Novel pharmaceutical or nutraceutical composition for treating or preventing epilepsy

Abstract

The present invention relates to novel pharmaceutical or nutraceutical compositions comprising multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, their preparation methods and their prophylactic or adjunctive use as adjuncts to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures.

Description

[Technical field]

[0001] The present invention relates to a novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, a process for its preparation and prophylactic or supportive uses of said pharmaceutical composition.

[0002] More particularly, the present invention relates to novel pharmaceutical or nutraceutical compositions for oral administration comprising multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids, methods for their preparation and their prophylactic or adjunctive use as adjuncts to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures.

[0003] More specifically, the present invention relates to novel pharmaceutical or nutritional supplement compositions for oral administration comprising multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids optimized for all age groups from children, adolescents, adults to the elderly, methods for their preparation and their prophylactic or adjunctive use as adjuncts to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures. [Background technology]

[0004] Epilepsy is a disorder of the central nervous system (nerve) that causes abnormal brain activity, resulting in seizures, abnormal behavior and sensations, and sometimes fainting. Epilepsy affects both men and women of all races, ethnicities, and ages.

[0005] Epilepsy affects approximately 50 million people worldwide and is characterised by recurrent seizures that consist of brief, involuntary movements of one part of the body (partial seizures) or the whole body (generalised seizures), sometimes accompanied by loss of consciousness and loss of control of bowel or bladder function.

[0006] Seizures are the result of excessive electrical discharges in groups of brain cells. These discharges can occur in different parts of the brain. Seizures can range from a brief loss of attention and muscle spasms to severe, prolonged convulsions. The frequency of seizures also varies, ranging from less than once a year to several times a day.

[0007] The types of epilepsy are: 1) Generalized seizures: "grand mal" or generalized tonic-clonic seizures, absence seizures, myoclonic, clonic, tonic, and atonic seizures, and 2) Partial (focal) seizures: simple partial seizures (without loss of consciousness), complex partial seizures (with impaired consciousness), partial seizures with secondary generalization.

[0008] Anticonvulsants (antiepileptics or antiseizure drugs) are a diverse group of medicines used to treat epileptic seizures. Different types of medicines are used to treat epilepsy depending on the category and type of epilepsy / seizures.

[0009] Anticonvulsants can be very helpful, but they don't work for everyone and, like any medication, carry the risk of side effects.

[0010] Alternative systems to drugs or nutritional supplements are being continuously developed worldwide, and they may be combined with existing anticonvulsant drugs to enhance the antiepileptic effect while minimizing side effects.

[0011] Research has revealed the important physiological roles that various vitamins, minerals and amino acids play in epilepsy and has established a correlation between deficiencies or excesses of these vitamins, minerals and amino acids in the human body and the causes of certain pathological conditions such as epilepsy.

[0012] Therefore, there remains a need to develop improved pharmaceutical or nutraceutical compositions to overcome the shortcomings associated with the products available on the market.

[0013] The inventors of the present invention have surprisingly found that the use of a synergistic combination of multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids provides the right vitamins, minerals, coenzymes, amino acids and omega-3 fatty acids in the right amounts at the right time, thereby ensuring sufficient intake of said multivitamins, minerals, coenzymes, amino acids and omega-3 fatty acids which can be used prophylactically or adjunctively as an adjunct to anticonvulsant drugs used in the treatment / prevention of various types of epilepsy or seizures.

[0014] The inventors of the present invention have also found that a novel pharmaceutical or nutritional supplement composition for oral administration comprising high quality and high purity multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids exhibits qualities such as, but not limited to, stability, ease of administration, easy dosage adjustment, minimal side effects, high therapeutic efficiency, and better patient compatibility, and said composition is indicated for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures.

[0015] Object of the invention It is an object of the present invention to provide a novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma- ceutically acceptable excipients.

[0016] It is an object of the present invention to provide a novel oral pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma- ceutically acceptable excipients.

[0017] The object of the present invention is to 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 pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0018] The object of the present invention is to 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 pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0019] The object of the present invention is to a) 0.001 mg to 20 mg of one or more vitamins, b) 0.001 mg to 500 mg of one or more minerals; c) 10.0 mg to 150 mg of one or more coenzymes; d) 200 mg to 500 mg of one or more amino acids; e) 500 mg to 1000 mg of one or more omega-3 fatty acids, and f) one or more pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0020] The object of the present invention is to 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; 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; c) one or more coenzymes, including but not limited to coenzyme Q10 (ubiquinone); d) one or more amino acids selected from the group consisting of taurine (tauric acid), leucine, arginine, glutamine, glycine, and combinations thereof; e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and combinations thereof; and f) one or more suitable pharma- ceutically acceptable excipients; The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0021] The object of the present invention is to a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride), b) 1.0 μg to 400 μg of vitamin B9 (folic acid), c) 1.0 μg to 5.0 μg of vitamin B12, d) 1 μg to 30 μg of vitamin D3 (cholecalciferol), e) 1 mg to 20 mg of vitamin E (tocopherol), f) 1 mg to 30 mg of zinc, g) 1 mg to 500 mg of magnesium, h) 1 mg to 10 mg of manganese; i) 1 μg to 80 μg of selenium, j) 1 mg to 1600 mg of omega-3 fatty acids, k) 1mg to 200mg of coenzyme Q10, l) 1 mg to 800 mg of taurine (2-aminoethanesulfonic acid), and m) one or more pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0022] The object of the present invention is to a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride), b) 25μg to 350μg of vitamin B9 (folic acid), c) 1.0 μg to 2.2 μg of vitamin B12, d) 1.0 μg to 20 μg of vitamin D3 (cholecalciferol), e) 1.0 mg to 15 mg of vitamin E (tocopherol), f) 1.0 mg to 20 mg of zinc, g) 1.0 mg to 500 mg of magnesium, h) 1.0 mg to 5.0 mg of manganese; i) 1.0 μg to 50 μg of selenium, j) 1.0 mg to 1000 mg of omega-3 fatty acids, k) 1.0 mg to 150 mg of coenzyme Q10, l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid), and m) one or more pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutritional supplement composition comprising:

[0023] Another object of the present invention is to a) dissolving multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids in a suitable solvent or pharmaceutical vehicle to obtain a solution; b) adding and dissolving one or more suitable pharma- ceutically acceptable excipients to the solution of step (a); c) filtering the solution of step (b) through a suitable filter; and d) filling into suitable bottles or containers; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0024] Another object of the present invention is to a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) screening one or more suitable pharma- ceutically acceptable excipients through suitable sieves; c) pre-lubricating and mixing the sieved materials of step (a) and step (b) in a suitable mixing device; d) lubricating and mixing the above materials for a suitable period of time; and e) compressing the mixture of step (d) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0025] Another object of the present invention is to a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) dry blending the ingredients of step (a); c) preparing a binder solution; d) granulating the mixture obtained in step (b) with the binder solution obtained in step (c); e) drying the granules obtained in step (d); f) sieving, mixing and lubricating the dried granules of step (e); and g) compressing the granules of step (f) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0026] Another object of the present invention is to provide a method of use of a novel oral pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures in patients of all age groups. Summary of the Invention

[0027] In one aspect, the present invention discloses novel pharmaceutical or nutraceutical compositions comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma-ceutically acceptable excipients.

[0028] In one aspect, the present invention relates to novel oral pharmaceutical or nutraceutical compositions comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma-ceutically acceptable excipients.

[0029] In another aspect, the present invention provides a method for producing a pharmaceutical 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 pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0030] In another aspect, the present invention provides a method for producing a pharmaceutical composition 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 pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0031] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) 0.001 mg to 20 mg of one or more vitamins, b) 0.001 mg to 500 mg of one or more minerals; c) 10.0 mg to 150 mg of one or more coenzymes; d) 200 mg to 500 mg of one or more amino acids; e) 500 mg to 1000 mg of one or more omega-3 fatty acids, and f) one or more pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0032] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: 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; 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; c) one or more coenzymes, including but not limited to coenzyme Q10 (ubiquinone); d) one or more amino acids selected from the group consisting of taurine (tauric acid), leucine, arginine, glutamine, glycine, and combinations thereof; e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and combinations thereof; and f) one or more pharma- ceutically acceptable excipients The present invention discloses a novel oral pharmaceutical or nutraceutical composition comprising:

[0033] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride), b) 1.0 μg to 400 μg of vitamin B9 (folic acid), c) 1.0 μg to 5.0 μg of vitamin B12, d) 1 μg to 30 μg of vitamin D3 (cholecalciferol), e) 1 mg to 20 mg of vitamin E (tocopherol), f) 1 mg to 30 mg of zinc, g) 1 mg to 500 mg of magnesium, h) 1 mg to 10 mg of manganese; i) 1 μg to 80 μg of selenium, j) 1 mg to 1600 mg of omega-3 fatty acids, k) 1mg to 200mg of coenzyme Q10, l) 1 mg to 800 mg of taurine (2-aminoethanesulfonic acid), and m) one or more suitable pharma- ceutically acceptable excipients The present invention discloses a novel oral pharmaceutical or nutraceutical composition comprising:

[0034] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride), b) 25μg to 350μg of vitamin B9 (folic acid), c) 1.0 μg to 2.2 μg of vitamin B12, d) 1.0 μg to 20 μg of vitamin D3 (cholecalciferol), e) 1.0 mg to 15 mg of vitamin E (tocopherol), f) 1.0 mg to 20 mg of zinc, g) 1.0 mg to 500 mg of magnesium, h) 1.0 mg to 5.0 mg of manganese; i) 1.0 μg to 50 μg of selenium, j) 1.0 mg to 1000 mg of omega-3 fatty acids, k) 1.0 mg to 150 mg of coenzyme Q10, l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid), and m) one or more suitable pharma- ceutically acceptable excipients The present invention discloses a novel oral pharmaceutical or nutraceutical composition comprising:

[0035] In another aspect, the present invention also relates to a method for preparing a novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma-ceutically acceptable excipients.

[0036] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) dissolving multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids in a suitable solvent or pharmaceutical solvent to obtain a solution; b) adding and dissolving one or more suitable pharma- ceutically acceptable excipients to the solution of step (a); c) filtering the solution of step (b) through a suitable filter; and d) filling into suitable bottles or containers; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0037] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) screening one or more suitable pharma- ceutically acceptable excipients through suitable sieves; c) pre-lubricating and mixing the sieved materials of step (a) and step (b) in a suitable mixing device; d) lubricating and mixing the above materials for a suitable period of time; and e) compressing the mixture of step (d) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0038] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) dry blending the ingredients of step (a); c) preparing a binder solution; d) granulating the mixture obtained in step (b) with the binder solution obtained in step (c); e) drying the granules obtained in step (d); f) sieving, mixing and lubricating the dried granules of step (e); and g) compressing the granules of step (f) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0039] In another aspect, the present invention discloses a method of use of a novel oral pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures in patients of all age groups. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] As used herein, the terms "composition," "pharmaceutical composition," "pharmaceutical composition for oral administration," "stable composition for oral administration," and "nutraceutical composition" synonymously include dosage forms such as tablets, capsules, effervescent tablets, chewable tablets, pills, granules, powders, pellets, oral syrups, oral solutions, oral suspensions, and the like.

[0041] Pharmaceutical compositions preferably refer to tablets, capsules, effervescent tablets, chewable tablets, oral syrups, and oral solutions.

[0042] The term "composition" in pharmaceutical or nutraceutical compositions is intended to encompass pharmaceutical / nutraceutical agents including multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and other inactive ingredients (pharmaceutical acceptable excipients).

[0043] The term "nutraceutical composition" includes multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and other inactive ingredients (pharmaceutical acceptable excipients).

[0044] The present invention relates to novel pharmaceutical or nutraceutical compositions comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more pharma-ceutically acceptable excipients.

[0045] The term "multivitamin" is used broadly to include combinations of different vitamins.

[0046] The term "mineral" is used broadly to include one or more minerals.

[0047] The term "amino acid" is used broadly to include one or more amino acids, such as, but not limited to, taurine (tauric acid), leucine, arginine, glutamine, and glycine.

[0048] The term "omega-3 fatty acid" is used broadly to include one or more omega-3 fatty acids, such as, but not limited to, alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA).

[0049] As used herein, the term "stable" refers to a formulation in which the labeled amount of active pharmaceutical ingredient is maintained approximately during storage for a commercially relevant period of time, and the content of drug-related impurities in the formulation is maintained within acceptable limits.

[0050] The terms "treat", "treating" and "treatment" refer to obtaining a desired pharmacological and / or physiological effect, which may be prophylactic or therapeutic, and includes partially or substantially achieving one or more of the following: partially or completely reducing the severity of a disease, disorder or syndrome; ameliorating or improving clinical symptoms or indicators associated with a disorder; or delaying, inhibiting or reducing the likelihood of progression of a disease, disorder, syndrome and / or symptoms thereof.

[0051] The terms "prevent" or "prevention" refer to the administration of a treatment to prevent an individual, particularly those with risk factors for a disease, from developing a disease.

[0052] The term "epilepsy" refers to a group of neurological disorders characterized by recurrent epileptic seizures.

[0053] The term "seizure," formally called an "epileptic seizure," refers to a symptom caused by abnormally excessive or synchronized activity of nerve cells in the brain.

[0054] The term "pharmaceutically acceptable excipient" or "suitable pharma- ceutically acceptable excipient" refers to an ingredient that is added to a pharmaceutical or nutraceutical composition, other than the active ingredient.

[0055] The term "adjunctive" refers to the administration of a composition of the present invention, which may be administered simultaneously, sequentially, before or after the administration of an anticonvulsant.

[0056] In the text describing the invention (particularly in the text of the claims which follow), the terms "a," "an," "the," and similar pronouns are intended to cover both the singular and the plural, unless otherwise indicated in the specification or the context clearly contradicts.

[0057] In this specification and the appended claims, the words "comprise," "have," "contain," and "include," as well as variations such as "comprises," "comprising," "having," "containing," "includes," and "including," are to be understood to be inclusive, unless the context indicates otherwise. That is, use of these words may imply the inclusion of elements not specifically recited.

[0058] Excipients can be added to facilitate manufacturing, improve 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, flavorings, coating agents, colorants, solvents, drug solvents, cosolvents, solubility enhancers, anti-adherents, preservatives, adsorbents, sweeteners, release-controlling polymers, stabilizers, acidic agents, basic agents, foaming agents, buffers, viscosity adjusters, pH adjusters, and other excipients well known in the art for making pharmaceutical compositions.

[0059] In one embodiment, the present invention relates to a stable composition for oral administration comprising a multivitamin, a mineral, a coenzyme, an amino acid, and an omega-3 fatty acid according to the present invention, which can be formulated into a single dose pharmaceutical composition that is immediate release, sustained release, controlled release, delayed release, or any combination thereof.

[0060] The novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids according to the present invention may be in the form of tablets, effervescent tablets, chewable tablets, sustained release tablets, controlled release tablets, delayed release tablets, capsules, granules, pellets, beads, sachets, oral syrup, oral solution, solutions, suspensions, or emulsions, etc.

[0061] In another embodiment, the present invention also relates to a method for preparing a novel pharmaceutical or nutraceutical composition for oral administration comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids.

[0062] In another embodiment, the present invention comprises 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 the like, and any combination thereof.

[0063] In one embodiment, vitamin D is a fat-soluble secosteroid that promotes intestinal absorption of calcium. Vitamin D has other roles in the body, including regulating cell growth, neuromuscular and immune function, and reducing inflammation. Vitamin D is available in various forms, with cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2) being the two main forms in humans. Vitamin D3 is produced photochemically in the skin upon exposure to sunlight. Vitamin D can also be obtained from the diet or supplements.

[0064] Vitamin D is used as one of the vitamins in the present invention in an amount of about 1.0 μg to about 30 μg, more preferably about 1.0 μg to about 20 μg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0065] In one embodiment, vitamin E, a fat-soluble vitamin, is an antioxidant vitamin involved in the metabolism of all cells. Vitamin E protects vitamin A and essential fatty acids from oxidation in body cells, preventing the destruction of body tissues. Vitamin E is a collective term for a group of related substances including α-tocopherol, β-tocopherol, γ-tocopherol, and δ-tocopherol. Furthermore, each of these four compounds has a natural type "d" type and a synthetic type "d1" type. Preferably, vitamin E is natural. The amount of vitamin E is about 1.0 mg to about 20 mg, more preferably about 1.0 mg to about 15 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0066] In one embodiment, vitamin B6 is a member of the B vitamins and is an essential nutrient. Its active form, pyridoxal 5'-phosphate, functions as a coenzyme in over 140 enzymatic reactions in the metabolism of amino acids, glucose, and lipids.

[0067] Vitamin B6 is a water-soluble vitamin and a member of the B vitamin family. The vitamin is actually composed of six chemically related compounds, or vitamers, all of which have a pyridine ring at their core. These are pyridoxine, pyridoxal, pyridoxamine, and their phosphorylated derivatives, pyridoxine 5'-phosphate, pyridoxal 5'-phosphate, and pyridoxamine 5'-phosphate. Pyridoxal 5'-phosphate is the most biologically active, but the others can be converted to pyridoxal 5'-phosphate. Vitamin B6 functions as a coenzyme in over 140 cellular reactions, the majority of which are related to the biosynthesis and catabolism of amino acids, but also participates in fatty acid biosynthesis and other physiological functions.

[0068] The amount of vitamin B6 (pyridoxine hydrochloride) is preferably about 0.001 mg to about 5.0 mg, and more preferably about 0.001 mg to about 3.5 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0069] In one embodiment, vitamin B9 refers to the many forms of folic acid and its related compounds, including tetrahydrofolate (the active form), methyltetrahydrofolate (the major form in the blood), methenyltetrahydrofolate, folinic acid, folacin, and pteroylglutamic acid.

[0070] The amount of vitamin B9 (folic acid) is preferably about 1.0 μg to about 400 μg, more preferably about 25 μg to about 350 μg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0071] In one embodiment, vitamin B12 or cyanocobalamin is also used to treat pernicious anemia, vitamin B12 deficiency (due to low dietary intake or inability to absorb due to genetic or other factors), thyrotoxicosis, bleeding, malignancies, liver disease, and kidney disease.

[0072] Vitamin B12 deficiency has profound effects on the nervous system, causing irreversible damage with progressive loss of myelinated neurons, demyelination, and death of nerve cells in the spinal cord and cerebral cortex, resulting in symptoms such as numbness in the hands and feet, loss of touch and position sense, resulting in unsteadiness, confusion, moodiness, loss of memory and central vision, and in some cases delirium, hallucinations, or frank psychosis.

[0073] The amount of vitamin B12 (cyanocobalamin) is preferably about 1.0 μg to about 5.0 μg, more preferably about 1.0 μg to about 2.2 μg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0074] In another embodiment, the present invention comprises 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, sodium selenite, chromium, and the like, and combinations thereof.

[0075] In one embodiment, magnesium is the fourth most abundant mineral in the human body and is involved in approximately 325 enzymatic reactions, including cellular energy production through ATP-Mg complex formation, cell membrane stabilization, and synthesis of nucleic acids, proteins, and cytoplasmic organelles. Thus, this mineral plays an important role in regulating the electrical stability and integrity of cell membranes, muscle contraction, nerve conduction, and vascular tone. It is also associated with anxiety-related disorders. Deficiency (hypomagnesemia) causes nervous system hypersensitivity with tetany, fatigue, vasodilation, localized muscle spasms and cramps, generalized convulsions, tremors, depression, and psychotic behavior.

[0076] The amount of magnesium is preferably about 1.0 mg to about 500 mg based on the total weight of the pharmaceutical or nutritional supplement composition.

[0077] In one embodiment, manganese (Mn), a required micronutrient for humans, is a trace element essential for many physiological processes due to its role in the activity of various metalloprotein enzymes. There are 11 known oxidation states of manganese, of which Mn 2+ , Mn 3+ , Mn 4+ is present in humans and animals.

[0078] Manganese is found in high concentrations in the bones, liver, kidneys, and pancreas. Manganese helps form connective tissue, bones, blood clotting factors, and sex hormones. Manganese also plays a role in fat and carbohydrate metabolism, calcium absorption, and blood sugar regulation. Manganese is also needed for normal brain and nerve function. Low manganese levels in the body can cause infertility, bone deformities, weakness, and seizures.

[0079] The amount of manganese is preferably about 1.0 mg to 10 mg, more preferably about 1.0 mg to 5.0 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0080] In one embodiment, zinc is considered an essential nutrient, meaning that it cannot be produced or stored by the body. Zinc is an essential mineral and is not produced by the body. Zinc aids in growth, DNA synthesis, immune function, etc. Currently, approximately 70 enzymes (many of which are essential for human health) are known to contain zinc, and it is well established that many (if not all) of these enzymes require zinc for their activity.

[0081] The amount of zinc is preferably about 1.0 mg to about 30 mg, more preferably about 1.0 mg to about 20 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0082] In one embodiment, selenium is a trace mineral, meaning that only small amounts are required by the body. Selenium is found naturally in foods or as a supplement. Selenium is an essential component of various enzymes and proteins called selenoproteins, which help make DNA and protect cells from damage and infection. These proteins are also involved in reproduction and thyroid hormone metabolism. Most of the selenium in the body is stored in muscle tissue, but the thyroid gland retains the most selenium due to the presence of various selenoproteins that aid in thyroid function. Selenium is a component of selenoproteins and enzymes. They have antioxidant properties and help break down peroxides, which can damage tissues and DNA and lead to inflammation and other health problems.

[0083] The amount of sodium selenite is preferably about 1.0 μg to 80 μg, more preferably about 1.0 μg to 50 μg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0084] In one embodiment, the present invention comprises one or more amino acids selected from the group consisting of taurine (tauric acid), leucine, arginine, glutamine, glycine, and the like.

[0085] In another embodiment, taurine (2-aminoethanesulfonic acid) is a conditionally essential amino acid. It is found in free or simple peptides, but is not used in protein synthesis. In vivo studies have shown that taurine is essential for many aspects of mammalian development. Furthermore, low taurine levels are associated with a variety of pathological lesions, including cardiomyopathy, retinal degeneration, and growth retardation. Taurine is known to play an important role in numerous physiological functions, including detoxification, membrane stabilization, osmoregulation, and regulation of cellular calcium levels. Taurine has also been used to treat cardiovascular disease, epilepsy and other seizure disorders, macular degeneration, Alzheimer's disease, liver disorders, and cystic fibrosis.

[0086] The amount of taurine is preferably about 1.0 mg to about 800 mg, more preferably about 1.0 mg to 500 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0087] 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), eicosapentaenoic acid (EPA), and the like, and any combination thereof.

[0088] In another embodiment, omega-3 fatty acids, also called omega-3 oils, ω-3 fatty acids or n-3 fatty acids, are polyunsaturated fatty acids (PUFAs) characterized in their chemical structure by the presence of a double bond three atoms away from the terminal methyl group. There are three types of omega-3 fatty acids involved in human physiology: α-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. Seaweed and phytoplankton are the main sources of omega-3 fatty acids. DHA and EPA are accumulated in fish that eat these algae.

[0089] The amount of omega-3 fatty acid is preferably about 1.0 mg to about 1600 mg, more preferably about 1.0 mg to 1000 mg, based on the total weight of the pharmaceutical or nutritional supplement composition.

[0090] In one embodiment, the invention includes one or more coenzymes, including but not limited to Coenzyme Q10 (ubiquinone).

[0091] In another embodiment, coenzyme Q, also known as ubiquinone, is a family of coenzymes 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 isoprenyl chemical subunits in the tail. In natural ubiquinones, the number ranges from 6 to 10. This family is fat-soluble. CoQ has three redox states: fully oxidized (ubiquinone), semiquinone (ubisemiquinone), and fully reduced (ubiquinol). The molecule's ability to act as a two-electron carrier (transferring between the quinone and quinol forms) and one-electron carrier (transferring between the semiquinone form and these other forms), is central to CoQ's role in the electron transport chain, as the iron-sulfur cluster can only accept one electron at a time, and as an antioxidant that scavenges free radicals.

[0092] The amount of coenzyme Q10 is preferably 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.

[0093] The pharma- ceutically 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, colorants, solvents, cosolvents, drug vehicles, anti-adherents, preservatives, adsorbents, sweeteners, release-controlling polymers, stabilizers, acidic agents, basic agents, buffers, effervescent agents, pH adjusting agents, and other excipients known in the art for preparing pharmaceutical compositions.

[0094] Examples of pharmaceutical solvents in the present invention include, but are not limited to, the group consisting of sorbitol, water, purified water, polyhydric alcohols, hydroalcoholic solutions, buffer solutions, oils (e.g., vegetable oils, mineral oils, organic oily bases, emulsified bases, etc.), polyoxyl 40 hydrogenated castor oil (kolliphor RH 40), monopalmitate (Tween 60), sodium oleate, polyoxyethylene stearate, potassium oleate, and combinations thereof.

[0095] Examples of the solvent in the present invention include, but are not limited to, the group consisting of aqueous solvents, inert organic solvents, inorganic acids, alcohols, ketones, esters, ethers, aliphatic hydrocarbons, halogenated solvents, cycloaliphatic solvents, aromatic solvents, heterocyclic solvents, and mixtures thereof. Representative solvents include water, purified water, glycerin, acetone, diacetone alcohol, methanol, ethanol, isopropyl alcohol, butyl alcohol, ethylene glycol monoethyl ether, monoethyl acetate, cyclohexane, benzene, toluene, naphtha, 1,4-dioxane, tetrahydrofuran, hydrochloric acid (HCl), aqueous solvents containing inorganic salts (sodium chloride, calcium chloride, etc.), and mixed solvents thereof (acetone and water, acetone and methanol, acetone and ethyl alcohol, methylene dichloride and methanol, ethylene dichloride and methanol, etc.).

[0096] Examples of co-solvents in the present invention include, but are not limited to, the group consisting of propylene glycol, chloroform, ethanol glycerin, polyethylene glycol, and combinations thereof.

[0097] Examples of preservatives in the present invention include, but are not limited to, the group consisting of bronopol, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium benzoate, benzoic acid, phenethyl alcohol, benzyl alcohol, methylparaben, sodium methylparaben, sodium propylparaben, imidazolidinyl urea, p-hydroxybenzoic acid esters, chlorobutanol, dehydroacetic acid, benzalkonium chloride, merfen, thiomersal, cetyltrimethylammonium bromide, cetylpyridinium chloride, sorbic acid, and mixtures thereof.

[0098] Examples of buffering agents in the present invention include, but are not limited to, the group consisting of tartaric acid, citric acid, citric acid monohydrate, malic acid, acetic acid, glacial acetic acid, lactic acid, sodium citrate, and disodium hydrogen phosphate.

[0099] Examples of sweeteners in the present invention include, but are not limited to, the group consisting of aspartame, acesulfame potassium, aspartame acesulfame, glycerin, dipotassium glycyrrhizinate, stevia, thaumatin, sucrose, glucose, maltose, galactose; artificial sweeteners such as sodium saccharin, cyclamate, sucralose, sodium saccharin, neohesperidin dihydrochalcone, monoammonium glycyrrhizinate, glucose, invert sugar, fructose, Stevia rebaudiana (stevioside); sugar alcohols such as sorbitol, mannitol, xylitol, etc. Also contemplated are hydrogenated starch hydrolysates, synthetic sweeteners, their sodium salts, calcium salts, natural enhanced sweeteners, or mixtures thereof.

[0100] Examples of chelating agents in the present invention include, but are not limited to, the group consisting of sodium EDTA, disodium EDTA.

[0101] Examples of thickening agents in the present invention include, but are not limited to, the group consisting of xanthan gum, PVPK-30, PVPK-90, PEG400, hydroxyethyl cellulose, methyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose K4M, K100M, and water-soluble carboxyvinyl polymers.

[0102] Examples of flavoring agents in the present invention include, but are not limited to, the group consisting of hydroxypropyl betadex, vanilla, grape, lemon, lime, orange, cherry, grapefruit, berry, mint, licorice, coffee, chocolate, mint, peach, raspberry, and combinations thereof.

[0103] Examples of antioxidants in the present invention include, but are not limited to, the group consisting of 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, and combinations thereof.

[0104] Examples of flavoring agents in the present invention include, but are not limited to, the group consisting of fruit flavors, peppermint flavor, lemon, lemon lime, orange, sour cherry, mint, honey vanilla, citrus oil, grapefruit, grape, menthol, cranberry, vanilla berry, bubble gum, cherry; fruit essences including apple, pear, peach, strawberry, raspberry, plum, pineapple, apricot, or other fruit flavors; and combinations thereof.

[0105] Examples of colorants in the present invention include, but are not limited to, the group consisting of quinolone yellow, sunset yellow, erythrosine, brilliant blue, and the like.

[0106] Examples of diluents or fillers in the present invention include, but are not limited to, the group consisting of EMDEX / dextrates, citric acid, mannitol, sorbitol, sucrose, microcrystalline cellulose, carboxymethylcellulose (carmellose), sodium carboxymethylcellulose (carmellose sodium), corn starch, potato starch, anhydrous lactose, lactose monohydrate, and combinations thereof.

[0107] Examples of acidic or acidifying agents in the present invention include, but are not limited to, the group consisting of citric acid, maleic acid, tartaric acid, fumaric acid, adipic acid, succinic acid, lactic acid, glycolic acid, alpha-hydroxy acids, ascorbic acid, amino acids, anhydrides, salts and derivatives of these acids, and combinations thereof.

[0108] Examples of basic agents in the present invention include, but are not limited to, the group consisting of potassium carbonate, sodium carbonate, sodium hydrogen carbonate, sodium bicarbonate, potassium hydrogen carbonate, arginine carbonate, glycine carbonate, lithium carbonate, calcium carbonate, ammonium carbonate, L-lysine carbonate, sodium glycine carbonate, sodium carbonate of amino acids, anhydrous sodium perborate, effervescent perborate, sodium perborate monohydrate, sodium percarbonate, sodium dichloroisocyanurate, sodium hypochlorite, calcium hypochlorite, tris, tartrate, acetate, phosphate, and mixtures thereof.

[0109] Examples of lubricants in the present invention include, but are not limited to, the group consisting of calcium stearate, magnesium stearate, sodium stearyl fumarate, fumaric acid, calcium stearate, polyethylene glycol, sodium benzoate, potassium benzoate, sodium lauryl sulfate, talc, colloidal silica, sucrose fatty acid esters, stearic acid, zinc stearate, hydrogenated vegetable oils, mineral oil, glyceryl behenate, polyoxyethylene glycol, sodium benzoate, dimethicone, liquid paraffin, and mixtures thereof.

[0110] The binder in the present invention includes, but is not limited to, the group consisting of pregelatinized starch; partially pregelatinized starch; cellulose or its derivatives such as microcrystalline cellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl cellulose (carmellose sodium), hydroxyethyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, and the like; xanthan gum, cellulose gum, guar gum, pullulan, gum arabic, acacia powder, polyvinylpyrrolidone, polyacrylamide, polyvinyloxoazolidone, polyvinyl alcohol, and combinations thereof.

[0111] Examples of lubricants in the present invention include, but are not limited to, the group consisting of colloidal silica, colloidal silicon dioxide, pyrogen silica, hydrated sodium silicoaluminate, magnesium stearate, sodium stearyl fumarate, starch, talc, tribasic calcium phosphate, magnesium oxide, magnesium silicate, magnesium trisilicate, stearic acid, calcium stearate, and mixtures thereof.

[0112] In one embodiment, the present invention provides 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 suitable pharma- ceutically acceptable excipients; The present invention provides a novel pharmaceutical or nutraceutical composition comprising:

[0113] In one embodiment, the present invention provides 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 suitable pharma- ceutically acceptable excipients; The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0114] In one embodiment, the present invention provides 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 pharma- ceutically acceptable excipients; The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0115] In one embodiment, the present invention provides a) 0.001 mg to 20 mg of one or more vitamins, b) 0.001 mg to 500 mg of one or more minerals; c) 10.0 mg to 150 mg of one or more coenzymes; d) 200 mg to 500 mg of one or more amino acids; e) 500 mg to 1000 mg of one or more omega-3 fatty acids, and f) one or more suitable pharma- ceutically acceptable excipients; The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0116] In one embodiment, the present invention provides 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; 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; c) one or more coenzymes, including but not limited to coenzyme Q10 (ubiquinone); d) one or more amino acids selected from the group consisting of taurine (tauric acid), leucine, arginine, glutamine, glycine, and combinations thereof; e) one or more omega-3 fatty acids selected from the group consisting of docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and combinations thereof; and f) one or more suitable pharma- ceutically acceptable excipients; The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0117] In one embodiment, the present invention provides a) 0.001 mg to 5.0 mg of vitamin B6 (pyridoxine hydrochloride), b) 1.0 μg to 400 μg of vitamin B9 (folic acid), c) 1.0 μg to 5.0 μg of vitamin B12, d) 1 μg to 30 μg of vitamin D3 (cholecalciferol), e) 1 mg to 20 mg of vitamin E (tocopherol), f) 1 mg to 30 mg of zinc, g) 1 mg to 500 mg of magnesium, h) 1 mg to 10 mg of manganese; i) 1 μg to 80 μg of selenium, j) 1 mg to 1600 mg of omega-3 fatty acids, k) 1mg to 200mg of coenzyme Q10, l) 1 mg to 800 mg of taurine (2-aminoethanesulfonic acid), and m) one or more suitable pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0118] In one embodiment, the present invention provides a) 0.001 mg to 3.5 mg of vitamin B6 (pyridoxine hydrochloride), b) 25μg to 350μg of vitamin B9 (folic acid), c) 1.0 μg to 2.2 μg of vitamin B12, d) 1.0 μg to 20 μg of vitamin D3 (cholecalciferol), e) 1.0 mg to 15 mg of vitamin E (tocopherol), f) 1.0 mg to 20 mg of zinc, g) 1.0 mg to 500 mg of magnesium, h) 1.0 mg to 5.0 mg of manganese; i) 1.0 μg to 50 μg of selenium, j) 1.0 mg to 1000 mg of omega-3 fatty acids, k) 1.0 mg to 150 mg of coenzyme Q10, l) 1.0 mg to 500 mg of taurine (2-aminoethanesulfonic acid), and m) one or more suitable pharma- ceutically acceptable excipients The present invention provides a novel oral pharmaceutical or nutraceutical composition comprising:

[0119] In one embodiment, the present invention also relates to a method for the preparation of a novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, omega-3 fatty acids, and one or more suitable pharma- ceutically acceptable excipients.

[0120] In one embodiment, the present invention provides a) dissolving multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids in a suitable solvent or pharmaceutical solvent to obtain a solution; b) adding and dissolving one or more suitable pharma- ceutically acceptable excipients to the solution of step (a); c) filtering the solution of step (b) through a suitable filter; and d) filling into suitable bottles or containers; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0121] In one embodiment, the present invention provides a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) screening one or more suitable pharma- ceutically acceptable excipients through suitable sieves; c) pre-lubricating and mixing the sieved materials of step (a) and step (b) in a suitable mixing device; d) lubricating and mixing the above materials for a suitable period of time; and e) compressing the mixture of step (d) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0122] In one embodiment, the present invention provides a) screening the multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids through suitable sieves; b) dry blending the ingredients of step (a); c) preparing a binder solution; d) granulating the mixture obtained in step (b) with the binder solution obtained in step (c); e) drying the granules obtained in step (d); f) sieving, mixing and lubricating the dried granules of step (e); and g) compressing the granules of step (f) into a suitable dosage form; The present invention provides a method for preparing a novel oral pharmaceutical or nutraceutical composition comprising the steps of:

[0123] In another embodiment, the present invention discloses a method of use of a novel pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures in patients of all age groups.

[0124] In another embodiment, the present invention discloses a method of use of a novel oral pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures in patients of all age groups.

[0125] In another embodiment, the present invention discloses that a novel oral pharmaceutical or nutraceutical composition comprising multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids can be used prophylactically or adjunctively when used as an adjunct to anticonvulsants such as, but not limited to, brivaracetam, carbamazepine, clobazam, clonazepam, diazepam, ethosuximide, gabapentin, lacosamide, lamotrigine, levetiracetam, midazolam, oxcarbazepine, perampanel, phenobarbitone, phenytoin, pregabalin, primidone, rufinamide, sodium valproate, tiagabine, topiramate, vigabatrin, zonisamide, or combinations thereof. EXAMPLES

[0126] The following examples are intended to illustrate embodiments of the present invention and are not intended to limit the scope of the invention.

[0127] Example 1: Omega-3 Fatty Acid, Coenzyme Q10, and Taurine Syrup with Multivitamins and Multiminerals TIFF2025506550000001.tif152161 qs: Sufficient amount

[0128] Manufacturing method 1. Dissolve the active ingredient (number 1-12) in the drug solution or solvent and stir at 250 rpm for 15 minutes; 2. Add all remaining inactive ingredients (numbers 13-18) to the above solution and dissolve; 3. Filter the solution through a 5 μm PES filter; 4.Fill into 200mL amber plastic bottles.

[0129] Example 2: Omega-3 Fatty Acids, Coenzyme Q10, and Taurine Solution Combined with Multivitamins and Multiminerals TIFF2025506550000002.tif159161 qs: Sufficient amount

[0130] Manufacturing method 1. Dissolve the active ingredient (number 1-12) in water and propylene glycol with hydroxypropyl betadex and stir at 500 rpm for 30 minutes; 2. Add and dissolve all remaining inactive ingredients into the above solution; 3. Filter the solution through a 5 μm PES filter; 4.Fill into 250mL amber plastic bottles.

[0131] Example 3: Effervescent tablet of omega-3 fatty acids, coenzyme Q10, and taurine with multivitamins and multiminerals (direct compression method) TIFF2025506550000003.tif161161

[0132] Manufacturing method 1. Pass all active ingredients (Nos. 1-12) and diluent (dextrates) through a No. 30 sieve. 2. Pass the citric acid, sodium bicarbonate, aspartame, and flavor through a No. 30 sieve; 3. Pre-lubricate the above materials using a mixing device at 10 rpm for 15 minutes; 4. Pass the PRUV through a No. 40 sieve. 5. The above materials are lubricated using a mixing device at 10 rpm for 5 minutes; Direct compression with a 6.22 mm x 10 mm oval punch.

[0133] Example 4: Effervescent tablets of omega-3 fatty acids, coenzyme Q10, and taurine with multivitamins and multiminerals TIFF2025506550000004.tif174161 qs: Sufficient amount

[0134] Manufacturing method 1. Pass all active ingredients (Nos. 1-12) and diluent through a No. 30 sieve. 2. Pass the sorbitol, sodium bicarbonate, tartaric acid, aspartame, and flavor through a No. 30 sieve; 3. Pre-lubricate the above materials with a mixing device at 10 rpm for 15 minutes; 4. Pass the PRUV through a No. 40 sieve. 5. Use a mixing device to lubricate the above materials at 10 rpm for 5 minutes; Direct compression with a 6.22 mm x 10 mm oval punch.

[0135] Example 5: Chewable tablets of omega-3 fatty acids, coenzyme Q10, and taurine with multivitamins and multiminerals TIFF2025506550000005.tif202161

[0136] Manufacturing method 1. Pass all active ingredients (Nos. 1-12) and sucrose together through a No. 30 sieve. 2. Dry mix the above materials in an RMG for 10 minutes at 12 rpm; 3. Prepare a binder by adding acacia powder to sufficient amount of water, and add the binder to the above dry mixed materials; 4. Sieve through No. 30 sieve and dry at 35°C to an LOD of less than 3%. 5. Pass the dried granules through a No. 30 sieve. 6. In a mixer, pre-lubricate the above dry granules, methyl hydroxybenzoate, propyl hydroxybenzoate, Pearlitol® 200 SD mannitol, colloidal silicon dioxide, citric acid monohydrate, flavored fruit, and aspartame for 10 minutes at 12 rpm; 7. Pass the magnesium stearate through a No. 60 sieve. 8. Mix the above materials using a mixing device at a suitable speed of 10 rpm for 5 minutes; 9. Lubricate the mixture and compress it into an 18mm x 9mm oval punch.

Claims

1. 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 pharma- ceutically acceptable excipients 1. An oral pharmaceutical or nutritional supplement composition comprising:

2. 2. The composition of claim 1 , 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 pharma- ceutically acceptable excipients; A composition comprising:

3. 2. The composition of claim 1 , The composition, 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. 2. The composition of claim 1 , The composition, wherein the minerals are 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. 2. The composition of claim 1 , The composition, wherein the coenzyme is coenzyme Q10 (ubiquinone).

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

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

8. 2. The composition of claim 1 , The composition, wherein the pharma- ceutically 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, colorants, solvents, co-solvents, drug solvents, anti-adherents, preservatives, adsorbents, sweeteners, release-controlling polymers, stabilizers, acidic agents, basic agents, buffers, effervescent agents, pH adjusters, and combinations thereof.

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

10. A method for producing a novel oral pharmaceutical or nutraceutical composition comprising the steps of: a) dissolving multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids in a solvent or pharmaceutical solvent to obtain a solution; b) adding and dissolving one or more pharma- ceutically acceptable excipients to the solution obtained in step (a); c) filtering the solution obtained in step (b) through a suitable filter; and d) filling the filtrate obtained in step (c) into bottles or containers; A method for producing a novel oral composition for pharmaceutical or nutritional supplement use, comprising the steps of:

11. 1. A method for producing an oral pharmaceutical or nutraceutical composition, comprising: a) screening multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids; b) sieving one or more pharma- ceutically acceptable excipients; c) pre-lubricating the undersize material obtained in step (a) and step (b) and mixing them in a mixer to obtain a mixture; d) lubricating and mixing the mixture obtained in step (c) for 5 to 10 minutes; and e) compressing the lubricated mixture of step (d) into a dosage form; The manufacturing method of the present invention.

12. 1. A method for producing an oral pharmaceutical or nutraceutical composition, comprising: a) screening multivitamins, minerals, coenzymes, amino acids, and omega-3 fatty acids; b) dry blending the components of step (a); c) preparing a binder solution; d) granulating the mixture obtained in step (b) with the binder solution obtained in step (c); e) drying the granules obtained in step (d); f) sieving, mixing and lubricating the dried granules of step (e); and g) compressing the granules of step (f) into a dosage form; The manufacturing method of the present invention.

13. 2. The composition of claim 1 , A composition for prophylactic or adjunctive use as an adjunct to anticonvulsants used in the treatment / prevention of various types of epilepsy or seizures in patients of all ages.

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