TW201000027A - Organic compounds - Google Patents

Abstract

The present invention relates to a nutritional or dietary supplement composition that strengthens and promotes retinal health.

Description

201000027 VI. Description of the Invention: [Technical Field of the Invention] The present invention relates to a nutrient or dietary supplement composition for inhibiting, stabilizing, reversing, and/or treating loss of visual sensitivity of a person suffering from certain eye diseases, Enhance and promote retinal health. More specifically, the present invention relates to an antioxidant and lutein supplement composition which develops advanced or severe leprotic age-related macular degeneration by reducing age-related macular degeneration. The risk to reduce visual sensitivity loss. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a nutritional or dietary supplement composition that effectively inhibits, stabilizes, reverses, and/or treats loss of jaundice and/or visual (10) degrees. Another object of the present invention is to provide a A safe nutritional or dietary supplement composition (4) stabilization, reversal, and/or treatment of macular degeneration and/or loss of visual acuity 'is particularly in accordance with all specific examples and claims of the present invention. Another object of the present invention is to provide an effective and safe method for inhibiting, stabilizing, reversing and/or treating macular degeneration and/or visual sensitization. Another object of the present invention is to provide a method for inhibiting, stabilizing, reversing and A method of treating a safe nutrient or dietary supplement composition for macular degeneration and/or loss of visual acuity. [Embodiment] The following detailed description is made to enable those skilled in the art to make and use the invention, Preferred nutritional or dietary supplement compositions of the invention are preferably those which comprise a major component of the levels listed, for example, in Table 137643.doc 201000027 1 and/or which may be ingested daily. Table 1 In the preferred embodiment each composition, for example one capsule or multiple capsules (up to 4 capsules per day), comprises the following ingredients: Ingredient content source Vitamin C 500 mg Ascorbic acid about dihydrate, USP Vitamin E 400 IU alpha tocopheryl acetate, USP zinc 35 mg oxidized copper 1.2 mg copper oxide, copper sulfate, copper gluconate or carbonate (copper present in shells and / or fillers) lutein 10 mg FloraGlo 20% natural source or Pure material zeaxanthin 2 mg from lutein and/or DHA in pure form 400 mg EPA 600 mg total omega-3 fatty acid 1200 mg omega-3 acid triglyceride Ph. Eur. DHA = docosahexaenoic acid EPA = eicosapentaenoic acid Table 2 In a preferred embodiment, a copper salt (e.g., copper sulfate, copper gluconate or copper carbonate) is incorporated into a capsule shell comprising the following ingredients. Specifically, the excipient used to make the shell is, for example: - cowhide gelatin 175 bloom bovine

-glycerin 99%, USP - soybean oil flakes (hydrogenated), NF - soybean oil USP

Coloring agent (if desired), organic and/or inorganic such as titanium dioxide USP. A preferred daily dose of the composition of the invention as described above may be administered in one or more dosage units, such as capsules, dragees, or the like, preferably capsules. . 137643.doc 201000027 The daily dose of the composition of the present invention is used four times, - her ugly heart is in the best form, daily service: a total of 4 dose units per day, or taken three times a day, - no green u 1 Α ϊ early 兀Form, type, taken twice a day, _ Γ day total fn / or in a single dose form with a total daily dose, daily _A _ early position. With - one day, one or more dosage units can be changed: suction: and the amount of liquid per dose. </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> <RTIgt; The minimum content of each capsule is greater than the main component used to compensate for some degradation that may occur over time. This is the normal practice if the main ingredient is an antioxidant (such as vitamin C, strontium or lutein). Less food intake of eight foods. The amount is mainly determined, for example, by considering the patient/moving metal salt, such as a salt or a steel salt, which is generally not affected by degradation, and therefore its content is generally not higher than the listed content. In general, the listed ingredients of the compositions of the present invention may be present in amounts ranging from less than 5% of the respective "曰疋 content to 5% of the specified content of each ingredient. Therefore, the indicated concentrations may include the indicated and List the ingredients + / _ 5 weight Α ' Unless otherwise stated. Customs, for the explanation, 400 IU of vitamin Ε can contain, for example, 380 to 420 mg of vitamin ε. By providing a higher content of the main ingredients in each capsule, It can be ensured that even if the ingredients are degraded, the orally administered capsules can provide the total content of the specified ingredients in the capsule sales during the specified period of the capsule. Another consideration of the composition is 137643.doc 201000027 The individual component degradation rates may vary depending on the source and/or method of manufacture of the individual ingredients. Thus, the particular formulation of the compositions of the present invention may vary with the source of the individual ingredients and the specified length of shelf life of the product prior to expiration. Generally, nutritional or dietary supplements Shelf life is about 2 to 3 years. Capsule formulations may also vary with the technical specifications within the scope of the control, slightly deviating from the manufacturing specifications within the allowable range of control. Differences contemplated for administration to a human or animal composition of the invention include, but are not limited to, the manufacture of capsules that are released over time for administration in a single dose or other multi-dose dose. In addition, in addition to oral administration, this document also covers Other alternative routes of administration, for example, but not limited to, intraperitoneal, intravenous, subcutaneous, sublingual, transdermal, intramuscular or similar administration forms. The preferred route of administration is oral beta, as used herein. The terms lozenge, capsule, dragee, pill, suppository, formulation are used interchangeably unless otherwise indicated. Thus, the terms lozenge, capsule, dragee, pill, suppository, formulation are, inter alia, included in the compositions of the present invention. Each of the dosage units or all components of the gale dosage unit or tablet are included. The functions encompassed by the ingredients included in the compositions of the invention are now described and the desired levels and qualities are described, especially if deemed important.

Vitamin C Vitamin C is a well-known water-soluble antioxidant. People rely on external sources of vitamin C to meet their vitamin C needs. The aqueous humor in the human eye was found to be resistant to vitamin C in acid form. Vitamin C generally protects the retina from the side effects of light. 137643.doc 201000027 The US recommended dietary supply (rda) of vitamin C in the ascorbic acid form is 90 mg. The composition of the invention provides a daily dose of preferably 500 mg of vitamin C or ascorbic acid. As used herein, vitamin C is equal to ascorbic acid and vice versa. Calcium ascorbate, especially calcium ascorbate dihydrate, is a preferred source of vitamin C in capsules, although other sources, such as free ascorbic acid or sodium ascorbate, can be used interchangeably. In a preferred embodiment, the pharmaceutical composition of the invention comprises about 500 mg of ascorbic acid. Generally, the composition of the present invention contains about an excess of the amount to compensate for the degradation. In a preferred embodiment, the pharmaceutical composition of the invention comprises 6 〇 52 mg of calcium ascorbate dihydrate. The total amount of vitamin C in total daily dose # is as high as 6 〇〇, more preferably 450 to 550 mg, more preferably 47 〇 to 53 〇, and even more preferably ο to 520 mg.

Vitamin E Vitamin E is also a well-known antioxidant. Vitamin E works synergistically with vitamin C to protect life cell functions from common oxidants. When supplementing the DHA (docosahexahexanoate) of the present invention, it is necessary to supplement the vitamin E which has a protective effect on the membrane lipid. Vitamin E is a relatively non-toxic fat-soluble I. Health and vitamin. Vitamin E is easily oxidized' so it significantly reduces activity during storage prior to ingestion. Once ingested, vitamins can be stored in the body and maintain vitamin E throughout the body for up to one year. The compositions of the present invention preferably provide about 400 IU of vitamin E per capsule. As used in 137643.doc 201000027, d,la tocopheryl acetate represents vitamin E, and is the preferred source of vitamin E for the capsule, although other sources of vitamin E may also be used, such as, for example, d, l may be used instead. -ot Tocopheryl acetate and/or vitamin E succinate. 1_0 mg of vitamin E is equal to 1 IU d, l-a tocopheryl acetate. Alternatively, i mg d-a tocopheryl acetate is equivalent to 5.5(1)^丨...tocopheryl acetate. A preferred aspect of the pharmaceutical composition of the present invention comprises about 439 mg d,1 a of acetic acid. The amount generally comprises an excess of 1% for degradation. The total dose of vitamin E is generally 35 to 45 〇 ILJ, especially 380 to 420 IU' and especially 390 to 410 IU. Zinc is important for maintaining the health of the eye's retina and is an important part of the 100 enzymes involved in digestion, metabolic reproduction and wound healing. The RDA of bismuth zinc is about 40 mg. The word is used as a cofactor in enzymes that are directly involved in oxidant protection. The concentration of words is highest in the human retina and choroid. Studies have shown that zinc slows the visual field loss of AMD patients. The compositions of the present invention preferably provide about 35 mg per capsule. The capsule (t) is preferably in the form of zinc oxide because it provides the most concentrated form of the alizarin zinc and is well tolerated in the digestive system. However, other forms may be used instead, such as zinc gluconate, zinc citrate, zinc acetate, zinc carbite, zinc lactate, or sulphuric acid in the compositions of the present invention or in combination with zinc oxide. As used herein, the zinc finger zinc salt is more preferably zinc oxide, gasification or zinc gluconate, and preferably refers to gluconic acid. 137643.doc 201000027 In a preferred aspect, the pharmaceutical composition of the invention comprises 436 zinc gluconate. For the words, generally no excess is required, because zinc does not degrade. In the total daily dose, the zinc-like content is from 2 to 42, more preferably from 41 mg, most preferably from 34 to 41 mg and especially from 37 to 4 bark. Copper is similar to zinc. 'Bronze is another important cofactor for metalloenzymes. It is a secondary cofactor for ruthenium peroxide. The total strontium dose of copper is generally about U mg. It has been reported in the literature that when Zanggu County pulls the amount of zinc, the lack of copper leads to anemia (the lack of oxygen in the gold). To this end, the daily dosage composition according to the invention comprises copper. = Salt can be used interchangeably, and is good for cu, but also contains Μ. The copper salt preferably comprises a pharmaceutically acceptable anion such as, for example, a hydroxide, a glucosamine, a carbonate, a sulfate or the like. In L-day agent 1, the steel-like content is ^ red to h4 mg, especially 〇·8 to l.h, and the best is 丨.2^. Ten does not require excessive copper, because copper does not degrade. The omega-3-fatty acid and various Mm% compositions are easily decomposed when they are pulled with the steel enamel or the compound of the show. The decomposition of the H compound in the presence of such compounds and / or compositions also refers to traces of water, such as "problem especially in the presence of water. Water - species of electricity in the micro" wet, composition and or compound species, · And the knife or from the environment moisture. According to a preferred embodiment of the composition of the invention, the steel salt is provided with a suitable handoff 137643.doc 201000027 or a coating. The coating 4 coating generally prevents interaction with steel sensitive compounds and/or compositions. The copper salt is, for example, covered or encapsulated or embedded in gelatin or liposome and/or both, e.g., the coated copper salt is embedded in gelatin. There are other methods for protecting copper salts, such as monoglyceride and diglyceride. For example, the commercially available product Descote® bismuth copper salt forms a stable complex with a suitable cyclodextrin compound. The cyclodextrin compound generally releases its free copper salt at the final stage, for example, when needed, for example, when the enzyme is subjected to an enzyme-analyzed complex in the intestine. Copper salts can coat zwitterionic phospholipids&apos; including but not limited to squamous choline, phospholipids, phospholipids, ethanolamines, sphingomyelines and other neurosteroids, and a variety of other zwitterionic phospholipids. As used herein, the term "masked, coated or embedded copper or steel salt" relates to copper salts and masking agents, coating agents or embedding agents which are effective in preventing the copper salt from being sensitive to copper compounds and/or compositions. Directly react with each other. As used in the text 1f7, the digestible capsule material is, for example, the shell material described in Table 2 above, but is generally any capsule or capsule shell or shell # that can be used in the related art of pharmaceutical/dietary/nutritional food capsules, It is generally an organic poly-sigma composition and is pharmaceutically compatible (non-toxic, biodegradable, enteric or intragastrically digestible as appropriate). In a preferred embodiment, the cleavable capsule material (especially the digestive tract digestible capsule material) comprising the masked and/or coated copper salt represents the masking and/or coating material of the copper salt. Another preferred embodiment is a digestible capsule material as defined in the above paragraph, wherein the copper salt has been coated in 137643.doc 201000027, the coating being compatible with the capsule material (IV) or another masking material; When present in the filler (i.e., unmasked, uncoated or unembedded copper), the copper in the composition of the present invention is preferably in the form of copper oxide, although other forms may be used in the composition of the present invention. Copper, such as, for example, copper carbonate, hydrochloric acid, copper sulphate or sulfuric acid steel or used in combination with copper oxide. When copper is present in the shell (i.e., shielded, coated or embedded copper), the copper in the composition of the invention is preferably in the form of copper sulfate, (tetra) copper sulphate and/or copper carbonate, although the combination of the invention Other forms of copper such as copper oxide or copper sulfate, copper gluconate and/or copper carbonate may also be used. In a preferred aspect, the pharmaceutical composition of the present invention comprises 47 mg of copper sulfate (in the shell), 8.58 mg of copper gluconate (in the shell), 2 M mg of copper carbonate (in the shell) or 1.5 mg of copper oxide ( In the filler). Lutein 〇 Lutein is a carotenoid. Lutein is also an antioxidant found in the retina of healthy eyes. Lutein and zeaxanthin are (caraxanthine), which is a carotenoid group. Lutein and maize flavin are pigments found in the retina, most of which are in the macular area, which have a blue-light effect and may have an antioxidant effect. These pigments cannot be synthesized in the body, so it is necessary to supplement the macular pigment composition from the outside (food). Lutein is a precursor of zeaxanthin. Epidemiological studies have shown that the consumption of lutein may be inversely related to eye diseases (eg 137643.doc 11 - 201000027 AMD). Human studies have shown that supplementation with lutein increases macular pigmentation. It can be seen from the study that supplementation of 1 mg per day can reduce the incidence of AMD. Therefore, the composition of the present invention preferably provides 1 mg of pure lutein per capsule. Preferably, lutein in the form of pure Flora Glo (supplier DSM or Kemin) is used. This comes with the crystallized lutein and zeaxanthin, a marigold resin extracted from marigold flowers. According to its label, lutein, zeaxanthin and other carotenoids account for 80% of the weight of the “Fl〇raGLO crystalline lutein” material. It will be considered when used in the compositions of the present invention. In a preferred embodiment, the pharmaceutical composition of the present invention comprises 55 mg of lutein (20 °/. in safflower oil) in an amount comprising an excess of i〇% for degradation. The compositions presented preferably also comprise from about 1 to 2 mg, more preferably from 3 to 17 mg, even more preferably from 7 to 14 mg lutein per day. Zeaxanthin: Similar to lutein' zeaxanthin is a carotenoid. Zeaxanthin is an antioxidant that also appears in the retina of healthy eyes. The total daily dose is preferably from about 100 to 3000 micrograms (〇·1 to 3 mg) depending on whether zeaxanthin is supplemented or replaced and/or lutein. The total sputum dose is preferably between about 1.7 and 2.3 mg. In a preferred aspect, the pharmaceutical composition of the invention comprises 2 micrograms of zeaxanthin. Omega-3-Fatty Acids The fatty acids of the omega-3 group are mainly eicosapentaenoic acid (EpA) and docosahexaenoic acid (DHA). Other omega-3 fatty acids are alpha linolenic acid (Ala), stearidonic acid (SA), arachidonic acid (ETA) and docosapentaenoic acid (DpA). This 137643.doc 12 201000027

The fatty acid is modified, for example, by the membrane of the composition. It also modifies the distribution of membrane protein receptors. Therefore, the protective effect of AMD can be presented from different machines, such as: improving the regeneration of rhodopsin (retinal pigment) at the pigmented epithelium/photoreceptor level and/or possibly improving the activity of rhodopsin, eosin The lipid plays a role in the background. Preferred examples of the omega-3 fatty acid are docosahexaenoic acid and eicosapentaenoic acid.

❹ In a preferred embodiment, the daily dose of omega-3 fatty acid is about 12 mg/day. Supplementation of both EPA/DHA may be beneficial because the retina contains DHA and EPA is known as the physiological precursor of DHA. A preferred source of omega-3 fatty acids is fish oil. The source of fish oil may affect the content of DHA and EPA. DHA: EPA ratio can be between 1:4; 1:.3; 1.2; 1:1; 2:1; 3:1 to 4:1 (including 1:1.43). The compositions of the present invention preferably provide from about 1 to 1800 mg, more preferably from 1050 to 1350 mg, most preferably from 1100 to 1300 mg, especially from 1150 to 1250 omega-3 fatty acids per day. The omega-3 fatty acid according to the present invention may be in the form of a triglyceride, an ethyl ester or an oxime ester (supplier EPAX, Ocean Nutrition, Polaris, DSM). The omega-3 fatty acid is preferably in the form of a triglyceride such as the EPAX commercial name EPAX 6000 TG or EPAX 1050 TG. Benefits of the Invention Free radicals cause local molecular instability leading to cell damage. Free radicals 137643.doc -13· 201000027 Formation is caused by metabolism, sunlight (blue light spectrum), other free radicals, lack of antioxidants, and other factors. This process can cause vision deterioration, age-related macular degeneration (AMD) and/or diabetic retinopathy (DR) 补充 Supplement 3 Antioxidants with certain nutrients can block the chain reaction of free radical damage via neutralizing electron imbalance. Supplementing the antioxidant potential of the retina can effectively reduce the oxidant against the potential and slow or reduce the deterioration of the retina. There is strong scientific evidence that the ingredients of the present invention contribute to Amd patients, i.e., reduce the risk of developing severe AMD and reduce the risk of loss of vision. Furthermore, the formulations of the invention may not only treat or prevent retinal degeneration. Another benefit of the present invention is the use of omega-3 fatty acids with specific and more stable vitamin molecules as well as specific and more stable combinations of zinc and copper containing molecules. The antioxidant vitamins (vitamin C and strontium) and minerals (Ζη and/or Cu) can prevent free radical damage to the eyes. In addition, it is believed that lutein and/or zeaxanthin restores the apparent pigment density of the macula, which in turn provides protection against radiation damage to the retina. Salt is considered to contain high levels of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) omega-3 fatty acids so it can initiate/maintain DHA in the photoreceptor cells to protect the eye from converted light pulses into the brain's neural input nickname Ability (the ability of retinal image processing). It also protects the photocell from cell death. It inhibits the activity of COX1 and COX2, which controls/reduces eye inflammation. The compositions of the present invention generally exhibit highly improved stability, and their improved stability ensures a better processing step&apos; because stable formulations provide reproducible treatment. 137643.doc 201000027 The above stability is improved by the following methods: Compounds containing metal ions are generally chosen to be rendered water-insoluble, as water-soluble metal compounds generally cause degradation of other active ingredients, especially vitamins. 'Vitamins can also be converted to more stable compounds, that is, the use of heart acid tocopheryl phenolate instead of alpha-tocopherol and the use of calcium ascorbate instead of ascorbic acid for the preparation of the composition. This unique combination produces a synergistically improved stability to the compositions according to the invention. Manufacture/Preparation The compositions, capsules, formulations or capsules of the invention are prepared in a known manner, for example by conventional mixing, granulating, coating, dissolving or lyophilizing processes. The compositions may be sterilized, for example, in batchwise, in the order of ingredients, and/or may contain excipients such as stabilizers, colorants, curing agents, wetting agents and/or emulsifiers, solubilizing agents, and osmotic adjustments. Pressed salts and/or buffers 'and are prepared in a known manner', for example by conventional dissolution and image drying methods. The solution or suspension may contain a tackifier, typically sodium carboxymethylcellulose, carboxymethylcellulose, dextran, polyvinylpyrrolidone, or gelatin, or a solubilizing agent such as Tween 80 [polyoxyethylene (20) Sorbitol monooleate; trademark ICI Americas, Inc, USA]. Suitable carriers are, in particular, fillers, such as sugars, for example: lactose, sucrose, mannitol or sorbitol, cellulose preparations, and/or calcium phosphates, for example, acid-filled tri- or linonic acid feeds, and binders. Such as: starch, for example: corn, wheat, rice or potato starch, methyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, and / or polyvinylpyrrolidine 137643.doc 201000027 ketone And/or a disintegrating agent to be used if necessary, such as the above starch, and carboxymethyl starch, crosslinked polyvinylpyrrolidone, alginic acid or a salt thereof, such as sodium alginate. Other excipients are especially flow regulators and lubricants such as capric acid, talc, stearic acid or salts thereof, such as magnesium or calcium stearate, and/or polyethylene glycol, or derivatives thereof. Compositions for oral administration also include hard or soft capsules composed of gelatin, sealed capsules composed of gelatin and a plasticizer such as glycerol or sorbitol. The hard knee capsule may comprise the active ingredient in the form of granules, for example mixed with a filler such as corn starch, a binder, and/or a glidant such as talc or magnesium stearate, and optionally a stabilizer. In soft capsules, the active ingredient is preferably dissolved or suspended in a suitable liquid excipient such as fatty oil, paraffin oil or liquid polyethylene glycol or a fatty acid ester of ethylene glycol or propylene glycol. Agents and detergents, such as polyoxyethylene sorbitan fatty acid ester type. Example 1 Omega 3 fatty acids are at 4 Torr.稳定性 (ambient humidity, ie 50-70% relative humidity) stability after 30 days of storage (change in omega-3 fatty acid content) This method is based on the standard method described in European Pharmacopoeia 5.4 for gas chromatography The percentage (weight ratio) of EPA to DHA after storage was measured. Omega-3 fatty acid component Triglyceride form (EPAX1050TG) Ethyl form (DSMROPUFA75) No detectable change Reduced by 5.5% 137643.doc • 16- 201000027

DHA wt% reduction 1.3% reduction 14.6 % Other omega-3 fatty acids** % by weight except EPA and DHA 0.3% lower 8.2 % &quot;Other omega-3 fatty acids represent alpha-linolenic acid (ALA), stearic acid (SA) , eicosatetraenoic acid (ETA) and docosapentaenoic acid (DPA). The stability test of the control showed that the omega-3 fatty acid in the form of triglyceride was significantly more stable than the omega-3 fatty acid in the ethyl ester form. 137643.doc 17-

Claims (1)

201000027 VII. Application for Patent Park: 1 · A composition comprising (based on sputum dose): about 400 to 600 mg of vitamin C, about 350 to 450 IU of vitamin E, about 1 to 20 mg of lutein, about 20 to 42 mg words, about 1000 to 1800 mg omega 3 fatty acids, and about 0.8 to 1.35 mg copper. © 2. The composition of claim 1 which comprises zeaxanthin, preferably in an amount of from about 1.7 to 2.3 mg. 3. The composition of claim 1, wherein the omega-3 fatty acid comprises docosahexaenoic acid and eicosapentaenoic acid. 4. The composition of claim 1, wherein the (1) fatty acid comprises from about 3 to 45 mg of docosahexaenoic acid (Dha). 5. If requested! The composition 'wherein the omega 3 fatty acid comprises about 540 to 66 mg of eicosapentaenoic acid (ΕρΑ). 6. The composition of claim 1, wherein the omega 3 fatty acid is in the form of a triglyceride. « 7. The composition according to claim 1, wherein the copper is a steel salt selected from the group consisting of vaporized copper, copper oxide, copper hydrogen sulfide, copper gluconate, copper carbonate and copper sulfate. The composition of claim 1 wherein the copper is a masked or coated copper. 9. The composition of claim 8 wherein the coating is a zwitterionic phospholipid, 137643.doc 201000027 includes but is not limited to phospholipid choline, phospholipid lysine, phospholipid amide, sphingomyelin Phospholipids with other neurosteroids, as well as a variety of other zwitterions. 10. The composition of claim 8 wherein the copper is a copper cyclodextrin complex. 11. The composition of claim 1, wherein the vitamin C comprises or consists essentially of calcium ascorbate, the vitamin E comprising or consisting essentially of 4, 丨α acetic acid, vinegar vinegar, the zinc comprising or consisting essentially of oxidized words, the copper being selected from A group consisting of copper chloride, copper oxide, copper hydroxide, copper gluconate, copper carbonate and copper sulfate. 12. The composition of claim 1 which is a lozenge, capsule or pill and comprising: 500 mg of vitamin C (calcium ascorbate dihydrate, USP), 400 IU of vitamin Ε (alpha tocopheryl acetate, USP), 40 mg zinc gluconate, 4.7 mg copper sulfate or 1.5 mg copper oxide, 2.14 mg copper carbonate, 8.58 mg copper gluconate, 400 mg DHA, 600 mg EPA, 1200 mg total omega-3 fatty acid (Ω-3 fatty acid triglyceride Ph Eur) 10 mg lutein (FloraGlo 20% natural source (containing some zeaxanthin) or pure substance), 2 mg zeaxanthin (synthetic source)' Contains the following excipients for the manufacture of the outer shell as needed: Gelatin 175 bloom bovine ' n7643.doc 201000027 Glycerin USP 99%, soy oil flakes (hydrogenated) NF, soybean oil USP, and titanium dioxide USP. 13. The composition of claim 12, wherein the copper sulfate, copper carbonate or copper gluconate in the shell is masked or coated. 14. Use of a composition according to any one of claims 13 to 13 for the manufacture of a medicament for the treatment and/or prevention of age-related macular degeneration (AMD) and/or diabetic retinopathy (DR). 15. The use of claim 14, wherein the treatment and/or prevention reduces the risk of developing a serious AMD and reducing the risk of loss of vision. The composition of any one of claims 1 to 13 for use in the treatment and/or prevention of AMD and/or DR in a patient in need thereof. 17. A method of making a stable composition as claimed, comprising: mixing U4 with vitamin C (which comprises or consists essentially of ascorbate), 'vitamin E (which comprises or consists primarily of d, l α-acetate, a zinc (', 〇 3 or mainly containing zinc oxide or zinc gluconate), copper (which contains or mainly contains copper oxide, copper sulfate, copper carbonate or copper gluconate) and (1) (tetra) acid (its Contains or consists essentially of omega-3 fatty acids in the form of triglycerides. 18. A composition comprising the total content specified below and present in the total amount of -, two, three, four or more dosage units (% by weight of the total): 5 mg of calcium ascorbate dihydrate , usp 137643.doc 201000027 400 mg α acetic acid fertilization 'vinegar' USP 40 mg zinc gluconate 4.7 mg copper sulfate or 1.5 mg copper oxide, 2.14 post copper carbonate, 8.58 mg copper gluconate, 400 mg DHA 600 mg EPA 1200 Mg total omega-3 fatty acids (Ω-3 fatty acid triglyceride Ph. Eur) 10 mg lutein (FloraGlo 20% natural source (including some zeaxanthin)) 2 mg zeaxanthin (synthetic source), included as needed Excipients for making the outer shell, namely gelatin 175 bloom bovine glycerin USP 99%, soybean oil flakes (hydrogenated) NF soy oil USP, and titanium dioxide USP. 19. The composition of claim 18, wherein the copper sulfate, copper sulphate or copper citrate in the shell is masked or coated. 20. The composition of any one of claims 1 to 13, 18 and 19 in the form of a elixirs, capsules, dragees, pills, or suppositories. 21. The method of claim 17, wherein the composition is in the form of a key, capsule, smear, pill, or suppository. 22. The use of claim 14 or 15, wherein the composition is in the form of a troche, a capsule, a dragee, a pill, or a suppository. 137643.doc 201000027 IV. Designated representative map: (1) The representative representative of the case is: (none) (2) The symbol of the symbol of the representative figure is simple: 5. If there is a chemical formula in this case, please reveal the best indication of the characteristics of the invention. Chemical formula: (none) 137643.doc