Compositions containing coenzyme Q10 and their use for treating eye and heart disorders

Abstract

The present disclosure describes a composition comprising vitamin C, vitamin E, zinc, copper, lutein, zeaxanthin, and coenzyme Q10, and any of the pharmaceutically acceptable salts thereof.The composition is useful in methods for treating conditions associated with vision loss, including age-related macular degeneration, and for supporting heart health.

Description

[Technical Field]

[0001] Disclosed herein are compositions and methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, including, for example, age-related macular degeneration, and / or at least one disease, disorder, and / or condition associated with heart disease. [Prior art documents] [Non-patent literature]

[0002] [Non-Patent Document 1] Stedman's Medical Dictionary [Non-patent document 2] SM Berge et al., J. Pharmaceutical Sciences, 1977, 66, 1-19 [Non-patent document 3] Higuchi, T et al., "Prodrugs as Novel Delivery Systems," ACS Symposium Series, Vol. 14 [Non-patent document 4] Bioreversible Carriers in Drug Design, edited by Edward B. Roche, American Pharmaceutical Association and Pergamon Press, 1987 [Non-patent document 5] Remington: The Science and Practice of Pharmacy, 21st edition, 2005, edited by DB Troy, Lippincott Williams & Wilkins, Philadelphia. [Non-patent document 6] Encyclopedia of Pharmaceutical Technology, edited by J. Swarbrick and JC Boylan, 1988-1999, Marcel Dekker, New York [Non-Patent Document 7] "Pharmaceutical dosage form tablets," edited by Liberman et al. (New York, Marcel Dekker, Inc., 1989) [Non-patent document 8] "Remington--The science and practice of pharmacy," 20th edition, Lippincott Williams & Wilkins, Baltimore, Md., 2000. [Non-Patent Document 9] "Pharmaceutical dosage forms and drug delivery systems," 6th ed., Ansel et al. (Media, Pa.: Williams and Wilkins, 1995) Summary of the Invention

[0003] In some embodiments, disclosed herein is a composition comprising vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt thereof, vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt thereof, zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt thereof, copper, a prodrug thereof, and / or a pharmaceutically acceptable salt thereof, lutein, a prodrug thereof, and / or a pharmaceutically acceptable salt thereof, zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable form thereof, and coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable form thereof. In some embodiments, coenzyme Q10 is in the form of ubiquinol. In some embodiments, coenzyme Q10 is in the form of ubiquinone.

[0004] 350 mg to 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin C; 100 mg to 550 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E; 20 mg to 90 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of zinc; and 1.5 mg to 2.5 mg of copper, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or prodrug of copper. Also disclosed herein is a composition comprising 5 mg to 50 mg of lutein, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of lutein, 1 mg to 20 mg of zeaxanthin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of zeaxanthin, and 100 mg to 400 mg of coenzyme Q10, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of coenzyme Q10.

[0005] Also disclosed herein is a composition comprising 500.0 mg vitamin C, which may be in the form of ascorbic acid, 180.0 mg vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg zinc, which may be in the form of zinc oxide, 2.0 mg copper, which may be in the form of copper oxide, 10.0 mg R'R' lutein, 2.0 mg R'R' zeaxanthin, and 100 mg coenzyme Q10.

[0006] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0007] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0008] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0009] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0010] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0011] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0012] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0013] Also disclosed herein is a composition comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0014] About 350 mg to about 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or 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 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 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, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug. Also disclosed herein is a composition comprising an amount of a copper prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug, about 5 mg to about 50 mg of lutein, or an equivalent amount of a lutein prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, about 1 mg to about 20 mg of zeaxanthin, or an equivalent amount of a zeaxanthin prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug, and about 20 mg to about 400 mg of coenzyme Q10.

[0015] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0016] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0017] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0018] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0019] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0020] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0021] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0022] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0023] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0024] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0025] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0026] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0027] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0028] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0029] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0030] Also disclosed herein is a composition comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0031] Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people aged 55 and older in the United States and Western Europe. An estimated 1.75 million individuals in the United States have advanced AMD, accounting for most cases of severe vision loss. An additional 7.3 million people have early AMD, which is typically associated with little or no vision loss, but increases the risk of developing AMD. This is associated with a collection of clinically recognizable ocular findings that can lead to blindness. These findings include drusen, retinal pigment epithelium (RPE) damage including pigment clumping and / or shedding, RPE detachment, geographic atrophy, subretinal neovascularization, and disciform scar. Not all of these signs are required to consider AMD present.

[0032] Disclosed herein are compositions for eye and / or heart health, e.g., 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, the compositions are pharmaceutical compositions. In some embodiments, the present disclosure relates to antioxidant nutritional supplements comprising Coenzyme Q10. In some embodiments, the compositions disclosed herein can enhance and / or promote retinal health, e.g., through stabilizing and / or treating vision loss in humans with certain eye diseases, disorders, and / or conditions. In some embodiments, the compositions disclosed herein can improve and / or promote heart health, e.g., by treating and / or preventing the development of heart failure and / or other cardiac risks. In some embodiments, administering the compositions can reduce vision loss, e.g., by reducing a patient's risk of developing late-stage or progressive age-related macular degeneration. In some embodiments, the compositions disclosed herein simultaneously promote eye health and heart health.

[0033] Also disclosed herein are methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, comprising administering a composition disclosed herein to a subject in need thereof. In some embodiments, the at least one disease, disorder, and / or condition associated with vision loss is selected from macular degeneration, age-related macular degeneration (AMD), atrophy of the retinal pigment epithelium (RPE), atrophy of at least one photoreceptor, drusen, drusen-like pigment epithelial detachment (PED), diabetic retinopathy, cataracts, 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 condition associated with vision loss further treats and / or prevents at least one disease, disorder, and / or condition associated with cardiac health.

[0034] Also disclosed herein are methods for regressing drusen and / or drusen-like pigment epithelial detachment (PED), treating and / or preventing atrophy of the retinal pigment epithelium (RPE) and / or at least one photoreceptor, treating and / or preventing vision loss and / or improving vision, and / or treating and / or preventing at least one heart disease, heart disorder, or heart condition, comprising administering to a subject in need thereof a composition disclosed herein.

[0035] In accordance with the present disclosure, compositions and methods are provided that improve eye health and / or slow the progression of macular degeneration. In some embodiments, compositions and methods are also provided that improve heart health and / or slow the onset or progression of heart disease. In some embodiments, the compositions and methods of the present disclosure improve both eye and heart health.

[0036] Additionally, combining the disclosed coenzyme Q10 with other AREDS ingredients, such as zinc, copper, lutein, zeaxanthin, vitamin C, and vitamin E, can also provide protection against macular degeneration and / or heart failure. These ingredients are powerful antioxidants that help protect cells, such as retinal pigment epithelial (RPE) cells, which make up the retina and are responsible for visual function, and can lower blood pressure and treat heart failure and other cardiac conditions. Thus, when a subject receives a supplement containing the combination, the coenzyme Q10 in conjunction with the AREDS vitamins helps ensure that RPE cells are not further damaged or subjected to less stress. This combination of coenzyme Q10 and AREDS nutrients should promote improved eye health and slow the progression of AMD, and can also be used to treat heart failure and / or other cardiac conditions, and in some cases, prevent at least one heart disease, heart disorder, and / or cardiac condition. DETAILED DESCRIPTION OF THE INVENTION

[0037] Definitions of certain terms used in this application are provided below: Unless defined otherwise, all technical and scientific terms used herein have the ordinary and commonly understood meanings as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0038] As used herein, "a," "an," and "the" refer to one or to more than one (i.e., to at least one) of the grammatical object of the article.

[0039] As used herein, administration of a "daily" amount of a described element or composition refers to the total amount administered in one day, but without limiting the number of administrations per day. The daily amount administered to a patient can be administered once per day, or multiple times per day, for example, twice per day or three times per day (where each multiple administration includes administering some amount of the described element or composition that is less than the "daily" amount, considering that the "daily" amount refers to the total amount administered in one day). Each administration of the described element or composition can consist of administering the described element or composition in single-dose form (e.g., as a single tablet or a single capsule, etc.) or in multiple-dose form (e.g., as multiple (i.e., two or more) tablets and / or capsules, etc.).

[0040] As used herein, the terms "treat" and "treatment" include the medical management of a subject's disease, disorder, and / or condition as would be understood by one of ordinary skill in the art (see, e.g., Stedman's Medical Dictionary). Generally, an appropriate dosage and treatment regimen will administer at least one of the compositions of the present disclosure sufficient to provide a therapeutic and / or prophylactic benefit. With respect to both therapeutic treatment and prophylactic or preventative measures, therapeutic and / or prophylactic benefit includes, for example, improved clinical outcomes with the goal of preventing, slowing, or attenuating an undesirable physiological change or disorder, or preventing, slowing, or attenuating the progression or severity of such a disorder. As discussed herein, beneficial or desired clinical results of treating a subject include, but are not limited to, amelioration, alleviation, or reduction of symptoms resulting from or associated with the disease, condition, and / or disorder being treated, reduction in the occurrence of symptoms, improved quality of life, prolonged symptom-free state (i.e., reducing the likelihood or tendency of a subject to exhibit symptoms that are the basis for diagnosing a disease), attenuation of the severity of the disease, disorder, and / or condition, stabilized (i.e., not worsening) state of the disease, disorder, and / or condition, delay or slowing of the progression of the disease, disorder, and / or condition, amelioration or palliation of the state of the disease, disorder, and / or condition, and detectable or undetectable remission (whether partial or total), and / or overall survival.

[0041] As used herein, "prevention" of or "preventing" a disorder or condition refers to reducing the occurrence of or reducing the severity of one or more symptoms of the disorder or condition in a treated sample relative to an untreated control sample, including delaying the onset, progression, or reduction in severity of one or more symptoms of the disorder or condition relative to an untreated control sample.

[0042] As used herein, the term "pharmaceutically acceptable salt" refers to a compound in salt form, where the salt is non-toxic and includes such salts derived from suitable inorganic and organic acids and bases. Pharmaceutically acceptable salts are well known in the art. For example, S.M. 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 chloride, bromide, sulfate, nitrate, phosphate, sulfonate, methanesulfonate, formate, tartrate, maleate, succinate, malonate, citrate, benzoate, salicylate, and ascorbate. Non-limiting examples of suitable pharmaceutically acceptable base addition salts include sodium, potassium, lithium, ammonium (substituted and unsubstituted), calcium, magnesium, iron, zinc, copper, manganese, and aluminum salts. Non-limiting examples of pharmaceutically acceptable salts include pharmaceutically acceptable salts derived from appropriate bases, including but not limited to alkali metal, alkaline earth metal, ammonium, and N + (C 1~4 Examples of suitable salts include aryl, ...

[0043] The terms "patient," "subject," "individual," and the like, as used herein, are interchangeable and refer to any animal, which may be a human or non-human animal.

[0044] As used herein, "age-related macular degeneration" or "AMD" includes all forms of macular degeneration, including "wet" (exudative) and "dry" (atrophic) forms.

[0045] 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. Discussions of prodrugs can be found, for example, in Higuchi, T. et al., "Prodrugs as Novel Delivery Systems," ACS Symposium Series, Vol. 14, and Bioreversible Carriers in Drug Design, edited by Edward B. Roche, American Pharmaceutical Association and Pergamon Press, 1987. The term "prodrug" also includes covalently bonded carriers that release an active compound described herein in vivo when such a prodrug is administered to a subject. Non-limiting examples of prodrugs include ester and amide derivatives of hydroxy, carboxy, mercapto, and amino functional groups in the compounds described herein.

[0046] The term "nutritional composition" as used herein includes food products for human consumption.

[0047] As will be understood by those skilled in the art, when disclosed herein, each range includes all possible subranges and individual numerical values ​​within that range. For example, a range of "1.0 to 5.0" will be understood to include and specifically specify subranges such as "1.0 to 3.0," "1.5 to 3.7," "2.1 to 4.3," etc., and all individual numerical values ​​within the specified range, such as 1.0, 1.1, 1.2, 1.3, etc.

[0048] 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 salt of any of the foregoing; Coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; Disclosed herein is a composition comprising a vitamin complex comprising:

[0049] In some embodiments, vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises vitamin C, which may be in the form of ascorbic acid. In some embodiments, vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises dl-alpha tocopherol acetate and / or alpha-tocopherol. In some embodiments, zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises zinc oxide and / or zinc gluconate. In some embodiments, copper, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises copper oxide and / or copper gluconate. In some embodiments, zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises zeaxanthin (R'R'). In some embodiments, coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises coenzyme Q10, which may be in the form of ubiquinol.

[0050] In some embodiments, the composition comprises vitamin C, which may be in the form of ascorbic acid, vitamin E, which may be in the form of dl-alpha tocopherol acetate, zinc, which may be in the form of zinc oxide, thiamine, copper, which may be in the form of copper oxide, R'R' lutein, R'R' zeaxanthin, and coenzyme Q10, which may be in the form of ubiquinol.

[0051] In some embodiments, the vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises ascorbic acid. In some embodiments, the vitamin C, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing is ascorbic acid. The U.S. Recommended Dietary Allowance (RDA) for vitamin C in the form of ascorbic acid is 60 mg. In some embodiments, the composition comprises 60 mg to 850 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 100.0 mg to 800.0 mg, e.g., 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 vitamin C prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 500.0 mg of vitamin C, which may be in the form of ascorbic acid. In some embodiments, the composition contains about 60 mg to about 850 mg of vitamin C, or an equivalent amount of a vitamin C prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 100 mg to about 800 mg, e.g., about 150 mg to about 800 mg, about 250 mg to about 800 mg, about 250 mg to about 750 mg, about 500 mg to about 775 mg, about 600 mg to about 750 mg, about 500 mg, or about 750 mg of ascorbic acid, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin C. In some embodiments, the composition contains about 500 mg of vitamin C, which may be in the form of ascorbic acid.

[0052] In some embodiments, vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises alpha-tocopherol. In some embodiments, vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing is dl-alpha tocopherol acetate. The RDA for vitamin E is 15 mg. No adverse effects of vitamin E have been observed at levels as high as 800 mg. In some embodiments, the composition comprises 15 mg to 800 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. In some embodiments, the composition contains 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, or 300.0 mg to 350.0 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition contains 180 mg of vitamin E. In some embodiments, the composition contains about 15 mg to about 800 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition contains 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, or about 300 mg to about 350 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E. In some embodiments, the composition contains about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate.

[0053] In some embodiments, the zinc, prodrug, and / or pharmaceutically acceptable form of any of the foregoing comprises zinc oxide. In some embodiments, the zinc, prodrug, and / or pharmaceutically acceptable form of any of the foregoing is zinc oxide. The RDA for zinc is about 15 mg. In some embodiments, the composition contains 15 mg to 100 mg of zinc, or an equivalent amount of a zinc prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable form of the prodrug. In some embodiments, the composition contains 15.0 mg to 100.0 mg, e.g., 40.0 mg to 95.0 mg, 50.0 mg to 90.0 mg, 60.0 mg to 85.0 mg, 70.0 mg to 80.0 mg, or 80.0 mg of zinc, or an equivalent amount of a zinc prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 80.0 mg of zinc, which may be in the form of zinc oxide. In some embodiments, the composition contains 25.0 mg of zinc, which may be in the form of zinc oxide. In some embodiments, the composition contains about 15 mg to about 100 mg of zinc, or an equivalent amount of a zinc prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable form of the prodrug. In some embodiments, the composition contains about 15 mg to about 100 mg, e.g., 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 zinc prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 80 mg of zinc, which may be in the form of zinc oxide. In some embodiments, the composition contains about 25 mg of zinc, which may be in the form of zinc oxide.

[0054] In some embodiments, the copper, its prodrug, and / or pharmaceutically acceptable forms of any of the foregoing comprise copper oxide. In some embodiments, the copper, its prodrug, and / or pharmaceutically acceptable forms of any of the foregoing is copper oxide. The RDA for copper is 2.0 mg. In some embodiments, the composition contains 1.5 mg to 2.5 mg of copper, or an equivalent amount of a copper prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 1.5 mg to 2.0 mg, e.g., 2.0 mg, of copper, or an equivalent amount of a copper prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 2.0 mg of copper, which may be in the form of copper oxide. In some embodiments, the composition contains about 1.5 mg to about 2.5 mg of copper, or an equivalent amount of a copper prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 1.5 mg to about 2.0 mg, e.g., about 2.0 mg, of copper, or an equivalent amount of a copper prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 2.0 mg of copper, which may be in the form of copper oxide.

[0055] 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, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 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, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of lutein. In some embodiments, the composition contains 10.0 mg of lutein. In some embodiments, the composition contains 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, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 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, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 10 mg of lutein.

[0056] 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, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition contains 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 of zeaxanthin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of zeaxanthin. In some embodiments, the composition contains 2.0 mg of zeaxanthin. In some embodiments, the composition contains 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, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of zeaxanthin.In some embodiments, the composition comprises about 1 mg to about 20 mg, e.g., about 1 mg to about 3 mg, about 3 mg to about 5 mg, e.g., about 1.5 mg to about 2 mg, about 2 mg to about 2.5 mg, such as 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 zeaxanthin prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition comprises about 2 mg of zeaxanthin.

[0057] In some embodiments, the composition further comprises coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of coenzyme Q10. In some embodiments, the coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of coenzyme Q10 is ubiquinone. In some embodiments, the 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 coenzyme Q10 prodrug, pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains 60 mg to 450 mg, e.g., 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, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of coenzyme Q10. In some embodiments, the composition contains 100 mg of coenzyme Q10. In some embodiments, the composition contains 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, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of coenzyme Q10. In some embodiments, the composition contains about 60 mg to about 450 mg, e.g., 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 coenzyme Q10 prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug. In some embodiments, the composition contains about 100 mg of coenzyme Q10.

[0058] In some embodiments, the composition comprises: 350.0 mg to 800.0 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin C; 50.0 mg to 550.0 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E; 20.0 mg to 90.0 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug of zinc; 1.5 mg to 2.5 mg of copper, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug of copper; 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 the prodrug of lutein; 1.0 mg to 20.0 mg of zeaxanthin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of zeaxanthin; 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; Includes.

[0059] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R',R' lutein, 2.0 mg of R',R' zeaxanthin, and / or 100 mg of coenzyme Q10, which may be in the form of ubiquinol.

[0060] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R',R' lutein, 2.0 mg of R',R' zeaxanthin, and / or 100 mg of coenzyme Q10, which may be in the form of ubiquinone.

[0061] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R',R' lutein, 2.0 mg of R',R' zeaxanthin, and / or coenzyme Q10, which may be in the form of ubiquinol.

[0062] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R',R' lutein, 2.0 mg of R',R' zeaxanthin, and / or coenzyme Q10, which may be in the form of ubiquinone.

[0063] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0064] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0065] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0066] In some embodiments, the composition comprises 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0067] In some embodiments, the composition comprises: About 350 mg to about 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin C; 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; about 20 mg to about 90 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of the prodrug of zinc; 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 the 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 the 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; About 20 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; Includes.

[0068] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0069] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0070] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0071] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0072] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0073] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0074] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinol.

[0075] In some embodiments, the composition comprises about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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, which may be in the form of ubiquinone.

[0076] In some embodiments, the compositions described herein may be dietary or nutritional supplements or pharmaceutical compositions. In some embodiments, the compositions may be in the form of a food product or a food ingredient. The compositions of the present disclosure may be advantageously utilized in methods for promoting the health of an individual, such as eye and / or heart health.

[0077] In some embodiments, the composition is formulated in a form suitable for oral, intraperitoneal, intravenous, subcutaneous, sublingual, transdermal, and / or intramuscular administration. In some embodiments, the composition is formulated in a form suitable for oral administration. Non-limiting examples of suitable solid oral formulations include tablets, capsules, cachets, lozenges, powders, pills, granules, and pellets. Non-limiting examples of suitable liquid oral formulations include solutions, suspensions, dispersions, emulsions, and oils. In some embodiments, the composition is in liquid, semi-solid, or solid form. For example, the composition may be administered as a tablet, gel pack, capsule, gelatin capsule, flavored beverage, or as a powder that can be reconstituted. In some embodiments, the composition is in the form of a tablet, capsule, soft gel, liquid, or powder. In some embodiments, the composition is in the form of a soft gelatin capsule or hard gelatin capsule. In some embodiments, the composition is in the form of a chewable oral formulation, such as a chewable tablet.

[0078] In some embodiments, the composition is in the form of an immediate release formulation or a controlled release formulation, such as a delayed and / or sustained release formulation.

[0079] In some embodiments, the composition may further comprise at least one pharmaceutically acceptable excipient. Non-limiting examples of suitable excipients include surfactants, humectants, plasticizers, binders, crystallization inhibitors, wetting agents, bulking agents, solubilizers, bioavailability enhancers, pH adjusters, and flavoring agents. As used herein, at least one pharmaceutically acceptable excipient also includes any and all solvents, diluents, other liquid vehicles, dispersion aids, suspension aids, surfactants, isotonicity agents, thickeners, emulsifiers, preservatives, solid binders, and lubricants, as appropriate for the desired specific dosage form. Remington: The Science and Practice of Pharmacy, 21st ed., 2005, D.B. Troy, ed., Lippincott Williams & Wilkins, Philadelphia, and Encyclopedia of Pharmaceutical Technology, J. Swarbrick and J.C. Boylan, eds., 1988-1999, Marcel Dekker, New York, disclose various excipients used in formulating oral compositions and known techniques for their preparation. Except to the extent that any conventional carrier is incompatible with the vitamins of the present disclosure, such as by producing any undesirable biological effect or by adversely interacting with any other component of the composition, its use is contemplated as being within the scope of the present disclosure.Non-limiting examples of suitable pharmaceutically acceptable excipients include 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 monohydrogen phosphate, sodium chloride, and zinc salts), colloidal silica, magnesium trisilicate, polyvinylpyrrolidone, polyacrylates, waxes, polyethylene-polyoxypropylene-block polymers, wool fat, sugars (such as lactose, glucose, and sucrose), starches (such as corn starch and potato starch), cellulose and its derivatives (such as sodium carboxymethylcellulose, The following ingredients may be used in the preparation of pharmaceutical compositions: cellulose, ethylcellulose, and cellulose acetate), powdered tragacanth, malt, gelatin, talc, excipients (such as cocoa butter and suppository waxes), oils (peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil), glycols (such as propylene glycol and polyethylene glycol), esters (such as ethyl oleate and ethyl laurate), agar, buffers (such as magnesium hydroxide and aluminum hydroxide), alginic acid, pyrogen-free water, isotonic saline, Ringer's solution, ethyl alcohol, phosphate buffer, non-toxic compatible lubricants (such as sodium lauryl sulfate and magnesium stearate), colorants, release agents, coating agents, sweeteners, flavors, fragrances, preservatives, and antioxidants.

[0080] In some embodiments, the composition further comprises cellulose, gelatin, magnesium stearate, water, vegetable oil, glycerin, beeswax, and / or silica.

[0081] In some embodiments, the composition further comprises or is co-administered with at least one additional active ingredient. In some embodiments, the at least one additional therapeutic agent is selected from anti-inflammatory agents (e.g., anti-IL-6 agents, anti-IL-8 agents, aspirin, ibuprofen, and naproxen), anti-angiogenic agents (e.g., anti-VEGF agents, ranibizumab, bevacizumab, acadesine, and AMPK activators), antioxidants (e.g., vitamin C, vitamin E, vitamin A, glutathione, catalase, etc.), omega-3 fatty acids (e.g., alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)), and vitamins and minerals (e.g., vitamin C, vitamin E, vitamin A, lutein, zeaxanthin, zinc, and copper). In some embodiments, the composition further comprises lutein and zeaxanthin.

[0082] In some embodiments, the compositions disclosed herein further comprise vitamin B. 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.

[0083] The combination of the disclosed compositions with at least one additional active ingredient may advantageously produce one or more of the following effects: (1) additive and / or synergistic benefits; (2) reduced side effects and / or adverse effects associated with the use of prescription drugs in the absence of the compositions disclosed herein; and / or (3) the ability to lower the dosage of prescription drugs compared to the amount of prescription drug required in the absence of the compositions disclosed herein.

[0084] The compositions disclosed herein can be prepared according to any known method for producing dietary supplements or pharmaceutical preparations.As will be recognized by those skilled in the art, several methods are known.For information on materials, equipment, and processes for preparing formulations and dosage forms, please refer to "Pharmaceutical dosage forms tablets", edited by Liberman et al. (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. (Media, Pa.: Williams and Wilkins, 1995), which provides information on carriers, materials, equipment, and processes for preparing formulations.

[0085] Methods for making the compositions disclosed herein can include combining the described vitamins with any desired excipients and mechanically mixing, for example, using a blender, to form a blend. If necessary, the blend can then be tumbled until uniform. The blend can then be compressed using a tablet press to form tablets. Optionally, the tablets can be sprayed with a coating and tumbled until dry. Alternatively, the blend can be placed in medium-chain triglycerides to form a slurry for inclusion in a soft gel capsule, the blend can be placed in a gelatin capsule, or the blend can be placed in other dosage forms known to those skilled in the art.

[0086] Disclosed herein are methods for treating and / or preventing at least one disease, disorder, and / or condition associated with vision loss, including, for example, age-related macular degeneration (AMD), and / or at least one disease, disorder, and / or condition associated with cardiac health, such as heart disease, 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.

[0087] At least one disease, disorder, and / or condition associated with vision loss comprises age-related macular degeneration (AMD). In some embodiments, the methods disclosed herein are effective in preventing, slowing, or inhibiting the progression of AMD. In some embodiments, the AMD is wet AMD or dry AMD.

[0088] In some embodiments, the at least one disease, disorder, and / or condition associated with loss of vision is selected from macular degeneration, age-related macular degeneration (AMD), atrophy of the retinal pigment epithelium (RPE), atrophy of at least one photoreceptor, drusen, drusen-like pigment epithelial detachment (PED), diabetic retinopathy, cataracts, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration, Stargardt's disease, and oxygen-induced retinopathy.

[0089] In some embodiments, the at least one disease, disorder, and / or condition is associated with cardiac health. In some embodiments, the methods disclosed herein are effective in preventing, attenuating, or slowing the progression of at least one ocular disease, disorder, and / or condition and at least one cardiac disease, disorder, and / or condition.

[0090] In some embodiments of the methods disclosed herein, the compositions disclosed herein are administered to a subject in 1, 2, 3, or 4 doses per day. In some embodiments, the compositions are administered in the form of 1, 2, 3, or 4 dosage units, each administered 1, 2, 3, or 4 times per day, for example, two tablets taken twice per day, or one tablet taken twice per day.

[0091] Also disclosed herein is a method for regressing drusen and / or drusen-like pigment epithelial detachment (PED), comprising administering a composition disclosed herein to a subject. Also disclosed herein is a method for treating and / or preventing atrophy of the retinal pigment epithelium (RPE) and / or at least one photoreceptor, comprising administering a composition disclosed herein to a subject. Also disclosed herein is a method for treating and / or preventing vision loss and / or improving vision. Also disclosed herein is a method for treating and / or preventing heart disease, heart disorders, and / or cardiac conditions and / or improving cardiac health. In some embodiments, the methods disclosed herein are used to treat and / or prevent at least one ocular disease, disorder, and / or condition and at least one heart disease, heart disorder, and / or cardiac condition.

[0092] In some embodiments, administration of the compositions described herein results in complete disappearance of drusen (i.e., 100% regression), hi some embodiments, administration of the compositions described herein prevents atrophy of the RPE and / or photoreceptors (i.e., geographic atrophy) in a patient.

[0093] In some embodiments of the disclosed methods, the subject to which the composition is administered is selected from a subject suspected of having at least one disease, disorder, and / or condition associated with loss of vision, a subject known to have at least one disease, disorder, and / or condition associated with loss of vision, and a subject at risk of developing at least one disease, disorder, and / or condition associated with loss of vision.

[0094] In some embodiments, the disclosed methods further comprise identifying a subject at risk of developing at least one disease, disorder, and / or condition associated with vision loss. In some embodiments, the disclosed methods further comprise identifying a subject at risk of developing AMD. In some embodiments, the disclosed methods further comprise identifying a subject with AMD. In some embodiments, the disclosed methods further comprise identifying a subject at risk of developing AMD.

[0095] 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, cows, rodents, and other domestic, livestock, and zoo animals.

[0096] Subjects at risk for developing at least one disease, disorder, and / or condition associated with vision loss can be identified by one or more diagnostic or prognostic assays described herein and / or known to those of skill in the art.

[0097] In some embodiments, the methods disclosed herein treat and / or prevent at least one disease, disorder, and / or condition associated with loss of vision, as evidenced by improved vision. In some embodiments, the methods disclosed herein further comprise monitoring the subject for the effectiveness of administering a composition disclosed herein to the subject. For example, in some embodiments, the methods disclosed herein further comprise monitoring the subject for improved vision, comprising measuring a parameter indicative of vision in the subject at a first time point before administration of a composition disclosed herein, measuring the same parameter in the subject at a second time point after administration of a composition disclosed herein, and comparing the results of the two measurements to assess the improvement.

[0098] The method disclosed herein comprises administering a daily dose of the composition disclosed herein.The determination and adjustment of the appropriate daily administration regimen (for example, the number of doses and the number of administrations) can be performed by a person skilled in the relevant field, and will depend on various factors such as the nature and progression of at least one disease, disorder, and / or condition associated with vision loss, and the health status and / or age of the subject.

[0099] In some embodiments, the compositions disclosed herein are formulated in the form of one tablet, two tablets, three tablets, four tablets, etc., and are administered to a subject in a single dose per day, two doses per day, three doses per day, four doses per day, etc., or up to, for example, 10 doses per day. In some embodiments, the compositions disclosed herein are formulated in the form of four tablets, which are administered to a subject in two doses per day, two tablets each. In some embodiments, the compositions disclosed herein are administered to a subject for at least 1 week, at least 2 weeks, at least 3 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 12 months, at least 1 year, or more than 1 year.

[0100] Also disclosed herein is a method for preventing, stabilizing, reversing, and / or treating macular degeneration or vision loss by reducing the risk of developing late or progressive age-related macular degeneration in a person with early age-related macular degeneration, comprising administering to a subject a daily dosage on the order of or greater 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 dosage is administered as two tablets taken twice daily or as one tablet taken twice daily.

[0101] The effectiveness of the compositions and methods of the present disclosure in treating and / or preventing at least one disease, disorder, and / or condition associated with, for example, vision loss, can be determined by those skilled in the relevant art. One or any combination of diagnostic methods, including physical examination, evaluation, and monitoring of symptoms, and the performance of analytical tests and methods described herein, can be used to monitor at least one disease, disorder, and / or condition. For example, eye examinations such as biomicroscopy, tonometry, stereoscopic fundus examination (e.g., color fundus photography), macular function assessment, optical coherence tomography (OCT), autofluorescence, and / or angiography (e.g., fluorescein angiography and OCT-based angiography (OCTA)) can be used.

[0102] For example, visual acuity can be assessed by any suitable method known to those skilled in the art. In some embodiments, visual acuity is assessed by determining the smallest letter a patient can read on a standard eye chart at a set distance. Further, for example, AMD progression can be assessed by measuring parameters such as neovascularization. Maintenance or reduction of a measured parameter from a first time point to a second time point is indicative of prevention of AMD progression. In some embodiments, AMD progression and / or drusen regression is assessed by determining a particular parameter of drusen in a patient at a first time point (e.g., before administration of a high-dose statin), determining the same parameter in the same patient at a second time point (e.g., after administration of a high-dose statin), and comparing the measured parameter between the first and second time points. The drusen parameter can be, for example, volume, height, diameter, and / or number. For example, drusen regression can be at least 5%, at least 10%, at least 15%, 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% regression. In some embodiments, drusen are reduced by 5% to at least 40%, e.g., 90%. Additionally, atrophy can be assessed by measuring parameters such as autofluorescence or retinal thickness, PED can be assessed for flattening by measuring parameters such as volume, height, and / or diameter, and reattachment to Bruch's membrane can be assessed by measuring parameters such as separation distance.

[0103] Expected implementation The following compositions can be prepared. The amount of each composition is listed on a daily dosage basis. Each composition can be formulated into two or more dosage units, which can be administered to a subject daily.

[0104] [Table 1]

[0105] The composition combining the nutritional dietary ingredients listed above is prepared by mixing the ingredients described. The composition can be stable at about room temperature for at least two years.

Claims

1. 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 salt of any of the foregoing; Coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing; 10. A composition for visual and / or heart health comprising:

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

3. 3. The composition of claim 1 or 2, wherein the vitamin E, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises alpha-tocopherol.

4. 4. The composition of claim 1, wherein the zinc, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises zinc oxide.

5. 5. The composition of claim 1, wherein the copper, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises copper oxide.

6. 6. The composition of claim 1, wherein the lutein, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises lutein (R',R').

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

8. 7. The composition of claim 1, wherein the zeaxanthin, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises zeaxanthin (R',S').

9. 9. The composition of claim 1, wherein the coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises ubiquinol.

10. 9. The composition of claim 1, wherein the coenzyme Q10, a prodrug thereof, and / or a pharmaceutically acceptable salt of any of the foregoing comprises ubiquinone.

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

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

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

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

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

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

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

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

19. 16. The composition of any one of claims 1 to 15, comprising 1.0 mg to 20.0 mg of a mixture of R',R'-zeaxanthin and R',S'-zeaxanthin, or an equivalent amount of prodrugs, pharmaceutically acceptable salts, and / or pharmaceutically acceptable salts of the prodrugs of R',R'-zeaxanthin and R',S'-zeaxanthin.

20. 20. The composition of any one of claims 1 to 19, comprising 50.0 mg to 500.0 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.

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

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

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

24. 24. The composition of any one of claims 1 to 23, comprising 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 the prodrug of copper.

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

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

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

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

29. 26. The composition of any one of claims 1 to 25, comprising 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 prodrugs, pharmaceutically acceptable salts, and / or pharmaceutically acceptable salts of the prodrugs of R',R'-zeaxanthin and R',S'-zeaxanthin.

30. 30. The composition of any one of claims 1 to 29, comprising 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.

31. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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.

32. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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.

33. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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.

34. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be 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.

35. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R'R' lutein, 2.0 mg of R',S' zeaxanthin, and 100 mg of coenzyme Q10.

36. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 400.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R'R' lutein, 2.0 mg of R',S' zeaxanthin, and 100 mg of coenzyme Q10.

37. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 80.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R'R' lutein, 2.0 mg of R',S' zeaxanthin, and 100 mg of coenzyme Q10.

38. 31. The composition of any one of claims 1 to 30, comprising 500.0 mg of vitamin C, which may be in the form of ascorbic acid, 180.0 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, 25.0 mg of zinc, which may be in the form of zinc oxide, 2.0 mg of copper, which may be in the form of copper oxide, 10.0 mg of R'R' lutein, 2.0 mg of R',S' zeaxanthin, and 100 mg of coenzyme Q10.

39. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

40. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

41. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

42. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

43. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

44. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

45. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

46. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be 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.

47. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be in the form of copper oxide, about 10 mg of R'R' lutein, about 2 mg of R',R' zeaxanthin, and about 400 mg of coenzyme Q10.

48. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 400 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be in the form of copper oxide, about 10 mg of R'R' lutein, about 2 mg of R',R' zeaxanthin, and about 400 mg of coenzyme Q10.

49. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 80 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be in the form of copper oxide, about 10 mg of R'R' lutein, about 2 mg of R',R' zeaxanthin, and about 400 mg of coenzyme Q10.

50. 31. The composition of any one of claims 1 to 30, comprising about 500 mg of vitamin C, which may be in the form of ascorbic acid, about 180 mg of vitamin E, which may be in the form of dl-alpha tocopheryl acetate, about 25 mg of zinc, which may be in the form of zinc oxide, about 2 mg of copper, which may be in the form of copper oxide, about 10 mg of R'R' lutein, about 2 mg of R',R' zeaxanthin, and about 400 mg of coenzyme Q10.

51. 51. The composition of any one of claims 1 to 50, in the form of one or more tablets, capsules, soft gels, liquids, or powders.

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

53. 52. The composition of any one of claims 1 to 51, formulated into 1, 2, 3, or 4 dosage units for daily administration.

54. 54. The composition of any one of claims 1 to 53, formulated into 1, 2, 3, or 4 tablets for daily administration.

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

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

57. 350 mg to 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin C; 50 mg to 550 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of vitamin E; 20 mg to 90 mg of zinc, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or pharmaceutically acceptable salt of a prodrug of zinc; and 1.5 mg to 2.5 mg of copper, or an equivalent amount of a prodrug, pharmaceutically acceptable form, and / or prodrug of copper.

57. The composition of claim 56, comprising a pharmaceutically acceptable salt of a drug, 5.0 mg to 50.0 mg of lutein, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of lutein, 1.0 mg to 20.0 mg of zeaxanthin, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of zeaxanthin, and 50.0 mg to 500.0 mg of coenzyme Q10, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of coenzyme Q10.

58. about 350 mg to about 800 mg of vitamin C, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the prodrug of vitamin C; about 200 mg to about 550 mg of vitamin E, or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of the 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 pharmaceutically acceptable salt of the prodrug of zinc; about 1.5 mg to about 2.5 mg of copper, or an equivalent amount of a prodrug, pharmaceutically acceptable form, of copper; 57. The composition of claim 56, comprising: 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. 59. The composition of any one of claims 1 to 58, further comprising vitamin B.

60. 60. The composition of any one of claims 1 to 59, further comprising an omega-3 fatty acid.

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

62. 62. The composition of any one of claims 1 to 61, on a daily dosage basis.

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

64. 63. The composition of any one of claims 1 to 62, for use in treating heart disease, heart disorders, and / or heart conditions.

65. 63. The composition of any one of claims 1 to 62, for use in treating at least one eye disease, disorder, and / or condition and at least one heart disease, heart disorder, and / or heart condition.

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

67. 63. A method for treating and / or preventing at least one disease, disorder, and / or condition associated with loss of vision, comprising administering to a subject a composition described in any one of claims 1 to 62.

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

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

70. 63. A method for treating at least one eye disease, disorder, and / or condition and at least one heart disease, heart disorder, and / or heart condition, comprising administering to a subject a composition of any one of claims 1 to 62.

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

72. 63. A method for lowering blood pressure, comprising administering to a subject a composition described in any one of claims 1 to 62.

73. 73. The method of any one of claims 66 to 72, wherein the composition is administered to the subject daily in 1, 2, 3, or 4 daily doses.

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