FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
AND
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10; rule 13]
1. TITLE OF THE INVENTION
"Compositions containing proline-rich polypeptide"
2. APPLICANT
(1) NAME: USV LIMITED
(2) NATIONALITY: Indian Company incorporated under the
Companies Act 1956
(3) ADDRESS: B.S.D. Marg, Govandi, Mumbai 400 088,
Maharashtra, India
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the
manner in which it is to be performed.

Technical field of the invention:
The present invention relates to compositions comprising proline-rich
polypeptide.
Background of the invention:
Colostrum is the yellowish fluid secreted by the mammary glands at the time of parturition and precedes the production of true milk. Colostrum contains high concentration of antibodies and is a valuable source of antibodies for the new-born infant. Colostrum contains immunoglobulins, minerals, lactoferrin, proline-rich polypeptides, growth hormones, growth factors such as insulin-like growth factors (IgF-1 and IgF-2), leukocytes, glycoproteins, vitamins and enzymes, cytokines and lymphokines. Bovine colostrum contains more immune factors than human colostrum.
Colostrinin, a proline-rich polypeptide complex is derived from mammalian colostrum and is known for use in the treatment of disorders of the central nervous system such as neurological disorders and mental disorders. Neurological disorders that can be treated by colostrinin include dementia and neurodegenerative disorders like senile dementia and motor neurone disease. It is found effective in the treatment of neurodegenerative diseases like Alzheimer's disease. Mental disorders such as psychosis and neurosis are also treated using colostrinin. It is also used to treat depression in psychiatric patients and for treatment of drug addicts after a period of detoxification and in persons dependent on stimulants. Colostrinin is also used in the treatment of disorders of the immune system.
A proline-rich polypeptide (PRP) later called colostrinin (CLN) was originally found as a fraction accompanying sheep colostral immunoglobulins.
Colostrinin, commercially available from Regen Therapeutics Plc is a proline-rich

polypeptide (PRP) complex isolated from bovine colostrum. Colostrinin is marketed by Metagenics under the brand name CogniSure™ as a nutraceutical. CogniSure™ supports healthy brain aging & cognition. The product was first launched in North American market in October 2007. Colostrinin is also marketed by Golgi Pharmaceuticals Ltd under the brand name Cognase™.
WOl999065329 discloses a dietary supplement comprising colostrinin in combination with lactoferrin.
WO2000075173 discloses the amino acid sequence of several peptides present in Colostrinin and which are useful in the treatment of disorders of the immune system and the central nervous system.
WO2001055199 discloses peptide fragments of colostrinin useful in the treatment of disorders of the immune system and the central nervous system. These peptides are also useful as food additives.
WO2004081038 discloses purification of the peptides from colostrum, particularly purification of colostrinin from colostrum. The method of purification involves the addition of an alcohol such as methanol or ethanol to the mixture in order to form an alcohol phase rich in the peptides and a precipitate. The peptide-rich alcohol phase is subsequently recovered and subjected to further fractionation.
WO2008103023 discloses the treatment of intestinal barrier function disorders involving administration of colostrum.
A study conducted by Michal Zimecki to find the therapeutic effect of colostrinin in patients with Alzheimer's disease (AD) is described in "A Proline-Rich Polypeptide from Ovine Colostrum: Colostrinin with Immunomodulatory

Activity" (Ref.: Advances in Experimental Medicine and Biology 2008; 606:241-50). The study demonstrated the therapeutic benefit of colostrinin in Alzheimer's disease (AD) patients by delaying progress of the disease.
A double-blind, placebo-controlled study conducted by M. Janusz et.al to find the effect of Colostrinin in patients with Alzheimer's disease is described in "Colostral Proline-Rich Polypeptides - Immunoregulatory Properties and Prospects of Therapeutic Use in Alzheimer's Disease" (Ref.: Archivum Immunologiae at Therapiae Experimentalis, 1999; 47(6):377-85). The study mentions that oral administration of Colostrinin improves the outcome of Alzheimer's disease patients with mild to moderate dementia.
Cognitive dysfunction involves poor mental function associated with confusion, forgetfulness and difficulty in concentration. Neuron impairment and oxidative stress are the factors contributing to memory loss and cognitive impairment, Proline rich polypeptide complex such as colostrinin promotes healthy brain aging by protecting the neuronal structure responsible for synthesizing acetylcholine and moderating oxidative stress. Colostrinin reduces the oxidative stress and prevents beta-amyloid aggregation. Various clinical trials confirm the advantages of colostrinin for "healthy brain aging" thereby aiding memory and cognition.
MG Stewart in "Colostrinin: a naturally occurring compound derived from mammalian colostrum with efficacy in treatment of neurodegenerative diseases, including Alzheimer's" (Expert opinion on Pharmacotherapy 2008 Oct; 9 (14):2553-9) discusses the evidence for the clinical efficacy of colostrinin and the recent data examined shows the remarkable ability of Colostrinin to reduce oxidative stress, prevent beta-amyloid aggregation and prolong the lifespan in a laboratory model of premature aging. The application of Colostrinin as a nutraceutical product for use in the early stages of cognitive decline in humans is

also discussed.
Although there are various commercially available products containing proline-rich polypeptide, there exists a need for developing compositions of proline-rich polypeptide, colostrinin which remain stable even in a moist/humid environment and has better patient compliance.
Object of Invention:
An object of the invention is to provide compositions comprising proline-rich polypeptide and process for their preparation.
Another object of the invention is to provide compositions comprising proline-rich polypeptide complex (colostrinin) which remain stable and does not become sticky even in moist/humid environment.
Yet another object of the invention is to provide tablet compositions comprising proline-rich polypeptide complex which possess good aesthetic appearance and patient compliance.
Another object of the invention is to provide chewable nutraceutical compositions comprising proline-rich polypeptide complex which supports healthy brain aging and the maintenance of normal mental function.
Summary of Invention:
The present invention provides compositions comprising proline-rich polypeptides. Particularly, the invention provides nutraceutical compositions comprising proline-rich polypeptide complex (colostrinin) and suitable excipients.
According to one aspect, the invention provides compositions comprising proline-rich polypeptide complex (colostrinin), one or more polyols and atleast one

disintegrant.
Preferably, the polyol is selected from the group consisting of inositol, mannitol, isomalt, xylitol, lactitol, erythritol and maltitol. Preferably, the polyol is not a sorbitol.
According to another aspect, the invention provides nutraceutical chewable compositions comprising colostrinin, one or more polyols and atleast one disintegrant. Said nutraceutical compositions of colostrinin supports healthy brain aging and the maintenance of normal mental function.
According to one aspect, the invention provides compositions comprising colostrinin and a combination of reducing sugar and polyol; wherein the ratio of reducing sugar to polyol is 10:1.
According to a preferred aspect, the invention provides compositions comprising colostrinin and a combination of reducing sugar and polyol; wherein the ratio of reducing sugar to polyol is 6:1.
According to one aspect, the invention provides chewable nutraceutical compositions comprising colostrinin and atleast one disintegrant.
According to one aspect, the invention provides chewable compositions comprising from about 1.0% to 6.0% by weight of colostrinin, 5.0% to 50.0% by weight of polyol and 1.0% to 10.0% by weight of disintegrant.
According to a preferred aspect, the invention provides chewable compositions comprising from about 1.0% to 6.0% by weight of colostrinin, 5.0% to 50.0% by weight of mannitol and 1.0% to 10.0% by weight of croscarmellose sodium.

According to a more preferred aspect, the composition comprises from about 3.5% to 4.5% by weight of colostrinin, 5.0% to 20.0% by weight of mannitol and 3.0% to 7.0% by weight of croscarmellose sodium.
According to one aspect, the invention provides a process for preparing compositions of colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of said colostrinin, atleast one polyol, atleast one disintegrant and optionally other suitable excipients;
(c) mixing atleast one lubricant with the blend of step (b) to get lubricated blend; and
(d) compressing the lubricated blend into tablet or filling the lubricated blend into capsules.
Additional aspects and/or advantages of the present invention will be evident from the description that follows.
Description of the invention:
The present invention discloses compositions comprising proline-rich polypeptides. More particularly, the invention discloses chewable compositions comprising proline-rich polypeptide (PRP) (colostrinin).
Proline Rich Polypeptides are the essential components in Colostrum. PRPs are characterized as PRP1, PRP2, PRP3, PRP4 and PRP5. PRP2 contains active peptides which modulate cytokine levels in the body, particularly IFN-beta or beta-interferon. PRP3 contains peptides that modulate the IFN-alpha cytokine levels in the body which is responsible for modulating auto-immune responses. Researchers have found that PRP is highly anti-inflammatory and it is found to act on T-cell precursors to produce helper T-cells and suppresser T-cells.

Colostrinin is a proline-rich polypeptide derived from mammalian colostrum. Several factors have been isolated and characterised from mammalian colostrum. In 1974, Janusz et al (FEBS Lett., 49,276-279) isolated a proline-rich polypeptide (PRP) from ovine colostrum, which is called colostrinin.
Colostrinin may be isolated from mammalian colostrum by the process as disclosed in WO 1998014473. This process involves the following steps:
(a) removing lipids from the colostrum by centrifuging and removing the majority of proteins from the colostrum by pH lowering;
(b) separating Colostrinin bound to immunoglobulin from the colostrum by processing the fraction formed after the removal of lipids and proteins by ion exchange chromatography, eluting with phosphate buffered saline and collecting a fraction containing Colostrinin bound to immunoglobulin;
(c) separating the Colostrinin from the immunoglobulin by sieving chromatography and purifying the Colostrinin by de-salting the fraction below 30,000 Daltons molecular weight and introducing antibodies to immunoglobulins and thereby remove this class of proteins to obtain the final product.
In the practice of the present invention, the proline-rich polypeptide (PRP) colostrinin that is used may be derived naturally from any mammalian source, such as bovine, ovine or caprine.
In a preferred embodiment, the colostrinin used is isolated from the bovine colostrum. Colostrinin, commercially available from Regen Therapeutics Pic is a proline-rich polypeptide (PRP) complex isolated from bovine colostrum and the polypeptides in Colostrinin™ are mainly casein-derived hydrophobic peptides (with a high content of proline, leucine, and valine) that occur naturally in colostrum. One liter of bovine colostrum contains approximately 200-300 mg of Colostrinin™.

Colostrinin, commercially available from Regen Therapeutics Plc is a "Proline-Rich Peptide Complex (Colostrinin™) 1%, which is a proline rich peptide complex on a potato maltodextrin carrier.
Although there are various commercially available products containing proline-rich polypeptide, some of the compositions have the tendency to absorb moisture and becomes sticky. Thus there exists a need for developing compositions which are stable even in a moist/humid environment and which also possess better tablet aesthetic properties and does not become sticky and thereby better patient compliance.
According to one embodiment, the invention provides compositions comprising proline-rich polypeptide complex (colostrinin), one or more polyols and atleast one disintegrant.
According to one embodiment, the invention provides compositions in the form of chewable tablet comprising proline-rich polypeptide complex (colostrinin), one or more polyols and atleast one disintegrant.
According to another embodiment, the invention provides chewable nutraceutical compositions comprising colostrinin, atleast one polyol and atleast one disintegrant.
According to another embodiment, the invention provides a nutraceutical composition comprising colostrinin and atleast one disintegrant.
The inventors have successfully developed compositions of proline-rich polypeptides by proper choice of the excipients and more particularly by proper selection of diluents such as reducing sugars and polyols.

According to one embodiment, the invention provides chewable nutraceutical compositions comprising colostrinin and a combination of reducing sugar and polyol; wherein the ratio of reducing sugar to polyol is 10:1.
According to a preferred embodiment, the invention provides chewable nutraceutical compositions comprising colostrinin and a combination of reducing sugar and polyol; wherein the ratio of reducing sugar to polyol is 6:1.
According to a more preferred embodiment, the invention provides chewable nutraceutical compositions comprising colostrinin and a combination of fructose and mannitol; wherein the ratio of fructose to mannitol is 6:1.
In the practice of the present invention, the polyol is selected from the group consisting of inositol, mannitol, isomalt, xylitol, lactitol, erythritol and maltitol.
In the practice of the present invention, the reducing sugar is selected from the group consisting of glucose, fructose, lactose, glyceraldehyde, arabinose, maltose and mixtures thereof.
The inventors of the present invention have developed compositions by eliminating the use of sorbitol as a diluent. Sorbitol has a tendency to absorb moisture and tends to make the blend sticky and poses problem in the flow
properties.
According to a preferred embodiment, the proline-rich polypeptide chewable compositions are devoid of sorbitol.
According to one embodiment, the invention provides chewable compositions comprising colostrinin in an amount from about 1,0 % to 6.0% by weight of total composition.

According to another embodiment, the compositions of the present invention comprises from about 1.0% to 6.0% by weight of colostrinin, 5.0% to 50.0% by weight of polyol and 1.0% to 10.0% by weight of disintegrant.
According to one preferred embodiment, the compositions of the present invention comprises from about 1.0% to 6.0% by weight of colostrinin, 5.0% to 50.0% by weight of mannitol and 1.0% tol0.0% by weight of croscarmellose sodium.
According to a more preferred embodiment, the composition comprises from about 3.5% to 4.5% by weight of colostrinin, 5.0% to 20.0% by weight of mannitol and 3.0% to 7.0% by weight of croscarmellose sodium.
According to another preferred embodiment, the composition comprises from about 3.5% to 4.5% by weight of colostrinin, 5.0% to 20.0% by weight of mannitol and 3.0% to 7.0% by weight of crospovidone.
In the practice of the present invention, the unit dose strength of proline-rich polypeptide complex is from about 50 micrograms to about 150 micrograms.
The compositions of the present invention may be provided in the form of oral dosage forms such as tablets, chewable tablets, capsules or powders.
The compositions containing proline rich polypeptide complex as described herein are stable even in humid/moist environment.
Compositions of the present invention supports healthy brain aging and the maintenance of normal mental function. Said compositions may be used as a nutraceutical agent or as a pharmaceutical agent for desired benefits. The compositions are also useful in the treatment of Alzheimer's disease and cognitive

impairment.
Compositions of colostrinin are recommended to be taken one tablet every alternate day for 3 weeks, then discontinued for 2 weeks, and then this dosing schedule is repeated.
Suitable excipients that may be used according to the present invention include one or more excipients selected from diluent, disintegrant, lubricant, glidant, flavoring agents and the like.
According to the invention, the excipients chosen are such that they do not pick up moisture which tends to make the blend and tablets sticky.
Diluents are substances which usually provide bulk to the composition. Suitable diluents for use in the compositions of the invention include, but are not limited to maize starch, lactose anhydrous, microcrystalline cellulose, dibasic calcium phosphate anhydrous, pre gelatinized starch and the like.
Disintegrants are substances added to the drug formulation to facilitate the breakup or disintegration of the tablet or capsule contents into smaller particles that dissolve more rapidly than in the absence of the disintegrant. Suitable disintegrant for use in the pharmaceutical composition of the invention include, but are not limited to pregelatinised starch, croscarmellose sodium and crospovidone. Disintegrants may be used in an amount from about 2.0% to about 10.0% by weight of total composition; preferably from about 3.0% to about 7.0% by weight of total composition.
Lubricants are substances that are used to prevent adhesion of powder blend to manufacturing equipments such as hoppers. Lubricants reduce the interparticle friction and improves the flow of the powder blend and also assist the ejection of

the tablet from the tabletting die. Suitable lubricants for use in the composition of the invention include, but are not limited to magnesium stearate, zinc stearate, stearic acid, glyceryl monostearate, glyceryl behenate, glyceryl palmitostearate, hydrogenated vegetable oil, mineral oil, polyethylene glycol and the like. Lubricants may be present in an amount from about 0.5% to about 5.0% by weight of total composition.
Glidants are substances that are used to facilitate powder flow by reducing interparticle friction and cohesion. Suitable glidants for use in the composition of the invention include, but are not limited to talc, colloidal silicon dioxide, silicon dioxide and the like. Glidants may be present in an amount from about 0.5% to about 5.0% by weight of total composition.
Flavoring agents such as chocolate flavour, cocoa powder, vanilla flavor, monoammonium glycyrrhizinate and the like may be used. Synthetic flavors are advantageous over the natural flavors as natural flavors easily absorbs environmental moisture and tends to make the product sticky.
According to one embodiment, the compositions of the present invention may also be used in patients with fluctuating blood glucose levels. Such compositions may contain sucralose, which has no glycemic value as sweetener and the excipients may include mannitol, lactose, microcrystalline cellulose or mixture of lactose and microcrystalline cellulose and the like.
The features of the present invention can be extended to other polypeptides.
According to one embodiment, the invention provides a process for preparing compositions of colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of said colostrinin, one or more polyol, atleast one disintegrant and optionally other suitable excipients;

(c) mixing atleast one lubricant with the blend of step(b) to get lubricated blend; and
(d) compressing the lubricated blend into tablet.
According to another embodiment, the invention provides a process for preparing compositions of colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of said colostrinin, one or more polyol, atleast one disintegrant and optionally other suitable excipients;
(c) mixing atleast one lubricant with the blend of step(b) to get lubricated blend; and
(d) filling the lubricated blend into capsules.
According to a preferred embodiment, the invention provides a process for preparing chewable nutraceutical compositions comprising colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of colostrinin, fructose, mannitol, croscarmellose sodium and optionally other suitable excipients;
(c) mixing magnesium stearate with the blend of step(b); and
(d) compressing the lubricated blend into tablet.
According to one embodiment, the invention provides a process for preparing chewable compositions of colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of said colostrinin, atleast one polyol, atleast one disintegrant and optionally other suitable excipients;
(c) compressing the blend of step(b) into tablet;
wherein said colostrinin is of ovine or bovine origin.
The powder blend prepared by the process as described herein exhibits a 'loss on

drying' (LOD) value of less than 1.5% w/w at 60°C and a bulk density in the range of about 0.5 g/cm3 to 0.7 g/cm3.
According to one embodiment, the invention provides a process for preparing chewable compositions of colostrinin, said process comprising the steps of:
(a) providing colostrinin;
(b) preparing a blend of said colostrinin, atleast one polyol, atleast one disintegrant and optionally other suitable excipients;
(c) slugging the blend of step (b);
(d) milling the slug of step (c) to form granules; and
(e) compressing the granules into tablet or filling the granules into capsules.
In the practice of the invention, the process of blending or mixing may be done in a conventional mixer, such as cone blender, planetary mixer or the like. Tablets may be compressed using suitable punches and dies. Tablets may be of oval, elliptical, spherical or caplet shape. Compression can be carried out using equipments known in the art such as a rotary tablet press or any other compression machine.
The advantages of the compositions as described herein are as follows,
(1) The tablet compositions of proline-rich polypeptide complex prepared by the process as described herein possess good aesthetic appearance.
(2) The chewable nutraceutical compositions of the present invention does not become sticky upon exposure to humid environment.
(3) The chewable nutraceutical compositions of the present invention does not pose any problem of stickiness during manufacturing and packing as it does not stick to the equipments.
(4) The chewable nutraceutical compositions of the present invention provides better patient compliance difficulty.

As used herein, the term "composition", unless otherwise defined refers to all solid oral dosage forms that contain proline-rich polypeptides such as tablets, chewable tablets, powders, granules, capsules and the like.
As used herein, the term "excipient" refers to ingredients that are commonly used in the nutraceutical or pharmaceutical technology for preparing oral dosage forms.
The present invention is further illustrated by reference to the following examples which is for illustrative purpose only and does not limit the scope of the invention in any way.
Examples:
Example 1
Proline-rich polypeptide complex 1% (bovine source) (10.2 g) and lactose (20.8 g) were sifted separately through suitable sieve on sifter. Mannitol (125g), cocoa powder (25.0 g) and colloidal silicon dioxide (4 g) were co-sifted. Croscarmellose sodium (15 g), monoammonium glycyrrhizinate (2 g), chocolate flavor (25 g) and vanilla flavor (15 g) were co-sifted. Mixed all the above blend in a contablender for 10 minutes. Sifted magnesium stearate (8 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable punches and dies to produce tablets with satisfactory physical parameters.
Example 2
Proline-rich polypeptide complex 1% (142.8 g) and fructose (1750 g) were sifted separately through suitable sieve on sifter. Mannitol (291.2 g), cocoa powder (350g) and colloidal silicon dioxide (56 g) were co-sifted. Croscarmellose sodium (210 g), monoammonium glycyrrhizinate (28 g), chocolate flavor (350 g) and vanilla flavor (210 g) were co-sifted. Mixed all the above blend in a conta blender for 10 minutes. Sifted magnesium stearate (112 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable

punches and dies to produce tablets with satisfactory physical parameters.
Example 3
Proline-rich polypeptide complex 1% (10.2 g) was sifted through suitable sieve on sifter. Mannitol (143.55 g), cocoa powder (25g) and colloidal silicon dioxide (4.25g) were co-sifted. Sodium saccharine (9.0g) and vanilla flavor (40 g) were co-sifted. Mixed all the above blend in a conta blender for 10 minutes. Stearic acid (18 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable punches and dies to produce tablets with satisfactory physical parameters.
Example 4
Proline-rich polypeptide complex 1% (10.20 gj was sifted through suitable sieve on sifter. Mannitol (161.65 g), cocoa powder (25 g) and colloidal silicon dioxide (4.25 g) were co-sifted. Monoammonium glycyrrluzinate (0.9 g), chocolate flavor (20 g) and vanilla flavor (10 g) were co-sifted. Mixed all the above blend in a conta blender for 10 minutes. Stearic acid (18 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable punches and dies to produce tablets with satisfactory physical parameters.
Example 5
Proline-rich polypeptide complex 1% (10.20 g) and fructose (101.65 g) was sifted separately through suitable sieve on sifter. Mannitol (57.40 g), cocoa powder (25 g) and colloidal silicon dioxide (4.25 g) were co-sifted. Croscarmellose sodium (10 g), monoammonium glycyrrhizinate (1.5 g), chocolate flavor (20 g) and vanilla flavor (10 g) were co-sifted. Mixed all the above blend in a conta blender for 10 minutes. Sifted magnesium stearate (10 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable punches and dies to produce tablets with satisfactory physical parameters.

Example 6
Proline-rich polypeptide complex 1% (10.20 g) and fructose (125.0 g) was sifted separately through suitable sieve on sifter. Mannitol (20.8 g), cocoa powder (25 g) and colloidal silicon dioxide (4.0 g) were co-sifted. Croscarmeilose sodium (15 g), monoammonium glycyrrhizinate (2.0 g), chocolate flavor (25 g) and vanilla flavor (15 g) were co-sifted. Mixed all the above blend in a conta blender for 10 minutes. Sifted magnesium stearate (8.0 g) was added to the above blend and mixed for further 3 minutes. This blend was compressed using suitable punches and dies to produce tablets with satisfactory physical parameters.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative examples and that the present invention may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, rather than to the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

We Claim,
1. A composition comprising proline-rich polypeptide complex (colostrinin), one or more polyols and atleast one dis integrant.
2. The composition as claimed in claim 1, wherein the disintegrant is selected from croscarmellose sodium, pregelatined starch and crospovidone; preferably croscarmellose sodium.
3. A composition comprising proline-rich polypeptide complex (colostrinin) and a combination of reducing sugar and polyol; wherein the ratio of reducing sugar to polyol is 6:1.
4. The composition as claimed in claim 1 or claim 3, wherein the polyol is not sorbitol.
5. The composition as claimed in claim 3, wherein the polyol is selected from the group consisting of inositol, mannitol, isomalt, xylitol, lactitol, erythritol and maltitol and the reducing sugar is selected from the group consisting of glucose, fructose, lactose, glyceraldehyde, arabinose, maltose and mixtures thereof.
6. The composition as claimed in claim 1 or claim 3, wherein the colostrinin is derived from bovine, ovine or caprine source.
7. The composition as claimed in claim 1 or claim 3, wherein the unit dose strength of colostrinin is from about 50 micrograms to about 150 micrograms.
8. The composition as claimed in claim 1 or claim 3, wherein the

composition further comprises excipients selected from one or more of diluent, lubricant, glidant and flavouring agent.
9. The composition as claimed in claim 1 or claim 3, wherein the composition is in the form of an oral dosage form selected from tablets, chewable tablets, capsules or powders.
10. The composition as claimed in claim 9, wherein the composition is in the form of a chewable tablet.
11. The composition as claimed in claim 9, wherein the composition is a nutraceutical.
12. The composition as claimed in claim 10, wherein the chewable tablet comprises from about 1.0% to 6.0% by weight of colostrinin, 5.0% to 50.0% by weight of polyol and 1.0% tol0.0% by weight of disintegrant.
13. The composition as claimed in claim 10, wherein the chewable tablet comprises from about 3.5% to 4.5% by weight of colostrinin, 5.0% to 20.0% by weight of mannitol and 3.0% to 7.0% by weight of croscarmellose sodium.
14. A process for preparation of the composition as defined in claim 1, wherein said process comprises the steps of:

(a) providing colostrinin;
(b) preparing a blend of said colostrinin, one or more polyol, atleast one disintegrant and optionally other suitable excipients;
(c) mixing atleast one lubricant with the blend of step(b) to get lubricated blend; and
(d) compressing the lubricated blend into tablet.

15. The process as claimed in claim 14, wherein the lubricated blend has a loss on drying (LOD) value of less than 1.5% w/w at 60°C and a bulk density in the range of about 0.5 g/cm3 to 0.7 g/cm3.