Abstract: The present invention to provide a nutraceutical or pharmaceutical or dietary formulation or composition comprising a) vitamins recommended for consumption by children or young adults, (b) a suitable calcium source, (c) at least one dibasic amino acid, (d) taurine, (e) at least one solubilizer, (f) at least one additional agent selected from the group consisting of sweetening agents, flavouring agents, flavour enhancers, preservatives, antioxidants, co-solvents, and (g) water as their core ingredients and additives. The invention provides a formulation in the form of emulsified aqueous syrup where the oil and aqueous phase comprising necessary ingredients or nutraceutical components are emulsified along with additives; it also discusses a method of preparation thereof.
DESC:The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.
The embodiments will be described in detail with corresponding marked references to the drawings, in which the illustrative components of the invention are outlined. The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are construed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.
The present invention relates to a pharmaceutical composition or dietary supplement composition or nutraceutical composition to cure or betterment of certain conditions of just a general health supplement. The present invention in particular relates to a pharmaceutical composition or dietary supplement composition or nutraceutical formulation where the effective amount or a pharmaceutically acceptable derivative thereof in combination with additives like a taste masking agent, a flavor masking agent, a solubilizer, a thickener, a surfactant, a coloring agent, a flavourant, an effervescent agent, an antioxidant, a bio adhesive agent, a pH modifying agent, vitamins, minerals, a dietary supplement, or mixtures thereof can be provided in the form of oral supplement like tablet, gel, powder and specifically as syrup.
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans.
It has further become recognized that various, groups of the human population require different quantities and types of vitamins and minerals to prevent or alleviate diseases, as well as to maintain general good health. For example, it is known that lysine as an essential amino acid enhances appetite and, together with Vitamin D3, improves the absorption of calcium.
Problems, thus, arise concerning the compliance of children for taking different dosage forms, in order to have a complete coverage of their needs regarding micronutrients. Accordingly, there is a need to provide humans, in particular children and/or juveniles with supplementation of essential amino acids and vitamins. Moreover, the vitamin and mineral preparations available up to now for children do not provide sufficient active ingredients to improve appetite and growth.
Furthermore, the invention relates to the use of a pharmaceutical or dietary unit dosage form according to the invention, for the preparation of a pharmaceutical or dietary composition for supplementing the dietary needs of a child or young adult.
The present invention relates to a pharmaceutical composition or dietary supplement composition or nutraceutical composition consisting essentially of
(a) vitamins recommended for consumption by children or young adults,
(b) a suitable calcium source,
(c) at least one dibasic amino acid,
(d) taurine,
(e) at least one solubilizer,
(f) at least one additional agent selected from the group consisting of sweetening agents, flavoring agents, flavor enhancers, preservatives, antioxidants, co-solvents,
and
(g) water.
The present invention relates to the method of preparation method of preparation of nutraceutical or pharmaceutical or dietary formulation or composition in the form of tablet, powder, gel or aqueous syrup.
The present invention also discusses the method of preparation of a nutraceutical or pharmaceutical or dietary formulation or composition which can be prepared in the form of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a liquid composition. The liquid composition can be a solution, a spirit, an elixir, a spray, a syrup.
In prior art discusses onlysingle therapeutic formulations like Brain enhancer (DHA), immunity boosters (Beta glucan & Elder Berry) and wellbeing (Multivitamins & Minerals) and not the complete comprehensive solution for
To meet the above all of the three categories, in one formulation we developed a liquid emulsion-based syrup called as X-rich (Brand Name). Which contains oily phase and aqueous phase along with stabilizers.
DHA & Vitamins A, D3 and E are insoluble in water, all these are solubilized in oil phase by adding suitable emulsifiers. Beta glucon and other Vitamin B complex and Minerals are solubilized in aqueous phase with suitable preservatives. Oil phase and aqueous phase are mixed together under constant temperature and stirring to form an emulsion.
Method of Preparation:
Preparation of Oil Phase:
1. Take tween 80 and heat up to 60°C, then add DHA, BHT, BHA with continuous stirring till a solution is formed.
2. Add Vitamin A, E to the above oil phase with continuous stirring.
3. Heat PG up to 60°C and add vitamin D2 with constant stirring.
4. The required temperature is 45 -50°C.
Preparation off aqueous Phase:
1. Take sorbitol, liquid glucose and honey in a separate tank.
2. Dissolve propylene glycol, di sodium EDTA, Sodium benzoate and Methyl paraben, Propyl paraben in hot water. Stir to form a clear solution.
3. Add the solution to the sorbitol solution tank.
4. Dissolve Vitamin C in hot water heated up to 45°C and added to aqueous phase.
5. Dissolve Calcium panthonate, Vitamins B2, B6 and B12 in water and added to the aqueous phase.
6. Add Elder berry extract to the aqueous phase.
7. Dissolve Beta glucon in hot water and soak it overnight. Filter the solution and add the filtrate to the aqueous phase under constant stirring.
8. Dissolve Zinc sulphate and L-lysine separately and add to the aqueous phase.
9. The required temperature is 45 - 50° C.
Emulsion
1. Add slowly the oily phase to aqueous phase with constant stirring and temperature.
2. Addition of the oil phase to aqueous phase should be minimum two hours, to get stable emulsion.
3. Dissolve citric acid and add to the main bulk solution to maintain the pH 4.5-5.5.
4. Addition of flavouring agents and colouring agents to the emulsion.
,CLAIMS:1. A nutraceutical composition in the form of an emulsified aqueous syrup including essentially of:
(a) vitamins recommended for consumption by children or young adults,
(b) a suitable calcium source,
(c) at least one dibasic amino acid,
(d) taurine,
(e) at least one solubilizer,
(f) at least one additional agent selected from the group consisting of sweetening agents, flavoring agents, flavor enhancers, preservatives, antioxidants, co-solvents,
and
(g) solvent.
2. A nutraceutical composition in the form of an emulsified aqueous syrup comprising:
a. an oil phase containing nutraceutical components solubilized using suitable emulsifiers;
b. an aqueous phase including nutraceutical stabilized with suitable preservatives;
the said oil phase and aqueous phase are mixed under controlled temperature and stirring to form a stable liquid emulsion,
wherein the said phases with nutraceutical components include components for growth and development, skin and digestive health and brain function and memory, strengthen bones and teeth, skin and vision health along with calcium sources;
the said composition further includes additives which include flavouring agent, colouring agent, preservative, chelating agent,antioxidant, emulsifier along with solvent,
3. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1 and 2 includes:
a. an oil phase containing nutraceutical components like (Docosahexaenoic Acid) and vitamins wherein the said DHA and vitamins are solubilized using suitable emulsifiers;
the said vitamins include at least vitamins A, D3, and E,
b. an aqueous phase containing Beta Glucan, Elderberry extract, Vitamin B-complex, multivitamins and essential minerals and calcium source wherein said aqueous phase is stabilized with suitable preservatives;
the said oil phase and aqueous phase are mixed under controlled temperature and stirring to form a stable liquid emulsion,
the composition further includes additives of at least one flavouring agent, colouring agent, preservative, chelating agent, emulsifier along with solvent,
wherein the said oil droplets are dispersed in the aqueous medium, thereby ensuring the bioavailability of both fat-soluble and water-soluble ingredients in a single formulation.
4. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1, wherein the emulsifiers used are polysorbate 80.
5. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1, wherein the multivitamins and minerals in the aqueous phase include at least one or more of Vitamin B12, Vitamin C, magnesium, calcium, and zinc.
6. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1 wherein preservatives are methylparaben, propylparaben and sodium benzoate either alone or in combination.
7. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1 wherein chelating agent is D-sodium EDTA.
8. A nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1, can be orally consumed and provides enhanced bioavailability and nutritional efficacy for the enhancement of brain function, immune support and overall well-being.
9. An embodiment of nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1 wherein the composition specifically includes
Elder berry (liq. Extract), Beta glucan,Vitamin C, Zinc sulphate, L-Lysine hydrochloride, Methylparaben, Propylparaben, Sodium benzoate, D-Sodium EDTAPropylene glycol, Sorbitol 70%, Liquid Glucose, Honey are incorporated in the aqueous phase
B vitamins viz Riboflavin sodium (B2), Niacin (B3), Pyridoxine (B6), Cyanocobalamin (B12), along with DHA, Ergocalciferol (D2thi
Vitamin A Palmitate, Butylated Hydroxy toluene, Butylated Hydroxy Anisole are in oil phase
wherein purified water is the solvent
vanilla essence, honey are the flavouring agent
caramel is the colouring agent
polysorbate 80 emulsifier
citric acid pH balancer
and the said composition includes additives includes at least one flavouring agent, one emulsifier, one colouring agent, one chelating agent, stabilizer, preservatives
10. An embodiment of nutraceutical composition in the form of an emulsified aqueous syrup as claimed in claim 1 wherein 10 ml of syrup includes:
100 mg of elder berry (liq. Extract),
40mg of Beta Glucan,
35mg ofVitamin C,
1.3 mg of Riboflavin (B2),
9 mg of Niacin (B3),
1.2 mg of Pyridoxine (B6),
2.2 mcg of Cyanocobalamin (B12),
4.5mg of Zinc sulphate,
100 mg of DHA,
30mg of L-Lysine Hydrochloride
600 IU of Ergocalciferol (D2) ,
510 mcg of Vitamin A Palmitate,
4mg of Calcium pantothenate,
7.5 mg of Vitamin E,
10mg of Methylparaben,
0.1 mg of Propylparaben,
30 mg of Sodium benzoate,
10 mg of D-Sodium EDTA,
5 mg of Thiourea,
250 mg of Popylene glycol ,
4 grams of Sorbitol 70%,
1.5 gm of Liquid Glucose,
1 gram of Honey,
20 mg of Citric acid,
16.25 mg of Acesulfame potassium
340 mg of polysorbate 80
0.55mg of Butylated Hydroxy toluene,
0.55 mg of Butylated Hydroxy Anisole,
100 mg of Colour Caramel,
20 mg of Vanilla Essence,
Purified Water in required amount.
11. A method of preparingnutraceutical composition in the form of an emulsified aqueous syrup, comprises steps of:
d) forming an oil phase by solubilizing DHA, Vitamins A, D3, and E in an oil phase with suitable emulsifiers;
e) forming an aqueous phase by dissolving Beta Glucan, Elderberry extract, Vitamin B-complex, and minerals in water, stabilizing the aqueous phase with preservatives;
f) mixing the oil phase and aqueous phase under controlled temperature and stirring conditions to create a stable emulsion;
wherein the oil phase and aqueous phase are emulsified at a temperature range of 50°C to 70°C to ensure complete solubilization and optimal stability of the emulsion.
| # | Name | Date |
|---|---|---|
| 1 | 202341065941-PROVISIONAL SPECIFICATION [30-09-2023(online)].pdf | 2023-09-30 |
| 2 | 202341065941-FORM FOR SMALL ENTITY(FORM-28) [30-09-2023(online)].pdf | 2023-09-30 |
| 3 | 202341065941-FORM FOR SMALL ENTITY [30-09-2023(online)].pdf | 2023-09-30 |
| 4 | 202341065941-FORM 1 [30-09-2023(online)].pdf | 2023-09-30 |
| 5 | 202341065941-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [30-09-2023(online)].pdf | 2023-09-30 |
| 6 | 202341065941-EVIDENCE FOR REGISTRATION UNDER SSI [30-09-2023(online)].pdf | 2023-09-30 |
| 7 | 202341065941-APPLICATIONFORPOSTDATING [30-09-2024(online)].pdf | 2024-09-30 |
| 8 | 202341065941-COMPLETE SPECIFICATION [28-12-2024(online)].pdf | 2024-12-28 |