Nutraceutical composition and a process for its preparation

Abstract

The present disclosure relates to a nutraceutical composition and a process for its preparation The nutraceutical composition of the present disclosure is capable of improving overall health, preventing disease, and address nutrient deficiencies without causing adverse side effects. The process for the preparation of the nutraceutical composition is simple and environmentally friendly.

Description

[0001] NUTRACEUTICAL COMPOSITION AND A PROCESS FOR ITS PREPARATION FIELD

[0002] The present disclosure relates to the field of nutraceuticals. Particularly, the present disclosure relates to a nutraceutical composition and a process for its preparation.

[0003] BACKGROUND

[0004] The background information herein below relates to the present disclosure but is not necessarily prior art.

[0005] Nutraceutical compositions are products that provide health benefits similar to medicines but are derived from food or food components and are consumed for their health benefits, particularly fortheir preventive and medicinal qualities. These compositions are formulated for improving health, preventing diseases, or addressing specific health conditions. Nutraceutical compositions contain various components such as vitamins, minerals, herbal ingredients, antioxidants, probiotics and the like.

[0006] Nutraceutical compositions offer a diverse range of health benefits, such as preventing chronic diseases, supporting overall well-being, managing specific health conditions and the like. Further, nutraceutical compositions can be used to provide supplements for nutrients that may be lacking in the diet, helping to restore balance and prevent or treat nutrient deficiencies.

[0007] In recent years, there has been a growing demand globally for nutraceutical compositions owing to the numerous health benefits associated with the nutraceutical compositions for supporting overall wellness, managing chronic conditions and maintaining a healthy lifestyle. This has resulted in nutraceutical compositions becoming an integral part of modem health practices.

[0008] Therefore, there is felt a need to provide a nutraceutical composition that can improve health, prevent disease, alleviate specific health conditions or prevent / treat nutrient deficiencies.

[0009] OBJECTS

[0010] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:It is an object of the present disclosure to ameliorate one or more drawbacks of the background or to at least provide a useful alternative.

[0011] Another object of the present disclosure is to provide a nutraceutical composition.

[0012] Still another object of the present disclosure is to provide a nutraceutical composition in the form of a soft gel capsule.

[0013] Yet another object of the present disclosure is to provide a process for the preparation of a nutraceutical composition.

[0014] Still another object of the present disclosure is to provide a process for the preparation of a nutraceutical composition that is simple and environmentally friendly.

[0015] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure. SUMMARY

[0016] In an aspect, the present disclosure relates to a nutraceutical composition in the form of a soft gel capsule. The nutraceutical composition comprises:

[0017] i. a core comprising:

[0018] • a predetermined amount of at least one carrier;

[0019] • a predetermined amount of at least one micronutrient;

[0020] • a predetermined amount of at least one antioxidant; and

[0021] • a predetermined amount of at least one first flavouring agent, and ii. a shell comprising:

[0022] • a predetermined amount of water;

[0023] • a predetermined amount of at least one gelling agent;

[0024] • a predetermined amount of at least one first plasticizer;

[0025] • a predetermined amount of at least one second plasticizer;

[0026] • a predetermined amount of at least one sweetening agent;

[0027] • a predetermined amount of at least one second flavouring agent

[0028] • a predetermined amount of at least one coloring agent; and

[0029] • optionally, a predetermined amount of at least one anti-caking agent, wherein the core is encapsulated in the shell.In an embodiment of the present disclosure,

[0030] • the carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee);

[0031] • the micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin;

[0032] • the antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate (Vitamin E), rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof;

[0033] • the first flavouring agent and the second flavoring agent are independently selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom, and a combination thereof;

[0034] • the gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof;

[0035] • the first plasticizer and second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and a combination thereof;

[0036] • the sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, coconut sugar, date syrup, date sugar, jaggery, and honey; and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, erythritol, and cyclamate;

[0037] • the preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof;

[0038] • the coloring agent is selected from the group consisting of Quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof.

[0039] In an embodiment of the present disclosure,

[0040] • the fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K; and• the water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, and vitamin B12.

[0041] In an embodiment of the present disclosure, the anti -caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof.

[0042] In an embodiment of the present disclosure,

[0043] • the predetermined amount of the carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of the nutraceutical composition;

[0044] • the predetermined amount of the micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of the nutraceutical composition; and • the predetermined amount of the first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of the nutraceutical composition.

[0045] • the predetermined amount of the gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of the nutraceutical composition;

[0046] • the predetermined amount of the second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of the nutraceutical composition;

[0047] • the predetermined amount of the sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the second flavoring agent is in the range of 1 mass% to 2 mass% with respect to the total mass of the nutraceutical composition;

[0048] • the predetermined amount of the preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of the nutraceutical composition; and• the predetermined amount of the anti -caking agent is in the range of 0 mass% to 5 mass % with respect to the total mass of the nutraceutical composition.

[0049] In an embodiment of the present disclosure, the nutraceutical composition has a shelf life in the range of 22 months to 26 months.

[0050] In another aspect, the present disclosure relates to a process for the preparation of a nutraceutical composition in the form of soft gel capsules. The process comprises the following steps:

[0051] a) melting a predetermined amount of at least one carrier at a first predetermined temperature to obtain a melted carrier;

[0052] b) cooling the melted carrier to a second predetermined temperature, followed by adding a predetermined amount of at least one micronutrient, a predetermined amount of at least one antioxidant and a predetermined amount of at least one first flavouring agent under stirring to obtain a core composition;

[0053] c) separately, heating a predetermined amount of water at a third predetermined temperature, followed by adding predetermined amounts of at least one gelling agent, at least one first plasticizer, at least one second plasticizer, at least one sweetening agent, at least one preservative, at least one coloring agent, at least one second flavouring agent and optionally, a predetermined amount of at least one anti-caking agent to obtain a shell composition;

[0054] d) serially, injecting a predetermined amount of the shell composition maintained at a fourth predetermined temperature in a bath containing at last one pharmaceutically acceptable oil maintained at a fifth predetermined temperature, immediately followed by inj ecting a predetermined amount of the core composition maintained at a sixth predetermined temperature, to enable the shell composition to encapsulate the core composition in the bath to obtain capsules; and e) washing the capsules with a solvent, followed by drying to obtain the nutraceutical composition in the form of soft gel capsules.

[0055] In an embodiment of the present disclosure,

[0056] • the micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin;

[0057] • the carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee);• the antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate, rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof;

[0058] • the first flavouring agent and the second flavouring agent are independently selected from the group consisting of lemon oil, peppermint oil, anise, orange, holy basil (tulsi), cinnamon, cardamom, vanilla flavour and a combination thereof;

[0059] • the gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof;

[0060] • the first plasticizer and the second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and a combination thereof;

[0061] • the sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, coconut sugar, date syrup, date sugar, jaggery, and honey; and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, erythritol, and cyclamate;

[0062] • the preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof;

[0063] • the coloring agent is selected from the group consisting of quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof; and

[0064] • the anti-caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof. In an embodiment of the present disclosure,

[0065] • the fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K; and

[0066] • the water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, and vitamin B12.

[0067] In an embodiment of the present disclosure,• the predetermined amount of the shell composition is in the range of 20 mass% to 30 mass% with respect to the total mass of the nutraceutical composition; and • the predetermined amount of the core composition is in the range of 70 mass% to 80 mass% with respect to the total mass of the nutraceutical composition. In an embodiment of the present disclosure,

[0068] • the predetermined amount of the micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of the nutraceutical composition;

[0069] • the predetermined amount of the antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of the nutraceutical composition; and • the predetermined amount of the first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of the nutraceutical composition.

[0070] In an embodiment of the present disclosure,

[0071] • the predetermined amount of the gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of the nutraceutical composition;

[0072] • the predetermined amount of the first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of the nutraceutical composition;

[0073] • the predetermined amount of the second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of the nutraceutical composition; • the predetermined amount of the second flavouring agent is in the range of 1 mass% to 2 mass% with respect to the total mass of the nutraceutical composition;• the predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of the nutraceutical composition; and

[0074] • the predetermined amount of the anti-caking agent is in the range of 0 mass% to 5 mass % with respect to the total mass of the nutraceutical composition. In an embodiment of the present disclosure,

[0075] • the first predetermined temperature is in the range of 60 °C to 80 °C;

[0076] • the second predetermined temperature is in the range of 30 °C to 50 °C;

[0077] • the third predetermined temperature is in the range of 85 °C to 95 °C; • the fourth predetermined temperature is in the range of 85 °C to 95 °C;

[0078] • the fifth predetermined temperature is in the range of 15 °C to 30 °C; and • the sixth predetermined temperature is in the range of 30 °C to 50 °C. In an embodiment of the present disclosure, the pharmaceutically acceptable oil is selected from the group consisting of a mineral oil, a medium chain triglyceride oil, and a refined vegetable oil.

[0079] In an embodiment of the present disclosure, the solvent is selected from the group consisting of hexane, ethanol, isopropyl alcohol and a combination thereof.

[0080] DETAILED DESCRIPTION

[0081] The present disclosure relates to a nutraceutical composition and a process for its preparation. Particularly, the present disclosure relates to a nutraceutical composition and a process for its preparation.

[0082] Different embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.The terminology used, in the present disclosure, is only to explain a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open-ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units, and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

[0083] The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer, or section from another component, region, layer, or section. Terms such as first, second, third, etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.

[0084] It may be noted that any phrase written in British English and American English would be considered identical. For Example, “Colour” and “Color” or “Fibre” and “Fiber” or “Flavour” and “Flavor” or the like may be used interchangeably and still would mean the same.

[0085] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed elements.

[0086] Nutraceutical compositions offer a diverse range of health benefits, such as preventing chronic diseases, supporting overall well-being, managing specific health conditions and the like. Further, nutraceutical compositions can be used to provide supplements for nutrients that may be lacking in the diet, helping to restore balance and prevent or treat nutrient deficiencies. In recent years, there has been a growing demand globally for nutraceutical compositions owing to the numerous health benefits associated with the nutraceutical compositions for supporting overall wellness, managing chronic conditions and maintaining a healthy lifestyle. This has resulted in nutraceutical compositions becoming an integral part of modem health practices.In an aspect, the present disclosure provides a nutraceutical composition in the form of a soft gel capsule. The composition comprises:

[0087] i. a core comprising:

[0088] • a predetermined amount of at least one carrier;

[0089] • a predetermined amount of at least one micronutrient;

[0090] • a predetermined amount of at least one antioxidant; and • a predetermined amount of at least one first flavouring agent, and ii. a shell comprising:

[0091] • a predetermined amount of water;

[0092] • a predetermined amount of at least one gelling agent;

[0093] • a predetermined amount of at least one first plasticizer;

[0094] • a predetermined amount of at least one second plasticizer;

[0095] • a predetermined amount of at least one sweetening agent;

[0096] • a predetermined amount of at least one second flavouring agent

[0097] • a predetermined amount of at least one coloring agent; and

[0098] • optionally, a predetermined amount of at least one anti-caking agent, wherein the core is encapsulated in the shell.

[0099] In an embodiment of the present disclosure, the micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin.

[0100] In an embodiment of the present disclosure, the fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K, and the water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, and vitamin B 12. In an exemplary embodiment of the present disclosure, the micronutrient is Vitamin D, preferably Vitamin D3.

[0101] Vitamin D3 (cholecalciferol) is essential for maintaining healthy bones and teeth by enhancing the absorption and utilization of calcium and phosphorus in the body. It plays a vital role in supporting immune function, helping the body defend against infections and inflammatory conditions. Vitamin D3 also contributes to muscle strength, proper nerve signaling, and overall skeletal health. Adequate levels are associated with improved mood and may lower the risk of chronic illnesses such as osteoporosis and cardiovascular disorders. Deficiency of Vitamin D3can result in weakened bones, leading to conditions such as rickets in children and osteomalacia in adults.

[0102] In an embodiment of the present disclosure, the predetermined amount of the micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the micronutrient is 0.42 mass% with respect to the total mass of the nutraceutical composition.

[0103] In an embodiment of the present disclosure, the carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee). In an exemplary embodiment of the present disclosure, the carrier is clarified butter (ghee).

[0104] Ghee serves as an effective carrier in soft gel capsules due to its lipid-rich composition, which enhances the solubility and bioavailability of fat-soluble active ingredients such as vitamins and nutraceuticals. It provides excellent oxidative stability, helping to protect sensitive active ingredients from degradation and extending product shelf life. Ghee also supports uniform dispersion of the active compounds, ensuring consistent dosing and improved absorption in the gastrointestinal tract. Additionally, its natural origin and biocompatibility make it a suitable and consumer-friendly excipient for oral delivery systems.

[0105] In an embodiment of the present disclosure, the predetermined amount of the carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the carrier is 67.93 mass% with respect to the total mass of the nutraceutical composition.

[0106] In an embodiment of the present disclosure, the antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate, rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof. In an exemplary embodiment of the present disclosure, the antioxidant is DL-alpha-tocopheryl acetate.

[0107] DL-alpha-tocopheryl acetate functions as an effective antioxidant in soft gel capsules by protecting lipid-based fill materials and active ingredients from oxidative degradation. It helps prevent rancidity in oil or ghee and preserves the potency, stability, and shelf life of the composition. Due to its fat-soluble nature, it integrates well into lipid-based matrices, ensuringuniform distribution throughout the capsule fill. Additionally, it provides supplementary nutritional benefits, supporting cellular protection against free radical damage.

[0108] In an embodiment of the present disclosure, the predetermined amount of the antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the antioxidant is 0.54 mass% with respect to the total mass of the nutraceutical composition. In an embodiment of the present disclosure, the first flavouring agent is selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom and a combination thereof. In an exemplary embodiment of the present disclosure, the first flavouring agent is a combination of lemon oil and peppermint oil.

[0109] Flavouring agents in soft gel capsules play an important role in improving the organoleptic properties of the dosage form, making it more palatable and acceptable to consumers. They help to mask unpleasant tastes and odours of the active ingredients, particularly in nutraceutical and herbal formulations. By enhancing the overall sensory experience, the flavouring agents support better patient compliance and ease of consumption.

[0110] In an embodiment of the present disclosure, the predetermined amount of the first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the first flavouring agent is 8.69 mass% with respect to the total mass of the nutraceutical composition.

[0111] In an embodiment of the present disclosure, the gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof. In an exemplary embodiment of the present disclosure, the gelling agent is carrageenan.

[0112] Gelling agents in soft gel capsules are essential for forming and maintaining the structural integrity of the capsule shell. They provide the elasticity, strength, and flexibility required to encapsulate liquid or semi-solid fills without leakage. Gelling agents also contribute to controlled dissolution and disintegration of the capsule in the gastrointestinal tract, ensuring proper release of the active ingredients. Additionally, they help to achieve uniform shell thickness and stability during manufacturing, storage, and handling.In an embodiment of the present disclosure, predetermined amount of the gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the gelling agent is 4.08 mass% with respect to the total mass of the nutraceutical composition.

[0113] In an embodiment of the present disclosure, the second flavoring agent is selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom, and a combination thereof. In an exemplary embodiment of the present disclosure, the second flavoring agent is vanilla flavor.

[0114] In an embodiment of the present disclosure, the predetermined amount of the second flavoring agent is in the range of 1 mass% to 2 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the second flavoring agent is 1.63 mass% with respect to the total mass of the nutraceutical composition.

[0115] In an embodiment of the present disclosure, the first plasticizer and the second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and combinations thereof. In an exemplary embodiment of the present disclosure, the first plasticizer is glycerin, and the second plasticizer is sorbitol. In an embodiment of the present disclosure, the predetermined amount of the first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the first plasticizer is 0.82 mass% with respect to the total mass of the nutraceutical composition.

[0116] In an embodiment of the present disclosure, the predetermined amount of the second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the second plasticizer is 6.52 mass% with respect to the total mass of the nutraceutical composition.

[0117] Plasticizers in soft gel capsules are used to enhance the flexibility and elasticity of the capsule shell, preventing brittleness and cracking during manufacturing, storage, and handling. Theyhelp to maintain the moisture balance within the shell, ensuring softness and mechanical strength overtime. Plasticizers also improve the sealing properties of the capsule, reducing the risk of leakage of the fill material. Additionally, they contribute to the overall stability and durability of the soft gel capsule under varying environmental conditions.

[0118] In an embodiment of the present disclosure, the sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, erythritol, coconut sugar, date syrup, date sugar, jaggery, and honey, and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, and cyclamate. In an exemplary embodiment of the present disclosure, the sweetening agent is sucralose.

[0119] Sweetening agents in soft gel capsules are used to improve the taste and overall palatability of the dosage form, particularly when the formulation contains bitter or unpleasant-tasting active ingredients. They help mask undesirable flavors, making the capsule more acceptable to consumers and enhancing patient compliance. Sweetening agents also contribute to a pleasant sensory experience without significantly affecting the stability of the formulation.

[0120] In an embodiment of the present disclosure, the predetermined amount of the sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the sweetening agent is 0.82 mass% with respect to the total mass of the nutraceutical composition.

[0121] In an embodiment of the present disclosure, the preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof. In an exemplary embodiment of the present disclosure, the preservative is sodium benzoate.

[0122] Preservatives in soft gel capsules are incorporated to inhibit the growth of microorganisms such as bacteria, yeast, and moulds, thereby ensuring product safety and extending shelflife. They help to maintain the stability and integrity of both the capsule shell and fill material during storage and use. Preservatives also prevent spoilage and degradation caused by microbial contamination, particularly in formulations containing moisture or natural ingredients.

[0123] In an embodiment of the present disclosure, the predetermined amount of the preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of the nutraceuticalcomposition. In an exemplary embodiment of the present disclosure, the predetermined amount of the preservative 0.16 mass% with respect to the total mass of the nutraceutical composition. In an embodiment of the present disclosure, the coloring agent is selected from the group consisting of quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof. In an exemplary embodiment of the present disclosure, the coloring agent is quinoline yellow.

[0124] Colouring agents in soft gel capsules are used to enhance the visual appeal and aesthetic quality of the dosage form, making it more attractive and easily identifiable to consumers. They assist in product differentiation, brand recognition, and dose identification, especially when multiple strengths or formulations are available. Colouring agents can also help to mask the undesirable appearance of the fill material, providing a uniform and appealing look.

[0125] In an embodiment of the present disclosure, the predetermined amount of the coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the coloring agent is 0.23 mass% with respect to the total mass of the nutraceutical composition.

[0126] In an embodiment of the present disclosure, the predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of the nutraceutical composition. The nutraceutical composition of the present disclosure is in the form of soft gel capsules and accordingly the predetermined amount of water in the range of 5 mass% to 10 mass% is also with respect to dried capsules.

[0127] In an exemplary embodiment of the present disclosure, predetermined amount of water is 8.15 mass% with respect to the total mass of the nutraceutical composition.

[0128] In an embodiment of the present disclosure, the anti-caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof.

[0129] Anti-caking agents in soft gel capsule formulations are used to prevent the clumping or aggregation of powdered ingredients during processing and storage. They improve the flow properties of excipients, ensuring uniform mixing, accurate dosing, and efficientmanufacturing. Anti-caking agents also help to maintain the physical stability and free-flowing nature of materials, reducing moisture-induced lump formation.

[0130] In an embodiment of the present disclosure, the anti-caking agent is present in an amount in the range of 0 mass% to 5 mass% with respect to the total mass of the nutraceutical composition.

[0131] The addition of an anticaking agent depends on the type of packaging used. When the soft gel capsules of the present disclosure are stored in bottles, an anti -caking agent is incorporated into the capsule preparation to prevent the capsules from sticking together onto the bottle.

[0132] In an embodiment of the present disclosure, the nutraceutical composition has a shelf life in the range of 22 months to 26 months.

[0133] In another aspect, the present disclosure provides a process for the preparation of a nutraceutical composition in the form of a soft gel capsule. The process comprises the following steps:

[0134] a) melting a predetermined amount of at least one carrier at a first predetermined temperature to obtain a melted carrier;

[0135] b) cooling the melted carrier to a second predetermined temperature, followed by adding a predetermined amount of at least one micronutrient, a predetermined amount of at least one antioxidant and a predetermined amount of at least one first flavouring agent under stirring to obtain a core composition;

[0136] c) separately, heating a predetermined amount of water at a third predetermined temperature, followed by adding predetermined amounts of at least one gelling agent, at least one first plasticizer, at least one second plasticizer, at least one sweetening agent, at least one preservative, at least one coloring agent, at least one second flavouring agent and optionally, a predetermined amount of at least one anti-caking agent to obtain a shell composition;

[0137] d) serially, injecting a predetermined amount of the shell composition maintained at a fourth predetermined temperature in a bath containing a pharmaceutically acceptable oil maintained at a fifth predetermined temperature, immediately followed by injecting a predetermined amount of the core composition maintained at a sixth predetermined temperature, to enable the shell composition to encapsulate the core composition in the bath to obtain capsules; ande) washing the capsules with a solvent, followed by drying to obtain the nutraceutical composition in the form of soft gel capsules.

[0138] The process for preparation of the nutraceutical composition in the form of a soft gel capsule is provided in detail below:

[0139] A predetermined amount of a carrier is melted at a first predetermined temperature to obtain a melted carrier.

[0140] In an embodiment of the present disclosure, the carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee). In an exemplary embodiment of the present disclosure, the carrier is clarified butter (ghee).

[0141] In an embodiment of the present disclosure, the predetermined amount of the carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the carrier is 67.93 mass% with respect to the total mass of the nutraceutical composition.

[0142] In an embodiment of the present disclosure, the first predetermined temperature is in the range of 60 °C to 80 °C. In an exemplary embodiment of the present disclosure, the first predetermined temperature is 65°C.

[0143] The melted carrier is cooled to a second predetermined temperature, followed by adding a predetermined amount of a micronutrient, a predetermined amount of an antioxidant and a predetermined amount of a first flavouring agent under stirring to obtain a homogeneous mixture.

[0144] In an embodiment of the present disclosure, the second predetermined temperature is in the range of 30 °C to 50 °C. In an exemplary embodiment of the present disclosure, the second predetermined temperature is 40°C.

[0145] In an embodiment of the present disclosure, the micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin.

[0146] In an embodiment of the present disclosure, the fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K, and the water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, andvitamin B 12. In an exemplary embodiment of the present disclosure, the micronutrient is Vitamin D, preferably Vitamin D3.

[0147] In an embodiment of the present disclosure, the predetermined amount of the micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the micronutrient is 0.42 mass% with respect to the total mass of the nutraceutical composition.

[0148] In an embodiment of the present disclosure, the antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate, rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof. In an exemplary embodiment of the present disclosure, the antioxidant is DL-alpha-tocopheryl acetate.

[0149] In an embodiment of the present disclosure, the predetermined amount of the antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the antioxidant is 0.54 mass% with respect to the total mass of the nutraceutical composition. In an embodiment of the present disclosure, the first flavouring agent is selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom and a combination thereof. In an exemplary embodiment of the present disclosure, the first flavouring agent is a combination of lemon oil and peppermint oil.

[0150] In an embodiment of the present disclosure, the predetermined amount of the first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the first flavouring agent is 8.69 mass% with respect to the total mass of the nutraceutical composition.

[0151] Separately, a predetermined amount of water is heated at a third predetermined temperature, followed by adding predetermined amounts of at least one gelling agent, at least one first plasticizer, at least one second plasticizer, at least one sweetening agent, at least one preservative, at least one coloring agent, at least one second flavouring agent and optionally, a predetermined amount of at least one anti-caking agent to obtain a shell composition.In an embodiment of the present disclosure, the third predetermined temperature is in the range of 85 °C to 95 °C. In an exemplary embodiment of the present disclosure, the third predetermined temperature is 90 °C.

[0152] In an embodiment of the present disclosure, the gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof. In an exemplary embodiment of the present disclosure, the gelling agent is carrageenan.

[0153] In an embodiment of the present disclosure, the predetermined amount of the gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the gelling agent is 4.08 mass% with respect to the total mass of the nutraceutical composition.

[0154] In an embodiment of the present disclosure, the first plasticizer and the second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and combinations thereof. In an exemplary embodiment of the present disclosure, the first plasticizer is glycerin, and the second plasticizer is sorbitol. In an embodiment of the present disclosure, the predetermined amount of the first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the first plasticizer is 0.82 mass% with respect to the total mass of the nutraceutical composition.

[0155] In an embodiment of the present disclosure, the predetermined amount of the predetermined amount of the second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the second plasticizer is 6.52 mass% with respect to the total mass of the nutraceutical composition.

[0156] In an embodiment of the present disclosure, the sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, coconut sugar, date syrup, date sugar, jaggery, and honey, and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, erythritol, and cyclamate. In an exemplary embodiment of the present disclosure, the sweetening agent is sucralose.In an embodiment of the present disclosure, the predetermined amount of the sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the sweetening agent is 0.82 mass% with respect to the total mass of the nutraceutical composition.

[0157] In an embodiment of the present disclosure, the preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof. In an exemplary embodiment of the present disclosure, the preservative is sodium benzoate.

[0158] In an embodiment of the present disclosure, the predetermined amount of the preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the preservative is 0.16 mass% with respect to the total mass of the nutraceutical composition.

[0159] In an embodiment of the present disclosure, the coloring agent is selected from the group consisting of quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof. In an exemplary embodiment of the present disclosure, the coloring agent is quinoline yellow.

[0160] In an embodiment of the present disclosure, the predetermined amount of the coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amount of the coloring agent is 0.23 mass% with respect to the total mass of the nutraceutical composition.

[0161] In an embodiment of the present disclosure, the second flavouring agent is selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom and a combination thereof. In an exemplary embodiment of the present disclosure, the second flavouring agent is vanilla flavour.

[0162] In an embodiment of the present disclosure, the predetermined amount of the second flavouring agent is in the range of 0.9 mass% to 2 mass% with respect to the total mass of the nutraceutical composition. In an exemplary embodiment of the present disclosure, the predetermined amountof the second flavouring agent is 1.63 mass% with respect to the total mass of the nutraceutical composition.

[0163] In an embodiment of the present disclosure, the predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of the nutraceutical composition. The nutraceutical composition of the present disclosure is in the form of soft gel capsules and accordingly the predetermined amount of water in the range of 5 mass% to 10 mass% is also with respect to the dried capsules.

[0164] In an exemplary embodiment of the present disclosure, predetermined amount of water is 8.15 mass% with respect to the total mass of the nutraceutical composition.

[0165] In an embodiment of the present disclosure, the anti-caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof.

[0166] In an embodiment of the present disclosure, the anti-caking agent is present in an amount in the range of 0 mass% to 5 mass % with respect to the total mass of the nutraceutical composition.

[0167] Next, serially, a predetermined amount of the shell composition maintained at a fourth predetermined temperature is injected in a bath containing at least one pharmaceutically acceptable oil maintained at a fifth predetermined temperature, immediately followed by injecting a predetermined amount of the core composition maintained at a sixth predetermined temperature, to enable the shell composition to encapsulate the core composition in the bath to obtain capsules.

[0168] In an embodiment of the present disclosure, the predetermined amount of the shell composition is in the range of 20 mass% to 30 mass% with respect to the total mass of the nutraceutical composition; and the predetermined amount of the core composition is in the range of 70 mass% to 80 mass% with respect to the total mass of the nutraceutical composition.

[0169] In an exemplary embodiment of the present disclosure, the predetermined amount of the shell composition is 22.40 mass% with respect to the total mass of the nutraceutical composition; and the predetermined amount of the core composition is in the range of 77.60 mass% with respect to the total mass of the nutraceutical composition.In an embodiment of the present disclosure, the fourth predetermined temperature is in the range of 85 °C to 95 °C. In an exemplary embodiment of the present disclosure, the fourth predetermined temperature is 90 °C.

[0170] In an embodiment of the present disclosure, the fifth predetermined temperature is in the range of 15 °C to 30 °C. In an exemplary embodiment of the present disclosure, the fifth predetermined temperature is 20 °C.

[0171] In an embodiment of the present disclosure, the sixth predetermined temperature is in the range of 30 °C to 50 °C. In an exemplary embodiment of the present disclosure, the sixth predetermined temperature is 40 °C.

[0172] In an embodiment of the present disclosure, the pharmaceutically acceptable oil is selected from the group consisting of a mineral oil, a medium chain triglyceride oil, and a refined vegetable oil. In an exemplary embodiment of the present disclosure, the pharmaceutically acceptable oil is medium-chain triglyceride oil.

[0173] On injecting the shell composition and the core composition into the cold pharmaceutically acceptable oil with a pulsating action, the drop solidifies on contact with the cold oil to enable the shell composition to encapsulate the core composition in the bath and forms a solid capsule. Capsules are then washed with a solvent, followed by drying to obtain the nutraceutical composition in the form of soft gel capsules.

[0174] In an embodiment of the present disclosure, the solvent is selected from the group consisting of hexane, ethanol, isopropyl alcohol and a combination thereof. In an exemplary embodiment of the present disclosure, the solvent is hexane.

[0175] In an embodiment of the present disclosure, the nutraceutical composition of the present disclosure is capable of improving overall health, preventing disease, and address nutrient deficiencies without causing adverse side effects.

[0176] The nutraceutical composition uses ghee as a carrier in the preparation of soft gel capsules due to its superior stability, compatibility with lipophilic active ingredients, and resistance to oxidative degradation compared to conventional vegetable oils. Its semi-solid nature at ambient temperatures facilitates uniform dispersion of the active component while minimizing leakage and improving encapsulation efficiency. Additionally, ghee contains a balanced profile of shortand medium-chain faty acids that can promote improved solubilization of fat-soluble actives, thereby enhancing their absorption in the gastrointestinal tract. This lipid matrix supports improved bioavailability of the encapsulated ingredient by facilitating lymphatic transport and reducing first-pass metabolism, ultimately contributing to beter therapeutic efficacy of the nutraceutical composition of the present disclosure.

[0177] The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment but are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

[0178] The present disclosure is further illustrated herein below with the help of the following nonlimiting experiments. The experiments disclosed under these examples herein are intended merely to facilitate an understanding of how the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the experiments should not be construed as limiting the scope of embodiments herein. These laboratory-scale experiments can be scaled up to an industrial / commercial scale and the results obtained can be extrapolated to industrial / commercial scale.

[0179] EXPERIMENTAL DETAILS

[0180] Example 1: Process for preparing a nutraceutical composition in the form of soft gel capsules, in accordance with the present disclosure

[0181] Table 1: Ingredients of a nutraceutical composition, in accordance with the present disclosure

[0182]

[0183]

[0184] *- The nutraceutical composition comprises approximately 30% excess Vitamin D3 to compensate for potential degradation during storage and to ensure maintenance of the intended standard dose throughout the product ’s shelflife.

[0185] **The amount of water is with respect to dried capsules (nutraceutical composition).

[0186] The nutraceutical composition in the form of soft gel capsules, in accordance with the present disclosure, was prepared using the ingredients and amounts as summarized in Table 1.

[0187] Initially, 125 mg of ghee (carrier) was melted at a temperature of 65 °C (first predetermined temperature) to obtain a melted ghee. The melted ghee was cooled to 40 °C (second predetermined temperature), followed by adding 0.78 mg of Vitamin D3 (micronutrient), 1 mg of DL-alpha-tocopheryl acetate (antioxidant), 12 mg of cold-pressed lemon oil and 4 mg of peppermint oil (first flavouring agent) under stirring to obtain a core composition.

[0188] Separately, 15 ml water was heated at 90 °C (third predetermined temperature), followed by adding 7.5 mg of carrageenan (gelling agent), 1.5 mg of glycerin (first plasticizer), 12 mg ofsorbitol (second plasticizer), 1.5 mg of sucralose (sweetening agent), 0.3 mg of sodium benzoate (preservative), 0.42 mg of quinoline yellow (coloring agent), and 3 mg of vanilla flavour (second flavouring agent) to obtain a shell composition.

[0189] Serially, 41.22 mg of the shell composition maintained at 90 °C temperature (fourth predetermined temperature) was injected in a bath containing a medium chain triglyceride oil (pharmaceutically acceptable oil) maintained at 20 °C (fifth predetermined temperature), immediately followed by injecting 142.78 mg of the core composition maintained at 40 °C (sixth predetermined temperature), to enable the shell composition to encapsulate the core composition in the bath to obtain capsules. The capsules were washed with hexane (solvent), followed by drying to obtain the nutraceutical composition in the form of soft gel capsules.

[0190] Example 2: Efficacy study of the nutraceutical composition, in accordance with the present disclosure

[0191] Studies were conducted to evaluate the efficacy of the nutraceutical composition prepared in accordance with Example 1. The study group consisted of both male and female subjects aged between 20 and 60 years. The participants were instructed to take the nutraceutical composition formulated as soft gel capsules every day (one capsule, once a day, 30 minutes after breakfast). The details of the participants and the outcomes observed during the study are summarized in Table 2.

[0192] Table 2: Clinical data of a nutraceutical composition, in accordance with the present disclosure

[0193]

[0194]

[0195] It is seen that after 45 days, most of the participants demonstrated stabilization or modest changes in the vitamin D3 levels. The level of vitamin D3 for participant No 1 increased from 10.34 ng / mL (baseline) to 13.17 ng / mL (after 45 days) and for participant No 5, the vitamin D3 level increased to 20.88 ng / mL, indicating progressive improvement. Notably, individuals with lower baseline levels exhibited marked enhancement by day 45; for example, participant No 1 and participant No 2 demonstrated a clear increase in vitamin D3 level, while participant No 8 showed an increase from 18.25 ng / mL (baseline) to 24.47 ng / mL (after 45 days). Participants with moderate baseline levels also showed sustained elevation, such as participant No 14, who showed an increase from 29.41 ng / mL (baseline) to 36.82 ng / mL (after 45 days); and participant No 15, who showed an increase from 32.83 ng / mL (baseline) to 34.75 ng / mL (after 45 days). A slight decrease in the vitamin D3 levels was observed in a few cases (participants No. 6, 11, 12, 13, 16) due to irregular intake of the nutraceutical composition. None of the participants reported any adverse side effects after consumption of the nutraceutical composition of the present disclosure.

[0196] The overall available data indicate that by day 45, the majority of the participants demonstrated either stabilization or a measurable increase in vitamin D3 levels, with the most pronounced improvements seen in participants with lower baseline levels. Participants with moderate baseline levels also showed sustained increases, while minor decreases were observed in a few cases due to irregular intake. Overall, the data indicate that the nutraceutical composition effectively and consistently enhances vitamin D3 levels over the 45-day period.

[0197] Example 3: Comparative Study

[0198] The nutraceutical composition of the present disclosure demonstrated effective and sustained improvement in serum vitamin D3 levels at moderate doses, including in participants with low baseline values. Importantly, none of the participants reported any adverse effects, highlighting a favorable safety profile. In contrast, many marketed vitamin D3 supplements often require high doses to achieve comparable increases, which are associated with side effects such as gastrointestinal discomfort or, in some cases, risk of hypercalcemia. Additionally, serumvitamin D3 levels from high-dose marketed supplements tend to fluctuate and may decline after cessation of the supplement, whereas the nutraceutical composition of the present disclosure maintained stable levels over the 45 -day period, indicating minimal risk of relapse. Overall, the nutraceutical composition of the present disclosure offers a safer, more consistent, and effective alternative to conventional high-dose vitamin D3 supplementation.

[0199] TECHNICAL ADVANCEMENTS

[0200] The present disclosure described hereinabove has several technical advantages, including, but not limited to, the realization of a nutraceutical composition that;

[0201] • is capable of improving health;

[0202] • can prevent and / or treat nutrient deficiencies;

[0203] • is capable of maintaining a stable level of nutrients over a long period of time; and • does not have adverse effects on the human body,

[0204] and

[0205] a process for the preparation of the nutraceutical composition that is simple, economic and easy to scale-up.

[0206] The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.

[0207] The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and / or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein. The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.Any discussion of documents, acts, materials, devices, articles, or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application. The numerical values mentioned for the various physical parameters, dimensions, or quantities are only approximations and it is envisaged that the values higher / lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

[0208] Having described and illustrated the principles of the present disclosure with reference to the described embodiments, it will be recognized that the described embodiments can be modified in arrangement and detail without departing from the scope of such principles. While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS:

1. A nutraceutical composition in the form of a soft gel capsule comprising:i. a core comprising:• a predetermined amount of at least one carrier;• a predetermined amount of at least one micronutrient;• a predetermined amount of at least one antioxidant; and • a predetermined amount of at least one first flavouring agent, and ii. a shell comprising• a predetermined amount of water;• a predetermined amount of at least one gelling agent;• a predetermined amount of at least one first plasticizer;• a predetermined amount of at least one second plasticizer;• a predetermined amount of at least one sweetening agent;• a predetermined amount of at least one second flavouring agent• a predetermined amount of at least one coloring agent; and• optionally a predetermined amount of at least one anti-caking agent, wherein said core is encapsulated in said shell.

2. The nutraceutical composition as claimed in claim 1, wherein• said carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee);• said micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin;• said antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate (Vitamin E), rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof;• said first flavouring agent and said second flavoring agent are independently selected from the group consisting of lemon oil, peppermint oil, vanilla flavour, anise, orange, holy basil (tulsi), cinnamon, cardamom, and a combination thereof;• said gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof;• said first plasticizer and second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and a combination thereof;• said sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, coconut sugar, date syrup, date sugar, jaggery, and honey; and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, erythritol, and cyclamate;• said preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof;• said coloring agent is selected from the group consisting of Quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof.

3. The nutraceutical composition as claimed in claim 2, wherein• said fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K; and• said water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, and vitamin B12.

4. The nutraceutical composition as claimed in claim 1, wherein said anti -caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof.

5. The nutraceutical composition as claimed in claim 1, wherein• said predetermined amount of said carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of said nutraceutical composition; and• said predetermined amount of said first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of said nutraceutical composition.• said predetermined amount of said gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said second flavoring agent is in the range of 1 mass% to 2 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of said nutraceutical composition; and• said predetermined amount of said anti-caking agent is in the range of 0 mass% to 5 mass % with respect to the total mass of said nutraceutical composition.

6. The nutraceutical composition as claimed in claim 1 has a shelf life in the range of 22 months to 26 months.

7. A process for the preparation of a nutraceutical composition in the form of soft gel capsules, said process comprising the following steps:a) melting a predetermined amount of at least one carrier at a first predetermined temperature to obtain a melted carrier;b) cooling said melted carrier to a second predetermined temperature, followed by adding a predetermined amount of at least one micronutrient, a predeterminedamount of at least one antioxidant and a predetermined amount of at least one first flavouring agent under stirring to obtain a core composition;c) separately, heating a predetermined amount of water at a third predetermined temperature, followed by adding predetermined amounts of at least one gelling agent, at least one first plasticizer, at least one second plasticizer, at least one sweetening agent, at least one preservative, at least one coloring agent, at least one second flavouring agent and optionally, a predetermined amount of at least one anti-caking agent to obtain a shell composition;d) serially injecting a predetermined amount of said shell composition maintained at a fourth predetermined temperature in a bath containing at least one pharmaceutically acceptable oil maintained at a fifth predetermined temperature, immediately followed by injecting a predetermined amount of said core composition maintained at a sixth predetermined temperature, to enable said shell composition to encapsulate said core composition in said bath to obtain capsules; ande) washing said capsules with a solvent, followed by drying to obtain said nutraceutical composition in the form of soft gel capsules.

8. The process as claimed in claim 7, wherein• said micronutrient is selected from a fat-soluble vitamin and a water-soluble vitamin;• said carrier is selected from the group consisting of a vegetable oil, a fish oil, and clarified butter (ghee);• said antioxidant is selected from the group consisting of DL-alpha-tocopheryl acetate, rosemary extract, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), propyl gallate, ubiquinone, and a combination thereof;• said first flavouring agent and said second flavouring agent are independently selected from the group consisting of lemon oil, peppermint oil, anise, orange, holy basil (tulsi), cinnamon, cardamom, vanilla flavour and a combination thereof;• said gelling agent is selected from the group consisting of carrageenan, gelatin, gellan gum, pectin, agar, and a combination thereof;• said first plasticizer and said second plasticizer are independently selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol, triethyl citrate, and a combination thereof;• said sweetening agent is selected from a natural sweetener selected from the group consisting of stevia, monk fruit extract, coconut sugar, date syrup, date sugar, jaggery, and honey; and an artificial sweetener selected from the group consisting of sucralose, aspartame, acesulfame-K, saccharin, erythritol, and cyclamate;• said preservative is selected from the group consisting of sodium benzoate, potassium sorbate, methylparaben, propylparaben, calcium propionate, and a combination thereof;• said coloring agent is selected from the group consisting of quinoline yellow, sunset yellow FCF, tartrazine, titanium dioxide, iron oxides, and a combination thereof; and• said anti-caking agent is selected from the group consisting of starch, silicon dioxide, calcium silicate, magnesium stearate, talc, and a combination thereof.

9. The process as claimed in claim 8, wherein• said fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin E, and vitamin K; and• said water-soluble vitamin is selected from the group consisting of vitamin C, vitamin Bl, vitamin B2, vitamin B6, and vitamin B12.

10. The process as claimed in claim 7, wherein• said predetermined amount of said shell composition is in the range of 20 mass% to 30 mass% with respect to the total mass of said nutraceutical composition; and• said predetermined amount of said core composition is in the range of 70 mass% to 80 mass% with respect to the total mass of said nutraceutical composition.

11. The process as claimed in claim 7, wherein• said predetermined amount of said micronutrient is in the range of 0.35 mass% to 0.5 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said carrier is in the range of 65 mass% to 80 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said antioxidant is in the range of 0.1 mass% to 0.8 mass% with respect to the total mass of said nutraceutical composition; and • said predetermined amount of said first flavouring agent is in the range of 8 mass% to 10 mass% with respect to the total mass of said nutraceutical composition.

12. The process as claimed in claim 7, wherein• said predetermined amount of said gelling agent is in the range of 3 mass% to 5 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said first plasticizer is in the range of 0.5 mass% to 1 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said second plasticizer is in the range of 6 mass% to 8 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said sweetening agent is in the range of 0.7 mass% to 1 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said preservative is in the range of 0.1 mass% to 0.2 mass% with respect to the total mass of said nutraceutical composition; • said predetermined amount of said coloring agent is in the range of 0.1 mass% to 0.3 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of said second flavouring agent is in the range of 1 mass% to 2 mass% with respect to the total mass of said nutraceutical composition;• said predetermined amount of water is in the range of 5 mass% to 10 mass% with respect to the total mass of said nutraceutical composition; and • said predetermined amount of said anti-caking agent is in the range of 0 mass% to 5 mass % with respect to the total mass of said nutraceutical composition.

13. The process as claimed in claim 7, wherein• said first predetermined temperature is in the range of 60 °C to 80 °C;• said second predetermined temperature is in the range of 30 °C to 50 °C;• said third predetermined temperature is in the range of 85 °C to 95 °C;• said fourth predetermined temperature is in the range of 85 °C to 95 °C;• said fifth predetermined temperature is in the range of 15 °C to 30 °C; and • said sixth predetermined temperature is in the range of 30 °C to 50 °C.

14. The process as claimed in claim 7, wherein said pharmaceutically acceptable oil is selected from the group consisting of a mineral oil, a medium chain triglyceride oil, and a refined vegetable oil.

15. The process as claimed in claim 7, wherein said solvent is selected from the group consisting of hexane, ethanol, isopropyl alcohol and a combination thereof.

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