Title of Invention

DIETARY NUTRITIONAL SUPPLIMENTS IN PELLET FORM AND METHOD OF PREPARATION THEREOF

Abstract The present invention is dietary nutritional supplements in the form of pellets and metod of preparation tereof. The pellet composition compries the nutritional supplement protein-milk protein, soya protein, amino acid L-Lycine; carbohhydrats-sucrose, Malto Dextrine, Coca poser; fats; Vitamin-Vitamin A from natural source of mixed Carotenoids, Cynocobalmine, Vitamin D, Vitamin B, Vitamin B, Vitamin B, Vitamin C, Vitamin E, Vitamin K, Folic Acid, Calcium Pantothenate, Niacinaide; minerals-Calcium, Phoaphorous, CarbonyI Iron Magnesium, Magnanese, Copper, Zinc, Chromium, Selenium; permitted food colour and flavour. All the ingredients are crushed in uniform powder and coated on sugar pellets containing lactose by loading/spraying method, drying & sieving the pellets and blending in double cine blender. This is more stable form and easily eat with/without milk/water. On dispersion in milk or water, it does not form lumps. Pellet composed of dietary nutritional supplement gives synergistic affect and adds nutritional.
Full Text FORM - 2
THE PATENTS ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATION
[SECTION 10; RULE 13]
1. DIETARY NUTRITIONAL SUPPLEMENTS IN PELLET FORM AND METHOD OF PREPARATION THEREOF.
2. (a) SKYMAX LABORATORIES PVT LTD.

(b) Plot No. G/1445-46, Lodhika G.I.D.C., Metoda-360035. Dist. Rajkot. Gujarat State, India.
(c) Nationality: Indian.
The following specification particularly describes the nature of this invention and the manner in which it is to be performed.

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The present invention relates to dietary nutritional supplements in pellet form and method of preparation thereof.
In one aspect the invention includes the composition of dietary nutritional supplements in pellet or granule form. The pellet composition is prepared using protein, amino acid, vitamin, fat, carbohydrate and mineral in adequate amount.
In another aspect the invention includes the method of preparation of pellet (granule) containing dietary nutritional supplements. The pellet dose is recommended to give any individual. Intake of pellet adds nutritional value to the physiological processes of one"s body. Prior Art:
Nutritional supplements are widely used to fulfill nutritional requirements of human. These nutritional supplements contain vitamins, minerals and other substances that play important role in physiological requirements and deficiency of these supplements leads to malnutrition.
Proteins play important role in formation of cytoskeletons, immunoglobulins, and hormone. Under certain conditions protein catabolized to supply energy. Protein intake also facilitates maintenance of electrolyte and water balance in body.
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Carbohydrates are chief source of energy. Degradation product of carbohydrates utilized for synthesis of other substances such as fatty acid, cholesterol, and amino acid. It yields 4.0 C/gm energy.
Fats (Lipids) are important dietary constituent. It yields 9.5 C/gm energy. Some of fats are important constituents of cell wall and cell organelles like mitochondrion etc.
Vitamin A plays important role in vision, reproduction, epithelialization, bone and teeth formation. It also has antioxidant properties.
Vitamin D3 deficiency causes rickets in children and osteomalacia in adults. It helps in mineralization and calcification of bones.
Vitamin B1 (thiamine) is considered as antiberiberi factor. It is also required as a cofactor for some enzyme. Vitamin B2 (riboflavin) is important for healthy hair and mucous membrane. Requirements of vitamin B2 increases during pregnancy, lactation, and injury/burns. It also helps in production of red blood cells and antibodies. Vitamin B6 (pyridoxine) plays important role in formation of shingomyelin, intra mitochondrial fatty acid synthesis, DNA and RNA synthesis.
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Vitamin C helps in collegen synthesis, absorption of iron, electron
transport system, activation of enzyme (e.g. arginase and papain), inhibition of enzyme (e.g. urease and B-amylase), formation of carnitine. Vitamin C in both leucocytes and platelets is found to be lowered significantly in women taking oral contraceptive pills. Vitamin C deficiency leads to scurvy.
Vitamin E has antioxidant property. Vitamin E deficiency causes muscular dystrophy, hemolytic anemia, nocturnal muscle cramps, intermittent claudication, fibrocystic breast disease and atherosclerosis.
Vitamin K is important in blood coagulation, oxidative phosphorylation and increases capacity of calcium binding protein to deposit calcium in the tissues concerned.
Folic acid plays important role in synthesis of DNA and RNA, red blood cells, white blood cells. Folic acid deficiency leads to anemic condition.
Panthothenic acid is esstintial for (3- oxidation, biosynthesis of fatty acids and synthesis of adrenal gland hormone.
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Vitamin D3 niacin acts as a pellagra-preventing factor. It is necessary for production of sex hormones, helps to lower cholesterol and maintain blood circulation.
Calcium is an important mineral mainly found in bone and teeth. It helps in process of bone formation, teeth formation, blood coagulation, neuromuscular transmission, a excitability of nerves, muscle contraction, permeability of gap junction and secondary or tertiary messenger in hormone action.
Phosphorous plays important role in energy transfer, acid-base balance, and enzymatic action. It is one of the constituent of phospholipids, nucleotides/nucleic acids, lipoproteins, phosphoproteins. Iron is an important constituent of haemoglobin, and myoglobin. It is required for action of different enzymes (e.g. xanthine oxidase, cytochrome C reductase). Deficiency of iron leads to anemic condition.
Magnesium is extremely essential for life and is present as intracellular ion in all living cells and tissues. Magnesium is involved as a cofactor and as an activator to wide spectrum of enzymatic action. It is one of the constituents of bone and teeth. It also exerts an effect on neuromuscular irritability.
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Manganese acts either as a cofactor or as an activator of many enzymes. It plays important role in animal reproduction, bone formation, carbohydrate metabolism, porphyrin synthesis, fat metabolism and proteoglycan synthesis.
Copper requires in enzymatic action (e.g. cytochrome oxidase, tyrosinase), maturation of elastin, formation of bones and maintenance of myelin sheath of nerve fibers. Copper helps in the utilization of iron for haemoglobin synthesis. In invertebrates haemocyanin is found which functions as haemoglobin in the storage and transport of oxygen.
Zinc is needed for release of vitamin A from liver into the blood and thus increases its plasma level and its utilization in rhodopsin synthesis. It also helps in insulin secretion, growth and reproduction, wound healing and biosynthesis of mononucleotides.
Chromium is a true potentiator of insulin. In protein energy malnutrition (PEM) states, chromium supplementation is beneficial for weight gain. When chromium is supplied in deficient diets it decreases serum cholesterol levels and prevents or decreases athermanous plaque formation in aorta.
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A positive role of selenium in human health has been suggested. It is needed for action of glutathione peroxidase, which enzyme functions in the cytosol as part of a multi-component antioxidant defense system within the cell. Selenium helps in retention of vitamin E in the blood plasma lipoproteins.
In prior art various oral and/or parental dosage forms containing nutritional supplements were supplemented to individuals, to suppress the nutritional deficiency occur in many individuals because of lack of such nutritional supplements.
Patent WO2004034986 describes novel agglomerated granular protein-rich nutritional supplements able to be absorbed directly onto the tongue or rapidly dissolved in aqueous liquids, as well as methods for supplementing the nutritional needs of individuals of various ages, genders, and levels of activity.
Patent WO 01/01789 describes a gelled nutritional composition and a method of providing nutrition to patient suffering from dysphagia. Gelled nutritional composition comprising whey protein, carbohydrate source, minerals and vitamins. The composition is suitable for dysphagia patients, children and athletes.
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Patent WO 2004/060342 describes nutritional supplement composition containing a mixture of whey protein, amino acids, and other beneficial constituents, and a method for making the composition in nutritionally compact, easy-to-use form i.e. in gel form.
Patent WO 01/50889 discloses nutritional drink, which can with good tolerance be taken by persons suffering from feeling of nausea, or which are expected to be sick when consuming food or drink. Energy value of drink is preferably 40-60 Kcal/100 ml drink, osmolality 350-400 mOsmol/kg water. Nutritional drink contains proteins 0.5-5 gm/100 ml drink, carbohydrate 6-20 gm/100 ml drink, salts and acidifying agents to maintain pH 3 and 6, aroma, flavouring agents and vitamins.
US patent 6,716,466 describes a balanced food powder and a method of enhancing the energetic and protein content of a food without affecting the taste of the food, which comprise providing a powder composition of neutral flavour comprising at least one fat or oil source, at least one protein source & maltodextrin. Wherein energetic amount of protein is about 20%-30%, fat or oil is about 40%-50%, maltodextrin is about 25%-35% of the composition and adding the powder composition to food wherein the powder composition does not change the flavour of food.
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Nutritional supplements are also available in powder or uneven granular form in commercial market. The powder contains protein, vitamins, minerals etc. It has different bulk density (specific gravity). Nutritional value of the protein, vitamin, carbohydrate, minerals present in powder form do not remain intact and these ingredients get segregated due to different bulk density during the time of packing, handling of powder in manufacturing unit and during transportation of the powder from one place to another. Consequently those contents present in packing having higher specific gravity get settle down, leads to unequal application of therapeutic dose. Thus the patient taking the spoonful dose of the powder does not contain uniform quantity of all the ingredients. Moreover, the fine powder contains the sucrose, is highly hygroscopic and easily absorbs the moisture from environment; due to this reason the final product have lower stability and decomposition of the product takes place. Intake of spoonful powder dose stick to teeth & mouth cavity. Fine powder produces lumps on dispersing it in milk or water.
To come over and control these problems the present invention is made to provide dietary nutritional supplements in pellet form and method of preparation thereof.
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The field of invention:
It is an objective of the present invention is to provide granules or pellets of dietary nutritional supplements, which is given to any individual, any time, any place. The pellet contains protein, amino acid, carbohydrate, vitamins, fat and minerals as nutritional supplements.
It is another objective of the invention is the method used to prepare dietary nutritional supplements in pellet form in uniform size and weight. Size and weight uniformity of the pellet containing dietary nutritional supplements aids nonsegregation of pellet during packing, handling and transportation. Consequently the content uniformity of the pellet dosage form is maintained.
In the present invention all nutritional supplements are taken in powder form and then pellets or granules are prepared. In the said invention method of preparing pellets, sugar pellets are coated with other ingredients to prepare more stable pellet (granule).
In the preparation of pellets nutritional supplements are tasteful and flavoured, is taken with/without milk or water. It is easily dispersed in milk or water, without forming lump in dispersion. Moreover, the pellet
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formulation does not stick to teeth and mouth cavity so it is more favorable for any individual.
In the present invention pellet composition is enriched with nutritional supplements. The pellet composition contains Protein-milk protein, soya protein; Amino acid-L-lycine; Carbohydrates-sucrose, Malto Dextrine, Cocoa powder; fats; Vitamins-Vitamin A from natural source of mixed Carotenoids, Cynocobalmine, Vitamin D3, Vitamin B1? Vitamin B2, Vitamin B6, Viamin C, Vitamin E, Vitamin K, Folic Acid, Calcium Pantothenate, Niacinamide; Minerals-Calcium, Phosphorous, Carbonyl Iron, Magnesium, Manganese, Copper, Zinc, Chromium & Selenium. Table-A: The pellet composition comprised of dietary nutritional
supplements possessing nutritional value are as following:
Protein: 31 gm/100 gm of powder
L-Lycine: 25 mg/100 gm of powder
Carbohydrate: 65 gm/100 gm of powder
Fat: > 2 gm/100 gm of powder
Vitamin A: 5000 IU
Cynocobalmine: 5 ug/100 gm of powder
Vitamin D3: 400 IU
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Vitamin B1:
Vitamin B2:
Vitamin B6:
Vitamin C:
Vitamin E:
Vitamin K:
Folic Acid:
Calcium Pantothenate:
Niacinamide:
Calcium:
Phosphorous:
Carbonyl Iron:
Magnesium:
Manganese:
Copper:
Zinc:
Chromium:
Selenium:

5 mg/100 gm of powder 5 mg/100 gm of powder 4 mg/100 gm of powder 50 mg/100 gm of powder 20 mg/100 gm of powder 10 mg/100 gm of powder 1.5 mg/100 gm of powder 3 mg/100 gm of powder 50 mg/100 gm of powder 1000 mg/100 gm of powder 425 mg/100 gm of powder 100 mg/100 gm of powder 12 mg/100 gm of powder 30 ug/100 gm of powder 2.5 mg/100 gm of powder 30 mg/100 gm of powder 75 ug/100 gm of powder 100 ug/100 gm of powder

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Nutritional supplementary pellets also contain permitted food colour and added flavour. Pellet composed of dietary nutritional supplements gives synergistic effect, adds nutritional value to an individual.
Method of preparing pellets (granules) comprising dietary nutritional supplements is as following: Step 1;
All the nutritional supplements - milk protein, soya protein; L-lycine; sucrose, Malto Dextrine, Cocoa powder; fats; Vitamin A from natural source of mixed Carotenoids, Cynocobalmine, Vitamin D3, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C, Vitamin E, Vitamin K, Folic Acid, Calcium Pantothenate, Niacinamide; Calcium, Phosphorous, Carbonyl Iron, Magnesium, Manganese, Copper, Zinc, Chromium & Selenium; permitted food colour and flavour are individually crushed in fine uniform size powder. All these supplements are taken in the pellet preparation are as mentioned in table-A.
The uniform powder of all ingredients are mixed in double cone blender for 45 minute or till uniform mixing of all the ingredients.
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Step 2:
40/60 size pharmagrade sugar crystals are taken into coating pan and lactose powder is sprayed/loaded on the sugar crystals using binder Polyvinylpyrrolidone (PVP K-30) solution in water and dried to form uniform sized round pellets. Step 3;
About 75% of powder used from total amount prepared in step-1, and loaded/sprayed on sugar pellets as obtained from step-2 with using binder Polyvinylpyrrolidone (PVP K-30) solution in water. Dry the pellets by hot air. Remaining amount of powder about 25% is reloaded/resprayed as same way on above pellets. Step 4;
All the pellets as obtained from step-3 are collected into Stainless steel tray and dried at 40° C for 6 hrs or till complete drying of pellets. Step 5:
Dry pellets as obtained from step-4 are sieved through required size sieve and blend the same in double cone blander.
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Step 6:
The mixed pellets as obtained from step-5 are collected in double layer plastic bag in airtight container. and packed in commercial pack as required.
The present invention is not restricted to particular ages, genders, diseased condition and levels of activity.



15

We claim,
1. The dietary nutritional supplement in the pellet form and method of preparation thereof, wherein the pellet is comprising a mixture of; protein 31 gm/100 gm powder (soya protein, milk protein); L-Lycine (amino acid) 25 mg/100 gm powder, carbohydrate 65 gm/100 gm powder (sucrose, malto dextrine, cocoa powder), fat >2 gm/100 gm powder, Vitamin A as natural mixed carotenoids 5000 IU, cynocobalmine 5 ug/100 gm powder, vitamin D3 400 IU, vitamin B1 5 mg/100 gm powder, vitamin B2 5 mg/100 gm powder, vitamin B6 4 mg/100 gm powder, vitamin C 50 mg/100 gm powder, vitamin E 20 mg/100 gm powder, vitamin K 10 mg/100 gm powder, folic acid 1.5 mg/100 gm powder, calcium pantothenate 3 mg/100 gm powder, niacinamide 50 mg/100 gm powder, calcium 1000 mg/100 gm powder, phosphorous 425 mg/100 gm powder, carbonyl iron 100 mg/100 gm powder, magnesium 12 mg/100 gm powder, manganese 30 ug/100 gm powder, copper 2.5 mg/100 gm powder, zinc 30 mg/100 gm powder, chromium 75 ug, selenium 100 ug/100 gm powder, permitted food colour and flavour.
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2. The method of preparing dietary nutritional supplements as claimed in claim 1 comprising the steps of;
(a) all the dietary nutritional supplements - milk protein, soya protein; L-lycine; sucrose, Malto Dextrine, Cocoa powder; fats; Vitamin A from natural source of mixed Carotenoids, Cynocobalmine, Vitamin D3, Vitamin B1? Vitamin B2, Vitamin B6, Vitamin C, Vitamin E, Vitamin K, Folic Acid, Calcium Pantothenate, Niacinamide; Calcium, Phosphorous, Carbonyl Iron, Magnesium, Manganese, Copper, Zinc, Chromium, Selenium, permitted food colour and flavour are individually crushed in fine uniform size powder form and mixing in double cone blender for 45 minute till uniform mixing of all the ingredients; herein concentration of all supplements are taken as claimed in claim 1;
(b) taking 40/60 size pharmagrade sugar crystals into coating pan and lactose powder is sprayed/loaded on the sugar crystals using binder Polyvinylpyrrolidone (PVP K-30) solution in water and drying to form uniform sized round pellets;
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(c) using about 75% of powder from total amount prepared in step-a, and loaded/sprayed on sugar pellets as obtained from step-b with using binder Polyvinylpyrrolidone (PVP K-30) solution in water, drying the pellets by hot air, remaining amount of powder about 25% is reloaded/resprayed as same way on above pellets;
(d) collecting all the pellets obtained from step-c into stainless steel tray and drying at 40° C for 6 hrs or till complete drying of pellets;
(e) sieving the dry pellets obtained from step-d through required size sieve and blending the same in double cone blander;
(f) collecting all the pellets obtained from step-e in double layer plastic bag in airtight container and packing in commercial pack as required.

3. The dietary nutritional supplement in the pellet form and method of preparation thereof, as claimed in claim 1 & 2 wherein the pellets are in uniform size and weight.
4. The method of preparing pellet form containing dietary nutritional supplements as claimed in claim 2 wherein sugar is added in pellet
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form in the preparation process of dietary nutritional supplementing pellets. 5. The dietary nutritional supplements in pellet form and method of
preparation thereof as herein described with foregoing description.

Dated this on 2nd of August 2004.

Dr. RajeshKumar H. Acharya
Advocate & Patent agent
For and on behalf of the applicant.
19

Documents:

568-mum-2004-abstract(4-8-2004).doc

568-mum-2004-abstract(4-8-2004).pdf

568-mum-2004-cancelled pages(4-8-2004).pdf

568-mum-2004-claims(granted)-(4-8-2004).doc

568-mum-2004-claims(granted)-(4-8-2004).pdf

568-mum-2004-correspondence(21-4-2005).pdf

568-mum-2004-correspondence(ipo)-(27-12-2004).pdf

568-mum-2004-form 1(4-8-2004).pdf

568-mum-2004-form 19(18-8-2004).pdf

568-mum-2004-form 2(granted)-(4-8-2004).doc

568-mum-2004-form 2(granted)-(4-8-2004).pdf

568-mum-2004-form 26(4-8-2004).pdf

568-mum-2004-form 3(4-8-2004).pdf

568-mum-2004-form 5(4-8-2004).pdf


Patent Number 210712
Indian Patent Application Number 568/MUM/2004
PG Journal Number 43/2007
Publication Date 26-Oct-2007
Grant Date 08-Oct-2007
Date of Filing 19-May-2004
Name of Patentee SKYMAX LABORATORIES PVT LTD.
Applicant Address Plot No.G/1445-46, Lidhika G.I.D.C., Metoda-360035. Dist. Rajkot.
Inventors:
# Inventor's Name Inventor's Address
1 PATEL DHARMENDERBHAI BHAGWANBHAI D-4, Ravi Ratna Park, University Ring Road, DIST. Rajkot.
PCT International Classification Number A23L 3/40
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA