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AU2003100587A4 - Granulation of Colostrum Powder - Google Patents

Granulation of Colostrum Powder Download PDF

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Publication number
AU2003100587A4
AU2003100587A4 AU2003100587A AU2003100587A AU2003100587A4 AU 2003100587 A4 AU2003100587 A4 AU 2003100587A4 AU 2003100587 A AU2003100587 A AU 2003100587A AU 2003100587 A AU2003100587 A AU 2003100587A AU 2003100587 A4 AU2003100587 A4 AU 2003100587A4
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AU
Australia
Prior art keywords
weight
powder
colostrum
granulate
colostrum powder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
AU2003100587A
Inventor
Teodor Stelmasiak
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glutagen Pty Ltd
Original Assignee
Glutagen Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glutagen Pty Ltd filed Critical Glutagen Pty Ltd
Priority to AU2003100587A priority Critical patent/AU2003100587A4/en
Application granted granted Critical
Publication of AU2003100587A4 publication Critical patent/AU2003100587A4/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Description

P/00/009 Regulation 3.2
AUSTRALIA
Patents Act 1990 INNOVATION PATENT SPECIFICATION Invention Title: GRANULATION OF COLOSTRUM POWDER Applicant: GLUTAGEN PTY.LTD.
The invention is described in the following statement: C:%vnosTEMFJnnovat~on oover (l),doc 2 GRANULATION OF COLOSTRUM POWDER This invention relates to a method of treating colostrum powder to obtain a granulate which is more soluble than untreated colostrum powder.
Colostrum powder is obtained from colostrum, that is, mammalian milk produced during the first few days post-partum. It is produced by removing fats, casein, sugar and water from colostrum, to leave a powder having a high concentration of proteins. By immunising the mammal producing the colostrum against specific diseases, it is possible to obtain a colostrum powder which contains active antibodies to those diseases. It is envisaged that the colostrum powder used in the present invention may come from an immunized mammal and contain active antibodies to one or more diseases.
Production of colostrum powder from colostrum may be achieved in a number of ways, and reference is made to UK Patent 1,573,995 and to PCT Application PCT/AU94/00562, which disclose methods of obtaining colostrum powder.
High quality colostrum powder is typically 75-85% protein. The proteins may include active antibodies and other proteins, making the colostrum powder useful as a pharmaceutical or as a dietary supplement.
Although colostral proteins exist in colostrum as colloidal solutions, the high proportion of protein in colostrum powder means that it is difficult to dissolve colostrum powder in an aqueous media, such as saliva. When water or saliva contacts particles of colostrum powder, a gelatinous layer is formed on the surface of the particles, restricting water penetration to the inner core of the particles, and preventing further break-up of the particles to form a colloidal solution. This means that colostral proteins cannot readily be administered in the upper digestive tract, for example, in the form of a chewable tablet, because uptake of the colostral proteins is delayed by the poor solubility of the colostrum powder.
C:\windows\TEMP\Granulation of Colostrum Powder Innovation Patent.doc 3 The present invention seeks to provide a method by which the solubility of colostrum powder may be improved. The invention also provides a chewable tablet formulation including the treated colostrum powder.
According to the invention, colostrum powder is mixed with sorbitol. The proportion of colostrum powder to sorbitol may range from 7:3 to 3:7 by weight, but preferably the colostrum powder and sorbitol are present in substantially equal proportions by weight. The colostrum powder and sorbitol are thoroughly blended, preferably in a pharmaceutical grade blender, to form a blended powder mix. The blended powder mix is then placed in a granulating machine and an alcohol/water solution is added, preferably by spraying the solution on to the powder mix. Preferably, the alcohol is ethanol. The solution may range from 5% to 40% alcohol, but is preferably about 20% alcohol. The alcohol/water solution is added to the blended powder mix, until it reaches to 15% of the powder weight. Preferably, the alcohol/water solution is added until it reaches 10% of the powder weight. The blended powder mix and alcohol/water solution are thoroughly blended to form a uniform mass of granulate. Preferably, the addition of the alcohol/water solution and blending to form a uniform mass of granulate are carried out in a granulating machine such as a Diosna Universal Mixer/Granulator V Series, manufactured by Dierks&Sohne GmbH, Osnabruck, Germany.
After blending, the blended mass of granulate is dried, preferably on open trays at about 40 0 C. Whilst the exact temperature is not critical, care must be taken not to denature active proteins in the blended mass by over-heating. The dried granulate is then milled to a suitable size. Preferably, the granulate is milled to about size 200 mesh. The granulate produced in this way is found to be relatively soluble and suitable for use in formulating chewable, soluble colostrum tablets and other soluble pharmaceutical formulations.
The present invention also provides a chewable tablet formulation. The tablet preferably comprises 75-85%; more preferably about 80% colostrum/sorbitol granulate made in accordance with the method described above, but this proportion can be lowered, if desired, to include other active components in the C:\windows\TEMP\Granulation of Colostrumrn Powder Innovation Patent.doc 4 tablet formulation. The remainder of the tablet is comprised of fillers, binders, lubricants, flavours and sweeteners, colourings, and other pharmaceutically acceptable excipients.
Fillers which may be used in accordance with the invention include dextrose, lactose, starch, mannitol, microcrystalline cellulose, dicalcium phosphate dihydrate, calcium sulphate dihydrate, calcium carbonate, sucrose, inositol and amylose.
Binders which may be used in accordance with the invention include acacia, tragacanth, sodium alginate, guar gum, polyethylene glycol and magnesium aluminium silicate.
Lubricants which may be used in accordance with the invention include stearates, talc, waxes, sodium lauryl sulphate, magnesium lauryl sulphate, sodium acetate and silica.
Other active ingredients which may be incorporated in the tablet formulation of the invention include vitamins; minerals; gastrointestinal drugs; expectorants; microencapsulated proteins, peptides or live cells; interferon; antihistamines; antibiotics and antiemetics.
In a preferred tablet formulation in accordance with the invention, a 1200 mg tablet is produced containing the ingredients set out in Table 1.
Table 1 Component Mass (mg) Percentage by Weight Colostrum powder (Bovine) 500.00 41.67% Sorbitol 438.00 36.50% Dextrose 220.00 18.33% Magnesium Stearate 15.00 1.25% Silica-Colloidal Anhydrous 15.00 1.25% Flavouring (Vanilla) 12.00 1.00% Total 1,200.00 100.00% C:\windows\TEMP\Granulation of Colostrum Powder Innovation Patent.doc 1 Other formulations using different excipients or including further active ingredients are envisaged, and fall within the scope of the present invention.
C:%witndows\TEMP\Granulaio of Colostrum Powder Innovation Patent.doc

Claims (4)

1. A method of treating colostrum powder to obtain a granulate which is more soluble than untreated colostrum powder, comprising the steps of: a) mixing colostrum powder with sorbitol in a weight ratio of from 3:7 to 7:3 to produce a blended powder mix; b) adding the blended powder mix to a granulator, together with sufficient solution of from 5 to 40% alcohol in water to reach 5 to of the weight of the blended powder mix, and blending to form a uniform mass of granulate; c) drying the granulate at a temperature low enough to avoid denaturing proteins in the colostrum powder; and d) milling the dried granulate.
2. A method according to claim 1 wherein the weight ratio of colostrum powder to sorbitol is about 1:1; the solution of alcohol in water added to the blended powder mix is a 20% solution of ethanol in water, which is added to the blended powder mix by spraying until the weight of the solution is about 10% of the weight of the blended powder mix; and wherein the granulate is dried on an open tray at a temperature of about 400C, and then milled to size 200 mesh.
3. A tablet containing a granulate produced in accordance with either one of claims 1 or 2.
4. A tablet in accordance with claim 3, wherein the granulate forms about percent by weight of the tablet. C:\wndows\TEMP\GranulaUtion of Colostrum Powder Innovation Patent.doc A tablet in accordance with either one of claims 3 or 4, comprising 41.67 weight colostrum powder, 36% weight sorbitol, 18.33 weight dextrose, 1.25 weight magnesium stearate, 1.25 weight silica- colloidal anhydrous and 1 weight flavouring. DATED 17 July, 2003 PHILLIPS ORMONDE FITZPATRICK Attorneys for: GLUTAGEN PTY LTD C:\windows\TEMP\Granulation of Colostrum Powder Innovation Patent.doc
AU2003100587A 2003-07-17 2003-07-17 Granulation of Colostrum Powder Ceased AU2003100587A4 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003100587A AU2003100587A4 (en) 2003-07-17 2003-07-17 Granulation of Colostrum Powder

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU2003100587A AU2003100587A4 (en) 2003-07-17 2003-07-17 Granulation of Colostrum Powder

Publications (1)

Publication Number Publication Date
AU2003100587A4 true AU2003100587A4 (en) 2003-10-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2003100587A Ceased AU2003100587A4 (en) 2003-07-17 2003-07-17 Granulation of Colostrum Powder

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AU (1) AU2003100587A4 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024189541A1 (en) 2023-03-13 2024-09-19 University Of Tartu Colostrum tablets

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024189541A1 (en) 2023-03-13 2024-09-19 University Of Tartu Colostrum tablets

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FGI Letters patent sealed or granted (innovation patent)
MK22 Patent ceased section 143a(d), or expired - non payment of renewal fee or expiry