Use of vitelline protein B as a microencapsulating additive

Abstract

The present invention includes compositions and methods for the use of an encapsulation additive having between about 0.1 to about 30 percent isolated and purified vitelline protein B to provide for mixed and extended release formulations.

1 . An encapsulation additive comprising between about 0.1 to about 90 percent isolated and purified vitelline protein B.  
   
   
       2 . The additive of  claim 1 , wherein the vitelline protein B comprises a  Trematode  sp. protein.  
   
   
       3 . The additive of  claim 1 , wherein the additive is non-antigenic, is resistant to acid pH, resistant to basic pH or combinations thereof.  
   
   
       4 . The additive of  claim 1 , wherein the additive slows the release of an active agent to between about 1 hour to about 8 hours, between about 1 hour to about 2 weeks, and between about 1 hour to about 6 months.  
   
   
       5 . The additive of  claim 4 , wherein the one or more active agents comprise a pharmaceutical agent, an enzyme, a cytokine, a growth promoting agent, an antibody, an antigen, a vaccine, a cell, a live-attenuated pathogen, a heat-killed pathogen, a virus, a bacteria, a fungi, a peptide, a carbohydrate, a nucleic acid, a lipid, mixtures and combinations thereof.  
   
   
       6 . The additive of  claim 1 , wherein the vitelline protein B is encapsulated by coacervation, oil-and-water emulsion, liposomes, spray freezing, spray drying, mixed with alginate or combinations thereof.  
   
   
       7 . The additive of  claim 1 , wherein the formulation is formulated for administration to a mammal in need of a therapeutic effective amount of an active agent.  
   
   
       8 . The additive of  claim 1 , wherein the one or more active agents is selected from the group consisting of protein, peptide, carbohydrate, polysaccharide, glycoprotein, lipid, hormone, growth factor, cytokine, interferon, receptor, antigen, allergen, antibody, antiviral, antifungal, antihelminthic, substrate, metabolite, cofactor, inhibitor, drug, pharmaceutical, nutrient, toxin, poison, explosive, pesticide, chemical warfare agent, biowarfare agent, biohazardous agent, infectious agent, prion, radioisotope, vitamin, heterocyclic aromatic compound, carcinogen, mutagen, narcotic, amphetamine, barbiturate, hallucinogen, waste product, contaminant, heavy metal, virus, bacterium,  Salmonella, Streptococcus, Brucella, Legionella, E. coli, Giardia, Cryptosporidium, Rickettsia,  spore, mold, yeast, algae, amoebae, dinoflagellate, unicellular organism, pathogen, cell, combinations and mixtures thereof, that is encapsulated in a mixed release polymer comprising between about 0.1 to 26 weight percent isolated and purified vitelline protein B.  
   
   
       9 . An extended release pharmaceutical formulation comprising: 
 one or more active agents microencapsulated in a mixed release polymer and between about 0.1 to 26 percent isolated and purified vitelline protein B.    
   
   
       10 . The formulation of  claim 9 , wherein the polymer is selected from the group consisting of cellulose, ethylcellulose, methylcellulose, propylcellulose, methoxypropylcellulose, cellulose nitrate, poly(vinyl alcohol), poly(vinyl chloride), polystyrene, polyethylene, polypropylene, poly(ethylene-co-vinyl acetate), poly(hydroxybutyric acid), poly(hydroxyvalerianic acid-co-hydroxybutyric acid), poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acid), poly(epsilon(-caprolactones), poly(epsilon(-caprolactone-co-DL-lactic acid), poly(maleic anhydride), polyamides, gelatin, chitosan, collagen, poly(hydroxyalkyl)-L-glutamines, poly(gamma(-ethyl-L-glutaminate-co-glutamic acid), poly(L-leucine-co-L-aspartic acid), poly(proline-co-glutamic acid), poly(alkyl 2-cyanoacrylates), polyurethanes, poly(methyl methacrylate), poly(methyl methacrylate-co-methacrylic acid) and poly(methacrylate-co-hydroxypropyl methacrylate).  
   
   
       11 . The formulation of  claim 9 , wherein the vitelline protein B comprises a  Trematode  sp. protein.  
   
   
       12 . The formulation of  claim 9 , wherein the additive is non-antigenic, is resistant to acid and base pH or both.  
   
   
       13 . The formulation of  claim 9 , wherein the additive slows the release of an active agent to between about 1 hour to about 8 hours, between about 1 hour to about 2 weeks, and between about 1 hour to about 6 months.  
   
   
       14 . The formulation of  claim 9 , wherein the one or more active agents comprise a pharmaceutical agent, an enzyme, a cytokine, a growth promoting agent, an antibody, an antigen, a vaccine, a cell, a live-attenuated pathogen, a heat-killed pathogen, a virus, a bacteria, a fungi, a peptide, a carbohydrate, a nucleic acid, a lipid, mixtures and combinations thereof.  
   
   
       15 . The formulation of  claim 9 , wherein the vitelline protein B is combined by coacervation.  
   
   
       16 . The formulation of  claim 9 , wherein the vitelline protein B is added into an oil-and-water emulsion.  
   
   
       17 . A method of encapsulation comprising mixing one or more active agents with one or more cross-linkable monomers and a vitelline protein B, wherein the vitelline protein B modifies the release profile of the one or more active agents.  
   
   
       18 . A method of making an extended release formulation comprising the steps of: 
 mixing one or more active agents with alginate and vitelline protein B, wherein the vitelline protein B modifies the release profile of one or more of the active agents.    
   
   
       19 . The method of  claim 18 , wherein the one or more active agents are released for between about 1 hour to about 8 hours, between about 1 hour to about 2 weeks, and between about 1 hour to about 6 months.  
   
   
       20 . The method of  claim 18 , wherein the vitelline protein B comprises a  Trematode  sp. protein.  
   
   
       21 . The method of  claim 18 , wherein the vitelline protein B sequence has been scrambled but maintains about the same amino acid ratio.  
   
   
       22 . The method of  claim 18 , wherein the one or more active agents comprise a pharmaceutical agent, an enzyme, a cytokine, a growth promoting agent, an antibody, an antigen, a vaccine, a cell, a live-attenuated pathogen, a heat-killed pathogen, a virus, a bacteria, a fungi, a peptide, a carbohydrate, a nucleic acid, a lipid, mixtures and combinations thereof.  
   
   
       23 . The method of  claim 18 , wherein the vitelline protein B is combined by coacervation, an oil-and-water emulsion, liposomes, spray freezing, spray drying, mixed with alginate or combinations thereof.  
   
   
       24 . The method of  claim 18 , wherein the formulation is administered to a mammal in need of a therapeutic effective amount of the one or more active agents.  
   
   
       25 . The method of  claim 18 , further comprising mixing poly-L lysine with the vitelline protein B, wherein the ratio of the poly-L lysine to vitelline protein B is between about 30:70 to 70:30 weight to weight.  
   
   
       26 . A mixed release pharmaceutical formulation comprising: 
 one or more pharmaceutical agents encapsulated with a mixed release polymer comprising between about 1 to 26 weight percent isolated and purified vitelline protein B.    
   
   
       27 . The mixed release formulation of  claim 26 , wherein the one or more pharmaceutical agents is selected from wherein the one or more agents may be steroids, respiratory agents, sympathomimetics, local anesthetics, antimicrobial agents, antiviral agents, antifungal agents, antihelminthic agents, insecticides, antihypertensive agents, antihypertensive diuretics, cardiotonics, coronary vasodilators, vasoconstrictors, β-blockers, antiarrhythmic agents, calcium antagonists, anti-convulsants, agents for dizziness, tranquilizers, antipsychotics, muscle relaxants, drugs for Parkingson's disease, respiratory agents, hormones, non-steroidal hormones, antihormones, vitamins, antitumor agents, miotics, herb medicines, antimuscarinic, interfereons, immunokines, cytokines, muscarinic cholinergic blocking agents, mydriatics, psychic energizers, humoral agents, antispasmodics, antidepressant drugs, anti-diabetics, anorectic drugs, anti-allergenics, decongestants, expectorants, antipyretics, antimigrane, anti-malarials, anti-ulcerative, peptides, anti-estrogen, anti-hormone agents, antiulcer agents, anesthetic agent, drugs having an action on the central nervous system, protein, peptide, carbohydrate, polysaccharide, glycoprotein, lipid, hormone, growth factor, cytokine, interferon, receptor, antigen, allergen, antibody, substrate, metabolite, cofactor, inhibitor, drug, pharmaceutical, nutrient, toxin, poison, explosive, pesticide, chemical warfare agent, biowarfare agent, biohazardous agent, infectious agent, prion, radioisotope, vitamin, heterocyclic aromatic compound, carcinogen, mutagen, narcotic, amphetamine, barbiturate, hallucinogen, waste product, contaminant, heavy metal, virus, bacterium,  Salmonella, Streptococcus, Brucella, Legionella, E. coli, Giardia, Cryptosporidium, Rickettsia,  spore, mold, yeast, algae, amoebae, dinoflagellate, unicellular organism, pathogen, cell, combinations and mixtures thereof, that is encapsulated in a mixed release polymer comprising between about 1 to 26 weight percent isolated and purified vitelline protein B.  
   
   
       28 . The formulation of  claim 26 , wherein the polymer is selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers, polysaccharides, carbohydrates, proteins, and combinations thereof.  
   
   
       29 . A vaccine comprising: 
 one or more antigens encapsulated in a mixed release comprising between about 1 to 26 weight percent isolated and purified vitelline protein B, the antigen selected from protein, peptide, carbohydrate, polysaccharide, glycoprotein, lipid, hormone, growth factor, cytokine, interferon, receptor, antigen, allergen, antibody, substrate, metabolite, cofactor, inhibitor, drug, pharmaceutical, nutrient, toxin, poison, explosive, pesticide, chemical warfare agent, biowarfare agent, biohazardous agent, infectious agent, prion, radioisotope, vitamin, heterocyclic aromatic compound, carcinogen, mutagen, narcotic, amphetamine, barbiturate, hallucinogen, waste product, contaminant, heavy metal, virus, bacterium,  Salmonella, Streptococcus, Brucella, Legionella, E. coli, Giardia, Cryptosporidium, Rickettsia,  spore, mold, yeast, algae, amoebae, dinoflagellate, unicellular organism, pathogen, cell, combinations and mixtures thereof.    
   
   
       30 . An adhesive comprising between about 0.1 to about 90 percent isolated and purified vitelline protein B.  
   
   
       31 . A method of treating an animal, the method comprising administering the extended release formulation of  claim 9  to a mammal.  
   
   
       32 . A bent core mesogen piezoelectric component comprising a VpB protein.