Nutraceutical formulations and process for production thereof

Abstract

The present invention relates to a stable nutraceutical edible formulation enriched with synergistic blends of spice extracts such as curcumin, cinnamon, and piperine, along with functional additives including vitamins, polyols, and natural preservatives. The formulation delivers functional ingredients as an organoleptically acceptable format such as gummies, chewables, lozenges, or functional confections. A unique two-stage thermal process—High Temperature-Less Time (HTLT) and Low Temperature-More Time (LTMT)—is employed to optimize the retention of actives during cooking. Water-soluble vitamins are infused at controlled lower temperatures to preserve potency. The optimized matrix ensures over 90% bioactive retention, color stability (∆E ≤ 2.3), oxidative safety (PV ≤ 0.1 meq O₂ / kg), and microbial stability (≤1.5×10² CFU / g) over atleast till 6 months storage. The invention provides a consumer-friendly alternative to capsules or tablets, suitable for preventive healthcare and wellness, especially in children and elderly populations.

Description

[0001] NUTRACEUTICAL FORMULATIONS AND PROCESS FOR PRODUCTION THEREOF

[0002] FIELD OF THE INVENTION

[0003] The present invention provides immunity boosting nutraceutical formulations and process of preparation thereof. Particularly the present invention provides edible immunity boosting nutraceutical formulations comprising a sugar-free pectin base with curcumin, cinnamon, and piperine extracts along with primarily acerola extract and zinc. More particularly the present invention provides a process of production of edible formulations which exhibit antioxidant, antimicrobial, anti-inflammatory, and immunity-enhancing properties.

[0004] BACKGROUND OF THE INVENTION

[0005] Functional food ingredients or supplements need to be administered to the needy patients or subjects through the oral route, which has been the most convenient route of administration. A more sophisticated formulation approach available commercially is the edible gummies. The advantage of gummies as a mode of administering is having multiple functionalities in a single dose to achieve the desired objectives. It is an alternative formulation approach designed with natural materials and incorporated with active ingredients. Many researchers have started working in this area and few innovations have been demonstrated in the recent past.

[0006] Gummy and other forms of edibles (like, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffee or caramels, bars, biscuits or cookies etc) bears invention having natural materials and active ingredients and similar chewable food products are typically available for individuals without chewing disorders or dysphagia, and they present an innovative solution that can potentially broaden the consumer market due to their perceived benefits. The edibles offer a chewable, confectionary appearance, making them appealing to both children and adults. The base of the product typically includes jellifying agents like pectins, modified starch, or gelatin, along with sugars. This composition allows for the dissolution of water-soluble ingredients and suspension of insoluble ones in a viscous matrix, impacting rheological properties [https: / / healthandwellness.medpick.in / product / olly- kids-wellmune-acerola-cherryelder berry-and-zinc-cherry-berry-mighty-immunity-gummy- supplements50-count / ]. However, challenges arise in using gummy as food supplements or nutraceuticals due to the presence of partially or fully hydrogenated oils and high sugar content, often exceeding 50%. Such formulations provide little nutritional value and may contribute to health issues like cardiovascular disease, hyper-glycemia etc. Additionally, concerns arise regarding the suitability of gummies and other related edibles with sugar syrup for diabetic patients and children with attention -def icit / hyperactivity disorder (ADHD). Also, there are acerola based gummies for vitamin-C. These products mainly made for addressing kids’ requirements, but the proposed invention is for all age groups [https: / / bestpharmacy.gr / en / forte-pharma-acerola-vitamin-c-gummies60gummies.html; https: / / euro-pharmas.com / en / vitality / 1506-acerola-vitamin-c-kids-gummies-upsa.html].

[0007] However, the retention of vitamin-C after processing is under high ambiguity. The efforts are also missing to achieve the reduction in oxidative damage of vitamin-C during processing and storage.

[0008] In the same context, there are several reports on the immunity boosting nutraceutical formulated gummies using certain natural ingredients were reported. For example, a chewable tablet formulation containing erythritol, galactooligosaccharide, xylooligosaccharide, acerola cherry powder, kiwi powder as the main raw material was prepared by Wang et [Containing phlox cherry powder chewable tablet and preparation method thereof, Wang, Yongqun; Li, Cheng; An, Qingsong, China, CN106605904 A 2017-05-03]. The inventors claim that the tablet can help support immunity, removing freckles and enhance the beauty, anti-aging function, easy to use, is worthy of popularization etc. However, studies on the availability of the functional ingredients upon exposure to heat during processing of gummies have not been reported.

[0009] Another invention discloses a chewable tablet containing pearl, acerola cherry and natural vitamin E and a preparation method thereof, wherein the raw material combination comprises of pearl powder, acerola cherry powder, D-a-tocopheryl succinate, sorbitol, magnesium stearate, - cyclodextrin and cherry essence. The chewable tablet disclosed by the invention, claims that the pearl powder is rich in divalent metal ions such as calcium, can be complexed with the vitamin C component in the acerola cherry to be in a molecular state. The formulation promotes the absorption of the effective components of pearl and the vitamin C. It endows the health-care functions of enhancing immunity, removing chloasma, and has a significant health-care effect [Chewing tablet containing pearl, acerola cherry and natural vitamin E and preparation method thereof, Zhou, Shuli, CN1 10558557 A 2019-12-13]. Whereas, in this invention, the dual efficacy both in product quality (including shelf life) & health / immunity boosting benefits (through vitamin C retention) has been hypothesized to claim.

[0010] Chen et al. [A chewable tablet containing acerola cherry powder, vc and taurine and preparation method thereof, Inventors: Chen, Qiangju; Zeng, Qi; Lv, Jie; Liu, Dan; Zhang, Jinyong; Liu, Shubing, CN108065286 A 2018-05-25] provides a formulation, a chewable tablet containing acerola cherry powder, vitamin C, taurine, strawberry freeze-dried powder, kiwifruit powder and auxiliary materials. The mass percentage of each component was 10- 20% of acerola cherry powder, 5-10% of vitamin C, 5-10% of taurine, 5-10% of strawberry freeze-dried powder, 5-10% of kiwifruit powder and 40- 70% of auxiliary materials. The formulation was claimed to have high nutritional ingredients with cherry, strawberry and kiwifruit combined with vitamin C and taurine. The tablet is claimed to have the functions of enhancing immunity and relieving physical fatigue. However, the said inventors neither studied the effect of processing conditions on the retention of nutritional values in the tablet nor the effect during during the storage period, the shelf-life and reduction in efficacy of the functional ingredients with ageing during storage.

[0011] Another invention reports on Fructus Phyllanthi compound containing chewable tablets and the preparation method thereof. The tablet is formed by the component of following mass percentage: Fructus Phyllanthi powder 30-80%, Acerola cherry extract 10-30%, xylitol 5-30%, Dsorbite 4.5-40%, menthol 0.01 -0.5%, dolomol 0.1 -0.5%, superfine silica gel powder 0.1 -0.5 %. Initially Fructus Phyllanthi powder and Acerola cherry extract were prepared according to proportion, followed by sieving respective components and then mixing evenly. Pure drinking water is then added, pressed into Fructus Phyllanthi compound chewable tablets. Fructus Phyllanthi compound chewable tablets contain abundant vitamin C, Polyphenols, flavonoids, multiple aliphatic acids, amino acid and several mineral materials. It is also claimed to have good effects in improving human body resistance, slowing down aging, enhancing immunity, promoting the production of body fluid to quench thirst, cleaning throat and benefitting larynx, and supplementing vitamin C. It is also claimed to have decent effect on beauty treatment and cancer. The present invention has reasonable recipe claiming obvious effect and ease of procuring the raw material with a simple technique.[A kind of fructus phyllanthi compound chewable tablets and preparation method thereof, Tan et al, CN103549322 A 2014-02-05].

[0012] Further, a review was reported about a study on the role of various ingredients on the immune system. The chapter reviewed the efficacy of spices such as turmeric (curcumin), cinnamon, ginger, black pepper, saffron, capsaicin, and cumin by investigating the effects of these compounds as COVID-19 disease severity biomarkers. [Spices and Biomarkers of COVID-19: A Mechanistic and Therapeutic Perspective, Shirani, Masha; Talebi, Shokoofeh; Shojaei, Mehrnaz; Askari, Gholamreza; Bagherniya, Mohammad; Guest, Paul C; Sathyapalan, Thozhukat; Sahebkar, Amirhossein, Advances in experimental medicine and biology, 1412, 375-395, DOI: 10.1007 / 978-3-031 -28012-2_20 (2023)]. The study did not specify any formulation and any concept related to production, product quality, and storage study for any product developed by using the ingredients. It also did not answer any problems related to the objective of the proposed invention as claimed in this specification.

[0013] A further study was also reported, which assessed the practice of herbs and spices in view of enhancing immunity during COVID 19. It was carried out over a period of four months (March 2020 to June 2020) at Mysuru city. It was found that study population consumed herbs and spices like Lemon (98%), Tulsi (94%), Pudina (88%) Ginger (95%), Amlakki, (78) curcumin (90%), pepper (92), clove (87%), cardamom (78%), cinnamon (88%), Jeera (98%) to boost immunity during COVID 19. [An observational study to assess the knowledge and practice of herbs and spices during COVID 19, Keerthy, S. P.; Shambhavi, K., European Journal of Biomedical and Pharmaceutical Sciences, 7(10), 450-451 (2020)]. However, no concept on nutraceutical formulations of any edible product has been mentioned, and hence also nothing has been disclosed as synergistic functions among active igredients. No data related to the product quality by the ingredients itself was shown and hence neither the effect on processing conditions on the shelf life of the product has been established.

[0014] In another study [Why do red- and yellow-colored edible herbs create warmth: A system pharmacological view of curcumin-mediated protection of mice from cold stress, Wei, He; Li, Zhao Xue; Ji, Xin Ye; Wang, Xiao Qin; Zhang, Bo, Journal of Functional Foods, 108, 105726, DOI: 10.1016 / j.jff.2O23.105726 (2023)], due to the cold winter, people living in the northwest region of China often eat red or yellow edible herbs to help keep their bodies warm and improve their immunity. Examples of red foods include Chili Peppers and Cinnamon, and examples of yellow foods include Turmeric, Dried Ginger and Carrots. However, the pharmacological properties and warming active compounds of these foods remain unclear. Therefore, an approach combining network pharmacological prediction and experimental validation was adopted to explore the phytochemicals and biological functions of red- and yellow-colored edible herbs for the first time. The results indicated that the warmer Q-markers of red- and yellow-colored edible herbs promoted body heat production and alleviated cold damage by regulating various biological pathways, among which thyroid hormone-mediated thermogenesis was highly correlated. Furthermore, curcumin was indicated to activate the thyroid by upregulating TSHR / TG / TPO / NIS to prolong the survival of mice exposed to -20°C cold stress. The work is in no way related to the technical aspects of present invention.

[0015] In another review, in millennia, nutritionists are motivated to explore innovative approaches against lifestyle-related syndromes for improving public health and life span. Spices are the most promising and cost-effective choice for consumer owing to their high antioxidant potential, i.e., ability to entrap free radicals at cellular level to alleviate various metabolic syndromes. Besides that, spices are not only popular in developed countries, but also attaining consideration in developing world due to their extensive biological activity and safe status. In this regard, contemporary nutrition regime has gained researchers’ attention on spices to mitigate various metabolic syndromes. Moreover, the promising bioactive moieties - i.e., curcumin and curcuminoids (turmeric); limonene (cardamom), allicin, allyl isothiocyanate (garlic), cinnamic aldehyde, 2-hydroxycinnamaldehyde, and eugenol (cinnamon); gingerol, zingiberone, zingiberene (ginger), dipropyle disulfides, and quercetin (onion); piperidine piperine, limonene, a- and p-pinene (black pepper); crocetin, crocin, and safranal (saffron) - have been identified as chemopreventing agents against various malignancies. The review highlighted the immunomodulatory individual active components but fails to prove the use of cuircumin and other claimed ingredients of this patent application and synergistic effect of the ingredients in maintaining the content at the time of processing and during the shelf life of the product [Immunomodulatory perspectives of potential biological spices with special reference to cancer and diabetes, Imran, Muhammad; Nadeem, Muhammad; Saeed, Farhan; Imran, Ali; Khan, Moazzam Rafiq; Khan, Muhammad Asif; Ahmed, Sheraz; Rauf, Abdur, Food and Agricultural Immunology, 28(4), 543-572 (2017)].

[0016] In another review, it is disclosed that lifestyle-related variables such as physical activity and nutritional supplements can decrease inflammatory markers, increase anti-inflammatory and antioxidant status, and improve the immune system. The review highlights the effects of physical activity and nutrients supplements on the immune system and their possible benefits in combating the harms caused by infection with the COVID-19 virus. The article reviews the effects of physical activity and nutrients supplements on the immune system and their possible benefits in combating the harms caused by infection with the COVID-19 virus, but did not state anything on nutraceutical formulations of any edible product. No data related to the product quality was shown and hence neither the effect on processing conditions nor shelf life upon storage of the product was disclosed [Physical Activity and Natural Products and Minerals in the SARS-CoV-2 Pandemic: An Update, Saeidi, Ayoub; Tayebi, Seyed Morteza; To-Aj, Oam; Karimi, Niloofar; Kamankesh, Sahar; Niazi, Saber; Khosravi, Abedin; Khademosharie, Mitra; Soltani, Mohammad; Johnson, Kelly E; Rashid, Harunor; Laher, Ismail; Hackney, Anthony C; Zouhal, Hassane, Annals of Applied Sport Science, 9 (2021)].

[0017] None of the above studies and inventions revealed the specific combination of active ingredients in the specified ratio as immunity gummy or other forms of edibles (like, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffee or caramels, bars, biscuits or cookies etc) to be claimed in the present invention.

[0018] OBJECTS OF THE INVENTION

[0019] The main object of the invention is to provide immunity boosting nutraceutical gummy formulation or other forms of edibles (like, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffee or caramels, bars, biscuits or cookies etc) suitable for all age groups.

[0020] Another object of present invention is to provide a process of preparation of immunity boosting nutraceutical formulation.

[0021] Yet another object of the present invention is to optimize the sugar free pectin based formulation of natural ingredients namely curcumin, cinnamon and piperine extracts in specific proportions along with immunity boosting natural vitamin C from Acerola extract and Zinc to achieve the maximum retention of functional ingredients in the product.

[0022] Yet another object of present invention is to establish the effect of the synergistic nutraceutical formulation of the edibles in the prevention of depletion of functionality of the product by achieving maximum retention of functional ingredients during the harsh processing conditions during the production of the product.

[0023] Still another object of this study is to ensure the effect of the synergistic formulation in the prevention of depletion of functionality of the product during storage.

[0024] Still another object of present invention is to establish the synergistic microbial resistance effect of the functional ingredients (during the complete storage study.

[0025] Still another object of present invention is to provide the individual and potential synergistic effect of curcumin, cinnamon and piperine, on storage stability are tested in all 7 formulations.

[0026] Yet another object of present invention is to provide optimum parameter for shelf life assessment of the immunity boosting nutraceutical formulations over 0 to 180days of storage.

[0027] SUMMARY OF THE INENTION

[0028] Accordingly the present invention provides a nutraceutical formulation for boosting immunity comprising spice extracts selected from curcumin extract, cinnamon extract, and piperine extract in a ratio of 10:0.8:0.09 to 10:12:1.2 along with functional additives and base matrix, wherein said formulation is edible and provide health benefits.. In an embodiment of present invention the edible form is selected from one or more of the group consisting of gummies, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffees, caramels, nutrition bars, or functional cookies and biscuits.

[0029] In another embodiment of present invention the functional additives and base matrix are selected from Acerola extract, Polyols such as maltitol, sorbitol, and xylitol, Fructooligosaccharides, Pectin (INS 440) or other polysacharides, Zinc citrate, Citric acid (INS 330) and trisodium citrate, Natural flavoring agents including lemon oil, Medium chain triglycerides (MCT), Sodium chloride, Preservatives such as potassium sorbate (INS 202), Natural sweeteners, and Water-soluble vitamins including but not limited to vitamins C, and B- complex.

[0030] In yet another embodiment of present invention the said formulation exhibits long-term stability with a shelf life ranging from 0 to 180 days, while retaining around 90% of initial active ingredient potency including curcumin, piperine, cinnamon and Vitamin C under temperature in range of 4 to 32eC, relative humidity in range of 40 to 80%, without direct sunlight exposure.

[0031] In still another embodiment of present invention the said formulation demonstrates antioxidant activity with >67% ABTS inhibition retained over 180 days, with peroxide value ranging from 0.0 to 0.1 meq O2 / kg, indicating high oxidative stability and bacterial load <1.5x102CFU / g over shelf life, confirming microbial safety, and color change AE <2.3 and stable textural attributes, ensuring consumer appeal and functional integrity during storage.

[0032] In still another embodiment of present invention the said formulation comprise sweetners selected from natural sweetner steviol glycosides (INS 960), sugar-free, reduced sugar, and is suitable for all age groups including children and elderly, offering palatable delivery of phytonutrients and vitamins in stable, chewable food formats.

[0033] In yet another embodiment, the present invention provides a process for the preparation of the nutraceutical gummy formulation, wherein the said process comprising steps of: i. preparing a sugar-polyol base by mixing fructo oligosaccharides, maltitol, sorbitol, xylitol, medium chain triglycerides, and water to achieve required stability and consistency; ii. preparing a gelling system by mixing pectin (1.5% to 5.0%, w / w), sodium chloride (0.05% to 0.5%, w / w), and citric acid (0.3% to 1 .5%, w / w) in water; iii. combining the base and gelling mixtures, followed by controlled heating at temperature in range of 110°C-120°C for 15-20 minutes, followed by heating at at 90°C-100°C for 35-45 minutes, under constant stirring at RPM rage of 40-100 to obtain mixture of 60°B-75°B Brix value; iv. sequentially adding functional additives, spice extracts, at defined intervals of 1 to 5 minutes from each addition, wherein the water-soluble vitamin additives are introduced at a temperature in the rage of 70-80°C; v. pouring the final mixture into edible oil-coated moulds or forming trays and cooling at 8°C-14°C to form the edible product; vi. allowing the edible product obtained in step (v) to set for 24 to 36 hours for complete gelation or solidification followed by wrapping and packaging the hardened or dried product in airtight conditions for storage.

[0034] In still another embodiment of present invention the said formulation provides retention of curcumin, piperine, vitamin-C and cinnamon actives with minimum degradation (<10%) for upto 180 days.

[0035] DETAILED DESCRIPTION OF THE INVENTION

[0036] The present invention relates to the preparation of a nutraceutical impregnated, herb enriched, functionally optimized, immunity boosting edible products / formulation (including gummies, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffee or caramels, bars, biscuits or cookies etc) suitable for all age groups. The said formulations are prepared and optimized using sugar free pectin base with mixture of ingredients namely curcumin, cinnamon and piperine extracts in specific ratios along with anti-oxidant boosting vitamin C rich Acerola extract and Zinc.

[0037] The present invention involves the preparation of immunity-boosting edibles (including gummies, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffee or caramels, bars, biscuits or cookies etc) using a sugar-free polysaccharide-base with mixture of spices and other functional agents namely curcumin, cinnamon, piperine, Acerola and zinc. These ingredients are known for their immune-boosting, antioxidant, antiinflammatory properties, antimicrobial, along with health improving features. Basically, due to the antioxidant nature of the ingredients, it has been anticipated to offer protection to each other synergistically and hence potentially hypothesized to retain functionality of active ingredients and increase shelf-life by protecting each other during processing and storage. Various analytical techniques are employed to identify the best combination of the formulation, includes: parameters such as changes in curcumin, vitamin C, and piperine retention, retention of cinnamon actives, texture, color, moisture absorption, rancidity, FFA, trans fat formation and microbial assays. These parameters were further used to study the shelf life of the gummy during the complete storage period with a specific time interval of 90 days for 6 months. The developed gummy to undergo a comprehensive shelf-life study for assessing their functionality retention and microbial resistance efficacy to evaluate the synergistic effect of the standardized proportions of functional ingredients developed for the produced gummy.

[0038] The formulation addresses the increasing demand for immunity-boosting products, particularly during the pandemics and unprecedented situations like COVID-19, offering a promising market potential. The invention claims both the product (gummy) and the process for making it in steps: i. preparing a sugar-polyol base by mixing fructo oligosaccharides, maltitol, sorbitol, xylitol, medium chain triglycerides, and water to achieve required stability and consistency; ii. preparing a gelling system by mixing pectin (1.5% to 5.0%, w / w), sodium chloride (0.05% to 0.5%, w / w), and citric acid (0.3% to 1 .5%, w / w) in water; iii. combining the base and gelling mixtures, followed by controlled heating at temperature in range of 110°C-120°C for 15-20 minutes, followed by heating at at 90°C-100°C for 35-45 minutes, under constant stirring at RPM rage of 40-100 to obtain mixture of 60°B-75°B Brix value; iv. sequentially adding functional additives, spice extracts, at defined intervals of 1 to 5 minutes from each addition, wherein the water-soluble vitamin additives are introduced at a temperature in the rage of 70-80°C; v. pouring the final mixture into edible oil-coated moulds or forming trays and cooling at 8°C-14°C to form the edible product; vi. allowing the edible product obtained in step (v) to set for 24 to 36 hours for complete gelation or solidification followed by wrapping and packaging the hardened or dried product in airtight conditions for storage.

[0039] Further the formulations are studied for retention of the active ingredients during processing, and storage. Also, the synergistic effect of the active ingredients, viz- the curcumin, cinnamon, vitamin C and piperine in the preservation efficacy of potassium sorbate as microbial resistant is also being studied. The complete shelf life study can establish the preliminary findings. The above preliminary findings shall be explored by studying their changes upon storage / ageing.

[0040] The present invention selects the nutraceutical gummy as an exemplary and preferred embodiment due to its popularity, ease of consumption, and compatibility with a wide range of active ingredients. However, the scope of the invention is not limited to gummies alone, as the underlying principle lies in evaluating and optimizing the delivery and retention of bioactive compounds within a food matrix, thereby enhancing nutraceutical potency across diverse edible formats.

[0041] The invention’s broader claims encompass other food forms such as soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffees or caramels, bars, biscuits, and cookies, based on the following justifications:

[0042] Functional Equivalence of Formats: All the listed edible forms share similar physicochemical properties, such as being solid / semi-solid, chewable or dissolvable in the oral cavity, and suitable for oral delivery of nutraceutical actives. They also allow for controlled release, taste-masking, and uniform dispersion of bioactives.

[0043] Commonality in Composition: These food products generally employ comparable matrices — such as sugar / sugar alcohols, gelling agents, emulsifiers, binders, flavoring and coloring agents, and stabilizers — making the incorporation and retention behavior of active ingredients comparable across formats.

[0044] Shared Processing Technologies: Most of the covered formats utilize similar preparation techniques (e.g., heating, molding, compression, or extrusion), which influence the stability and bioavailability of the incorporated nutraceuticals in a consistent manner.

[0045] Scientific Generalization: The invention seeks to analyze and optimize the nutraceutical profile in edible forms by evaluating bioactive behavior in various food systems, and such learnings are generalizable across food formats with comparable matrices and consumption methods.

[0046] Regulatory and Commercial Interchangeability: In the nutraceutical and functional food sectors, these formats are often treated interchangeably for regulatory, therapeutic, and consumer purposes. Thus, limiting the invention to only one form (e.g., gummies) would artificially constrain its utility and applicability. Intent of the Invention: The core intent is not the form factor per se, but to enhance the efficacy and stability of bioactives delivered through a food matrix. The gummy is taken as a representative embodiment, but the claimed invention applies equally to similar delivery systems across the food product spectrum.

[0047] EXAMPLES

[0048] The following examples are given by way of illustration and therefore should not be construed to limit the scope of the present invention.

[0049] EXAMPLE 1 : PROCESS FOR THE PREPARATION OF NUTRACEUTICAL, IMMUNITY GUMMIES

[0050] Cooking : Fructo oligosaccharides, maltitol, sorbitol, xylitol, medium chain triglycerides, and water are taken into a container at appropriate proportion in the specified and optimized range, based on the outcomes of pre-experimental trials. In another container, pectin, sodium chloride, citric acid, and water was added at standardized proportions and both the mixtures were mixed properly. Then, the mixtures were heated in medium to high temperatures in the range of above 100°C for a period of at least one hour. The heating was done in a specialized way that can be termed as High Temperature Less Time (HTLT) & Low Temperature More Time (LTMT) to minimize nutrient deterioration. To avoid lump formation, the mixtures were continuously stirred during heating at an RPM range of 40 to 100. The main objective of this cooking stage is to mix and condense the base ingredients or base matrix in such a way that a maximum degree brix value of 60°B to 75°B can be reached as specified in the product specification.

[0051] Addition of functional ingredients: To make the final gel mixture, both the syrups or base matrix prepared in ‘Step-1 ’ were mixed together and cooked under light to medium heat below 100°C. The heating pattern again followed HTLT and LTMT. Then all the functional ingredients and extracts were added in a sequence with 1 -2 minutes interval between subsequent additions to the syrup mix along with natural lemon flavor, Potassium sorbate (INS 202) and natural sweetners like steviol glycosides (INS 960) or sugar free. After mixing all functional ingredients, water soluble vitamins were injected at disposition or moulding point at temperature below 70°C - 80°C.

[0052] Cooling : The prepared mixture is poured into a mould coated with edible oil. The Moulds were filled with the final mixture by lightly tapping to release air bubbles. The moulds were then passed through the cooling chamber with a temperature ranging between 8°C to 14°C. By this process, the moulded mix turns into thick gel and gummies are formed. The gummies are then set aside at least 24 hours and once the gummies have hardened, they are removed from the mould, wrapped and stored in an airtight container. The storage study of the produced samples were conducted under ambient condition (temperature: 28±5eC and RH: 60±20%, without direct sunlight exposure) or under 4±2eC refrigeration.

[0053] The composition of the active ingredients has been experimentally varied and their retention and synergistic effect of the individual components under various processing conditions are being studied. Also, complete shelf life study will be carried out to establish the preliminary findings on the potential positive impact on product functionality and shelf life of gummies during storage. The details on the results, best methods with data of the experiments will be given in the final specification.

[0054] EXAMPLE 2 - EXPERIMENTAL DESIGN

[0055] There are seven types of gummy formulations that have been formulated for developing the most effective gummy to achieve the desired goals of the instant invention. The basic ingredients of the functional immunity boosting gummy include: Fructo oligosaccharides; Maltitol, Sorbitol, Xylitol; Pectin (INS 440); Acerola extract (25% Vitamin C); Zinc citrate; Citric acid (INS 330) & Trisodium citrate (INS 331 (iii); Natural Lemon flavor; Medium chain triglycerides; Sodium chloride; Potassium sorbate (INS 202); Steviol glycosides (INS 960). The range of content of each ingredient in the gummy has been standardized and formulated by pre-experimental trials and keeping the consideration of allowable range of regulatory standards.

[0056] In this invention, three variables of functional ingredients are curcumin extract (95%), cinnamon extract (10% polyphenols), Acerola extract (vitamin C) and piperine (black pepper extract). These extracts are purchased from commercially available suppliers and did not directly use from natural origin of biological resources. The sources of purchase of the biological materials till this stage of work are provided bellow:

[0057] Details of Biological Resources used in invention

[0058] By following the standard experimental design with these three functional ingredients, seven gummy formulations were made to experimentally establish the claims on multiple objectives. Formulations 1 , 2, and 3 (Gummy 1 , 2, 3) each contain one of the functional ingredients — curcumin, cinnamon, or piperine. Formulations 4, 5, and 6 (Gummy 4, 5, 6) consist of different combinations of two functional ingredients. Gummy 7 contains all three functional ingredients: curcumin, cinnamon, and piperine. Other basic ingredients of the gummy were kept constant within the range for all the seven gummy types. The composition and range of ingredients of all seven gummy types are tabulated in Table 1 . Table 1 : The composition and range of ingredients of all seven gummy types

[0059] (G1, G2, G3, G4, G5, G6 & G7 refers to Gummy type 1 , Gummy type 2, Gummy type 3, Gummy type 4, Gummy type 5, Gummy type 6, and Gummy type 7 respectively)

[0060] EXAMPLE 3: IDENTIFICATION OF THE MOST EFFECTIVE FUNCTIONAL GUMMY

[0061] Keeping in view on the objective of the invention and to establish the claims on synergistic effect of the formulation on the retention of vitamin C and other functional ingredients during the process of gummy making, as well as throughout the storage period, and also there effect on shelf life extension, and also further the novel effect of the process of making the gummy on maximum retention of functional ingredients, it has been decided to carry out the following studies on different gummy formulations - fresh as well as on storage / ageing. The gummies are initially extracted with ethanol in which the curcumin, Vitamin C and piperine are soluble. The concentrated ethanol solution is made into stock solutions and used for various analysis

[0062] Curcumin retention: Concentration of the curcumin present in different gummies has been analyzed using HPLC UV-Detector at 421 nm against the standard curcumin. The curcumin content (mg / g) in different gummy samples & their changes during storage are tabulated bellow:

[0063] Vitamin C retention: Vitamin C concentration present in different gummies has been determined by assessing the ascorbic acid content in the gummy extract. This method employs a redox titration using iodine and starch. The ascorbic acid content (mg / g) in different gummy samples and their changes during storage are as tabulated bellow:

[0064] Piperine retention: HPLC reverse phase column, UV-Vis detector at 343 nm has been employed to analyze the piperine concentration in different gummy samples in fresh as well as at various stages during storage. The piperine content (mg / g) in different gummy samples and their changes during storage are as tabulated bellow:

[0065] Cinnamon active: HPLC reverse phase column has been employed to analyze the cinnamon active concentration in different gummy samples in fresh as well as at various stages during storage. The cinnamon active content (mg / g) in different gummy samples and their changes during storage are as tabulated bellow:

[0066] Texture: It is determined employing a texturometer, where hardness, adhesiveness, cohesiveness, chewiness, springiness, and resilience of the product are revealed. This is being carried out for different gummy samples in fresh as well as during storage. The rheological or textural properties, like- hardness-1 (g), hardness-2 (g), cohesiveness, springiness (mm), and adhesiveness (mJ) of different gummy samples and their changes during storage are as tabulated bellow: TABLE 6: RHEOLOGICAL / TEXTURAL PROPERTIES OF DIFFERENT GUMMY SAMPLES

[0067] Color [L, a, b, Hue, Chroma & AE]: It is determined using a colorimeter (R-400). The Cartesian coordinates CIE LAB with L* - Lightness (varying from 0-black to 100- white). Where a* and b* opposed colour coordinates carry from -60 to +60. AE represents the overall colour change of the gummy during storage with storage time as a function. The value of overall color change (AE) was calculated from L*, a* and b* value by using the following formula:

[0068] The AE of different gummy samples at different storage points are as tabulated bellow: Moisture absorption / content: Hot air oven method is being used for this purpose, where the sample is flattened and broken and kept in an oven at 105°C till a constant weight of the sample is reached. The difference in weights is taken as the amount of moisture in the sample. The % moisture content (wb) of different gummy samples and their changes during storage are as tabulated bellow:

[0069] FFA: FFA is being determined by titrating the sample dissolved in methanol against 0.1 N KOH solution. The % free fatty acid (%FFA) of different gummy samples and their changes during storage are as tabulated bellow:

[0070] Anti-oxidant property: The antioxidant capacity of the formulation was determined using the ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid)) radical cation decolorization assay. In this method, the ABTS*+radical is generated by reacting ABTS with an oxidizing agent, and the reduction in absorbance at 734 nm upon addition of the sample is measured. The extent of decolorization is proportional to the antioxidant activity of the test compound. The % ABTS inhibition of different gummy samples and their changes during storage are as provided in TABLE-10 of the specification.

[0071] Table 10: Percentage ABTS inhibition of different gummy samples at different volume and their changes during storage

[0072] Oxidative rancidity: It is being determined by estimation of peroxide value of the gummy samples. The peroxide value (meq O2 per Kg) of different gummy samples and their changes during storage are as tabulated bellow:

[0073] Microbial assay at every three months: Having different carbohydrate & nutrient sources in the gummies, it is possible that different microbes, including bacteria may get attracted and grow on it. So, the microbial assay of the gummy samples w.r.t. bacterial and fungal load in terms of CFU (colony forming unit) shall be assessed for entire storage period of the gummy samples at every three months’ interval keeping storage time as a function till six months of storage (TABLE-12). It is the important part to establish our hypothesis on synergistic effect of the functional ingredients w.r.t. their antimicrobial efficacy, and hence contribution in extension of shelf life of the product. EXAMPLE 4: Countering ability of the formulations and specially designed heating process on the effect of processing conditions: A key innovation in the described process for nutraceutical gummy preparation lies in the strategic application of dual thermal processing techniques (DTPT), namely High Temperature-Less Time (HTLT) and Low Temperature- More Time (LTMT). These thermal modes are scientifically integrated to maximize nutrient retention, particularly of heat-sensitive bioactives like curcumin, vitamin C, and piperine, during cooking and syrup formation stages. The HTLT approach involves heating the gummy base ingredients or base matrix to temperatures above 100°C — typically in the range of 105°C to 115°C — but only for a brief period of 8 to 15 minutes. This method is particularly useful during the initial cooking phase to rapidly achieve the desired Brix level (60°-75°) without prolonged exposure to heat, thus minimizing thermal breakdown of macronutrients and carriers like MCT oil and sugar alcohols. Conversely, the LTMT approach employs lower temperatures (85°C to 95°C) sustained for a longer duration of 25 to 40 minutes, allowing gradual thickening and better incorporation of heat-sensitive ingredients. This phase is critical when the pectin-citric acid system is activated for gel matrix formation, and especially when functional extracts are added in a stepwise fashion. The 1-2 minute interval between additions of curcumin, cinnamon, piperine, and other botanicals allows better emulsification while preventing localized heating or chemical incompatibility. A particularly novel feature of the method is the late-stage addition of water-soluble vitamins, such as vitamin C. These are introduced just before moulding, at a reduced temperature range of 70°C to 80°C, preventing their exposure to denaturing heat. This ensures significantly higher vitamin retention — demonstrated by over 90% vitamin C stability after 180 days in optimized formulations like G7. Post-cooking, the process uses a temperature-controlled cooling chamber (8°C to 14°C), where the filled gummy moulds are hardened rapidly. This fast cooling not only preserves the textural integrity of the gummies but also arrests residual enzymatic or oxidative degradation, particularly crucial for antioxidant-rich ingredients. Additional supportive steps like tapping the moulds to release air bubbles reduce oxygen incorporation, thereby limiting oxidation of lipophilic actives (e.g., curcumin and MCT), while Potassium sorbate (INS 202) and steviol glycosides (INS 960) contribute to microbial safety and clean sweetness, enhancing product shelf stability. The process is further reinforced by pre-experimental optimization trials, where different combinations and concentrations of active ingredients were evaluated for synergistic stability and bioactivity. The integration of HTLT and LTMT strategies, along with timed ingredient addition and cold-set gelation, makes this method a comprehensive, science-backed protocol for producing functionally potent and shelf-stable nutraceutical gummies. The following table shows the retention percentage of the bioactives and functional ingredients in different gummy samples sustaining the processing conditions: Table 13: retention percentage of the bioactives and functional ingredients in different gummy samples sustaining the processing conditions

[0074] EXAMPLE 5: Comparative shelf-life study: The immunity gummies were stored at room temperature packaged in manual wrappers. The individual and potential synergistic effect of curcumin, cinnamon and piperine, on storage stability are tested in all 7 gummy samples, to identify the best combination. This is done by assessing the gummy samples for the above listed parameters with respect to storage time as a function. The tests are carried out at every 90-days interval till 6 months or till any visible development of deterioration, whichever is earlier. The studies start with testing freshly prepared samples (0 Day) as a control, then continue with assessments of the finished product at 90 and 180days of storage. In this regard, to identify the optimum gummy type, out of the seven gummy samples, the following criteria have been adopted: Table 13: Desirability criteria for the Identification of the most effective functional gummy

[0075] The results of the above analysis for fresh and stored gummies were analyzed based on the criteria as mentioned in Table 13 and best gummy out of the seven combinations has been identified. The findings for the above criteria in order to determine the best gummy formulation is as follows: i. Gummy G7 provides maximum curcumin stability, with 100% retention after 180 days, indicating excellent formulation and / or antioxidant protection. Gummy G7 also shows the highest vitamin C stability over 180 days, with 91.3% retention, making it the most stable formulation among all tested types. G7 is statistically the best gummy in terms of piperine retention, with: highest mean content, lowest degradation (least variation), and minimal loss even after 180 days. ii. All cinnamon-containing gummies (G2, G4, G5, G7) show excellent stability (range < 0.04 mg / g). G5 has the highest mean content and minimal degradation. G2 and G4 are extremely stable with slightly lower cinnamon content. G7 is good but showed or detected the lowest cinnamon among the gummy types. According to the analysis, G5 is the best gummy type for cinnamon active retention — highest content with excellent stability. G2 and G4 follow closely due to near-perfect retention and consistent values. However, overall best gummy type shall be decided based on the outcomes of other criteria being assessed. iii. G7 is observed to be most balanced across all parameters: stable hardness, springiness, cohesiveness, and adhesiveness. G4 showed excellent stability in all textural parameters except slightly lower hardness-1 as per the analysis revealed in ANOVA. G1 is also observed good, but adhesiveness increases too much. G2 is observed moderate in statistical analysis; increasing stickiness is observed with time. G3 showed lowest cohesion, acceptable otherwise. G5 and G6 demonstrated increase in adhesiveness and loss in springiness over time. Therefore, as per statistical analysis of rheological properties, the overall ranking of the 7 gummy samples, based on their rheological effectiveness goes as follows: G7>G4>G1 / G3>G2>g5 / G6. iv. Based on AE analysis, Gummy G7 ranks best, showing the highest color stability over 180 days. G6 and G5 also performed well with minimal visible change. G3 and G4 showed borderline acceptability after 180 days. G2 and G1 demonstrated significant and unacceptable changes in color, reducing their consumer appeal. This analysis confirms that Gummy G7 offers the most optically stable formulation, ideal for long-term shelf presence without compromising visual quality. v. Gummy G4 and G7 showed the least moisture variability, with only a 1 % drop from Day 0 to Day 90 and complete stability thereafter. With a mean moisture content of 32.3% and a range of just 1 %, these gummies are statistically the most moisture-stable, suggesting optimal formulation for long-term textural integrity. Gummy G1 , G5, and G6 exhibited moderate fluctuations in moisture (2% range), but the mean values (31 .0%— 31 .3%) remained consistent and within an acceptable range. These are considered statistically acceptable in terms of moisture retention, though less optimal than G4 and G7. Gummy G2 had a notable increase in moisture from 32% to 34%, which was sustained through Day 180. The mean moisture content of 33.3% was the highest among all types. While the range remained at 2%, the upward trend in moisture may raise concerns regarding microbial stability unless preservatives are optimized. Gummy G3 showed a clear downward trend, with a 3% total drop in moisture over 180 days (from 32% to 29%). This is the widest range among all samples and may lead to increased hardness and reduced chewability, making G3 statistically the least preferred in terms of moisture stability. This statistical evaluation supports the selection of G4 and G7 as optimal formulations for longterm storage without compromising moisture balance. vi. Best performers in FFA stability: G7 and G4, with near-flat FFA trends and minimal oxidation. Acceptable stability: G1 , G2, G3, G5 — moderate increase, but within permissible limits. Least desirable: G6 — highest FFA increase, may be prone to lipid oxidation and off-flavor over time. Thus, G7 stands out statistically for its overall minimal FFA rise, making it the most oxidatively stable formulation over time. vii. Statistical analysis of %ABTS inhibition across storage time points reveals that G7 exhibits the highest mean antioxidant activity (67.25%) with a minimal decline of only 1 .6% over 180 days, establishing it as the most potent and stable formulation. G4 and G6 follow closely with strong antioxidant profiles (mean -58-60%) and moderate degradation (-3.3-3.5%), suggesting effective matrix protection of active ingredients. In contrast, G1 and G2 showed the lowest mean inhibition (31.35% and 28.86% respectively) and the highest percentage decline, indicating poor antioxidant retention and formulation instability. These findings, supported by time-series mean comparison and relative percent degradation, statistically confirm that formulations combining curcumin, cinnamon, and piperine (as in G7) ensure superior and sustained antioxidant performance in nutraceutical gummies. viii. The mean peroxide value after 180 days is 0.114 meq O2 / kg, with a standard deviation of 0.083, indicating relatively low but variable oxidation across samples. G4 and G7 show no increase in PV, suggesting excellent oxidative stability, possibly due to the presence of potent antioxidants and / or minimal lipid content. G2, G5, and G6 recorded the highest peroxide increase (+0.2 meq O2 / kg), which, while still within acceptable limits for low-fat gummies, indicates mild oxidation. G1 and G3 showed a modest increase (+0.1 ), staying below the commonly accepted threshold of 1.0 meq O2 / kg for lipid-containing foods. Peroxide value analysis confirms that G7 and G4 are the most stable formulations against oxidative degradation, showing no measurable increase in PV over 180 days. The slight increases observed in G2, G5, and G6 (up to 0.2 meq / kg) remain within safe limits but indicate a higher susceptibility to lipid oxidation, possibly due to minor lipid components or less synergistic antioxidant presence. Statistically, these results reinforce G7’s overall superiority in long-term chemical stability, aligning with its strong antioxidant profile and robust retention of bioactives. ix. Mean bacterial load across all samples and times: 131.0 CFU / g, which is well below the general acceptable limit for functional foods (typically 103CFU / g or lower for total aerobic count). G3, G4, and G7 maintained absolute microbial stability, with no increase at 90 or 180 days — suggesting good preservative effect and effective hygiene in formulation. G7 had the lowest and most stable count (100 CFU / g) throughout, implying superior microbial quality and shelf-stability. G1 , G2, G5, and G6 showed a modest increase (6-8%), yet the final values remained well within safe microbial limits. No significant bacterial proliferation occurred over 180 days, indicating good formulation hygiene, effective use of preservatives (e.g., potassium sorbate), and proper packaging. Statistical evaluation of bacterial count over time confirms that G7 is microbiologically the safest and most stable gummy, followed closely by G3 and G4. Despite minor increases in some samples (G1 , G2, G5, G6), all formulations maintained bacterial counts below critical thresholds. This reinforces that the nutraceutical gummies, especially G7, are suitable for long-term storage under recommended conditions, with negligible risk of microbial spoilage. The trend of changes during 180 days suggests its safe use with best quality till 360 days and even beyond. So, the invention mainly focuses on the gummy formulations and their preparation process.

[0076] EXAMPLE 6: Optimised gummy formulation based on the performance of different gummy formulations: Based on a comprehensive multivariate statistical assessment across twelve key formulation and stability parameters, Gummy G7 emerges as the optimized formulation and the best overall gummy type for nutraceutical application. It consistently outperforms or matches other formulations in critical domains: 100% curcumin retention, highest vitamin C and piperine stability, best antioxidant activity (ABTS inhibition mean 67.25%), zero peroxide development, and minimal free fatty acid (FFA) increase, confirming its superior chemical stability. G7 also ranks first in texture and rheological consistency with balanced values across hardness, springiness, cohesiveness, and adhesiveness, and demonstrates highest color stability (AE = 2.24), ensuring aesthetic appeal. Microbiologically, G7 maintains the lowest and most stable bacterial load (100 CFU / g) throughout storage, affirming excellent hygienic formulation and preservative efficacy. Though it contains the least cinnamon active content among cinnamon-containing variants, its retention is statistically stable. While G5 is the best in cinnamon retention and G4 follows closely in certain secondary parameters (moisture, FFA, and microbial stability), neither match G7’s combined performance. Thus, statistically and scientifically, G7 is the optimal gummy formulation, offering the best compromise between bioactive retention, textural and visual appeal, microbial safety, and chemical stability over extended storage.

[0077] ADVANTAGES OF THE INVENTION

[0078] 1. The optimized ratio of active ingredients formulated for the gummy making, namely curcumin, cinnamon, piperine, acerola and zinc, when used in specific ratiosact synergistically retaining the anti-oxidant and anti-microbial properties of the product . The anti-oxidation effect of the ingredients in optimized ratio formulated for the gummy reduces oxidation and retention of functionality (including vitamin-C) during storage, hence increasing the shelf life. The anti-microbial property helps in protecting against contamination during the preparation and storage

Claims

WE CLAIM1. A nutraceutical formulation for boosting immunity comprising spice extracts selected from curcumin extract, cinnamon extract, and piperine extract in a ratio of 10:0.8:0.09 to 10:12:1.2 along with functional additives and base matrix, wherein said formulation is edible and provide health benefits..

2. The nutraceutical formulation as claimed in claim 1 , wherein the edible form is selected from one or more of the group consisting of gummies, soft chews, chewable tablets, lozenges, pastilles, jellies, hard candies, lollipops, toffees, caramels, nutrition bars, or functional cookies and biscuits.

3. The nutraceutical formulation as claimed in claim 1 , wherein the functional additives and base matrix are selected from Acerola extract, Polyols such as maltitol, sorbitol, and xylitol, Fructo-oligosaccharides, Pectin (INS 440) or other polysacharides, Zinc citrate, Citric acid (INS 330) and trisodium citrate, Natural flavoring agents including lemon oil, Medium chain triglycerides (MCT), Sodium chloride, Preservatives such as potassium sorbate (INS 202), Natural sweeteners, and Water-soluble vitamins including but not limited to vitamins C, and B-complex.

4. The nutraceutical formulation as claimed in claim 1 , wherein the said formulation exhibits long-term stability with a shelf life ranging from 0 to 180 days, while retaining around 90% of initial active ingredient potency including curcumin, piperine, cinnamon and Vitamin C under temperature in range of 4 to 32eC, relative humidity in range of 40 to 80%, without direct sunlight exposure.

5. The nutraceutical formulation as claimed in claim 1 , wherein said formulation demonstrates antioxidant activity with >67% ABTS inhibition retained over 180 days, with peroxide value ranging from 0.0 to 0.1 meq O2 / kg, indicating high oxidative stability and bacterial load <1.5x102CFU / g over shelf life, confirming microbial safety, and color change AE <2.3 and stable textural attributes, ensuring consumer appeal and functional integrity during storage.

6. The nutraceutical formulation as claimed in claim 1 , wherein the said formulation comprise sweetners selected from natural sweetner steviol glycosides (INS 960), sugar-free, reduced sugar, and is suitable for all age groups including children and elderly, offering palatable delivery of phytonutrients and vitamins in stable, chewable food formats.

7. A process for the preparation of the nutraceutical gummy formulation as claimed in claim 1 , wherein the said process comprising steps of: i. preparing a sugar-polyol base by mixing fructo oligosaccharides, maltitol, sorbitol, xylitol, medium chain triglycerides, and water to achieve required stability and consistency; ii. preparing a gelling system by mixing pectin (1.5% to 5.0%, w / w), sodium chloride (0.05% to 0.5%, w / w), and citric acid (0.3% to 1 .5%, w / w) in water; iii. combining the base and gelling mixtures, followed by controlled heating at temperature in range of 110°C-120°C for 15-20 minutes, followed by heating at at 90°C-100°C for 35-45 minutes, under constant stirring at RPM rage of 40- 100 to obtain mixture of 60°B-75°B Brix value; iv. sequentially adding functional additives, spice extracts, at defined intervals of 1 to 5 minutes from each addition, wherein the water-soluble vitamin additives are introduced at a temperature in the rage of 70-80°C; v. pouring the final mixture into edible oil-coated moulds or forming trays and cooling at 8°C-14°C to form the edible product; vi. allowing the edible product obtained in step (v) to set for 24 to 36 hours for complete gelation or solidification followed by wrapping and packaging the hardened or dried product in airtight conditions for storage.

8. The process for the preparation of the nutraceutical formulation as claimed in claim 9, wherein the said formulation provides retention of curcumin, piperine, vitamin-C and cinnamon actives with minimum degradation (<10%) for upto 180 days.

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