Novel pharmaceutical or nutritional composition for treating or preventing epilepsy

Abstract

The present invention relates to novel pharmaceutical or nutritional compositions comprising a plurality of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, as well as methods of preparation and their prophylactic or supportive use as adjuvants for anticonvulsive medicaments for the treatment / prevention of various types of epilepsy or epileptic seizures.

Description

Technical Field

[0001] The present invention relates to a novel pharmaceutical composition or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, a preparation method thereof and the preventive or supportive use of the pharmaceutical composition.

[0002] More specifically, the present invention relates to novel pharmaceutical or nutritional compositions for oral administration comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids; methods for their preparation and their preventive or supportive use as adjuvants to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or seizures.

[0003] More specifically, the present invention relates to novel pharmaceutical compositions or nutritional compositions for oral administration comprising a variety of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids suitable for all age groups from pediatrics, adolescents, adults to the elderly, a method for preparing the same, and prophylactic or supportive use thereof as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures. Background Art

[0004] Epilepsy is a central nervous system (neurological) disorder in which brain activity becomes abnormal, triggering a seizure or a period of unusual behavior, sensations, and sometimes loss of consciousness. Epilepsy affects men and women of all races, ethnic backgrounds, and ages.

[0005] Epilepsy affects approximately 50 million people worldwide. It is characterised by recurring seizures, brief episodes of involuntary movements that may involve one part of the body (localized) or the entire body (generalized), sometimes accompanied by loss of consciousness and loss of control of bowel or bladder function.

[0006] An epileptic seizure is the result of an excessive discharge of electricity from a group of brain cells. Different parts of the brain can be the site of these discharges. An epileptic seizure can range from the briefest inattention or muscle twitch to a severe and prolonged convulsion. The frequency of epileptic seizures also varies, from less than once a year to several times a day.

[0007] The types of epilepsy are as follows:

[0008] 1) Generalized epileptic seizures: “grand mal seizures” or generalized tonic-clonic seizures, absence seizures, myoclonic seizures, clonic seizures, tonic seizures, and atonic seizures;

[0009] and

[0010] 2) Partial (focal) seizures: simple partial (no loss of consciousness), complex partial (impaired consciousness), and partial with secondary generalization

[0011] Anticonvulsants (antiepileptic drugs or antiseizure drugs) are a diverse group of pharmacological agents used to treat epileptic seizures. Different types of drugs are used to treat epilepsy, depending on the category or type of seizure / epilepsy.

[0012] Although the anticonvulsant medications listed above have been found to be extremely helpful, these medications may not be appropriate for everyone and, as with any medication, may carry the risk of side effects.

[0013] There is ongoing research around the world to develop alternative drug or nutritional supplement systems that, when used in combination with existing anticonvulsant drugs, can enhance the anti-epileptic effect with minimal side effects.

[0014] Studies have shown that various vitamins, minerals, and amino acids play important physiological roles in epilepsy, and have established a correlation between the deficiency or excess of these vitamins, minerals, and amino acids and the etiology of certain human disease states (such as epilepsy).

[0015] Therefore, there remains a need to develop improved pharmaceutical or nutritional compositions that overcome the disadvantages associated with the products available on the market.

[0016] The inventors of the present invention have unexpectedly discovered that the use of a synergistic combination of multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, which provides the right amounts of the right vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids at the right time to ensure adequate intake of the multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, can be used for preventive or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures.

[0017] The inventors of the present invention have also discovered that a novel pharmaceutical composition or nutritional composition for oral administration comprising high-quality and high-purity multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids exhibits properties such as, but not limited to, stability, ease of administration, ease of dosage adjustment, minimal side effects, high therapeutic efficiency and better patient compliance, wherein the composition indicates its preventive or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures.

[0018] Purpose of the Invention

[0019] The object of the present invention is to provide a novel pharmaceutical composition or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0020] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition, which comprises multiple vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0021] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0022] a) one or more vitamins;

[0023] b) one or more minerals;

[0024] c) one or more coenzymes;

[0025] d) one or more amino acids;

[0026] e) one or more omega-3 fatty acids; and

[0027] f) one or more pharmaceutically acceptable excipients.

[0028] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0029] a) 0.001 mg to 50 mg of one or more vitamins;

[0030] b) 0.001 mg to 500 mg of one or more minerals;

[0031] c) 1 mg to 200 mg of one or more coenzymes;

[0032] d) 1 mg to 800 mg of one or more amino acids;

[0033] e) 1 mg to 1600 mg of one or more omega-3 fatty acids; and

[0034] f) one or more pharmaceutically acceptable excipients.

[0035] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0036] a) 0.001 mg to 20 mg of one or more vitamins;

[0037] b) 0.001 mg to 500 mg of one or more minerals;

[0038] c) 10.0 mg to 150 mg of one or more coenzymes;

[0039] d) 200 mg to 500 mg of one or more amino acids;

[0040] e) 500 mg to 1000 mg of one or more omega-3 fatty acids; and

[0041] f) one or more pharmaceutically acceptable excipients.

[0042] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0043] a) one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, or a combination thereof;

[0044] b) one or more minerals selected from the group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium, or combinations thereof;

[0045] c) one or more coenzymes, such as but not limited to coenzyme Q10 (ubiquinone);

[0046] d) one or more amino acids selected from the group consisting of taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, or a combination thereof;

[0047] e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA) and eicosapentaenoic acid (EPA), or a combination thereof; and

[0048] f) one or more suitable pharmaceutically acceptable excipients.

[0049] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0050] a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride);

[0051] b) 1.0 mcg to 400 mcg of vitamin B9 (folic acid);

[0052] c) 1.0 mcg to 5.0 mcg of vitamin B12;

[0053] d) 1 mcg to 30 mcg of vitamin D3 (cholecalciferol);

[0054] e) 1 mg to 20 mg of vitamin E (tocopherol);

[0055] f) 1 mg to 30 mg of zinc;

[0056] g) 1 mg to 500 mg of magnesium;

[0057] h) 1 mg to 10 mg of manganese;

[0058] i) 1 mcg to 80 mcg of selenium;

[0059] j) 1 mg to 1600 mg of omega 3 fatty acids;

[0060] k) 1 mg to 200 mg coenzyme Q10;

[0061] l) 1 mg to 800 mg taurine (2-aminoethanesulfonic acid); and

[0062] m) one or more pharmaceutically acceptable excipients.

[0063] The object of the present invention is to provide a novel oral pharmaceutical composition or nutritional composition comprising:

[0064] a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride);

[0065] b) 25 mcg to 350 mcg of vitamin B9 (folic acid);

[0066] c) 1.0 mcg to 2.2 mcg of vitamin B12;

[0067] d) 1.0 mcg to 20 mcg of vitamin D3 (cholecalciferol);

[0068] e) 1.0 mg to 15 mg of vitamin E (tocopherol);

[0069] f) 1.0 mg to 20 mg of zinc;

[0070] g) 1.0 mg to 500 mg of magnesium;

[0071] h) 1.0 mg to 5.0 mg of manganese;

[0072] i) 1.0 mcg to 50 mcg of selenium;

[0073] j) 1.0 mg to 1000 mg of omega 3 fatty acids;

[0074] k) 1.0 mg to 150 mg of coenzyme Q10;

[0075] l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid); and

[0076] m) one or more pharmaceutically acceptable excipients.

[0077] Another object of the present invention is to provide a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0078] a) dissolving a plurality of vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids in a suitable solvent or vehicle to obtain a solution;

[0079] b) adding and dissolving one or more suitable pharmaceutically acceptable excipients in the solution of step (a);

[0080] c) filtering the solution of step (b) through a suitable filter; and

[0081] d) Fill into suitable bottles or containers.

[0082] Another object of the present invention is to provide a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0083] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0084] b) sieving one or more suitable pharmaceutically acceptable excipients through a suitable sieve;

[0085] c) pre-lubricating the sieved materials of step (a) and step (b) and mixing them in a suitable blender;

[0086] d) lubricating the above materials and mixing them for a suitable time; and

[0087] e) compressing the mixture of step (d) into a suitable dosage form.

[0088] Another object of the present invention is to provide a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0089] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0090] b) dry mixing the components of step (a);

[0091] c) preparing a binder solution;

[0092] d) granulating the mixture obtained in step (b) using the binder solution obtained in step (c);

[0093] e) drying the particles obtained in step (d);

[0094] f) sieving, mixing and lubricating the dried granules of step (e); and

[0095] g) compressing the granules of step (f) into a suitable dosage form.

[0096] Another object of the present invention is to provide a method of using a novel oral pharmaceutical or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids for prophylactic or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures in patients of all age groups. Summary of the invention

[0097] In one aspect, the present invention discloses novel pharmaceutical compositions or nutritional compositions comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0098] In one aspect, the present invention relates to novel oral pharmaceutical or nutritional compositions comprising a plurality of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0099] In another aspect, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0100] a) one or more vitamins;

[0101] b) one or more minerals;

[0102] c) one or more coenzymes;

[0103] d) one or more amino acids;

[0104] e) one or more omega-3 fatty acids; and

[0105] f) one or more pharmaceutically acceptable excipients.

[0106] In another aspect, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0107] a) 0.001 mg to 50 mg of one or more vitamins;

[0108] b) 0.001 mg to 500 mg of one or more minerals;

[0109] c) 1 mg to 200 mg of one or more coenzymes;

[0110] d) 1 mg to 800 mg of one or more amino acids;

[0111] e) 1 mg to 1600 mg of one or more omega-3 fatty acids; and

[0112] f) one or more pharmaceutically acceptable excipients.

[0113] In another aspect, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0114] a) 0.001 mg to 20 mg of one or more vitamins;

[0115] b) 0.001 mg to 500 mg of one or more minerals;

[0116] c) 10.0 mg to 150 mg of one or more coenzymes;

[0117] d) 200 mg to 500 mg of one or more amino acids;

[0118] e) 500 mg to 1000 mg of one or more omega-3 fatty acids; and

[0119] f) one or more pharmaceutically acceptable excipients.

[0120] In another aspect, the present invention discloses a novel oral pharmaceutical composition or nutritional composition comprising:

[0121] a) one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, and combinations thereof;

[0122] b) one or more minerals selected from the group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium, and combinations thereof;

[0123] c) one or more coenzymes, such as but not limited to coenzyme Q10 (ubiquinone);

[0124] d) one or more amino acids selected from the group consisting of taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, and combinations thereof;

[0125] e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), and eicosapentaenoic acid (EPA), and combinations thereof; and

[0126] f) one or more pharmaceutically acceptable excipients.

[0127] In another aspect, the present invention discloses a novel oral pharmaceutical composition or nutritional composition comprising:

[0128] a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride);

[0129] b) 1.0 mcg to 400 mcg of vitamin B9 (folic acid);

[0130] c) 1.0 mcg to 5.0 mcg of vitamin B12;

[0131] d) 1 mcg to 30 mcg of vitamin D3 (cholecalciferol);

[0132] e) 1 mg to 20 mg of vitamin E (tocopherol);

[0133] f) 1 mg to 30 mg of zinc;

[0134] g) 1 mg to 500 mg of magnesium;

[0135] h) 1 mg to 10 mg of manganese;

[0136] i) 1 mcg to 80 mcg of selenium;

[0137] j) 1 mg to 1600 mg of omega 3 fatty acids;

[0138] k) 1 mg to 200 mg of coenzyme Q10;

[0139] l) 1 mg to 800 mg of taurine (2-aminoethanesulfonic acid); and

[0140] m) one or more suitable pharmaceutically acceptable excipients.

[0141] In another aspect, the present invention discloses a novel oral pharmaceutical composition or nutritional composition comprising:

[0142] a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride);

[0143] b) 25 mcg to 350 mcg of vitamin B9 (folic acid);

[0144] c) 1.0 mcg to 2.2 mcg of vitamin B12;

[0145] d) 1.0 mcg to 20 mcg of vitamin D3 (cholecalciferol);

[0146] e) 1.0 mg to 15 mg of vitamin E (tocopherol);

[0147] f) 1.0 mg to 20 mg of zinc;

[0148] g) 1.0 mg to 500 mg of magnesium;

[0149] h) 1.0 mg to 5.0 mg of manganese;

[0150] i) 1.0 mcg to 50 mcg of selenium;

[0151] j) 1.0 mg to 1000 mg of omega 3 fatty acids;

[0152] k) 1.0 mg to 150 mg of coenzyme Q10;

[0153] l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid); and

[0154] m) one or more suitable pharmaceutically acceptable excipients.

[0155] In another aspect, the present invention also relates to a method for preparing a novel pharmaceutical composition or nutritional composition comprising a plurality of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0156] In another aspect, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0157] a) dissolving a plurality of vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids in a suitable solvent or vehicle to obtain a solution;

[0158] b) adding and dissolving one or more suitable pharmaceutically acceptable excipients in the solution of step (a);

[0159] c) filtering the solution of step (b) through a suitable filter; and

[0160] d) Fill into suitable bottles or containers.

[0161] In another aspect, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0162] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0163] b) sieving one or more suitable pharmaceutically acceptable excipients through a suitable sieve;

[0164] c) pre-lubricating the sieved materials of step (a) and step (b) and mixing them in a suitable blender;

[0165] d) lubricating the above materials and mixing them for a suitable time; and

[0166] e) compressing the mixture of step (d) into a suitable dosage form.

[0167] In another aspect, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0168] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0169] b) dry mixing the components of step (a);

[0170] c) preparing a binder solution;

[0171] d) granulating the mixture obtained in step (b) using the binder solution obtained in step (c);

[0172] e) drying the particles obtained in step (d);

[0173] f) sieving, mixing and lubricating the dried granules of step (e); and

[0174] g) compressing the granules of step (f) into a suitable dosage form.

[0175] In another aspect, the present invention discloses a method of using a novel oral pharmaceutical or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids for prophylactic or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures in patients of all age groups. DETAILED DESCRIPTION OF THE INVENTION

[0177] As used herein, the term "composition" or "pharmaceutical composition" or "pharmaceutical composition for oral administration" or "stable composition for oral administration" or "nutritional composition" synonymously includes dosage forms such as tablets, capsules, effervescent tablets, chewable tablets, pills, granules, powders, pellets, oral syrups, oral solutions, oral suspensions, and the like.

[0178] Preferably, the pharmaceutical composition refers to tablets, capsules, effervescent tablets, chewable tablets, oral syrups and oral solutions.

[0179] The term "composition", as in pharmaceutical composition or nutritional composition, is intended to cover pharmaceutical products / nutrients comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and other inert ingredients (pharmaceutically acceptable excipients).

[0180] The term "nutritional composition" comprises a variety of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and other inert ingredients (pharmaceutically acceptable excipients).

[0181] The present invention relates to a novel pharmaceutical composition or nutritional composition, which comprises multiple vitamins, minerals, coenzymes, amino acids, ω-3 fatty acids and one or more pharmaceutically acceptable excipients.

[0182] The term "multivitamin" is used in a broad sense to include combinations of different types of vitamins.

[0183] The term "mineral" is used in a broad sense to include one or more types of minerals.

[0184] The term "amino acid" is used in a broad sense and includes one or more types of amino acids, such as, but not limited to, taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, and the like.

[0185] The term "ω-3 fatty acid" is used in a broad sense and includes one or more types of ω-3 fatty acids, such as, but not limited to, alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), among others.

[0186] As used herein, the term "stable" means that the formulation substantially retains the labeled amount of the therapeutically active ingredient during storage for a commercially relevant time and that the levels of drug-related impurities in the formulation remain within acceptable limits.

[0187] The terms "treat", "treating" or "treatment" refer to obtaining a desired pharmacological and / or physiological effect. The effect may be preventive or therapeutic, including partially or substantially achieving one or more of the following results: partially or completely alleviating the extent of a disease, disorder or syndrome; improving or ameliorating clinical symptoms or indicators associated with the disorder, or delaying, inhibiting or reducing the likelihood of progression of a disease, disorder or syndrome and / or its symptoms.

[0188]

[0063] The terms "preventing" or "prevention" refer to the procedure of preventing the occurrence of a disease by treating an individual, particularly those individuals who have risk factors for the disease.

[0189] The term "epilepsy" refers to a group of neurological disorders characterized by recurrent epileptic seizures.

[0190] The term "seizure," formally known as an epileptic seizure, is a period of symptoms caused by abnormally excessive or synchronized neuronal activity in the brain.

[0191] The term "pharmaceutically acceptable excipient" or suitable pharmaceutically acceptable excipients are components other than active ingredients added to a pharmaceutical composition or a nutritional composition.

[0192] The term "adjuvant" refers to the administration of the composition of the present invention, which can be administered simultaneously with, sequentially with, before or after the administration of the anticonvulsant drug.

[0193] The use of the terms "a," "an," and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context.

[0194] Throughout this specification and the appended claims, it should be understood that the words "comprise," "have," "contain," and "include," and variations thereof such as "comprising," "having," "containing," "includes," and "including," are to be interpreted inclusively unless the context requires otherwise. That is, use of these words may mean inclusion of one or more elements not specifically listed.

[0195] Excipients may be added to facilitate manufacturing, enhance stability, enhance product properties, enhance patient acceptability, etc. Pharmaceutically acceptable excipients include, but are not limited to, diluents, binders, disintegrants, lubricants, glidants, antioxidants, fillers, taste masking agents, chelating agents, thickeners, flavoring agents, coating agents, colorants, solvents, carriers, co-solvents, solubility enhancers, anti-adhesives, preservatives, adsorbents, sweeteners, release controlling polymer stabilizers, acidic agents, alkaline agents, effervescent agents, buffers, viscosity modifiers, pH modifiers, and any other excipients known in the art for preparing pharmaceutical compositions.

[0196] In one embodiment, the present invention relates to a stable composition for oral administration comprising multiple vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids according to the present invention which can be prepared as a single-dose pharmaceutical composition with immediate release or modified release or controlled release or delayed release or any combination thereof.

[0197] The novel pharmaceutical composition or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids according to the present invention can be in the form of tablets, effervescent tablets, chewable tablets, modified release tablets, controlled release tablets, delayed release tablets, capsules, granules, pellets, beads or sachets, oral syrups, liquid oral solutions, solutions or suspensions or emulsions, etc.

[0198] In another embodiment, the present invention also relates to a method for preparing a novel pharmaceutical or nutritional composition for oral administration, which composition comprises multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids.

[0199] In another embodiment, the present invention comprises one or more vitamins selected from the following: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, etc. or any combination thereof.

[0200] In one embodiment, vitamin D is a fat-soluble steroid that enhances intestinal absorption of calcium. Vitamin D has other effects in the body, including regulating cell growth, neuromuscular and immune function, and reducing inflammation. Vitamin D includes multiple forms, including two main forms in humans, cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2). Vitamin D3 is photochemically produced after the skin is exposed to sunlight. Vitamin D can also be taken from diet or supplements.

[0201] Vitamin D is used as one of the vitamins according to the present invention, and is present in an amount of about 1.0 mcg to about 30 mcg, more preferably about 1.0 mcg to about 20 mcg, relative to the total weight of the pharmaceutical composition or the nutritional composition.

[0202] In one embodiment, vitamin E (fat-soluble vitamin) is an antioxidant vitamin that participates in all cellular metabolism. It protects vitamin A and essential fatty acids from being oxidized in cells in the body and prevents the decomposition of body tissues. Vitamin E is a general term for a group of related substances including alpha-tocopherol, beta-tocopherol, gamma-tocopherol and delta-tocopherol. In addition, each of these four compounds has a "d" form, i.e., a natural form, and a "d1" form, i.e., a synthetic form. Preferably, vitamin E is in natural form. Relative to the gross weight of a pharmaceutical composition or a nutritional composition, it is present in an amount of about 1.0 mg to about 20 mg of vitamin E; and more preferably, it is present in an amount of about 1.0 mg to about 15 mg.

[0203] In one embodiment, vitamin B6 is one of the B vitamins and is therefore an essential nutrient. Its active form (pyridoxal 5'-phosphate) functions as a coenzyme in more than 140 enzyme reactions in amino acid, glucose and lipid metabolism.

[0204] Vitamin B6 is a water-soluble vitamin, which is one of the B vitamins. This vitamin actually includes a group of six chemically related compounds (i.e., isovitaminosis), all of which contain a pyridine ring as their core. These compounds are pyridoxine, pyridoxal, pyridoxamine and their respective phosphorylated derivatives pyridoxine 5'-phosphate, pyridoxal 5'-phosphate and pyridoxamine 5'-phosphate. Pyridoxal 5'-phosphate has the highest biological activity, but other compounds can be converted into this form. Vitamin B6 acts as a cofactor in more than 140 cellular reactions, mainly related to amino acid biosynthesis and catabolism, but also participates in fatty acid biosynthesis and other physiological functions.

[0205] Preferably, vitamin B6 (pyridoxine hydrochloride) is present in an amount of about 0.001 mg to about 5.0 mg, more preferably about 0.001 mg to about 3.5 mg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0206] In one embodiment, vitamin B9 refers to various forms of folate and its related compounds, including tetrahydrofolate (the active form), methyltetrahydrofolate (the major form found in the blood), methenyltetrahydrofolate, folinic acid, folic acid, and pteroylglutamate.

[0207] Preferably, vitamin B9 (folic acid) is present in an amount of about 1.0 mcg to about 400 mcg, more preferably about 25 mcg to about 350 mcg, relative to the total weight of the pharmaceutical or nutritional composition.

[0208] In one embodiment, vitamin B12 or cyanocobalamin is also used to treat pernicious anemia, vitamin B12 deficiency (due to low food intake or inability to absorb due to genetic or other factors), thyrotoxicosis, bleeding, malignancy, liver disease, and kidney disease.

[0209] Vitamin B12 deficiency has a significant effect on the nervous system, causing irreversible lesions, progressive increase in myelinated neurons, demyelination and death of neurons in the spinal cord and cerebral cortex, symptoms such as paresthesias in the hands and feet, decreased vibration and position sense, resulting in instability, confusion, moodiness, and loss of memory and central vision. It may also manifest as delirium, hallucinations, and even frank psychosis.

[0210] Preferably, vitamin B12 (cyanocobalamin) is present in an amount of about 1.0 mcg to 5.0 mcg, more preferably about 1.0 mcg to about 2.2 mcg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0211] In another embodiment, the present invention comprises one or more minerals selected from the group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chloride, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, sodium selenite, chromium, etc. or any combination thereof.

[0212] In one embodiment, magnesium is the fourth mineral with the highest content in the body of the human organism, and it is involved in about 325 enzymatic reactions, including the production of cellular energy through ATP-Mg complex formation, cell membrane stabilization and nucleic acid, protein and cytoplasmic organelle synthesis. Therefore, this mineral plays an important role in the electrical stability and integrity of cell membranes, muscle contraction, nerve conduction, vascular tone regulation, etc. It is also associated with anxiety-related disorders. Deficiency (hypomagnesemia) can lead to nervous system irritability, as well as tetany, fatigue, vasodilation, muscle spasms or cramps, convulsions, tremors, depression and psychotic behavior.

[0213] Preferably, magnesium is present in an amount of about 1.0 mg to about 500 mg relative to the total weight of the pharmaceutical or nutritional composition.

[0214] In one embodiment, manganese (Mn), an essential micronutrient for humans, is a trace element necessary for many physiological processes due to its role in the activity of various metalloproteinases. Manganese has 11 known oxidation states, of which Mn2+, Mn3+ and Mn4+ are present in humans and animals.

[0215] It is mainly found in bones, liver, kidneys and pancreas. Manganese helps the body form connective tissue, bones, clotting factors and sex hormones. It also plays a role in fat and carbohydrate metabolism, calcium absorption and blood sugar regulation. Manganese is also necessary for normal brain and nerve function. Low levels of manganese in the body can cause infertility, bone deformities, weakness and seizures.

[0216] Preferably, manganese is present in an amount of about 1.0 mg to 10 mg, more preferably about 1.0 mg to 5.0 mg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0217] In one embodiment, zinc is considered an essential nutrient, meaning your body cannot produce or store it. Zinc is an essential mineral that your body cannot make on its own. It helps with growth, DNA synthesis, immune function, and more. Today, approximately 70 enzymes, many of which are essential to human health, are known to contain zinc, and strong evidence suggests that many, if not all, of these enzymes require zinc to express their activity.

[0218] Preferably, zinc is present in an amount of about 1.0 mg to about 30 mg, more preferably about 1.0 mg to about 20 mg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0219] In one embodiment, selenium is a trace mineral, meaning that the human body only needs a small amount of selenium. It occurs naturally in foods or as a supplement. Selenium is an important component of various enzymes and proteins (called selenoproteins) that help make DNA and protect against cell damage and infection; these proteins are also involved in reproduction and in the metabolism of thyroid hormones. Most of the selenium in the body is stored in muscle tissue, although the thyroid gland holds the highest concentration of selenium because various selenoproteins help thyroid function. Selenium is a component of selenoproteins and enzymes. They have antioxidant properties and help break down peroxides, which can damage tissue and DNA, leading to inflammation and other health problems.

[0220] Preferably, sodium selenite is present in an amount of about 1.0 mcg to 80 mcg, more preferably about 1.0 mcg to 50 mcg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0221] In one embodiment, the present invention comprises one or more amino acids selected from the group consisting of taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, and the like.

[0222] In another embodiment, taurine (2-aminoethanesulfonic acid) is a conditionally essential amino acid. It is found free or in simple peptides, but is not used in protein synthesis. In vivo studies have shown that taurine is essential for many aspects of mammalian development. In addition, low levels of taurine are associated with different pathological lesions, including cardiomyopathy, retinal degeneration, and growth retardation. It is well known that taurine plays an important role in many physiological functions, including detoxification, membrane stabilization, osmoregulation, and regulation of cellular calcium levels. Taurine is also used to treat cardiovascular disease, epilepsy and other seizure disorders, macular degeneration, Alzheimer's disease, liver disorders, and cystic fibrosis.

[0223] Preferably, taurine is present in an amount of about 1.0 mg to about 800 mg, more preferably about 1.0 mg to 500 mg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0224] In one embodiment, the present invention comprises one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), and eicosapentaenoic acid (EPA), or the like, or any combination thereof.

[0225] In another embodiment, ω-3 fatty acids (also referred to as ω-3 oils, ω-3 fatty acids, or n-3 fatty acids) are polyunsaturated fatty acids (PUFAs) characterized by the presence of a double bond, three atoms away from the terminal methyl group in its chemical structure. The three types of ω-3 fatty acids involved in human physiology are alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). ALA is found in plants, while DHA and EPA are found in algae and fish. Marine algae and phytoplankton are the main sources of ω-3 fatty acids. DHA and EPA accumulate in fish that feed on these algae.

[0226] Preferably, the omega-3 fatty acids are present in an amount of about 1.0 mg to about 1600 mg, more preferably about 1.0 mg to 1000 mg, relative to the total weight of the pharmaceutical composition or nutritional composition.

[0227] In one embodiment, the present invention comprises one or more coenzymes, such as but not limited to coenzyme Q10 (ubiquinone) and the like.

[0228] In another embodiment, coenzyme Q, also known as ubiquinone, is a family of coenzymes that are ubiquitous in animals and most bacteria (hence the name ubiquinone). In humans, the most common form is Coenzyme Q10 or ubiquinone-10. It is a 1,4-benzoquinone, where Q refers to the quinone chemical group, and 10 refers to the number of isopyridine chemical subunits at its tail. In natural ubiquinones, this number can be anywhere between 6 and 10. This family is fat-soluble. CoQ has three redox states: fully oxidized (ubiquinone), semiquinone (ubisemiquinone), and fully reduced (ubiquinol). The ability of this molecule to act as a two-electron carrier (moving between the quinone and quinol forms) and a one-electron carrier (moving between semiquinone and one of these other forms) is key to its role in the electron transport chain, as the iron-sulfur cluster can only accept one electron at a time and acts as a free radical scavenging antioxidant.

[0229] Preferably, coenzyme Q10 is present in an amount of about 1.0 mg to about 200 mg, more preferably about 1.0 mg to 150 mg, relative to the total weight of the pharmaceutical composition.

[0230] Pharmaceutically acceptable excipients are selected from diluents, binders, disintegrants, lubricants, glidants, fillers, preservatives, antioxidants, taste masking agents, chelating agents, thickeners, flavoring agents, coating agents, coloring agents, solvents, cosolvents, vehicles, anti-adhesives, preservatives, adsorbents, sweeteners, release controlling polymer stabilizers, acidic agents, alkaline agents, buffers, effervescent agents, pH adjusters and any other excipients known in the art for preparing pharmaceutical compositions.

[0231] Examples of vehicles according to the present invention include, but are not limited to, sorbitol, water, purified water, polyols, hydroalcoholic solutions and buffers or oils (e.g., vegetable oils or mineral oils, organic oil bases, emulsifying bases, etc.), polyethylene glycol 40 hydrogenated castor oil (kolliphor RH 40), monopalmitate (Tween 60), sodium oleate, polyoxyethylene stearate, potassium oleate, and combinations thereof.

[0232] Examples of solvents according to the present invention include, but are not limited to, aqueous or inert organic solvents or inorganic acids, alcohols, ketones, esters, ethers, aliphatic hydrocarbons, halogenated solvents, alicyclic solvents, aromatic solvents, heterocyclic solvents and mixtures thereof. Typical solvents include water, purified water, glycerol, acetone, diacetone alcohol, methanol, ethanol, isopropanol, butanol, ethylene glycol monoethyl ether, monoethyl acetate, cyclohexane, benzene, toluene, naphtha, 1,4-dioxane, tetrahydrofuran, hydrochloric acid (HCl), aqueous solvents containing inorganic salts (e.g., sodium chloride, calcium chloride, etc.) and mixtures thereof (e.g., acetone and water, acetone and methanol, acetone and ethanol, methylene chloride and methanol, ethylene dichloride and methanol) or mixtures thereof.

[0233] Examples of co-solvents according to the present invention include, but are not limited to, propylene glycol, chloroform, ethanol glycerol, polyethylene glycol, and combinations thereof.

[0234] Examples of preservatives according to the present invention include, but are not limited to, bronopol, methylparaben, propylparaben, sodium benzoate, benzoic acid, phenylethyl alcohol, benzyl alcohol, methylparaben, sodium methylparaben, sodium propylparaben, imidazolidinyl urea, parabens, chlorobutanol, dehydroacetic acid, benzalkonium chloride, merfen, sodium thimerosal, cetyltrimethylammonium bromide, cetylpyridinium chloride, sorbic acid, or mixtures thereof.

[0235] Examples of buffers according to the present invention include, but are not limited to, tartaric acid, citric acid, citric acid monohydrate, malic acid, acetic acid, glacial acetic acid, lactic acid, sodium citrate, and disodium hydrogen phosphate.

[0236] Examples of sweeteners according to the present invention include, but are not limited to, aspartame, acesulfame potassium, aspartame acesulfame potassium, glycerol, dipotassium glycyrrhizinate, stevioside, thaumatin, sucrose, glucose, maltose, galactose, and artificial sweeteners, such as saccharin sodium, sodium cyclamate, sucralose, saccharin sodium, neohesperidin dihydrochalcone, glycyrrhizic acid monoammonium salt, dextrose, invert sugar, fructose, stevia (stevioside); sugar alcohols, such as sorbitol, mannitol, xylitol, etc. Also covered are hydrogenated starch hydrolysates and synthetic sweeteners and their sodium and calcium salts, as well as natural fortified sweeteners, or mixtures thereof.

[0237] Examples of chelating agents according to the present invention include, but are not limited to, sodium EDTA, disodium EDTA.

[0238] Examples of thickeners according to the present invention include, but are not limited to, xanthan gum, PVPK-30, PVPK-90, PEG 400, hydroxyethyl cellulose, methyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose K4 M, K100M, and water-soluble carboxyvinyl polymers.

[0239] Examples of taste masking agents according to the present invention include, but are not limited to, hydroxypropyl beta-cyclodextrin, vanilla, grape, lemon, lime, orange, cherry, grapefruit, berries, mints, licorice, coffee, chocolate, mint, peach, raspberry, or a combination thereof.

[0240] Examples of antioxidants according to the present invention include, but are not limited to, butylated hydroxytoluene, butylated hydroxyanisole, DL-α-tocopherol, propyl gallate, octyl gallate, ascorbyl palmitate, acetylcysteine, ascorbic acid, sodium ascorbate, fumaric acid, lecithin, sodium metabisulfite, sodium sulfite, or a combination thereof.

[0241] Examples of flavoring agents according to the present invention include, but are not limited to, fruit flavors, mint flavors, lemon, lemon lime, orange, sour cherry, mint, honey vanilla, citrus oil, grapefruit grape, menthol, cranberry, vanilla berry, bubble gum, cherry, fruit flavors including apple, pear, peach, strawberry, raspberry, plum, pineapple, apricot or other fruit flavors or combinations thereof.

[0242] Examples of the colorant according to the present invention include, but are not limited to, quinolone yellow, sunset yellow, erythrosine, brilliant blue, and the like.

[0243] Examples of diluents or fillers according to the present invention include, but are not limited to, Emdex / Glucose binders, Citric acid, mannitol, sorbitol, sucrose, microcrystalline cellulose, carboxymethyl cellulose (carboxymethylcellulose), sodium carboxymethyl cellulose (sodium carboxymethylcellulose), corn starch, potato starch, anhydrous lactose, lactose monohydrate, or a combination thereof.

[0244] Examples of acidic agents or acidulants according to the present invention include, but are not limited to, citric acid, maleic acid, tartaric acid, fumaric acid, adipic acid, succinic acid, lactic acid, glycolic acid, alpha-hydroxy acids, ascorbic acid and amino acids, anhydrides, salts and derivatives of these acids or combinations thereof.

[0245] Examples of alkaline agents according to the present invention include, but are not limited to, potassium carbonate, sodium carbonate, sodium hydrogen carbonate, sodium bicarbonate, potassium bicarbonate, arginine carbonate, glycine carbonate or lithium carbonate, calcium carbonate, ammonium carbonate, L-lysine carbonate, sodium glycine carbonate, sodium carbonate of amino acids, anhydrous sodium perborate, perborate effervescent tablets, sodium perborate monohydrate, sodium percarbonate, sodium dichloroisocyanurate, sodium hypochlorite, calcium hypochlorite, tris(hydroxymethyl)aminomethane, tartrate, acetate, phosphate or a mixture thereof.

[0246] Examples of lubricants according to the present invention include, but are not limited to, calcium stearate, magnesium stearate, sodium stearyl fumarate, fumaric acid, calcium stearate, polyethylene glycol, sodium benzoate, potassium benzoate, sodium lauryl sulfate, talc, colloidal silicon dioxide, sucrose fatty acid esters, stearic acid, zinc stearate, hydrogenated vegetable oil, mineral oil, glyceryl behenate, polyoxyethylene glycol, sodium benzoate, dimethicone or liquid paraffin, or a mixture thereof.

[0247] Binders according to the present invention include, but are not limited to, pregelatinized starch, partially pregelatinized starch, cellulose or its derivatives, such as microcrystalline cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl cellulose (sodium carboxymethyl cellulose), hydroxyethyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, xanthan gum, cellulose gum, guar gum, pullulan, gum arabic, acacia powder, polyvinyl pyrrolidone, polyacrylamide, polyvinyl oxazolidinone, polyvinyl alcohol or a combination thereof.

[0248] Examples of glidants according to the present invention include, but are not limited to, colloidal silica, colloidal silica dioxide, fumed silica, hydrated sodium aluminosilicate, magnesium stearate, sodium stearyl fumarate, starch, talc, tricalcium phosphate, magnesium oxide; magnesium silicate, magnesium trisilicate, stearic acid, calcium stearate, or mixtures thereof.

[0249] In one embodiment, the present invention provides a novel pharmaceutical composition or nutritional composition comprising:

[0250] a) one or more vitamins;

[0251] b) one or more minerals;

[0252] c) one or more coenzymes;

[0253] d) one or more amino acids;

[0254] e) one or more omega-3 fatty acids; and

[0255] f) one or more suitable pharmaceutically acceptable excipients.

[0256] In one embodiment, the present invention provides a novel pharmaceutical or nutritional composition for oral administration comprising:

[0257] a) one or more vitamins;

[0258] b) one or more minerals;

[0259] c) one or more coenzymes;

[0260] d) one or more amino acids;

[0261] e) one or more omega-3 fatty acids; and

[0262] f) one or more suitable pharmaceutically acceptable excipients.

[0263] In one embodiment, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0264] a) 0.001 mg to 50 mg of one or more vitamins;

[0265] b) 0.001 mg to 500 mg of one or more minerals;

[0266] c) 1 mg to 200 mg of one or more coenzymes;

[0267] d) 1 mg to 800 mg of one or more amino acids;

[0268] e) 1 mg to 1600 mg of one or more omega-3 fatty acids; and

[0269] f) one or more suitable pharmaceutically acceptable excipients.

[0270] In one embodiment, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0271] a) 0.001 mg to 20 mg of one or more vitamins;

[0272] b) 0.001 mg to 500 mg of one or more minerals;

[0273] c) 10.0 mg to 150 mg of one or more coenzymes;

[0274] d) 200 mg to 500 mg of one or more amino acids;

[0275] e) 500 mg to 1000 mg of one or more omega-3 fatty acids; and

[0276] f) one or more suitable pharmaceutically acceptable excipients.

[0277] In one embodiment, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0278] a) one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, and combinations thereof;

[0279] b) one or more minerals selected from the group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium, and combinations thereof;

[0280] c) one or more coenzymes, such as but not limited to coenzyme Q10 (ubiquinone);

[0281] d) one or more amino acids selected from the group consisting of taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, and combinations thereof;

[0282] e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), and eicosapentaenoic acid (EPA), and combinations thereof; and

[0283] f) one or more suitable pharmaceutically acceptable excipients.

[0284] In one embodiment, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0285] a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride);

[0286] b) 1.0 mcg to 400 mcg of vitamin B9 (folic acid);

[0287] c) 1.0 mcg to 5.0 mcg of vitamin B12;

[0288] d) 1 mcg to 30 mcg of vitamin D3 (cholecalciferol);

[0289] e) 1 mg to 20 mg of vitamin E (tocopherol);

[0290] f) 1 mg to 30 mg of zinc;

[0291] g) 1 mg to 500 mg of magnesium;

[0292] h) 1 mg to 10 mg of manganese;

[0293] i) 1 mcg to 80 mcg of selenium;

[0294] j) 1 mg to 1600 mg of omega 3 fatty acids;

[0295] k) 1 mg to 200 mg of coenzyme Q10;

[0296] l) 1 mg to 800 mg of taurine (2-aminoethanesulfonic acid); and

[0297] m) one or more suitable pharmaceutically acceptable excipients.

[0298] In one embodiment, the present invention provides a novel oral pharmaceutical composition or nutritional composition comprising:

[0299] a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride);

[0300] b) 25 mcg to 350 mcg of vitamin B9 (folic acid);

[0301] c) 1.0 mcg to 2.2 mcg of vitamin B12;

[0302] d) 1.0 mcg to 20 mcg of vitamin D3 (cholecalciferol);

[0303] e) 1.0 mg to 15 mg of vitamin E (tocopherol);

[0304] f) 1.0 mg to 20 mg of zinc;

[0305] g) 1.0 mg to 500 mg of magnesium;

[0306] h) 1.0 mg to 5.0 mg of manganese;

[0307] i) 1.0 mcg to 50 mcg of selenium;

[0308] j) 1.0 mg to 1000 mg of omega 3 fatty acids;

[0309] k) 1.0 mg to 150 mg of coenzyme Q10;

[0310] l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid); and

[0311] m) one or more suitable pharmaceutically acceptable excipients.

[0312] In one embodiment, the present invention also relates to a method for preparing a novel pharmaceutical composition or nutritional composition comprising a plurality of vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids and one or more suitable pharmaceutically acceptable excipients.

[0313] In one embodiment, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0314] a) dissolving a plurality of vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids in a suitable solvent or vehicle to obtain a solution;

[0315] b) adding and dissolving one or more suitable pharmaceutically acceptable excipients in the solution of step (a);

[0316] c) filtering the solution of step (b) through a suitable filter; and

[0317] d) Fill into suitable bottles or containers.

[0318] In one embodiment, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0319] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0320] b) sieving one or more suitable pharmaceutically acceptable excipients through a suitable sieve;

[0321] c) pre-lubricating the sieved materials of step (a) and step (b) and mixing them in a suitable blender;

[0322] d) lubricating the above materials and mixing them for a suitable time; and

[0323] e) compressing the mixture of step (d) into a suitable dosage form.

[0324] In one embodiment, the present invention provides a method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising the following steps:

[0325] a) sieving the multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids through a suitable sieve;

[0326] b) dry mixing the components of step (a);

[0327] c) preparing a binder solution;

[0328] d) granulating the mixture obtained in step (b) using the binder solution obtained in step (c);

[0329] e) drying the particles obtained in step (d);

[0330] f) sieving, mixing and lubricating the dried granules of step (e); and

[0331] g) compressing the granules of step (f) into a suitable dosage form.

[0332] In another embodiment, the present invention discloses a method of using a novel pharmaceutical or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids for prophylactic or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures in patients of all age groups.

[0333] In another embodiment, the present invention discloses a method of using a novel oral pharmaceutical or nutritional composition comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids for prophylactic or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures in patients of all age groups.

[0334] In another embodiment, the present invention discloses novel oral pharmaceutical or nutritional compositions comprising multiple vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids for preventive or supportive use when used as an adjuvant to an anticonvulsant drug, such as but not limited to brivaracetam, carbamazepine, clobazam, clonazepam, diazepam, ethosuximide, gabapentin, lacosamide, lamotrigine, levetiracetam, midazolam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, sodium valproate, tiagabine, topiramate, vigabatrin, zonisamide or any combination thereof.

[0335] The following examples are provided to illustrate embodiments of the present invention. However, they are not intended to limit the scope of the present invention.

[0336] Example 1: Omega-3 fats, coenzyme Q10, taurine and multivitamin & multimineral syrup:

[0337]

[0338] qs: sufficient

[0339] Manufacturing process:

[0340] 1. Dissolve active sequence number 1-12 in vehicle or solvent and stir at 250 RPM for 15 minutes

[0341] 2. Add and dissolve all remaining inactive ingredients serial numbers 13-18 into the above solution

[0342] 3. Filter the solution through a PES 5 µm filter

[0343] 4. Packed into 200 mL amber PET bottles.

[0344] Example 2: Omega-3 fat, coenzyme Q10, taurine and multivitamin & multimineral solution:

[0345]

[0346] qs: sufficient

[0347] Manufacturing process:

[0348] 1. Dissolve the active ingredients of sequence numbers 1-12 in propylene glycol with water and hydroxypropyl-β-cyclodextrin and stir at 500 RPM for 30 minutes;

[0349] 2. Add and dissolve all remaining inactive ingredients into the above solution;

[0350] 3. Filter the solution through a PES 5 µm filter; and

[0351] 4. Packed into 250mL amber PET bottles.

[0352] Example 3: Omega-3 fat, coenzyme Q10, taurine and multivitamin & multimineral effervescent tablets (direct compression)

[0353]

[0354] Manufacturing process:

[0355] 1. All active ingredients of sequence numbers 1 to 12 and diluent (dextrate) were sieved together using a #30 sieve;

[0356] 2. Pass citric acid, sodium bicarbonate, aspartame and flavor through a #30 sieve;

[0357] 3. Pre-lubricate the above ingredients in a blender at 10 RPM for 15 minutes;

[0358] 4. Sieve the PRUV through a #40 sieve;

[0359] 5. Mix the above ingredients in a blender at 10 RPM for 5 minutes; and

[0360] 6. Press directly with a 22mm X10 mm oval punch.

[0361] Example 4: Omega-3 fat, coenzyme Q10, taurine, multivitamins and multimineral effervescent tablets

[0362]

[0363] qs: sufficient

[0364] Manufacturing process:

[0365] 1. All active ingredients of sequence numbers 1 to 12 and the diluent were sieved together using a #30 sieve;

[0366] 2. Pass sorbitol, sodium bicarbonate, tartaric acid, aspartame and flavor through a #30 sieve;

[0367] 3. Pre-lubricate the above ingredients in a blender at 10 RPM for 15 minutes;

[0368] 4. Sieve the PRUV through a #40 sieve;

[0369] 5. Mix the above ingredients in a blender at 10 RPM for 5 minutes; and

[0370] 6. Press directly using a 22mm X 10 mm oval punch.

[0371] Example 5: Omega-3 fat, coenzyme Q10, taurine and multivitamin and multimineral chewable tablets

[0372]

[0373] Manufacturing process:

[0374] 1. All active ingredients of sequence numbers 1-12 and sucrose were sieved through a #30 sieve;

[0375] 2. Dry mix the above materials in RMG at 12 RPM for 10 minutes;

[0376] 3. Prepare a binder using acacia powder in sufficient water and add the binder to the above dry mixed materials;

[0377] 4. Sieve through #10 sieve. And dry at 35°C to achieve the desired LOD less than 3%;

[0378] 5. Sieve the dry granules through a #24 sieve;

[0379] 6. Pre-lubricate the above dry granules with methylparaben, propylparaben, Pearlitol® 200 SD mannitol, colloidal silicon dioxide, citric acid monohydrate, fruit flavor and aspartame in a blender at RPM 12 for 10 minutes;

[0380] 7. Sieve magnesium stearate through a #60 sieve;

[0381] 8. Mix the above materials in a blender at a moderate 10 RPM for 5 minutes; and

[0382] 9. Lubricate the mixture for compaction using an 18 mm x 9 mm oval punch.

Claims

1. An oral pharmaceutical composition or nutritional composition comprising: a) one or more vitamins; b) one or more minerals; c) one or more coenzymes; d) one or more amino acids; e) one or more omega-3 fatty acids; and f) one or more pharmaceutically acceptable excipients.

2. The composition of claim 1, comprising: a) 0.001 mg to 50 mg of one or more vitamins; b) 0.001 mg to 500 mg of one or more minerals; c) 1 mg to 200 mg of one or more coenzymes; d) 1 mg to 800 mg of one or more amino acids; e) 1 mg to 1600 mg of one or more omega-3 fatty acids; and f) one or more suitable pharmaceutically acceptable excipients.

3. The composition of claim 1, wherein the vitamin is selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, and combinations thereof.

4. The composition of claim 1, wherein the mineral is selected from the group consisting of calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium, chromium, and combinations thereof.

5. The composition of claim 1, wherein the coenzyme is coenzyme Q10 (ubiquinone).

6. The composition of claim 1, wherein the amino acid is selected from the group consisting of taurine (2-aminoethanesulfonic acid), leucine, arginine, glutamic acid, glycine, and combinations thereof.

7. The composition of claim 1, wherein the ω-3 fatty acid is selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), and eicosapentaenoic acid (EPA), and combinations thereof.

8. The composition of claim 1, wherein the pharmaceutically acceptable excipient is selected from the group consisting of diluents, binders, disintegrants, lubricants, glidants, fillers, preservatives, antioxidants, taste masking agents, chelating agents, thickeners, flavoring agents, coating agents, coloring agents, solvents, co-solvents, vehicles, anti-adhesives, preservatives, adsorbents, sweeteners, release controlling polymers, stabilizers, acidic agents, alkaline agents, buffers, effervescent agents, pH adjusters, and combinations thereof.

9. The composition of claim 1, wherein the composition is formulated into a dosage form selected from the group consisting of tablets, effervescent tablets, chewable tablets, modified release tablets, controlled release tablets, delayed release tablets, capsules, granules, pellets, beads or sachets, oral syrups, liquid oral solutions, solutions, suspensions, emulsions, and combinations thereof.

10. A method for preparing a novel oral pharmaceutical composition or nutritional composition, comprising: a) dissolving a plurality of vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids in a solvent or vehicle to obtain a solution; b) adding and dissolving one or more pharmaceutically acceptable excipients into the solution obtained in step (a); c) filtering the solution obtained in step (b) through a suitable filter; as well as d) Fill the filtered solution obtained in step (c) into bottles or containers.

11. A method for preparing an oral pharmaceutical composition or a nutritional composition, comprising: a) sieving various vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids through a sieve; b) sieving one or more pharmaceutically acceptable excipients through a sieve; c) pre-lubricating the sieved materials obtained in step (a) and step (b), and mixing them with a blender to obtain a mixed material; d) lubricating the mixed material obtained in step (c) and continuing to mix it for 5 to 10 minutes; and e) compressing the lubricated mixture from step (d) into dosage forms.

12. A method for preparing an oral pharmaceutical composition or a nutritional composition, comprising: a) sieving various vitamins, minerals, coenzymes, amino acids and ω-3 fatty acids through a sieve; b) dry mixing the components of step (a); c) preparing a binder solution; d) granulating the mixture obtained in step (b) using the binder solution obtained in step (c); e) drying the particles obtained in step (d); f) sieving, mixing and lubricating the dried granules of step (e); and g) compressing the granules of step (f) into dosage forms.

13. The composition as claimed in claim 1, wherein the composition is for prophylactic or supportive use as an adjuvant to anticonvulsant drugs for the treatment / prevention of various types of epilepsy or epileptic seizures in patients of all age groups.

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