WO2016187258A1

WO2016187258A1 - Synergistic natural cardiovascular support supplement and method

Info

Publication number: WO2016187258A1
Application number: PCT/US2016/033003
Authority: WO
Inventors: Thomas J. MCCRINK; Danielle Marie DECKER
Original assignee: Vascure Natural, Inc.
Priority date: 2015-05-19
Filing date: 2016-05-18
Publication date: 2016-11-24

Abstract

There is provided a synergistic composition of natural ingredients exhibiting advantageous effects in delaying or mitigating the onset of hypertension, managing hypertension and overall improvement of cardiovascular health of a patient and therefore can be useful as a composition for effectively mitigating or inhibiting cardiovascular diseases, including ischemic heart disease, stroke, hypertensive heart disease, rheumatic heart disease, aortic aneurysms, cardiomyopathy, atrial fibrillation, congenital heart disease, endocarditis and peripheral artery disease, the composition comprising: Magnesium, L-arginine, Celery seed, Grape seed extract, and CoQ10 in a clinically optimized dosage form acting synergistically as cardiovascular support supplement.

Description

SYNERGISTIC NATURAL CARDIOVASCULAR SUPPORT SUPPLEMENT AND

METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 62/163,435, filed on May 19, 2015, the entire content of which is hereby incorporated by reference in its entirety.

BACKGROUND [0002] Field

[0003] The present invention relates to supplements, compositions and methods useful in providing various general health benefits, including, but not limited to cardiac benefits, including delaying or minimizing the onset of hypertension, and overall improvement of cardiovascular health of the patient specific to blood pressure control.

[0004] Related Art

[0005] According to a WHO data, 12.8% of the total number of deaths is caused by elevated blood pressure levels. Elevated blood pressure levels are also a major risk factor for coronary heart disease, ischemic and hemorrhagic stroke. Globally cardiovascular disease accounts for approximately 17 million deaths a year. Of these, complications arising due to hypertension account for 9.4 million deaths worldwide every year.

[0006] Hypertension, or high blood pressure, is dangerous because it can lead to strokes, heart attacks, heart failure, or kidney disease. The goal of hypertension treatment is to lower high blood pressure and protect important organs, like the brain, heart, and kidneys from damage. Treatment for hypertension has been associated with reductions in stroke (reduced an average of 35%-40%), heart attack (20%-25%), and heart failure (more than 50%), according to research. [0007] As a part of hypertension therapy, one has to change his/her lifestyle. This involves a change in composition of one's diet, exercising to maintain a healthy weight and regulate metabolism. Many times lifestyle changes are not enough to control hypertension. In such cases a doctor prescribes medication depending upon the age, sex, race and medical conditions of the patient. The prescribed drugs may include Thiazide diuretics, Beta-blockers, Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers (ARBs), Calcium channel blockers Renin inhibitors, or Aliskiren (Tekturna). Additional medications to treat high blood pressure may include Alpha-blockers, Alpha-beta blockers, Central-acting agents, Vasodilators, or Aldosterone antagonists.

[0008] Amongst these drugs, many have side effects associated with their usage, e.g., reported side effects of diuretics include frequent urination, erectile dysfunction in some men, weakness, leg cramps, or fatigue due to frequent urination leading to decrease in the body's levels of minerals and potassium.

[0009] ACE inhibitors or angiotensin II receptor blockers (ARBs) can cause harmful side effects for pregnant women and their developing babies. ACE inhibitors may cause dry, hacking cough, skin rash and loss of taste. Angiotensin II Receptor Blockers (ARBs) may not allow blood vessel to narrow down, resulting in the blood vessels to stay open. ARBs may also results in dizziness, hypotension, adverse renal effects and hyperkalemia. Calcium channel Blockers (CCBs) may cause these side effects: constipation, dizziness, headache, irregular or very rapid heartbeat (palpitations), and swollen ankles.

[0010] Alpha-blockers may cause dizziness, lightheadedness, weakness, or a fast heart rate. Alpha-2 receptor agonist may cause drowsiness or dizziness. Alpha-beta blockers may cause a drop in blood pressure, dizziness, lightheadedness, or weakness. Central agonists may cause anemia, constipation, dizziness, lightheadedness, drowsiness, dry mouth, erection problems and fever.

[0011] Peripheral adrenergic inhibitors can cause diarrhea, dizziness, lightheadedness, erection problems, heartburn and a stuffy nose. Vasodilators may cause excessive hair growth, fluid retention, headaches, irregular or very rapid heartbeat (palpitations), joint aches and pains, swelling around the eyes. Renin inhibitor can cause cough, diarrhea, stomach pain, heartburn, and rash.

[0012] Further, current health care expenditure on cardiovascular diseases alone accounts for 20% of total health care expenditure. Treating the complications of hypertension entails costly interventions such as cardiac bypass surgery, carotid artery surgery and dialysis, draining individual and government budgets. Households often then spend a substantial share of their income on hospitalization and care following complications of hypertension, including heart attack, stroke and kidney failure. Over the period between 2011 and 2025, the cumulative lost output in low- and middle-income countries associated with non-communicable diseases is projected to be US $ 7.28 trillion. The annual loss of approximately US $ 500 billion is due to major non-communicable diseases amounts to approximately 4% of gross domestic product for low and middle-income group countries. Cardiovascular disease, including hypertension, accounts for nearly half of the cost.

[0013] Thus, there is a need for a synergistic, natural supplement and method for providing cardiac benefits and overall improvement of cardiovascular health with minimum side effects.

SUMMARY

[0014] Embodiments of the present invention comprise supplements, compositions and methods for the management of hypertension, specifically related to cardiovascular health.

[0015] Yet another embodiment of the present invention comprises a natural composition in which the concentration of each of the ingredient is optimized to act synergistically as a cardiovascular support supplement.

[0016] Another embodiment of the present invention comprises a natural composition in optimal dosage form to an individual to improve that person's wellbeing, with possible implications to lowering the risks of cardiovascular disease and mismanaged blood pressure. [0017] Another embodiment of the present invention comprises a natural composition in optimal dosage form to an individual for improvement of cardiovascular health of the patient specific to blood pressure control, either therapeutically or prophylactically.

[0018] Another embodiment of the present invention comprises a natural composition in optimal dosage form showing negligible to no side effects resulting in better patient compliance, efficacy and outcomes.

[0019] Another embodiment of the present invention comprises a natural composition in optimal dosage form to be used as a food or a drink or a supplement or a drug.

[0020] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which reduces water retention, which may help reduce swelling and regulate blood pressure.

[0021] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which regulates both systolic and diastolic blood pressure and thus regulates the blood pressure.

[0022] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which can improve energy production at cellular, and subsequently organism, level.

[0023] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which can act as antioxidant and strengthen the body's defense against harmful free radicals.

[0024] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which can stabilize membrane fluidity.

[0025] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which can decrease blood viscosity.

[0026] Another embodiment of the present invention comprises a natural composition in optimal dosage form, which can increases capillary strength in people with hypertension and diabetes. [0027] In an embodiment, there is provided a composition comprising about 2 to 28% by weight of Magnesium, 7 to 52% by weight of L-Arginine, 3 to 28% by weight of Celery Seed, 7 to 28% by weight of Grape seed extract 1 to 41% by weight of Coenzyme-QlO; at least one or more excipients; and wherein the form of the composition is selected from the group consisting of a pill, a tablet, a caplet, a capsule, powder, a suspension, and a gel.

[0028] In an embodiment, there is provided a composition comprising: about 12 to 38% by weight of Magnesium, 17 to 62% by weight of L-Arginine, 13 to 38% by weight of Celery Seed, 17 to 38% by weight of Grape seed extract 11 to 51% by weight of Coenzyme-QlO; at least one or more excipients; and wherein the form of the composition is selected from the group consisting of a pill, a tablet, a caplet, a capsule, powder, a suspension, and a gel.

[0029] In an embodiment, there is provided a composition comprising: about 22 to 48% by weight of Magnesium, 27 to 72% by weight of L-Arginine, 23 to 48% by weight of Celery Seed, 27 to 48% by weight of Grape seed extract 21 to 61% by weight of Coenzyme-Q-10; at least one or more excipients; and wherein the form of the composition is selected from the group consisting of a pill, a tablet, a caplet, a capsule, powder, a suspension, and a gel.

[0030] In an embodiment, there is provided a composition comprising: about 42 to 68% by weight of Magnesium, 47 to 92% by weight of L-Arginine, 43 to 68% by weight of Celery Seed, 47 to 68% by weight of Grape seed extract 41 to 81% by weight of Coenzyme-Q-10; at least one or more excipients; and wherein the form of the composition is selected from the group consisting of a pill, a tablet, a caplet, a capsule, powder, a suspension, and a gel.

BRIEF DESCRIPTION OF THE FIGURE

[0031] So the manner in which the above recited features of embodiments of the present invention may be understood in detail, a more particular description of embodiments of the present invention, briefly summarized above, may be had by reference to embodiments, and a figure, wherein: [0032] Figure 1 is an example of the combination and concentration levels of a synergistic mixture of ingredients in accordance with an embodiment of the present invention.

[0033] The Figure and the detailed description are not to be considered limiting, and other equally effective examples are possible and likely.

[0034] The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word "may" is used in a permissive sense (meaning having the potential to), rather than the mandatory sense (meaning must). Similarly, the words "include," "including," and "includes" mean including but not limited to.

[0035] DETAILED DESCRIPTION

[0036] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of embodiments or other examples described herein. In some instances, well-known methods, procedures, components and compositions have not been described in detail, so as to not obscure the following description.

[0037] Figure 1 shows an embodiment of different components of a synergistic mixture along with a range of possible variations in the dose of each of the ingredients to achieve the maximum possible benefit for cardiovascular support.

[0038] There are certain naturally occurring products, which have been clinically shown to have a beneficial effect in the treatment of hypertension, e.g., L-Arginine. It is a natural amino acid, which has been identified to provide certain general health benefits including, for example, cardiovascular benefits, such as Towering cholesterol' in the consumer, and treating, preventing, and/ or inhibiting heart disease and poor circulation.

[0039] Grape seed extract GSE has biologically active Polyphenols, which are powerful antioxidants. There are overall health benefits from antioxidant-rich foods consumed in the diet. Antioxidants have been associated with a wide range of health benefits, including their ability to scavenge free radicals, maintain healthy vision and, perhaps most importantly their ability to improve cardiovascular health. To this end, health professionals frequently recommend the inclusion of Polyphenol rich foods. Supplements have been developed that are rich in antioxidant Polyphenols. GSE is a complex mixture of Proanthocyanidin monomers (primarily Catechin and Epicatechin), Dimers, Trimers and larger species. Grape seeds contain about 5-8% by weight flavonoids.

[0040] Celery Seed (Apium Graveolens) extract improves body's immune system and exerts anti-inflammatory effects by inhibiting cyclooxygenase and 5- lipooxygenase.

[0041] Coenzyme Q10 (CoQIO) is an antioxidant and anti-inflammatory agent that has been demonstrated to reduce systolic and diastolic blood pressure in both rodents and humans. In eight human clinical trials, CoQIO decreased the mean systolic blood pressure by 16 mm Hg and the mean diastolic blood pressure by 10 mm Hg, which is comparable to the effects of the standard antihypertensive drugs. It has been demonstrated that CoQIO further lowers blood pressure in patients taking antihypertensive drugs and protects against blood pressure variability.

[0042] Magnesium has been found that by the linkage addition of a divalent Magnesium salt to L-Arginine, it is possible to formulate stabilized oral compositions of the aforementioned active agents. In addition, the resultant compositions have the additional health benefit of effecting gradual release properties to the oral dosage form; thereby reducing the gastrointestinal erosion potential of the active agents released in-vivo in the body.

[0043] Similarly, there are many natural products, which have proven to be beneficial in controlling hypertension individually, but there are no known formulations, which combine the individual components in a synergistic manner to affect an advantageous result. It has been observed, that over the years, the control of hypertension has been less than satisfactory, because of overly complicated approaches to diagnosis, treatment and management of hypertension. [0044] Embodiments of the present invention provide a novel, synergistic composition and method for the treatment of hypertension through the use of natural, clinically proven, safe and most effective ingredients in optimized proportions working in a synergistic manner.

[0045] Embodiments of the present invention are directed to compositions and methods, which are useful for providing general health benefits to the consumer, particularly cardiovascular benefits. Embodiments of the present invention are further directed to a cardiovascular support supplement for providing various general health benefits including, but not limited to cardiac benefits, including delaying or mitigating the onset of hypertension, treating, preventing or inhibiting cardiovascular diseases, including ischemic heart disease, stroke, hypertensive heart disease, atherosclerosis, restenosis, thrombosis, poor circulation.

[0046] Embodiments of the present invention encompass methods for providing certain health benefits, particularly, lowering blood pressure or an improvement of cardiovascular health or other cardiovascular problems or diseases (as set forth herein) comprising systemically (generally, orally) administering to a mammal (preferably, a human) successive therapeutically effective doses of the present compositions. Such methods include treating, preventing, and/ or inhibiting (collectively referred to herein as treating) one or more of the following: cardiovascular problems including, but not limited to, atherosclerosis, restenosis, thrombosis, hypercholesterolemia, hypertension, diabetes, vascular dysfunction, and poor circulation, and other problems such as shock. Preferred methods herein include treatment of hypertension.

[0047] The composition and methods of embodiments of the present invention are effective in regulating both systolic and diastolic blood pressure, reduce water retention, which may reduce swelling and regulate blood pressure. The combination of individual components, e.g., Magnesium, L-Arginine, Celery Seed, Grape Seed Extract, Coenzyme Q-10, included in embodiments of the present invention, have been shown in clinical trials to help maintain healthy blood pressure levels. Composition embodiments of the present invention can improve energy production. The disclosed embodiments include a composition that works by decreasing blood viscosity and thereby regulates hypertension, further, increasing capillary strength in people with hypertension and diabetes, produces energy at the cellular level, and fortifies the body's defense against harmful free radicals by acting as an antioxidant.

[0048] The composition and methods disclosed in embodiments of the present invention is unique in itself, each of these components have been selected to offer irrefutable clinical evidence to treat hypertension. The combination offers synergistic mechanism of actions to treat hypertension and other cardiovascular diseases.

[0049] In an embodiment herein, the compositions, there comprises: 250 mg of Coenzyme-QlO; 300 mg of Celery seed standardized to 45% 3-N-butylphthalide; 300 mg of Grape seed extract standardized for 95% Proanthocyanidin; 500 mg L- Arginine; 100 mg of Magnesium in the form of a capsule Fig 1, Table 1.

Table 1 below showing the main ingredients of the formulation with amount in milligrams in accordance with an embodiment of the present invention:

Table 1

[0050] In accordance with another embodiment of the present invention, the present composition comprises: about 10 mg to about 600 mg of Coenzyme-QlO; about 50 mg to about 450mg of Celery seed; about 100 mg to about 400 mg of Grape seed extract; about 100 mg to about 750 mg L-Arginine; about 25mg to about 400 mg of Magnesium Fig 1.

[0051] In accordance with the methods of embodiment of the present invention, the present composition can be fortified with one or more nutrients, especially one or more vitamins, minerals, amino acids and or Omega 3 fatty acids. Any amino acid may be utilized herein, especially the naturally occurring amino acids. In an embodiment, amino acids for inclusion herein are L-lysine.

[0052] In accordance with an embodiment of the present invention, there is provided a method wherein the present composition is administered to a mammal, preferably a human. Preferably such administration is oral.

[0053] Administration of the present compositions may be via any systemic method; however, such administration may also be oral. Typically such administration is as a dietary supplement, two (2) capsules daily with food. It can be taken as 2 capsules together once a day or 1 capsules twice a day or as directed by a healthcare professional. Other dosages of the present compositions will vary. As one of ordinary skill will recognize such variations are largely dependent upon factors such as age, gender, weight, and health state of the consumer, all such variations contemplated by the present invention.

[0054] In another embodiment, the compositions and methods of the present invention may include bioflavonoids.

[0055] In another embodiment, the compositions and methods include bioflavonoids, extracted from a natural source selected from one or more of plants or foods consisting of grape seeds, onions, parsley, legumes, green tea, and citrus fruits. In another embodiment, the compositions and methods of the present invention may include natural grape seed extract bioflavonoids. In another embodiment, the compositions and methods may include bioflavonoids selected from one or more of the group consisting of: Oligomeric Proanthocyanidins (also known as Procyanidolic oligomers), Epicatechin, Genistein, Hesperidin, Quercetin, Rutin, Narirutin, Naringin, Hesperetin, Neohesperidin, Tangeretin, Nobiletin and Sinensetin. In another embodiment, the compositions and methods may include bioflavonoids extracted from natural grape seeds that comprise Oligomeric Proanthocyanidins (OPC's).

[0056] A particularly potent bioflavonoid, Oligomeric Proanthocyanidins (OPC's), are thought to be potent antioxidants possessing 20 times the antioxidant power of vitamin C and 50 times the antioxidant power of vitamin E. Grapes contain beneficial compounds called flavonoids, which are phyto-nutrients that give the vibrant purple color to grapes, grape juice and red Wine; the stronger the color, the higher the concentration of flavonoids. These flavonoid compounds include Quercetin, as well as a second flavonoid-type compound (falling into the chemical category of Stilbene) called resveratrol. In addition to resveratrol and Saponins, grapes contain yet another compound called Pterostilbene, powerful antioxidants that are already known to fight cancer and may also help lower cholesterol. Researchers have found not only an increase in blood anti-oxidant activity, but also discovered that grape juice protected LDL cholesterol from oxidation, a phenomenon that can turn LDL into an artery-damaging molecule. Although LDL is often called the "bad" form of cholesterol, it becomes harmful when damaged by free radicals or "oxidized."

[0057] In a specific embodiment, the composition of embodiments of the invention includes another natural product coenzyme Q-10 (ubiquinone or CoQIO). CoQIO is an antioxidant and anti-inflammatory agent that has been demonstrated to reduce systolic and diastolic blood pressure in both rodents and humans. In eight human clinical trials, CoQIO decreased the mean systolic blood pressure by 16 mm Hg and the mean diastolic blood pressure by 10 mm Hg, which is comparable to the effects of the standard antihypertensive drugs. Because it has been demonstrated that CoQIO further lowers blood pressure in patients taking antihypertensive drugs and further protects against blood pressure variability, the present invention recognizes that CoQIO acts synergistically with the other known natural products to control hypertension.

[0058] In an embodiment, the composition of embodiments of the invention includes another efficacious antihypertensive composition comprising the amino acid arginine. This amino acid changes into Nitric Oxide (NO). Nitric Oxide is a powerful neurotransmitter that helps blood vessels relax and also improves circulation.

[0059] Arginine may help improve blood flow in the arteries of the heart and may improve symptoms of clogged arteries, chest pain or angina, and coronary artery disease. Because Arginine may help arteries relax and improve blood flow, it may also help with erectile dysfunction. There are other potential health benefits with Arginine, such as possible reduction of blood pressure in some people and improved walking distance in patients with intermittent leg cramping and weakness known as intermittent claudication.

[0060] In an embodiment, embodiments of the present invention also include a glidant. The glidant can be any known USP grade glidant including, e.g., Silicon Dioxide.

[0061] In an embodiment, the glidant is colloidal Silicone Dioxide. In one embodiment, the glidant is present at less about 3% by weight of the formulation. In another embodiment, the glidant is present at less about 2% of the formulation. In a preferred embodiment, the glidant is present at less than about 1% by weight of the formulation.

[0062] Fillers useful in the formulation include those commonly known to the skilled artisan. Typical fillers include, but are not limited to cellulose preparations such as Methyl Cellulose, Hydroxypropyl Methylcellulose, Sodium Carboxymethyl Cellulose, Polyvinylpyrrolidone, and mixtures thereof. Microcrystalline cellulose can also function as a compression agent as well as filler. [0063] In an embodiment the filler/ compression agent is microcrystalline cellulose. In one embodiment, the filler is present at less than about 50% by weight of the formulation. In another embodiment, the filler is present at about 2% to about 20% by weight of the formulation including, for example, at about 8% to about 9%, at about 9% to about 10%, at about 10% to about 11%, at about 11% to about 12%, and at about 12% to about 13% by weight of the formulation. In an embodiment, the filler is present at about 10% by weight of the formulation. All ranges within each of the above ranges are within the scope of the present invention.

[0064] Release agents or lubricants useful in the formulation include those commonly known to the skilled artisan. Typical lubricants include, but are not limited to Stearate, Magnesium Stearate, Zinc Stearate, Calcium Stearate, Stearic Acid, Hydrogenated Vegetable Oils (e.g., hydrogenated cottonseed oil), Sodium Stearyl Fumarate, Glyceryl Palmitostearate, Glyceryl Behenate, Sodium Benzoate, Sodium Lauryl Sulfate, Magnesium Lauryl Sulfate, Mineral Oil, Talc, and mixtures thereof. In an embodiment, the lubricant is Magnesium Stearate. In other embodiments, lubricants are chosen so as to insure optimal absorption and utilization of nutrients. In one embodiment, the lubricant is present at less than about 20% by weight of the formulation. In another embodiment, the lubricant is present at about 2% to about 20% by weight of the formulation. In an embodiment, the lubricant is present at about 10% by weight of the formulation.

[0065] Formulations used in embodiments of the present invention provide methods comprising a pharmaceutical carrier according to conventional pharmaceutical compounding techniques. The carrier may take a wide variety of forms depending on the form of the preparation desired for oral administration. In preparing the formulations for oral dosage form any of the usual pharmaceutical media may be employed. In an embodiment, the oral solid preparations are tablets and gel caps. Alternatively, the formulations of the present invention may be incorporated into a Gelatin capsule. In another embodiment, the formulation may be incorporated within a Gelatin capsule. [0066] Combination Treatment for Hypertension

[0067] Studies show that many people obtain better control of blood pressure with combination treatment than with one drug. Many medications are used in combination to help control high blood pressure. The goal is clear: control hypertension and one can lower the risk of heart disease.

[0068] Combination treatment means another class of blood pressure medication is added to a first drug to increase effectiveness. Frequently, one drug cannot control high blood pressure. Healthcare providers may increase the dose or change the medication, yet the blood pressure stays high. That is when a second drug may be added. Sometimes, patients with higher blood pressure need combination treatment — even initially— to bring it to a normal range. Combination treatment for hypertension is individualized. It gives the best possible control of blood pressure with the fewest side effects. Also, combination treatment may cost less. There may be less frequent doctor visits as the drug combination effectively manages the hypertension.

[0069] The complimentary and synergistic benefit of the embodiments of the present invention offer both consumers and healthcare providers alike an alternative option for the treatment and or maintenance of hypertension. This unique formula can be taken as a standalone treatment option as well as a beneficial adjunct to an existing blood pressure regimen.

[0070] While the foregoing is directed to embodiments of the present disclosure, other and further embodiments of the invention may be devised without departing from the basic scope thereof. It is understood that various embodiments described herein may be utilized in combination with any other embodiment described, without departing from the scope contained herein. Further, the foregoing description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. No element, act, or instruction used in the description of the present application should be construed as critical or essential to the invention unless explicitly described as such.

[0071] It must be understood that the present invention is in no way limited to the above embodiments, combinations and amounts of each ingredient according to all claims, and that many changes may be brought thereto without departing from the scope of the invention as defined by the appended claims.

[0072] The foregoing discussion of the present invention has been presented for purposes of illustration and description. It is not intended to limit the present invention to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the present invention are grouped together in one or more embodiments, configurations, or aspects for the purpose of streamlining the disclosure. The features of the embodiments, configurations, or aspects may be combined in alternate embodiments, configurations, or aspects other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention the present invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment, configuration, or aspect. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of the present invention.

[0073] Moreover, though the description of the present invention has included description of one or more embodiments, configurations, compositions, methods or aspects and certain variations and modifications, other variations, combinations, and modifications are within the scope of the present invention, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments, configurations, or aspects to the extent permitted, including alternate, interchangeable and/ or equivalent compositions, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/ or equivalent compositions, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

CLAIMS What is claimed is:

1. A composition of material for imparting cardiac benefits comprising:

about 25 mg to about 400 mg by weight of magnesium or a pharmaceutically acceptable salt thereof;

about 100 mg to about 750 mg by weight of 1-arginine;

about 50 mg to about 450 mg by weight of celery seed;

about 100 mg to about 400 mg by weight of grape seed extract; and about 10 mg to about 600 mg by weight of coenzyme q-10.

2. The composition of claim 1 further comprising :

about 2% to about 28% by weight of magnesium or a pharmaceutically acceptable salt thereof;

about 7% to about 52% by weight of 1-arginine;

about 3% to about 28% by weight of celery seed;

about 7% to about 28% by weight of grape seed extract; and about 1% to about 41% by weight of coenzyme q-10.

3. The composition of claim 1 further comprising :

about 7% to about 52% by weight of L-arginine;

about 3% to about 28% by weight of celery seed;

about 7% to about 28% by weight of grape seed extract; about 1% to about 41% by weight of coenzyme q-10;

about 1% to about 10% by weight of microcrystalline cellulose; and less than about 1% by weight of silicon dioxide in an optimized dose formulation.

4. The composition of claim 1 further comprising:

about 12% to about 38% by weight of magnesium or a pharmaceutically acceptable salt thereof;

about 17% to about 62% by weight of L-arginine; about 13% to about 38% by weight of celery seed;

about 17% to about 38% by weight of grape seed extract; about 11% to about 51% by weight of coenzyme q-10;

about 2% to about 20% by weight of microcrystalline cellulose; and less than about 1% by weight of silicon dioxide in an optimized dose formulation.

5. The composition of claim 1 further comprising:

about 22% to about 48% by weight of magnesium or a pharmaceutically acceptable salt thereof;

about 27% to about 72% by weight of L-arginine;

about 23% to about 48% by weight of celery seed;

about 27% to about 48% by weight of grape seed extract; about 21% to about 61% by weight of coenzyme q-10;

about 0.5% to about 30% by weight of microcrystalline cellulose; and less than about 2% by weight of silicon dioxide in an optimized dose formulation.

6. The composition of claim 1 further comprising:

about 42% to about 68% by weight of magnesium or a pharmaceutically acceptable salt thereof;

about 47% to about 92% by weight of L-arginine;

about 43% to about 68% by weight of celery seed;

about 47% to about 68% by weight of grape seed extract; about 41% to about 81% by weight of coenzyme q-10;

about 0.5% to about 30% by weight of microcrystalline cellulose;

about 0.5% to about 20% by weight of is magnesium stearate; and about 2% by weight of silicon dioxide in an optimized dose formulation.

7. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the celery seed is standardized to about 20% to about 60% 3-n-butylphthalide.

8. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the grape seed extract is standardized to about 50% to about 98% proanthocyanidins.

9. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the composition is for management of hypertension specifically related to cardiovascular health.

10. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the composition is for improving overall cardiovascular health of an individual.

11. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the components act in a synergistic manner to provide maximum beneficial effect to the cardiac benefits of an individual.

12. The composition according to claim 1, wherein the components synergistically lower the risks of cardiovascular diseases.

13. The composition according to claim 12, wherein the cardiovascular diseases further comprises a disease selected from a group consisting of ischemic heart disease, stroke, hypertensive heart disease, hypercholesterolemia, atherosclerosis, restenosis, thrombosis and poor circulation.

14. The composition of claims 1, 2, 3, 4, 5 or 6 wherein the composition is most effective in:

regulating both systolic and diastolic blood pressure;

reducing water retention;

reinforcing the body's defense against harmful free radicals;

increasing capillary strength in individuals effected with hypertension and diabetes; and

increasing cellular energy production.

15. A method for treating a subject having a cardiovascular disorder, said method comprising administering a therapeutic effective amount of composition comprising magnesium, L-arginine, celery seed, grape seed extract, coenzyme q-10 in an optimized dose to a subject in need thereof.

16. A method of claim 15, wherein the cardiovascular disorder is selected from the group consisting of: ischemic heart disease, stroke, hypertensive heart disease, atherosclerosis, restenosis, thrombosis and poor circulation, unregulated blood pressure and combinations thereof.

17. A method for the management of hypertension specifically related to cardiovascular health comprising administering a therapeutic effective amount of a composition comprising magnesium, L-arginine, celery seed, grape seed extract, and coenzyme q-10.

18. A method according to claim 17, wherein cardiovascular health of a patient is improved specific to blood pressure control.

19. A method of maintaining cardiac functionality through oral intake of a formulation comprising 250 mg of coenzyme-q-10; 300 mg of celery seed; 300 mg of grape seed extract; 500 mg L-arginine; 100 mg of magnesium.

20. A method of effectively preventing, ameliorating or inhibiting cardiovascular diseases comprising regularly administering to an individual a therapeutic effective amount of composition comprising magnesium, L-arginine, celery seed, grape seed extract, and coenzyme q-10.