Compositions comprising coenzyme Q10 and their use in treatment of ocular and cardiac diseases

Abstract

The present disclosure describes compositions comprising vitamin C, vitamin E, zinc, copper, lutein, zeaxanthin, and Coenzyme Q10, as well as pharmaceutically acceptable salts of any one of the foregoing. The compositions are useful for treating diseases associated with loss of visual acuity, including, for example, age-related macular degeneration, and supporting cardiac health.

Description

[0001] Disclosed herein are compositions and methods for treating and / or preventing at least one disease, disorder, and / or condition associated with loss of visual acuity (including, for example, age-related macular degeneration) and / or at least one disease, disorder, and / or condition associated with heart disease.

[0002] In some embodiments, disclosed herein are compositions comprising: vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; copper, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; lutein, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable form of any of the foregoing; and coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable form of any of the foregoing. In some embodiments, coenzyme Q10 is in the form of ubiquinol. In some embodiments, coenzyme Q10 is in the form of ubiquinone.

[0003] Also disclosed herein are compositions comprising 350 mg to 800 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C; 100 mg to 550 mg of vitamin E or an equivalent amount of a prodrug of vitamin E, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E; 20 mg to 90 mg of zinc or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of zinc; 1.5 mg to 2.5 mg of copper or an equivalent amount of copper; prodrugs, pharmaceutically acceptable forms and / or pharmaceutically acceptable salts of copper prodrugs; 5 mg to 50 mg lutein or an equivalent amount of a prodrug of lutein, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of lutein; 1 mg to 20 mg zeaxanthin or an equivalent amount of a prodrug of zeaxanthin, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin; 100 mg to 400 mg coenzyme Q10 or an equivalent amount of a prodrug of coenzyme Q10, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of coenzyme Q10.

[0004] Also disclosed herein are compositions comprising 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), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10.

[0005] Also disclosed herein are compositions comprising 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 mg of zinc (optionally in the form of zinc oxide), 2.0 mg of copper (optionally in the form of copper oxide), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 400 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0006] Also disclosed herein are compositions comprising 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 mg of zinc (optionally in the form of zinc oxide), 2.0 mg of copper (optionally in the form of copper oxide), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0007] Also disclosed herein are compositions comprising 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 mg of zinc (optionally in the form of zinc oxide), 2.0 mg of copper (optionally in the form of copper oxide), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0008] Also disclosed herein are compositions comprising 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 mg of zinc (optionally in the form of zinc oxide), 2.0 mg of copper (optionally in the form of copper oxide), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 400 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0009] Also disclosed herein are compositions comprising 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), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0010] Also disclosed herein are compositions comprising 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), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0011] Also disclosed herein are compositions comprising 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), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0012] Also disclosed herein are compositions comprising 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), 10.0 mg of R'R' lutein, 2.0 mg of R'R' zeaxanthin, and 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0013] Also disclosed herein are compositions comprising 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 a prodrug of vitamin C; about 100 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 a prodrug of vitamin E; about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of zinc; and about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of copper; about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein; about 1 mg to 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 of zeaxanthin; and about 20 mg to about 400 mg of coenzyme Q10.

[0014] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid); about 400 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0015] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid); about 400 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0016] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid); about 400 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0017] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid); about 400 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0018] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0019] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein, about 2 mg of R'R' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0020] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein; about 2 mg of R'R' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0021] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein, about 2 mg of R'S' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0022] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid); about 400 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 10 mg of R'R' lutein; about 2 mg of R'S' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0023] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid), about 400 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 10 mg of R'R' lutein, about 2 mg of R'S' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0024] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid), about 400 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 10 mg of R'R' lutein, about 2 mg of R'S' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0025] Also disclosed herein are compositions comprising about 500 mg of vitamin C (optionally in the form of ascorbic acid), about 400 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 10 mg of R'R' lutein, about 2 mg of R'S' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0026] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein; about 2 mg of R'S' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0027] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein; about 2 mg of R'S' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0028] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein; about 2 mg of R'S' zeaxanthin; and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinol).

[0029] Also disclosed herein are compositions comprising 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 10 mg of R'R' lutein, about 2 mg of R'S' zeaxanthin, and about 100 mg of coenzyme Q10 (optionally in the form of ubiquinone).

[0030] Age-related macular degeneration (AMD) is the leading cause of severe visual acuity loss in people aged 55 and older in the United States and Western Europe. An estimated 1.75 million people in the United States have late AMD, which accounts for the majority of cases of severe vision loss. Another 7.3 million people have early AMD, which is usually associated with little or no vision loss but increases the risk of developing AMD. It is associated with a range of clinically recognizable ocular findings that can lead to blindness. These findings include drusen, retinal pigment epithelial (RPE) disorders including pigment accumulation and / or detachment, RPE detachment, geographic atrophy, subretinal neovascularization, and disciform scars. Not all of these findings are necessary for a diagnosis of AMD.

[0031] Disclosed herein are compositions for eye and / or heart health, for example, for preventing or treating macular degeneration and / or heart disease. In some embodiments, the compositions disclosed herein are nutritional or dietary supplement compositions. In some embodiments, these compositions are pharmaceutical compositions. In some embodiments, the disclosure relates to antioxidant nutritional supplements comprising Coenzyme Q10. In some embodiments, the compositions disclosed herein can enhance and / or promote retinal health, for example, by stabilizing and / or treating visual acuity loss in people with specific eye diseases, disorders and / or conditions. In some embodiments, the compositions disclosed herein can improve and / or promote heart health, for example, by treating and / or preventing the occurrence of heart failure and / or other cardiac risks. In some embodiments, administering these compositions can reduce visual acuity loss, for example, by reducing the risk of a patient developing late or late-stage age-related macular degeneration. In some embodiments, the compositions of the disclosure promote both eye health and heart health.

[0032] Also disclosed herein is a method for treating and / or preventing at least one disease, disorder and / or illness related to loss of visual acuity, the method comprising administering a composition disclosed herein to a subject in need thereof. In some embodiments, the at least one disease, disorder and / or illness related to loss of visual acuity is selected from macular degeneration, age-related macular degeneration (AMD), retinal pigment epithelium (RPE) atrophy, at least one photoreceptor atrophy, drusen, drusen-like pigment epithelial detachment (PED), diabetic retinopathy, cataract, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration and oxygen-induced retinopathy. In some embodiments, the method for treating and / or preventing at least one disease, disorder and / or illness related to loss of visual acuity is also used to treat and / or prevent at least one disease, disorder and / or illness related to heart health.

[0033] Also disclosed herein are methods for regressing drusen and / or drusen-like pigment epithelial detachment (PED), methods for treating and / or preventing retinal pigment epithelium (RPE) and / or at least one photoreceptor atrophy, methods for treating and / or preventing vision loss and / or improving acuity, and / or methods for treating and / or preventing at least one heart disease, disorder, or condition. The methods include administering a composition disclosed herein to a subject in need thereof.

[0034] According to the present disclosure, compositions and methods for improving eye health and / or slowing the progression of macular degeneration are provided. In some embodiments, compositions and methods for improving heart health and / or slowing the onset or progression of heart disease are also provided. In some embodiments, the compositions and methods of the present disclosure improve both eye and heart health.

[0035] In addition, the coenzyme Q10 in the present disclosure and other compositions (for example AREDS compositions, such as zinc, copper, lutein, zeaxanthin, vitamin C and vitamin E) are used in combination, and also can prevent macular degeneration and / or heart failure.These compositions are potent antioxidants, help to protect cells, for example constitute the retina and be responsible for the retinal pigment endothelial cells (RPE) of visual function, and can lower blood pressure, treat heart failure and other heart diseases.Therefore, coenzyme Q10 and AREDS vitamin combination are used, and will help to ensure that when the experimenter is given the supplement containing this combination, RPE cells will not be further damaged or reduce stress. The combination of coenzyme Q10 and AREDS nutrients should promote the improvement of eye health and the progress of AMD to slow down, and also can be used for treating heart failure and / or other heart diseases, may prevent at least one heart disease, obstacle and / or disease.

[0036] Definitions of certain terms used in this application are as follows. Unless otherwise defined, all technical and scientific terms used herein have the normal and customary meanings that are commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0037] As used herein, "a," "an," and "the" refer to one or more (ie, to at least one) of the grammatical object of the article.

[0038] As used herein, the "daily" dosage of the element or composition refers to the total amount administered in one day, but does not limit the frequency of administration every day. The daily dosage given to the patient can be administered once a day or multiple times, for example, twice a day or three times a day (wherein, each administration in multiple administrations includes administering a certain amount of the element or composition, and this amount is less than "daily" amount, because "daily" amount refers to the total amount administered in one day). Each administration of the composition or composition can include administering the composition or composition in the form of a single dose (for example, a tablet or a capsule) or multiple doses (for example, multiple (i.e., two or more) tablets and / or multiple (i.e., two or more) capsules).

[0039] As used herein, the terms "treat" and "treatment" include the medical management of a disease, disorder, and / or condition of a subject as understood by those skilled in the art (see, e.g., Stedman's Medical Dictionary). Generally, an appropriate dosage and treatment regimen provides at least one composition of the present disclosure sufficient to provide a therapeutic and / or prophylactic benefit. For therapeutic treatments and prophylactic measures, therapeutic and / or prophylactic benefit includes, for example, improving clinical outcome, where the object is to prevent, slow, or alleviate an undesirable physiological change or disorder, or to prevent, slow, or alleviate the expansion or severity of such a disorder. As described herein, beneficial or desired clinical results of treating a subject include, but are not limited to, alleviation, reduction or relief of symptoms caused by or associated with the disease, disorder and / or condition being treated; reduction in the occurrence of symptoms; improved quality of life; longer periods of symptom-free status (i.e., a reduction in the likelihood or propensity of a subject to develop the symptoms on which the disease is diagnosed); a reduction in the extent of the disease, disorder and / or condition; a stable state (i.e., no 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 palliation of the state of the disease, disorder and / or condition; and remission (whether partial or complete), whether detectable or undetectable; and / or overall survival rate.

[0040] As used herein, "preventing" or "preventing" a disorder or condition refers to reducing or decreasing the occurrence of the disorder or condition in a treated sample relative to an untreated control sample, and includes delaying the onset, progression, or reduction in severity of one or more symptoms of the disorder or condition relative to an untreated control sample.

[0041] As used herein, the term "pharmaceutically acceptable salt" refers to a salt form of a compound, wherein the salt is non-toxic and includes salts derived from suitable inorganic and organic acids and bases. Pharmaceutically acceptable salts are well known in the art. For example, SM Berge 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, sulfonates, mesylates, formates, tartrates, maleates, succinates, malonates, citrates, benzoates, salicylates, and ascorbates. Non-limiting examples of suitable pharmaceutically acceptable base addition salts include sodium salts, potassium salts, lithium salts, ammonium salts (substituted and unsubstituted), calcium salts, magnesium salts, iron salts, zinc salts, copper salts, manganese salts, and aluminum salts. Non-limiting examples of pharmaceutically acceptable salts include pharmaceutically acceptable salts derived from appropriate bases, including alkali metal salts, alkaline earth metal salts, ammonium salts and N + (C 1-4 The present disclosure also contemplates quaternization of any basic nitrogen-containing groups of the compounds disclosed herein. Pharmaceutically acceptable salts can be obtained, for example, using standard procedures well known in the pharmaceutical arts. One skilled in the art will recognize that the stability and other properties of different pharmaceutically acceptable salts of the ingredients described herein may vary, and these differences should be taken into account when selecting an appropriate pharmaceutically acceptable salt.

[0042] As used herein, the terms "patient," "subject," "individual," and the like are used interchangeably to refer to any animal, whether human or non-human.

[0043] As used herein, "age-related macular degeneration" or "AMD" includes all forms of macular degeneration, including the "wet" (exudative) and "dry" (atrophic) forms.

[0044] The term "prodrug" includes compounds that can be converted (e.g., under physiological conditions or by solvolysis) to biologically active compounds. Thus, the term "prodrug" includes metabolic precursors of pharmaceutically acceptable compounds. For a discussion of prodrugs, see, for example, Higuchi, T. et al., "Pro-drugs as Novel Delivery Systems," ACSSymposium Series, Vol. 14 and Edward B. Roche, ed., Bioreversible Carriers in Drug Design, American Pharmaceutical Association and Pergamon Press, 1987. The term "prodrug" also includes covalently bound carriers that release the active compounds described herein in vivo when such prodrugs are administered to a subject. Non-limiting examples of prodrugs include ester and amide derivatives of hydroxyl, carboxyl, sulfhydryl, and amino functional groups in the compounds described herein.

[0045] As used herein, the term "nutritional composition" includes food products intended for human consumption.

[0046] It will be understood by those skilled in the art that each range disclosed herein encompasses all possible subranges as well as individual numerical values ​​within that range. For example, a range of "1.0 to 5.0" includes and should be understood to specifically disclose subranges such as "1.0 to 3.0," "1.5 to 3.7," "2.1 to 4.3," and all individual numerical values ​​within the disclosed range, such as 1.0, 1.1, 1.2, 1.3, etc.

[0047] Disclosed herein are compositions comprising a vitamin complex comprising:

[0048] Vitamin C, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing;

[0049] Vitamin E, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing;

[0050] zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing;

[0051] copper, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing;

[0052] Lutein, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing;

[0053] Zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; and

[0054] Coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing.

[0055] In some embodiments, vitamin C, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include vitamin C, optionally in the form of ascorbic acid. In some embodiments, vitamin E, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include dl-alpha tocopheryl acetate and / or alpha-tocopherol. In some embodiments, zinc, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include zinc oxide and / or zinc gluconate. In some embodiments, copper, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include copper oxide and / or copper gluconate. In some embodiments, zeaxanthin, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include zeaxanthin (R'R'). In some embodiments, coenzyme Q10, its prodrugs, and / or a pharmaceutically acceptable salt of any of the foregoing include coenzyme Q10, optionally in the form of ubiquinol.

[0056] In some embodiments, the composition comprises vitamin C (optionally in the form of ascorbic acid), vitamin E (optionally in the form of dl-alpha tocopheryl acetate), zinc (optionally in the form of zinc oxide), thiamine, copper (optionally in the form of copper oxide), R'R' lutein, R'R' zeaxanthin, and coenzyme Q10 (optionally in the form of ubiquinol).

[0057] In some embodiments, vitamin C, its prodrug and / or a pharmaceutically acceptable salt of any of the foregoing comprises ascorbic acid. In some embodiments, vitamin C, its prodrug and / or a pharmaceutically acceptable salt of any of the foregoing is ascorbic acid. The U.S. Recommended Dietary Allowance (RDA) of vitamin C in the form of ascorbic acid is 60 milligrams. In some embodiments, the composition comprises 60 mg to 850 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition comprises 100.0 mg to 800.0 mg, 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 ascorbic acid or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally 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 of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition comprises from about 100 mg to about 800 mg, e.g., from about 150 mg to about 800 mg, from about 250 mg to about 800 mg, from about 250 mg to about 750 mg, from about 500 mg to about 775 mg, from about 600 mg to about 750 mg, from about 500 mg, or about 750 mg of ascorbic acid, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid.

[0058] In some embodiments, vitamin E, its prodrug and / or a pharmaceutically acceptable salt of any of the foregoing comprises alpha-tocopherol. In some embodiments, vitamin E, its prodrug and / or a pharmaceutically acceptable salt of any of the foregoing is dl-alpha-tocopheryl acetate. The recommended dietary intake (RDA) of vitamin E is 15.0 mg. No adverse effects of vitamin E were observed at doses up to 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 of vitamin E, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition comprises 15.0 mg to 800.0 mg of vitamin E, e.g., 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, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E. 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, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition comprises about 15 mg to about 800 mg of vitamin E, e.g., 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, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition comprises about 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate.

[0059] In some embodiments, zinc, its prodrug and / or a pharmaceutically acceptable form of any of the foregoing include zinc oxide. In some embodiments, zinc, its prodrug and / or a pharmaceutically acceptable form of any of the foregoing is zinc oxide. The recommended dietary intake (RDA) of zinc is about 15 milligrams. In some embodiments, the composition comprises 15 to 100 milligrams of zinc or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable form of a prodrug of zinc. In some embodiments, the composition comprises 15.0 to 100.0 milligrams, for example, 40.0 to 95.0 milligrams, 50.0 to 90.0 milligrams, 60.0 to 85.0 milligrams, 70.0 to 80.0 milligrams, or 80.0 milligrams of zinc or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of zinc. In some embodiments, the composition comprises 80.0 milligrams of zinc, optionally in the form of zinc oxide. In some embodiments, the composition comprises 25.0 mg of zinc, optionally in the form of zinc oxide. In some embodiments, the composition comprises about 15 mg to about 100 mg of zinc, or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable form of a prodrug of zinc. In some embodiments, the composition comprises about 15 mg to about 100 mg, 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 an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of zinc. In some embodiments, the composition comprises about 80 mg of zinc, optionally in the form of zinc oxide. In some embodiments, the composition comprises about 25 mg of zinc, optionally in the form of zinc oxide.

[0060] In some embodiments, copper, its prodrug and / or a pharmaceutically acceptable form of any of the foregoing include copper oxide. In some embodiments, copper, its prodrug and / or a pharmaceutically acceptable form of any of the foregoing is copper oxide. The recommended dietary allowance (RDA) of copper is 2.0 mg. In some embodiments, the composition comprises 1.5 mg to 2.5 mg of copper, or an equivalent amount of a prodrug of copper, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of copper. In some embodiments, the composition comprises 1.5 mg to 2.0 mg (e.g., 2.0 mg) of copper, or an equivalent amount of a prodrug of copper, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of copper. In some embodiments, the composition comprises 2.0 mg of copper, optionally in the form of copper oxide. In some embodiments, the composition comprises approximately 1.5 mg to approximately 2.5 mg of copper, or an equivalent amount of a prodrug of copper, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of copper. In some embodiments, the composition comprises from about 1.5 mg to about 2.0 mg (e.g., about 2.0 mg) of copper, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of copper. In some embodiments, the composition comprises about 2.0 mg of copper, optionally in the form of copper oxide.

[0061] In some embodiments, the composition further comprises lutein, a prodrug thereof, and / or a pharmaceutically acceptable salt of lutein. In some embodiments, the lutein, a prodrug thereof, 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 (e.g., 5.0 mg to 15.0 mg) of lutein, or an equivalent amount of a prodrug of lutein, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein. In some embodiments, the composition comprises 5.0 mg to 50.0 mg, e.g., 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 prodrug of lutein, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein. In some embodiments, the composition comprises 10.0 mg of lutein. In some embodiments, the composition comprises about 5 mg to about 50 mg (e.g., about 5 mg to about 15 mg) of lutein, or an equivalent amount of a prodrug of lutein, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein. In some embodiments, the composition comprises about 5 mg to about 50 mg (e.g., 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 prodrug of lutein, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein. In some embodiments, the composition comprises about 10 mg of lutein.

[0062] In some embodiments, the composition further comprises zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of zeaxanthin. In some embodiments, the zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of zeaxanthin is R',R'-zeaxanthin. In some embodiments, the zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of zeaxanthin is R',S'-zeaxanthin. Zeaxanthin is a carotenoid. In some embodiments, the composition comprises 0.01 mg to 40.0 mg (e.g., 1.5 mg to 2.5 mg) of zeaxanthin, or an equivalent amount of a prodrug of zeaxanthin, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition comprises 0.04 mg to 40.0 mg, e.g., 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 zeaxanthin, or an equivalent amount of a prodrug of zeaxanthin, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition comprises 2.0 mg zeaxanthin. In some embodiments, the composition comprises about 1 mg to about 20 mg (e.g., about 1.5 mg to about 2.5 mg) of zeaxanthin or an equivalent amount of a prodrug of zeaxanthin, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition comprises about 1 mg to about 20 mg, 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 of zeaxanthin, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition comprises about 2 mg zeaxanthin.

[0063] In some embodiments, the composition further comprises Coenzyme Q10, a prodrug thereof and / or a pharmaceutically acceptable salt of Coenzyme Q10. In some embodiments, Coenzyme Q10, a prodrug thereof and / or a pharmaceutically acceptable salt of Coenzyme Q10 is ubiquinone. In some embodiments, Coenzyme Q10, a prodrug thereof and / or a pharmaceutically acceptable salt of Coenzyme Q10 is ubiquinol. In some embodiments, the composition comprises 50 mg to 500 mg (e.g., 55 mg to 475 mg) of Coenzyme Q10, or an equivalent amount of a prodrug of Coenzyme Q10, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10. In some embodiments, the composition comprises 60 mg to 450 mg, for example, 65 mg to 425 mg, 70 mg to 400 mg, 75 mg to 375 mg, 80 mg to 350 mg, 85 mg to 325 mg, 90 mg to 300 mg, 95 mg to 275 mg, 100 mg to 250 mg, 100 mg to 200 mg, 100 mg to 175 mg, 100 mg to 150 mg, 100 mg to 125 mg, or 100 mg of Coenzyme Q10 or an equivalent amount of a prodrug of Coenzyme Q10, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10. In some embodiments, the composition comprises 100 mg of Coenzyme Q10. In some embodiments, the composition comprises about 50 mg to about 500 mg, e.g., about 55 mg to about 475 mg, of Coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10. In some embodiments, the composition comprises about 60 mg to about 450 mg, for example, about 65 mg to about 400 mg, about 70 mg to about 375 mg, about 75 mg to about 350 mg, about 80 mg to about 325 mg, about 85 mg to about 300 mg, about 90 mg to about 275 mg, about 95 mg to about 250 mg, about 100 mg to about 225 mg, about 100 mg to about 200 mg, about 100 mg to about 175 mg, about 100 mg to about 150 mg, about 100 mg to about 125 mg, or about 100 mg of Coenzyme Q10 or an equivalent amount of a prodrug of Coenzyme Q10, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10. In some embodiments, the composition comprises about 100 mg of Coenzyme Q10.

[0064] In some embodiments, the composition comprises:

[0065] 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt thereof, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C;

[0066] 50.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug of vitamin E, a pharmaceutically acceptable salt thereof, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E;

[0067] 20.0 mg to 90.0 mg zinc or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of zinc;

[0068] 1.5 mg to 2.5 mg copper or an equivalent amount of a copper prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a copper prodrug;

[0069] 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug of lutein, a pharmaceutically acceptable salt of lutein, and / or a pharmaceutically acceptable salt of a prodrug of lutein;

[0070] 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin; and

[0071] 50 mg to 500 mg of Coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10.

[0072] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and / or 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0073] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and / or 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0074] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and / or coenzyme Q10, optionally in the form of ubiquinol.

[0075] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and / or coenzyme Q10, optionally in the form of ubiquinone.

[0076] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein, 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0077] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein, 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0078] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0079] In some embodiments, the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0080] In some embodiments, the composition comprises:

[0081] about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C;

[0082] about 200 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E;

[0083] about 20 mg to about 90 mg zinc or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of zinc;

[0084] about 1.5 mg to about 2.5 mg of copper, or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of copper;

[0085] about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of lutein;

[0086] about 1 mg to 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 of zeaxanthin; and

[0087] About 20 to about 500 mg of Coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10.

[0088] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0089] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0090] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0091] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0092] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide, about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0093] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide, about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0094] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinol.

[0095] In some embodiments, the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10, optionally in the form of ubiquinone.

[0096] In some embodiments, the compositions described herein can be a dietary or nutritional supplement, or a pharmaceutical composition. In some embodiments, the compositions can be in the form of food or food ingredients. The compositions of the present disclosure can be advantageously used in methods for promoting individual health (e.g., eye and / or heart health).

[0097] In some embodiments, the composition is formulated into a form suitable for oral, intraperitoneal, intravenous, subcutaneous, sublingual, transdermal and / or intramuscular administration. In some embodiments, the composition is formulated into a form suitable for oral administration. Non-limiting suitable solid oral formulations include tablets, capsules, cachets, 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 can be administered in the form of tablets, gel packs, capsules, gelatin capsules, flavored beverages or reconstructible powders. In some embodiments, the composition is in the form of tablets, capsules, soft capsules, liquids or powders. In some embodiments, the composition is in the form of soft gelatin capsules or hard gelatin capsules. In some embodiments, the composition is in the form of chewable oral formulations, such as chewable tablets.

[0098] In some embodiments, the composition is in the form of an immediate release formulation or a modified release formulation, such as a delayed release and / or extended release formulation.

[0099] In some embodiments, said composition may also include at least one pharmaceutically acceptable excipient. Non-limiting examples of suitable excipients include surfactants, humectants, plasticizers, adhesives, crystallization inhibitors, wetting agents, fillers, solubilizers, bioavailability enhancers, pH regulators and flavorings. At least one pharmaceutically acceptable excipient used herein also includes any and all solvents, diluents, other liquid carriers, dispersing aids, suspension aids, surfactants, isotonic agents, thickeners, emulsifiers, preservatives, solid binders and lubricants to adapt to required specific dosage forms. Remington: The Science and Practice of Pharmacy, 21st edition, 2005, DB Troy edited, Lippincott Williams & Wilkins publishers, Philadelphia, and Encyclopedia of Pharmaceutical Technology, J. Swarbrick and JC Boylan edited, 1988-1999, Marcel Dekker, New York discloses various excipients and known preparation techniques thereof for preparing oral compositions. Unless any conventional carrier is incompatible with the vitamins of the present disclosure, such as producing any adverse biological effect or causing deleterious interactions with any other component of the composition, its use is within the scope of the present disclosure. Non-limiting examples of suitable pharmaceutically acceptable excipients include, but are not limited to, ion exchangers, alumina, aluminum stearate, lecithin, serum proteins (such as human serum albumin), buffer substances (such as phosphates, glycine, sorbic acid and potassium sorbate), partial glyceride mixtures of saturated vegetable fatty acids, water, salts and electrolytes (such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride and zinc salts), colloidal silicon dioxide, magnesium trisilicate, polyvinyl pyrrolidone, polyacrylates, waxes, polyethylene-polyoxypropylene-block polymers, lanolin, sugars (such as lactose, glucose and sucrose), starches (such as corn starch and potato starch), cellulose and its derivatives (e.g., sodium carboxymethylcellulose, ethylcellulose, and cellulose acetate), powdered tragacanth, malt, gelatin, talc, excipients (e.g., cocoa butter and suppository waxes), oils (e.g., peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil), glycols (e.g., propylene glycol and polyethylene glycol), esters (e.g., ethyl oleate and ethyl laurate), agar, buffers (e.g., magnesium hydroxide and aluminum hydroxide), alginic acid, pyrogen-free water, isotonic saline, Ringer's solution, ethanol, phosphate buffer solution, nontoxic compatible lubricants (e.g., sodium lauryl sulfate and magnesium stearate), coloring agents, releasing agents, coating agents, sweeteners, flavoring agents, aromas, preservatives, and antioxidants.

[0100] In some embodiments, the composition further comprises cellulose, gelatin, magnesium stearate, water, vegetable oil, glycerin, beeswax, and / or silicon dioxide.

[0101] In some embodiments, the composition further comprises or is co-administered with at least one other active ingredient. In some embodiments, the at least one other therapeutic agent is selected from anti-inflammatory agents (e.g., anti-IL-6 agents, anti-IL-8 agents, aspirin, ibuprofen and naproxen), anti-angiogenic agents (e.g., anti-VEGF agents, ranibizumab, bevacizumab, acadexin and AMPK activators), antioxidants (e.g., vitamin C, vitamin E, vitamin A, glutathione, catalase, etc.), ω-3 fatty acids (e.g., α-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.

[0102] In some embodiments, the compositions disclosed herein further comprise B vitamins. In some embodiments, the compositions disclosed herein further comprise omega-3 fatty acids. In some embodiments, the compositions disclosed herein further comprise very long chain polyunsaturated fatty acids.

[0103] The combination of the disclosed compositions and at least one additional active ingredient can advantageously produce one or more of the following effects: (1) additive and / or synergistic benefits; (2) reduction of side effects and / or adverse reactions associated with the use of prescription drugs in the absence of the disclosed compositions; and / or (3) the ability to reduce the dosage of the prescription drug compared to the amount of the prescription drug required in the absence of the disclosed compositions.

[0104] Composition disclosed herein can be prepared according to the preparation method of any known dietary supplement or pharmaceutical preparation.It will be appreciated by those skilled in the art that many methods are all known.Information about the materials, equipment and process for preparing preparations and dosage forms, refer to " Pharmaceutical dosage form tablets ", Liberman et al. edit (New York, Marcel Dekker, Inc., 1989), " Remington--The science and practice of pharmacy ", 20th edition, Lippincott Williams & Wilkins, Baltimore, Md., 2000 and " Pharmaceutical dosage forms and drug delivery systems ", 6th edition, Ansel et al. edit (Media, Pa.: Williams and Wilkins, 1995), wherein provide information about carriers, materials, equipment and process for preparing preparations.

[0105] The preparation method of the composition disclosed herein can include mixing the vitamins and any desired excipients, followed by mechanical mixing, such as using a blender to form a blend. If necessary, the blend can be tumbled until uniform. The blend can then be pressed into tablets using a tablet press. Optionally, a coating can be sprayed on the tablets, and the tablets can be tumbled until dry. Alternatively, the blend can be placed in a medium-chain triglyceride to form a slurry to be contained in a soft capsule, the blend can also be placed in a gelatin capsule, or the blend can be placed in other dosage forms known to those skilled in the art.

[0106] Disclosed herein are methods of treating and / or preventing at least one disease, disorder, and / or condition associated with loss of visual acuity, including, for example, age-related macular degeneration (AMD) and / or heart health (e.g., such heart diseases disclosed herein), comprising administering to a subject a composition disclosed herein. In some embodiments, the composition disclosed herein is selected from a composition comprising: vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; zinc, a prodrug thereof, and / or a pharmaceutically acceptable form of any of the foregoing; copper, a prodrug thereof, and / or a pharmaceutically acceptable form of any of the foregoing; lutein, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; and coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing.

[0107] At least one disease, obstacle and / or condition relevant to visual acuity loss include age-related macular degeneration (AMD).In some embodiments, method disclosed herein can effectively prevent, weaken or suppress the progress of AMD.In some embodiments, AMD is wet AMD or dry AMD.

[0108] In some embodiments, the at least one disease, disorder, and / or condition associated with loss of visual acuity 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, cataracts, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration, Stargardts disease, and oxygen-induced retinopathy.

[0109] In some embodiments, at least one disease, disorder and / or condition is related to cardiac health. In some embodiments, the methods disclosed herein are effective in preventing, alleviating or inhibiting the progression of at least one ocular disease, disorder and / or condition and at least one cardiac disease, disorder and / or condition.

[0110] In some embodiments of the methods disclosed herein, the compositions disclosed herein are administered to the subject in one, two, three, or four doses daily. In some embodiments, the compositions are each administered in one, two, three, or four dosage units, once, twice, three, or four times a day, for example, in the form of two tablets taken twice a day or one tablet taken twice a day.

[0111] Also disclosed herein is a method for detaching drusen and / or drusen-like pigment epithelial detachment (PED), including administering a composition disclosed herein to a subject. Also disclosed herein is a method for treating and / or preventing retinal pigment epithelium (RPE) and / or at least one photoreceptor atrophy, wherein the method includes administering a composition disclosed herein to a subject. Also disclosed herein is a method for treating and / or preventing vision loss and / or improving acuity. Also disclosed herein is a method for treating and / or preventing heart disease, disorder and / or illness and / or improving heart health. In some embodiments, the method disclosed herein is used to treat and / or prevent at least one eye disease, disorder and / or illness and at least one heart disease, disorder and / or illness.

[0112] In some embodiments, administration of the compositions described herein can result in complete disappearance of drusen (i.e., 100% regression). In some embodiments, administration of the compositions described herein can prevent atrophy of the patient's retinal pigment epithelium (RPE) and / or photoreceptors (i.e., geographic atrophy).

[0113] In some embodiments of the disclosed methods, the subject to whom the composition is administered is selected from a subject suspected of having at least one disease, disorder, and / or condition associated with loss of visual acuity, a subject known to have at least one disease, disorder, and / or condition associated with loss of visual acuity, and a subject at risk of developing at least one disease, disorder, and / or condition associated with loss of visual acuity.

[0114] In some embodiments, disclosed method also comprises the risk that identification experimenter faces at least one disease, obstacle and / or illness relevant to visual acuity loss.In some embodiments, disclosed method also comprises the risk that identification experimenter faces AMD generation.In some embodiments, disclosed method also comprises the risk that identification experimenter faces AMD.In some embodiments, disclosed method also comprises the risk that identification experimenter faces AMD.

[0115] In some embodiments of the methods described herein, the subject is a human. In some embodiments of the methods described herein, the subject is a non-human animal. Non-human animals include mammals, such as non-human primates, pigs, horses, dogs, cats, cattle, rodents, and other domestic, farm, and zoo animals.

[0116] A subject at risk for developing at least one disease, disorder, and / or condition associated with loss of visual acuity can be identified by one or more diagnostic or prognostic assays described herein and / or known to those of ordinary skill in the art.

[0117] In some embodiments, the methods disclosed herein treat and / or prevent at least one disease, disorder, and / or condition associated with loss of visual acuity, as evidenced by an improvement in vision. In some embodiments, the methods disclosed herein further comprise monitoring the efficacy of the subject administering the compositions disclosed herein. For example, in some embodiments, the methods disclosed herein further comprise monitoring the subject's vision improvement, comprising measuring a parameter indicating vision of the subject at a first time point before administering the compositions disclosed herein, measuring the same parameter of the subject at a second time point after administering the compositions disclosed herein, and comparing the two measurements to assess improvement.

[0118] The methods disclosed herein include daily administration of the compositions disclosed herein. Suitable daily dosing regimens (e.g., adjusting the number of doses and the frequency of administration) can be determined and adjusted by one of ordinary skill in the relevant art and depend on a variety of factors, such as the nature and progression of at least one disease, disorder, and / or condition associated with loss of visual acuity, and the health and / or age of the subject.

[0119] In some embodiments, the compositions disclosed herein are formulated in the form of one, two, three, four, etc. tablets and are administered to a subject in a single daily dose, two doses per day, three doses per day, four doses per day, etc., or up to, for example, ten doses per day. In some embodiments, the compositions disclosed herein are formulated in the form of four tablets and administered to a subject in two doses per day, two tablets each time. 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.

[0120] Also disclosed herein are methods for preventing, stabilizing, reversing, and / or treating macular degeneration or loss of visual acuity by reducing the risk of developing late or advanced age-related macular degeneration in a patient with early-stage age-related macular degeneration, the method comprising providing to the subject a daily dose of no less than about 500 mg of vitamin C, about 400 mg of vitamin E, about 80 mg of zinc, about 2 mg of copper, about 10 mg of lutein, about 2 mg of zeaxanthin, and about 100 mg of coenzyme Q10. In some embodiments, the daily dose is provided as two tablets taken twice daily, or as one tablet taken twice daily.

[0121] The effectiveness of the compositions and methods of the present disclosure, for example, in treating and / or preventing at least one disease, disorder and / or condition associated with loss of visual acuity, can be determined by a person of ordinary skill in the relevant art. The at least one disease, disorder and / or condition can be monitored using a combination of one or more diagnostic methods (including physical examination, symptom assessment and monitoring, and performing analytical tests and methods as described herein). For example, an eye examination can be used, such as biomicroscopy, intraocular pressure measurement, stereo 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)).

[0122] For example, vision can be assessed by any suitable means well known by persons skilled in the art.In some embodiments, vision is assessed by determining that the patient can read the minimum letter at a set distance on a standard visual acuity chart.Further for example, the progress of AMD can be assessed by measurement parameter (for example neovascularization).From the first time point to the second time point, the maintenance or reduction of measurement parameter show that AMD progress is prevented.In some embodiments, by determining the specific parameters of patient's drusen at the first time point (for example, before using high-dose statins), at the second time point (for example, after using high-dose statins), determine the same parameters of same patient, and relatively measure the parameter at the first time point and the second time point, assess the progress of AMD and / or the disappearance of drusen.The parameter of drusen can be for example volume, height, diameter and / or quantity. For example, drusen can be reduced by 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%. In addition, atrophy can be assessed by measuring parameters such as autofluorescence or retinal thickness, while PED can be assessed by, for example, measuring parameters such as volume, height, and / or diameter to assess its degree of flattening, and its reattachment to Bruch's membrane can be assessed by, for example, measuring parameters such as separation distance.

[0123] Prophetic Embodiments

[0124] The following compositions can be prepared. The content of each composition is based on the daily dose. Each composition can be formulated into two or more dosage units, which can be administered to a subject daily.

[0125]

[0126] By mixing the above ingredients, a composition comprising the above nutritional dietary ingredients can be prepared, which can be stored stably at room temperature for at least two years.

Claims

1. A composition for vision and / or heart health, comprising: Vitamin C, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing; Vitamin E, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing; zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; copper, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; Lutein, its prodrugs and / or pharmaceutically acceptable salts of any of the foregoing; Zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; and Coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing.

2. The composition according to claim 1, wherein the vitamin C, its prodrug and / or pharmaceutically acceptable salt of any of the foregoing comprises ascorbic acid.

3. The composition according to any one of claims 1-2, wherein the vitamin E, its prodrug and / or pharmaceutically acceptable salt of any one of the foregoing comprises α-tocopherol.

4. The composition according to any one of claims 1 to 3, wherein the zinc, prodrug thereof and / or pharmaceutically acceptable salt of any of the foregoing comprises zinc oxide.

5. The composition according to any one of claims 1 to 4, wherein the copper, prodrug thereof and / or pharmaceutically acceptable salt of any of the foregoing comprises copper oxide.

6. The composition according to any one of claims 1 to 5, wherein the lutein, its prodrug and / or pharmaceutically acceptable salt of any one of the foregoing comprises lutein (R', R').

7. The composition according to any one of claims 1 to 6, wherein the zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the foregoing comprises zeaxanthin (R', R').

8. The composition according to any one of claims 1 to 6, wherein the zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the foregoing comprises zeaxanthin (R', S').

9. The composition according to any one of claims 1 to 8, wherein the Coenzyme Q10, its prodrug and / or pharmaceutically acceptable salt of any of the foregoing comprises ubiquinol.

10. The composition according to any one of claims 1 to 8, wherein the coenzyme Q10, its prodrug and / or pharmaceutically acceptable salt of any of the foregoing comprises ubiquinone.

11. The composition according to any one of claims 1 to 10, wherein the composition comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C.

12. The composition according to any one of claims 1 to 11, wherein the composition comprises 100.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug of vitamin E, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin E.

13. The composition according to any one of claims 1 to 12, wherein the composition comprises 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of zinc.

14. The composition according to any one of claims 1 to 13, wherein the composition comprises 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of copper.

15. The composition according to any one of claims 1 to 14, wherein the composition comprises 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of lutein.

16. The composition according to any one of claims 1 to 15, wherein the composition comprises 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt of zeaxanthin and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin.

17. The composition according to any one of claims 1 to 15, wherein the composition comprises 1.0 mg to 20.0 mg of R',R'-zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of R',R'-zeaxanthin.

18. The composition according to any one of claims 1 to 15, wherein the composition comprises 1.0 mg to 20.0 mg of R',S'-zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of R',S'-zeaxanthin.

19. The composition according to any one of claims 1 to 15, wherein the composition comprises 1.0 mg to 20.0 mg of a mixture of R',R'-zeaxanthin and R',S'-zeaxanthin, or an equivalent amount of a prodrug of R',R'-zeaxanthin and a prodrug of R',S'-zeaxanthin, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of R',R'-zeaxanthin and a prodrug of R',S'-zeaxanthin.

20. The composition according to any one of claims 1 to 19, wherein the composition comprises 50.0 mg to 500.0 mg of Coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10.

21. The composition according to any one of claims 1 to 20, wherein the composition comprises about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C.

22. The composition according to any one of claims 1 to 21, wherein the composition comprises about 100 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug of vitamin E, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin E.

23. The composition according to any one of claims 1 to 22, wherein the composition comprises from about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug of zinc, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of zinc.

24. The composition according to any one of claims 1 to 23, wherein the composition comprises from about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug of copper.

25. The composition according to any one of claims 1 to 24, wherein the composition comprises from about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of lutein.

26. The composition according to any one of claims 1 to 25, wherein the composition comprises from about 1.0 mg to about 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt of zeaxanthin and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin.

27. The composition according to any one of claims 1 to 25, wherein the composition comprises about 1.0 mg to about 20.0 mg of R',R'-zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt of R',R'-zeaxanthin and / or a pharmaceutically acceptable salt of a prodrug of R',R'-zeaxanthin.

28. The composition according to any one of claims 1 to 25, wherein the composition comprises about 1.0 mg to about 20.0 mg of R',S'-zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of R',S'-zeaxanthin.

29. The composition according to any one of claims 1 to 25, wherein the composition comprises from about 1.0 mg to about 20.0 mg of a mixture of R',R'-zeaxanthin and R',S'-zeaxanthin, or an equivalent amount of a prodrug of R',R'-zeaxanthin and a prodrug of R',S'-zeaxanthin, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of R',R'-zeaxanthin and a prodrug of R',S'-zeaxanthin.

30. The composition according to any one of claims 1 to 29, wherein the composition comprises about 50 mg to about 500 mg of Coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of Coenzyme Q10.

31. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10.

32. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10.

33. The composition of any one of claims 1-30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10.

34. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',R' zeaxanthin; and 100 mg coenzyme Q10.

35. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',S' zeaxanthin; and 100 mg coenzyme Q10.

36. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 400.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',S' zeaxanthin; and 100 mg coenzyme Q10.

37. The composition according to any one of claims 1 to 30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',S' zeaxanthin; and 100 mg coenzyme Q10.

38. The composition of any one of claims 1-30, wherein the composition comprises: 500.0 mg vitamin C, optionally in the form of ascorbic acid; 180.0 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 25.0 mg zinc, optionally in the form of zinc oxide; 2.0 mg copper, optionally in the form of copper oxide; 10.0 mg R',R' lutein; 2.0 mg R',S' zeaxanthin; and 100 mg coenzyme Q10.

39. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10.

40. The composition according to any one of claims 1 to 30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10.

41. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10.

42. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 100 mg coenzyme Q10.

43. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',S' zeaxanthin; and about 100 mg coenzyme Q10.

44. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',S' zeaxanthin; and about 100 mg coenzyme Q10.

45. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',S' zeaxanthin; and about 100 mg coenzyme Q10.

46. ​​The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',S' zeaxanthin; and about 100 mg coenzyme Q10.

47. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 400 mg coenzyme Q10.

48. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 400 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 400 mg coenzyme Q10.

49. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 400 mg coenzyme Q10.

50. The composition of any one of claims 1-30, wherein the composition comprises: about 500 mg vitamin C, optionally in the form of ascorbic acid; about 180 mg vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg zinc, optionally in the form of zinc oxide; about 2 mg copper, optionally in the form of copper oxide; about 10 mg R',R' lutein; about 2 mg R',R' zeaxanthin; and about 400 mg coenzyme Q10.

51. The composition according to any one of claims 1 to 50, wherein the composition is in the form of one or more tablets, capsules, softgels, liquids or powders.

52. The composition according to any one of claims 1 to 51, wherein the composition is in the form of an immediate release formulation or a modified release formulation.

53. The composition according to any one of claims 1 to 51, wherein the composition is formulated as one, two, three or four dosage units for daily administration.

54. The composition according to any one of claims 1 to 53, wherein the composition is formulated as one, two, three or four tablets for daily administration.

55. The composition according to any one of claims 1 to 54, wherein at least one vitamin is derived from a natural source of said vitamin.

56. The composition according to any one of claims 1 to 54, wherein at least one vitamin is derived from a synthetic source of said vitamin.

57. The composition according to claim 56, wherein the composition comprises 350 mg to 800 mg of vitamin C or an equivalent amount of a prodrug of vitamin C, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of vitamin C; 50 mg to 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E; 20 mg to 90 mg zinc or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of zinc; 1.5 mg to 2.5 mg copper or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of copper; 5.0 mg to 50.0 mg lutein or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of lutein; 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt of zeaxanthin and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin; and 50.0 mg to 500.0 mg of coenzyme Q10 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of coenzyme Q10.

58. The composition according to claim 56, wherein the composition comprises from about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin C; from about 200 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of vitamin E; from about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a prodrug of zinc; and from about 1.5 mg to about 2.5 mg of Copper or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of copper; about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of lutein; about 1 mg to about 20 mg of zeaxanthin or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of zeaxanthin; and about 50 mg to about 500 mg of coenzyme Q10 or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of coenzyme Q10.

59. A composition according to any one of claims 1 to 58, wherein the composition further comprises B vitamins.

60. The composition according to any one of claims 1 to 59, wherein the composition further comprises omega-3 fatty acids.

61. The composition according to any one of claims 1 to 60, wherein the composition further comprises a very long chain polyunsaturated fatty acid.

62. The composition according to any one of claims 1 to 61, wherein the composition is on a daily dose basis.

63. A composition according to any one of claims 1 to 62 for use in treating at least one ophthalmic disease, disorder and / or condition.

64. A composition according to any one of claims 1 to 62 for use in the treatment of a cardiac disease, disorder and / or condition.

65. A composition according to any one of claims 1 to 62 for use in treating at least one ophthalmic disease, disorder and / or condition and at least one cardiac disease, disorder and / or condition.

66. A method of delaying the progression and / or onset of macular degeneration, the method comprising administering to a human in need thereof a composition according to any one of claims 1 to 62.

67. A method of treating and / or preventing at least one disease, disorder and / or condition associated with loss of visual acuity, the method comprising administering to a subject a composition according to any one of claims 1 to 62.

68. A method of delaying the progression and / or onset of heart failure, the method comprising administering to a human in need thereof a composition according to any one of claims 1 to 62.

69. A method of treating and / or preventing at least one disease, disorder and / or condition associated with cardiac disease, the method comprising administering to a subject a composition according to any one of claims 1 to 62.

70. A method of treating at least one ocular disease, disorder and / or condition and at least one cardiac disease, disorder and / or condition, the method comprising administering to a subject a composition according to any one of claims 1-62.

71. A method of treating at least one ocular disease, disorder and / or condition and lowering blood pressure, the method comprising administering to a subject a composition according to any one of claims 1-62.

72. A method of lowering blood pressure comprising administering to a subject a composition according to any one of claims 1-62.

73. The method according to any one of claims 66-72, wherein the composition is administered to the subject daily in one, two, three or four daily doses.

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