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Last Updated: March 28, 2024

Claims for Patent: 6,652,875


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Summary for Patent: 6,652,875
Title: Casein formulations for the delivery of bioactive constituents
Abstract:The present invention provides a formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises a suspensions or solution of at least one isolated and purified casein protein or salt thereof, in water, together with at least one bioactive constituent.
Inventor(s): Bannister; Dennis James (Mount Pleasant, AU)
Assignee: Pacific Biolink Pty. Limited (Hornsby, AU)
Application Number:09/744,593
Patent Claims:1. A confectionary formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises an aqueous or dried solid confectionary base, a water soluble form of at least one isolated and purified casein phosphoprotein, or salt thereof, complexed with at least one bioactive constituent, wherein the bioactive constituent is selected from the group consisting of calcium phosphate and calcium phosphate admixed with at least one other bioactive.

2. The formulation of claim 1, wherein said casein protein is selected from the group consisting of: .alpha.-casein, .beta.-casein, .kappa.-casein, and mixtures thereof.

3. The formulation of claim 1, wherein said casein phosphoprotein is in the form of caseinate calcium phosphate or caseinate calcium fluorophosphate.

4. The formulation of claim 3, wherein the amount of casein calcium phosphate present in the formulation is between about 0.05 and 50% by weight.

5. The formulation of claim 1, wherein said bioactive constituents comprise ions selected from the group consisting of: calcium, phosphate, fluorophosphates, fluoride, magnesium, barium, strontium, zinc, iron, copper, aluminium, tin; and salts of said bioactive constituents selected from the group consisting of: titanium dioxide, zinc oxide, zirconia, calcium fluoride, sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, cobalt ammonium fluoride calcium phosphate, calcium fluorophosphates and calcium oxide.

6. The formulation of claim 1, wherein said bioactive constituent is an antimicrobial agent.

7. The formulation of claim 6, wherein the anti-microbial agent is selected from the group consisting of: halogenated diphenyl esters, phenolic compounds, mono- and poly-alkyl and aromatic halophenols, resorcinol, n-methyl hexyl resorcinol; bisphenolic compounds and halogenated carbanilides.

8. The formulation of claim 6, wherein the anti-microbial agent is selected from the group consisting of: glycerol, ethanol sorbitol, mannitol, sodium benzoate, methyl-p-hydroxybenzoate, ethyl-p-hydroxybenzoate, N-propyl p-hydroxybenzoate, butyl-p-hydroxybenzoate, phenoxy ethanol, benzethonium chloride, and diisobutyl-phenoxyethoxyethyl dimethyl benzyl ammonium chloride.

9. The formulation of claim 8, wherein said antimicrobial agent is sodium benzoate or ethanol.

10. The formulation of claim 9, wherein the amount of sodium benzoate present in the formulation is between 0.001 and 0.1% by weight.

11. The formulation of claim 10, wherein the amount of ethanol present in the formulation is between about 2 and 6% by weight.

12. The formulation of claim 1, wherein said formulations also includes a thickening agent.

13. The formulation of claim 12, wherein said thickening agent is selected from the group consisting of: clay, polymer, or a combination thereof.

14. The formulation of claim 13, wherein said clay is selected from the group consisting of laponite, laponite DF, hectorite, calcium montmorillonite, sodium montmorillonite (bentonite), sodium exchanged montmorillonite, acid activated bleaching earth and palygorskite.

15. The formulation of claim 13, wherein said polymer is selected from the group consisting of: alginate, cellulose, carboxymethyl cellulose, Irish moss, gum tragacanth, starch polyvinylpyrrolidone, hydroxyethylpropylcellulose, hydroxybutyl methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, and colloidal silica.

16. The formulation of claim 12, wherein the amount of thickening agent present in the formulation is up to about 20% by weight.

17. A method for treating and/or preventing dental caries and/or tooth erosion in humans or animals in need of said treatment and/or prevention, said method comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling or preventing dental caries and/or tooth erosion in humans or animals.

18. The method of claim 17, wherein said bioactive constituents of the formulation are selected from the group consisting of: tetrasodium pyrophosphate; N-methylpyrrolidone or 2-pyrrolidone-5,5-diethyl phosphonic acid.

19. A method of treating and/or preventing dental sensitivity in humans or animals in need of said treatment and/or prevention, said method comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling and/or preventing dental sensitivity in humans or animals.

20. The method of claim 19, wherein said bioactive constituents are selected from the group consisting of: glycerine, strontium chloride, sodium citrate, potassium nitrate and dicalcium phosphate.

21. A method of treating and/or preventing gingivitis in humans or animals in need of said treatment and/or prevention, said method comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling and/or preventing gingivitis in humans or animals.

22. A method of treating or preventing mouth odour in humans or animals in need of said treatment and/or prevention, said method comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling or preventing mouth odour in humans or animals.

23. The method of claim 21, wherein said bioactive constituent include an antimicrobial agent.

24. The method of claim 23, wherein said anti-microbial agent is selected from the group consisting of halogenated diphenyl ethers, phenolic compounds, mono- and poly-alkyl and aromatic halophenols, resorcinol, n-methyl hexyl resorcinol, bisphenolic compounds, and halogenated carbanilides.

25. A method of recrystallising and/or remineralising enarnel and/or dentine in humans or animals in need of said recrystallising and/or remineralising, said method comprising administering an effective amount of the formulation of claim 1, wherein said formulation is capable of recrystallising and remineralising enamel and/or dentine in humans or animals.

26. The method of claim 26, wherein said the bioactive constituents are selected from the group consisting of: fluoride, a calcium phosphate complex and a calcium fluorophosphate complex.

27. A method of buffering plaque against a decrease in pH in humans or animals in need of said buffering, said method comprising administering an effective amount of the formulation of claim 1, wherein said formulation is capable of buffering plaque against a fall in pH in humans or animals.

28. A method of treating and/or preventing osteoporosis in humans or animals in need of said treatment and/or prevention, said method comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling or preventing osteoporosis in humans or animals.

29. The method of claim 28, wherein said bioactive constituents are selected from the group consisting of: vitamin D, calcium phosphate complex and/or calcium fluorophosphate complex, wherein said calcium phosphate complex and/or calcium fluorophosphate complex provides a soluble (bioavailable) source of calcium.

30. A method of treating and/or preventing calculus formation in the oral cavity of humans or animals in need of said treatment and/or prevention, comprising administering a therapeutically effective amount of the formulation of claim 1, wherein said formulation is capable of controlling and/or preventing calculus formation in the oral cavity of humans or animals.

31. The method of claim 30, wherein said bioactive constituents are selected from the group consisting of: casein phosphoprotein, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, and mixtures thereof.

32. The formulation of claim 1, wherein said formulation additionally comprises a dispersing agent.

33. The formulation of claim 32, wherein said dispersing agent is selected from the group consisting of: sugars, carbohydrates, proteins, peptides, amino acids, lipids, urea, uric acid, and mixtures thereof.

34. The formulation of claim 33, wherein said carbohydrate is selected from the group consisting of: sugar, monosaccharides, disaccharides, oligosaccharides, polysaccharides and derivatives thereof.

35. The formulation of claim 33, wherein said protein is selected from the group consisting of: whey protein, glycoproteins, hydrolysed proteins and hydrolysed dephosphorylated proteins.

36. The formulation of claim 33, wherein said peptide is selected from the group consisting of: adrenocorticotropic hormone and fragments, angiotensin, atrial natriurertic peptides, bradykinin, chemotactic peptides, dynorphin, endorphins and .beta.-lipotropin fragments, enkephalin, enzyme inhibitors, fibronectin fragments, gastrointestinal peptides, growth hormone releasing peptides, luteinizing hormone releasing peptides, melanocyte stimulating hormone, neurotensin, opioid peptides, oxytocin, vasopressin, vasotocin, parathyroid hormone and fragments, protein kinase related peptides, somatostatin, substance p, and mixtures thereof.

37. The formulation of claim 33, wherein said amino acid is selected from the group consisting of: alanine, arginine, asparagine, aspartic acid, .alpha.-aminobuberic acid, cysteine, glutamine, glutamic acid, glycine, histidine, homoserine, hydroxyproline, isoleucine, leucine, lysine, methionine, norleucine, norvalineornithine, pencillamine, proglutamic acid, phenylalanine, proline, sarcosine, serine, staline, threonine, tyrptophan, tyrosine, valine and analogues and mixtures thereof.

38. The formulation of claim 1, further comprising a salivary stimulator, wherein said formulation acts as a salivary substitute in humans or animals.

39. The formulation of claim 38, wherein said salivary stimulator is pilocarpine.

40. The formulation of claim 1, wherein said formulation is pre-dried prior to use in solid form.

41. The formulation of claim 1, wherein said formulation is pre-dried prior to resuspension in aqueous form.

42. The formulation of claim 7, wherein halogenated diphenyl ether is 2',4,4'-trichloro-2-hydroxy-diphenyl ether (Triclosan).

43. The formulation of claim 7, wherein said phenolic compound is selected from the group consisting of 2-methyl-phenol, 3-methyl-phenol, 4-methyl-phenol, 4-ethyl-phenol, 2,4-dimethylphenol, 3,4-dimethyl-phenol, 2,6-dimethyl-phenol, and 2,2-methylene bis (4-chloro-6-bromophenol).

44. The formulation of claim 7, wherein said mono- and poly-alkyl and aromatic halophenol is selected from the group consisting of methyl-p-chlorophenol, ethyl-p-chlorophenol, n-propyl-p-chlorophenol, n-butyl-chlorophenol, o-chlorophenols, p-bromophenols and -o-bromophenols.

45. The method of claim 24, wherein said halogenated diphenyl ether is 2',4,4'-trichloro-2-hydroxydiphenyl ether (Triclosan).

46. The method of claim 24, wherein said phenolic compound is selected from the group consisting of 2-methyl-phenol, 3-methyl-phenol, 4-methyl-phenol, 4-ethyl-phenol, 2,4-dimethyl-phenol, 3,4-dimethyl-phenol, 2,6-dimethyl-phenol, and 2,2-methylene bis (4-chloro-6-bromo-phenol).

47. The method of claim 24, wherein said mono- and poly-alkyl and aromatic halo-phenol is selected from the group consisting of methyl-p-chlorophenol, ethyl-p-chlorophenol, n-propyl-p-chlorophenol, n-butyl chlorophenol; -o-chlorophenols; p-bromophenols; and -o-bromophenols.

48. The formulation of claim 1, wherein said confectionary formulation is a chewing gum.

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