DESC:
FIELD OF THE INVENTION
The present invention provides the chewable composition. The chewable composition according to present invention is indicated for treatment of diseases arising from deficiencies of various nutrients. The present invention further relates to the process of preparing the novel composition comprising nutritional ingredients.

BACKGROUND OF THE INVENTION
Vitamin deficiencies are very common globally. Unless severe, they are often clinically unrecognized, yet even mild deficiency may have significant adverse consequences. Vitamin deficiencies affect all ages and frequently co-exist with mineral (zinc, iron, iodine) deficiencies. The groups most susceptible to vitamin deficiencies are pregnant and lactating women, and young children, because of their relatively high needs for these compounds and susceptibilities to their absence. These include death from infectious diseases, anemia, death during pregnancy or childbirth and impaired cognition and physical development. The effects of vitamin deficiencies are related to the biochemical roles they play. Some of the most common deficiencies relate to vitamin A, B-Complex vitamins, vitamin B-9 (folate) and vitamin D. Supplementation programs have made diseases such as scurvy (vitamin C deficiency) or pellagra (niacin deficiency) rare.

Vitamin D (also referred to as “calciferol”) is a fat-soluble vitamin that is naturally present in a few foods, added to others, and available as a dietary supplement. It is also produced endogenously, when ultraviolet (UV) rays from sunlight strike the skin and trigger vitamin D synthesis.

Vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations to enable normal bone mineralization and to prevent hypocalcemic tetany (involuntary contraction of muscles, leading to cramps and spasms). It is also needed for bone growth and bone remodeling by osteoblasts and osteoclasts. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D also helps protect older adults from osteoporosis. In foods and dietary supplements, vitamin D has two main forms, D2 (ergocalciferol) and D3 (cholecalciferol), which differ chemically only in their side-chain structures. Both forms are well absorbed in the small intestine. Absorption occurs by simple passive diffusion and by a mechanism that involves intestinal membrane carrier proteins. The concurrent presence of fat in the gut enhances vitamin D absorption, but some vitamin D is absorbed even without dietary fat. Neither aging nor obesity alters vitamin D absorption from the gut.

There are several marketed formulations comprising multiple ingredients including multivitamin and other natural nutritional ingredients, which are indicated to overcome the deficiencies. The commonly available dosage forms are multivitamin capsules, tablets, syrup, and solutions. Chewable dosage forms are not conventional forms for drug delivery purpose. Chewable dosage forms provide several advantages including oral drug delivery without the need for water, ease of swallowing, palatable taste, the stability advantages of solid dosage forms, and patient-centric drug delivery. They provide a convenient means of pediatric drug delivery and the delivery of nutritional products such as chewable multivitamins. Chewable dosage forms are a widely used dosage forms for the delivery of pharmaceutical, nutraceutical, and veterinary active substances. Chewable dosage forms have the advantages of conventional tablets in terms of manufacturability, dosing accuracy, portability, and long-term stability. Additionally, chewable dosage forms facilitate swallowing as the product is initially broken down into particles in the oral cavity. This is a useful patient-centric advantage for populations such as pediatrics and geriatric patients for whom swallowing of conventional dosage forms is a concern. As water is not required for their administration, there is a benefit of convenience when dosing.

There are several prior art documents disclosing the pharmaceutical compositions in the form of chewable dosage form:
US5405613 discloses a composition comprising Shilajit or an extract thereof in a vitamin and/or mineral preparation. Shilajit is a compact mass of vegetable organic matter, composed of a gummy matrix interspersed with vegetable fibers and minerals. Substances which have been identified in Shilajit include moisture, gums, albuminoids, calcium, potassium, nitrogen, silica, resin, vegetable matter, magnesium, sulphur, iron, chloride, phosphorous, iodine, glycosides, tannic acid, benzoic acid and a number of vitamins and enzymes.
WO2018236990 discloses the method of making a gummy composition, comprising providing a gelatin blend, comprising gelatin and a swelling agent, providing a bonding blend, comprising a combination of at least two of a monosaccharide, a disaccharide and a tri-saccharide, providing an active blend, comprising an active agent and a liquid solvent, wherein the liquid solvent comprises a diprotic solvent, tri-protic solvent, or a combination thereof, combining the active blend, the bonding blend and a gelatin blend to provide a molding blend, and forming the molding blend into a gummy composition.
WO2022051165 discloses a gummy composition including a set emulsification of an oil phase in a water phase, wherein the water phase comprises a structurant, and wherein the gummy composition has a hardness of 150 g Force or greater and a water activity below 0.73. A method including administering a gummy composition including a set emulsification of an oil phase in a water phase and the gummy composition includes a hardness of 150 g Force or greater and a water activity below 0.73.
There are several disadvantages of the available multivitamin and nutritional dosage forms such as they are commonly available in conventional dosage forms which may not be sometimes user friendly for some segments of patients like pediatrics and geriatrics. Further, the source of conventionally available multivitamins and nutritional composition as well as the gummies may be animal based or agar based, which is not acceptable by the wide range of patient population in India following vegetarian or vegan diet. Additionally, the conventional dosage forms may face the issue with absorptions through gastrointestinal tract as most of the nutritional ingredients are macromolecules and may not easily absorb through GIT.

The present inventors, however, have come up with a novel composition comprising nutritional ingredients in the form of chewable dosage form, wherein the said composition overcomes the drawbacks posed by the conventional dosage forms. The dosage form according to present invention is found to be cost-effective, easy to administer, patient compliant, having desirable taste and texture, highly acceptable and having improved bioavailability owing to good absorption through GIT. Further, all the ingredients in the present invention are obtained from plant-based or vegan source and hence have improved acceptability by all the segments of patients.

OBJECT OF THE INVENTION
One object of the present invention is to provide the composition comprising nutritional ingredients.
Another object of the present invention is to provide the composition in the form of solid oral chewable dosage form comprising nutritional ingredients and optionally one or more excipients.
Yet another object of the present invention is to provide the process for preparing the composition in the form of solid oral chewable dosage form comprising nutritional ingredients.
A further object of the present invention is to provide a composition comprising nutritional ingredients capable of exhibiting acceptable palatability, and preferably a consistency that is suitable for children, women, adults and geriatrics.
Other objects of the present invention will be apparent from the description of the invention herein below.
SUMMARY OF THE INVENTION
In one aspect, the present invention provides the novel composition in the form of solid oral chewable dosage form.
In another aspect, the present invention provides the novel composition in the form of solid oral chewable dosage form, preferably gummies, wherein the said composition comprises one or more vitamins, nutritional ingredients and optionally one or more excipients.
In yet another aspect, the present invention provides the novel composition in the form of solid oral chewable dosage form, preferably gummies, comprising one or more vitamins, nutritional ingredients, wherein the said nutritional ingredients are obtained from vegan sources.
In another aspect, the present invention provides the composition in the form of gummies, wherein the said composition comprises
a) one or more vitamins,
b) optionally one or more plant based nutritional component, and
c) at least one gelling agent obtained from vegan source,
d) at least one bulking agent,
e) optionally one or more other excipients.
In yet another aspect, the present invention provides the process for preparation of novel composition in the form of gummies.
In another aspect, the novel composition is intended as food supplement for children, women, adults and geriatrics.
DESCRIPTION OF THE INVENTION
The invention will now be described in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully interpreted and comprehended. However, any skilled person or artisan will appreciate the extent to which such embodiments could be generalized in practice.
The term “composition” herein refers to the combination of one or more drug substances and one or more excipients, “drug product”, “pharmaceutical dosage form”, “dosage form,” “final dosage form” and the like, refer to a pharmaceutical composition and/or nutritional composition that is administered to a subject in need of treatment and generally may be in the form of tablets, capsules, tablets filled in capsule, gummies, gels, mini tablets filled in capsule, sachets containing powder or granules, pellets, liquid solutions or suspensions, patches and the like.
The present invention discloses, cost-effective, easy to administer, patient compliant, bioavailable, improved composition comprising nutritional ingredients and plant-based ingredients.
The present invention discloses, cost-effective, easy to administer, patient compliant, bioavailable, stable composition comprising nutritional ingredients and plant-based ingredients.
According to the first embodiment, the present invention provides novel composition comprising nutritional ingredients and plant-based ingredients. The composition of the present invention is in the form of solid oral chewable dosage form which may be selected from but is not limited to chewable tablet, pellets, or gummies and the like. The chewable dosage form according to the present invention is preferably in the form of gummies.
Formulation of gummies requires consideration of certain factors that are insignificant in other oral delivery systems. For example, taste is most important factor, therefore, electing good-tasting raw materials is helpful and produces a more acceptable result, ultimately yielding a greater probability of success for the product. Other factors under consideration are color as many active ingredients can have powerful or sometimes off-putting colors and dosage, which can be used to determine serving size when given usage rate. Further, selecting the active agents to be incorporated in gummies keeping the above aspects in picture is one of the tricky tasks, as taste of the components is one of the deciding factors.
It is presented that the gummies composition comprising natural ingredients to overcome the deficiencies of micronutrients especially vitamins and minerals. The novel composition comprising nutritional ingredients, wherein the said ingredients may act as the sources of various macro and/or micro-nutrients comprising vitamins and minerals as well as phytonutrients. The vitamins according to present invention is selected from the group comprising from but not limiting to vitamin A, vitamin B-complex, vitamin C, various types of vitamin D includes vitamin D2 and vitamin D3. The other nutrients according to the present invention may constitute various minerals and phytonutrients comprising but not limiting to carotenoids, phenolics, ellagic acid, resveratrol, glycosylates, anthocyanins, flavonoids, phytoestrogens and the like.
The mineral sources are selected from but not limited to zinc sulphate, potassium sorbate, tricalcium phosphate.
In one embodiment the composition optionally comprises the plant-based ingredients which acts as a source of various nutrients such as vitamins and minerals. The plant based nutritional source according to the present invention may be selected from the group comprising of vaccinium leschenaultia (cranberry), vitis vinifera (grape pomace), aloe barbadensis miller (aloe gel), malpighia emarginat (acerola cherry), curcuma longa (turmeric), citrus limon (lemon), psidium guajava (guava), tamarindus indica (tamarind), emblica officinalis (amla), various forms of lichens and the like.
In a preferred embodiment, the present invention provides the composition in the form of gummies, comprising one or more vitamins, one or more plant based nutritional component, and one or more excipients.
In one embodiment, the present invention provides the novel composition comprising nutritional ingredients, wherein all the nutritional ingredients are obtained from vegan sources.
The composition according to the present invention further comprises the vegetable oil base. The absorption of the fat-soluble vitamins is facilitated by the concurrent presence of fats in the composition. After administration of the gummies, the absorption is enhanced by utilizing vegetable oil base containing triglycerides. Upon ingestion, the fate of vitamins in gastrointestinal tract is driven by the fate of co-formulated triglycerides identical to those of major dietary lipids. The process governing permeation of vitamin across the enterocytes includes various steps such as emulsification of the vitamin-oil composite, solubilization of vitamin-oil composite in physiological micelles, diffusion across the unstirred water layer lining the gut mucosa and passive diffusion across the enterocytes. The vitamin micelles thus formed are nano-sized and promote efficient solubilization and permeation of vitamin across the gut mucosa. Thus, the present invention provides the improved bioavailability upon oral administration.
In yet another embodiment, the present invention provides the novel composition in the dosage form of gummies delivery system, wherein the said dosage form is having desirable taste and texture and easily acceptable by all the patient groups.
In another embodiment, the present invention provides the composition in the form of gummies, comprising one or more vitamins, one or more plant based nutritional component, and one or more excipients, wherein the said composition further comprises the vegetable oil base.
In another embodiment the excipient comprises but are not limited to gelling agent, bulking agent, buffering agent, preservative, colorant, flavoring agent, sweetener, vehicle, and the like.
The gelling agent according to present invention is selected from but not limiting to Starches obtained from sources such as arrowroot, cornstarch, potato starch, sago, tapioca; vegetable gums: guar gum, xanthan gum, locust bean gum; agar, carrageenan, sodium pyrophosphate, lecithin, mono- and diglycerides pectin, aglupectin and the like.
The bulking agent according to present invention is selected from group consisting of but not limiting to saccharides, saccharide derivatives, hydrogenated carbohydrates, emulsifiers, proteins, processing aids, inorganic salts, Liquid glucose and Sugar and the like.
The buffering agent according to present invention is selected from group consisting of but not limiting to sodium citrate, potassium citrate, Citric acid and Trisodium citrate and the like.
The preservative according to present invention is selected from group consisting of but not limiting to potassium sorbate, citric acid, grapefruit seed extract, sodium sulfite, benzoic acid, calcium sorbate, erythorbic acid, potassium nitrate, sodium benzoate and the like.
The colorants according to present invention is selected from group consisting of but not limiting to E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset Yellow FCF, E120 - Cochineal, carminic acid, Carmines, E122 Azorubine (Carmoisine), E123 Amaranth, E124 Ponceau 4R (Cochineal Red A), E127 Erythrosine, E129 Allura Red, E131 Patent Blue, E132 Indigo Carmine (Indigotine), E133 Brilliant Blue, and E151 Brilliant Black BN and the like.
The flavoring agent according to present invention is selected from group consisting of but not limiting to natural flavoring agents, complex volatile oil (anise oil), aldehyde (vanillin), ginger oil, peppermint oil, and lemongrass oil, orange flavour; artificial or synthetic flavoring agents like methyl salicylate (wintergreen flavor) natural and artificial flavoring agents a blend of esters, aldehydes, ketones, and lactones with natural essential oils and the like.
The sweetening agent according to present invention is selected from group consisting of but not limiting to Acesulfame K, Alitame, Aspartame, Dextrose, Fructose, Galactose, Inulin, Isomalt, Lactitol, Maltitol, Maltose, Mannitol, Neohesperidin, dihydrochalcone, Saccharin, Sodium cyclamate, Sorbitol, Stevia, Sucralose, Sucrose, Tagatose, Thaumatin, Trehalose, Xylitol and the like.
One of the most important components in the formation of gummies is the gelling or thickening agents which are added to the gummy formula to provide the structural support needed for the piece to maintain its shape. Traditionally, gelatin, which is currently sourced from bovine or porcine hides as the most popularly used gelling agent. Gelatin is a robust coagulation agent that performs well with high active usage rates, and produces a bouncy, desirable springy texture. It is also a multifunctional protein and the lowest cost option in most cases. However, the primary disadvantage is that as gelatin is animal product, acceptability is limited only to the non-vegetarian patients. Additional limitations are melting point, as well as the fact that there may be slightly higher regulatory requirements that come with animal-sourced ingredients. The present invention however provides the gummies prepared from the vegetarian sources, with improved acceptance from the vegetarian population and few regulatory compliances.

In another embodiment, the present invention provides the pharmaceutical composition in the form of gummies, wherein the said composition comprises:
a) one or more vitamins,
b) optionally one or more plant based nutritional component,
c) optionally one source of minerals, and
d) one or more pharmaceutically acceptable excipients.
In another embodiment, the present invention provides the composition in the form of gummies, wherein the said composition comprises:
a) one or more vitamins,
b) optionally one or more plant based nutritional component, and
c) at least one gelling agent obtained from vegan source,
d) at least one bulking agent,
e) optionally one or more other excipients.
In yet another preferred embodiment, the present invention provides a process for preparation of novel composition comprising nutritional ingredients wherein the said composition is in the form of solid oral chewable dosage form selected from tablet, pellets or gummies and the like.
In yet another embodiment, the vitamin in present invention is present in concentration range between 0.002% w/w to 1.0% w/w per gummy. More specifically, the vitamin in present invention is present in concentration range of 0.002%w/w to 0.60%w/w per gummy.
In yet another embodiment, the mineral used in the present invention is present in concentration range of 0.05-25%w/w per gummy. More specifically, the mineral used in the presentation invention is the concentration range of 0.05-20 %w/w per gummy.
In further embodiment, the plant-based component in the present invention is present in the concentration range of 0.01-2%w/w per gummy.
In yet another embodiment, the present invention provides a process for manufacturing the composition in the form of gummies, comprising one or more vitamins, one or more plant based nutritional component, and one or more excipients, wherein the said composition further comprises the vegetable oil base.
In yet another embodiment, the present invention provides a process for manufacturing the composition in the form of gummies, wherein the said processes comprise:
i) preparing the sugar and preservative solution having brix value more than 60%;
ii) adding vitamins and plant based nutritional ingredients;
iii) preparing slurry of gelling agent and bulking agent and then heating;
iv) optionally adding other excipients;
v) optionally adding minerals; and
vi) molding, cooling, and drying the gummies.
Degrees Brix is the sugar content of a composition. One degree Brix is 1 gram of sucrose in 100 grams of solution and represents the strength of the solution as percentage by mass. If the solution contains dissolved solids other than pure sucrose, then the °Bx only approximates the dissolved solid content. For example, when one adds equal amounts of salt and sugar to equal amounts of water, the degrees of refraction (BRIX) of the salt solution rises faster than the sugar solution. In one embodiment, the brix value (Degree brix) of the composition reaches more than 60% during the processing.
The curcumin extract was obtained from Sami Labs Limited based in Bangalore rural, Karnataka. Curcumin C3 Complex (Curcuma longa extract) is prepared from the dried rhizomes of Curcuma longa (Turmeric) and standardized for a minimum of 95% Curcuminoids.
Further, the Acerola cherry extract was obtained from Herbo Nutra located in Kasna Surajpur Industrial Area, Gautam Budh Nagar, Greater Noida, Uttar Pradesh, India
In another embodiment, the present invention provides a novel composition comprising nutritional ingredients wherein the said composition is indicated for treatment of various diseases originating from the nutritional deficiency. The present invention also provides nutritional supplements for maintaining bone strength, normal blood levels of minerals like calcium and phosphorus that are required for normal mineralization of bones, muscle contraction, nerve conduction and general cellular function. The present invention can be indicated to further improve the immune function, improving bone mineral density and preventing osteoporosis.

EXAMPLES
The following examples represent various embodiments according to the present invention. The examples are given solely for the purpose of illustration and not to be construed as limiting of the present invention, as many variations thereof are possible without departing from the spirit and scope of invention.
Following examples illustrate the preparation of chewable composition.
Example. 1:
Sr. No. Ingredients F1 F2 F3
%w/w %w/w %w/w
1 Vitamin D3 0.01 0.01 0.01
2 Acerola cherry extract 1.10 1.10 1.10
3 Sugar (Part-1) 26.44 28.64 28.20
4 Sugar (Part-2) 2.20 8.81 2.20
5 Liquid Glucose 30.84 22.03 28.64
6 Purified water (Part-1, for Sugar Syrup) 20.24 20.24 20.24
7 Purified water (Part-2, for Pectin mixture) 16.15 16.15 16.15
8 Potassium sorbate 0.06 0.06 0.06
9 Pectin 2.20 2.20 2.64
10 Tri sodium citrate 0.22 0.22 0.22
11 Citric acid monohydrate 0.29 0.29 0.29
12 Sunset Yellow 0.02 0.02 0.02
13 Flavoring agent 0.23 0.23 0.23

Manufacturing Process:
1) Potassium sorbate and sugar part 1 was dissolved in water and heat upto 90°C-100°C.
2) Liquid glucose was added and continued heating.
3) Vitamin D3 and acerola cherry extract was added and mixed well.
4) Pectin, sugar part 2, sunset yellow, sodium citrate and citric acid monohydrate was Added pre mixed and water was added.
5) Step 3 mixture was heated at 70-80°C for 5-15 minutes.
6) step 5 gummy base slurry was added to step 3 solution and mix well at 70-85°C.
7) Flavoring agent was added to step 6 and mixed.
8) Mixture was poured into moulds and allowed to cool Solidify.
9) Final formulation was removed from moulds after solidification.
10) Formulation was dried at 45°±5°C in hot air oven for 12-24 hours and removed.

Example. 2:
Sr. No. Ingredients Qty. (%w/w)
1 L-lysine HCl 3.14393
2 Vitamin B3 (Nicotinamide) 0.13839
3 Vitamin B6 (Pyridoxine HCl) 0.01887
4 Vitamin B12 (Cyanocobalamin) 0.00003
5 Zinc sulphate 0.07297
6 Pectin 3.01938
7 Sugar part 1 10.06461
8 Sugar part 2 22.64537
9 Glucose syrup 35.22613
10 Potassium sorbate 0.03774
11 Citric acid monohydrate 0.05032
12 Neelicol Ponceau 4R 0.02516
13 Mixed fruit flavor 0.30194
14 Purified water part 1 12.58076
15 Purified water part 2 11.32269
16 Purified water part 3 1.25808
17 Sweetener 0.09363

Manufacturing Process:
1) Sugar part 2, purified water part 2, and glucose syrup was heated on hot plate.
2) Citric acid, colour, potassium sorbate, pectin, sugar part 1 was Pre-mixed and add to purified water part 1 and heated.
3) lysine, nicotinamide, pyridoxine, cyanocobalamin, and zinc sulphate were added to purified water part 3.
4) Step 3 dispersion was added to step 1.
5) step 4 mixture was added to step 2 and mixed. sweet modulator and flavor were added to it and mixed well.
6) 3 ml of 50% w/v citric acid solution was added.
7) mixture was poured into molds and allowed to solidify.
8) Gummies were dried at 45°±5°C in hot air oven for 24 hours and removed the same after complete drying.
Example 3
Sr. No. Ingredients Qty. (%w/w)
1 Purified water 24.18
2 Potassium Sorbate 0.12
3 Liquid glucose 20.54
4 Maltitol syrup (Malty Liquid) 25.67
5 Pectin 2.05
6 Citric Acid monohydrate 0.74
7 Trisodium Citrate 0.16
8 Sugar 23.62
9 L-Lysine HCl 1.90
10 Vitamin B3 (Nicotinamide) 0.13
11 Vitamin B6 (Pyridoxine HCl) 0.02
12 Vitamin B12 (Cyanocobalamin) 0.000031
13 Zinc (Zinc citrate dihydrate) 0.18
14 Color 0.10
15 Flavor 0.51
16 Sweetener 0.08
17 Capol 4915 k qs
18 Olive Oil qs

Manufacturing Process:
1) Sugar part 2, purified water part 2, Maltitol syrup and glucose syrup was heated on hot plate.
2) Citric acid, colour, potassium sorbate, pectin, sugar part 1 was Pre-mixed and add to purified water part 1 and heated.
3) lysine, nicotinamide, pyridoxine, cyanocobalamin, and zinc sulphate were added to purified water part 3.
4) Step 3 dispersion was added to step 1.
5) step 4 mixture was added to step 2 and mixed. sweet modulator and flavor were added to it and mixed well.
6) 3 ml of 50% w/v citric acid solution was added.
7) mixture was poured into molds and allowed to solidify.
8) Gummies were dried at 45°±5°C in hot air oven for 24 hours and removed the same after complete drying.
Example 4
Sr. No Ingredients Qty. (%w/w)
1 Ascorbic acid (for pectin slurry) 0.43
2 Ascorbic acid (Vitamin C) 0.57
3 Zinc sulphate 0.29
4 Curcumin extract 0.12
5 Pectin 2.87
6 Sugar part 1 (for pectin slurry) 7.18
7 Sugar part 2 (for sugar syrup) 28.73
8 Liquid glucose 13.17
9 Potassium sorbate 0.04
10 Sodium citrate (for pectin slurry) 0.36
11 Sodium citrate 0.41
12 Purified water part 2 (for sugar syrup) 19.16
13 Purified water part 1 (for pectin) 21.55
14 Purified water part 3 (for nutrients) 4.79
15 Sweet modulator 0.07
16 Flavor 0.24
17 Coloring agent 0.02

Manufacturing Process:
1) Potassium sorbate and sugar part 2 was heated in water part 2 on hot plate.
2) Liquid glucose was added to step 1 and mix well. Heat for 5-10 minutes.
3) Ascorbic acid, zinc, curcumin extract, sodium citrate, and color were added to water part 3 and mix well. solution was further added this to step 2 and heat till Brix reaches between 85-90%.
4) Pre-mix sugar part 1, pectin, sodium citrate, and ascorbic acid, and add to water part 1. Heat at 60-70°C for 5 min.
5) step 4 slurry was added to step 3 and mix well. Further, flavor and sweet modulator was added to it, mixed, heated for 3-4 mins and poured into molds for solidification.
6) Gummies were dried at 45°±5°C in hot air oven for 24 hours and removed drying is completed
Example 5:
Sr. No. Ingredients Qty. (%w/w)
1 Purified water 33.41
2 Potassium Sorbate 0.12
3 Liquid glucose 15.91
4 Maltitol syrup (Malty Liquid) 23.86
5 Pectin 2.39
6 Citric Acid monohydrate 0.91
7 Trisodium Citrate 0.25
8 Sugar 20.68
9 Vitamin C (plain) 0.99
10 Zinc (as Zinc citrate dihydrate) 0.43
11 Curcumin C3 Complex 0.18
12 Sweet Modulator 0.07
13 Flavor 0.80
14 Capol 4915 k qs
15 Olive Oil qs

Manufacturing Process:
1) Potassium sorbate and sugar part 2 was heated in water part 2 on hot plate.
2) Liquid glucose was added to step 1 and mix well. Heat for 5-10 minutes.
3) Ascorbic acid, zinc, curcumin, sodium citrate, and color were added to water part 3 and mix well. solution was further added this to step 2 and heat till Brix reaches between 85-90%.
4) Pre-mix sugar part 1, pectin, sodium citrate, and ascorbic acid, and add to water part 1. Heat at 60-70°C for 5 min.
5) step 4 slurry was added to step 3 and mix well. Further, flavor and sweet modulator was added to it, mixed, heated for 3-4 mins and poured into molds for solidification.
6) Gummies were dried at 45°±5°C in hot air oven for 24 hours and removed drying is completed.

Example 6:
S. No Ingredients Qty % w/w
1 Vitamin D3 0.006
2 Tricalcium phosphate 16.260
3 Curcumin extract 0.100
3 Sugar (Part-1, for Sugar Syrup) 24.000
4 Sugar (Part-2, for Pectin Dry Mix) 6.000
5 Liquid Glucose 20.000
6 Purified water (Part-1, for Sugar Syrup) 18.374
7 Purified water (Part-2, for Pectin mixture) 13.017
8 Potassium sorbate 0.053
9 Pectin 1.500
10 Tri sodium citrate 0.200
11 Citric acid monohydrate 0.260
12 Sunset Yellow 0.020
13 Flavoring agent 0.210
Total 100.000

Manufacturing Process:
1) Potassium sorbate and sugar part 1 was dissolved in water and heat upto 90°C-100°C.
2) Liquid glucose was added and continued heating.
3) Vitamin D3, Tricalcium phosphate and curcumin extract was added and mixed well.
4) Pectin, sugar part 2, sunset yellow, sodium citrate and citric acid monohydrate was added premixed and water was added.
5) Step 3 mixture was heated at 70-85°C for 5-15 minutes.
6) step 5 gummy base slurry was added to step 3 solution and mix well at 70- 85°C.
7) Flavoring agent was added to step 6 and mixed.
8) Mixture was poured into moulds and allowed to cool Solidify.
9) Final formulation was removed from moulds after solidification.
10) Formulation was dried at 45°±5°C in hot air oven for 12-24 hours and removed.

Example 7:
S. No Ingredients Qty % w/w
1 Tri Calcium Phosphate 15.24
2 Vitamin D3 * (1 Million IU/g,Oil form) 0.01
3 Curcumin C3 Extract Complex 0.09
4 Sugar ( Part-1, for Sugar Syrup) 23.80
5 Sugar (Part-2, for Pectin Dry Mix) 1.88
6 Liquid Glucose (C*Sweet M 01521) 25.05
7 Purified water (Part-1, for Sugar Syrup) 17.53
8 Purified water (Part-2, for Pectin mixture) 13.77
9 Potassium sorbate (Merck) 0.05
10 Aglupectin 1.88
11 Tri sodium citrate 0.19
12 Citric acid monohydrate (Part-1, for Pectin Dry-mix) 0.18
13 Citric acid monohydrate ( Part-2,for Sugar syrup) 3.33
14 Stevia Extract Powder (A97) 0.06
15 Sunset Yellow Supra 0.02
16 Orange Juicy SPL OS FLV 187301(Kerry) 0.20
17 Capol 4915 K (Carnauba wax) qs
18 Olive Oil qs

Manufacturing Process:
1) Purified water (Part-1) was added into the steam jacketed Vessel. Potassium Sorbate was added and dissolved and heated at 100°C. Sugar (Part-1) was added and mix for 15 minutes. Citric acid (Part-2) was dissolved in Purified water (taken from Part-1) and added to the hot sugar syrup. Liquid Glucose was added into the steam jacketed vessel containing hot sugar Syrup solution and heated at 100°C and mixed for 10 minutes to get clear solution. Tricalcium phosphate and Curcumin was mixed into the mixing tank and 15 minutes. Vitamin D3 was added into the mixing tank and mix for 5 minutes.
2) Aglupectin, Tri sodium Citrate, Citric acid monohydrate (Part-1) & Sugar (Part-2), Sunset Yellow supra, Stevia powder was dry mixed to form Gummy Base Mixture). Purified water (Part-2) was added into the S.S Vessel and mixture from step-1 was dispersed and stir well to wet completely.
Pass this wet mass into the Colloidal mill without any circulation. Mixing was continued for 15 minutes at 80°C temperature to get smooth, free-flow, translucent slurry.
3) Nutrient Sugar syrup was mixed under continuous stirring for 5 minutes by maintaining the temperature between 70-95°C.
4) Flavor was added under continuous stirring into Step-3 and mix for 5 minutes
5) The suspension was deposited into the mold, cooled and gummies were collected and dried.

• Stability Data:
The gummies were subjected to stability and various parameters like water content, Assay, microbial limit test was evaluated during stability. The examples complied with all the stability parameters. The stability data was found to be as per below table:

Sr. no. Stability Parameter Specification Results obtained after 06 months stability
1 Description Orange to pale orange colour, orange shaped gummies having orange flavour Complies
2 Water content (%w/w) Not more than 15.0% 8.5 %
3 Assay (%w/w) Not less than 90.0% 96.9-158.1 %
4 Microbial Limit test
a. Total viable aerobic count
b. Total Yeast and molds
c. Staphylococcus aureus
d. Escherichia coli
e. Salmonella species
f. Listeria monocytogenes
g. Deslatomaculum nigrificans
h. Bacillus cereus
i. Clostridium perfringens
Not more than 1000
Not more than 100
Absent in 50g
Absent in 50g
Absent in 25g
Absent in 25g
Absent in 2g
Absent in 50g
Absent in 2g
30
Less than 10
Absent
Absent
Absent
Absent
Absent
Absent
Absent
,CLAIMS:1) A chewable composition in the form of gummies, wherein the said composition comprises:
a) one or more vitamin,
b) one or more plant-based component,
c) one or more source of minerals, and
d) one or more pharmaceutically acceptable excipients.

2) The chewable composition as claimed in claim 1, wherein the vitamin is selected from the group comprising of vitamin B3, vitamin B6, vitamin B12, vitamin C and vitamin D3.

3) The chewable composition as claimed in claim 1 wherein the vitamin is present in concentration range between 0.002% w/w to 1.0% w/w per gummy.

4) The chewable composition as claimed in claim 1 wherein the plant-based component is present in concentration range between 0.01% w/w to 2% w/w per gummy.

5) The chewable composition as claimed in claim 1 wherein the minerals are present in concentration range between 0.05% w/w to 25% w/w per gummy.

6) The chewable composition as claimed in claim 1, wherein the plant-based component is selected from the group comprising but not limiting to vaccinium leschenaultia (cranberry), vitis vinifera (grape pomace), aloe barbadensis miller (aloe gel), malpighia emarginat (acerola cherry), curcuma longa (turmeric), citrus limon (lemon), psidium guajava (guava), tamarindus indica (tamarind), emblica officinalis (amla), forms of lichens.

7) The chewable composition as claimed in claim 1, wherein the sources of mineral are selected from but not limited to zinc sulphate, potassium sorbate, tricalcium phosphate.

8) The chewable composition as claimed in claim 1, wherein the excipients are selected from gelling agent, bulking agent, buffering agent, preservative, colorant, flavoring agent, sweetener, vehicle.

9) The chewable composition as claimed in claim 8, wherein the gelling agent is obtained from vegan source and is selected from starches obtained from sources such as arrowroot, cornstarch, potato starch, sago, tapioca; vegetable gums: guar gum, xanthan gum, locust bean gum; agar, carrageenan, sodium pyrophosphate, lecithin, mono- and diglycerides pectin, aglupectin.

10) A process for preparing a chewable composition in the form of gummies, wherein the said processes comprise:
i) preparing sugar and preservative solution having brix value more than 60%;
ii) adding vitamins and plant based nutritional ingredients;
iii) preparing slurry of gelling agent and bulking agent and then heating;
iv) optionally adding other excipients;
v) optionally adding minerals; and
vi) molding, cooling, and drying the gummies.