MXPA06011027A - Multi-vitamin and mineral nutritional supplements - Google Patents

Abstract

The invention provides a nutritional supplement which includes micronutrients to facilitate reduction of cholesterol, and/or reduction of homoystein and/or reduction of low-density lipoprotein-cholesterol (LDL-C) oxidation in humans. In one embodiment the supplement is a multi-vitamin, a mineral supplement which includes at least one component known to reduce cholesterol. The invention further provides a method for tableting one fourth to one half of the daily effective dosage of a phytosterol containing nutritional supplement in a practical sized tablet and a method for reducing blood cholesterol in humans.

Description

MULTIVITAMINIC AND MINERAL NUTRITIONAL COMPLEMENTS Field of the Invention This invention relates to nutritional supplements. The features of the invention include the provision of multivitamins and / or mineral supplements of ingredients and micronutrients to facilitate the reduction of cholesterol, and / or reduction of homocysteine, and / or reduction of oxidation of low density lipoprotein cholesterol (LDL- C) in humans. In particular, the invention is related to. multivitamin and / or mineral supplements which include at least one component known to reduce cholesterol. Background of the Invention It has been established for a long time that a number of chemical compounds typically referred to as vitamins and minerals provide significant value in maintaining an individual in a healthy state and / or treating specific medical conditions even when they are supplied in relatively small amounts. Over the years a variety of such vitamins and minerals have been identified. For example, vitamins include A, C, D, E and the family of B vitamins and the minerals include iron, zinc, calcium and chromium. The human body does not synthesize 1-a majority of these compounds which are essential to maintain health REF: i75654 of the human body. In this way these necessary vitamins and minerals - they must be obtained from an external source. The two most common external sources are food and nutritional supplements. Food is typically the primary source for obtaining the necessary nutrients; however, most people do not eat foods that consistently provide the necessary daily requirements of vitamins and minerals. In this way, the nutritional supplement of vitamins and minerals has become a recognized method to meet accepted medical and healthy standards. • While certain vitamins and minerals have been shown to be essential for maintaining the health of an individual, the use of nutritional supplements of vitamins and minerals has produced the possibility of including micronutrients which, although not absolutely essential for maintaining health, they provide significant benefit to maintain health. For example, U.S. Pat. No. - €, 3"61.8O0 for" Cooper et al. provides a multivitamin complement preparation with a nutrient composition which is proposed to decrease plasma levels of homocysteine and plasma glucose levels. A significant health issue for many individuals is the problem of high cholesterol. While many medications are available to treat this problem, most common medications require doctor supervision for use and are relatively expensive. Certainly medical care and the use of these medications in cases of highly elevated or chronically elevated cholesterol are very important but medications are used when the level of cholesterol is a serious health issue. Some - vitamin and / or mineral and / or nutritional herbal / natural compounds that contain phytosterols, compounds which are believed to facilitate the reduction of cholesterol, are commercially available. However, the efficiency of these herbal / natural product compositions for reducing cholesterol is questionable since they typically contain 20 to 50 mg of phytosterol per dose.

This is substantially below the amount that the FDA (Food and Drug Administration) recognizes as an effective dose of phytosterol to reduce cholesterol levels.

In 21 CFR 101.83 dated February 14, 2003, the FDA indicates that -800 mg / day is the lowest effective intake of phytosterols to reduce the risk of coronary heart disease. • Therefore, it may be desirable to have a convenient, practical and relatively inexpensive way to facilitate reducing cholesterol levels, and / or reduce homocysteine, and / or decrease the oxidation of LDL-C in humans before the cholesterol reaches a level that becomes a danger to health. SUMMARY OF THE INVENTION The present invention provides a nutritional supplement which facilitates providing an adequate intake of vitamins, minerals and other desirable micronutrients for disease prevention, protection against nutritional losses and deficiencies due to inadequate dietary intake patterns of style factors. of vi and provide micronutrients to facilitate the reduction of cholesterol, and / or reduction of homocysteine, and / or reduction of LDL cholesterol in humans. The invention also provides a method for preparing an effective dose of the nutritional supplement in a practical dosage form and a method for reducing the levels of cholesterol and / or LDL cholesterol and / or homocysteine in humans. In one embodiment the invention provides a nutritional supplement for administration to humans which comprises: an effective amount of at least one vitamin selected from the group consisting of Vitamin A; Vitamin C; Vitamin E, Vitamin B6, Vitamin B2, folate and Vitamin Ba2, and an effective amount of at least one cholesterol-lowering agent selected from the group consisting of phytosterols, phytostanols, policosanols and statins.

In one embodiment the invention provides a nutritional supplement for administration to humans which comprises: an effective amount of at least one mineral selected from the group consisting of selenium, chromium and zinc, and an effective amount of at least one reducing agent • Cholesterol selected from the group consisting of phytosterols, phytostanols, policosanols and statins. In one embodiment, the invention provides a nutritional, uitivitamin and mineral supplement for administration to humans which comprises at least a cholesterol-lowering agent from the group consisting of phytosterols, phytostanols, policosanols and statins in an amount effective to reduce cholesterol and an effective amount of vitamins A, B2, B? , B? 2, folate (folic acid), and E. The composition may further comprise at least one of an effective amount of lycopene and an effective amount of selenium. In another embodiment, the invention provides a multivitamin and mineral nutritional supplement for administration to humans which comprises pharmaceutically acceptable forms of the following: at least about 800 mg of phytosterols; at least about 3500 I.U of vitamin A and / or vitamin A precursors; at least approximately -d? «Mg of vitamin C; for approximately 400 I.U. of vitamin D; at least about 30 I.U of vitamin E; at least about 25 mcg of vitamin K; approximately 1.5 mg of thiamine; at least about 1.7 mg of vitamin B2 (riboflavin); at least about 20 mg of niacin; at least about 5 mg of vitamin Be; at least about 800 mcg of folic acid; at least about 200 mcg of vitamin Bi2; at least about 30 mcg of biotin; at least about 10 mg of pantothenic acid; at least about 6 mg of iron; approximately 150 mcg of iodine; at least about 210 mg of magnesium; at least about 7.5 mg of zinc; at least about 20 mcg of selenium; at least about 0.7 mg of copper; at least about 2 mg of manganese; at least about 108 mg of calcium; at least about 80 mg of phosphorus; at least about 75 mcg of molybdenum; at least about 320 mcg of boron; at least about 5 mcg of nickel; at least about 2 mg of silicon; at least about 10 mcj of-tin; at least about 10 mcg-vanadium; at least about 120 mcg of chromium; at least about 64 mg of potassium; at least about 7-8 mg of chlorine; at least about 300 mcg of lycopene; and at least about 250 mcg of lutein.

Another embodiment of the invention provides a multivitamin and mineral nutritional supplement for administration to humans which comprises pharmaceutically acceptable forms of the following: at least one ingredient to facilitate the reduction of cholesterol, at least one ingredient to facilitate the reduction of homocysteine or facilitate the reduction of low density lipoprotein (LDL-C) cholesterol and approximately 1300 IU to approximately 10,000 IU of vitamin A and / or vitamin A precursors; approximately 200 I.U to 2000 I.U of vitamin D; about -0 mcg to about 50 mcg of vitamin K; about 1.2 mg to about 4.5 mg of thiamine; about 5 mg to about 40 mg of niacin; about 0 to about 550 mg of choline; about 0 mcg to about 1400 mcg of folic acid; about 0 mcg to about 300 mcg of biotin; about 0 mg to about 16 mg of pantothenic acid; about 0 mg to about 18 mg of iron; about 0 mcg to about 300 mcg of iodine; about 0 mg to about 100 mg of magnesium; about 3 mg to about 15 mg of zinc; about 0 mg to about 2 mg of copper; about 0 mg to about 6 mg of manganese; about 0 to about 200 mg of calcium; about 0 mg to about 750 g of phosphorus; about 0 mcg to about 250 mcg of molybdenum; about 0 mcg to about 150 mcg of boron; about 0 mcg to about 10 mcg of nickel; about 0 mg to about 40 mg of silicon; approximately 0 mcg; to about 35 mcg of tin; about 0 mcg to about 25 mcg of vanadium; about 0 mcg to about 300 mcg of chromium; about O mg to about 125 mg of potassium; about 0 mg to about 120 mg of chlorine; about 0 to 3 g of Omega-3 fatty acids; about 0 to 3 g of lycopene; about 0 to 3 g of zeaxanthin; and about 0 mcg to about 3 g of lutein. The ingredients for ~ facilitating cholesterol reduction may comprise one or more of the following ingredients in an amount effective to reduce cholesterol: phytosterols, phytostanols, or their equivalents, in free or esterified form, policosanol and statins. Suitable statins include, for example, atorvastatin, provastatin, simvastatin, lovastatin, or flavastatin. Typical and approximately 0.8 grams to approximately 3 grams of phytosterol. This oil or its equivalents can be used in nutritional multivitamin and mineral supplements. Policosanol amounts of up to about 200 mg can be used in multivitamin and mineral nutritional supplements. Statins can be used in amounts of up to 80 mg and are typically used in amounts of about 40 mg to about 80 mg. More particularly with respect to statins, provastatin and simvastatin are preferably used in amounts of about 40 mg, and atorvastatin, lovastatin and fluvastatin are typically used in amounts of about 80 mg. The ingredients for facilitating homocysteine reduction may comprise one or more of the following: up to about 40 mg of vitamin B2 (riboflavin); to approximately 10 mg of vitamin B6; up to about 1 mg of folate, and up to about 2 mg of vitamin B? 2. The ingredients for facilitating homocysteine reduction may more preferably comprise one or more of the following: about 1.3 mg to about 5.1 mg of vitamin B2 (riboflavin): up to about 1400 about 800 mcg of folate; about 1 mg to about 6 mg of vitamin B; and about 2. mcg to about 200 mcg of vitamin Bl2- The ingredients to facilitate the oxidation reduction of low density lipoprotein (LDL-C) cholesterol, which may comprise one or more of the following: up to about 2-grams of vitamin C; up to approximately 800 I.U. of vitamin E; up to about 6 grams of lycopene; and up to about 350 mcg of selenium. The ingredients for facilitating the oxidation reduction of cholesterol, low density lipoprotein cholesterol (LDL-C), may more preferably comprise one or more of the following: about 45 mg to about 250 mg of vitamin C; approximately 20 I.U to approximately 200 I.U of vitamin E; about 0 mcg to about 3 g of lycopene; and about 0 mcg to about 75 mcg of selenium. The composition described herein may further include a diluent such as, for example, a calcium compound, magnesium compound, microcrystalline cellulose, starch or a combination thereof. The composition described herein may also include an absorbent such as silicon dioxide, for example. In some embodiments, the silicon dioxide can be precipitated, smoked or a mixture thereof. The invention further provides a method for reducing cholesterol levels, reducing "homocysteine, and • decreasing the oxidation of low density lipoprotein (LDL-C) cholesterol in humans by administering the composition of the invention to a human. includes a method for tableting nutritional supplements which comprise at least one phytosterol, the method comprising: providing at least one phytosterol and at least one diluent: granulating phytosterol and at least one diluent under high shear granulation conditions to form a granulation, grind the -granulation; and add an absorbent to the granulation. For wet granulation methods, the method may further comprise drying the granulation and the absorbent - it is preferably added after drying. A fluid bed dryer is an example of a dryer suitable for drying the granulation. The method may comprise compressing the granulation to form a tablet. The tablet can be coated with a film coating comprising polyvinyl alcohol (PVA for its acronym in English), for example. In one embodiment, an effective daily amount of nutritional supplement comprises two tablets, each of the two tablets having a volume of 2 cubic centimeters. In one embodiment, a daily effective amount of the nutritional supplement comprises four tablets or less. Each tablet that has a volume of less than 1.5 cubic centimeters. In some embodiments, the tablets may have an obloid, oval, modified oval, or capsular conformation.

Alternatively, a daily effective amount of the nutritional supplement may comprise one or more capsules, one or more chewable delivery units, a powder, or a sachet. Brief Description of the Figures Figure 1 is an end view of an exemplary embodiment of a tablet of the composition of the invention. Figure 2 is a top view of an example embodiment of a tablet of the composition of the invention; Figure 3 is a side view of an example embodiment of a table of the composition of the invention; Figure 4 is a graph which shows the disintegration data of tablets for tablets of two exemplary embodiments of the composition of the invention in water; and Figure 5 is a graph which shows the disintegration data of tablets for tablets of two example embodiments of the invention in acid. Detailed Description of the Invention The invention provides a nutritional supplement which in one embodiment is a nutritional muitivitamin and mineral supplement for administration to humans, which has at least one ingredient to facilitate cholesterol reduction. The cholesterol-lowering ingredient may include phytosterols and / or stanols, and / or statins, and / or policosanol. In some embodiments, the nutritional supplement also includes at least one ingredient for homocysteine reduction and / or reduction of low density lipoprotein cholesterol (LDL-C). The multivitamin and mineral nutritional supplement may comprise one or more of: vitamin A and / or vitamin A precursors; vitamin C; vitamin D; Vitamin E; vitamin K; thiamine; vitamin B2 (riboflavin); niacin; vitamin Bg; folic acid; vitamin B? 2; biotin: pantothenic acid; iron; iodo; magnesium; zinc; selenium; copper; manganese; calcium: phosphorus; molybdenum; boron; nickel; silicon; tin; vanadium; chrome; potassium; chlorine; Choline: lycopene; and lutein. When administered to a human on a regular basis (eg, daily); the composition of the invention facilitates the adequate intake of vitamins and minerals and the provision of other micronutrients to promote good health including micronutrients which facilitate lowering cholesterol levels, and / or reducing homocysteine, and / or decreasing oxidation of low density lipoprotein cholesterol (LDL-C) in humans. In other embodiments, the nutritional supplement may include one or more vitamins in combination with at least one ingredient that reduces cholesterol, or at least one mineral in combination with at least one ingredient that lowers cholesterol. The terms "nutritional supplement" or "complement" should be taken to refer to any or all of the -modalities (e.g., a multivitamin and mineral supplement with at least one cholesterol-lowering agent, a composition which comprises at least one vitamin and at least one agent that reduces cholesterol, or a composition which comprises at least one mineral and at least one agent that lowers cholesterol). The nutritional supplement may "in some embodiments also comprise other assets such as, for example, assets that decrease homocysteine or one or more different assets that provide a nutritional and / or health benefit. A preferred embodiment of the invention is a multivitamin and mineral supplement with at least one agent that decreases cholesterol, since such a supplement provides a simple method for managing nutritional deficiencies and promotes compliance in use by an individual in need of supplementation. nutritional The invention further provides a method for preparing solid dosage forms which comprise components of nutritional supplements - in effective amounts in a unit or units compatible with convenient human consumption. (For example, in a dosage form in which a daily effective amount of at least one supplement of vitamin and / or mineral and at least one ingredient that lowers cholesterol is contained in 2-4 tablets of a size that an adult human can practically swallow). Typically the number and amount of vitamin and mineral components necessary to provide an effective daily dose to generally supplement nutritional deficiencies constitutes the substantial volume of tablet. The provision of an additional component in the supplement to facilitate the reduction of cholesterol also increases the volume. of the material to be included in a dosage form. Prepare a solid dosage form which contains effective amounts of a significant number of vitamins and minerals and phytosterol in a unit of practical doses, for example, is particularly challenging to that with a minimum of 800 mg of fistoterol per day that is necessary to meet the FDA standard for efficacy and phytosterol is a wax material with a low volume density. The inventors have addressed these problems by developing a preparation method (eg, manufacturing process) that employs granulation techniques and / or the use of diluent and / or the use of absorbent excipients to prepare a tabletted dosage form which comprises effective daily amounts of the components of the nutritional supplement in preferably 2-4 tablets of a tablet size suitable for being swallowed by a human. As used herein, the phrase "cholesterol lowering agent" or "cholesterol lowering agent" means any compound, combination of compounds, including any naturally occurring or processed plant extract or component, or synthetic compound having the property of lowering cholesterol levels when administered in an effective amount. All amounts specified herein are based on milligrams unless otherwise indicated. The term "I.U" represents the international units. The term "mcg" means micrograms, "mg" means milligrams, and "g" means grams. Furthermore, it should be understood that the amounts of components described herein are for a daily dose and that a daily dose may comprise a dosage unit or a plurality of dosage units. "An effective dose" of a nutrient is at least the minimum amount of the nutrient needed on a daily basis recognized by the United States Food and Drug Administration (FDA) to provide a nutritional or healthful benefit. In addition, it is noted that in some guidelines the FDA recommends that daily doses of multivitamin and mineral supplements are divided and administered in two units of doses taken at separate intervals during the day. Typically, with meals or food, for example such as twice a day with meals. Therefore the amounts are given for daily doses but it must be understood that the daily dose may be in multiple dose units and the consumption of these units may occur at the same time or different times during the day.

Typically, sterols and stems derived from plant sources are named phytosterols and phytostanols. Phytosterols and phytostanols are natural compounds that can be consumed regularly as part of a healthy diet. Accordingly, while plant-derived materials are the preferred source of these compounds, the equivalents of tin and stear, or tin and sterols synthesized from other sources, can be used in the practice of the invention. Any reference to using phytosterol or phytosetals herein should be taken to apply to equivalent sterols or steels from alternative sources. It should be understood that in terms of discussing amounts of the composition, the tin or phytostanols may be used in a similar amount or vice versa. There are multiple specific chemical entities classified as phytosterols, including but not limited to beta-sitosterol, campesterol, and stigmasterol. for example. For the nutritional supplements of this invention either a species - simple specific phytosterol chemistry or mixtures comprised of a plurality of specific phytosterol-specific species may be employed. For example, a mixture of phytosterols having beta-sitosterol, campesterol and sig asterol as main components is an example of a mixture suitable for use in the practice of the invention. Commercial preparations of mixed phytosterols are available from suppliers such as Cargill and ADM (Archer Daniels Midland), for example. Similarly, the class of phytostanols includes multiple specific chemical species of phytostanols and a specific chemical species of phytostanol or a mixture of a plurality of specific chemical species of phytostanols can be used in the practice of the invention. Accordingly, with reference to phytosterols or phytostanols in compositions discussed herein should be taken to include both forms of simple specific chemical species as well as mixtures. Foods such as fruits, vegetables, breads and other whole grain products, and most vegetable oils contain at least some phytosterols. However, it is difficult to consume enough of these foods - on a daily basis to obtain - enough phytosterol intake to have a cholesterol lowering effect. Based on clinical trial data on the use of phytosterols in the diet, a daily intake of at least 0.8 grams (800 mg) of phytosterols as part of a diet low in saturated fat and cholesterol is recommended by the FDA to provide significant reducing benefits of cholesterol. 'Consuming the nutritional supplements of this invention is a way to ensure that an effective daily intake is obtained.

It is believed, but in the present invention it is not desired to be bound by any theory, that ingested plant sterols and stems compete with cholesterol to decrease cholesterol absorption and resorption in the small intestine since they are structurally similar to cholesterol. At this point, the more sterol, such as phytosterol, in free form that is present in the intestine after a meal, the less absorption and reabsorption of cholesterol will occur. In addition, phytosterols, phytostanols consumed and their equivalents, are not absorbed to any appreciable extent. Therefore, phytosterols that are believed to inhibit the uptake of cholesterol by the body are discarded through the system without absorption. One study showed that the total effect may be a total decline in blood levels of "bad" low density lipoprotein cholesterol (eg, "LDL-C") of 8-15% without adverse effects seen or identified. (See "Plant Sterol-Fortified Orange Juice Effectively Lowers Cholesterol Lev is in Mildly Hypercholesterolemic Healthy Individuals." Arterioscler, Thromb. Vasc. Biol. 2O04 Sea; 24 (3): e25-8, Epub 2004 Feb 05). Preferably, the multivitamin and mineral nutritional supplement comprises up to about 3 g of the free form of the esterified form of phytosterols and more preferably at least about 800 mg of phytosterols. More preferably, the supplement comprises about 800 mg of phytosterols in the free form. In some embodiments, phytosterol can be replaced with phytostanols or a combination of phytosterols and phytostanols can be used. Policosanol is the generic term used for a mixture of primary aliphatic saturated large chain alcohols that can reduce total serum cholesterol and low density lipoprotein (LDL-C) cholesterol levels. Policosanol is also known as policosanol, policosanal, policosino, policosanal, policosinal and policosinol. These alcohols are derived from the waxes of such plants such as sugar cane (Saccharum offiainarium) and sweet potatoes (for example Dicscor & a). They are also found in beeswax. The main large chain alcohol in policosanol is 1-octanosol of 28 carbons, and the most abundant is 1-triacontanol of 30 carbons. Other long-chain alcohols present in much lower concentrations include: 1-docosonal (C22), 1-tetracosanol (C2), 1-hexacosanol iC2ß) # 1-heptacosanol (-C27), 1-nonacosanol (C2g), 1-dotriacontanol (C32) and 1-tetracontanol -i * C34). These long chain alcohols are solid waxy substances and are insoluble in water. They are collectively known as aliphatic alcohols. The mechanism of action of. • Policosanol reported cholesterol-lowering activity is unknown and the inventors do not wish to join any theory. Several theories regarding the method of action of policosanol have been suggested in the literature including the suggestion of some studies in animals that policosanol can inhibit cholesterol synthesis in the liver by indirectly down-regulating HMG-CoA reductase. (see "Policosanol Safety Dow Regulates HMG-CoA Reductase-Potential As A Component of the Esselstyn Regimen" Med. Hypotheses 202 Sept; 59 (3): 268-79). Others have suggested that policosanol can damage cholesterol synthesis between the stages of acetate and mevalonate production and / or increase the LDL-C processing dependent on the receptor. (see, "Policosanol: Clinical Pharmacology and Therapeutic Significance of a New Lipid-Lowering Agent" Am. Heart J. 2002 Feb; 143 (2): 356-65). Others have suggested that policosanol can also reduce lipid peroxidation (see "Effect of Policosanol on In Vitro and In Vivo Rat Liver Microsomal Lipid Peroxidation." Arch. Med Res. 1997 Autumn; 28 (3): 355-60). It is believed that the large chain alcohols appear to have different biological activities, for example, octacosanol itself may not have the same activities as policosanol and that at least in some cases the combination of all or some of the alcohols in The policosanol can work si-nergistically. In one modality, policosanol is included in the multivitamin and nutritional nutritional supplement. The modality of the multivitamin and mineral nutritional supplement-including policosa-nol comprises up to about 200 mg of policosanol and more preferably about 10 to about 20 mg of policosanol. Statins that include atorvastatin, pravastatin, simvastatin, lovastatin, and fluvastatin, are believed to be competitive 3-hydroxy-3-methyl glutaryl CoA, after which they are referred to as HMGCoA reductase inhibitors. Accordingly, they are believed to be effective in reducing cholesterol, and are believed to be effective in preventing not only recurrent heart attacks, but also the first heart attacks. In some cases, statins may also reduce the risk of heart attacks. In one modality the statins They can be included in the multivitamin and mineral nutritional supplement. The form of nutritional supplement which includes the statins may comprise up to about 80 mg of a statin or a mixture of statins and more preferably comprises about 5 to about 80 mg of a statin or a mixture of statins. Provastatin and simvastatin are referentially used in amounts of approximately 80 mg. Several vitamins and minerals are known to facilitate cholesterol reduction, reduction of homocysteine and / or reduction of lipoprotein cholesterol - low density. By providing one of these agents, or a combination thereof, in a multivitamin and nutritional mineral supplement, this invention provides a relatively inexpensive, convenient and convenient way to facilitate the reduction of cholesterol levels, and / or reduce homocysteine levels. , and / or decrease the oxidation of LDL-C in humans. Vitamin C, also known as ascorbic acid, is believed to be necessary for the synthesis of collagen and is used as an antioxidant. It is believed that Vitamin C helps against infections, reduces inflammation, heals wounds, reduces the risk of heart ase by reducing oxidation of LDL-C, lowers cholesterol, reduces the risk of lung, stomach and esophagus cancers, reduces cervical epithelial abnormalities, inhibits N-nitrosamine and reduces the severity of colds. The nutritional supplement may comprise up to about 2000 mg of Vitamin C, more preferably and about 45 mg to about 250 mg, and more preferably and about 60 mg of Vitamin C. Vitamin E is necessary for the maintenance of cell membranes and for health neurological Vitamin E helps against hot flashes, aids in mastodynia, helps fight fibrocystic ase, reduces breast tumors, reduces the risk of lung cancer, and reduces the risk of heart ase by reducing oxidation. LDL-C cholesterol. Vitamin E is the generic term for a group of related substances, which include alpha-tocopherol, beta-tocopherol, gamma-tocopherol, and delta-tocopherol. In addition, each of these four compounds has a "d" form, which is the natural form, and a "di" form, which is the synthetic form. All forms of substances covered by Vitamin E are included in this. The nutritional supplement may comprise up to about 15-00 I.U of vitamin?, And more preferably and about 15 I.U to about 800 I.U. More preferably, the multivitamin complement and mineral nutritional supplement may comprise approximately 20 I.U. to 200 I.U of Vitamin? The nutritional supplement may comprise one or more B vitamins. The B vitamins included in the nutritional supplement may include thiamin (Vitamin B2), riboflavin (Vitamin B2), niacin (Vitamin B3), pantothenic acid (Vitamin B5), pyridoxine ( Vitamin B6), biotin, folic acid, and cobalamins (Vitamin B? 2) or a combination thereof. The B vitamins are soluble in water. Of these vitamins, B2, B6, B? 2 * (? Or example or cobalamines), are known to reduce homocysteine levels. However, due to the nature of the B vitamins, in general, all of these are contemplated for use in one embodiment of the invention. Vitamin Bi or thiamine helps maintain connective and mucosal membranes rich in healthy collagen, helps maintain smooth muscles, aids in the formation of blood cells, and is necessary for proper function of the nervous system. The nutritional supplement may comprise about 0.9 mg to about 100 mg, more preferably and about 1.2 mg to about 4.5 mg and more preferably and about 1.5 mg of thiamine. Vitamin B2 or riboflavin is necessary for healthy hair, nails and mucous membranes and is involved in the formation of red blood cells, reduction of homocysteine, production of antibodies and total growth. The nutritional supplement of the invention may comprise up to about 40 mg of riboflavin, more preferably and about 0.9 mg to about 5.1 mg and more preferably and about 1.3 to 1.7 mg of riboflavin. Vitamin B3 or niacin helps in the production of most sex hormones, dilates blood vessels and helps maintain blood circulation. Niacin is the generic name for a group of compounds, which exhibit niacin activity and includes niacinamide and nicotinic acid. The nutritional supplement may comprise about 5 mg to about 500 mg of niacin, more preferably and about 5 mg to about 40 mg and more preferably and about 20 mg of niacin as niacinamide. Vitamin B6 or pyridoxine is involved in the production of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA), reduction of homocysteine, and many other reactions in the body. Pyridoxine refers to and includes three different compounds: pyridoxine, pyridoxamine and pyridoxal. The nutritional supplement may comprise about 1 mg to about 10 mg of Vitamin Be, more preferably and about 1 mg to about 6 mg, and more preferably and about 5 mg of Vitamin Be. Folic acid is used in the production of red blood cells, the production of hormones, and the synthesis of DNA. The nutritional supplement may comprise up to about 1000 mcg of folic acid, more preferably and about 0 mcg to about 800 mcg of folate (folic acid), and more preferably, about 800 mcg of folic acid. Vitamin B 2 (for example cobalamines) is necessary for total metabolism, nervous system function, folic acid metabolism, homocysteine reduction, and the production of red blood cells. There are at least three active forms of cobalamin: cyanocobalamin; hydroxocobalamin and nitrocobalamin. The nutritional supplement may comprise up to about 20Og mcg of Vitamin B 2, more preferably and about 2.4 mcg to about 200 mcg, and more preferably and about 200 mcg of Vitamin B 2. Biotin is necessary for the metabolism of carbohydrates, proteins and fats and is necessary for healthy skin and hair. The nutritional supplement may comprise up to about 900 mcg of biotin and more preferably and about 0 mcg to about 300 mcg, and more preferably and about 30 -mcg of biotin. Pantothenic acid, also known as Vitamin B5, is important for the production of hormones from the adrenal gland, increases total energy, and helps convert food into energy. The nutritional supplement may comprise up to about 20 mg of pantothenic acid, more preferably and about 0 mg to about 10 mg, and more preferably, about 10 mg of pantothenic acid. Vitamin A is also contemplated for use in the multivitamin and mineral nutritional supplement of the invention. Vitamin A prevents night blindness and other eye disorders, maintains moisture and elasticity of the skin, keeps hair healthy, skin and gums, reduces the risk of breast cancer, helps relieve mastodynia, reduces the risk of cancer of lung, maintains the cellular structure and integrity, works as an antioxidant to prevent cell aging, helps prevent infection, and prevents skin wrinkles and the effects of 2% sun damage. Vitamin A is a fat-soluble vitamin. The term vitamin A is used to include retinol and other chemically similar compounds referred to as retinoids. In the practice of the invention, vitamin A can be provided as a form of vitamin A, as carotenoids of the precursor of vitamin A, such as beta-carotene, or as a mixture thereof. For example, in a typical embodiment 29% of vitamin A can be provided as beta-carotene, with the rest supplied as vitamin A acetate. The nutritional supplement of the invention can comprise up to about 10,000 I.U. of vitamin A including vitamin A precursors, more preferred and approximately 1300 I.U. to approximately 5000 I.U. and more preferably and about 3500 I.U of vitamin A in the form of Vitamin A or vitamin A and the precursor of vitamin A eta-carotene. Beta-carotene and other carotenoids are provitamins, that is, vitamin precursors, and are converted to vitamins or vitamin-like substances, as the body requires. Although the carotenoids include lutein, zeaxanthin and lycopene, the amounts of these compounds are specifically specified herein and any amounts of vitamin A precursors described herein should not be construed to include any appreciable amount of lutein, zeaxanthin or lycopene. Vitamin D is also an essential mineral which helps in the mineralization and calcification of bones, prevents rickets in children, prevents osteomalacia in adults, preserves bones and teeth growth, and lowers blood pressure. Vitamin D is soluble in fat and colcalciferol or D3 is the preferred form. Preferably, the nutritional supplement can comprise up to about 2000 I.U of vitamin D and more preferably and about 2U0 to about 400 I.U. of vitamin D. Vitamin K is an active blood coagulation agent and helps in the formation of bones. It can also help remove calcium from atherosclerotic plaques. Phylloquinone or II and menoquinone or K2 are the preferred forms. Preferably, the nutritional supplement can comprise up to about 1 mg of vitamin K, more preferably and about 0 mcg to about 90 mcg of vitamin K and more preferably and about 25 mcg of vitamin K. Choline is necessary for function of the nervous system and function cerebral. It is also important for the glandular bladder and liver function. Choline helps maintain the structural integrity of membranes that surround every cell in the body but can also play a role in signaling - nerve, cholesterol transport, and energy metabolism. In the nutritional supplement, the choline can be provided in the form of a pharmaceutically acceptable choline salt, such as, for example, bitartarate. The nutritional supplement may optionally comprise up to about 3500 mg of choline, and more preferably, from about 50 mg to about 550 mg of choline in the form of choline bitartarate. Iron is used in the production of hemoglobin and myoglobin. In the nutritional supplement, the iron is dosed in the form of a pharmaceutically acceptable iron compound. As used herein, "pharmaceutically acceptable" is a component which is suitable for use in humans without prolonged side effects, such as irritation, toxicity, and allergic response. The pharmaceutically useful acceptable iron compounds include, but are not limited to, ferrous fumarate, ferrous sulfate, ferrous carbonyl, ferrous gluconate, ferrous chloride, ferrous lactate, ferrous tartrate, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous choline isocitrate , ferrous carbonate, iron-sugar-carboxylate complexes and combinations thereof. The nutritional supplement may comprise up to about 18 mg of iron dosed in a pharmaceutically acceptable iron compound and more preferably, about 5 g to about 18 mg of iron.

Iodine helps metabolize fats, is necessary for proper function of the thyroid, and reduces fibrocystic breast conditions. In the nutritional supplement of the invention, the iodine is dosed in the form of a pharmaceutically acceptable iodine compound. Useful pharmaceutically useful iodine compounds include, but are not limited to, potassium iodide, sodium iodide, and combinations thereof. The nutritional supplement may comprise up to about 1100 mcg of dosed iodine in the form of a pharmaceutically acceptable iodine compound, more preferably up to about 150 mcg, and more preferably, about 150 mcg of iodine. Magnesium is used in the formation and growth of bone, prevents bone loss, relaxes the coronary arteries, is used to treat pre-eclampsia, treat cardiac arrhythmias, and manage diabetes. In the nutritional supplement, the magnesium is dosed in the form of a pharmaceutically acceptable magnesium compound. The pharmaceutically useful acceptable magnesium compounds include, but are not limited to, magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium sulfate and combinations thereof. The nutritional supplement may comprise up to about 400 mg of magnesium dosed in the pharmaceutically acceptable form of magnesium compound, more preferably up to about 350 mg, and more preferably, about 100 mg of magnesium. Zinc is required for proper formation of DNA and RNA and is necessary for the growth, immunity and sexual development of women. In the multivitamin and mineral nutritional supplement of the invention, the zinc is dosed in the form of a pharmaceutically acceptable zinc compound. The pharmaceutically acceptable zinc compounds include, but are not limited to, zinc sulfate, zinc chloride, zinc oxide and combinations thereof. The nutritional supplement may comprise about 3 mg to about 40 mg of zinc dosed in the form of a more preferably pharmaceutically acceptable zinc compound and about 3 mg to about 15 mg and more preferably about 15 mg of zinc. Selenium reduces the risk of heart attacks and heart disease reduces the risk of cancer, protects against metal poisoning and is believed to be synergistic with vitamin E to reduce the oxidation of LDL cholesterol. The pharmaceutically acceptable selenium compounds include but are not limited to sodium selenate, selenocysteine, selenomethionine or other amino acid chelates, and combinations thereof. The nutritional supplement may comprise up to about 400 mcg of selenium more preferably up to about 75 mcg and more preferably and about 15 mcg to about 75 mcg of selenium dosed in a pharmaceutically acceptable form. Copper helps maintain elastic blood vessels, is necessary for the formation of elastin and collagen, functions as an iron oxidant, and is necessary for the proper functioning of Vitamin C. In the nutritional supplement, it is dosed into a compound of pharmaceutically acceptable copper. The pharmaceutically acceptable copper compounds include, but are not limited to, cupric oxide, cupric citrate, cupric sulfate, cupric carbonate, cupric gluconate, and combinations thereof. The nutritional supplement may comprise up to about 10 mg of copper metered in the form of a pharmaceutically acceptable copper compound, and more preferably, about IO mg of copper metered in the form of gluconate, sulfate or cupric citrate. Calcium is necessary for the body to build and maintain strong bones and teeth, facilitate neural transmission, and regulate muscle contraction and heartbeat. Calcium - is lost through damaged skin, nails, hair sweat, urine and feces. If the intake is not enough, the body can remove calcium from the bone to obtain the mineral which can adversely affect bone density and lead to bones being more susceptible to damage. The pharmaceutically acceptable calcium compounds include, but are not limited to, calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium gluconate, calcium lactate, calcium citrate and combinations thereof. The nutritional supplement may comprise up to about 1500 mg of calcium, more preferably up to about 200 mg and more preferably and about 100 mg to about 162 mg of calcium dosed - in a pharmaceutically acceptable form. A low level of manganese in the body can be associated with diabetes. Therefore, manganese seems to have a role in the control of blood sugar levels. Manganese may also have a role in the metabolism of amino acids and certain vitamins. The pharmaceutically acceptable manganese compounds include, but are not limited to, manganese chloride, manganese sulfate, and combinations thereof. The nutritional supplement may comprise up to about 12 mg of manganese dosed in a pharmaceutically acceptable form more preferably the nutritional supplement may comprise about 0 mg to about 4 mg of manganese and more preferably and about 1 mg of manganese. It is believed that silicon is to be used for the accumulation of collagen in bones and connective tissue. Pharmaceutically acceptable silicone compounds include, but are not limited to, sodium silicate, sodium silicoaluminate, sodium dioxide, and combinations thereof. The nutritional supplement may comprise about 0 mg to about 500 mg of silicon dosed in a more preferred pharmaceutically acceptable form and about 0 mg to about 60 mg of silicon, and more preferably and about 2 mg of silicon. Molybdenum can facilitate the proper metabolism of fats, carbohydrates and iron and can protect against certain cancers. The pharmaceutically acceptable molybdenum compounds include, but are not limited to, sodium molybdate, molybdenum amino acid chelates, and combinations thereof. The nutritional supplement may comprise up to about 2000 mcg of molybdenum dosed in a pharmaceutically acceptable form. More preferably the nutritional supplement may comprise about 0 mcg to about 75 mcg, and more preferably the nutritional supplement comprises about 75 mcg of molybdenum. It is believed that vanadium has a role in the regulation of blood sugar levels. The pharmaceutically acceptable vanadium compounds include, but are not limited to, vanadium tartrate and ammonium, sodium metavanadate, vanadyl sulfate and combinations thereof. The nutritional supplement may comprise up to about 1.8 mg of vanadium in a more preferred pharmaceutically acceptable form and about 6 mcg to about 18 mcg of vanadium and more preferably and about 10 mcg of vanadium. Boron may have a role in mineral metabolism. Pharmaceutically acceptable boron compounds include, but are not limited to, sodium borate, boron citrate, amino acid chelates and boron, and combinations thereof. The nutritional supplement can comprise up to about 0 mcg to about 1.35 mg of boron, and more preferably and about 150 mcg to about 350 mcg of boron. Nickel can activate or inhibit the action of some enzymes or hormones. The pharmaceutically acceptable nickel compounds include, but are not limited to, nickel sulfate. The nutritional supplement may comprise up to about 1.0 mg of nickel dosed in a pharmaceutically acceptable form, more preferably and about 0 mcg to about 100 mcg of nickel and more preferably and about 5 mcg of nickel. It is known that tin is found in the human body. In rats a tin deficiency can depress growth. Pharmaceutically acceptable tin compounds include, but are not limited to, stannous chloride. The nutritional supplement may comprise up to about 2-00 mcg of dosed tin in a more preferred pharmaceutically acceptable form and about 0 mcg to about 10 mcg of tin and more preferably and about 10 mcg of tin. Phosphorus is necessary for bone development and is a constituent in all major classes of biochemical compounds. Phosphorus, in the form of adenosine phosphate n triphosphate is a key energy source required for most metabolic processes. Pharmaceutically acceptable phosphorus compounds include, but are not limited to, forms of calcium phosphate, sodium phosphate, potassium phosphate, ammonium phosphate, glycerol phosphate, and combinations thereof. The nutritional supplement may comprise up to about 1250 mg of phosphorus, more preferably and about 0 mg to 750 mg, more preferably and about 1-09 mg of phosphorus, dosed in a pharmaceutically acceptable form. Chromium helps in the regulation of glucose metabolism, is used in the synthesis of fatty acids and cholesterol, helps - in transporting proteins, lowers blood levels of LDL, and increases blood levels of high density lipoproteins. In the nutritional supplement, the chromium is dosed in a pharmaceutically acceptable chromium compound. The pharmaceutically useful chromium-acceptable compounds include, but are not limited to, chromium chloride, chromium linked to yeast, picolinate, chromium linked to niacin, and combinations thereof. The nutritional supplement may comprise up to about 10 mg of chromium dosed in a more preferred pharmaceutically acceptable form and about 0 mcg to about 150 mcg of chromium, and more preferably and about 120 mcg of chromium. Potassium is necessary to regulate water balance, acidity levels, blood pressure and neuromuscular function. Potassium is also required for carbohydrate metabolism proteins. In the nutritional supplement, the potassium is dosed in the form of a pharmaceutically acceptable potassium compound. Useful pharmaceutically useful potassium compounds include, but are not limited to, potassium chloride, potassium sulfate, potassium glycerophosphate, potassium citrate, potassium gluconate, potassium phosphate, and combinations thereof. The nutritional supplement may comprise up to about 3900 mg of potassium dosed in a pharmaceutically acceptable form of the more preferred potassium compound and about 0 mg to about 80 mg of potassium, and more preferably and about 50 mg to about 80 mg of potassium.

It has been found that lycopene reduces the risk of cancer and has also been found to decrease the oxidation of LDL cholesterol through its antioxidant capacities. Lycopene is found mainly in tomatoes, red grapes, watermelon, and other sources, and is a carotenoid. The nutritional supplement may comprise up to about 6 g of lycopene, more preferably and about 0 mcg to about 3 g of lycopene and more preferably and about 300 mcg of lycopene. Lutein and zeaxanthin are carotenoid antioxidants that help maintain healthy eye vision, and have been found to reduce the risk of cancer and heart disease. It has been found that lutein decreases the risk and prevents the progress of macular degeneration, the leading cause of blindness in those over 65 years. Lutein and zeaxanthin are found mainly in yellow corn, egg yolk, spinach, broccoli and other green leafy vegetables. The nutritional supplement may comprise up to about 6 g of lutein in a more preferred pharmaceutically acceptable form and about 0 mcg to about 3 g of lutein and more preferably and about 250 mcg of lutein. The nutritional supplement can comprise up to about 6 g of zeaxanthin in a pharmaceutically acceptable form, more preferably about 0 mcg to about 3 g of zeaxanthin and more preferably and about 300 mcg of zeaxanthin. Epidemiological and intervention tests have shown a cardiovascular benefit from increased levels of Omega-3 fatty acids. In a recent meta-analysis (2002) Bucher et al observed the beneficial effects of Omega-3 fatty acids in randomized controlled trials. This analysis includes 11 tests with 7951 patients. Bucher et al. "N-3 Polyunsaturated Fatty Acids in Coronary Heart Disearch: A MetaAnalysis of Randomized Control Triais", Am. J. Med .; March 2002, 112 (4): p. 298-304. The tests include both dietary sources and supplements of Omega-3 fatty acids. They confirm a statistically significant 30% reduction in the rate of sudden cardiac death in the population with increased intakes of Omega-3 fatty acids from both the diet and source of supplements. Preferably the nutritional supplement comprises up to about 6 g of Omega-3 fatty acids, more preferably and about 0 g to about 3 g and more preferably and about 1 g of Omega-3 fatty acids. Chloride is necessary to help maintain the ionic and fluid balance in the body, and is an essential component of gastric and intestinal secretions. The pharmaceutically useful chlorine-useful compounds include, but are not limited to, sodium chloride, chromium chloride, stannous chloride and potassium chloride. The multivitamin and mineral nutritional supplement preferably comprises up to about 100 mg of chloride, more preferably and about 0 mg to about 80 mg and more preferably and about 50 mg to about 75 mg of chloride. The multivitamin and mineral nutritional supplement of the invention is proposed for oral administration and can be provided in a solid form. In addition to the active material, the multivitamin and mineral nutritional supplement may also comprise excipients and processing aids such as: absorbers, diluents, flavorings, colorants, stabilizers, fillers, binders, disintegrants, lubricants, wetting agents, glidants, anti-adherents, sugar or film coating agents, preservatives, buffer, artificial sweeteners, natural sweeteners, dispersants, thickeners, solubilizing agents and the like or some combinations thereof. The dosage forms of the present invention are typically considered to be solid. However, they may contain liquid or semi-solid components. Suitable "solid dosage forms" of the present invention include, but are not limited to, tablets, dragees, capsules which include soft gel capsules, chewable dosage forms and sachets and the like. The daily dose may be included in a single delivery unit or may comprise multiple delivery units. Dividing the daily dose between the multiple delivery units may be desirable if a tablet is used, for example, to provide a tablet size which is convenient to swallow. If the multiple delivery units are used, they can be administered at one time or administered at intervals during the dose period (eg, typically one day) if desired. The current FDA guidelines recommend that the daily dose be divided and administered in two units of doses taken at separate intervals. However, at present it is noted that - at least three current clinical studies indicate once that the daily dosage of phytosterols is - effective, - (see Plat J, et al: Effects on Serum Lipids, Lipoproteins and Fat Soluble Antioxidant Concentrations of Consuption Frequency of Margarines and Shortenings Enriched With Plant Sterol Esters, Eur J. Clin. Nutr 2000, 54.-671-677; Matvieno OA et al. A Single Daily Dose of Soybean Phytosterols in Ground Beef Decr aces Serum Total Cholesterol and LDL Cholesterol in Young Mildly HyperCholesterolemeic Men. Am J Clin Nutr 2002, 76: 57-64; and Volpe, -R. et al. Effects of Yogurt Enriched With Plant Sterols on Serum Lipids in Patients With Modérate • Hypercholesterolemia. British Journal of Nutrition. 2001; 86: 233-39). It should therefore be understood that the amounts of the vitamins, minerals and reducing agents described herein are for a daily dose and that the dose can be delivered in a single delivery unit or multiple delivery units. In some embodiments, the packaging design can be used to facilitate the identification of the appropriate daily dose to the consumer. For example, a vial packet with a label to indicate a daily dose can be used. Tableting compositions containing sterols such as phytosterol present challenges. Phytosterol has a waxy nature, is hydrophobic, typically does not flow well in micronized form and has a low bulk density. These properties cause problems during the process of forming the tablet (tabletting), which includes, but is not limited to, taking and gluing the materials to tools, the materials that stick to the press change during compression and there is poor control of the weight of the tablet. In addition, phytosterol is difficult to -moil because it has to cover the sieve of the mill unless it is criomuela. Prior to the present invention, "phytosterol concentrate tablets typically exhibit poor compressibility and once compressed have a disintegration of the tablet which adversely impacts the supply of the phytosterol after ingestion." It is believed that disintegration in time is important for the In the present it is believed, without wishing to be bound by any theory, that phytosterol acts in a primary particle form in the gastrointestinal lumen.It has been surprisingly discovered that the use of certain granulation methods can produce a tablet. which contains at least half of the effective daily dose of phytosterol and at least one other mineral vitamin in a single tablet which has a size that can be swallowed by a human.In addition, the tablet of the invention disintegrates into primary particles in a time consistent with the time of gastric emptying, for example the compacted phytosterol that contains The tablet of the invention is believed to disintegrate substantially before reaching the gastrointestinal lumen. In an embodiment at least half of the effective daily dose of phytosterol and at least half of the effective daily dose of a plurality of vitamins and minerals are tabletted into a single tablet that can be swallowed by a human and which is disintegrates in time consistent with gastric emptying. In an embodiment in which an effective daily dose of the nutritional supplement is contained in two tablets, it is preferable that the volume of each tablet be less than about 2 cubic centimeters. In another embodiment, an effective daily dose of the nutritional complement of the invention is tabletted in four tablets or less each of a size that can be swallowed by a human. Preferably when an effective daily dose is contained in three or four tablets each tablet has a volume of about 1.5 cubic centimeters or less. The conformation of the tablet of a nutritional supplement is believed to contribute to several factors that can improve user compliance. In the present it is believed, without wanting to sustain any theory, that the compact ovoid, oval, oval modified and capsular conformation of approximately 1.5 cubic centimeters in volume or less, for example is easier for a consumer to swallow than those, for example, the compact round ones of approximately 1.5 cubic centimeters or less, for example. In some cases tablets that are easier to swallow can improve user compliance with dosing regimen. Figures 1 to 3 show an example embodiment and any other conformations may be equally suitable in the practice of the invention. In one embodiment, the tablets can be prepared using a high shear wet granulation method. In the exemplary high shear wet granulation method, the phytosterol is granulated with at least one diluent. The diluent may comprise one or more of the mineral inorganic nutrients described herein, such as, for example, a magnesium compound, or calcium compound, other active agents; inactive diluents such as, for example, celluloses, cellulose derivatives, lactose or other sugars, polyols, starches, starch derivatives, polymers or a mixture thereof. Using one or more of the mineral inorganic nutrients as the diluent or a portion of the diluent has the advantage of minimizing added excipients and facilitates the formation of a smaller tablet. Dibasic calcium phosphate, and magnesium oxide are examples of the specific magnesium and calcium compounds which both act as a nutrient and are useful as diluents. These diluents are an example and other diluents and granulation components or mixtures thereof known to those skilled in the art can be used for granulation. Other granulation excipients known to those skilled in the art can be added such as povidone, disintegrants, co-integrators, super-disintegrants, surfactants, glidants, lubricants and binders. In addition, other assets such as low dose mineral assets can be included in the granulation mixture. The inclusion of other low dose activities in the granulation may only contribute modestly to the granulation properties but the addition to the granulation mixture facilitates the uniform distribution of these low dose actives. In an exemplary embodiment the mixture subjected to granulation comprises the phytosterol, diluents, the polyvinylpyrrolidone binder (PVP), crosprovidone excipients, and water. The water is slowly added to the remaining ingredients while they are mixed in a high shear granulator. Optionally the granulation can be dried. The drying can be carried out in a fluid bed dryer, for example! The granulation is milled to a suitable particle size. In an example embodiment, a 0.05 sieve is used. However, an expert in the art will appreciate that this is an example and other sizes can be employed. After grinding, the milled granulation is mixed with an absorbent. Silicon dioxide is an example of a suitable absorbent. Other materials known to those skilled in the art as absorbers can also be used in the practice of the invention. Other vitamins, minerals and cholesterol-lowering agent can be mixed in the granulation-grinding with an absorbent preferably in an ordered mixture after a portion of the absorbent is combined with the granulation. These additional components may be added as simple ingredients, preformed mixtures or a combination thereof. Other excipients such as flavorings, colorants, stabilizers, fillers, binders, disintegrants, lubricants, grinding agents, glidants, anti-adherents, preservatives, buffers, sweeteners, dispersants, thickeners, solubilizing agent and the like or the combination thereof can be optionally included.

After mixing the composition can be formed into tablets using compression methods, for example. Optionally the tablets can be coated using materials and tablet coating methods such as those known to those skilled in the art. The wax nature of phytosterols has been discovered to make difficult adhesion of a film coating material to the core of the tablet. The inventors have discovered that satisfactory adhesion can be obtained by using an aqueous-based film coating system which comprises polyvinyl alcohol. Furthermore, it is believed herein without wishing to be bound by any theory, that using a film coating comprising polyvinyl alcohol can improve patient compliance by producing a tablet that is easier to swallow. The inventors believe without wishing to be bound by any theory that their discovery of ordered mixing of the granulation of phytosterol with absorbent to coat or partially coat the granules facilitates the disintegration of the tablet. In this way the discovery of the present handles the problems that untreated wax phytosterols tend to form compact with longer disintegration times which are undesirable. Compacts of untreated compacts similarly pass through the gastrointestinal tract with minimal, if any, disintegration, to primary particles which are believed to be necessary for efficacy. In the present invention it is further believed that the physical nature and size of the absorbent particle can modify the rate of disintegration of the tablet. For example, it has been found in the present invention that when silicon dioxide absorbent is used in a 1: 8 w / w ratio with phytosterols, less disintegration is observed with a smoked silicon dioxide of about 0.2-0.3 microns in size. particle and approximately 200 square meters per gram of surface area than with a precipitated silicon dioxide of approximately 7 microns in particle size and approximately 300 square meters per gram of surface area. In the present invention it is believed that it is preferable to use precipitated silicon dioxide as described above as the absorbent for an immediate release of phytosterol nutritional supplement and that a smoked silicon dioxide as described above as the absorbent can be used to modulate the disintegration speed. Since the nature and physical size of the absorbent seems to impact the rate of disintegration in some embodiments it may be desirable to use a mixture of absorbent types and / or particle size to facilitate obtaining the desired disintegration profile. Although silicon dioxide is referred to as an absorbent herein, in the present invention it is noted that silicon dioxide can also function as an adsorbent (eg, it can be a sorbent). For the purposes of this description, the distinction between absorbent and adsorbent is not critical and should be taken as reference to the absorbent to include absorbent, adsorbent, sorbents or combinations thereof. Figures 4 and 5 show the example disintegration date for two examples of the composition of the invention in water and acid, respectively. All the examples in Figures 4 and 5 have decay times compatible with the timely disintegration in the gastrointestinal tract. However, the times vary depending on the shape of the silicon dioxide used as shown in Figures 4 and 5. The high shear granulation method described herein is an example of a suitable method for preparing the composition of the invention . The inventors also note that the wet granulation method described herein does not require expensive criomolide. Alternatively, methods such as dry block, compact dry roll or extrusion can be used to prepare the compositions of the invention. Optionally the nutritional supplement can be provided in a liquid and / or semi-solid preparation. In addition to the active material such liquid and / or semi-solid preparations may include excipients and processing aids such as: flavoringsdyes, stabilizers, buffers, artificial sweeteners, natural sweeteners, sequestering and / or chelating agents, dispersants, thickeners, solubilizing agents, humectants, antioxidants, emulsifiers, water, ethanol, glycerine, propylene glycol and the like or some combination thereof same. The amount of the active material in a dose of the muitivitamin preparation unit is varied according to the particular application and potency of the active ingredients. The determination of the appropriate dose for a particular situation is within the skill of the art. Optionally, the multivitamin and mineral nutritional supplement can be presented in a controlled release formulation. Although the composition of the invention is preferably proposed for administration to humans it should be understood that the formulation can also be used in veterinary applications for animals. Example 1 Nutritional supplement imiltivitamin and mineral The composition of an example embodiment of the invention is given in table 1. This composition is representative and is one of many compositions that are within the scope of the invention and is provided for illustrative purposes. The multivitamin and mineral nutritional supplement exemplified in Example 1 is proposed to be a daily dose and typically can be administered in one or more dosage units (eg, one to four tablets). If multiple dose units are used they can be taken at a separate time or intervals during the day. TABLE 1 Example 2 Nutritional multivitamin and mineral supplement The composition of another embodiment of the invention is given in Table 2. This is another composition representative of the composition within the scope of the invention and is provided for illustrative purposes. The multivitamin and mineral nutritional supplement of Example 2 is proposed to be a daily dose and typically can be administered in one or more unit doses (for example one to four tablets). If multiple dose units are used they can be taken at a time or at separate intervals during the day. TABLE 2 Example 3 Multivitamin and mineral nutritional supplement The composition of another exemplary embodiment of the invention is provided in Table 3. This is another composition representative of the composition within the scope of the invention and is provided for illustrative purposes. The multivitamin and mineral nutritional supplement of Example 3 is proposed to be a daily dose and typically can be administered in one or more dosage units (eg, one to four tablets). If multiple dose units are used they can be taken at a time or at separate intervals during the day. TABLE 3 Example 4 Method for preparing a nutritional supplement An exemplary multivitamin and mineral nutritional supplement is prepared which comprises a plurality of nutritional supplement components of vitamins and minerals and phytosterol using the following wet granulation method. Phytosterol is broken down using a low energy oscillation system equipped with a sieve. The discarded phytosterol is then transferred to a high shear granulator and combined with MgO, and dibasic calcium phosphate diluents (which are also active), ZnO a low dose mineral active, microcrystalline cellulose, super disintegrant and binder of Polyvinylpyrrolidine are added to the granulation pot. The granulation is initiated with low speed mixing and water is added gradually with mixing to form an acceptable granulation. A person skilled in the art is familiar with the appearance and physical characteristics of an acceptable granulation. Once the acceptable granulation is obtained, the granulation is dried in a fluid bed dryer with air at an airflow temperature of about 90 ° C. The granulation is dried at a moisture content of no more than about 1.5% w / w as determined by an infrared loss in drying equilibrium. The dry granulation is cooled and milled at a medium speed, with blades forward using a 0.50 sieve. Approximately half of the milled granulation is placed in an oblique cone mixer, followed by a mesh sieved silicon dioxide. #twenty. The rest of the milled granulation is added and the mixture is mixed. Additional active ingredients and excipients which include ascorbic acid and vitamin E acetate, dibasic calcium phosphate (a second portion), chromium chloride, sodium molybdate, stannous chloride, sodium metavanadate, nickel sulphate, sodium selenate, sodium sulphate, manganese, biotin, vitamin K, riboflavin, thiamine mononitrate, potassium iodide, niacinamide, copper sulfate, calcium pantothenate, pyridoxine hydrochloride, folic acid, cyanocobalamin, potassium chloride, ferrous fumarate, vitamin A acetate, beta -carotene, vitamin O3, lycopene, lutein, croscarmellose sodium, -crospovidone, and microcrystalline cellulose (second portion) are added and mixed for approximately 10 minutes. The magnesium stearate is screened through a # 20 mesh screen is added to the composition and mixing is continued for approximately 1.5 minutes.

The granulation of this obtained form is compressed into tablets using tabletting techniques known to those skilled in the art using a tableting tool with an oval shape. In the present invention it is believed that compact obloid, modified oval, and capsular can be easier to consume by swallowing than compact rounds of similar volume. In this embodiment, an effective daily dose of phytosterol and the indicated vitamins and minerals is tabletted in two tablets each tablet having a volume of approximately 1.2 cm 3. The tablets are then coated using an aqueous-based film coating system which comprises polyvinyl alcohol. Although the invention mentioned herein has been described - in the form of illustration and examples for purposes of clarity of understanding it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims. Modification of the modes described above for practicing the invention that are obvious to persons skilled in the art and is proposed to be included within the scope of the following claims. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention.

Claims (3)

1. CLAIMS Having described the invention as described above, the content of the following claims is claimed as property: 1. A nutritional supplement for administration to humans characterized in that it comprises: an effective amount of at least one vitamin selected from the group consisting of the vitamin TO; vitamin C; vitamin B6; vitamin-B2; folate; Vitamin Bi2; Vitamin E; and an effective amount of at least one cholesterol reducing agent selected from the group consisting of phytostanols; phytosterols, policosanols, and statins.
2. 2. A nutritional supplement for administration to humans characterized in that it comprises: an effective amount of at least one mineral selected from the group consisting of sel-enium, chromium and zinc, and an effective amount of at least one cholesterol-lowering agent selected of the group - which consists of phytosterols, phytostanols, policosanols and statins. 3. A nutritional and mineral supplement for administration to humans characterized in that it comprises: an effective amount of vitamin A; an effective amount of vitamin C; an effective amount of vitamin B6; an effective amount of vitamin B2; an effective amount of folate; an effective amount of vitamin B? 2; an effective amount of vitamin E; and at least one cholesterol reducing agent selected from the group consisting of phytosterols, phytostanols, policosanols and statins wherein the at least cholesterol-lowering agent is present in an amount effective to reduce cholesterol. . The composition according to claim 3, characterized in that it also comprises at least an effective amount of lycopene and an effective amount of selenium. 5. A nutritional supplement for administration to humans, characterized in that it comprises: at least about 800 mg of a phytosterol; at least about 3500 I.U of vitamin A and vitamin A precursors of at least about 60 mg of vitamin C; at least about 400 IU of vitamin D; at least about 30 IU of vitamin ?; at least about 25 mcg of vitamin K; at least about 1.5 mg of thiamin; at least about 1.7 mg of vitamin B2 (riboflavin); at least about 20 mg of niacin; at least about 5 mg of vitamin B6; at least about 800 mcg of folic acid; at least about 200 mcg of vitamin B 2; at least about 30 mcg of biotin; . at least about 10 mg of pantothenic acid; at least about 6 mg of iron dosed in the form of a pharmaceutically acceptable iron compound; at least about 150 mcg of iodine dosed in the form of a pharmaceutically acceptable iodine compound; at least about 40 mg of magnesium dosed in the form of a pharmaceutically acceptable magnesium compound; at least about 7.5 mg of zinc dosed in the form of a pharmaceutically acceptable zinc compound; at least about 20 mg of selenium dosed in the pharmaceutically acceptable form of a selenium compound; at least about 0.7 mg of copper metered in the form of a pharmaceutically acceptable copper compound; at least about 2 mg of manganese dosed in the form of a pharmaceutically acceptable manganese compound; at least about 108 mg of calcium dosed in the form of a pharmaceutically acceptable calcium compound; at least about 80 mg of phosphorus metered in the form of a pharmaceutically acceptable phosphorus compound; at least about 75 mcg of metered molybdenum - in a pharmaceutically acceptable molybdenum compound; -at least about 32 mcg of boron dosed in a pharmaceutically acceptable boron compound; at least about 5 mcg of nickel dosed in a pharmaceutically acceptable nickel compound; at least about 2 mcg of silicon metered in a pharmaceutically acceptable silicon compound; at least about 10 mcg of tin dosed in a pharmaceutically acceptable tin compound; at least about 10 mcg of vanadium dosed in a pharmaceutically acceptable vanadium compound; at least about 120 mcg of chromium dosed in the form of a pharmaceutically acceptable chromium compound; • at least about 64 mg of potassium metered in the form of a pharmaceutically acceptable potassium compound; at least about 58 mg of chlorine metered in the form of a pharmaceutically acceptable chlorine compound; at least about 300 mcg of lycopene dosed in the form of a pharmaceutically acceptable lycopene compound; at least about 250 mcg of lutein dosed in the form of a pharmaceutically acceptable lutein compound. . A nutritional supplement for administration to humans, characterized in that it comprises: approximately 800 mg to approximately 3 g of phyllosterol; approximately 1300 I.U to approximately 12,000 I-U of vitamin A; about 45 mg to about 250 mg of vitamin C; approximately 200 IU to approximately 2000 IU of vitamin D; about 20 IU to about 200 IU of vitamin E; about 10 mcg to about 90 mcg of vitamin K; about 1.2 mg to about 4.5 mg of thiamine; about 1.3 mg to about 5.1 mg of vitamin B2 (riboflavin); about 0 mg to about 550 mg of choline; about 5 mg to about 40 mg of niacin; about 1 mg to about 8 mg of vitamin B6; about 0 mcg to about 1400 mcg of folic acid; about 2. mcg to about 400 mcg of vitamin B? 2; about 0 mg to about 300 mcg of biotin; about 0 mg to about 16 mg of pantothenic acid; about 0 mg to about 18 mg of iron dosed in the form of a pharmaceutically acceptable iron compound; about 0 mcg to about 300 mcg of iodine dosed in the form of a pharmaceutically acceptable iodine compound; about 0 mg to about 100 mg of magnesium dosed in the form of a pharmaceutically acceptable magnesium compound; about 3 mg to about 15 mg of zinc dosed in the form of a pharmaceutically acceptable zinc compound; about 15 mcg to about 75 mcg of selenium dosed in the form of a pharmaceutically acceptable selenium compound; about 0 mg to about 10 mg of copper metered in the form of a pharmaceutically acceptable copper compound; about 0 mg to about 6 mg of manganese dosed in the form of a pharmaceutically acceptable manganese compound; about 0 mg to about 200 mg of calcium dosed in the form of a pharmaceutically acceptable calcium compound; about 0 mg to about 750 mg of phosphorus metered in the form of a pharmaceutically acceptable phosphorus compound; about 0 mcg to about 250 mcg of molybdenum dosed in a pharmaceutically acceptable molybdenum compound; about 0 mg to about 1.35 mg boron metered into a pharmaceutically acceptable boron compound; about 0 mg to about 100 mg of nickel dosed into a pharmaceutically acceptable nickel compound; about 0 mg to about 40 mg of silicon dosed into a pharmaceutically acceptable silicon compound; about 0 mg to about 35 mg of tin dosed in a pharmaceutically acceptable tin compound; about 6 mcg to about 25 mcg of vanadium dosed in a pharmaceutically acceptable vanadium compound; about 0 mcg to about 300 mg of chromium dosed in the form of a pharmaceutically acceptable chromium compound; about 0 mg to about 125 mg of potassium metered in the form of a pharmaceutically acceptable potassium compound; about 0 mg to about 120 mg of chlorine metered in the form of a pharmaceutically acceptable chloro compound; about 0 g to about 3 mg of omega-3 fatty acids; about 0 to 3 g of lycopene dosed in the form of a pharmaceutically acceptable lycopene compound; about 0 mg to about 3 mg of zeaxanthin dosed in the form of a pharmaceutically acceptable zeaxanthin compound; and about 0 g to about 3 g of lutein dosed in the form of a pharmaceutically acceptable lutein compound. 7. A nutritional supplement for administration to humans, characterized in that it comprises: up to about 3 g of phytosterols or phytostanols; to about 20 mg of policosanol; up to about 4-0 to 80 mg of statins; up to approximately 10,000 IU of vitamin A and vitamin A precursors to approximately 2 g of vitamin C; approximately 2000 IU of vitamin D; to approximately 1500 IU of vitamin E; up to about 1 mg of vitamin K; to approximately 100 mg of thiamine; up to about 40 mg of vitamin B2 (riboflavin); to approximately 500 mg of niacin; to approximately 10 mg of vitamin B6; up to about 1.5 mg of folic acid; to approximately 2 mg of vitamin Bi2; to about 900 mcg of biotin; to about 200 mg of pantothenic acid; to about 3500 mg of choline dosed in the form of a pharmaceutically acceptable choline compound; to about 18 mg iron dosed in the form of a pharmaceutically acceptable iron compound; to about 1100 mcg of iodine dosed in the form of a pharmaceutically acceptable iodine compound; to about 400 mg of magnesium dosed in the form of a pharmaceutically acceptable magnesium compound; to about 40 mg of zinc dosed in the form of a pharmaceutically acceptable zinc compound; to about 400 mg of selenium dosed in the form of a pharmaceutically acceptable selenium compound; to about 10 mg of copper metered in the form of a pharmaceutically acceptable copper compound; to about 12 mg of manganese dosed in the form of a pharmaceutically acceptable manganese compound; to about 1500 mg of calcium dosed in the form of a pharmaceutically acceptable calcium compound; to about 1250 mg of phosphorus dosed in the form of a pharmaceutically acceptable phosphorus compound; to about 2000 mcg of molybdenum dosed in a pharmaceutically acceptable molybdenum compound; to about 20 mg of boron dosed in a pharmaceutically acceptable boron compound; to about 1 mg of nickel dosed in a pharmaceutically acceptable nickel compound; to about 500 mg of silicon dosed in a pharmaceutically acceptable silicon compound; to about 200 mcg of tin dosed in a pharmaceutically acceptable tin compound; to about 1.8 mg of vanadium dosed in a pharmaceutically acceptable vanadium compound; to about 10 mg of chromium dosed in the form of a pharmaceutically acceptable chromium compound; to about 3900 mg of potassium dosed in the form of a pharmaceutically acceptable potassium compound; to about 150 mg of chlorine metered in the form of a pharmaceutically acceptable chloro compound; to approximately 6 g of Omega-6 fatty acids; to about 6 g of lycopene dosed in the form of a pharmaceutically acceptable lycopene compound; to about 6 g of zeaxanthin dosed in the form of a pharmaceutically acceptable zeaxanthin compound; and up to about 6 g of lutein dosed in the form of a pharmaceutically acceptable lutein compound. 8. The nutritional supplement according to any of claims 1-7, characterized in that it also comprises a diluent. 9. The nutritional supplement according to claim 8, characterized in that the diluent is selected from the group consisting of calcium compounds, magnesium compounds, microcrystalline cellulose, starch and a combination thereof. 10. The nutritional supplement according to any of claims 1-9, characterized in that it also comprises an absorbent. 11. The nutritional supplement according to claim 10, characterized in that the absorber is silicon dioxide. The nutritional supplement according to claim 11, characterized in that the silicon dioxide is selected from the group consisting of smoked silicon dioxide, precipitated silicon dioxide and a mixture thereof. 13. A method for a nutritional supplement for a human which facilitates the reduction of blood cholesterol, characterized in that it comprises providing a human with an effective amount of the nutritional supplement according to any of claims 1-12. 14. A method for making a granulation for use in tabletting a component which comprises a phytosterol, characterized in that it comprises: providing at least one phytosterol and at least one diluent; granulating the phytosterol and the at least diluent under high shear granulation conditions to form a granulation; grind the granulation; and adding an absorbent to the granulation, and compressing the granulation to form a tablet. 15. The method according to claim 14, characterized in that it further comprises adding at least one nutrient selected from the group consisting of vitamins and minerals and mixtures thereof. 16. The method according to claim 14, characterized in that it also comprises drying the granulation. 17. The method according to claim 16, characterized in that the drying is carried out in a fluid bed dryer. 18. The method according to claim 14, characterized in that the diluent comprises at least one mineral. 19. The method according to the claim 14, characterized in that the at least portion of the diluent is selected from a calcium compound and a magnesium compound or a mixture thereof. 20. The method according to claim 14, characterized in that the absorber is silicon dioxide. 21. The method according to claim 20, characterized in that the silicon dioxide is selected from smoked silicon dioxide, precipitated silicon dioxide and a mixture thereof. 22. The method according to claim 14, characterized in that once the tablet is formed, it is coated. 23. The method according to claim 22, characterized in that the tablet is coated with a film coating, the film coating comprising polyvinyl alcohol. 24. The supplement according to any of claims 1 to 12, characterized in that the supplement is in the selected form of a tablet, a lozenge, a capsule, a chewable dose unit, or an envelope. 25. The supplement according to claim 24, characterized in that it is in the form of a tablet. 26. The supplement according to claim 25, characterized in that the tablet is coated. 27. The complement according to claim 26, characterized in that the coating is a film coating. 28. The supplement according to claim 27, characterized in that the film coating comprises polyvinyl alcohol. 2.
3. 3 . A method for a nutritional supplement for a human, wherein the complement reduces or decreases cholesterol, lowers or reduces homocysteine levels or decreases or reduces the oxidation of low density lipoprotein cholesterol characterized in that it comprises providing an effective amount to a human of the nutritional supplement according to any of claims 1-12. 30. The nutritional supplement according to any of claims 1 to 12, characterized in that the daily effective amount of the nutritional supplement comprises two tablets and wherein each of the two tablets has a volume of less than about 2 cubic centimeters. 31. The nutritional supplement according to any of claims 1 to 12, characterized in that a daily effective amount comprises four tablets or less and wherein each tablet has a volume of less than 1.5 cubic centimeters. 32. The nutritional supplement according to claims 30 and 31, characterized in that the tablets have an ovoid, capsular, oval modified or oval conformation. 33. The nutritional supplement according to any of claims 30-32, characterized in that the tablets are coated with a film coating which comprises polyvinyl alcohol.