WO2005110120A1

WO2005110120A1 - Pellets comprising protein and nutritional supplements and method for preparation thereof

Info

Publication number: WO2005110120A1
Application number: PCT/IN2004/000397
Authority: WO
Inventors: Dharmendrabhai Bhagwanbhai Patel
Original assignee: Skymax Laboratories Pvt. Ltd.
Priority date: 2004-05-19
Filing date: 2004-12-22
Publication date: 2005-11-24

Abstract

The present invention is dietary nutritional supplements in the form of pellets and method of preparation thereof. The pellet composition comprises the nutritional supplements protein-milk protein, Soya protein; amino acid L-Lycine; carbohydrate-sucrose, Malto Dextrine, Cocoa powder; fats; Vitamin-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; minerals-Calcium, Phosphorous, Carbonyl Iron, Magnesium, Manganese, 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 amending in double cone 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 supplements gives synergistic effect and adds nutritional value to an individual.

Description

PELLETS COMPRISING PROTEIN AND NUTRITIONAL SUPPLEMENTS AND METHOD FOR PREPARATION THEREOF

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 ol

these supplements leads to malnutrition.

Proteins play important role in formation of cytoskeletons, immunoglobulins,

and hormone. Under certain conditions protein catabolizcd to supply energy. Protein

intake also facilitates maintenance of electrolyte and water balance in body.

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 Bj (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.

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 β- oxidation, biosynthesis of fatty acids and

synthesis of adrenal gland hormone.

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 piays 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.

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.

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.

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 b-y-per-sons -suffering-from feeIing~of~nausea, or which are expected to be sick

when consuming food or drink. Energy value of drink is preferably 40-60 Kcal/100 c 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.

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 a food wherein the powder composition does not change the flavour of

food.

Nutritional supplements are also available in powder or uneven granular form

in commercial- arket. 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.

Detail Description of the 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-dispers-ion- oreover— the-pellet 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 B_h 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 μg/100 gm of powder

Vitamin D₃: 400 IU

Vitamin Bj: 5 mg/100 gm of powder

Vitamin B₂: 5 mg/100 gm of powder

Vitamin B₆: 4 mg/100 gm of powder

Vitamin C: 50 mg/100 gm of powder

Vitamin E: 20 mg/100 gm of powder

Vitamin K: 10 mg/100 gm of powder

Folic Acid: 1.5 mg/100 gm of powder

Calcium Pantothenate: 3 mg/100 gm of powder

Niacinamide: 50 mg/100 gm of powder

Calcium: 1000 mg/100 gm of powder

Phosphorous: 425 mg/100 gm of powder

Carbonyl Iron: 100 mg/100 gm of powder

Magnesium: 12 mg/100 gm of powder

Manganese: 30 μg/100 gm of powder

Copper: 2.5 mg/100 gm of powder

Zinc: 30 mg/100 gm of powder Chromium: 75 μg/100 gm of powder

Selenium: 100 μg/100 gm of powder

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 Bj, Vitamin B₂, Vitamin

B₆, Vitamin C, Vitamin E, Vitamin K, Folic Acid, Calcium Pantothenate,

Niacinamide;,, Caicium,_ Phosphorous_^ CarhonyL Ir,on,_ 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.

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.

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.

Claims

We claim, 1. Dietary nutritional supplements 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 μgm/100 gm powder, vitamin D₃ 400 IU, vitamin Bi 5 mg/100 gm powder, vitamin B₂ 5 mg/100 gm powder, vitamin B₆ 4 mg/100 gm powder, vitamin C 50 mg/'l 00~ 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 powdeι,_caιbon.yl_iron- 100 mg L0.0. gri powder, magnesium 12 mg 100 gm powder, manganese 30 μcg/100 gm powder, copper 2.5 mg/100 gm powder, zinc 30 mg/100 gm powder, chromium 75 μcg, selenium 100 μcg/100 gm powder, permitted food colour and flavour.

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 Bi , Vitamin B , 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; (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. Dietary nutritional supplements 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 form in the preparation process of dietary nutritional supplementing pellets.

5. Dietary nutritional supplements in pellet form and method of preparation thereof as herein described with foregoing description.