heath effects that can be easily associated with their
addiction. Although caffeine affects almost every organ system in
the body, producing (relatively minor and positive) mental and
physical effects, it is consumed in a relatively safe manner.
[0042] S-Adenosyl-Methionine (SAMe)--Many scientists have known for
years that most of us do not get all the vitamins we need from our
food and that the RDA levels of many vitamins are absurdly low. We
also know that the levels of folate and SAMe in the blood of many
people are too low for their optimum health, mental and physical.
Likewise, we know that homocysteine levels in the upper half of the
normal range are a risk factor for many diseases, including hearth
attack.
[0043] Unfortunately today it is considered normal to have a heart
attack even at a young age. However, today thank to SAMe many, if
not most heart attacks and strokes are almost entirely preventable!
In fact, the basic process of vascular disease, artherosclerosis
and athrosclerosis is largely preventable.
[0044] SAMe is a naturally occurring molecule that is part of all
living cells, and affect so many different aspects of human biology
and pathology being a metabolic helper that is produced during
methylation and facilitates nearly all methylation reactions in
your body. As one of the primary methyl group donors, SAMe is
extremely important and historically unappreciated. One of its many
roles is methylating DNA. When DNA is properly laced with methyl
groups, your cells are protected form the abnormal expression of
DNA, a behavior associated with disease and aging. Aside from this
sole in DNA methylation, SAMe also acts as a natural
antidepressant, possibly through its role in creating the
neurotransmitter melatonin. Clinical studies have long shown oral
intake of SAMe to have antidepressant effects.
SUMMARY OF THE INVENTION
[0045] The main object of the present invention aims to help
smokers to reduce slowly tobacco smoking addiction and thereby
abate smoking related harm. Moreover the object is based upon the
idea that since nicotine is the chemical reinforcement of the
smoking habit, it might be possible to produce a chewable tablet
containing Tobacco-Antioxidants in a micro-powdered form, which
would satisfy the smoker's craving for nicotine without exposure to
harmful ingredients developed by the tobacco combustion.
[0046] An object of the present invention is to slowly substitute
tobacco smoking with a Tobacco-Antioxidants formulation to be
ingested. The underlying reasoning is simple and correct; it is the
smoke from a cigarette, not the nicotine that causes disease. Yet,
Tobacco-Antioxidants tablets easily provide enough nicotine to
satisfy smokers craving and pose a minimal health risk to anyone.
This risk is estimated to be less than two percent as large as the
risk associated with smoking. And as fringe benefits, the
Tobacco-Antioxidants formulation poses no risk to anyone else and
its use is sufficiently discreet that the user will not be
ostracized in any way.
[0047] Accordingly, the objective which underlines this invention
is to provide a Tobacco-Antioxidants composition and
Tobacco-Antioxidants composition with or without brewed and/or
soluble caffeinated and/or decaffeinated coffee (all compositions
collectively referred to as Tobacco-Antioxidants composition
hereinafter) which in a relatively short time will induce the
smoker to smoke less due to the strong aversion to smoking provoked
by the good feeling and satisfaction in chewing the present
composition. The non-toxic components of this invention produce a
strong satisfactory nicotine effect, while helping to reduce the
harm caused by tobacco smoke. The Tobacco-Antioxidants composition
of the present invention is a major advance in treatment for
smokers. It reduces withdrawal effects, enhances success in
short-term cessation, reduces relapse if use is not curtailed too
soon, and roughly doubles long-term success rates compared with
placebo and various psychological methods. The aroma and tobacco
flavors included in the formulation produce a pleasant and desired
fragrance and have a sweeter spicy, wood-oriental, Virginia hay
tobacco notes and taste, with much more body and much more natural
tobacco-like aroma prior and during chewing or ingesting the
formulation of the present invention. Certain compositions of the
present invention can also include a brewed and/or soluble coffee
flavor and/or taste.
[0048] Recent discoveries about Antioxidants substances have caused
great optimism in the search for allies in the fight against
cancer, the most important, and particularly effective for the
prevention and/or treatment of tobacco related diseases are the
Antioxidants. Antioxidants offer us some protection against lung
cancer and cancer of the esophagus. They may also help ward off
colon, rectal, bladder, prostate, breast, cervical, larynx,
gastrointestinal and skin cancers, among others. The evidence to
support these claims comes from worldwide studies of populations
with diets full of food rich in Vitamin C, Vitamin E and
Beta-carotene, as well as from laboratory studies of the vitamin's
ability to prevent cancers in experimental animals. Antioxidants
appear to have such powerful anticancer effects that the cancer
establishment has started clinical trials for its use in the
treatment of cancer as well as for its prevention. Such prevention
seems to be particularly effective in the case of bronchogenic
squamous carcinoma, since the latter has a long latency period
during which metaplasia slowly develops.
[0049] Surveys conducted in the U.S.A. and several European
Universities revealed that smokers with diets deficient in
Antioxidants had twice as much lung cancer as smokers whose
Antioxidants & Vitamins intake was not deficient. At first,
these patients were treated with high doses of conventional
anti-cancer drugs, but they suffered from side effects of this
therapy before any effect on their cancer could be documented. When
researchers started experimenting with beta-carotene and retinoic
acid derivatives a sensible improvement was immediately noted.
Recommended Daily Allowance (RDA) of Antioxidants provides to build
a strong protection against free radicals.
[0050] While the present invention has been described with
reference to use orally a Tobacco and Antioxidants Composition it
will be understood by those skilled in this art that various other
antioxidants not included in the following list can be used without
departing from the spirit of the invention. Thus, the composition
of the invention can include one or more of the following and/or
one or more other antioxidants: Acetyl-L-Carnitine, Adenosine,
Allicin, Aloe, Alpha Lipoic Acid, BHA, BHT, Bilirubin, Capsaicin,
Catalases, Catechin, Cysteine, Coenzyme Q10, Copper Sebacate,
Coumarin, Curcumin, Dimethylglycine, Glycine, Ferrous Fumarate,
Folic Acid, Genistein, Ginger, Ginko Biloba, Gallates, Gluconate,
Glutathione or Glutathione Peroxidase, Green Tea, Inositol,
Isoascorbic Acid, L-Glutamine, Linoleic Acid, L-Methyl Methionine,
L-Seleno Cysteine, L-Seleno Methionine or Methionate, Lycopene,
Lutein, Manganese, Melatonin, Methionine Reductase w/(Cu--Zn or
Mn), N-Acetylcysteine or L-Cysteine, N-Acyl 1-Cysteine Esters,
N-Acyl 1-Methionine Esters, Poplar Bud, Procyanidin, Pycnogenol,
Resveratrol, Rosemary, Rutin, Rutinose, Selenium-Yeast, Seleno
Cysteine, Seleno Methionine or Methionate, Silybum Marianum, Sodium
Bisulfite, Sodium Metasulfite, Sodium Sulfite, Sodium Thiosulfite,
Spirulina, Sulfuraphane, Superoxide Dismutase (SOD), Taurine,
Thioglycerol, Thiol, Thiosorbitol, Thiourea, Vitamin A compounds,
Vitamin B2 compounds, Vitamin B6 compounds, Vitamin B12 compounds,
Vitamin C compounds, Vitamin E compounds, Wheat Grass and/or Zinc
Gluconate.
[0051] It is reasonable to expect that we can stay healthier and
live longer, increasing life expectancy 20 or more years, while
possible increasing the maximum life span slightly beyond 100
years, if we curtail free radical activity using in our diet
various radical scavengers as above listed.
[0052] There is a group of amino acids, vitamins, minerals and
enzymes called antioxidants that have been shown in laboratory
tests to help in protecting the body from the formation of free
radicals, inhibiting the development of cancer. At the National
Cancer Institute there has been established a test to identify the
most powerful antioxidants useful to prevent cancer, and up-to-date
several hundreds of them have been found, that might do something
to influence cancer risk, and over fifty of the most promising ones
are further being tested in animal models. Many important studies
that further solidify the connection between smoking cancer, free
radicals, and antioxidants continue to proliferate.
[0053] The response to this blizzard of scientific support seems
clear: a sound comprehensive Antioxidant program is necessary to
achieve the best chance for continuing good health. Another
important ingredient of the compostion is S-Adenosyl-L-methionine
(SAMe) which intimately is involved with trans-sulfuration, a
process that produces a supremely important substance in our bodies
called glutathione. Sometimes called the "Master Antioxidant",
glutathione is at the center of the body defense system that
controls those ubiquitous scoundrels in our bodies known as free
radicals (Free radicals are not a rebellious political action group
that takes over our bodies, but for all thee damage they do, they
might as well be.). Free radicals are the unstable molecules in our
bodies and unstable oxygen molecules that are generated by the
basic chemical transaction of living: oxidizing calories into
energy. When these free radicals accumulate in our systems, the
results can be deadly: they can attack our DNA with the possible
result of cancer, they can attack the lipids in our blood causing
them to turn into the plaque that blocks our arteries and causes
heart attacks and strokes; and they can attack brain cells, causing
senility.
[0054] Thankfully, antioxidants are the natural enemies of free
radicals and that is why a diet rich in antioxidants like vitamins
C, E, and beta carotene, and L-glutathione is recommended to
promote health by protecting against the diseases borne of an
overpopulation of free radicals. But better yet is SAMe: It is
essential for the trans-sulfuration process that is the source of
the internal production of glutathione. Besides functioning as an
antioxidant, glutathione also plays an important anti-inflammatory
role in our systems.
[0055] Further and perhaps mot importantly, without SAMe the liver
is unable to produce the antioxidant glutathione causing the free
radicals to multiply and abet the proliferation of toxins in the
body, including the liver itself, being proved its natural
anti-inflammatory effect in our body. SAMe is one of the most vital
links to health known today in maintaining not only health but in
preventing diseases. Therefore, the composition object of the
present invention may be presented in a new form suitable for oral
administration. The administration of the composition may be solid
or liquid and may take the form of micro-powder granules, sparkling
powder, tablets, coated tablets sparkling tablets, capsules, gel,
lozenges, syrups, emulsions, suspensions, elixirs or drops.
[0056] In a preferred embodiment the present invention proposes to
use uncured tobacco leaves as a raw material preferably as soon as
harvesting to generate a composition that retains the natural
attributes of the plant, nicotine, proteins, chlorophylls, and
several enzymes. Another embodiment mixes or otherwise combines or
includes brewed and/or soluble caffeinated and/or decaffeinated
coffee with the tobacco element of the composition.
[0057] Thus, this embodiment, and all other embodiments including
coffee, can include either or both brewed and/or soluble coffee and
each version of the coffee (brewed, soluble, etc.) can be either or
both caffeinated and/or decaffeinated. Accordingly, the coffee
could be just in a brewed version and include both brewed
caffeinated and brewed decaffeinated coffee, or just brewed
caffeinated coffee or just brewed decaffeinated coffee. Similarly,
the coffee could be just in a soluble form and include both soluble
caffeinated and soluble decaffeinated coffee, or just soluble
caffeinated coffee or just soluble decaffeinated coffee.
Additionally, any combination of the above versions can also be
included and are considered within the scope of the invention.
Additionally, one non-limiting form for the soluble version of the
coffee can be a powder form. However, other soluble forms can also
be used and are considered within the scope of the invention.
[0058] The tobacco leaves can be used as picked, or they may be
dried at preferably no more than about 150.degree C. (though other
temperatures above and below are considered within the scope of the
invention) before processing. The Tobacco-Antioxidants Composition
of this invention can be prepared by the methods commonly employed
using conventional organic or inorganic additives such as an
excipient (e.g. sucrose, starch, mannitol, sorbitol, lactose,
glucose, cellulose, talc, calcium, phosphate, calcium carbonate,
etc. and the like), a binder (e.g. methilcellulose,
hydroxymethilcellulose, polypropylpyrollidone,
polyvinyl-pyrollidone, gelatin, gum arabic, polyethyleneglycol,
etc. and the like), a disintegrator (e.g. carboxymethylcellulose,
hydroxypropylstarch, sodium bicarbonate, calcium phosphate, calcium
citrate, etc. and the like), a lubricant (e.g. magnesium stearate,
light anydrous silicic acid, talc, sodium lauryl sulphate, etc. and
the like), a flavoring agent (e.g. citric acid, menthol, glycine,
orange powder, etc. and the like), a preservative (e.g. sodium
benzoate, sodium bisulfite, methylparaben, propylparaben, etc. and
the like), a stabilizer (e.g. citric acid, sodium citrate, acetic
acid, etc. and the like), a suspending agent (e.g. methylcellulose,
polyvinylpyrrolidone, aluminum stearate, etc. and the like), a
dispensing agent (e.g. hydroxypropylmethyl cellulose, etc. and the
like), a diluent (e.g. water, etc. and the like) and base wax (e.g.
cocoa butter, white petrolatum, polyethylene glycol, etc. and the
like).
[0059] The composition of the present invention can be prepared as
micro-powder form to provide an effective dose of Tobacco (combined
with or without brewed or soluble coffee) and Antioxidants in
capsules, tablets, sparkling powder or any other form suitable for
oral administration, having at least two or more active
ingredients, with each one preferably individually being a powerful
free radical scavenger with an amount at least sufficient for total
dosage requirement during a treatment period. Of course this can
greatly vary depending upon the relative amount of the ingredients.
In more details the composition can comprise at least two
therapeutically active substances, being homogeneously incorporated
into any such substance in a solid or nonsolid state. Furthermore,
if required, the therapeutic usefulness of the present composition
for oral administration can be improved by using one of any
suitable controlled sustained release formulation, which can be
used in preparation of the compositions in order to obtain the
required controlled rate in the digestive system.
[0060] The Tobacco-Antioxidants composition can include a plurality
of ingredients mixed in proportions obtaining a micro-powdered
mixture that is pleasant to the taste, which diminishes or obviates
slowly the desire to use tobacco. The Tobacco-Antioxidants
composition provides a scientifically proven treatment to help
smokers to slowdown the habit of the physical dependence on
nicotine, avoiding nicotine withdrawal symptoms, simply reducing
the nicotine in the blood. The Tobacco-Antioxidants Composition
will help gradually reduce the body need of nicotine responding at
the same time to overcome the psychological factor of non-smoking
because the chewing provides a pleasing taste and smell to the
user.
[0061] During the slow sucking and swallowing, of the tablet or
capsule of the present Tobacco-Antioxidants composition, the
smokers substitute the need of a cigarette with its tobacco taste
flavor and with a small amount of nicotine, but in sufficient
quantity to avoid the unpleasant sensation like irritability,
drowsiness, anxiety, restlessness, headaches, stomach upset,
difficulty to concentrate, normally resulting from the total
nicotine withdrawal.
[0062] In the Tobacco-Antioxidants composition, the quantity of
nicotine is far less than the quantity found in a cigarette but
while it satisfies the smokers' psychological need, will also be of
great beneficial health help to avoid the inhalation of other
toxic, irritating chemicals found in cigarette during smoking such
as tar and carbon monoxide, reducing the risk of cancer. Who finds
impossible to quit smoking at all, will still benefit from reducing
the number of cigarette smoked per day with the assistance of the
Tobacco-Antioxidants composition. In this way, the person who is
trying to drop the smoking habit has an occupation for the mouth,
and the ingestion and inhalation of the antioxidants aromatic
flavors, nicotine and other ingredients included in the gum or
tablet will satisfy its need of nicotine, knowing that is actually
chewing mild tobacco leaves and antioxidants useful in the
prevention of smoke related diseases.
[0063] The continued use of the Tobacco-Antioxidants composition
enables smokers over an extended period of time to gradually kick
the smoking habit, and is constantly available to help to prevent
reaction when smokers face new stress situations. Because they are
getting most of their nicotine from the Tobacco-Antioxidants
composition, some subjects have showed a sharp drop in the use of
nicotine compared with their customary cigarette consumption,
indicating this approach to smoking reduction and with time
cessation is likely to be feasible. The Tobacco-Antioxidants
composition contains substantial amount of active ingredients and
flavor, which significantly preserves the useful functions of the
active ingredients and flavor, reducing its diffusion rate and
volatility, having a soft gel consistency from which the
ingredients may escape for performing its functions. The
composition can also include brewed or soluble caffeinated or
decaffeinated coffee.
[0064] Another type of controlled release formulation, which may be
used, is that which is produced by a process involving
micro-encapsulation techniques. Another particular feature of the
Tobacco-Antioxidants composition is to be not only several time
more, effective of tobacco chewing gum in slowing the release of
flavor, but it delivers a continuous rich, full and true flavor for
a long period of time, exceeding skilled several fold any gum
composition heretofore known to those skilled in the art. The
Tobacco-Antioxidants composition can be used over a prolonged
period of time without noticeable toxic or harmful effects. With
the Tobacco-Antioxidants composition smokers at last have available
a safe partial substitute for conventional cigarettes.
[0065] Another object of the present invention is to provide a
novel method to reduce or eliminate tobacco smoking habit, as well
as the Nicotine dependency associated with that habit. The method
includes the step of gradually decreasing tobacco consumption over
several weeks until no further tobacco is desired. In brief, the
smoker should record the time, during which each cigarette is
consumed during the day, thereby reflecting his or her tobacco
consumption pattern. Then after, the smoker gradually should
decrease steadily the number of cigarettes to be smoked during the
day. The best results are obtained if the reduction is at least one
(1) cigarette per each succeeding weeks. For a smoker who consumes
approximately thirty (30) cigarettes per day, the present method to
reduce smoking at least 50% or more after thirty (30) to sixty (60)
weeks. Starting from the first day the Tobacco-Antioxidants
compound under subject is gradually ingested by the smoker and
slowly chewed during the day with an increasing dose as a
substitute for all cigarettes not smoked.
[0066] This serves to greatly reduce the intense craving,
restlessness and irritability of the individual. As a result, the
individual's confidence in breaking the stopping habit and the
associated nicotine dependence grows. Since the tobacco consumption
is decreased gradually there is less a trauma for the individual,
such as anxiety, irritability or other adverse symptoms are reduced
to a minimum.
[0067] Like nicotine, caffeine is found naturally in plants like
tea, coffee, kola nuts, and cacao beans (from which cocoa and
chocolate are made). In fact, it is even placed in the same general
chemical class as nicotine. Dried ripe seeds of coffee are the
source of caffeine (approximately or about 0.7 to approximately or
about 2%). In humans, caffeine, 1,3,7-trmethylxanthine, is
demethylated into three primary metabolites: theophyllne,
theobromine and paraxanthine. Since the early part of the 20.sup.th
century theophyllne has been used in therapeutics for
bronchodilatation, for acute ventricular failure and for long-term
control of bronchial asthma.
[0068] Caffeine (C.sub.8H.sub.10N.sub.40.sub.2) is used orally as a
mild CNS stimulant to aid in staying awake and to restore mental
alertness in fatigued patients. It stimulates all levels of the
central nervous system. In oral doses of about 100 to about 200 mg,
it stimulates the cerebral cortex producing a more rapid and clear
flow of thought, wakefulness or arousal in fatigued patients and
improved by psycomotor coordination. Its cortical effects are
milder and of shorter duration than those of amphetamines. In
slightly larger doses, caffeine stimulates medullary vagal,
vasomotor and respiratory centers, including bradycardia,
vasoconstriction and an increased respiratory rate.
[0069] Caffeine exerts multiple effects on the heart. It has a
positive inotropic effect on the myocardium and a positive
chronotropic effect on the sinoatrial node, causing a transient
increase in heart rate, force of contraction, cardiac output and
work of the heart. In doses of excess of about 250 mg. the
centrally mediated vagal effects of caffeine may be masked by
increased sinus rates, tachycardia, extrasystoles or other
ventricular arrhythmias may result. Caffeine constricts the
cerebral blood vessels but directly dilates peripheral blood
vessels; thus, it decreases peripheral vascular resistance. The
effect of this decrease in vascular resistance on blood pressure is
compensated for by increased cardiac output. Thus the overall
effect of caffeine on heart rate and blood pressure is dependent on
whether the central nervous system or peripheral effects
predominate. In most instances, therapeutic doses of caffeine
increase blood pressure only slightly.
[0070] Other pharmacological effects of caffeine include the
following: stimulate voluntary skeletal muscle, increasing the
force of muscle contraction and decreasing muscular fatigue; they
stimulate parietal cells, increasing gastric acid and secretion;
they induce a mild diuresis by increasing renal blood flow and
glomerular filtration rate and decreasing proximal tubular
re-absorption of sodium and water; and stimulate glycogenolysis and
lipolysis, but the increases in blood glucose and plasma lipids
usually are not significant in normal patients. One way of
including caffeine in the composition is by providing brewed or
soluble coffee (with either being caffeinated or decaffeinated) as
an ingredient of the composition.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0071] The invention provides an effective antismoking
Tobacco-Antioxidants composition which can consist of tobacco
leaves or Tobacco flavor, and various antioxidants (listed earlier
in this disclosure), with or without caffeine and SAMe, and other
ingredients for administration in unit dosage form, such as chewing
gums, tablets, capsules, pills, powders, granules, liquid solutions
micro-encapsulated or in suspensions. The composition can also
include brewed or soluble caffeinated or decaffeinated coffee. One
form of soluble coffee can be in a powder form, though such is not
considered limiting and other soluble forms are considered within
the scope of the invention.
[0072] For oral administration, either solid or fluid unit dosage
forms can be prepared, but most preferable in capsule or chewable
tablet. A provision of the invention is also the provision to use
the present composition in a liquid form embedded inside a soft
squeezable plastic cigarette for simulated smoking.
[0073] It is well known to entray in bulk polymers or microcapsules
to attain controlled sustained release of a permeant. Examples may
be found in my U.S. Pat. No. 4,906,488 which is incorporated herein
by reference. Therefore, another innovative feature of the
Tobacco-Antioxidants composition involves the utilization of my
Micro-Imbibed Polymer-Flavor Sponge technology to overcome the
disadvantage found in a chewable gum or tablet available on the
market (i.e. that when chewed the initial perception of the flavor
contained in, appear at a low after a minute or more, that increase
and after four or five minutes of chewing the flavor intensity drop
to an uninteresting level to slowly disappear). With my process the
tobacco flavor and other ingredients added to the
Tobacco-Antioxidants compound provide an almost instantaneous
tobacco flavor release with an extended high intensity constant,
continuous uninterrupted tobacco flavor perception time and with
evenly and uniformly controlled release of all active ingredients
over an extended period of time.
[0074] Such method, moreover substantially reduces, the diffusion
rate, volatility or susceptibility to oxidation or other form of
environmental attack upon the tobacco or other flavor, and is
effective in lengthening the shelf life of the composition by
preserving the entire composition for a longer period of time.
[0075] For preparing solid compositions such as tablets, the
principal active ingredient is mixed with conventional ingredients
such as, but not limited to, talc, magnesium stearate, dicalcium
phosphate, magnesium aluminum silicate, calcium sulfate, starch,
lactose, acacia, methylcellulose, and functionally similar
materials as pharmaceutical diluents or carriers. The tablets can
be coated or otherwise compounded to provide a dosage form
affording the advantage of prolonged or delayed action or
predetermined successive action of the enclosed medication. For
example, the tablet can comprise an inner dosage and an outer
dosage component, the latter can be in the form of an envelope over
the former. The two components can be separated by an enteric
layer, which serves to resist disintegration in the stomach and
permits the inner component to pass intact into the duodenum or to
be delayed in release. A variety of materials can be used for such
enteric layers or coatings such materials including a number of
polymeric acids or mixture of polymeric acids with such materials
as shellac, cetyl alcohol, cellulose acetate phthalate, styrene
maleic acid copolymer and the like. Wafers can be prepared in the
same manner as tablets, differing only in shape and in the
inclusion of sucrose or other sweetener and flavor. In their
simplest embodiment, capsules, like tablets, can be prepared by
mixing the compound of the formulation with an inert pharmaceutical
diluent and filling the mixture into a hard gelatin capsule of
appropriate size. In another embodiment, capsules are prepared by
filling hard gelatin capsules with polymeric acid coated beads
containing the compound of the formula. Soft gelatin capsules can
be prepared by machine encapsulation of a slurry of a herbal
compound preferably having an acceptable vegetable oil, light,
liquid petrolatum or other inert oil.
[0076] Fluid unit dosage forms for oral administration such as
syrups, elixirs, and suspensions can be prepared. The water-soluble
forms of the herbal composition can be dissolved in an aqueous
vehicle together with sugar, aromatic flavoring agents and
preservatives to form a syrup. An elixir can be prepared by using a
hydro-alcoholic (ethanol) vehicle with suitable sweeteners such as
sucrose together with an aromatic flavoring agent. Suspensions can
be prepared of the insoluble forms with a syrup vehicle with the
aid of a suspending agent such as acacia, tragacanth,
methylcellolose and the like.
[0077] The term "unit dosage form" as used in the specification and
claims, refers to physically discrete units suitable as unitary
dosages for human subjects, each unit containing a quantity (which
can be predetermined) of active ingredients (tobacco for its
nicotine content and one or more antioxidants) as free radical
scavenger calculated to produce the desired relief effect, and can
be in association with the required flavors, diluent colorants,
buffers or other conventional additives, carrier or vehicle. The
specifications for the novel unit dosage forms of this invention
can be dictated by and directly dependent on (a) the unique
characteristics of the active ingredients and the particular relief
effect to be achieved and (b) the limitation inherent in the art of
compounding such active ingredients for therapeutic use in
humans.
[0078] However, due to differences in smoking patterns, a heavy
smoker may require more dosage for the first few weeks. This is
generally sufficient to reduce a smoker's desire or need of
tobacco. The objective to help people reduce or lose their craving
for tobacco, which can be successfully reached using the
Tobacco-Antioxidants composition of the present invention, and
which can contain the following components in the amount indicated
by weight percentage.
[0079] The following are examples of compositions prepared in
accordance with this invention, but it is to be understood that
they are presented by way of illustration only, and the dosage form
and frequency of dosage of these forms can and may vary according
to the type of tobacco used and nature and severity of the
condition to be treated. The following examples should not be in
anyway construed to limit the scope of the present invention. The
two or three active ingredients of the nutraceutical formulation
prepared according to the present invention, can consist of Tobacco
leaves, tobacco fluid extract or food grade tobacco like aroma and
flavor, Antioxidants, with or without SAMe and Caffeine and/or
brewed or soluble caffeinated or decaffeinated coffee, in a Micro
Dry Powder form or liquid to be used by ingestion, administration
which can comprise the percentages hereinafter described or
fraction thereof:
[0080] From about or approximately 1% to about or approximately 85%
by weight (and all numerical ranges and values therebetween) of one
or more Antioxidants substance,
[0081] From about or approximately 1% to about or approximately 65%
by weight (and all numerical ranges and values therebetween) of
tobacco leaves,
[0082] From about or approximately 0.01% to about or approximately
5% (and all numerical ranges and values therebetween) caffeine,
[0083] From about or approximately 0.01% to about or approximately
5% (and all numerical ranges and values therebetween) SAMe; and
[0084] Where coffee is included, from about or approximately 1% to
about or approximately 99% (and all numerical ranges and values
therebetween) of coffee (brewed and/or soluble).
[0085] Where a maximum amount of coffee is included or approached
in the composition, the beginning range value for the Antioxidants
and tobacco may be slightly modified from the value stated above.
Additionally, including caffeinated coffee can also eliminate the
necessity of including caffeine in the composition where caffeine
is indicated for certain embodiments of the invention.
[0086] The preferred formulations comprise:
[0087] About or approximately 20% by weight of one or more
Antioxidants substance, about or approximately 20% by weight of
tobacco leaves, about or approximately 5% SAMe and about or
approximately 5% caffeine all in a dry powdered form or liquid,
plus the required necessary additives and flavors. This preferred
formulation can also include a percentage of coffee (brewed or in
soluble form which can also satisfy the caffeine percentage where
caffeinated coffee is included).
[0088] As a dietary supplement each Tobacco Antioxidants dose, as a
main active ingredient object of the present invention, can contain
a low dose of nicotine less than about or approximately 5 mg. and
most preferably from about or approximately 0.01 to about or
approximately 2 mg (and all numerical ranges therebetween). to
avoid accidental over-dosage and Antioxidants from about or
approximately 30 mg. to about or approximately 1 g (and all
numerical ranges therebetween). The addition of caffeine as
stimulant and mood lifter in the formulation of the present
invention will increase considerably nicotine levels and effects.
Such synergetic result consequently will reduce a great deal the
quantity of tobacco leaves required without caffeine.
[0089] In summary, numerous benefits have been described which
result from employing the concepts of the invention. The method
reduces the stress to which an individual is subjected during the
process of stopping smoking. Specifically, the method allows the
individual to first overcome the social and psychological causes
for smoking and then, and only then, is there a need to address and
overcome the nicotine dependency associated with smoking. By
approaching these causes one at a time, individuals can
successfully stop smoking. The tobacco-antioxidants composition can
be part of an overall stop-smoking program that also may include
behavior modification, counseling and support. The use of the
cigarette substitute of the present invention also causes
salivation, gastric acid secretion, and stimulation of the cranial
nerve endings in the tongue, in like fashion to the stimulation
caused by smoking cigarette and the like. Other physical effects
also occur in the body as a result of the use of the present
invention, including perhaps the production of endorphins in the
bloodstream.
[0090] The foregoing description of a preferred
Tobacco-Antioxidants Compound of the invention has been presented
for purposes of illustration and description. It is not intended to
be exhaustive or to limit the invention to the precise form
disclosed. Obvious modifications or variations are possible in
light of the above teaching. For example, various phases of the
method may be adjusted in length in order to reflect differences in
the smoking patterns of the individual.
[0091] The Tobacco-Antioxidants Compound was chosen and described
to provide the best illustration of the principles of this
invention and its practical application to thereby enable one of
ordinary skill in the art to utilize the invention in various
embodiments and with various modifications as are suited to the
particular use contemplated. All such modification and variations
are within the scope of the invention as determined by the appended
claims when interpreted in accordance with the breadth to which
they are fairly, legally and equitably entitled. As set forth the
single ingredients of the Tobacco-Antioxidants Compound object of
this invention are more effective when taken all together,
nevertheless each of the ingredients can be used singularly
concurrently with the use of tobacco.
[0092] Although the present invention has been described in a
practical and possibly preferred form, it is to be understood that
departures may be made therefrom within the scope of the present
invention which is not to be limited to the details disclosed
herein, but is to be accorded the full scope of the appended claims
so as to embrace any and all equivalent compositions and methods.
The suggested method of eliminating an individual's tobacco smoking
habit and associated nicotine dependence in regulated matter, of
course comprising the step of:
[0093] breaking a day down into smoking periods;
[0094] recording the number of cigarettes smoked;
[0095] reducing weekly the number of cigarettes smoked;
[0096] administering the dosage of the Tobacco-Antioxidants
compound as alternative replacement of a cigarette, to gradually
decreasing the amount of cigarettes to be gradually decreasing the
amount of cigarettes to be gradually decreasing the amount of
cigarettes to be smoked, while if necessary increasing the
administration of the Tobacco-Antioxidants composition until the
nicotine, the caffeine or SAMe administrations and smoking habit
has been successful reduced or cured.
[0097] The invention can have the following characteristics:
[0098] 1. A composition to help persons reduce or quit tobacco
smoking, which comprises a Tobacco-Antioxidants formulation, with
or without raw uncured tobacco in powdered form or tobacco fluid
extract or a food grade tobacco like aroma and flavors, or SAMe
and/or Caffeine and/or brewed and/or soluble decaffeinated or
caffeinated coffee, which can include as main ingredient
Antioxidants derived from one or more amino acids, enzymes,
chemicals, hormones, plants extracts, proteins, and when slowly
dissolved in the mouth it gives a dose of nicotine almost equal to
a cigarette, suitable for oral administration.
[0099] 2. Composition of characteristic 1 that can be administered
orally and is effective in preventing or curtailing very early
stage diseases, in tobacco smokers.
[0100] 3. Composition of characteristic 1 where the ingredients for
administration are in unit dosage form, such as chewing gums,
tablets, capsules, pills, powders, granules, liquid solutions,
liquid solutions mixed with brewed and/or soluble caffeinated or
decaffeinated coffee, or suspensions.
[0101] 4. Composition of characteristic 1 where the composition can
be used embedded inside a soft squeezable plastic cigarette for
simulated smoking.
[0102] 5. Composition of characteristic 1 where the composition can
be prepared by employed conventional organic or inorganic additives
and flavors.
[0103] 6. Composition of characteristic 1 where the flavor can be
preferably tobacco and the additives can be an excipient, a
preservative, a stabilizer, a suspending agent, a dispensing agent,
a diluent and/or a base wax.
[0104] 7. Composition of characteristic 1 where the tobacco can be
in liquid flavor or in liquid or powdered form and one or more
antioxidants with or without other ingredients or additives and
flavors.
[0105] 8. Composition of characteristic 1, where the antioxidant(s)
can be selected from one or more of the following Antioxidants:
Acetyl-L-Carnitine, Adenosine, Allicin, Aloe, Alpha Lipoic Acid,
BHA, BHT, Bilirubin, Capsaicin, Catalases, Catechin, Cysteine,
Coenzyme Q10, Copper Sebacate, Coumarin, Curcumin, Dimethylglycine,
Glycine, Ferrous Fumarate, Folic Acid, Genistein, Ginger, Ginko
Biloba, Gallates, Gluconate, Glutathione or Glutathione Peroxidase,
Green Tea, Inositol, Isoascorbic Acid, L-Glutamine, Linoleic Acid,
L-Methyl Methionine, L-Seleno Cysteine, L-Seleno Methionine or
Methionate, Lycopene, Lutein, Manganese, Melatonin, Methionine
Reductase w/(Cu--Zn or Mn), N-Acetylcysteine or L-Cysteine, N-Acyl
1-Cysteine Esters, N-Acyl 1-Methionine Esters, Poplar Bud,
Procyanidin, Pycnogenol, Resveratrol, Rosemary, Rutin, Rutinose,
Selenium-Yeast, Seleno Cysteine, Seleno Methionine or Methionate,
Silybum Marianum, Sodium Bisulfite, Sodium Metasulfite, Sodium
Sulfite, Sodium Thiosulfite, Spirulina, Sulfuraphane, Superoxide
Dismutase (SOD), Taurine, Thioglycerol, Thiol, Thiosorbitol,
Thiourea, Vitamin A compounds, Vitamin B2 compounds, Vitamin B6
compounds, Vitamin B12 compounds, Vitamin C compounds, Vitamin E
compounds, Wheat Grass and/or Zinc Gluconate.
[0106] 9. Composition of characteristic 1 where the composition
contains Nicotiana tabacum leaves reduced in a dry powdered form
which can contain between about 0.01% to about 8% of Nicotine and
the coffee can contain about 1% to 8% caffeine.
[0107] 10. Composition of characteristic 1 where the composition
contains tobacco fluid extract with or without nicotine.
[0108] 11. Composition of characteristic 1 where the composition
contains Food Grade Tobacco like Aroma and Flavor and sugar.
[0109] 12. Composition of characteristic 1 where the
S-Adenosyl-L-Methionine (SAMe) aids in the production of the master
oxidant Glutathione, which is a bona-fide treatment for diseases at
their source, of which each dose preferably does not exceed about
200 mg, though such value is not considered limiting.
[0110] 13. Composition of characteristic 1 where the Caffeine acts
as a central stimulant, of which each dose preferably does not
exceed 100 mg, though such value is not considered limiting.
[0111] 14. Composition of characteristic 1 wherein in liquid form
it can contain water, soft drink and/or fruit juices.
[0112] 15. Composition of characteristic 1 wherein in liquid form
it can contain beer, coffee, chocolate and/or alcoholic drink.
[0113] 16. Composition can comprise the following percentages: (1)
from about or approximately 1% to about or approximately 85% by
weight (and all numerical ranges therebetween) of one or more
Antioxidants substance, (2) from about or approximately 1% to about
or approximately 65% by weight (and all numerical ranges
therebetween) of tobacco leaves; (3) from about or approximately
0.01% to about or approximately 5% by weight (and all numerical
ranges therebetween) caffeine, and (4) from about or approximately
0.01% to about or approximately 5% by weight (and all numerical
ranges therebetween) SAMe.
[0114] 17. Composition can preferably comprise (1) about or
approximately 20% by weight of one or more Antioxidants substance,
about or approximately 20% by weight of tobacco leaves, about or
approximately 5% by weight SAMe and about or approximately 5% by
weight caffeine all in a dry powdered form or liquid, plus the
required necessary additives and flavors.
[0115] The invention provides a method and composition to help
persons reduce or quit smoking is disclosed, employing raw tobacco
leaves, or tobacco fluid extract, or food grade tobacco like flavor
and aroma, and antioxidants, with or without and. SAMe and/or
caffeine and/or brewed and/or soluble caffeinated and/or
decaffeinated coffee. All ingredients can be in a micro-powdered or
liquid form, for buccal administration. The composition can be in a
tablet or capsule that is intended to be slowly sucked and
dissolved in the mouth, and that delivers the nicotine, caffeine,
coffee and/or SAMe, proved to be effective in alleviating smoking
withdrawal symptoms, characterized by anxiety, irritability,
unpaired concentration and confusion. The smoker can also be helped
to quit or limit the amount of cigarettes smoked, the composition
can be embedded inside a soft squeezable plastic cigarette for
simulated smoking, providing additional periodic doses of nicotine,
caffeine, coffee and/or SAMe to satisfy cravings for cigarettes.
Meanwhile the user is inhaling a strong pleasant tobacco sweet
scent and swallowing a delicious aroma, meanwhile the antioxidants
will provide a strong protection against free radicals.
[0116] The short-term, more physically satisfying solution that
will save more lives sooner remains the antioxidants and tobacco
composition object of the present invention, providing satisfaction
of psychogenic drive to satisfy the craving for cigarette, to help
people quit or reduce smoking cigarettes.
[0117] While the invention has been described and disclosed in
certain terms and has been illustrated by disclosure of certain
embodiments or modifications, persons skilled in the art who have
acquainted themselves with the invention will appreciate that it is
not necessarily limited by such terms nor to the specific
embodiments and modifications disclosed herein. Thus, a wide
variety of alternatives, suggested by the teachings herein, can be
practiced without departing from the spirit of the invention, and
rights to such alternatives are particularly reserved, especially
those which fall within the scope of the appended claims.
* * * * *