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A Nuritional Supplement In Form Of Tablet For Prevention Of Neuropsychiatric Disorder

Abstract: The present invention relates to a nutraceutical product or nutritional supplement in the form of tablet. This composition is a dietary Supplement for Prevention of diseases. The composition is used for prevention of neuropsychiatric disorder.

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Patent Information

Application #
Filing Date
03 August 2023
Publication Number
06/2025
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

Rayo Pharma Private Limited
12, Kalyan Navjivan Society, Near Nagri Eye Hospital, Mithakhali, Ahmedabad 380006, Gujarat, India

Inventors

1. Munir M. Shah
Director, Rayo Pharma Private Limited, 12, Kalyan Navjivan Society, Near Nagri Eye Hospital, Mithakhali, Ahmedabad 380006, Gujarat, India

Specification

Description:FIELD OF THE INVENTION:
The present invention relates a nutraceutical product or nutritional supplement in the form of a tablet. This composition is a dietary supplement for the prevention of diseases. The composition is also used for the prevention of neuropsychiatric disorders.
BACKGROUND OF THE INVENTION
Neuropsychiatric disorders are some of the most debilitating, socially isolating and economically draining of all illnesses. The manifestations of neuropsychiatric disorders, often mistaken as wilful or controllable behaviours cause the illness to be misdiagnosed and thus poorly treated. Most treatments for neuropsychiatric disorders have severe and devastating side effects. These side effects will often discourage the patient from continuing treatment and are often the cause of relapse.
Psychotic disorders represent the most difficult of all neuropsychiatric disorders to control. The invariant nature of the presentation of symptoms of these disorders, together with the side effects exhibited by medications used to alleviate these symptoms, makes their treatment difficult.
Conventional or "typical" antipsychotic drugs, typified by chlorpromazine and haloperidol, have a proven track record in the treatment of neuropsychiatric disorders. However, the "typical" antipsychotics described in the art have substantial limitations. They are most effective against the psychotic symptoms of the illness in its early stages, but their side effects are troubling and contribute significantly to non-compliance, which leads to relapse and re-hospitalization.
OBJECT OF THE INVENTION
The main objective of the present invention is to provide nutraceutical composition in the form of a tablet.
Another objective of the present invention is to use the nutraceutical composition as a dietary supplement for the prevention of disease.
SUMMARY OF THE INVENTION
The present invention relates to nutraceutical products or nutritional supplements in the form of tablets. This composition is a dietary Supplement for the prevention of diseases. It can also be used for the prevention of neuropsychiatric disorders.
The present invention more specifically relates to a nutraceutical composition for the prevention of diseases and neuropsychiatric disorders. The composition comprises a combination of:
a. Ginkgo Biloba Extract in a concentration range of 80 mg to 150 mg;
b. 5-HTP (5-hydroxytryptophan) in a concentration range of 10 mg to 30 mg;
c. L-Arginine in a concentration range of 20 mg to 60 mg;
d. L-Glutamine in a concentration range of 5 mg to 20 mg;
e. L-Glutathione in a concentration range of 2 mg to 10 mg;
f. Co-Q10 in a concentration range of 5 mg to 20 mg;
g. Phosphatidylcholine in a concentration range of 5 mg to 20 mg;
h. Phosphatidylserine in a concentration range of 5 mg to 20 mg;
i. Beta-carotene in a concentration range of 1 mg to 5 mg;
j. multivitamins in a concentration range of 0.38 mg to 1.02 mg
k. minerals in a concentration range of 115 mg to 145mg.
The nutraceutical composition further comprises non-active ingredients, including Microcrystalline cellulose powder (MCCP), MAIZE STARCH, TALC, and Dicalcium phosphate (DCP). The multivitamins disclosed in the composition comprise a combination of Vitamin D (as D3 1000 IU) in 25 mcg; Vitamin E (a-TE) in 36 mg; Ascorbic Acid (Vitamin C) in 80 mg; Thiamine (Vitamin B1) in 25 mg; Riboflavin (Vitamin B2) in 3mg; Niacin (Vitamin B3) in 32 mg; Vitamin B6 in 10 mg; Folic Acid (Vitamin B9) in 400 mcg; Vitamin B12 in 100 mcg; and Pantothenic acid (Vitamin B5) in 36 mg. Herein, the minerals comprise a combination of Magnesium in 75 mg; Iron in 8 mg; Zinc in 15 mg; Copper in 250 mcg; Manganese in 2 mg; Selenium in 110 mcg; Chromium in 40 mcg; and Iodine in 150 mcg.
The present invention relates to nutraceutical composition preferably comprising a combination of the following active ingredient wherein, each tablet comprises:
a. Ginkgo Biloba Extract in 120 mg
b. 5-HTP (5-hydroxytryptophan) in 20 mg
c. L-Arginine in 40 mg
d. L-Glutamine in 10 mg
e. L-Glutathione in 5 mg
f. Co-Q10 in 10 mg
g. Phosphatidylcholine in 10 mg
h. Phosphatidylserine in 10 mg
i. Beta-carotene in 2 mg
j. Vitamin D (as D3 1000 IU) in 25 mcg
k. Vitamin E (a-TE) in 36 mg
l. Ascorbic Acid (Vitamin C) in 80 mg
m. Thiamine (Vitamin B1) in 25 mg
n. Riboflavin (Vitamin B2) in 3 mg
o. Niacin (Vitamin B3) in 32 mg
p. Vitamin B6 in 10 mg
q. Folic Acid (Vitamin B9) in 400 mcg
r. Vitamin B12 in 100 mcg
s. Pantothenic acid (Vitamin B5) in 36 mg
t. Magnesium in 75 mg
u. Iron in 8 mg
v. Zinc in 15 mg
w. Copper in 250 mcg
x. Manganese in 2 mg
y. Selenium in 110 mcg
z. Chromium in 40 mcg and
aa. Iodine in 150mcg.
The present invention further relates to a method for the preparation of the above nutraceutical composition in tablet form. The method comprising the steps of
a. Formulating tablets with the specified concentration ranges of active ingredients to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing, and use.
b. Ensuring the tablets are uniform in weight and drug content.
c. Formulating tablets that are bioavailable according to indication requirements. d. Ensuring tablets are chemically and physically stable over a long period of time, up to the claimed shelf-life.
e. Creating tablets with an elegant product identity, free from any tablet defects.
The relevant supplement for the different activities of the brain is illustrated below:
Brain Activity NUTRITIONAL SUPPLEMENT (Nutrition for Healthy Brain)
Memory L-Arginine, Phosphatidylserine, 5-HTP, Ginkgo Biloba, Coenzyme Q10, Beta-carotene, Vitamin E
Nervous System Vitamin B6, Vitamin B2, Vitamin B3 and Vitamin C
Mental Performance Phosphatidylcholine, Pantothenic Acid, Zinc, Iodine
Psychological Functions Vitamin B12, Vitamin B6, Vitamin B1, Folic Acid, Vitamin C and Magnesium, L-Glutamine
Cognitive Function & Mental Performance Zinc, Iodine, Vitamin B12, Vitamin B6
General Health & Vitality L-Glutathione, Vitamin C, Iron, Copper, Selenium, Zinc, Vitamin B6, Vitamin B12, Vitamin D3, Manganese, Selenium, Chromium
Further objectives, advantages, and features of the present invention will become apparent from the detailed description provided hereinbelow, in which various embodiments of the disclosed invention are illustrated by way of example.

BRIEF DESCRIPTION OF INVENTION:
The present invention relates to a novel nutraceutical composition in the form of a multivitamin and mineral tablet designed to serve as a dietary supplement for disease prevention and neuropsychiatric disorders. The composition comprises a combination of carefully selected vitamins and minerals, each present within specific concentration ranges to optimize the health benefits and bioavailability of the tablet.
The composition includes natural ingredients such as Ginkgo Biloba Extract, 5-HTP, L-Arginine, L-Glutamine, L-Glutathione, Co-Q10, Phosphatidylcholine, and Phosphatidylserine, along with essential nutrients like Beta-carotene. These ingredients work synergistically to promote overall well-being and provide preventive measures against various diseases.
In an embodiment of the present invention, the composition encompasses a comprehensive array of essential vitamins, such as Vitamin D, Vitamin E, Vitamin C, Vitamin B complex (B1, B2, B3, B6, B9, B12, B5), each present in carefully calculated concentration ranges. The composition ensures that the multivitamins are present in the composition in optimal amounts to support bodily functions, immunity, and cognitive health.
Similarly, the mineral category encompasses vital minerals like Magnesium, Iron, Zinc, Copper, Manganese, Selenium, Chromium, and Iodine, each present within specific concentration ranges to complement the multivitamins' effects and contribute to overall health and disease prevention.
In the preferred embodiment of the present invention, the present invention relates to a composition for the prevention of diseases and neuropsychiatric disorders. The composition comprises a combination of following active ingredient in a tablet form:
Composition:
The present invention comprises of below ingredients with specific concentration:
Each Tablet Contains:
Ginkgo Biloba Extract ……………………………………………………120 mg
5-HTP (5-hydroxytryptophan) ………………………………………………20 mg
L-Arginine…………………………………………………………………. 40 mg
L-Glutamine…………………………………………...…………………… 10 mg
L-Glutathione ……………………………………………………………….5 mg
Co-Q10……………………………………………………………………. 10 mg
Phosphatidylcholine…………………………………………………………10 mg
Phosphatidylserine…………………………………………………………...10 mg
Beta-carotene ………………………………………………………………. 2 mg
Vitamin D (as D3 1000 IU) ………………………………………………. 25 mcg
Vitamin E (a-TE) ……………………………………………………….….36 mg
Ascorbic Acid (Vitamin C) …………………………………………….80 mg
Thiamine (Vitamin B1) ……………………………………………………25 mg
Riboflavin (Vitamin B2) ……………………………………………………3 mg
Niacin (Vitamin B3) ……………………………………………………… 32 mg
Vitamin B6…………………………………………………………………10 mg
Folic Acid (Vitamin B9) …………………………………………………400 mcg
Vitamin B12………………………………………………………………100 mcg
Pantothenic acid (Vitamin B5) ……………………………………………36 mg
Magnesium…………………………………………………………………. 75 mg
Iron………………………………………………………………………... 8 mg
Zinc…………………………………………………………………………15 mg
Copper…………………………………………………………………... 250 mcg
Manganese………………………………………………………………..… 2 mg
Selenium…………………………………………………………………110 mcg
Chromium……………………………………………………………….. 40 mcg
Iodine…………………………………………………………………… 150mcg

Other Ingredients:
Microcrystalline cellulose powder (MCCP)………………………………… q.s.
MAIZE STARCH……………………………………………………………….q.s.
TALC………………………………………………………………………. q.s.
Dicalcium phosphate (DCP)……………………………………………….. q.s.
Another embodiment of the present invention the manufacturing process for the preparation of composition in solid form is disclosed.
Process for the preparation of composition in Tablet – Solid Form:
The primary Process includes:
1. To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use.
2. To formulate tablets that are uniform in weight and in drug content.
3. To formulate tablets that are bioavailable according to indication requirements.
4. To formulate tablets that are chemically and physically stable over a long period of time. (Up to the Claimed Shelf-Life)
5. To formulate tablets that have elegant product identity which is free from any tablet defects.
Manufacturing process of Tablet formulation
In general, formulation process of tablet manufacturing as per factors stated below:
1. Compression of the Active Pharmaceutical Ingredient (API) / drug substance.
2. Physical and chemical stability of the API during the manufacturing process.
3. Particle size of the formulation ingredients.
4. Availability of the necessary processing equipment.
5. Cost of the manufacturing/formulation process.
Manufacturing Process through its defined Area:
- Raw material warehouse
o Receiving quarantine Area
o Approved raw material Area
- Dispensing Area
- Production Area
- Mixing, Granulation and Drying Section
- Compression Section (Tablet Punching)
- Coating Section (Tablet Coating)
- Quality control section (QC)
- Packaging Section.
Another embodiment of the present invention, the manufacturing process for the composition includes dry granulation method and dry compression process.
Dry Granulation Method / Process
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry granulation method are listed below.
1. Weighing and milling of formulation ingredients (drug substance and excipients)
2. Mixing of milled powders.
3. Compression of mixed powders into slugs.
4. Milling and sieving of slugs.
5. Mixing with disintegrant and lubricant.
6. Compression into tablets
Direct Compression process
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry granulation method are listed below.
1. Milling of therapeutic agent and excipients
2. Mixing of milled powders, disintegrants and lubricants
3. Compression into tablets.
The tablets produced by direct compression are often softer than their counterparts that have been produced by wet granulation and therefore they may be difficult to film-coat.
Another embodiment of the present invention relates to in-Process Quality Control (IPQC) of Pharmaceutical Dosage Forms Contents
In-Process Quality Control (IPQC) of Pharmaceutical Dosage Forms Contents:
1 Objectives of In-Process Quality Control
2 Organization of In-Process Quality Control
3 Location of In-Process Quality Control
4 Sampling
5 Testing
6 Documentation and Evaluation of Data
7 Conclusion
1) Objectives of In-Process Quality Control
- To optimize the technological procedure used in manufacturing process.
- To monitor, control and improve effectively the whole applied operations at every stage of the finished pharmaceutical products.
- Inspection of raw material, equipment, environment, process, testing with respect to specification, packing, etc.
- Quality and process control.
2) Organization of In-Process Quality Control
All the in-process controls including those made in the production area by production personnel perform according to methods approved by quality control department (GMP guideline). Usually, tests are carried out by production personnel, especially for convenience. The personnel in the production area do not have to be directly responsible to the production manager or head with disciplinary responsibility.
On the basis of organizational instruction and process description, quality control personnel have carried out the necessary tasks, if carried out by the production personnel the head must make sure that the controls are used as a means of controlling process in accordance with the instructions and the results taken into account. The responsibility and tasks for the in-process control must be clearly laid down in the organizational instruction. When deviation occurs or where release analyses of intermediate are carried out outside production area, a method must be defined that prevent continued processing of the materials until the decision or the result is available. Materials may be rejected by means of operating data. Physical designation of the product by means of labelling is recommended.
3) Location of In-Process Quality Control
In-process control may be carried out within production area provided they do not jeopardize production. It means that care must be taken when sampling or testing. Examples of in-process tests influence on production are the influence of disintegration test on room humidity and the risk of microbial contamination posed by leak test on blisters. Tests are normally carried out in a segregated area and not directly at the manufacturing location.
4) Sampling
Uniform sampling is carried out throughout the entire batch production. A sampling plan includes the process and location for sampling, the number of samples and other information such as:
- State the type of sample container to be used,
- Describe collection technique that prevents contamination of product being sampled, prevents the contamination of sample taken and the aseptic technique if necessary
- Specify sampling instrument i.e. type and requirement (clean, sterile, pyrogen-free)
- Justify the use of composite sample
- Describe method for obtaining representative samples
- Describe scheme for identifying sample i.e. name of the item, lot number, date taken, sampler’s name etc.
5) Testing
Samples are tested to verify conformance with specifications such as identity, components conformity to written specifications, container/closure conformity with written specifications and examination for contamination. The tests to be performed and the methods to be used have to be defined and specifications also established. Also, use of certificates of analysis or certificates of conformance has to be established.
6) Documentation and Evaluation of Data
Any necessary in-process controls and environmental controls carried out must be recorded. This documentation record must include a record of the in-process controls, the initials of the person(s) carrying them out, and the results obtained. In case of deviation, the signature of the person who approved the deviation is required. Each deviation from the specifications must be countersigned by a qualified person. Also, reasons for deviation, measures including the justification for deviation, date, and name of the person authorizing it must be documented. The head of production is responsible for deviation procedure.
In addition to the numerical compilation of data, a graphical representation of process control values is recommended. This provides simplified overview that makes it possible for trends to be easily detected at early stage.
7) Conclusion
The quality of pharmaceutical dosage forms is essential to assure the maximum level of patient’s satisfaction. To safeguard quality, pharmaceutical companies should possess an organization which enables a proper system of quality assurance of pharmaceutical products and active ingredients. They should able to define in quantifiable terms the quality of raw materials used in the production processes and the quality of products/ drugs they manufacture. This will enhance a safe and healthier society.
Quality Control Tests for Tablets
Pharmacopoeia or Official tests
They are called official tests because the test methods are described in official compendia such as the British Pharmacopoeia, American Pharmacopoeias etc. They are standardized test procedures which have clearly stated limits under which compressed tablets could be accepted. These tests include:
1. Content of Active Ingredient/ Absolute drug content test
2. Uniformity of Weight
3. Uniformity of Content
4. Disintegration time test
5. Dissolution test
1) Content of Active Ingredient
This is determined from a sample of 20 tablets which should be randomly selected from a batch of tablets. The tablets are weighed together and are crushed in a mortar with a pestle.
An amount equivalent to the theoretical content of each tablet or the average of the crushed tablets is weighed out in an analytical balance. The weighed powder is dispersed in a solvent in which the active drug is freely soluble or in a solvent prescribed in the individual drug monograph.
This is filtered and an aliquot of the resultant filtrate is subjected to the stipulated assay procedures. The assay procedures are usually given in the individual drug monograph.
Analysis of the active drug is usually carried out using spectrophotometry or High-Performance Liquid Chromatography (HPLC).
2) Uniformity of Weight / Weight variation test
The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights. The individual weights are compared with the average weight.
3) Uniformity of Content
Content uniformity test was developed to ensure content consistency of active drug substances within a narrow range around the label claim in dosage units. This test is crucial for tablets having a drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total tablet weight.
4) Disintegration Time Test
For tablets, the first important step towards drug dissolution is breakdown of the tablets into granules or primary powder particles, a process known as disintegration. All USP tablets must pass a test for disintegration, which is conducted using a disintegration test apparatus.
5) Dissolution Test
This test measures the amount of time required for a given percentage of the drug substance in a tablet to go into solution under a specified set of conditions. It is intended to provide a step toward the evaluation of the physiological availability of the drug substances.
Non-Pharmacopoeia or Non-Official Tests
These are tests that are performed on tablets and which are not listed in official compendia and concern a variety of quality attributes that need to be evaluated, such as the porosity of tablets, hardness or crushing strength test, friability test, tensile strength determination, thickness test etc.
Some of these tests have no officially set limits for acceptance or rejection and thus may vary from manufacturer to manufacturer and from formulation to formulation.
Crushing strength and friability appeared in the 2001 Edition of British Pharmacopoeia (Appendix A324). There were however no definite set limits. The two tests are, therefore, here considered under non-pharmacopoeia tests.
1. Tablet Hardness or Crushing Strength Test
This measures the degree of force (in kilograms, pounds, or in arbitrary units) needed to fracture a tablet. Besides the concentration of binders used and the compression force, the hardness of a tablet depends on
The characteristics of the granules to be compressed e.g., hardness and deformation under load.
The type and concentration of lubricant used and
The space between the upper and lower punches at the time of compression.
2. Friability Test
This measures the resistance of tablets or granules to abrasion or fracture. The idea behind this test is to mimic the kind of forces, caused by phenomena such as collisions and sliding of tablets towards each other, which a tablet is subjected to during coating, packaging, handling, and shipping.
A minimum of 20 tablets are dedusted, weighed and subjected to a uniform tumbling motion for a specified time. They are then dedusted and reweighed.
The measure of abrasion/ friability loss is usually expressed as percentage loss in weight. It is calculated from the equation:

3. Tablet Thickness
Tablet thickness is determined by the diameter of the die, the amount of fill permitted to enter the die cavity, the compaction characteristics of the fill material, and the force or pressure applied during compression. To manufacture tablets of uniform thickness during and between batch productions for the same formulation, care must be exercised to employ the same factors of fill, die, and pressure.
The degree of pressure affects not only thickness but also hardness of the tablet; hardness is perhaps the more important criterion since it can affect disintegration and dissolution. Thus, for tablets of uniform thickness and hardness, it is doubly important to control pressure. Tablet thickness also becomes an important characteristic in packing operations and in counting of tablets using filling equipment which uses the uniform thickness of the tablets as a counting mechanism.
Tablet thickness is measured with a vernier calliper, thickness gauge or automated equipment (Automatic weight, hardness, thickness, and tablet diameter test instrument). The thickness of a tablet should be controlled within ±5% variation of a standard value depending on the size of the tablet.
Other non-pharmacopoeia tests include measurement of tablet diameter, porosity, liquid penetration, mechanical strength, and density.
Conclusion
Quality control of tablets involves various tests which require keen attention. To ensure that established product quality standards are met, these tests are being performed during production (in-process controls) and verified after the production of each batch. Packaging and storing of tablets Before tablets are sent out for distribution, they are usually packaged using appropriate packaging materials. The type of packaging material used is a matter of choice and is dependent on several factors including:
1. The degree of protection required
2. Compatibility of the packaging material with the formulation.
3. Presentation, particularly for those products which may be the subject of impulse buying
4. Customer convenience in terms of size, weight, method of opening or reclosing legibility of printing, etc.
5. Filling method and
6. Cost
Tablets are commonly packaged using blister and strip packs and are kept in places of low humidity, and protected from extremes temperature. The packaging provides excellent environmental protection for each unit of tablet, coupled with an aesthetically pleasing and efficacious appearance. Blister and strip packaging also provide some degree of tamper resistance to the dosage form.
For larger quantities delivered to the pharmacist, glass or plastic bottles, metal containers, cartons, or paperboard drums may be used along with polyethylene liners, where necessary, to give added protection from moisture. If cotton wool stuffing is used under these circumstances it is an advantage for it to be external to the liners so that any moisture that it contains does not gain access to the tablets. Tablets that are decomposed when exposed to moisture can also be packaged with a desiccant packet. Light sensitive tablets are packaged in light-resistant containers. With a few exceptions, tablets that are properly stored will remain stable for many years.

, Claims:WE Claim:
1. A nutraceutical composition for the prevention of diseases and neuropsychiatric disorders comprising a combination of:
a. Ginkgo Biloba Extract in a concentration range of 80 mg to 150 mg;
b. 5-HTP (5-hydroxytryptophan) in a concentration range of 10 mg to 30 mg;
c. L-Arginine in a concentration range of 20 mg to 60 mg;
d. L-Glutamine in a concentration range of 5 mg to 20 mg;
e. L-Glutathione in a concentration range of 2 mg to 10 mg;
f. Co-Q10 in a concentration range of 5 mg to 20 mg;
g. Phosphatidylcholine in a concentration range of 5 mg to 20 mg;
h. Phosphatidylserine in a concentration range of 5 mg to 20 mg;
i. Beta-carotene in a concentration range of 1 mg to 5 mg;
j. multivitamins in a concentration range of 0.38 mg to 1.02 mg
k. minerals in a concentration range of 115 mg to 145mg.

2. The nutraceutical composition as claimed in claim 1, wherein the composition further comprises non-active ingredients, including Microcrystalline cellulose powder (MCCP), MAIZE STARCH, TALC, and Dicalcium phosphate (DCP).

3. The nutraceutical composition as claimed in claim 1, wherein multivitamins comprise a combination of Vitamin D (as D3 1000 IU) in 25 mcg; Vitamin E (a-TE) in 36 mg; Ascorbic Acid (Vitamin C) in 80 mg; Thiamine (Vitamin B1) in 25 mg; Riboflavin (Vitamin B2) in 3mg; Niacin (Vitamin B3) in 32 mg; Vitamin B6 in 10 mg; Folic Acid (Vitamin B9) in 400 mcg; Vitamin B12 in 100 mcg; and Pantothenic acid (Vitamin B5) in 36 mg.

4. The nutraceutical composition as claimed in claim 1, wherein minerals comprise a combination of Magnesium in 75 mg; Iron in 8 mg; Zinc in 15 mg; Copper in 250 mcg; Manganese in 2 mg; Selenium in 110 mcg; Chromium in 40 mcg; and Iodine in 150 mcg.

5. The nutraceutical composition as claimed in claim 1, wherein the composition preferably comprises a combination of
a. Ginkgo Biloba Extract in 120 mg
b. 5-HTP (5-hydroxytryptophan) in 20 mg
c. L-Arginine in 40 mg
d. L-Glutamine in 10 mg
e. L-Glutathione in 5 mg
f. Co-Q10 in 10 mg
g. Phosphatidylcholine in 10 mg
h. Phosphatidylserine in 10 mg
i. Beta-carotene in 2 mg
j. Vitamin D (as D3 1000 IU) in 25 mcg
k. Vitamin E (a-TE) in 36 mg
l. Ascorbic Acid (Vitamin C) in 80 mg
m. Thiamine (Vitamin B1) in 25 mg
n. Riboflavin (Vitamin B2) in 3 mg
o. Niacin (Vitamin B3) in 32 mg
p. Vitamin B6 in 10 mg
q. Folic Acid (Vitamin B9) in 400 mcg
r. Vitamin B12 in 100 mcg
s. Pantothenic acid (Vitamin B5) in 36 mg
t. Magnesium in 75 mg
u. Iron in 8 mg
v. Zinc in 15 mg
w. Copper in 250 mcg
x. Manganese in 2 mg
y. Selenium in 110 mcg
z. Chromium in 40 mcg and
aa. Iodine in 150mcg.

6. A method for the preparation of the nutraceutical composition as claimed in claims 1 in tablet form, comprising the steps of
a. Formulating tablets with the specified concentration ranges of active ingredients to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing, and use.
b. Ensuring the tablets are uniform in weight and drug content.
c. Formulating tablets that are bioavailable according to indication requirements. d. Ensuring tablets are chemically and physically stable over a long period of time, up to the claimed shelf-life.
e. Creating tablets with an elegant product identity, free from any tablet defects.

7. The method as claimed in claim 6, wherein the tablets are manufactured through the direct compression process or dry granulation method.

Documents

Application Documents

# Name Date
1 202321052379-FORM FOR SMALL ENTITY(FORM-28) [03-08-2023(online)].pdf 2023-08-03
2 202321052379-FORM FOR SMALL ENTITY [03-08-2023(online)].pdf 2023-08-03
3 202321052379-FORM 3 [03-08-2023(online)].pdf 2023-08-03
4 202321052379-FORM 1 [03-08-2023(online)].pdf 2023-08-03
5 202321052379-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [03-08-2023(online)].pdf 2023-08-03
6 202321052379-EVIDENCE FOR REGISTRATION UNDER SSI [03-08-2023(online)].pdf 2023-08-03
7 202321052379-ENDORSEMENT BY INVENTORS [03-08-2023(online)].pdf 2023-08-03
8 202321052379-COMPLETE SPECIFICATION [03-08-2023(online)].pdf 2023-08-03
9 202321052379-Proof of Right [29-08-2023(online)].pdf 2023-08-29
10 202321052379-FORM-26 [29-08-2023(online)].pdf 2023-08-29