BIOACTIVE COMPOUNDS PROTECTION METHOD AND COMPOSITIONS CONTAINING THE SAME

Abstract

The present invention relates to means for protecting bioactive materials in mammalian food or feed formulations used to enhance the health status of mammals.

Claims

1. A method for encapsulating or embedding a heat sensitive bioactive ingredient in mammalian newborn food formulation or mammalian newborn feed formulation, comprising the steps of; (i) mixing a heat sensitive bioactive ingredient with an encapsulating material, wherein said encapsulating material is food-grade, feed-grade materials, either alone or in combination, with a liquid, forming a liquid blend, (ii) drying the liquid blend forming a dry blend, (iii) coating the dry blend with at least one additional encapsulating layer; (iv) mixing the dry blend with at least one additional food-grade or feed-grade material; and (v) adding the dry blend to the mammalian newborn formulation, wherein the steps of admixing all of the ingredients and drying are conducted at a temperature below 50 C., such that the activity of the heat sensitive bioactive ingredient is substantially maintained, thereby encapsulating or embedding the heat sensitive bioactive ingredient in a mammalian newborn formulation.

2. The method of claim 1, wherein the mammalian newborn food or feed is a human infant formula.

3. The method of claim 1, wherein the mammalian newborn food or feed is a milk replacer, a milk substitute or a combination thereof.

4. The method of claim 1, wherein the step of drying the liquid blend further comprises a step of grinding the dry blend.

5. The method of claim 1, wherein the heat sensitive bioactive ingredient is selected from the group consisting of insulin, a glycoprotein, an immunoglobulin, a peptide, a polypeptide, a hormone, an enzyme, IGF-I, IGF-II, EGF alpha-1 proteinase inhibitor, alkaline phosphatase, angiogenin, antithrombin III, chitinase, extracellular superoxide dismutase, Factor VIII, Factor IX, Factor X, fibrinogen, glucocerebrosidase, glutamate decarboxylase, human serum albumin, myelin basic protein, lactoferrin, lactoglobulin, lysozyme, lactalbumin, proinsulin, soluble CD4, component or complexes of soluble CD4, tissue plasminogen activator, a pharmaceutically acceptable salt thereof, an analog thereof, a variant thereof or a combination thereof.

6. The method of claim 1 wherein the step of drying the liquid blend is performed by freeze drying, spray freezing, low temperature vacuum heat drying, low temperature spraying drying or a combination thereof.

7. The method of claim 6, wherein said freeze-drying is preceded by spray-freezing.

8. The method of claim 7, wherein the spray-freezing is preceded by extrusion.

9. The method of claim 6, wherein said freeze drying, spray freezing, extrusion or a combination thereof, results in glassy droplets, containing at least one bioactive compound and at least one food-grade or feed-grade encapsulating material, either alone or in a combination.

10. The method of claim 1, wherein the mammalian newborn food or feed is specifically formulated for the consumption of the genera of primate, bovine, ovine, canine, feline, and caprine.

11. The method of claim 1, wherein the food-grade or feed-grade encapsulating material is polysaccharide, maltodextrin, milk powder, whey protein, lipid, gum Arabic microcrystalline cellulose or a combination thereof.

12. A newborn edible food or feed formulation comprising a heat sensitive bioactive ingredient, encapsulated by the method of claim 1.

13. The formulation of claim 12, wherein the formulation is in a form of a powder, a solution, a spread, an ointment, a semi-solid, a solid or a combination thereof

14. The formulation of claim 12, wherein the bioactive ingredient being encapsulated or embedded is released upon contact with a liquid.

15. The formulation of claim 12, comprised of uniformly sized particles of encapsulated bioactive ingredient, wherein the particles have a radius between about 1 m and 5,000 m.

16. A method of enriching a human infant formula, comprising admixing a bioactive ingredient into the human infant formula, said bioactive ingredient being encapsulated according to the method of claim 1, thereby enriching the human infant formula.

17. The method of claim 16, wherein the human infant formula is a milk replacer, a milk substitute or a combination thereof.

18. The method of claim 1, wherein said at least one additional encapsulating layer material comprises food grade material, feed grade material either alone or in combination.

19. The formulation of claim 12, wherein the formulation is a feed in form of pellets, mash, liquid, or a combination thereof.

20. The method of claim 1, wherein the step of coating further comprises a step of grinding the coated dry blend.

21. The method of claim 1, wherein the formulation is a food or feed and the step of adding the dry blend to the mammalian food or feed formulation further includes premixing the blend in a small volume of the mammalian newborn food or feed for ensuring homogeneity.

22. The formulation of claim 12, wherein the formulation is a feed and the step of mixing comprises adding the bioactive material as an emulsion.

23. The formulation of claim 22, wherein the emulsion is a nano-emulsion, a microemulsion or a combination thereof.

Description

EXAMPLES

Example 1

Effects of Dietary Insulin on Weight Gain in Bovine Neonates

Materials and Methods

[0137] 100 Friesy and Charole' calves in ages 12-15 days from birth, were used. Each calf received a milk replacer, of up to 6 litters a day, until the 37th day from birth. From the 37th day, milk replacer quantity was reduced by 0.5 litters every 2 days while simultaneously, pellets quantity increased, until the calf's 57th days old, when it is considered fully weaned. Calves in the experimental group receive 600 MicroUnits/cc. of liquid milk replacer. Calves in the control group receive no insulin at all. Daily growth in grams per each 1 Kg. of birth weight was measured and calculated for each calf.

Results

[0138] The insulin treated group gained up to 26% more weight comparing with the control group during the period of between days 17 and day 67 after birth. At the end of the study period, the average daily weight growth in grams per each Kg. of birth weight was 22.47, compared to 18.71 g/Kg birth weight in the control group at the same time period. These results confirm that insulin is an important factors contributing to the weight gain in calves at the age of between 12-15 days and 68 days from birth.

Example 2

[0139] Effects of Feed formula Enriched with Encapsulated Bioactive Ingredient on Caprine Neonates' Health Status

Materials and Methods

[0140] More than 1,000 Assaf specie lambs over a period of 12 months at the age of 2-3 days from birth, were used. The growing period was divided into two periods: 3-28 days from birth, during which the lambs were exclusively fed by a milk replacer; and 29-75 days from birth, during which the lambs were fed by post-weaning mix/mash. Lambs in the study groups received between 600 MicroUnits-3,000 MicroUnits of insulin/ml. of milk replacer, and between 1,600 MicroUnits-5,000 MicroUnits of insulin/gr. of mix/mash. The lambs in the control groups did not receive insulin at all.

[0141] A liquid blend, of 4 Kilograms of Maltodextrin, 40 Liters of Saline 0.9% and 100,000 IU (International Units) of insulin was blended (e.g., 25 IU insulin per 1 g of Maltodextrin). The liquid blend was then freeze-dried. The product of the process was maltodextrin encapsulated insulin. 97% of the bioactive properties of the insulin were maintained after the freeze-drying process. A premix of 10 Kg. was prepared from standard milk powder and the maltodextrin encapsulated insulin. The premix was then blended with 740 Kg. of standard milk replacer product, to generate 750 Kg. of insulin enriched commercial milk replacer.

Results

[0142] Weight gain: On average, lambs in the study groups which received insulin both in the milk replacer and the mix/mash, gained between 5% to 7% more weight in comparison to the control groups. Lambs in the study groups receiving insulin only in the milk replacer (but not in the mix/mash), gained between 3% to 5% more weight in comparison to the control groups.

[0143] Disease incidence: The lambs in the study groups suffered between 10%-25% fewer incidents of Diarrhea and/or Pneumonia, comparing with lambs in the control groups. Further, recovery of lambs suffering such disease states was between 5%-20% quicker in comparison with the lambs in the control groups.

[0144] Death rate: The death rate in the study groups was between 20% and 80% lower in comparison with control groups, depending on the specific study. For example, in one study, the insulin fed group started the study with 70 newly born lambs, and at marketing (e.g. 150 days after birth) 68 lambs survived. (2.8% death rate). In the control group, receiving no insulin, the group started with 69 newborn lambs, and at marketing, only 61 lambs survived (e.g. 11.6% death rate). This means that the death rate in the insulin-fed group was lower by 74.8% comparing with the control group.

[0145] These results confirm that insulin is an important factor contributing to the weight gain and health in lambs between the ages of 2-3 days and 75 days from birth. Furthermore, the result show that encapsulated insulin maintains biological activity of insulin during the preparation process of the solid feed and during the transfer in the lamb's digestion system.