U.S. patent application number 10/705284 was filed with the patent office on 2004-05-27 for method for dispensing s-adenosyl-methionine in a micro fine powdered form by inhalation.
Invention is credited to Pera, Ivo E..
Application Number | 20040101485 10/705284 |
Document ID | / |
Family ID | 8179032 |
Filed Date | 2004-05-27 |
United States Patent
Application |
20040101485 |
Kind Code |
A1 |
Pera, Ivo E. |
May 27, 2004 |
Method for dispensing S-adenosyl-methionine in a micro fine
powdered form by inhalation
Abstract
A method is provided for dispensing dry micro powdered SAMe
compositions (or SAM or AdoMet), an abbreviation for
S-adenosyl-methionine, wherein SAMe, as active ingredient is
contained in an amount effective to achieve its intended purpose,
with a membrane permeation enhancer such as lactose. The compound
is administered via a conventional dry powder inhaler to deliver
said the compound into the subject's respiratory tract in order to
enhance prophylactic and therapeutic effects of SAMe, without the
Aid or use of propellants, chlorinated, halogenated, gases,
liquids, vapors, aerosol, spray, vaporization, or any other similar
devices or delivery methods.
Inventors: |
Pera, Ivo E.; (Pembroke
Pines, FL) |
Correspondence
Address: |
MALIN HALEY AND DIMAGGIO, PA
1936 S ANDREWS AVENUE
FORT LAUDERDALE
FL
33316
US
|
Family ID: |
8179032 |
Appl. No.: |
10/705284 |
Filed: |
November 10, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10705284 |
Nov 10, 2003 |
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10085404 |
Feb 28, 2002 |
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6645469 |
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Current U.S.
Class: |
424/46 ;
514/15.1; 514/16.7; 514/17.6; 514/17.8; 514/21.9; 514/47;
514/53 |
Current CPC
Class: |
A61K 9/0075 20130101;
A61K 9/008 20130101 |
Class at
Publication: |
424/046 ;
514/047; 514/018; 514/053 |
International
Class: |
A61K 038/05; A61K
031/7076; A61L 009/04; A61K 009/14 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 1, 2001 |
EP |
EP 01125055.2 |
Claims
1. A method for dispensing S-Adenosylmethionine (SAMe) in the form
of a dry micro fine powder directly to a human subject by
inhalation, said method comprising the steps of: (a) forming a dry
micro fine powder composition comprising S-adenosylmethionine as an
active ingredient; and (b) directly administering the composition
to the subject's respiratory tract in a dry micro fine powder
form..
2. The method of claim 1 where step (b) comprises the step of
dispensing, upon breath activation by the human subject, of an
effective amount of the dry micro fine powder SAMe composition
directly into the mouth of the subject by a dry powder inhaler to
allow said composition to reach the subject's respiratory tract
without the use of propellants, chlorinated, halogenated, gas(es),
liquids, sprays aerosol(s) or vaporization
3. The method for dispensing of claim 1 wherein said dry micro fine
powder composition further consist of a membrane permeation
enhancer.
4. The method for dispensing of claim 3 wherein said membrane
permeation enhancer is lactose and/or glutathione.
5. The method for dispensing of claim 1 wherein said method allows
for delivery into the subject's respiratory tract SAMe, in order to
enhance prophylactic and therapeutic effects of the SAMe.
6. The method of claim 1 wherein said dry micro fine powder
composition consist of a plurality of particles which are between
approximately 0.1 micrometer and approximately 10 micrometer in
size.
7. The method of claim 3 wherein said membrane permeation enhancer
is magnesium stearate.
8. The method for dispensing of claim 3 wherein said membrane
permeation enhancer is lactose and/or one or more water soluble
antioxidants.
9. A method for dispensing a SAMe composition in a dry micro fine
powder form directly to a human subject with the use of a
conventional dry powder inhaler, said method comprising the steps
of: (a) forming a dry micro fine powder SAMe composition with or
without a membrane permeation enhancer; and (b) directly
administering the composition to the subject's respiratory tract in
a dry micro fine powder form.
10. The method of claim 9, wherein step (b) comprises the step of
dispensing, upon breath activation by the human subject, of an
effective amount of the dry micro fine powder SAMe composition
directly into the mouth of the subject with the dry powder inhaler
to allow said composition to reach the subject's respiratory tract,
without the aid or use of propellants, chlorinated, halogenated,
gas(es), liquids, spray, aerosol(s) or vaporization.
11. The method for dispensing of claim 9 wherein said method allows
for delivery of a SAMe composition into the subject's respiratory
tract in order to enhance prophylactic and therapeutic effects of
said SAMe.
12. The method for dispensing of claim 9 wherein said membrane
permeation enhancer is lactose and/or one or more water soluble
antioxidants.
13. The method of claim 9 wherein said dry micro fine powder
compound consist of a plurality of particles which are between
approximately 0.1 micrometer and approximately 10 micrometer in
size.
14. The method of claim 9 wherein said membrane permeation enhancer
is magnesium stearate.
15. The method for dispensing of claim 9 wherein said membrane
permeation enhancer is lactose and/or glutathione.
16. A method for improving the effectiveness of
S-Adenosylmethionine (SAMe) when administered to a human subject,
said SAMe composition in a dry micro fine powder form, said method
comprising the step of directly administering a SAMe composition to
the subject's respiratory tract in a dry micro fine powder form
17. The method for improving of claim 16, wherein the step further
comprising administering to a subject an effective dose of the dry
micro fine powder SAMe composition with or without lactose, and/or
antioxidants via a conventional dry powder inhaler, upon breath
activation by the human subject, to deliver said SAMe directly into
the subject's respiratory tract, without the use of gas(es),
liquids, spray, aerosol(s) or vaporization, in order to enhance
prophylactic and therapeutic effects of the SAMe.
18. The method of claim 16 wherein said dry micro fine powder
composition consist of a plurality of particles which are between
approximately 0.1 micrometer and approximately 10 micrometer in
size.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 10/085,404, filed Feb. 28, 2002, which claims the benefit of
and priority to European Patent Application No. EP 01125055.2,
filed Mar. 1, 2001. Both applications are incorporated herein by
reference.
DESCRIPTION
[0002] 1. Technical Field
[0003] The present invention relates generally to the technical
sector of chemistry and pharmacology and particularly to a new
method for dispensing a medicine. It doesn't consist of a
therapeutic treatment, since the therapeutic function of the
S-Adenosilmetionina (SAMe) is already known, but it discloses a new
use, by means of a method for dispensing it through the respiratory
tract.
[0004] 2. Background Art
[0005] The assimilation of an adequate quantity of physiologically
important S-Adenosylmethionine is essential to the health of
people. Failure of the body to assimilate the necessary amount of
such SAMe which acts as a methyl donor in over 35 methylation
reactions involving DNA, proteins, phospholipids and catechol and
indole amines, that can lead to the improvement of the biochemical
reactions of the body functions and the metabolic processes as well
as to the prevention or cure of variety of diseases and associated
symptoms. SAMe=S-Adenosyl-L-methionine,
S-(5'-deoxyadenosine-5')-methionine, active methionine, active
methyl, abbreviated as S-Ado-Met, SAM: a reactive sulfonium
compound which is the most important methylating agent in cellular
metabolism (transmethylation). It is formed by activation of
L-methionine with ATP: Met+ATP-SAM+PP.sub.1+P.sub.1. The adenosine
residue of the ATP is transformed to the methionine.
[0006] The transmethylation reaction produces, in addition to the
methylated product, S-adenosyl-L-homocysteine: systematic name
S-(5'deoxyadenosine-5')-homocysteine. It may be reconverted to SAM
after cleavage into adenosine and L-homocysteine. L-Homocysteine is
the substrate of dimethylthetin-homocysteine methyltransferase.
SAMe controls virtually all body functions in man beginning with
sugar metabolism and fatty acid metabolism and extending to the
immune system and even mental stability, through SAMe mediated
modification of a number of critical neurotransmitters and
hormones. Not surprisingly, SAMe also controls aging of the
organism. Hence, virtually all diseases and/or disorders associated
with aging, such as diabetes, atherosclerosis, arthritis and
Alzheimer's disease, are caused by abnormal perturbations of the
SAMe pathways.
[0007] SAMe has been clinically proven to promote joint health and
support emotional well-being.
[0008] SAMe is one of the most vital links to health known today in
maintaining not only health but in preventing diseases. SAMe most
significant claims include efficacy in treating depression,
osteoarthritis, cirrhosis of the liver, fibromyalgia, cancer,
cystic fibrosis, ALZHEIMER's and PARKINSON's diseases.
[0009] The importance of this reaction in maintaining health cannot
be overemphasized. Everything from activating or deactivating
enzymes to converting the coded messages in our DNA to actual
proteins involves methylation reactions, and therefore SAMe. Many
scientists have known for years that most of us don't 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.
[0010] Unfortunately today is considered normal to have a heart
attack even at a young age, but today thank to SAMe many, if not
most heart attacks and strokes are almost entirely preventable! In
fact, the basic process of vascular disease, arteriosclerosis and
athrosclerosis is largely preventable.
[0011] 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.
[0012] Clinical studies have long shown oral intake of SAMe to have
antidepressant effects. Recent clinical studies have also shown it
to be very effective in maintaining a healthy liver, and it is even
effective in people who already have alcoholic liver cirrhosis.
However, perhaps its greatest potential in preventing or delaying
serious age-related disease lies in its ability to regulate plasma
homocysteine metabolism. High levels of homocysteine, a
sulfur-containing amino acid, have been highly correlated with the
onset of cardiovascular and cerebrovascular disease. One very
important way your body gets rid of homocysteine is to put a methyl
group on it and form methionine, which is not harmful. SAMe is a
major contributor to this process, and it does this by methylating
a substance called tetrahydrofolate, which in turn methylates
homocysteine to methionine, SAMe taken orally has been shown to
increase levels of methylated tetrahydrofolate in humans, thus
potentially decreasing their risk of cerebrovascular (stroke) and
cardiovascular disease. This seems logical, when considered with
the fact that patients with coronary artery disease have been shown
to have significantly lower levels of SAMe than similar individuals
without coronary artery disease.
[0013] SAMe may also have a role in cancer prevention. In certain
types of cancer, reduced methylation of DNA may contribute to loss
of the control on genes that control normal cell division. In
human, low methylation of DNA has been observed in colorectal
cancers and in their adenomatous polyp precursors. Low dietary
folate and methionine and high intake of alcohol may reduce levels
of SAMe, which as noted previously is required for DNA methylation.
Therefore, oral supplementation of SAMe may be prophylactic in
individuals at risk for these types of cancers.
[0014] Improving the methylation process in the body, SAMe
will:
[0015] reduce the risk of hearth disease
[0016] reduce the risk of cancer
[0017] slow or reduce the risk of age-related diseases, including
Alzheimer's disease, Parkinson's and Arthritis
[0018] reduce the risk of a host of other diseases and conditions
including birth defects, liver disease
[0019] improve the mood
[0020] improve existing ailments such as herpes, diabetes,
depression, poor digestion and fatigue
[0021] control the weight and increase mass.
[0022] SAMe may be administered by different methods. The various
methods include oral, rectal, sublingual or buccal, parental
inhalation, topical, etc. The choice of method depends upon both
convenience and necessity. Obviously, drug substances are most
frequently administered orally for access to the systematic
circulation by means of solid dosage forms, such as tablets and
capsules. Oral administration does not always give rise to
sufficiently high plasma concentrations to be effective. Some drugs
are absorbed unpredictably or erratically. Patients occasionally
have an absorption malfunction.
[0023] Fillers and binders comprise the bulk of the contents in
SAMe tablets to which most people exhibit adverse side effects,
such as headaches, rashes, hives, itching, and upset stomach, while
the same vitamin doses when taken as the pure vitamin by injection
without fillers or binders does not produce these side effects.
[0024] Several doctors who use in their practice, drugs via oral
administration have observed many such undesirable reactions,
including headache, arthritis, joint pain, chronic fatigue,
depression, personality changes, gout attacks, and even chronic
earaches and infection in children. It has been discovered that the
allergic reactions are generally to table fillers and binders, not
to the drugs themselves (though it is recognized that even vitamins
cause problems in excessive doses).
[0025] In clinical research, it has been confirmed that 8 to 10
percent of the tested, clinical population is allergic to corn
starch and other corn products and about another 10 percent to soy
products. These allergies can be sufficiently severe to produce
very unpleasant symptoms when SAMe tablets using these fillers and
binders are taken.
[0026] Great interest has been recently developed to the highly
effective therapeutic usefulness of the Dry Micro-powdered
Inhalation Therapy. Such forms of administration offer many
advantages to the patient. It is well known that many drugs are
capable of being absorbed rapidly by inhalation.
[0027] The method of application of the present inhalation process
makes possible delivering the same into the respiratory tract of
humans in order to enhance the propylactic and therapeutic effects
of such same composition to decrease or prevent diseases, therefore
through dispensing such SAMe into the respiratory tract, and in
accordance with my numerous laboratory test, I have been successful
to confirm specific preventive effects, in the development of
numerous diseases.
[0028] Accordingly one purpose of my invention is to provide a dry
micro fine powder compound of SAMe for local administration by
inhalation. This system offers the advantage of (1) local
administration of small doses of the above SAMe with protective
effect against many diseases, in a "on-pharmacological" and
spontaneous way and (2) concomitant distribution of such SAMe in
the respiratory tract, which are more effectively absorbed and
retained in the human body with specific preventive effect.
[0029] The SAMe Inhalation therapy of the present invention offers
the following major advantages:
[0030] The inhaled SAMe composition is transmitted to the site
where it is required, namely through the respiratory system, where
it becomes far more effective and with greater speed than any
orally taken medication.
[0031] Due to the fact that the SAMe is transmitted directly into
the respiratory system only one tenth of the quantity is required
compared with any other form of administration, with the results
that undesirable side-effects are rare.
[0032] To decrease or prevent many diseases, my invention relates
to a method for delivering SAMe into the respiratory tract of
humans, in order to enhance the prophylactic and therapeutic
effects of same.
[0033] A further object of the present invention is to administer
in a dry microfine powdered form by inhalation as a prevention
means or as a medical treatment. In administering SAMe for
inhalation in dry powder form to deliver the same into systemic
circulation via the respiratory tract, the adsorption is virtually
immediate, since the alveolar and vascular epithelial membranes are
quite permeable, blood flow is abundant and there is a very large
surface for adsorption.
[0034] Dry Powder Inhalers (DPIs) deliver their dose on the breath
of the patient, consequently, the pattern of delivery is different
from that of the aerosol inhalers. The DPIs are extremely simple
and foolproof, especially with respect to accuracy of dosage and
accurate placement of the drug. For this reason, the DPIs are ideal
vehicles to dispense SAMe to the respiratory tract, and are
preferable to the aerosol inhaler, particularly over oral
preparations for several reasons. An example of a dry powder
Inhalers which can be utilizes to deliver dry powder drugs is shown
in my Patents and Patents pending for inhaler devices. Other
conventional dry powder inhalers may also be utilized and are
considered within the scope of the invention.
[0035] After the SAMe has been inhaled immediately it is absorbed
into the bloodstream and then pumped to all organs in the body,
instead if a tablet or a capsule is ingested, one must take a
relatively large amount of an oral drug to deliver a small dose to
a selected target organ, such as the lungs. The drug is also
transported to other organs where it is not needed and may cause
unwanted side effects. The shortcomings of oral drugs are overcome
by the present invention which delivered the SAMe directly to the
target organ.
[0036] The lung is considered to be one of the more effective
non-invasive routes of administration to the systemic circulation.
Numerous types of dry micro fine powdered SAMe formulations can be
used to treat a variety of conditions that accompany many different
diseases.
[0037] Therefore, to acquire full health protection, it is may be
necessary to fortify the body with SAMe as the latest scientific
findings from all over the world confirm, the potential of the SAMe
to provide health benefits which may include the following:
[0038] increased protection from many forms of cancer;
[0039] stronger defenses against cardiovascular disease, such as
atherosclerosis, heart attacks, and strokes, liver disorders,
kidney failure, rheumatoid arthritis, osteoarthritis, osteoporosis,
depression and other psychiatric disorders, type II diabetes and
complications of diabetes, fibromylagia, chronic fatigue syndrome,
Alzheimer's disease, cognitive decline, multiple sclerosis;
[0040] a delay in the onset of premature aging;
[0041] a more powerful immune system;
[0042] a decreased risk of early Parkinson's disease and other
chronic diseases, as well as a host of other major health
advantages.
[0043] The SAMe may also cure anxiety disorders, amebic dysentery,
anosmic aplasia, analgesic, cholecystitis, cushing syndrome,
menstruation and menopause distress, gastritis, crohn's disease,
leukemia, lymphopathy, obesity.
[0044] Many physicians have been taking SAMe for years, even before
the weight of scientific authority shifted so heavily in the SAMe
direction.
[0045] The determination of quantitative daily human requirements
for SAMe could be made if it were possible to correlate known
nutrient intake with specific biological responses in precisely
controlled studies, the daily amount suggested is:
[0046] up to 150 mg. per day to be inhaled three times (morning,
noon and evening).
[0047] Though the benefits of SAMe is well documented, methods of
delivering the vitamins to the respiratory area of a patient have
been far from superior, but unfortunately SAMe never has been
tested, dispensed or even suggested, until the present invention to
be administered in a microfine powder form by inhalation.
[0048] Thus, what is needed in the art is method for dispensing
SAMe within a patient which will allow for maximum benefits from
such medicine for therapeutic treatment of diseases through the
respiratory tract.
SUMMARY OF THE INVENTION
[0049] It is therefore, to the effective resolution of the
aforementioned problems and shortcomings that the present invention
is directed.
[0050] The present invention provides a method is provided for
dispensing dry micro powdered SAMe compositions (or SAM or AdoMet),
an abbreviation for S-adenosyl-methionine (all collectively
referred to as SAM for purposes of the disclosure and claims),
wherein SAMe, as active ingredient is contained in an amount
effective to achieve its intended purpose, with a membrane
permeation enhancer such as lactose. The compound is administered
via a conventional dry powder inhaler to deliver said the compound
into the subject's respiratory tract in order to enhance
prophylactic and therapeutic effects of SAMe, without the aid or
use of propellants, chlorinated, halogenated, gases, liquids,
vapors, aerosol, spray, vaporization, or any other similar devices
or delivery methods.
[0051] Thus, the method dispenses SAMe in dry, powdered form by
inhalation as prevention or for medical treatment for several
diseases. Preferably, SAMe is in a dry, ultra silky, micro, fine
powdered form. Many ingredients can be added as membrane permeation
enhancers to the SAMe formulation to increase their barrier
permeability, but the preferred one and the most effective are
lactose and glutathione.
[0052] The present invention method delivers the dry, micro fine
powder in one step through the respiratory tract and without the
aid or use of aerosols, liquids, vapors, gases, vaporization or any
other similar or like devices or delivery methods.
[0053] Preferably, the dry fine powder compound consist of a
plurality of particles which are between approximately 0.1
micrometer and approximately 10 micrometer in size, though such is
not considered limiting and other sizes and ranges can be used and
are considered within the scope of the invention.
[0054] The principal purpose of the present invention is to use any
inhaler known in the art to dispense a dry, powdered compound
consisting of SAMe, lactose and/or antioxidants through the mucosal
linings of tracheobronchial tree and the lungs, to prevent or cure
depression and other diseases.
[0055] The invention relates to a novel method of supplementing,
through the respiratory tract, essential SAMe by the use of a drug
powder inhaler which allows their immediate assimilation,
compensating for certain absorptive disorders and side effects.
[0056] A further object of the present invention is a method of
dispensing SAMe in a microfine powder form which is used to treat
or prevent diseases including but not limited to liver disorders,
kidney failure, arthritis, depression, fibromyalgia, Alzheimer and
Parkinson's diseases, atherosclerosis, heart attack, diabetes,
obesity, and cancer.
[0057] The essential SAMe composition, when administered through
the respiratory tract, is directly available for absorption into
the system without competition from other medications. When the
SAME is dispersed by inhalation through the respiratory tract, is
instantaneously assimilated by the plasma and is immune to possible
deterioration or interaction of prescribed medicaments and aspirin
and/or alcohol.
[0058] In recent years, a great deal of scientific literature has
been published, reporting the extraordinary effects of SAME. It is
not easy to summarize in a few pages the numerous properties of
these remarkable substances, the evidence accumulated to date
including the studies of the present invention, leave little doubt
that SAMe exert favorable effects on many types of diseases and, in
fact, there is published evidence demonstrating that the SAMe exert
a direct effect on preventing or curing several diseases
particularly depression.
[0059] Thus, it is an object of the invention to provide a
composition and method for selectively supplementing the essential
SAMe in the diet of people and for facilitating its absorption for
the prevention of diseases.
[0060] It is also an object of the invention to correct the
deficiency of SAMe in people due to the excessive homocysteine
activity which pose one of the greatest single threats to the
public health and to prevent and/or eliminate the symptoms of those
deficiencies. By so doing, deficiencies can be therapeutically
eliminated without the need for massive doses of drugs.
[0061] A further object of the invention is to administer SAMe in a
dry, powdered form by inhalation as a prevention means or as a
medical treatment.
[0062] In accordance with these and other objects which will become
apparent hereinafter, the instant invention will now be detailed in
the following pages.
DETAILED DESCRIPTION OF THE INVENTION
[0063] The present invention relates to employing a dry powder
inhalation device for delivering SAME in a microfine powdered form
into systemic circulation via the respiratory tract. Absorption is
virtually as rapid as the drug can be delivered into the alveoli of
the lungs, since the alveolar and vascular epithelial membranes are
quite permeable, blood flow is abundant and there is a very large
surface for adsorption.
[0064] Aerosol delivered from pressure-packaged, metered-dose
inhalers (MDIs) are composed of the drug, additives, and
propellants. The high vapor pressure of propellant supplies the
force necessary to generate aerosol droplets.
[0065] Aerosol of non-volatile substances may also be administered
by inhalation, but the route is infrequently used for delivery into
the systemic circulation because of various factors that contribute
to erratic or difficult-to-achieve blood levels. Whether or not an
aerosol reaches and is retained in pulmonary alveoli depends
crucially upon particle size; particles greater than 1 micrometer
in diameter tend to settle in the bronchiole and bronchi, whereas
particles less than 0.5 micrometer fail to settle and are mainly
exhaled. Aerosols are mostly employed when the purpose of
administration is an action of the drug upon the respiratory tract
itself.
[0066] Dry powder inhalers (DPIs) deliver their dose on the breath
of the patient, consequently, the pattern of delivery is different
from that of the metered dose inhalers. The DPI is extremely simple
and foolproof, especially with respect to accuracy of dosage and
accurate placement of the drug. For this reason, the DPIs are ideal
vehicles to dispense SAMe to the respiratory tract, and are
preferable to the aerosol inhaler, particularly over oral
preparations for several reasons. An example of a dry powder
inhaler which can be utilized to deliver a dose of microfine dry
powder composition is shown in my U.S. Pat Nos. 5,669,378 and
5,944,012 which are incorporated herein by reference. Other
conventional dry powder inhaler may also be utilized and are
considered within the scope of the invention.
[0067] The present invention provides a method for dispensing a
dry, powdered compound consisting of SAMe and lactose using a DPI,
which can be inhaled into the lungs to produce a faster onset of
action without any side effects. This new method of dispensing
antioxidant vitamins through the respiratory tract is
breath-activated, meaning the patient does not have to coordinate
inhalation with activating the inhaler and does not inhale
cardio-toxic gas propellants into the lung.
[0068] The lung is considered to be one of the more effective
non-invasive routes of administration to the systemic circulation.
A number of different dry, powder SAMe formulation can be used to
treat a variety of conditions that accompany many different
diseases.
[0069] SAMe as an extraordinary natural chemical is produced by a
healthy body each day being synthesized in the liver to perform
many of its basic functions, including regeneration of its own
tissue.
[0070] SAMe is the body's most important metabolic helper that
defend the body from the damaging effects of uncontrolled damage of
too much homocysteine in the body causing untold stroke or hearth
attack, and damage the DNA in our cells which control growth,
stimulate the immune system, and prevent or reduce the risk of
cancer, liver disease, premature aging and depression, as well as
protecting our bodies from harmful toxins, promoting optimum health
and well being.
[0071] Excess of homocysteine have been shown to an extremely toxic
substance that build up in cells to develop cancer, bacterial and
viral infections, stroke, arthritis, hearth attack and being a
major factor in causing many more diseases.
[0072] In recent years, much scientific research has been done and
the validity of using SAMe can dramatically improve health and to
prevent and/or cure diseases and to bolster the immune defenses
against excessive build up of homocysteine due to its powerful
damaging properties.
[0073] The method of application of the present invention makes
possible delivering the SAMe into the respiratory tract of humans
in order to enhance the prophylactic and therapeutic effects of
such SAMe to decrease the risk of diseases. Thus, dispensing SAMe
into the respiratory tract in accordance with our numerous
laboratory tests, we have been successful in confirming the
specific preventive effects in the several diseases.
[0074] Accordingly, one purpose of this invention is to provide a
dry, powder compound of SAMe for local administration by
inhalation. This system offers the advantages of (1) local
administration of small doses of the above SAMe with protective
effect against diseases, in a "non-pharmacological" and spontaneous
way; and (2) concomitant distribution of such SAMe in the
respiratory tract, which will be more effectively absorbed and
retained in the human body with specific preventive effect. When
SAMe levels are increased, some amazing things start to happen,
many people have found relief from such debilitating illness as
depression, liver diseases and many more.
[0075] While the present invention has been described with
reference to specific medical procedure for dispensing SAMe by
inhalation, it will be understood by those skilled in the art that
various other formulation with SAMe can be used 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.
[0076] Thus, in use SAMe and a membrane permeation enhancer such as
saccharide, glycosides, etc., such as lactose, sucrose, mannitol or
sorbitol, magnesium stearate, and/or one or more water soluble
antioxidants, all formed into a dry powder compound and kept
together, prior to use, by conventional means, such as a capsule
member. The capsule member, containing the dry powder compound is
disposed into a conventional dry powder inhaler. When the dry
powder compound is desired, the inhaler is activated causing the
compound to be delivered to the subject's respiratory tract in
order to enhance prophylactic and therapeutic effects of the SAMe.
Other ingredients can also be included within the dry powder SAMe
compound. Thus, the dry powdered compound is inhaled into the
subject's lungs to produce a faster onset of action. When
administered through the respiratory tract, SAMe is directly
available for absorption into the subject's system without
competition from other medications. When SAMe is dispersed by
inhalation through the respiratory tract, they are instantaneously
assimilated by the plasma and are immune to possible deterioration
or interaction of prescribed medicaments and aspirin and/or
alcohol.
[0077] The present invention method delivers the dry, micro fine
powder in one step and without the aid or use of aerosol(s),
propellants, chlorinated, halogenated, gas(es), liquids, spray,
vaporization or any other similar or like devices or methods.
[0078] Preferably, SAMe formulation can be in a dry, ultra silky,
micro fine powdered form. The dry powder compound preferably
consist of a plurality of particles which are between approximately
0.1 micrometer and approximately 10 micrometers in size, though
such is not considered limiting.
[0079] The relative amounts of the SAMe composition can vary a
great deal. For example, the amount of SAMe in the inhaling
composition will depend on a variety of factors, including the
disease to be treated, the desired effect, possible adverse
reactions and other factors within the particular knowledge of the
patient and physician. The amount of enhancer present in the
composition will similarly depend on a number of factors, e.g. on
the depth of penetration desired through the respiratory system,
the strength of the particular permeation enhancer duly selected,
and the like.
[0080] The instant invention has been shown and described herein in
what is considered to be the most practical and preferred
embodiment. It is recognized, however, that departures may be made
therefrom within the scope of the invention and that obvious
modifications will occur to a person skilled in the art.
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