Compositions and methods for eye health containing AREDS and vitamin B complex

Abstract

For example, the present invention provides compositions and methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, including age-related macular degeneration. [Solution] A composition is provided comprising vitamin C, vitamin E, zinc, copper, and a potent vitamin B complex, as well as a pharmaceutically acceptable salt of any of the above. The composition is useful, for example, in methods for treating conditions associated with vision loss, including age-related macular degeneration.

Description

Technical Field

[0001] Compositions and methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, including, for example, age-related macular degeneration, are disclosed herein. In some embodiments, vitamin C, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin E, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; zinc, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; copper, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B1, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B2, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B3, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B5, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B6, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B7, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B9, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof; vitamin B12, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof are disclosed herein. In some embodiments, the composition further comprises lutein, its prodrugs, and / or any of the pharmaceutically acceptable salts thereof, and / or zeaxanthin, its prodrugs, and / or any of the pharmaceutically acceptable forms thereof.

[0002] Furthermore, 350mg to 800mg of vitamin C, or an equivalent amount of vitamin C prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 50mg to 550mg of vitamin E, or an equivalent amount of vitamin E prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 20mg to 90mg of zinc, or an equivalent amount of zinc prodrug, pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug; and 1.5mg to 2.5mg of copper, or an equivalent amount of copper prodrug, drug A pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug, 5.0 mg to 50.0 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug, 1.0 mg to 20.0 mg of zeaxanthin, or an equivalent amount of a zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug, 0.1 mg to 25 mg of thiamine, or an equivalent amount of a vitamin B1 prodrug, a pharmaceutically acceptable salt, and / or prodrug A pharmaceutically acceptable salt of lag, 0.1 mg to 25 mg of riboflavin, or an equivalent amount of vitamin B2 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 1 mg to 300 mg of nicotinic acid and / or niacinamide, or an equivalent amount of vitamin B3 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 1 mg to 250 mg of pantothenic acid, or an equivalent amount of vitamin B5 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug A pharmaceutically acceptable salt, 25 mg to 200 mg of pyridoxine, or an equivalent amount of vitamin B6 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 0.01 mg to 1.0 mg of biotin, or an equivalent amount of vitamin B7 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 1 mg to 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of vitamin B9 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, and 0.Compositions comprising 25 mg to 3.0 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B12 are disclosed herein.

[0003] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, 1.5 mg of thiamine, 1.7 mg of riboflavin, 20 mg of nicotinic acid and / or niacinamide, 10.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.03 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0004] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R lutein, 2.0 mg of R'R' zeaxanthin, 1.5 mg of thiamine, 1.7 mg of riboflavin, 20.0 mg of nicotinic acid and / or niacinamide, 10.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.03 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0005] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R lutein, 2.0 mg of R'R' zeaxanthin, 3.0 mg of thiamine, 3.4 mg of riboflavin, 40.0 mg of nicotinic acid and / or niacinamide, 20.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.06 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0006] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R lutein, 2.0 mg of R'R' zeaxanthin, 3.0 mg of thiamine, 3.4 mg of riboflavin, 40.0 mg of nicotinic acid and / or niacinamide, 20.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.06 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0007] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R lutein, 2.0 mg of R'R' zeaxanthin, 4.5 mg of thiamine, 5.1 mg of riboflavin, 60 mg of nicotinic acid and / or niacinamide, 30.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.09 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0008] Also disclosed herein are compositions comprising, optionally, 500.0 mg of vitamin C in the form of ascorbic acid, optionally 400.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R'R lutein, 2.0 mg of R'R' zeaxanthin, 4.5 mg of thiamine, 5.1 mg of riboflavin, 60.0 mg of nicotinic acid and / or niacinamide, 30.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.09 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0009] In addition, approximately 350 mg to approximately 800 mg of vitamin C, or an equivalent amount of vitamin C prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; approximately 200 mg to approximately 550 mg of vitamin E, or an equivalent amount of vitamin E prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; and approximately 20 mg to approximately 90 mg of zinc, or an equivalent amount of zinc prodrug, pharmaceutically acceptable form, and / or prodrug. A pharmaceutically acceptable salt of , approximately 1.5 mg to approximately 2.5 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, approximately 5 mg to approximately 50 mg of lutein, or an equivalent amount of lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, approximately 1 mg to approximately 20 mg of zeaxanthin, or an equivalent amount of zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or This includes a pharmaceutically acceptable salt of a prodrug, approximately 0.1 mg to approximately 25 mg of thiamine, or an equivalent amount of a pharmaceutically acceptable salt of a prodrug of vitamin B1, and / or a pharmaceutically acceptable salt of a prodrug, approximately 0.1 mg to approximately 25 mg of riboflavin, or an equivalent amount of a pharmaceutically acceptable salt of a prodrug of vitamin B2, and / or a pharmaceutically acceptable salt of a prodrug, and approximately 1.0 mg to approximately 300 mg of nicotinic acid and / or niacinamide, or equivalent. A quantity of vitamin B3 prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, and approximately 1.0 mg to approximately 250 mg of pantothenic acid, or an equivalent amount of vitamin B5 prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, and approximately 25 mg to approximately 200 mg of pyridoxine, or an equivalent amount of vitamin B6 prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, and approximately 0.A composition comprising approximately 0.1 mg to about 1 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B7, approximately 1 mg to about 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B9, and approximately 0.25 mg to about 3 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B12 is disclosed herein.

[0010] Also disclosed herein are compositions comprising, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20 mg of nicotinic acid and / or niacinamide, about 10 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.03 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0011] Also disclosed herein are compositions optionally comprising about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20 mg of nicotinic acid and / or niacinamide, about 10 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.03 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0012] Also disclosed herein are compositions comprising, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 3 mg of thiamine, about 3.4 mg of riboflavin, about 40 mg of nicotinic acid and / or niacinamide, about 20 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.06 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0013] Also disclosed herein are compositions comprising, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 3 mg of thiamine, about 3.4 mg of riboflavin, about 40 mg of nicotinic acid and / or niacinamide, about 20 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.06 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0014] Also disclosed herein are compositions optionally comprising about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 4.5 mg of thiamine, about 5.1 mg of riboflavin, about 60 mg of nicotinic acid and / or niacinamide, about 30 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.09 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0015] Also disclosed herein are compositions comprising, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 400 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R'R lutein, about 2 mg of R'R' zeaxanthin, about 4.5 mg of thiamine, about 5.1 mg of riboflavin, about 60 mg of nicotinic acid and / or niacinamide, about 30 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.09 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin. [Background technology]

[0016] Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people aged 55 and older in the United States and Western Europe. An estimated 1.75 million people in the U.S. have progressive AMD, accounting for the majority of severe vision loss cases. Another 7.3 million people have early-stage AMD, which is usually not associated with vision loss but increases the risk of developing AMD. This is associated with a set of clinically recognizable ocular findings that can lead to blindness. These findings include retinal pigment epithelial (RPE) disorders, including drusen, pigment aggregation and / or shedding, RPE detachment, geographic atrophy, subretinal neovascularization, and discoid scarring. Not all of these symptoms are necessary for AMD to be considered present. [Overview of the project]

[0017] Compositions for eye health, for example, for preventing or treating macular degeneration, are disclosed herein. In some embodiments, the compositions disclosed herein are nutritional or health supplement compositions. In some embodiments, the compositions are pharmaceutical compositions. In some embodiments, the compositions disclosed herein may enhance and / or promote retinal health, for example, by stabilizing and / or treating vision loss in people having certain eye diseases, disorders, and / or conditions. In some embodiments, this disclosure relates to antioxidant nutritional supplements containing potent vitamin B complexes. In some embodiments, administration of the compositions may reduce vision loss, for example, by reducing the risk of developing late-stage or progressive age-related macular degeneration in patients.

[0018] Furthermore, methods for treating and / or preventing at least one disease, disorder, and / or condition related to vision loss are disclosed herein, the methods comprising administering the compositions disclosed herein to a subject requiring such administration. In some embodiments, the at least one disease, disorder, and / or condition related to vision loss is selected from macular degeneration, age-related macular degeneration (AMD), retinal pigment epithelium (RPE) atrophy, atrophy of at least one photoreceptor, drusen, drusenoid pigment epithelial detachment (PED), diabetic retinopathy, cataract, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration, and oxygen-induced retinopathy.

[0019] Furthermore, methods for degenerating drusen and / or drusenoid pigment epithelial detachment (PED), methods for treating and / or preventing atrophy of retinal pigment epithelium (RPE) and / or at least one photoreceptor, and methods for treating and / or preventing vision loss and / or improving vision are disclosed herein. These methods include performing them on subjects requiring administration of the compositions disclosed herein.

[0020] The "vitamin B complex" is a group of B vitamins essential for the function of certain enzymes in the body. Although chemically unrelated, they are generally found together in the same foods. Mechanistically, various types of vitamin B have been characterized as compounds that promote cellular metabolism or important chemical pathways to ensure cellular health. Many of these mechanisms are related to mixed biological pathways. Vitamin B levels may also be related to overall nerve / brain health, as many of them are involved in neurotransmitter networks and cell protection.

[0021] All of these compounds are classified as vitamins because they are nutrients that the body does not produce itself but are necessary for healthy functioning and must be consumed or replenished through food. In most cases, a diet containing legumes, meat, and grains usually provides enough to avoid deficiency. Some hypothesize that low systemic levels of vitamin B can lead to an unfavorable metabolic environment, such as higher homocysteine ​​levels (a marker of inflammation), which may lead to an increased risk of diseases such as cardiovascular disease.

[0022] According to the literature, vitamin B supplementation may help alleviate insufficient cellular metabolism that leads to disease / deficiency. However, long-term clinical evidence to determine which vitamin B levels need to be supplemented is difficult to obtain.

[0023] The National Eye Institute (NEI) funded a study evaluating the effects of potent doses of vitamin B6 (pyridoxine HCl 50 mg / day), vitamin B9 (folate 2.5 mg / day), and vitamin B12 (cyanocobalamin 1 mg / day) on the progression of macular degeneration in women with cardiovascular disease. The results of this study suggest that these vitamins may help mitigate or delay the progression of macular degeneration in this patient population, but further research is needed to confirm this. Additional clinical evaluations are also needed to assess the effects of vitamin B supplementation in larger populations, namely men and women without cardiovascular problems, as well as in AMD patients, and the effects of other B vitamins.

[0024] In accordance with this disclosure, compositions and methods are provided for improving eye health and / or slowing the progression of macular degeneration, comprising a potent vitamin B complex, the vitamin B complex comprising: vitamin B1, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B2, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B3, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B5, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B6, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B7, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B9, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; and vitamin B12, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts.

[0025] Vitamin B1 is important in cellular energy metabolic pathways, such as the neurometabolism of amino acids and carbohydrates. Vitamin B2 works with other B vitamins to promote cell growth, produce red blood cells, and extract energy from proteins. Vitamin B2 is involved in mitochondrial energy production and is a precursor of flavoproteins (such as flavin adenine dinucleotide (FAD)) in energy transport. FAD is required to convert retinol to retinoic acid and is necessary for fatty acid oxidation. Vitamin B2 is also essential for red blood cell production and exhibits antioxidant activity in the reduction of GSSG (oxidized glutathione) to GSH (reduced glutathione), which plays a role in reducing inflammation. Vitamin B3 has been shown to affect cardiovascular health, including lowering cholesterol and improving blood flow. Vitamin B3 is a precursor of NAD and NADH, promotes nitric oxide production, helps maintain a healthier lipid profile with low triglyceride ("TG") and very low-density lipoprotein ("VLDL") levels, and is an immunostimulant. Vitamin B5 plays a crucial role in the production of coenzyme A, a cofactor in important metabolic reactions that break down carbohydrates, proteins, and lipids for energy. Vitamin B5 is generally unevenly distributed and rarely deficient, but it is important to ensure that the molecule is present. Vitamin B6 is necessary for the production of carbohydrates, amino acids, and lipids. Vitamin B7 is a cofactor in the production of important enzymes used in metabolism, such as carboxylase enzymes. Vitamin B7 deficiency can lead to conditions that increase the risk of inflammation, such as rashes and acidosis. Vitamin B9 is necessary for the conversion of homocysteine ​​to methionine, DNA methylation, and one-carbon metabolism. Based on meta-analyses, vitamin B9 is also involved in improving cardiovascular health and reducing the risk of stroke. Folic acid deficiency inhibits cell division by limiting red blood cell production. Vitamin B9 is also thought to have effects on adaptive immune responses. Vitamin B12 is necessary for the conversion of homocysteine ​​to methionine and is essential for red blood cell synthesis.Therefore, it is suggested that the combination of B vitamins should promote the improvement of eye health and slow down the progression of AMD.

[0026] Furthermore, combining the vitamin complex of the present disclosure with other components such as AREDS components like zinc, copper, lutein, zeaxanthin, vitamin C, and vitamin E may also provide protection against macular degeneration. These components are powerful antioxidants that help protect cells, particularly the retinal pigment epithelial cells (RPE) that make up the retina and are involved in visual function. Therefore, the B-vitamin complex described in the present disclosure in combination with AREDS vitamins helps ensure that when a subject is given a dietary supplement containing the combination, the RPE cells are not further damaged or stressed. This combination of B vitamins and AREDS nutrients should promote the improvement of eye health and the delay of the progression of AMD.

[0027] Definitions of specific terms used in this application are provided below. Unless otherwise defined, all technical and scientific terms used in this specification have the meanings that are commonly and ordinarily understood by one of ordinary skill in the art to which this disclosure pertains.

[0028] As used herein, "a", "an", and "the" refer to one or more (i.e., at least one) of the grammatical objects of the article.

[0029] As used herein, administration of an "amount per day" of an enumerated element or composition refers to the total amount administered in a day, without limiting the frequency of administration per day. The amount per day administered to a patient can be administered once or multiple times a day, for example, twice or three times a day (where, considering that the "amount per day" refers to the total amount administered in a day, each of the multiple administrations involves administering an amount of the enumerated element or composition that is less than the "amount per day"). Each administration of the enumerated element or composition can consist of administering the enumerated element or composition in the form of a single administration (for example, a single tablet or a single capsule, etc.) or in the form of multiple administrations (for example, multiple (i.e., two or more) tablets and / or capsules, etc.).

[0030] As used herein, the terms “to treat” and “treatment” include the medical management of the disease, disorder, and / or condition in question as understood by those skilled in the art (see, for example, Stedman’s Medical Dictionary). Generally, an appropriate dose and treatment regimen provides at least one of the compositions of this disclosure sufficient to provide a therapeutic and / or preventive benefit. For both therapeutic measures and preventive or protective measures, the therapeutic and / or preventive benefit includes, for example, an improved clinical outcome, where the objective is to prevent, slow, or reduce an undesirable physiological change or disorder, or to prevent, slow, or reduce the progression or severity of such disorder. As discussed herein, beneficial or desirable clinical outcomes of treating a subject include, but are not limited to, a reduction, decrease, or alleviation of symptoms resulting from or associated with the disease, condition, and / or disorder being treated; a decrease in the occurrence of symptoms; an improvement in quality of life; a longer period of asymptomatic status (i.e., a reduction in the likelihood or tendency for the subject to exhibit symptoms based on the grounds for which a diagnosis of the disease is made); a reduction in the severity of the disease, disorder, and / or condition; a state of stabilization (i.e., not worsening) of the disease, disorder, and / or condition; a delay or slowing of the progression of the disease, disorder, and / or condition; an improvement or mitigation of the state of the disease, disorder, and / or condition; and remission (whether partial or complete), whether detectable or undetectable, and / or overall survival.

[0031] As used herein, “prevention” of a disorder or condition, or “preventing them,” means reducing the incidence of a disorder or condition in a treated sample compared to an untreated control sample, and includes delaying the onset, progression, or severity of one or more symptoms of the disorder or condition compared to an untreated control sample.

[0032] As used herein, the term “pharmaceutically acceptable salt” refers to a salt form of a compound, including salts in which the salt is nontoxic and derived from suitable inorganic and organic acids and bases. Pharmacochemically acceptable salts are well known in the art. For example, SMBerge, et al., describe pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences, 1977, 66, 1-19. Non-limiting examples of suitable pharmaceutically acceptable acid addition salts include chlorides, bromides, sulfates, nitrates, phosphates, sulfons, methanesulfons, formates, tartrates, maleates, succinates, malons, citrates, benzoates, salicylates, and ascorbicates. Non-limiting examples of suitable pharmaceutically acceptable base addition salts include sodium, potassium, lithium, ammonium (substituted and unsubstituted), calcium, magnesium, iron, zinc, copper, manganese, and aluminum salts. Non-limiting examples of pharmaceutically acceptable salts include pharmaceutically acceptable salts derived from suitable bases, such as alkali metals, alkaline earth metals, ammonium, and N + (C 1-4 This includes alkyl) tetrasalts. This disclosure also assumes quaternization of any basic nitrogen-containing group of the compounds disclosed herein. Pharmaceutically acceptable salts may be obtained, for example, using standard procedures well known in the field of pharmaceuticals. Those skilled in the art will recognize that the stability and other properties of different pharmaceutically acceptable salts of the components listed herein may differ and will take these differences into consideration when selecting a suitable pharmaceutically acceptable salt.

[0033] As used herein, terms such as “patient,” “subject,” and “individual” refer to any animal that is interchangeable and may be human or non-human.

[0034] As used herein, “age-related macular degeneration” or “AMD” includes all forms of macular degeneration, including “wet” (exudative) and “dry” (atrophic) forms.

[0035] The term “prodrug” includes compounds that can be converted to biologically active compounds (for example, under physiological conditions or by solvolysis). Therefore, the term “prodrug” includes metabolic precursors of pharmaceutically acceptable compounds. Discussions of prodrugs can be found, for example, in Higuchi, T., et al., “Pro-drugs as Novel Delivery Systems,” ACSSymposium Series, Vol. 14, and Bioreversible Carriers in Drug Design, ed. Edward B. Roche, American Pharmaceutical Association and Pergamon Press, 1987. The term “prodrug” also includes covalent carriers that, when administered to a subject, release the active compounds described herein in vivo. Non-limiting examples of prodrugs include ester and amide derivatives of hydroxy, carboxy, mercapto, and amino functional groups in the compounds described herein.

[0036] As used herein, the term “nutritional composition” includes food intended for human consumption.

[0037] As will be understood by those skilled in the art, where disclosed herein, each range includes all possible subranges, as well as the individual numbers within that range. For example, the range "1.0 to 5.0" is understood to include subranges such as "1.0 to 3.0," "1.5 to 3.7," and "2.1 to 4.3," as well as all the individual numbers within the disclosed range, such as 1.0, 1.1, 1.2, 1.3, etc., and to be specifically disclosed.

[0038] In this specification, Vitamin C, its prodrugs, and / or any pharmaceutically acceptable salt of any of the foregoing, Vitamin E, its prodrugs, and / or any pharmaceutically acceptable salt of any of the foregoing, Zinc, its prodrugs, and / or any pharmaceutically acceptable salt thereof, Copper, its prodrugs, and / or any pharmaceutically acceptable salt of any of the foregoing, Vitamin B1, its prodrugs, and / or any pharmaceutically acceptable salt of the foregoing, Vitamin B2, its prodrugs, and / or any pharmaceutically acceptable salt of any of the aforementioned, Vitamin B3, its prodrugs, and / or any pharmaceutically acceptable salt of any of the aforementioned, Vitamin B5, its prodrugs, and / or any pharmaceutically acceptable salt of the foregoing, Vitamin B6, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B7, its prodrugs, and / or any pharmaceutically acceptable salt of the foregoing, Vitamin B9, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, A vitamin complex comprising vitamin B12, its prodrug, and / or any pharmaceutically acceptable salt thereof, Optionally, compositions further comprising lutein, its prodrug, and / or any pharmaceutically acceptable salt thereof, and / or zeaxanthin, its prodrug, and / or any pharmaceutically acceptable salt thereof are disclosed.

[0039] In some embodiments, vitamin C, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include vitamin C in the form of ascorbic acid. In some embodiments, vitamin E, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include dl-alpha-tocopheryl acetate and / or alpha-tocopherol. In some embodiments, zinc, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include zinc oxide and / or zinc gluconate. In some embodiments, copper, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include copper oxide and / or copper gluconate. In some embodiments, vitamin B1, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include thiamine. In some embodiments, vitamin B2, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include riboflavin. In some embodiments, vitamin B3, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include nicotinic acid and / or niacinamide. In some embodiments, vitamin B5, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include pantothenic acid. In some embodiments, vitamin B6, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include pyridoxine. In some embodiments, lutein, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include lutein(R'R'). In some embodiments, zeaxanthin, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include zeaxanthin(R'R'). In some embodiments, vitamin B7, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include biotin. In some embodiments, vitamin B9, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include folic acid and / or methyl tetrahydrofolate.In some embodiments, vitamin B12, its prodrug, and / or any of the pharmaceutically acceptable salts described above include cyanocobalamin.

[0040] In some embodiments, the composition optionally comprises vitamin C in the form of ascorbic acid, vitamin E in the form of dl-alpha-tocopheryl acetate, zinc in the form of zinc oxide, thiamine, copper in the form of copper oxide, riboflavin, nicotinic acid and / or niacinamide, pyridoxine, pantothenic acid, biotin, folate and / or methyl tetrahydrofolate, and cyanocobalamin. In some embodiments, the composition further comprises R'R' lutein and R'R zeaxanthin.

[0041] In some embodiments, vitamin C, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises ascorbic acid. In some embodiments, vitamin C, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts is ascorbic acid. The U.S. Recommended Dietary Allowance (RDA) for vitamin C in the form of ascorbic acid is 60 mg. In some embodiments, the composition comprises 60 mg to 850 mg of vitamin C, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises 100.0 mg to 800.0 mg of ascorbic acid, for example, 150.0 mg to 800.0 mg, 250.0 mg to 800.0 mg, 250.0 mg to 750.0 mg, 500.0 mg to 775.0 mg, 600.0 mg to 750.0 mg, 500.0 mg, or 750.0 mg of an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid. In some embodiments, the composition comprises about 60 mg to about 850 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition comprises about 100 mg to about 800 mg of ascorbic acid, for example, about 150 mg to about 800 mg, about 250 mg to about 800 mg, about 250 mg to about 750 mg, about 500 mg to about 775 mg, about 600 mg to about 750 mg, about 500 mg, or about 750 mg of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C in an equivalent amount. In some embodiments, the composition optionally comprises about 500 mg of vitamin C in the form of ascorbic acid.

[0042] In some embodiments, vitamin E, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises alpha-tocopherol. In some embodiments, vitamin E, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts is dl-alpha-tocopheryl acetate. The RDA of vitamin E is 15.0 mg. No adverse effects of vitamin E have been observed at levels as high as 800.0 mg. In some embodiments, the composition comprises 15.0 mg to 800 mg of vitamin E, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises 15.0 mg to 800.0 mg of vitamin E, for example, 50.0 mg to 750.0 mg, 90.0 mg to 600.0 mg, 180.0 mg to 500.0 mg, 250.0 mg to 400.0 mg, 300.0 mg to 350.0 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. In some embodiments, the composition comprises 180 mg of vitamin E. In some embodiments, the composition comprises about 15 mg to about 800 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. In some embodiments, the composition comprises about 15 mg to about 800 mg of vitamin E, for example, about 50 mg to about 750 mg, about 90 mg to about 600 mg, about 180 mg to about 500 mg, about 250 mg to about 400 mg, about 300 mg to about 350 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. In some embodiments, the composition optionally comprises about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate.

[0043] In some embodiments, zinc, its prodrug, and / or any pharmaceutically acceptable form thereof as described above comprises zinc oxide. In some embodiments, zinc, its prodrug, and / or any pharmaceutically acceptable form thereof is zinc oxide. The RDA of zinc is about 15 mg. In some embodiments, the composition comprises 15 mg to 100 mg of zinc, or an equivalent amount of a zinc prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable form of the prodrug. In some embodiments, the composition comprises 15.0 mg to 100.0 mg of zinc, for example, 40.0 mg to 95.0 mg, 50.0 mg to 90.0 mg, 60.0 mg to 85.0 mg, 70.0 mg to 80.0 mg, or 80.0 mg of zinc, or an equivalent amount of a zinc prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition optionally comprises 80.0 mg of zinc in the form of zinc oxide. In some embodiments, the composition optionally contains 25.0 mg of zinc in the form of zinc oxide. In some embodiments, the composition contains about 15 mg to about 100 mg of zinc, or an equivalent amount of a zinc prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable form of the prodrug. In some embodiments, the composition contains about 15 mg to about 100 mg of zinc, for example, about 40 mg to about 95 mg, about 50 mg to about 90 mg, about 60 mg to about 85.0 mg, about 70 mg to about 80 mg, or about 80 mg of zinc, or a zinc prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition optionally contains about 80 mg of zinc in the form of zinc oxide. In some embodiments, the composition optionally contains about 25 mg of zinc in the form of zinc oxide.

[0044] In some embodiments, copper, its prodrug, and / or any of the aforementioned pharmaceutically acceptable forms include copper oxide. In some embodiments, copper, its prodrug, and / or any of the aforementioned pharmaceutically acceptable forms is copper oxide. The RDA of copper is 2.0 mg. In some embodiments, the composition contains 1.5 mg to 2.5 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 1.5 mg to 2.0 mg, for example, 2.0 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition optionally contains 2.0 mg of copper in the form of copper oxide. In some embodiments, the composition contains about 1.5 mg to about 2.5 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 1.5 mg to about 2.0 mg of copper, for example, about 2.0 mg, or an equivalent amount of a copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition optionally contains about 2.0 mg of copper in the form of copper oxide.

[0045] In some embodiments, vitamin B1, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include thiamine. In some embodiments, vitamin B1, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts are thiamine. Vitamin B1 is a water-soluble vitamin. The U.S. Recommended Dietary Allowance (RDA) for oral intake of vitamin B1 is 1.2 mg for men and 1.1 mg for women over 18 years of age. In some embodiments, the composition contains 0.1 mg to 25 mg of vitamin B1, or an equivalent amount of a vitamin B1 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 0.1 mg to 25.0 mg of thiamine, or an equivalent amount of a vitamin B1 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition is 0.1 mg to 25.0 mg, for example, 0.5 mg to 20.0 mg, 1.0 mg to 15.0 mg, 1.5 mg to 10.0 mg, 1.1 mg to 4.5 mg, 1.2 mg to 3.5 mg, 1.2 mg to 2.5 mg, 1.2 mg to 1.8 mg, 1.5 mg, 2.0 to 20.0 mg, 2.0 mg to 15.0 mg, 2.5 mg to 10.0 mg, 2.5 mg to 3.5 mg, 2 The composition contains 0.6 mg to 3.4 mg, 2.8 mg to 3.2 mg, 3 mg, 3.0 mg to 20.0 mg, 3.0 mg to 15.0 mg, 3.0 mg to 10.0 mg, 3.0 mg to 5.0 mg, 3.2 mg to 4.8 mg, 3.4 mg to 4.6 mg, or 4.5 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 1.5 mg of thiamine. In some embodiments, the composition contains 3.0 mg of thiamine. In some embodiments, the composition contains 4.5 mg of thiamine. In some embodiments, the composition contains about 0.1 mg to about 25 mg of vitamin B1, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug.In some embodiments, the composition comprises about 0.1 mg to about 25 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 0.1 mg to about 25 mg, for example, about 0.5 mg to about 20 mg, about 1 mg to about 15 mg, about 1.5 mg to about 10 mg, about 1.1 mg to about 4.5 mg, about 1.2 mg to about 3.5 mg, about 1.2 mg to about 2.5 mg, about 1.2 mg to about 1.8 mg, about 1.5 mg, about 2 to about 20 mg, about 2 mg to about 15 mg, about 2.5 mg to about 10 mg, and about 2.5 mg to about 3.5 mg. The composition contains approximately 2.6 mg to 3.4 mg, approximately 2.8 mg to 3.2 mg, approximately 3 mg, approximately 3 mg to 20 mg, approximately 3 mg to 15 mg, approximately 3 mg to 10 mg, approximately 3 mg to 5 mg, approximately 3.2 mg to 4.8 mg, approximately 3.4 mg to 4.6 mg, or approximately 4.5 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains approximately 1.5 mg of thiamine. In some embodiments, the composition contains approximately 3 mg of thiamine. In some embodiments, the composition contains approximately 4.5 mg of thiamine.

[0046] In some embodiments, vitamin B2, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises riboflavin. Vitamin B2 is a water-soluble vitamin. The U.S. Recommended Dietary Allowance (RDA) for oral intake of vitamin B2 is 1.1 mg for men and 1.3 mg for women over 18 years of age. In some embodiments, the composition comprises 0.1 mg to 25.0 mg of riboflavin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B2. In some embodiments, the composition is 0.1 mg to 25.0 mg, for example, 1.0 mg to 20.0 mg, 1.0 mg to 15.0 mg, 1.0 mg to 10.0 mg, 1.1 mg to 4.5 mg, 1.2 mg to 3.5 mg, 1.2 mg to 2.5 mg, 1.3 mg to 1.8 mg, 1.7 mg, 2.0 mg to 20.0 mg, 2.0 mg to 15.0 mg, 2.0 mg to 10.0 mg, 2.0 mg to 4.0 mg, 2. The composition contains 2 mg to 3.8 mg, 2.6 mg to 3.4 mg, 3.4 mg, 3.0 mg to 20.0 mg, 3.0 mg to 15.0 mg, 3.0 mg to 10.0 mg, 3.0 mg to 6.0 mg, 3.2 mg to 5.8 mg, 3.4 mg to 5.6 mg, or 5.1 mg of riboflavin, or an equivalent amount of a vitamin B2 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 1.7 mg of riboflavin. In some embodiments, the composition contains 3.4 mg of riboflavin. In some embodiments, the composition contains 5.1 mg of riboflavin. In some embodiments, the composition contains about 0.1 mg to about 25 mg of riboflavin, or an equivalent amount of a vitamin B2 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug.In some embodiments, the composition is approximately 0.1 mg to approximately 25 mg, for example, approximately 1.0 mg to approximately 20 mg, approximately 1 mg to approximately 15 mg, approximately 1 mg to approximately 10 mg, approximately 1.1 mg to approximately 4.5 mg, approximately 1.2 mg to approximately 3.5 mg, approximately 1.2 mg to approximately 2.5 mg, approximately 1.3 mg to approximately 1.8 mg, approximately 1.7 mg, approximately 2 mg to approximately 20 mg, approximately 2 mg to approximately 15 mg, approximately 2 mg to approximately 10 mg, approximately 2 mg to approximately 4 mg, approximately 2.2 The composition contains riboflavin in amounts of approximately 3.8 mg, 2.6 mg, 3.4 mg, 3 mg, 20 mg, 3 mg, 15 mg, 3 mg, 10 mg, 3 mg, 6 mg, 3.2 mg, 5.8 mg, 3.4 mg, 5.6 mg, or 5.1 mg, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B2. In some embodiments, the composition contains approximately 1.7 mg of riboflavin. In some embodiments, the composition contains approximately 3.4 mg of riboflavin. In some embodiments, the composition contains approximately 5.1 mg of riboflavin.

[0047] In some embodiments, vitamin B3, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises nicotinic acid and / or niacinamide. In some embodiments, vitamin B3, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts is nicotinic acid. Vitamin B3 is a water-soluble vitamin that has three chemical forms: nicotinic acid, nicotinamide, and niacinamide. The U.S. Recommended Dietary Allowance (RDA) for oral intake of vitamin B3 is 16 mg for males and 14 mg for females over 14 years of age. In some embodiments, the composition comprises 1.0 mg to 300.0 mg, for example, 5.0 mg to 150.0 mg, 10.0 mg to 100.0 mg, 20.0 mg to 60.0 mg of nicotinic acid and / or niacinamide, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B3. In some embodiments, the composition contains 18.0 mg to 25.0 mg of nicotinic acid and / or niacinamide, for example, 18.5 mg to 24.5 mg, 17.0 mg to 24.0 mg, 16.5 mg to 23.5 mg, 16.0 mg to 23.0 mg, or 16.0 mg to 22.0 mg, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of vitamin B3. In some embodiments, the composition contains 20.0 mg of nicotinic acid and / or niacinamide. In some embodiments, the composition contains 40.0 mg of nicotinic acid and / or niacinamide. In some embodiments, the composition contains 60.0 mg of nicotinic acid and / or niacinamide. In some embodiments, the composition comprises about 1.0 mg to about 300.0 mg, for example, about 5.0 mg to about 150.0 mg, about 10.0 mg to about 100.0 mg, or about 20.0 mg to about 60.0 mg of nicotinic acid and / or niacinamide, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B3.In some embodiments, the composition contains about 18 mg to about 25 mg of nicotinic acid and / or niacinamide, for example, about 18.5 mg to about 24.5 mg, about 17 mg to about 24 mg, about 16.5 mg to about 23.5 mg, about 16 mg to about 23 mg, or about 16 mg to about 22 mg, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of vitamin B3. In some embodiments, the composition contains about 20 mg of nicotinic acid and / or niacinamide. In some embodiments, the composition contains about 40 mg of nicotinic acid and / or niacinamide. In some embodiments, the composition contains about 60 g of nicotinic acid and / or niacinamide.

[0048] In some embodiments, vitamin B5, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises pantothenic acid. In some embodiments, vitamin B5, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts is pantothenic acid. The recommended dietary requirement (RDA) for vitamin B5 is 5 mg for persons over 14 years of age. In some embodiments, the composition comprises 1.0 mg to 250.0 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B5. In some embodiments, the composition is 1.0 mg to 250.0 mg, for example, 2.0 mg to 200.0 mg, 5.0 mg to 150.0 mg, 5.0 mg to 100.0 mg, 5.0 mg to 50.0 mg, 5.0 mg to 30.0 mg, 4.5 mg to 13.5 mg, 5.0 mg to 12.5 mg, 5.5 mg to 12.0 mg, 6.0 mg to 12.5 mg, 6.5 mg to 12.0 mg, 8.5 mg to 11.0 mg, 9.0 mg to 1 The composition contains 0.5 mg, or 10.0 mg, 10.0 mg to 25.0 mg, 10.5 mg to 24.5 mg, 12.0 mg to 22.0 mg, 20.0 mg, 20.0 mg to 45.0 mg, 25.0 mg to 35.0 mg, 28.0 mg to 32.0 mg, or 30.0 mg of vitamin B5, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 10.0 mg of pantothenic acid. In some embodiments, the composition contains 20.0 mg of pantothenic acid. In some embodiments, the composition contains 30.0 mg of pantothenic acid. In some embodiments, the composition contains about 1 mg to about 250 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug.In some embodiments, the composition is approximately 1 mg to approximately 250 mg, for example, approximately 2 mg to approximately 200 mg, approximately 5 mg to approximately 150 mg, approximately 5 mg to approximately 100 mg, approximately 5 mg to approximately 50 mg, approximately 5 mg to approximately 30 mg, approximately 4.5 mg to approximately 13.5 mg, approximately 5.0 mg to approximately 12.5 mg, approximately 5.5 mg to approximately 12 mg, approximately 6 mg to approximately 12.5 mg, approximately 6.5 mg to approximately 12 mg, approximately 8.5 mg to approximately 11.0 mg, approximately 9 mg. The composition contains 0 to approximately 10.5 mg, or approximately 10 mg, approximately 10 mg to approximately 25 mg, approximately 10.5 mg to approximately 24.5 mg, approximately 12 mg to approximately 22 mg, approximately 20 mg, approximately 20 mg to approximately 45 mg, approximately 25 mg to approximately 35 mg, approximately 28 mg to approximately 32 mg, or approximately 30 mg of vitamin B5, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains approximately 10 mg of pantothenic acid. In some embodiments, the composition contains approximately 20 mg of pantothenic acid. In some embodiments, the composition contains approximately 30 mg of pantothenic acid.

[0049] In some embodiments, vitamin B6, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts comprises pyridoxine. In some embodiments, vitamin B6, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts is pyridoxine. The Recommended Dietary Allowance (RDA) for vitamin B6 is 1.3 mg for persons aged 14–50 years. In some embodiments, the composition comprises 25.0 mg to 100.0 mg of pyridoxine, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B6. In some embodiments, the composition comprises 25.0 mg to 200.0 mg of vitamin B6, for example, 25.0 mg to 100.0 mg, 30.0 mg to 90.0 mg, 40.0 mg to 80.0 mg, 45.0 mg to 70.0 mg, 45.0 mg to 60.0 mg, 55.0 mg, or 50.0 mg of vitamin B6, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises 50.0 mg of pyridoxine. In some embodiments, the composition comprises about 25 mg to about 100 mg of pyridoxine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 25 mg to about 200 mg of vitamin B6, for example, about 25 mg to about 100 mg, about 30 mg to about 90 mg, about 40 mg to about 80 mg, about 45 mg to about 70 mg, about 45 mg to about 60 mg, about 55 mg, or about 50 mg of vitamin B6, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 50 mg of pyridoxine.

[0050] In some embodiments, vitamin B7, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts include biotin. In some embodiments, vitamin B7, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts are biotin. The Recommended Dietary Allowance (RDA) for vitamin B7 is 0.03 mg for persons over 18 years of age. In some embodiments, the composition includes 0.01 mg to 1.0 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B7. In some embodiments, the composition contains 0.01 mg to 1.0 mg of vitamin B7, for example, 0.01 mg to 0.75 mg, 0.02 mg to 0.75 mg, 0.02 mg to 0.05 mg, 0.02 mg to 0.04 mg, or 0.03 mg of vitamin B7, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 0.03 mg of biotin. In some embodiments, the composition contains 0.06 mg of biotin. In some embodiments, the composition contains 0.09 mg of biotin. In some embodiments, the composition contains about 0.01 mg to about 1 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 0.01 mg to about 1 mg of vitamin B7, for example, about 0.01 mg to about 0.75 mg, about 0.02 mg to about 0.75 mg, about 0.02 mg to about 0.05 mg, about 0.02 mg to about 0.04 mg, or about 0.03 mg of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin B7 in an equivalent amount. In some embodiments, the composition contains about 0.03 mg of biotin. In some embodiments, the composition contains about 0.06 mg of biotin. In some embodiments, the composition contains about 0.09 mg of biotin.

[0051] In some embodiments, vitamin B9, its prodrug, and / or any pharmaceutically acceptable salt of vitamin B9 contains folic acid. In some embodiments, vitamin B9, its prodrug, and / or any pharmaceutically acceptable salt of vitamin B9 contains folate. In some embodiments, vitamin B9, its prodrug, and / or any pharmaceutically acceptable salt of vitamin B9 contains methyl tetrahydrofolate. In some embodiments, vitamin B9, its prodrug, and / or any pharmaceutically acceptable salt of vitamin B9 contains folate, folic acid, and / or methyl tetrahydrofolate. The recommended dietary requirement (RDA) for vitamin B9 is 0.4 mg for persons over 19 years of age. In some embodiments, the composition contains 0.1 mg to 50.0 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B9. In some embodiments, the composition comprises 1.0 mg to 3.0 mg of folate and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B9. In some embodiments, the composition comprises 1.0 mg to 3.0 mg of vitamin B9, for example, 1.1 mg to 2.9 mg, 1.2 mg to 2.8 mg, 1.3 mg to 2.7 mg, 1.4 mg to 2.6 mg, 1.5 mg to 2.6 mg, 1.6 mg to 2.6 mg, 1.7 mg to 2.6 mg, 1.8 mg to 2.6 mg, 1.9 mg to 2.6 mg, 2.0 mg to 2.6 mg, 2.1 mg to 2.6 mg, or 2.5 mg of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B9. In some embodiments, the composition contains 2.5 mg of folic acid and / or methyl tetrahydrofolate. In some embodiments, the composition contains about 0.1 mg to about 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B9.In some embodiments, the composition contains about 1 mg to about 3 mg of folate and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B9. In some embodiments, the composition contains about 1 mg to about 3 mg, for example, about 1.1 mg to about 2.9 mg, about 1.2 mg to about 2.8 mg, about 1.3 mg to about 2.7 mg, about 1.4 mg to about 2.6 mg, about 1.5 mg to about 2.6 mg, about 1.6 mg to about 2.6 mg, about 1.7 mg to about 2.6 mg, about 1.8 mg to about 2.6 mg, about 1.9 mg to about 2.6 mg, about 2 mg to about 2.6 mg, about 2.1 mg to about 2.6 mg, or about 2.5 mg of vitamin B9, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 2.5 mg of folic acid and / or methyl tetrahydrofolate.

[0052] The composition contains vitamin B12. In some embodiments, vitamin B12, its prodrug, and / or any pharmaceutically acceptable salt of vitamin B12 contains cyanocobalamin. The Recommended Dietary Allowance (RDA) for vitamin B12 is 2.4 micrograms (0.0024 mg) for persons over 14 years of age. In some embodiments, the composition contains 0.25 mg to 3 mg of cyanocobalamin, or an equivalent amount of a vitamin B12 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 0.5 mg to 1.5 mg of cyanocobalamin, or an equivalent amount of a vitamin B12 prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 1 mg of cyanocobalamin. In some embodiments, the composition contains about 0.25 mg to about 3 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B12. In some embodiments, the composition contains about 0.5 mg to about 1.5 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B12. In some embodiments, the composition contains about 1 mg of cyanocobalamin.

[0053] In some embodiments, the composition further comprises lutein, its prodrug, and / or a pharmaceutically acceptable salt of lutein. In some embodiments, the lutein, its prodrug, and / or a pharmaceutically acceptable salt of lutein is R',R'-lutein. Lutein is a carotenoid. In some embodiments, the composition comprises 5.0 mg to 50.0 mg, for example, 5.0 mg to 15.0 mg of lutein, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of lutein. In some embodiments, the composition comprises 5.0 mg to 50.0 mg of lutein, for example, 6.0 mg to 40.0 mg, 7.0 mg to 30.0 mg, 8.0 mg to 20.0 mg, 9.0 mg to 11.0 mg, 20.0 mg to 30.0 mg, 30.0 mg to 40.0 mg, 40.0 mg to 50.0 mg, 5.0 mg to 15.0 mg, 6.0 mg to 14.0 mg, 7.0 mg to 13.0 mg, 8.0 mg to 12.0 mg, 9.0 mg to 11.0 mg, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, or 50.0 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. In some embodiments, the composition comprises 10.0 mg of lutein. In some embodiments, the composition comprises about 5 mg to about 50 mg, for example, about 5 mg to about 15 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 5 mg to about 50 mg, for example, about 5 mg to about 15 mg, about 6 mg to about 40 mg, about 6 mg to about 14 mg, about 7 mg to about 30 mg, about 7 mg to about 13 mg, about 8 mg to about 20 mg, about 8 mg to about 12 mg, about 9 mg to about 11 mg, about 20 mg to about 30 mg, about 30 mg to about 40 mg, about 40 mg to about 50 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, or about 50 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 10 mg of lutein.

[0054] In some embodiments, the composition further comprises zeaxanthin, its prodrug, and / or a pharmaceutically acceptable salt of zeaxanthin. In some embodiments, zeaxanthin, its prodrug, and / or a pharmaceutically acceptable salt of zeaxanthin is R',R'-zeaxanthin. Zeaxanthin is a carotenoid. In some embodiments, the composition comprises 0.01 mg to 40.0 mg, for example, 1.5 mg to 2.5 mg of zeaxanthin, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of zeaxanthin. In some embodiments, the composition contains 0.04 mg to 40.0 mg of zeaxanthin, for example, 1.0 mg to 30.0 mg, 3.0 mg to 25.0 mg, 5.0 mg to 20.0 mg, 10.0 mg to 20.0 mg, 1.0 mg to 15.0 mg, 3.0 mg to 12.0 mg, 5.0 mg to 20.0 mg, 7.0 mg to 19.0 mg, 8.0 mg to 15.0 mg, 1.5 mg to 2.5 mg, 1.5 mg to 2.0 mg, 2.0 mg to 2.5 mg, or 2.0 mg of zeaxanthin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. In some embodiments, the composition contains 2.0 mg of zeaxanthin. In some embodiments, the composition comprises about 1 mg to about 20 mg, for example, about 1.5 mg to about 2.5 mg of zeaxanthin, or an equivalent amount of a zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 1 mg to about 20 mg of zeaxanthin, for example, about 1 mg to about 3 mg, about 3 mg to about 5 mg, about 1.5 mg to about 2.5 mg, for example, about 1.5 mg to about 2 mg, about 2 mg to about 2.5 mg, about 5 mg to about 7 mg, about 7 mg to about 9 mg, about 9 mg to about 11 mg, about 11 mg to about 13 mg, about 13 mg to about 15 mg, about 15 mg to about 17 mg, about 17 mg to about 19 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 10 mg, or about 20 mg of zeaxanthin, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug.In some embodiments, the composition contains about 2 mg of zeaxanthin.

[0055] In some embodiments, the composition 350.0 mg to approximately 800.0 mg of vitamin C, or an equivalent amount of vitamin C prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, 50.0 mg to 550.0 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 20.0 mg to 90.0 mg of zinc, or an equivalent amount of a zinc prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, 1.5 mg to 2.5 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, 0.1 mg to 25 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 0.1 mg to 25 mg of riboflavin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 1.0 mg to 300.0 mg of nicotinic acid and / or niacinamide, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 1.0 mg to 250.0 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 25.0 mg to 200.0 mg of pyridoxine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 0.01 mg to 1.0 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, 0.1 mg to 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, It contains 0.25 mg to 3.0 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B12.

[0056] In some embodiments, the composition further comprises 5.0 mg to 50.0 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, and / or 1.0 mg to 20.0 mg of zeaxanthin, or an equivalent amount of a zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt.

[0057] In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 1.5 mg of thiamine, 1.7 mg of riboflavin, 20.0 mg of nicotinic acid and / or niacinamide, 10.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.03 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0058] In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 3.0 mg of thiamine, 3.4 mg of riboflavin, 40.0 mg of nicotinic acid and / or niacinamide, 20.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.06 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0059] In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0060] In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 4.5 mg of thiamine; 5.1 mg of riboflavin; 60.0 mg of nicotinic acid and / or niacinamide; 30.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.09 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0061] In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 25.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 1.5 mg of thiamine; 1.7 mg of riboflavin; 20.0 mg of nicotinic acid and / or niacinamide; 10.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.03 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0062] In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 25.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 3.0 mg of thiamine; 3.4 mg of riboflavin; 40.0 mg of nicotinic acid and / or niacinamide; 20.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.06 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0063] In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 25.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 4.5 mg of thiamine; 5.1 mg of riboflavin; 60.0 mg of nicotinic acid and / or niacinamide; 30.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.09 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0064] In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 400.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 3.0 mg of thiamine; 3.4 mg of riboflavin; 40.0 mg of nicotinic acid and / or niacinamide; 20.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.06 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin. In some embodiments, the composition comprises 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0065] In some embodiments, the composition Approximately 350 mg to approximately 800 mg of vitamin C, or an equivalent amount of a vitamin C prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 200 mg to approximately 550 mg of vitamin E, or an equivalent amount of vitamin E prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, Approximately 20 mg to approximately 90 mg of zinc, or an equivalent amount of a zinc prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 1.5 mg to approximately 2.5 mg of copper, or an equivalent amount of a copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 0.1 mg to approximately 25 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 0.1 mg to approximately 25 mg of riboflavin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 1 mg to approximately 300 mg of nicotinic acid and / or niacinamide, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 1 mg to approximately 250 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 25 mg to approximately 200 mg of pyridoxine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 0.01 mg to approximately 1 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, Approximately 0.1 mg to approximately 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, It contains approximately 0.25 mg to 3 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug of vitamin B12.

[0066] In some embodiments, the composition further comprises about 5 mg to about 50 mg of lutein, or an equivalent amount of a lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug, and / or about 1 mg to about 20 mg of zeaxanthin, or an equivalent amount of a zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt.

[0067] In some embodiments, the composition comprises, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20 mg of nicotinic acid and / or niacinamide, about 10 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.03 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin. In some embodiments, the composition contains about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0068] In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid; about 180 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 3 mg of thiamine; about 3.4 mg of riboflavin; about 40 mg of nicotinic acid and / or niacinamide; about 20 mg of pantothenic acid; about 50 mg of pyridoxine; about 0.06 mg of biotin; about 2.5 mg of folic acid and / or methyl tetrahydrofolate; and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0069] In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid; about 180 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 4.5 mg of thiamine; about 5.1 mg of riboflavin; about 60 mg of nicotinic acid and / or niacinamide; about 30 mg of pantothenic acid; about 50 mg of pyridoxine; about 0.09 mg of biotin; about 2.5 mg of folic acid and / or methyl tetrahydrofolate; and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0070] In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid; about 180 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 1.5 mg of thiamine; about 1.7 mg of riboflavin; about 20 mg of nicotinic acid and / or niacinamide; about 10 mg of pantothenic acid; about 50 mg of pyridoxine; about 0.03 mg of biotin; about 2.5 mg of folic acid and / or methyl tetrahydrofolate; and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0071] In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid; about 180 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 3 mg of thiamine; about 3.4 mg of riboflavin; about 40 mg of nicotinic acid and / or niacinamide; about 20 mg of pantothenic acid; about 50 mg of pyridoxine; about 0.06 mg of biotin; about 2.5 mg of folic acid and / or methyl tetrahydrofolate; and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0072] In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid; about 180 mg of vitamin E, optionally in the form of sl-alpha-tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 4.5 mg of thiamine; about 5.1 mg of riboflavin; about 60 mg of nicotinic acid and / or niacinamide; about 30 mg of pantothenic acid; about 50 mg of pyridoxine; about 0.09 mg of biotin; about 2.5 mg of folic acid and / or methyl tetrahydrofolate; and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[0073] In some embodiments, at least one vitamin is derived from a natural source. In some embodiments, at least one vitamin is derived from a synthetic source.

[0074] In some embodiments, the compositions described herein may be health or nutritional supplements or pharmaceutical compositions. In some embodiments, the compositions may be in the form of foods or food components. The compositions of this disclosure may be advantageously used in a manner that promotes the health of an individual.

[0075] In some embodiments, the composition is formulated in a form suitable for oral, intraperitoneal, intravenous, subcutaneous, sublingual, transdermal, and / or intramuscular administration. In some embodiments, the composition is formulated in a form suitable for oral administration. Non-limiting suitable solid oral formulations include tablets, capsules, wafers, lozenges, powders, pills, granules, and pellets. Non-limiting suitable liquid oral formulations include solutions, suspensions, dispersions, emulsions, and oils. In some embodiments, the composition is in liquid, semi-solid, or solid form. For example, the composition may be administered as a tablet, gel pack, capsule, gelatin capsule, flavored beverage, or reconstituted powder. In some embodiments, the composition is in the form of a tablet, capsule, soft gel, liquid, or powder. In some embodiments, the composition is a soft gelatin capsule and a hard gelatin capsule. In some embodiments, the composition is in the form of a chewable oral formulation, such as a chewable tablet.

[0076] In some embodiments, the composition is in the form of an immediate-release formulation, or a controlled-release formulation such as a delayed-release and / or sustained-release formulation.

[0077] In some embodiments, the composition may further comprise at least one pharmaceutically acceptable excipient. Non-limiting examples of suitable excipients include surfactants, humectants, plasticizers, binders, crystallization inhibitors, wetting agents, fillers, solubilizers, bioavailability enhancers, pH adjusters, and flavoring agents. As used herein, at least one pharmaceutically acceptable excipient may also comprise any solvent, diluent, other liquid vehicle, dispersion aid, suspension aid, surfactant, isotonic agent, thickener, emulsifier, preservative, solid binder, and lubricant to suit the desired specific dosage form. Remington: The Science and Practice of Pharmacy, 21st edition, 2005, ed. DB Troy, Lippincott Williams & Wilkins, Philadelphia, and Encyclopedia of Pharmaceutical Technology, eds. J. Swarbrick and JCBoylan, 1988-1999, Marcel Dekker, New York, disclose various excipients used in the formulation of oral compositions and known techniques for their preparation. Unless any conventional carrier is incompatible with the vitamins of this disclosure, for example, by causing any undesirable biological effect or otherwise interacting in a detrimental manner with any other component of the composition, its use is intended to be within the scope of this disclosure.Non-limiting examples of suitable pharmaceutically acceptable excipients include ion exchangers, alumina, aluminum stearate, lecithin, serum proteins (such as human serum albumin), buffers (such as phosphates, glycine, sorbic acid, and potassium sorbate), partial glyceride mixtures of saturated vegetable fatty acids, water, salts, and electrolytes (protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, and zinc salts), colloidal silica, magnesium trisilicate, polyvinylpyrrolidone, polyacrylates, waxes, polyethylene-polyoxypropylene-block polymers, wool fat, sugars (such as lactose, glucose, and sucrose), starches (such as corn starch and potato starch), cellulose and its derivatives (e.g., sodium carboxymethylcellulose). Examples of ingredients include, but are not limited to, cellulose (such as cocoa butter and suppository wax), tragacanth powder, malt, gelatin, talc, excipients (such as cocoa butter and suppository wax), oils (such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil), glycols (such as propylene glycol and polyethylene glycol), esters (such as ethyl oleate and ethyl laurate), agar, buffers (such as magnesium hydroxide and aluminum hydroxide), alginic acid, pyrogen-free water, isotonic saline, Ringer's solution, ethyl alcohol, phosphate buffer, non-toxic compatible lubricants (such as sodium lauryl sulfate and magnesium stearate), colorants, release agents, coating agents, sweeteners, flavoring agents, fragrances, preservatives, and antioxidants.

[0078] In some embodiments, the composition further comprises cellulose, gelatin, magnesium stearate, water, vegetable oil, glycerin, beeswax, and / or silica.

[0079] In some embodiments, the composition further comprises or is administered concurrently with at least one additional active ingredient. In some embodiments, the at least one additional therapeutic agent is selected from anti-inflammatory agents (e.g., anti-IL-6 drugs, anti-IL-8 drugs, aspirin, ibuprofen, and naproxen), anti-angiogenic agents (e.g., anti-VEGF drugs, ranibizumab, bevacizumab, akadesin, and AMPK activator), antioxidants (e.g., vitamin C, vitamin E, vitamin A, glutathione, catalase, etc.), omega-3 fatty acids (e.g., alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)), and vitamins and minerals (e.g., vitamin C, vitamin E, vitamin A, lutein, zeaxanthin, zinc, and copper). In some embodiments, the composition further comprises lutein and zeaxanthin.

[0080] The combination of the disclosed compositions and at least one additional active ingredient may advantageously result in one or more of the following effects: (1) additive and / or synergistic benefits; (2) reduction of side effects and / or adverse effects associated with the use of a prescription drug in the absence of the compositions disclosed herein; and / or (3) the ability to reduce the dosage of a prescription drug compared to the amount of a prescription drug required in the absence of the compositions disclosed herein.

[0081] The compositions disclosed herein may be prepared according to any known method for the manufacture of health supplements or pharmaceutical formulations. As will be understood by those skilled in the art, many methods are known. For information regarding materials, equipment, and processes for preparing formulations and dosage forms, please refer to “Pharmaceutical dosage form tablets”, eds. Liberman et al. (New York, Marcel Dekker, Inc., 1989), “Remington—The science and practice of pharmacy”, 20th ed., Lippincott Williams & Wilkins, Baltimore, Md., 2000, and “Pharmaceutical dosage forms and drug delivery systems”, 6th Edition, Ansel et al., (Media, Pa.: Williams and Wilkins, 1995), which provides information regarding carriers, materials, equipment, and processes for preparing formulations.

[0082] Methods for producing the compositions disclosed herein may include combining the listed vitamins and any desired excipients, and mechanically mixing them to form a blend, for example, using a blender. The blend may then be rotated, if necessary, until uniform. The blend may then be compressed using a tablet press to form tablets. Optionally, a coating may be sprayed onto the tablets and the tablets rotated until dry. Alternatively, the blend may be placed in medium-chain triglycerides to form a slurry for encapsulation in soft gel capsules, or in gelatin capsules, or in other dosage forms known to those skilled in the art.

[0083] For example, methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, including age-related macular degeneration (AMD), the methods comprising administering the compositions disclosed herein to a subject. In some embodiments, the compositions disclosed herein include: vitamin C, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts; vitamin E, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts; zinc, its prodrug, and / or any of the aforementioned pharmaceutically acceptable forms; copper, its prodrug, and / or any of the aforementioned pharmaceutically acceptable forms; vitamin B1, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B2, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B3, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B5 A composition comprising, , its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B6, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B7, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B9, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts; vitamin B12, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts, and optionally further comprising lutein, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts, and / or zeaxanthin, its prodrug and / or any of the aforementioned pharmaceutically acceptable salts, is selected from such compositions. In some embodiments, the composition comprises 350 mg to 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 50 mg to 550 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 20 mg to 90 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug; and 1.5 mg to 2.5 mg of copper, or an equivalent amount of copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug; 5.0 mg to 50.0 mg of lutein, or an equivalent amount of lutein prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 1.0 mg to 20.0 mg of zeaxanthin, or an equivalent amount of zeaxanthin prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; and 0. 1 mg to 25 mg of thiamine, or an equivalent amount of vitamin B1 prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 0.1 mg to 25 mg of riboflavin, or an equivalent amount of vitamin B2 prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; 1.0 mg to 300.0 mg of nicotinic acid and / or niacinamide, or an equivalent amount of vitamin B3 prodrug, pharmaceutically acceptable salt, and A pharmaceutically acceptable salt of a prodrug and / or a prodrug, along with 1.0 mg to 250.0 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt of vitamin B5, and / or a pharmaceutically acceptable salt of a prodrug, along with 25.0 mg to 200.0 mg of pyridoxine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt of vitamin B6, and / or a pharmaceutically acceptable salt of a prodrug, along with 0.01 mg to 1.0 mg of biotin, or an equivalent amount of a prodrug of vitamin B7. A drug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug; 1.0 mg to 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B9; 0.25 mg to 3 mg of cyanocobalamin, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B12. In some embodiments, the composition optionally contains 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, and 10.It contains 0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 1.5 mg of thiamine, 1.7 mg of riboflavin, 20.0 mg of nicotinic acid and / or niacinamide, 10.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.03 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 3.0 mg of thiamine, 3.4 mg of riboflavin, 40.0 mg of nicotinic acid and / or niacinamide, 20.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.06 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 80.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 4.5 mg of thiamine, 5.1 mg of riboflavin, 60.0 mg of nicotinic acid and / or niacinamide, 30.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.09 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition optionally contains 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 1.5 mg of thiamine, 1.7 mg of riboflavin, and 20.It contains 0 mg of nicotinic acid and / or niacinamide, 10.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.03 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 3.0 mg of thiamine, 3.4 mg of riboflavin, 40.0 mg of nicotinic acid and / or niacinamide, 20.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.06 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin. In some embodiments, the composition optionally comprises 500.0 mg of vitamin C in the form of ascorbic acid, optionally 180.0 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally 25.0 mg of zinc in the form of zinc oxide, optionally 2.0 mg of copper in the form of copper oxide, 10.0 mg of R',R'-lutein, 2.0 mg of R',R'-zeaxanthin, 4.5 mg of thiamine, 5.1 mg of riboflavin, 60.0 mg of nicotinic acid and / or niacinamide, 30.0 mg of pantothenic acid, 50.0 mg of pyridoxine, 0.09 mg of biotin, 2.5 mg of folic acid and / or methyl tetrahydrofolate, and 1.0 mg of cyanocobalamin.

[0084] In some embodiments, the composition comprises about 350 mg to about 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; about 200 mg to about 550 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug; and about 20 mg to about 90 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and and / or a pharmaceutically acceptable salt of the prodrug, and about 1.5 mg to about 2.5 mg of copper, or an equivalent amount of copper prodrug in a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, and about 5 mg to about 50 mg of lutein, or an equivalent amount of lutein prodrug in a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of the prodrug, and about 1 mg to about 20 mg of zeaxanthin, or an equivalent amount of zeaxanthin prodrug in a pharmaceutically acceptable form. A pharmaceutically acceptable salt and / or prodrug, approximately 0.1 mg to approximately 25 mg of thiamine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or prodrug of vitamin B1, approximately 0.1 mg to approximately 25 mg of riboflavin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or prodrug of vitamin B2, and approximately 1 mg to approximately 300 mg of nicotinic acid and / or niacinamide. , or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug, and approximately 1 mg to approximately 250 mg of pantothenic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug, and approximately 25 mg to approximately 200 mg of pyridoxine, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug, and approximately 0.It contains 0.1 mg to approximately 1 mg of biotin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B7; approximately 1 mg to approximately 50 mg of folic acid and / or methyl tetrahydrofolate, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B9; and approximately 0.25 mg to approximately 3 mg of cyanocobalamin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin B12. In some embodiments, the composition optionally comprises about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80.0 mg of zinc in the form of zinc oxide, optionally about 2.0 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20.0 mg of nicotinic acid and / or niacinamide, about 10 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.03 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin. In some embodiments, the composition optionally contains about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 3 mg of thiamine, about 3.4 mg of riboflavin, about 40 mg of nicotinic acid and / or niacinamide, about 20 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.06 mg of biotin, and about 2.The composition comprises 5 mg of folic acid and / or methyl tetrahydrofolate and about 1 mg of cyanocobalamin. In some embodiments, the composition comprises, optionally, about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 80 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 4.5 mg of thiamine, about 5.1 mg of riboflavin, about 60 mg of nicotinic acid and / or niacinamide, about 30 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.09 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate and about 1 mg of cyanocobalamin. In some embodiments, the composition optionally comprises about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20 mg of nicotinic acid and / or niacinamide, about 10.0 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.03 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin. In some embodiments, the composition optionally contains about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25.0 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 3.0 mg of thiamine, about 3.4 mg of riboflavin, about 40 mg of nicotinic acid and / or niacinamide, about 20 mg of pantothenic acid, about 50.0 mg of pyridoxine, about 0.06 mg of biotin, and about 2.The composition contains 5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin. In some embodiments, the composition optionally contains about 500 mg of vitamin C in the form of ascorbic acid, optionally about 180 mg of vitamin E in the form of dl-alpha-tocopheryl acetate, optionally about 25 mg of zinc in the form of zinc oxide, optionally about 2 mg of copper in the form of copper oxide, about 10 mg of R',R'-lutein, about 2 mg of R',R'-zeaxanthin, about 4.5 mg of thiamine, about 5.1 mg of riboflavin, about 60 mg of nicotinic acid and / or niacinamide, about 30 mg of pantothenic acid, about 50 mg of pyridoxine, about 0.09 mg of biotin, about 2.5 mg of folic acid and / or methyl tetrahydrofolate, and about 1 mg of cyanocobalamin.

[0085] At least one disease, disorder, and / or condition associated with vision loss includes age-related macular degeneration (AMD). In some embodiments, the methods disclosed herein are effective in preventing, mitigating, or inhibiting the progression of AMD. In some embodiments, the AMD is wet AMD or dry AMD.

[0086] In some embodiments, at least one disease, disorder, and / or condition associated with vision loss is selected from macular degeneration, age-related macular degeneration (AMD), retinal pigment epithelium (RPE) atrophy, at least one photoreceptor atrophy, drusen, drusenoid pigment epithelial detachment (PED), diabetic retinopathy, cataract, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration, Stargardt disease, and oxygen-induced retinopathy.

[0087] In some embodiments of the methods disclosed herein, the compositions disclosed herein are administered to a subject in once, twice, three, or four doses per day. In some embodiments, each composition is administered in the form of one, two, three, or four dose units per day, for example, two tablets twice daily, or one tablet twice daily.

[0088] Furthermore, a method for degenerating drusen and / or drusenoid pigment epithelial detachment (PED), comprising administering the compositions disclosed herein to a target, is disclosed herein. A method for treating and / or preventing atrophy of the retinal pigment epithelium (RPE) and / or at least one photoreceptor is disclosed herein, the method comprising administering the compositions disclosed herein to a target. A method for treating and / or preventing vision loss, and / or improving vision, is also disclosed herein.

[0089] In some embodiments, administration of the compositions described herein causes complete disappearance of drusen (i.e., 100% regression). In some embodiments, administration of the compositions described herein prevents atrophy of RPE and / or photoreceptors (i.e., geographic atrophy) in patients.

[0090] In some embodiments of the methods of the present disclosure, subjects to whom the composition is administered are selected from subjects suspected of having at least one disease, disorder, and / or condition related to vision loss, subjects known to have at least one disease, disorder, and / or condition related to vision loss, and subjects at risk of developing at least one disease, disorder, and / or condition related to vision loss.

[0091] In some embodiments, the methods of the Disclosure further include identifying a subject at risk of developing at least one disease, disorder, and / or condition related to vision loss. In some embodiments, the methods of the Disclosure further include identifying a subject at risk of developing AMD. In some embodiments, the methods of the Disclosure further include identifying a subject having AMD. In some embodiments, the methods of the Disclosure further include identifying a subject at risk of AMD progression.

[0092] In some embodiments of the methods described herein, the subject is human. In some embodiments of the methods described herein, the subject is non-human animals. Non-human animals include mammals, such as non-human primates, pigs, horses, dogs, cats, cattle, rodents, and other livestock, farm animals, and zoo animals.

[0093] Subjects at risk of developing at least one disease, disorder, and / or condition related to vision loss may be identified by one or more diagnostic or prognostic assays described herein and / or known to those skilled in the art.

[0094] In some embodiments, the methods disclosed herein treat and / or prevent at least one disease, disorder, and / or condition associated with vision loss, as is evident by improvement in vision. In some embodiments, the methods disclosed herein further include monitoring a subject for the effectiveness of administering the composition disclosed herein to the subject. For example, in some embodiments, the methods disclosed herein further include monitoring a subject for improvement in vision, which includes measuring a parameter indicating vision in the subject at a first time point before administration of the composition disclosed herein, measuring the same parameter in the subject at a second time point after administration of the composition disclosed herein, and comparing the two measurements to evaluate the improvement.

[0095] The methods disclosed herein involve administering a daily dose of the compositions disclosed herein. Determining and adjusting an appropriate daily dosing regimen (e.g., adjustment of the number and frequency of doses) may be carried out by those skilled in the art and depend on various factors such as the nature and progression of at least one disease, disorder, and / or condition relating to the subject's vision loss, health, and / or age.

[0096] In some embodiments, the compositions disclosed herein are formulated in the form of one, two, three, or four tablets, and administered to a subject in a single dose per day, two doses per day, three doses per day, four doses per day, or, for example, up to 10 doses per day. In some embodiments, the compositions disclosed herein are formulated in the form of four tablets, administered to a subject in two doses of two tablets per day. In some embodiments, the compositions disclosed herein are administered to a subject for at least one week, at least two weeks, at least three weeks, at least one month, at least two months, at least three months, at least four months, at least five months, at least six months, at least twelve months, at least one year, or more than one year.

[0097] Furthermore, methods for preventing, stabilizing, reversing, and / or treating macular degeneration or vision loss by reducing the risk of developing late or progressive age-related macular degeneration in individuals with early age-related macular degeneration are disclosed herein, and these methods include providing a daily dose of approximately 1.5 mg or more of thiamine, approximately 1.7 mg or more of riboflavin, approximately 20 mg or more of nicotinic acid and / or niacinamide, approximately 10 mg or more of pantothenic acid, approximately 50 mg or more of pyridoxine, approximately 0.03 mg or more of biotin, approximately 2.5 mg or more of folic acid and / or methyl tetrahydrofolate, and approximately 1 mg or more of cyanocobalamin. In some embodiments, the daily dose is administered in the form of two tablets taken twice daily, or one tablet taken twice daily.

[0098] For example, the effectiveness of the compositions and methods of this disclosure in treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss can be determined by those skilled in the art. One or any combination of diagnostic methods, including physical examination, assessment and monitoring of symptoms, and the performance of analytical tests and methods described herein, may be used to monitor at least one disease, disorder, and / or condition. For example, ophthalmic examinations such as biomicroscopy, intraocular tonometry, stereoscopic fundus examination (e.g., color fundus photography), macular function assessment, optical coherence tomography (OCT), autofluorescence, and / or angiography (e.g., fluorescein angiography and OCT-based angiography (OCTA)) may be used.

[0099] For example, visual acuity may be assessed by any preferred method known to those skilled in the art. In some embodiments, visual acuity is assessed by determining the smallest character that a patient can read on a standard visual acuity chart at a set distance. Furthermore, for example, the progression of AMD may be assessed by measuring parameters such as neovascularization. Maintenance or reduction of the measured parameters from a first time point to a second time point indicates prevention of AMD progression. In some embodiments, the progression of AMD and / or regression of drusen are assessed by determining specific parameters of drusen in a patient at a first time point (e.g., before administration of high-dose statins), determining the same parameters in the same patient at a second time point (e.g., after administration of high-dose statins), and comparing the parameters measured at the first and second time points. The parameters of drusen may be, for example, volume, height, diameter, and / or number. For example, drusen regression may be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99%. In some embodiments, drusen are reduced by 5% to at least 40%, for example, 90%. Furthermore, atrophy may be assessed by measuring parameters such as autofluorescence or retinal thickness, PED may be assessed for flattening by measuring parameters such as volume, height, and / or diameter, and reattachment to Bruch's membrane may be assessed by measuring parameters such as separation distance. [Modes for carrying out the invention]

[0100] Tabletop Example The following compositions may be prepared. The amounts in each composition are given on a daily dose basis. Each composition may be formulated into two or more dose units, which may be administered to the subject daily. [Table 1] [Table 2]

[0101] The compositions combining the nutritional and health components listed above are prepared by mixing the listed components. The compositions can be stable for at least two years at near room temperature.

Claims

[Claim 1] A composition for visual health, Vitamin C, its prodrugs, and / or any pharmaceutically acceptable salt of any of the foregoing, Vitamin E, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Zinc, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Copper, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B1, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B2, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B3, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B5, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B6, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B7, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, Vitamin B9, its prodrugs, and / or any of the aforementioned pharmaceutically acceptable salts, A compound comprising vitamin B12, its prodrug, and / or any of the aforementioned pharmaceutically acceptable salts, A composition further comprising, optionally, lutein, its prodrug, and / or any pharmaceutically acceptable salt thereof, and / or zeaxanthin, its prodrug, and / or any pharmaceutically acceptable salt thereof.

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