NZ570635A

NZ570635A - Bio-active delivery system using lipids extracted from milk to coat the active substance

Info

Publication number: NZ570635A
Application number: NZ57063503A
Authority: NZ
Inventors: Michail Borissenko
Original assignee: New Image Internat Ltd
Priority date: 2003-09-12
Filing date: 2003-09-12
Publication date: 2010-04-30

Abstract

A method of increasing the dispersibility of a bioactive substance in a liquid mixture comprising: (a) providing a bioactive substance, (b) providing a lipid mixture extracted from milk wherein the lipid mixture comprises an effective amount of sphingomylein, ganglioside and phospolipid, and (c) coating the bioactive substance with the lipid mixture, with the result that the dispersibility of the bioactive substance in the lipid mixture is increased. (62) Divided Out of 553242

Description

New Zealand Paient Spedficaiion for Paient Number 570635 * ' , 570635 4 * K *10056519719* Patents Form No. 5 57<>6 35 THE PATENTS ACT 1953 COMPLETE SPECIFICATION Bio-Active Delivery System I, New Image International Limited, a New Zealand company, of 19 Mahunga Drive, Mangare Bridge, Auckland, New Zealand, hereby declare this invention for which I pray that a patent may be granted to me, and the method by which it is to be 25 performed, to be particularly described in and by the following statement: INTELLECTUAL PROPERTY I OFFICE OF N.Z. f 9 AUG 2008 RECEIVED 570635 BIO-ACTIVE DELIVERY SYSTEM FIELD OF INVENTION The present invention relates to a method associated with delivering active pharmaceutical, nutraceutical, dietary and nutritional supplements to target areas of the body. Multi-functional biological actions of delivery systems within the scope of the invention relates to the fact that they are naturally derived and may possess beneficial biologically potent actions of their own. These beneficial biological properties may include the protection of the intestine against infection, improved gut health, and positive effects on brain & liver function. The delivery system may be in the way of a coating, micelle, liposome, emulsion or bipolar membrane and may include complex lipids; glycolipids, sphingolipids and phospholipids. The sources of these lipids are preferably dairy or milk based. The delivery systems can be used in oral, nasal, ophthalmic, topical or suppository application.

BACKGROUND OF INVENTION There is an ever increasing public and health industry awareness of the health and medical benefits associated with compounds found in nature. In the past pharmaceutical and chemical companies concentrated on making synthetic derivatives of bio-active and bio-functional compounds. This was based on a number of factors, including associated costs of processing and volumes required. Now there is a trend by which health industry is seeking natural alternatives to these synthetic compounds. In other words, the health industry is increasingly seeking treatments that avoid synthetic or non-naturally derived substances whenever possible. Notably, the public's natural-remedy consumption for specific health and emotional problems, as well as for general health promotion, has soared in recent years. 2 570665 Notwithstanding the desire for natural, non-synthetic products, some otherwise-natural products are unknowingly or unwittingly treated with non-naturally derived material during processing. For instance, it is known in the art that some ingestible preparations including some functional foods, nutraceutical, dietary & nutritional supplements, and even pharmaceutical preparations tend to clump when mixed with water based solvents such as gastrointestinal fluids. One method to avoid this or to decrease its effect is to apply a surfactant coating that promotes dispersion or dissolution. One frequently-used, dispersion-promoting surfactant is lecithin — which is extracted from soybeans. But soy lecithin comes from commercially grown soybeans, essentially ail the varieties of which have been genetically engineered or modified in one form or another. Thus, the typical method of promoting dispersion of functional foods, nutraceutical, dietary & nutritional supplements, and even pharmaceutical preparations introduces a hidden source of non-naturally derived substances into preparation intended to be completely natural.

What is desirable is a dispersion (dissolution)-enhancing surfactant that is substantially natural, available in economically useful quantities, and has at least the dispersion (dissolution)-enhancing capacity of similar substances commonly used in the functional food, nutraceutical, dietary & nutritional supplement, and pharmaceutical arts. This can facilitate the preparation of natural-sourced functional foods, nutraceuticals, dietary & nutritional supplements, and even pharmaceuticals.

BRIEF DESCRIPTION OF THE INVENTION For the remainder of this document, references to a pharmaceutical or pharmaceutical substance are meant to encompass any substance or mixture of substances that can be beneficially ingested, inhaled or inserted into or by animals or humans, or beneficially applied to animal or human skin or mucous membranes. The terms pharmaceuticals and pharmaceutical substances, thus encompass dietary 3 570^35 supplements (including athletic supplements such as creatine, soy protein powder, whey protein powder and 5HTP), pharmaceuticals, nutraceuticals, nutritional supplements, and functional foods. The terms pharmaceutical and pharmaceutical substance should be taken as synonymous with bioactive and bioactive substance and biofunctional and biofunctional substance. The term "herbals" means bioactive substances derived from plants and trees.

An important aspect of one embodiment of this invention is a method of increasing bioactive substance dispersibility (dissolution) using a natural lipid-based surfactant to coat the pharmaceutical substance. This lipid-based surfactant can be prepared by mixing individual phospholipids such as phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, ganglioside, ceramide, and sphingomylein. The lipid-based surfactant may function regardless of the source of the individual phospholipids used in the mixture, but to achieve the goal of excluding non-natural substances, the surfactant should be selected from phospholipids of only natural source. Besides preparing a mixture of phospholipids for use in coating pharmaceuticals, a naturally occurring mixture can also be used. One example of this is a lipid-based surfactant extrated form milk or dairy.

Another important aspect of an embodiment of this invention is an enhanced delivery method for delivering bioactive substances that employs bioactives treated with the lipid- based surfactant.

Some aspects of the invention are described in the claims, the content of which is incorporated in this "brief description of the invention" section of the specification by way of reference. 4 570835 DETAILED DESCRIPTION An embodiment of this invention provides a dispersion (dissolution) increasing surfactant for use in processing pharmaceuticals. One commonly-used, dispersion-increasing surfactant is soy lecithin. Soy lecithin often comes from farming, but many sources of soybean seeds are largely centralized in a few corporations. Most current sources of soy lecithin can be traced back to genetically altered soybean seeds. On the other hand, one major source of this invention's dispersion-increasing surfactant, the lipid mixture, is the bovine dairy (milk) industry. Dairy industry practices allow individual milk producers much control over content of the milk. This control allows milk producers to more easily avoid non-natural compounds. Thus, with suitable guidelines in place, a pharmaceutical manufacturer could obtain substantially natural-sourced, lipid-based surfactants for use in preparing its products. In addition to avoiding or reducing non-natural compounds in the final product, the components of the lipid-based surfactant themselves have positive health benefits. So rather than using a non-natural or bio-inert dispersing agent in its products, a manufacturer could use a surfactant according to this invention and provide to its products the additional benefit of further promoting health.

Increased dispersion (dissolution) of the bioactive and biofunctional substance is desirable in a number of respects. Increased dispersion (dissolution) in the gastrointestinal tract of an animal or human produces two related results. First, increased dispersion may mean increased reactive surface area of the bioactive and biofunctional substance, causing quicker digestion and utilization. Also, increased surface area may mean increased contact with intestinal epithelium (wall) tissue, increasing absorption of the bioactive and biofunctional substance in to the animal's and human's bloodstream. 570635 In a related manner, increasing the dispersion (dissolution) of bioactive and biofunctional substances in the fluid base of a topical ointment is also desirable. In that case, the goal is to keep the bioactive and biofunctional substances suspended in the ointment or lotion until the lotion is appled to the skin. After skin application, increased dispersion (dissolution) may mean faster uptake or permeation into or through the skin.

Although it is not certain, it is believed that the phospholipid's dual polar and non polar nature causes the surfactant's dispersion (dissolution) increasing effect. The terminal phosphate group on one end of the phospholipid creates the polar nature; a terminal fatty- organic chain on the phospholipid's other end creates the non-polar nature. The phospholipid's non-polar end has an affinity for substantially non-polar bioactive and biofunctional substances. This affinity may cause the phospholipid to arrange itself around bioactive and biofunctional substance particles so that each phospholipid molecule's non-polar end preferentially points inward. This leaves the molecule's polar phosphate end preferentially pointing outwards. These outward-pointing phosphate groups may prevent the particles from touching each other in the solid. When the coated particles are introduced into a water-based or ionic fluid, the surfactant's (negatively charged) phosphate groups interact with the water molecules' positive charged hydrogen atoms (in an aqueous ionic fluid, with the fluid molecules' positively charged portion) and thereby begin the typical aqueous solvation process seen in ionic solids. But since the particles are themselves large, the phosphate-group arrangement around the bioactive and biofunctional substance results in particle dispersion (dissolution) rather than solvation. The dispersion (dissolution) effect in that case may mostly result from the lipid preventing the bioactive and biofunctional substance particles from clumping together when in the solid. Clumping 6 570635 would prevent the coated particles from easily dispersing even though the ionic substance itself has an affinity for water or other ionic solvents.

A single lipid can function as the surfactant in this invention. Thus, the active dispersion (dissolution)-increasmg substance can be one or more non-toxic phospholipids. In such a case the main requirement is that the phospholipid's terminal organic chain be long enough to impart non-polar character to one end of the molecule. In a more preferred embodiment, the lipid-based surfactant comprises one or more of the following lipids derived from a substantially or completely natural source: phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, ganglioside, ceramide, and sphingomylein.

The most preferred embodiment of the invention uses a lipid-based surfactant extracted from dairy or milk. In general, the milk of almost any mammal will function in this invention. Because it is normally the most economical and available milk, it is anticipated that bovine milk will most commonly serve as the milk source, but particular applications may require some other animal or human milk. For example, some veterinary applications may require milk from the same type of animal that is being treated, or the treatment humans who are allergic to bovine milk may require using human milk as the lipid-based surfactant source. Porcine, equine, canine, feline, rodent, goat, and sheep milks are likely sources in addition to bovine and human milks.

The process of gathering the lipid-based surfactant may begin in the milk processing stage where the skim is separated from the cream. The lipid-based surfactant is extracted from the fat rich phase, the cream, buttermilk, and or butterfat. The process may include taking the fat-rich phase and dissolving it in a suitable, non-toxic solvent, 7 579635 such as ethanol, and using filtration technology and gradient fractionation to separate out the desired lipids. In this way the lipid based surfactants may be concentrated to a very high degree. After separation the lipids are dried by either freeze-drying (lyophilization), drum drying, scrape surface drying, or spray drying. For the purposes of this invention, spray drying using indirect heating is the preferred drying technology. The lipid-based surfactant obtained in this way may contain the following phospholids: phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, sphingomyleins, gangliosides, and other minor lipid components. These lipids may be nutritively, biofunctionally, and biologically important in their own right.

Phospholipids are often regarded as complex lipids and are important to at least many physiological membranes. They may be amphipathic lipid compounds essential to biological membranes. Phospholipids are present in cells of animals and plants. In animals they are found abundant in the tissues of the brain, heart, liver, muscle, kidneys, and bone marrow. Though phospholipids may function primarily as structural elements they may also be important in three very critical areas - the growth, maturation and proper functioning of the cells in the body.

Phospholipids can be derived from glycerol or sphingosine and may be designated either glycerophospholipids or sphingolipids respectively. The predominate form of phospholipids are the glycerophospholids of which phosphatidylcholine (lecithin), phosphatidylserine, phosphatidylethanolamine, and phosphatidylinositol are the predominate species. 8 570635 Sphingolipids are specific to animal sources and are generally not found in plants (such as soy). There are two types of sphingolipids: sphingophospholipids and sphingoglycolipids. As the nomenclature implies the sphingophosphotipids are phospholipids with a sphingosine backbone. Sphingoglycolipids also have a sphingosine backbone but instead of containing a phosphate group have a sugar group. Prime examples of sphingophospholids and sphingoglycolipids are sphingomylein and gangliosides respectively.

Phospholipids are an excellent source of choline, which has been shown to increase brain function. Phospholipids, in particular phosphotidylserine, have been associated with improved memory. Phospholipid supplementation has been shown to be beneficial in the treatment of Alzheimer's and similar diseases. Phospholipids have also been shown to reduce mood swings and elevate depression. Phospholipids in particular phosphatidylcholine, has been shown to have a protective effect on the liver— protecting it against damage caused from toxins including alcohol, drugs and viruses.

The sphingolipid sphingomyelin represents 25—33% of the total phospoholipids present in milk. Sphingolipids function in variety of physiological roles from initiating cellular defense, tumor suppression and cholesterol mobilisation to liposome membrane rigidifcation.

Milk derived sphingomylein has been shown in in vitro studies using a human cell line to boost cellular production of interferon-beta which plays an important role in cellular defense against virial infection. The breakdown products of sphingomylein are sphingosine and ceramide. Sphingosine has been shown to inhibit protein kinase C 9 f 570635 an important component in the internisation of growth factors into the cell. Thus it has been theorized that sphingomylein contains components that act as second messengers which are important in cell growth and regulation. The digestive products of sphingomylein have also been shown to be highly anti-microbial and be effective in vitro against such pathogens as Salmonella, Camplyobacter, Vibrio, Listeria, and pathogenic E coli.

Along with other phospholipids in milk, sphingomyelin can protect gastric mucosa against injury caused by acid, pepsin or exogenous irritants. Sphingomylein along with phosphatidylcholine is an important source of choline which is important for brain function. Sphingomylein accounts for approximately 10% of the lipids present in the brain — primarily associated as their name implies the myelin sheath of nerves.

Considerable research has been undertaken on the functions of phospholipids and, more recently, sphingolipids in health and disease. Recently it has been shown that both sphingolipids and their breakdown products — ceramide and sphingosine — are highly bioactive compounds having a profound effect on various biological functions in the body. Regulation of cell growth, differentiation, signalling, and programmed cell death (apoptosis) have all been attributed to sphingolipids. Further, sphingolipids have also been implicated in playing a vital role in neuronaf development. In animal studies it has been revealed that dietary sphingolipids inhibit colon carcinogenesis.

Studies on mice who were administered with 1,2 dimethlylhydrazine — a powerful tumour inducing agent — revealed that an up to 70% reduction of tumours was observed after being fed milk derived sphingomylein. With longer feeding even a greater reduction of tumours was observed. Of significance it was revealed that mice 570635 I fed as little as 25mg of sphingomylein/IOOg of diet had a 57% reduction in incidence of colon tumours. Further studies on mice fed milk derived sphingomylein, as compared to a control group fed a standard diet, showed a reduction in aberrant colon tumours, and most importantly revealed a shift from malignant tumours to ones that were benign. Thus it has been postulated that sphingomylein-containing foods may have anti-cancer activity. Though no clinical trials have been conducted on humans to date the results of in vitro studies using human cancer cells lines show great promise. Further Sphingomylein has been shown to increase the effectiveness of chemotherapy agents in killing cancer cells.

The sphingoglycolipids such as gangliosides are present in substantial amounts in nerve cell membranes. In addition gangliosides are found in the membranes of white and red blood cells. It is of interest that Ganglioside content is diminished in the brains of Alseihemer's patients. Of further interest is the significant and vital role Gangliosides play in the brain development of the young.

Gangliosides like sphingomylein exhibit a high level of antimicrobial activity — in that they are both bactericidal and bacteriostatic to organisms that are frequently associated with causing diarrhoea in young mammals. In addition gangliosides have been shown to act in protecting the intestine against disease.

Phosphotidyserine (PS) makes up approximately 8% of the total phospholipid in bovine milk. There is substantial evidence that indicates that PS improves memory and improves brain function. Phosphotidylserine is most concentrated in the brain where it functions to support many crucial nerve cell functions. It is the primary component of cellular membranes of neurons. In brain disorders such as Alzeimer's, 11 570635 Parkinson's, and Multiple Sclerosis there is an association with neuron degeneration and dysfunction. Phosphotidylserine has been shown to stimulate the production of a brain messenger chemical (dopamine) that helps regulate memory. PS has also been shown to stimulate protein kinase C production and help modify mood changes arising from stress. In addition there is a growing amount of evidence growing associated with the beneficial aspects of PS in elevateing mood and reduceing the symptoms of depression. Further PS has been shown to have positive effects in treating early Alzeimer's and the onset of premature memory loss due to dementia.

Phosphotidylethanolamine (PE) also known as Cephalin makes up approximately 30% of the total phospholipid content of bovine milk. Phosphotidylethanolamine comprises the backbone of cell membranes and contributes to the fluidity and structural enviroment of ceils. In regard to the brain and nervous tissue PE plays an important role in myelin structure (nerve covering) and nerve endings in the brain. Phospholipids, particularly PE has shown to be beneficial in lowering serum cholesterol levels and thus reduce the risk of heart disease.

Phosphotidyicholine (PC) also known as Lecithin makes up approximately 30% of the phospholipid present in bovine milk. Along with sphingomylein PC is a major source of choline. Choline is a major neurotransmitter Acetylcholine. Dietary PC has been shown to improve neurological malfunctions such as tremors, ataxis and mood swings. Choline is required to sustain tissue growth and thus a ready supply of this phospholipid is required for maintenance of good health.

Phosphotidyicholine is a major building block for all cell membranes, and it supports cellular, tissue and organ function. This is particularly true of the liver with it's vast 12 network of cellular membranes and thus the liver is particularly dependent on PC for proper function. In fact it has been shown in clinical trials that dietary PC has beneficial aspects in helping individuals recover from toxic liver damage. PC has also been shown to protect the liver from damage due to, viral infection, medication, alcohol, and nutritional deficiency. Also it has been shown to be beneficial in speeding the recovery process resulting from liver damage.

Phosphatidylinositol (PI) also known as Inositol comprises approximately 5% of the total phospholipid present in milk, inositol is necessary for the proper functioning of the brain, nerves and muscle. Inositol is a "lipotropic" substance helping to prevent build-up of fatty deposits in the liver. Further Inositol is an essential nutrient for proper growth in newborn children.

The significant difference between plant based soy lecithin and milk phospholipid is the actual composition of the phospholipids in question. As was mentioned previously animal based phospholipid preparations contain sphingomylein. In addition milk derived complex lipids are more similar to human lipids than at least most vegetable sources. Further, the emulsion properties of sphingomylein aee can be superior to those of soy lecithin. The actual phospholipid compositional differences are demonstrated below: Phospholipid Class Soybean Milk Phosphatidylcholine 30% 30% Phosphotidylethanolamine 20% 30% Phosphotidylserine 3% 10% 13 Phospatidylinositol 20% 5% Sphyngomylein Not present 25% as expressed as total phospholipid present.

For use, the phospholid or phospholipid mixture associated with the present invention may must be coated onto the bioactive and or biofunctonal substace. As previously stated, the bioactive and or biofunctional substance may be a mixture of one or more bioactive and or biofunctional components. Because the lipid-based surfactant can improve the dispersibility (dissolution) of substantially non-polar as well as substantially polar bioactive and biofunctional components, the range of bioactive and biofunctional components that will function in this invention may include vitamins, minerals, antibiotics, probiotics, prebiotics, natural plant and tree extracts, herbals enzymes, hormones, proteins, athletic supplements, dietary and nutitional supplements, functional foods, and pharmaceuticals. In some embodiments of the invention the following may be bioactive and/or biofunctional components: Bifidobacterium, lactobacillus, acidophilus, colostrum, milk and whey powders, arabinogaiactan, lactoferrin, growth factors, immunoglobulins, immune factors, olive leaf and it's extract, other plant and tree extracts. Echinacea, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase . Other plant and tree extracts suitable for use as the bioactive and biofunctional components can be found in the standard Pharmacopias AHPA and USP.

The coating step can be carried out using any process known in the art that is compatible with the lipid-based surfactant and the pharmaceutical. One process is referred to as agglomeration and is performed by spraying the surfactant as a damp 14 570635 powder on the boactive and/or biofunctional substance. In a preferred practice of this invention, a natural lipid-based surfactant replaces soy lecithin. As can be seen by the examples below, the lipid-based surfactant may improve colostrum dispersion four fold over untreated colostrum, and two fold over soy-lecithin-treated colostrum. In an exemplary embodiment in which colostrum is coated with a lipid-based surfactant, the lipid based surfactant may be 0.5 to 1 % by weight of the coated colostrum. This percentage can be varied as specified by the manufacturer to vary the thickness of the coating.

Because of the mechanism by which the surfactant of this invention may improves dispersion times, the surfactant treatment method is generally applicable to all bioactive and biofunctional substances and mixtures. Once the coated bioactive and/or biofunctional substance is prepared it functions in any application where improved dispersion (dissolution) is useful and/or desired. For instance, when the coated bioactive and or biofunctional substance is intended to be consumed, it is processed into one of several different forms for administration. When the coated substance is intended to be used topically, it may be added directly to a suitable carrier, such as a lotion or ointment base. Alternatively, the coated bioactive and/or biofunctional substance can be further processed as necessary before introduction into the topical carrier.

The coated bioactive substance may be prepared in several different ingestible forms. When the flavour of the bioactive and or biofunctional substance permits, the coated bioactive and or biofunctional substance may be processed into a powder for direct addition to food or for direct oral consumption. Likewise, it may function when mixed into a common liquid suspension such as commonly used for children's pharmaceutical products. Also, the coated bioactive and or biofunctional sustance is may be placed into gelatin or other standard medication capsules or cold pressed into tablet form, Processing as is commonly used in the art may be suitable for processing the coated bioactive and or biofunctional substances of this invention, as long as the processing does not harm the bioactive and or biofunctional substance and leaves the lipid coating intact.

EXAMPLES The dispersion time of lipid colostrum versus uncoated and soy-lecithin-coated colostrum was measured with results shown in the table below. Each sample was prepared similarly, except for the specific coating used. For example, both the soy-lecithin-coated colostrum and the lipid-coafed colostrum were prepared with bovine colostrum. This was also true of the uncoated sample. The agglomeration was performed as follows: dried bovine ciostrum was rewetted to about 12% moisture. It was then sprayed with either soy-lecithin or the lipid mixture in accordance with this invention and then left to dry. The uncoated colostrum was not treated. The dispersion (dissolution) time or the time it takes for powder to completely dissolve in water was then measured and the resulting times are given below.

Sample Dispersion Time - Seconds Untreated Bovine Colostrum 30 Soy TreatedBovine Colostrum 15 Lipid Trested Bovine Colostrum 7 16 570635 As conveyed above, the invention may involve the use of coatings which are themselves beneficial to the human or animal which receives them. However the invention is not dependent on this feature.

While specific preferred embodiments of the subject invention have been described above, it will be understood that changes and modifications can be made without departing from the scope of the appended claims. 57 570635

Claims

WHAT WE CLAIM IS:

1. A method of increasing the dispersibility of a bioactive substance in a liquid mixture comprising: (a) providing a bioactive substance, (b) providing a lipid mixture extracted from milk wherein the lipid mixture comprises an effective amount of sphingomylein, ganglioside and phospolipid, and (c) coating the bioactive substance with the lipid mixture, with the result that the dispersibility of the bioactive substance in the lipid mixture is increased.

2. The method of claim 1, further comprising: (d) providing a liquid phase; and (e) introducing the coated bioactive substance into the liquid phase, wherein the coated bioactive substance disperses in the liquid faster than the bioactive substance when not so coated; with the proviso that a method of medical treatment of the human body is disclaimed.

3. The method of claim 2, wherein step (e) the coated bioactive substance disperses in the liquid at least 50% faster than the bioactive substance when not so coated.

4. The method of claim 1, wherein the lipid mixture has been extracted from the milk of a dairy cow.

5. The method of any one of claims 1-4, wherein the milk is selected from the group consisting of human, bovine, porcine, equine, canine, feline, rodent, goat, and sheep milk.

6. The method of claim 1, wherein the bioactive substance is selected from the 18 570635 group consisting of nutraceuticals and pharmaceuticals.

7. The method of claim 1, wherein the bioactive substance is selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, enzymes, herbals, hormones, and athletic supplements.

8. The method of claim 1, wherein the bioactive substance is selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

9. The method of claim 1, wherein the bioactive substance comprises a mixture of at least two bioactive components.

10. The method of claim 9, wherein at least one bioactive component is selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, herbals, enzymes, hormones, and athletic supplements.

11. The method of claim 10, wherein at least one bioactive component is selected from the group consisting of bifidobacterium longhum, actobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

12. The method of claim 9, wherein each bioactive component is selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, herbals, enzymes, hormones, and athletic supplements.

13. The method of claim 12, wherein at least one of the bioactive components is selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosainine sulfate, cetyl myristoleate, and lipase 19 570635 enzyme.

14. The method of claim 9, wherein the bioactive substance includes colostrum.

15. The method of claim 9, wherein the bioactive substance includes lactoferrin.

16. The method of claim 2, wherein the liquid phase comprises gastric fluids contained in the intestinal tract of an animal.

17. The method of claim 2, wherein the liquid phase comprises at least two miscible liquids.

18. The method of claim 2, wherein the liquid phase comprises an emulsion of at least two immiscible liquids.

19. The method of claim 18, wherein the emulsion comprises a topical cream base or ointment base.

20. The method of claim 2, wherein introducing the bioactive substance comprises orally administering the bioactive substance to a non-human animal, thereby mixing the treated bioactive substance into the gastric fluid of the animal.

21. The method of claim 1, wherein the phospholipid comprises at least one of phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, a ganglioside, a ceraniide, and a sphyngomyelin.

22. The method of claim 1, wherein the phospholipid comprises phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine and phosphatidyl inisitol. 20 570635

23. The method of claim 1, wherein the lipid mixture comprises at least two phospholipids.

24. The method of claim 23, wherein the phospholipids comprise at least one of phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, a ganglioside, a ceramide, and a sphyngomyelin.

25. The method of claim 24, wherein the phospholipids comprises at least one of phosphatidyl choline and phosphatidyl ethanolamine.

26. The method of claim 24, wherein phospholipid comprises phosphatidyl choline and phosphatidyl serine.

27. The method of claim 24, wherein phospholipid comprises phosphatidyl ethanolamine and phosphatidyl serine.

28. A bioactive substance comprising one or more bioactive component prepared by: (a) providing at least one bioactive component; (b) providing a lipid mixture extracted from milk; and (c) treating at least one bioactive component by coating it with the lipid mixture comprising sphingomylein, ganglioside and phospholipid so that the bioactive component when so coated has greater dispersibility in a target liquid phase than when not so coated.

29. The bioactive substance of claim 28, wherein the coated bioactive component disperses in an aqueous liquid phase faster than the uncoated bioactive component.

30. The bioactive substance of claim 28, wherein the coated bioactive component disperses in the target liquid phase at least 50% faster than the uncoated bioactive component. 21 570635

31. The bioactive substance of claim 28, wherein the lipid mixture has been extracted from the milk of a dairy cow.

32. The bioactive substance of claim 28, wherein the milk is selected from the group consisting of human, bovine, porcine, equine, canine, feline, rodent, goat, and sheep milk.

33. The bioactive substance of claim 28, wherein the at least one bioactive component is selected from the group consisting nutaceuticals and pharmaceuticals.

34. The bioactive substance of claim 28, wherein the at least one bioactive component is selected from the group consisting vitamins, minerals, antibiotics, probiotics, natural extracts, enzymes and hormones.

35. The bioactive substance of claim 28, wherein the at least one bioactive component is selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, and methyl sulphonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

36. The bioactive substance of claim 28, wherein step (a) comprises providing at least two bioactive components.

37. The bioactive substance of claim 36, wherein at least one of the bioactive components comprises colostrum.

38. The bioactive substance of claim 36, wherein at least one of the bioactive components comprises lactoferrin.

39. A lipid mixture for treating a bioactive substance, the mixture comprising an effective amount of sphingomylein, ganglioside and phospholipid and prepared by: (a) separating the lipid mixture from milk: and (b) purifying the lipid mixture; the lipid mixture being such that it can be coated onto the bioactive substance, whereby the coating increases the bioactive substance's dispersibility in an aqueous or non-aqueous substance as the case may be. 22 570635

40. The lipid mixture of claim 39, wherein the milk is selected from the group consisting of human, bovine, porcine, equine, canine, feline, rodent, goat and sheep, milk.

41. The lipid mixture of claim 39, wherein the bioactive substance comprises one or more bioactive components).

42. The lipid mixture of claim 41, wherein the bioactive component is selected from the group consisting of nutraceuticals and pharmaceuticals.

43. The lipid mixture of claim 42, wherein the one or more bioactive component is selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, herbals, enzymes, hormones and athletic supplements.

44. The lipid mixture of claim 43, wherein the one or more bioactive component is selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

45. The lipid mixture of claim 39, wherein the bioactive substance comprises a mixture of at least two bioactive components.

46. The lipid mixture of claim 45, wherein the bioactive substance includes colostrum.

47. The lipid mixture of claim 45, wherein the bioactive substance includes lactoferrin.

48. A method for enhancing the delivery of a bioactive substance comprising: (a) providing an uncoated bioactive substance, (b) providing a lipid mixture extracted from milk, the mixture comprising an effective amount of sphingomylein, ganglioside and phospholipid, and (c) coating the bioactive substance with the lipid mixture, whereby the coated bioactive substance is or can be more highly dispersed in a target fluid than the uncoated bioactive substance. 23 570635

49. The method of claim 48, wherein the lipid mixture is extracted from the milk of a dairy cow.

50. The method of claim 48, wherein the milk is selected from the group consisting of human, bovine, porcine, equine, canine, feline, rodent, goat, and sheep milk.

51. The method of claim 48, wherein the bioactive substance comprises at least one bioactive component.

52. The method of claim 51, wherein the at least one bioactive component is selected from the group consisting of nutraceuticals and pharmaceuticals.

53. The method of claim 51, wherein the at least one bioactive component is selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, herbals, enzymes, hormones and athletic supplements.

54. The method of claim 51, wherein the at least one bioactive component is selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrum, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

55. The method of claim 48, wherein the bioactive substance comprises a mixture of at least two bioactive components.

56. The method of claim 55, wherein at least one of the bioactive substances includes colostrum.

57. The method of claim 55, wherein at least one of the bioactive substances includes lactoferrin.

58. A composition suitable for coating bioactive substances to improve dispersibility in a target liquid comprising comprising sphingomylein, ganglioside and at least one phospholipid extracted from milk, the phospholipid selected from the group consisting 24 570635 of phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, phosphatidyl inisitol, and sphyngomyelins.

59. The composition of claim 58, wherein the at least one phospholipid is separated from the milk of a dairy cow.

60. The composition of claim 58, wherein the milk is selected from the group consisting of human, bovine, porcine, equine, canine, feline, rodent, goat, and sheep milk.

61. The composition of claim 58, when coated on at least one bioactive substance.

62. The composition of claim 61, wherein the bioactive substance comprises one or more bio active components.

63. The composition of claim 61, wherein the bioactive component(s) is/are selected from the group consisting of nutraceuticals and pharmaceuticals

64. The composition of claim 63, wherein the bioactive component(s) is/are selected from the group consisting of vitamins, minerals, antibiotics, probiotics, natural extracts, herbals, enzymes, hormones, and athletic supplements.

65. The composition of claim 64, wherein the bioactive component(s) is/are selected from the group consisting of bifidobacterium longhum, lactobacillus, acidophilis, colostrums, arabinogalactan, lactoferrin, olive leaf extract, echinacea purpura, methyl sulfonyl methane, glucosamine sulfate, cetyl myristoleate, and lipase enzyme.

66. The composition of claim 61 wherein the bioactive substance comprises a mixture of at least two bioactive components. 25 570635

67. The composition of claim 66, wherein the bioactive substance includes colostrum.

68. The composition of claim 66, wherein the bioactive substance includes lactoferrin. New Image International Limited By Its Attorney A.J. Pietras & Co 26