METHODS AND PROCESSES FOR MANUFACTURE OF A TOPICALLY ADHERENT SELECTIVE BACTERICIDE
Disclosed herein are processes for the manufacture of a new topically adherent selective bactericide and products resulting therefrom. More specifically a method for producing a complexed stable microbiome regulating protein configured for topical application and use of that product as a medicament, effective for therapeutic effect against pathogenic bacteria, but not commensal bacteria.
1 . A complexed protein comprising:
a microbiome functional protein comprising lactoperoxidase, lactoferrin, lysomal alpha-mannosidase, immunoglobulin G, angiogenin, ribonuclease 4 or quiescin sulfhydryl oxidase and/or combinations thereof, complexed with a modified whey protein isolate (WPI) from milk, wherein the complexed microbiome functional protein is configured for topical application and, on application, to adhere to epithelial surfaces.
2 . The complexed protein as claimed in claim 1 , wherein the complexed protein is a semi-solid aqueous gel with a viscosity of approximately 0.25 to 4.5 Poise.
3 . The complex protein as claimed in claim 1 , wherein the microbiome functional protein is a blend of protein fractions that are selectively toxic to pathogenic bacteria, but which minimise any reduction in commensal bacteria population.
4 . The complexed protein of claim 1 , wherein the modified WPI is derived from bovine species milk.
5 . The complexed protein of claim 1 , wherein the ratio of microbiome regulating protein to modified WPI in the complexed protein is from 1:1 to 1:10.
6 . The complexed protein of claim 1 , in therapeutically effect amount for use as a medicament.
7 . (canceled)
8 . Use of the complexed protein of claim 1 , in the manufacture of a medicament for topical treatment of toxic pathogenic bacteria, or on an animal in need thereof, but minimising any reduction in commensal bacteria populations on epithelial surfaces of an animal.
9 . A method of selectively treating an animal for a toxic pathogenic bacteria, but minimising any reduction in commensal bacteria population, by the step of: topically administering a complexed protein as claimed in claim 1 and on application, the complexed protein adheres to the animal epithelial surfaces.
10 . The use or method as claimed in claim 8 , wherein the animal is a non-human animal.
11 . A topical composition comprising the complexed protein of claim 1 and further comprising at least one pharmaceutically acceptable excipient.
12 . A method of producing a complexed stable microbiome regulating protein configured for topical application, the method comprising the steps of:
selecting a microbiome regulating protein wherein the protein comprises:
lactoperoxidase, lactoferrin, lysomal alpha-mannosidase, immunoglobulin G, angiogenin, ribonuclease 4, or quiescin sulfhydryl oxidase, and/or combinations thereof in a powder form;
selecting a modified whey protein isolate (WPI) from milk in a gel form;
solubilising the microbiome regulating protein in an aqueous salt solution, the aqueous salt solution having an ionic strength of 25-200 mM NaCl;
blending together the solubilised microbiome regulating protein and modified WPI;
adjusting the pH to 2.0-6.0;
adjusting the temperature to 18-37° C.; and
holding the blend at a pH of 2.0-6.0 and a temperature of 18-37° C. for at least 30 minutes.
13 . The method as claimed in claim 12 , wherein the microbiome regulating protein is a blend of protein fractions that are selectively toxic to pathogenic bacteria, but which minimises any reduction in commensal bacteria population.
14 . The method as claimed in claim 12 , wherein the complexed protein produced is a semi-solid gel with a viscosity of approximately 0.25 to 4.5 Poise.
15 . The method of claim 12 to, wherein the modified WPI selected is initially in the form of an aqueous gel.
16 . The method of any of claim 12 , wherein the modified WPI selected is derived from bovine species milk.
17 . The method of claim 12 , to 16, wherein the ratio of microbiome regulating protein to modified WPI used in the method and present in the complexed protein is from 1:1 to 1:10.
18 . The method of claim 12 , wherein the salt solution comprises a mix of water and a chemical salt.
19 . The method of claim 12 , wherein the ionic strength of the salt solution is approximately 75 mM NaCl.
20 . The method of claim 12 , wherein the pH of the blend prior to pH adjustment is approximately 6.5 to 7.5.
21 . The method of claim 12 , wherein the pH of the blend after pH adjustment is approximately 4.0.
22 . The method of claim 12 , wherein the temperature of the blend after any adjustment is approximately 25° C.
23 . The method of claim 12 , wherein the holding time is approximately 60 minutes.
24 . The method of claim 12 , wherein the complexed protein is dried after holding to a water activity of less than 0.6.
25 . A complexed protein produced by the method as claimed in claim 12 .