Composition of macular carotenoids

Abstract

The present invention relates to the composition of stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients. More specifically, the present invention provides a composition comprising a synergistic combination of Lutein and Zeaxanthin isomers, either alone or in combination. The composition of the present invention is used for the Visual function. The present invention also pertains to the process for preparing a stabilized, solvent-free composition of macular carotenoids and / or fat-soluble nutrients.

Description

[0001] COMPOSITION OF MACULAR CAROTENOIDS

[0002] FIELD OF THE INVENTION

[0003]

[0001] The present invention relates to a stabilized, solvent-free composition of macular carotenoids and / or fat-soluble nutrients. More specifically, the present invention provides a composition comprising a synergistic combination of Lutein and Zeaxanthin isomers, either alone or in combination, obtained from marigold flowers.

[0004]

[0002] The present invention also relates to a stabilized, solvent-free composition for macular carotenoids and / or fat-soluble nutrients that are not soluble in water, as well as a solvent-free process for preparing these compositions.

[0005]

[0003] The invention more specifically relates to the process of preparing a stabilized solvent-free macular carotenoid composition comprising lutein and zeaxanthin isomers. The present invention also relates to stabilized macular carotenoid composition. Furthermore, the invention more specifically relates to the process of preparing a stabilized, solvent-free fat-soluble nutrient composition comprising curcumin, curcuminoids, and astaxanthin.

[0006]

[0004] The present invention also relates to the stabilized macular carotenoids and / or fat-soluble nutrients composition used for visual function.

[0007] BACKGROUND OF THE INVENTION

[0008]

[0005] Phytochemicals are plant-based bioactive compounds that can be derived from various sources, including vegetables, whole grains, herbs, nuts, flowers, and fruits. These phytochemicals possess strong antioxidant activities and exhibit anthelmintic, antidiarrheal, antispasmodic, anti-allergic, antimicrobial, and antiviral activities. The prominent classes of phytochemicals contributing to the antioxidant capacity include polyphenols, carotenoids, and the traditional antioxidant vitamins such as vitamin C and vitamin E. All these phytochemicals help in maintaining good health. Also, carotenoids have photoprotective and antioxidant properties.

[0009]

[0006] Light-induced degeneration of photoreceptor cells and the progression of the disease in the pre / age related macular degeneration (AMD) include reactive oxygens derived oxidative stress, and eventually, visual cell loss, which can be inhibited, or decelerated by thecontribution of antioxidants. Further, oxidative stress, inflammation, cell damage leading to cell death, and mitochondrial DNA damage are cellular processes associated with AMD.

[0010]

[0007] It has been shown that some carotenoids, such as Lutein and Zeaxanthin isomers, that are present in different regions of the eye, have effective properties against oxidative stress, and are also photo-oxidative protective. To protect the retinal pigment epithelium against photo-oxidative damage, carotenoids are proposed to act through two primary mechanisms: firstly, as filters for harmful blue light, and secondly, by removing triplet-state molecules or suppressing singlet molecular oxygen and types of reactive oxygen, such as lipid peroxides or superoxide radical anions.

[0011]

[0008] Lutein and Zeaxanthin isomers in eye tissue are associated with better vision. Both are identified as the main carotenoid pigment component in marigold flowers. Lutein and Zeaxanthin isomers are more effective than carotene in inhibiting the auto-oxidation of cellular lipids and protecting against oxidant-induced cell damage. Lutein is an isomer of Zeaxanthin, differing only in the placement of one double bond. Lutein and Zeaxanthin are the only macular pigments that prevent UV damage by virtue of their rich antioxidant activity.

[0012]

[0009] United States Patent Publication No. 10,716,767 B2 discloses a mixture of various nutrients including micronutrients to protect the eye components such as retinal pigment epithelial cells, lens and corneal cells from oxidative damage. The ‘767 patent further discloses nutrient mixture consisting of vitamin A, vitamin C, vitamin E, Lycopene, Lutein, marigold flower extract, a saffron extract, pine bark extract, grape seed extract, bilberry extract, lipoic acid, L- Arginine and zinc.

[0013]

[0010] United States Patent no US7691297 relates to manufacture of beadlet preparations of fatsoluble substances in a water-soluble or water-dispersible non-gelling matrix, wherein an aqueous emulsion of the fat-soluble substance(s) and the matrix component are fed through a spray nozzle in the upper section of a vertical spray tower. A stream of cold air is fed in the lower section of the spray tower so as to form a fluidised bed of starch-covered beadlets, in which the emulsion droplets of fat soluble substances is entrapped to form beadlets.

[0014]

[0011] International Patent Publication No. WO 2005063223 Al discloses oral formulations of Zeaxanthin isomers for promoting eye health and preventing ocular problems. The ‘223 application discloses formulation containing Zeaxanthin isomers, elemental zinc and at least two or more additional ocular-active nutrients.

[0012] US5487916 provides free-flowing powder of coated particles by means of a spray drying plant using a hot drying gas or a spray cooling plant using cold drying gas. A coating composition in liquid form is supplied to the atomizing means of the plant, and the liquid coating composition is atomized into a flow of liquid droplets, which are allowed to collide with particles of a carrier material dispersed in a transport gas. The direction and rate of flow of the transport gas are adapted to prevent contact between the drying gas and the droplets, so that the liquid coating composition, before any substantial drying thereof, will form a continuous liquid coating layer on the particles wherein the suitable coating compositions are fat-containing emulsions containing proteins.

[0015]

[0013] Japanese Patent Publication No. 2010513248 A discloses an antioxidant and lutein supplement composition that reduces vision loss by reducing the risk of progression to latestage or progressive age-related macular degeneration in humans with early age-related macular degeneration relates to the composition.

[0016]

[0014] US6763607 relates to an improved method for making homogeneous spray-dried solid amorphous dispersions of pharmaceuticals in a concentration-enhancing polymer by employing cylindrical drying chamber. Particularly the method includes the use of a gasdispersing means that facilitates organized plug flow of the drying gas in a drying chamber having a particular height and volume and an atomizing means that produces droplets with a median droplet diameter of 50 pm or larger, with less than about 10 volume % of the droplets having a size less than pm.

[0017]

[0015] United States Patent Publication No. 10,342,244 B2 discloses infant formulas and methods for using those formulas to promote retinal health and vision development in infants. Egg phospholipids free formulas comprise fat, protein, carbohydrate, vitamins, and minerals and lutein.

[0018]

[0016] United States Patent Publication No. 11, 197,493 B2 discloses composition of fat-soluble nutrient(s) with water soluble polymer. A process for preparation of a stabilized composition includes a fat-soluble nutrient solubilized in an organic solvent embedded in an aqueous polymer phase by evaporation to obtain an aqueous microparticulate mixture. The obtained mixture can be formulated for end use or can be layered on inert core to obtain stable beadlet for use in solid dosage forms.

[0019]

[0017] Considering the available state of arts, not limiting to the above stated prior arts, there exists a need to develop the more potent composition with better physicochemicalcharacteristics and to develop a formulation with improved performance in oral solid dosage forms.

[0020]

[0018] Japanese Patent Publication No. 2019178169 A discloses retinal protective composition that effectively protects a retinal pigment epithelial cell from damage due to active oxygen and inhibits retinal disorder. The ‘169 application further discloses composition of Lutein and at least one component selected from the group consisting of the following (a) to (d) as active ingredients.

[0021] (a) at least one plant material selected from kuzu, rice, and coconut;

[0022] (b) at least one amino acid selected from arginine, phenylalanine, serine, threonine, tryptophan, and tyrosine;

[0023] (c) gallic acid and chlorogenic acid At least one polyphenol; and

[0024] (d) at least one vitamin / mineral selected from vitamin Bl, vitamin D3, biotin, vitamin K, calcium, manganese, zinc, iron, molybdenum, and chromium.

[0025]

[0019] A macular carotenoids and / or fat-soluble nutrients composition, which is herein after referred to as the nutrient composition or composition. A macular carotenoids and / or Fatsoluble nutrients are primarily oily and difficult to handle. Owing to their nature, it is difficult to formulate oral dosage forms. Being lipophilic, they are very poorly absorbed in the body systems, thus exhibiting very low bioavailability. These nutrients are also prone to thermal and oxidative degradation.

[0026]

[0020] It is also difficult to combine lipophilic nutrients such as carotenoids, tocopherols, tocotrienols, lecithins, phytosterols and plant stanols, omega-3 fatty acids and other carotenoids singly or in combination with other nutrients into dry forms due to the oily, waxy or viscous nature of these products. Thus, it is challenging to prepare stable and soluble formulations of fat soluble nutrients.

[0027]

[0021] The present invention surprisingly provides improved stability due to the combined effect of Lutein and Zeaxanthin isomers. Advantageously, the present invention also provides improvement in visual function and an approach to preventing the retina from photo-oxidative damage.

[0028] BRIEF DESCRIPTION OF THE INVENTION

[0029]

[0022] The present invention discloses a stabilized, solvent-free macular carotenoids and / or fatsoluble nutrients composition (collectively referred to as “nutritional composition”) withimproved solubility and bioavailability. More specifically, the invention discloses synergistic combinations of Lutein and Zeaxanthin isomers and at least one nutraceutically accepted excipient. The invention's composition is advantageous in terms of bioavailability of the macular carotenoids and / or fat-soluble nutrients with relatively low aqueous solubility.

[0030]

[0023] The present invention also provides a nutritional composition comprising combinations of Lutein and Zeaxanthin isomers which may be formulated in different forms like orally administrable solid, semisolid, liquid forms, selected from, but not limited to dosages such as, powders, granules, pellets, beadlets, caplets, tablets, capsules, soft gel capsules, solution, emulsions, suspensions, oil suspensions, dispersions and like dosage forms.

[0031]

[0024] The present invention provides a process for preparing a composition comprising macular carotenoids and / or fat-soluble nutrients.

[0032]

[0025] The invention also relates to a macular carotenoids and / or fat-soluble nutrients composition is used of Visual function.

[0033] DETAILED DESCRIPTION OF THE INVENTION

[0034]

[0026] A "macular carotenoids” refers to lutein ester, lutein isomers, zeaxanthin, zeaxanthin isomers, alpha carotene, Beta carotene, gamma carotene, lycopene, Beta cryptoxanthin, curcumin (curcuminoids) and astaxanthin, either alone or in combination thereof.

[0035]

[0027] The term “fat-soluble nutrients” as used throughout the specification refers to the nutrients from a natural source that are lipophilic and exhibit poor solubility in aqueous or physiological medium.

[0036]

[0028] Various fat-soluble nutrients include, but are not limited to, curcumin contains curcuminoids, antioxidants, vitamin D, curcumin, vitamin B, resveratrol, omega-3 fatty acids, and carotenoids either alone or in combination thereof.

[0037]

[0029] Lutein is the primary macular pigment in the retina. It can protect retinal photoreceptors from blue light damage by boosting macular pigment density and enhancing Superoxide Dismutase (SOD), Glutathione Peroxidase (GPX), and Catalase (CAT) activities while reducing Reactive Oxygen Species (ROS) production, Interleukin- 1|3 (IL-ip), Interleukin-6 (IL-6), Tumor Necrosis Factor-a (TNF-a), and Monocyte Chemoattractant Protein 1 (MCP-1) levels.

[0030] Lutein is a naturally occurring antioxidant and plays a role in protecting and improving the eye function. It is part of a group of substances that are called as carotenoids. Lutein is synthesized by plants. Lutein is a yellow plant pigment belonging to the xanthophyll family of carotenoids and widely present in marigold flowers.

[0038]

[0031] Zeaxanthin isomers is one of the most common carotenoids in nature. When compared to Lutein, Zeaxanthin isomers are proven to be better antioxidant, better at absorbing the blue light and better at protecting the tissues from the products of lipid oxidation.

[0039]

[0032] Lutein and other carotenoids, such as Zeaxanthin isomers, may help in preventing or slowing down the macular degeneration. They also protect the eyes from harmful high-energy light waves like ultraviolet rays in sunlight. Lutein is an isomer of Zeaxanthin isomers, differing only in the placement of one double bond. They both are known to act as an antioxidant and also known for protecting the eyes from retinal damage.

[0040]

[0033] Curcumin contains curcuminoids, the active compound found in turmeric, shows potential to benefit visual function by acting as a protective agent against various eye diseases like age-related macular degeneration, diabetic retinopathy, glaucoma, and cataracts, primarily due to its potent anti-inflammatory and antioxidant properties which can help maintain retinal health and prevent damage to the eye tissues in overall helps to improve visual function.

[0041]

[0034] The term “nutraceutically acceptable excipient” as used throughout the specification refers to excipient which is of food grade and safe for human consumption, and which can be added in the compositions in specific percentages to aid the formulation process. The nonlimiting example of nutraceutically acceptable excipient include, but not limited to, antioxidant, encapsulating agent, filler, disintegrant and the combination thereof.

[0042]

[0035] The term “antioxidant” as used throughout the specification refers to compounds that inhibit oxidation, a chemical reaction that can produce free radicals. The non-limiting example of antioxidants include, but not limited to, [3-Carotene, Lycopene, Lutein, a-Tocopherol, Catalase, Glutathione, Melatonin, Oestrogen, Uni quinol- 10, N-Acetyl Cysteine, Lipoic Acid, Quercetin, Quercetagetin, Catechin, Cortisone, Estradiol, Estriol, Ascorbic acid and derivatives and the combination thereof.

[0043]

[0036] a-Tocopherol is the main source found in supplements and in dietary sources like olive and sunflower oils. Tocopherols and tocotrienols are fat-soluble antioxidants. Sodium ascorbate is also used as an antioxidant and as an acidity regulator. Sodium ascorbate is vitamin C supplement while a-Tocopherol is vitamin E supplement.

[0037] The term “modified starch” as used throughout the specification refers to starches that are improved to develop specific characteristics, such as the ability to bring texture and structure. Modified starches are used in all starch applications, such as in food products as a thickening agent, stabilizer or emulsifier; in pharmaceuticals as a disintegrant. The encapsulating agent and filler used in the present invention are selected from the modified starches.

[0044]

[0038] Hydrophobically modified starches such as octenyl succinic anhydride modified starches (OSA-starches) are also used in microencapsulation of oil-based flavours, nutrients, fragrances, and pharmaceutical actives. Primarily, OSA starches are highly functional, consistent, economical, and versatile for a variety of microencapsulation processes.

[0045]

[0039] The term “waxy maize starch” as used throughout the specification is also known as “waxy com starch.” The waxy maize starch is used as filler in nutraceutical composition.

[0046]

[0040] In one embodiment, the present invention provides a stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients composition comprising Lutein and Zeaxanthin isomers, trans lutein free from Zeaxanthin isomers, curcumin (curcuminoids), and R, R zeaxanthin, and one or more nutraceutically acceptable excipients.

[0047]

[0041] In one aspect, the invention provides the stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients composition comprising Lutein and Zeaxanthin isomers extracted from marigold pellet extract, paprika extract, curcumin extract, or astaxanthin extract and one or more nutraceutically acceptable excipients. The combined administration of these actives provides the treatment for the retina suffered from photo-oxidative damage in overall improve the visual function.

[0048]

[0042] In another aspect the composition of the invention can be formulated in different dosage forms like orally administrable solid, semisolid, liquid forms, but not limited to dosages such as, powders, granules, pellets, beadlets, caplets, tablets, capsules, soft gel capsules, solution, emulsions, suspensions, oil suspensions, dispersions and like.

[0049]

[0043] In one aspect, the invention provides the composition comprising Lutein and Zeaxanthin isomers obtained from marigold extract, green leafy vegetables (e.g., kale, spinach, broccoli, peas and lettuce) and egg yolks and one or more nutraceutically acceptable excipient.

[0050]

[0044] In one more aspect, the invention provides a composition of lutein and zeaxanthin isomers, more specifically in a 4:1 to 6:1 ratio, wherein the zeaxanthin isomers are present in 20:80 to 80:20 ratios.

[0045] The marigold extract present in the composition in is the range from about 12% w / w to about 50 % w / w, preferably ranges from about 13% w / w to about 38% w / w and more preferably ranges from about 15% w / w to about 25% w / w.

[0051]

[0046] The nutraceutically acceptable excipient as used in the present invention are selected from the group consisting of antioxidant, an encapsulating agent, a filler, a disintegrant and the combination thereof.

[0052]

[0047] In one embodiment, the present invention provides the composition comprising Lutein and Zeaxanthin isomers with nutraceutically acceptable excipient selected from one or more antioxidant, encapsulating agent, filler and disintegrant.

[0053]

[0048] In one aspect of the invention, the antioxidant present in the composition ranges from about 0.05% w / w to about 10% w / w, preferably ranges from about 0.1% w / w to about 8% w / w and more preferable ranges from about 1% w / w to about 6% w / w.

[0054]

[0049] In one embodiment of the invention the encapsulating agent presents in the composition ranges from about 40% w / w to about 80% w / w, preferably ranges from about 50% w / w to about 75% w / w and more preferable ranges from about 55% w / w to about 70% w / w.

[0055]

[0050] In another embodiment, the filler as used in the composition of the invention ranges from about 5% w / w to about 35% w / w, preferably from about 10% w / w to about 30% w / w, and more preferably from about 15% w / w to about 25% w / w.

[0056]

[0051] In one aspect, the present invention provides the composition comprising Lutein, Zeaxanthin isomers, one or more antioxidants, one or more encapsulating agent, one or more fillers and / or one or more disintegrants.

[0057]

[0052] The present invention provides the composition comprising Lutein, Zeaxanthin isomers, and / or R, R Zeaxanthin and / or astaxanthin and / or curcumin with Sodium Acerbate, DL-a-Tocopherol, Sodium Octenyl Succinate Modified Starch, Modified Waxy Maize Starch and purified water.

[0058]

[0053] In another embodiment, Sodium Acerbate and DL-a-Tocopherol as used in the composition of the invention ranges from about 0.05% w / w to about 10% w / w.

[0059]

[0054] In another embodiment, Sodium Octenyl Succinate Modified Starch as used in the composition of the invention ranges from about 40% w / w to about 80% w / w.

[0060]

[0055] In one aspect, Modified Waxy Maize Starch as used in the composition of the invention ranges from about 5% w / w to about 35% w / w.

[0056] The present invention provides the process of preparing the combination composition of Lutein and Zeaxanthin isomers beadlets wherein the process comprises

[0061] (a) dissolving Sodium Octenyl Succinate Modified Starch in water and keeping the temperature up to 44°C-50°C-55°C to get clear solution under stirring;

[0062] (b) cooling the clear obtained in step (a) to room temperature;

[0063] (c) adding sodium ascorbate in the solution of step (b) and stirring to get clear solution at room temperature;

[0064] (d) optionally, adding DL-a-tocopherol slowly in the solution of step (c) under stirring condition;

[0065] (e) adding Marigold Extract Concentrate or RR zeaxanthin, astaxanthin and curcumin added slowly in the solution of step (d) under stirring conditions.

[0066] (f) transferring the solution of step (e) to homogenizer at 2000 - 5000 RPM for 30 minutes for homogenization;

[0067] (g) carrying out the Bead Milling of solution step (f) out with a suitable tip speed, product temperature, and pressure.,

[0068] (h) drying of Modified Waxy Maize Starch at 105°C for 4 hrs, thereafter adding the same into spray pan and adding the dry ice to the chamber to bring down the temperature to 2-4°C;

[0069] (i) spraying of step (g) solution onto the dry starch under fluidization;

[0070] (j) encapsulating the carotenoid beadlets collected by sifting step (i) material and drying the beadlets into tray oven at 45°C - 55°C to get LOD less than 6%; and

[0071] (k) sifting of the dried the beadlets through mesh 30 & 80 sieves.

[0072]

[0057] The present invention also provides the process to prepare beadlet composition by layering the aqueous solution of fat-soluble nutrients on the dry starch.

[0073]

[0058] In one embodiment, the present invention provides the process to prepare beadlet composition wherein the process comprises

[0074] (a) drying of Modified Waxy Maize Starch at 105°C for 4 hrs, thereafter adding the same into spray pan and adding the dry ice to the chamber to bring down the temperature to 2-4°C;

[0075] (b) spraying of aqueous solution of fat-soluble nutrients comprising Lutein and Zeaxanthin isomers onto the dry starch under fluidization;(c) encapsulating the carotenoid beadlets collected by sifting step (b) material and drying the beadlets into tray oven at 45°C - 55°C to get LOD less than 6%; and

[0076] (d) sifting of the dried the beadlets through mesh 30 & 80 sieves.

[0077]

[0059] The present invention also provides the process to prepare an aqueous solution of macular carotenoids comprising Lutein and Zeaxanthin isomers, which can further be spray-dried onto the dry starch to get a beadlet formulation.

[0078]

[0060] In one aspect, the present invention provides the process to prepare an aqueous solution of Lutein and Zeaxanthin isomers, wherein the process comprises

[0079] (a) dissolving Sodium Octenyl Succinate Modified Starch in water and keeping the temperature up to 44°C-50°C-55°C to get clear solution under stirring;

[0080] (b) cooling the clear obtained in step (a) to room temperature;

[0081] (c) adding sodium ascorbate in the solution of step (b) and stirring to get clear solution at room temperature;

[0082] (d) slowly adding DL-a-tocopherol in the solution of step (c) under stirring condition; (e) adding Marigold Extract composition Concentrate added slowly in the solution of step (d) under stirring conditions;

[0083] (f) transferring the solution of step (e) to homogenizer at 2000 - 5000 RPM for 30 minutes for homogenization; and

[0084] (g) carrying out the Bead Milling of solution step (f) out with a suitable tip speed, product temperature, and pressure.

[0085]

[0061] The present invention also provides the composition comprising carotenoid beadlets of Lutein, Zeaxanthin isomers, lutein, curcumin contains curcuminoids, RR zeaxanthin, and Quercetagetin by using the above process.

[0086]

[0062] The present invention is explained in detail by referring to examples, which are not to be construed as limitative.

[0087]

[0063] Example 1 - Lutein and Zeaxanthin isomers in a 5:1 ratio- Beadlets

[0088]

[0089]

[0090]

[0064] Example 2 - Trans Lutein (free from Zeaxanthin isomers)- Beadlets

[0091]

[0092]

[0065] Example 3 - Astaxanthin (Total Astaxanthin)- Beadlets

[0093]

[0094]

[0066] Example 4 - 3R,3'R Zeaxanthin -Beadlets

[0095]

[0096]

[0067] Example 5 - Curcumin (Curcuminoids) - Beadlets

[0097]

[0098]

[0068] Examples 1 to 5 are carried out according to the unit of operations as follows.

[0099]

[0069] Preparation Process:

[0100] (a) dissolving Sodium Octenyl Succinate Modified Starch in water and keeping the temperature up to 44°C-50°C-55°C to get solution under stirring, and for curcumin solution process, lecithin and MCT are added;(b) cooling the clear obtained in step (a) to room temperature;

[0101] (c) adding sodium ascorbate in the solution of step (b) and stirring to get clear solution at room temperature;

[0102] (d) optionally, adding DL-a-tocopherol slowly in the solution of step (c) under stirring condition;

[0103] (e) adding Marigold Extract Concentrate added slowly in the solution of step (d) under stirring conditions.

[0104] (f) transferring the solution of step (e) to homogenizer at 2000 - 5000 RPM for 30 minutes for homogenization;

[0105] (g) carrying out the Bead Milling of solution step (f) out with a suitable tip speed, product temperature, and pressure

[0106] (h) drying of Modified Waxy Maize Starch at 105°C for 4 hrs, thereafter adding the same into spray pan and adding the dry ice to the chamber to bring down the temperature to 2-4°C;

[0107] (i) spraying of step (g) solution onto the dry starch under fluidization;

[0108] (j) encapsulating the carotenoid beadlets collected by sifting step (i) material and drying the beadlets into tray oven at 45°C - 55°C to get LOD less than 6%; and

[0109] (k) sifting of the dried the beadlets through mesh 30 & 80 sieves.

[0110]

[0070] Examples 6: Stability Data for Examples 1 to 5

[0111]

[0071] The below stability data highlighted the stability of the product obtained as per the examples 1 to 5, as per the stability protocol set by the ICH guideline - Temperature 40°C and relative humidity 75% for a period of 03 months, which means it extends applicable to 12 months.

[0112]

[0113]

[0114]

[0072] Note: The ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines are internationally recognized recommendations that aim to harmonize regulatory requirements for pharmaceutical development and registration, promoting efficiency and safety.

Claims

CLAIMS1. A stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients composition comprising Lutein and Zeaxanthin isomers, trans lutein free from Zeaxanthin isomers, curcumin (curcuminoids), and R, R zeaxanthin, and one or more nutraceutically acceptable excipients.

2. A stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients composition as claimed in claim 1, comprising Lutein and Zeaxanthin isomers is extracted from marigold extract and one or more nutraceutically acceptable excipients;Wherein, Lutein and Zeaxanthin isomers are present in 4: 1 to 6: 1 ratio, and zeaxanthin isomers are present in 80:20 to 20:80 ratios3. The composition as claimed in claim 1 wherein a nutraceutically acceptable excipient is selected from the group consisting of an antioxidant, an encapsulating agent, a filler, a disintegrant, and the combination thereof.

4. The composition as claimed in claim 3 wherein the antioxidant is selected from the group consisting of P-Carotene, Lycopene, Lutein, a-Tocopherol, Catalase, Glutathione, Melatonin, Oestrogen, Uni quinol- 10, N-Acetyl Cysteine, Lipoic Acid, Quercetin, Quercetagetin, Catechin, Cortisone, Estradiol, Estriol, Ascorbic acid and derivatives and the combination thereof.

5. The composition as claimed in claim 3 wherein antioxidant present in the composition ranges from about 0.05% w / w to about 10% w / w.

6. The composition as claimed in claim 3 wherein the encapsulating agent and filler are selected from the modified starches.

7. The composition as claimed in claim 6 wherein encapsulating agent present in the composition ranges from about 40% w / w to about 80% w / w.

8. The composition as claimed in claim 3 wherein filler present in the composition ranges from about 5% w / w to about 35% w / w.

9. The composition comprising Lutein and Zeaxanthin isomers obtained from marigold extract along with Sodium Acerbate, DL-a-Tocopherol, Sodium Octenyl Succinate Modified Starch, Modified Waxy Maize Starch and purified water.

10. The composition as claimed in claim 9 wherein amount of Sodium Acerbate and DL- a-Tocopherol present in the composition ranges from about 0.05% w / w to about 10% w / w.

11. The composition as claimed in claim 9 wherein amount of Sodium Octenyl Succinate Modified Starch present in the composition ranges from about 40% w / w to about 80% w / w.

12. The composition as claimed in claim 9 wherein amount of Modified Waxy Maize Starch present in the composition ranges from about 5% w / w to about 35% w / w.

13. A stabilized, solvent-free macular carotenoids and / or fat-soluble nutrients composition comprising Lutein and Zeaxanthin isomers is used for improvement in visual function.

14. The process of preparing the composition as claimed in claim 1 wherein the process for preparation comprising:(a) dissolving Sodium Octenyl Succinate, Modified Starch in water and keeping the temperature up to 44°C-50°C-55°C to get solution under stirring, and for curcumin, a lecithin and MCT oil are added along with the step (a);(b) cooling the clear obtained in step (a) to room temperature;(c) adding sodium ascorbate in the solution of step (b) and stirring to get clear solution at room temperature;(d) optionally, adding DL-a-tocopherol slowly in the solution of step (c) under stirring condition;(e) adding Marigold Extract Concentrate and / or paprika extract and / or astazanthin are added slowly in the solution of step (d) under stirring conditions.(f) transferring the solution of step (e) to homogenizer at 2000 - 5000 RPM for 30 minutes for homogenization;(g) carrying out the Bead Milling of solution step (f) out with a suitable tip speed, product temperature, and pressure(h) drying of Modified Waxy Maize Starch at 105°C for 4 hrs, thereafter adding the same into spray pan and adding the dry ice to the chamber to bring down the temperature to 2-4°C;(i) spraying of step (g) solution onto the dry starch under fluidization;(j) encapsulating the carotenoid beadlets collected by sifting step (i) material and drying the beadlets into tray oven at 45°C - 55°C to get LOD less than 6%; and (k) sifting of the dried the beadlets through mesh 30 & 80 sieves.

15. The process of preparing a composition as claimed in claim 14, by layering the aqueous solution of macular carotenoids and / or fat-soluble nutrients on the dry starch.

16. The process of preparing beadlet composition as claimed in claim 15, wherein the process comprises(a) drying of Modified Waxy Maize Starch at 105°C for 4 hrs, thereafter adding the same into spray pan and adding the dry ice to the chamber to bring down the temperature to 2-4°C;(b) spraying of aqueous solution of macular carotenoids and / or fat-soluble nutrients comprising onto the dry starch under fluidization;(c) encapsulating the carotenoid beadlets collected by sifting step (b) material and drying the beadlets into tray oven at 45°C - 55°C to get LOD less than 6%; and (d) sifting of the dried the beadlets through mesh 30 & 80 sieves.

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