US2005191319A1PendingUtilityA1

Microparticles with adsorbent surfaces, methods of making same, and uses thereof

61
Priority: Jan 30, 1997Filed: Apr 25, 2005Published: Sep 1, 2005
Est. expiryJan 30, 2017(expired)· nominal 20-yr term from priority
Inventors:Derek O' HaganManmohan SinghGary S. OttJohn BarackmanJina Kazzaz
A61K 2039/53A61K 2039/55505A61K 9/167C12N 2740/16234C12N 2770/24234A61K 39/245A61K 2039/55561C12N 2770/24211A61K 2039/55555A61K 39/12C12N 2740/16111A61K 39/39A61K 2039/545A61K 39/21A61K 9/1647C12N 2740/16134A61K 2039/543
61
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Claims

Abstract

Microparticles with adsorbent surfaces, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(α-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surface of the microparticles efficiently adsorb biologically active macromolecules, such as DNA, polypeptides, antigens, and adjuvants.

Claims

exact text as granted — not AI-modified
1 . A microparticle comprising: a biodegradable polymer; an anionic detergent; and an antigen comprising a polypeptide adsorbed on the surface of said microparticle, 
 wherein said microparticle is formed by a process that comprises: forming a microparticle comprising said polymer and said detergent, said microparticle being formed in the presence of said detergent; and exposing said microparticle to said antigen.    
     
     
         2 . The microparticle of  claim 1 , wherein the microparticle comprises a polymer selected from the group consisting of a poly(α-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and a polycyanoacrylate.  
     
     
         3 . The microparticle of  claim 1 , wherein the microparticle comprises a poly(α-hydroxy acid).  
     
     
         4 . The microparticle of  claim 1 , wherein the microparticle comprises a poly(α-hydroxy acid) selected from poly(L-lactide), poly(D,L-lactide) and poly(D,L-lactide-co-glycolide).  
     
     
         5 . The microparticle of  claim 1 , wherein the microparticle comprises poly(D,L-lactide-co-glycolide).  
     
     
         6 . The microparticle of any of  claim 1 , wherein said antigen is derived from a pathogenic organism.  
     
     
         7 . The microparticle of  claim 6 , wherein said pathogenic organism is a bacterium.  
     
     
         8 . The microparticle of  claim 6 , wherein said pathogenic organism is a virus.  
     
     
         9 . The microparticle of any of  claim 3 , wherein said antigen is derived from a pathogenic organism.  
     
     
         10 . The microparticle of  claim 9 , wherein said pathogenic organism is a bacterium.  
     
     
         11 . The microparticle of  claim 9 , wherein said pathogenic organism is a virus.  
     
     
         12 . The microparticle of any of  claim 5 , wherein said antigen is derived from a pathogenic organism.  
     
     
         13 . The microparticle of  claim 12 , wherein said pathogenic organism is a bacterium.  
     
     
         14 . The microparticle of  claim 12 , wherein said pathogenic organism is a virus.  
     
     
         15 . The microparticle of  claim 1 , wherein said antigen is a tumor antigen.  
     
     
         16 . The microparticle of  claim 3 , wherein said antigen is a tumor antigen.  
     
     
         17 . The microparticle of  claim 5 , wherein said antigen is a tumor antigen.  
     
     
         18 . The microparticle of any  claim 1 , wherein the polypeptide is selected from HIV polypeptides, hepatitis B virus polypeptides, hepatitis C virus polypeptides,  Haemophilus influenza  type B polypeptides,  Neisseria meningitides  B polypeptides, pertussis polypeptides, diphtheria polypeptides, tetanus polypeptides, and influenza A virus polypeptides.  
     
     
         19 . The microparticle of any  claim 3 , wherein the polypeptide is selected from HIV polypeptides, hepatitis B virus polypeptides, hepatitis C virus polypeptides,  Haemophilus influenza  type B polypeptides,  Neisseria meningitides  B polypeptides, pertussis polypeptides, diphtheria polypeptides, tetanus polypeptides, and influenza A virus polypeptides.  
     
     
         20 . The microparticle of  claim 5 , wherein the polypeptide is selected from HIV polypeptides, hepatitis B virus polypeptides, hepatitis C virus polypeptides,  Haemophilus influenza  type B polypeptides,  Neisseria meningitides  B polypeptides, pertussis polypeptides, diphtheria polypeptides, tetanus polypeptides, and influenza A virus polypeptides.  
     
     
         21 . The microparticle of  claim 1 , wherein the antigen is selected from an HIV gp120 antigen, an HIV gp160 antigen, an HIV p24gag antigen, an HIV p55gag antigen, and an Influenza A hemagglutinin antigen.  
     
     
         22 . The microparticle of  claim 3 , wherein the antigen is selected from an HIV gp120 antigen, an HIV gp160 antigen, an HIV p24gag antigen, an HIV p55gag antigen, and an Influenza A hemagglutinin antigen.  
     
     
         23 . The microparticle of  claim 5 , wherein the antigen is selected from an HUV gp120 antigen, an HIV gp160 antigen, an HIV p24gag antigen, an HIV p55gag antigen, and an Influenza A hemagglutinin antigen.  
     
     
         24 . The microparticle of  claim 1 , wherein the anionic detergent is sodium dodecyl sulfate.  
     
     
         25 . The microparticle of  claim 1 , wherein said microparticle does not comprise an entrapped antigen.  
     
     
         26 . The microparticle of  claim 1 , wherein said microparticle is formed in a double emulsion process.  
     
     
         27 . The microparticle of  claim 1 , wherein the microparticle has a diameter between 500 nanometers and 10 microns.  
     
     
         28 . The microparticle of  claim 3 , wherein the microparticle has a diameter between 500 nanometers and 10 microns.  
     
     
         29 . The microparticle of  claim 5 , wherein the microparticle has a diameter between 500 nanometers and 10 microns.  
     
     
         30 . The microparticle of  claim 1 , further comprising an additional biologically active macromolecule encapsulated within said microparticle, wherein the additional biologically active macromolecule is selected from a polypeptide, a polynucleotide, a polynucleoside, an antigen, a hormone, an enzyme, and an immunological adjuvant.  
     
     
         31 . The microparticle of  claim 3 , further comprising an additional biologically active macromolecule encapsulated within said microparticle, wherein the additional biologically active macromolecule is selected from a polypeptide, a polynucleotide, a polynucleoside, an antigen, a hormone, an enzyme, and an immunological adjuvant.  
     
     
         32 . The microparticle of  claim 5 , further comprising an additional biologically active macromolecule encapsulated within said microparticle, wherein the additional biologically active macromolecule is selected from a polypeptide, a polynucleotide, a polynucleoside, an antigen, a hormone, an enzyme, and an immunological adjuvant.  
     
     
         33 . A microparticle composition comprising a microparticle according to  claim 1  and a pharmaceutically acceptable excipient.  
     
     
         34 . A microparticle composition comprising a microparticle according to  claim 1 , a pharmaceutically acceptable excipient, and an immunological adjuvant.  
     
     
         35 . The microparticle composition of  claim 34 , wherein the immunological adjuvant is selected from CpG oligonucleotides,  E. coli  heat-labile toxin-K63 (LTK63),  E. coli  heat-labile toxin-R72 (LTR72), monophosphorylipid A (MPL), and an aluminum salt.  
     
     
         36 . The microparticle composition of  claim 33 , wherein said microparticle composition is an injectable composition.  
     
     
         37 . The microparticle composition of  claim 34 , wherein said microparticle composition is an injectable composition.  
     
     
         38 . A method of raising an immune response, comprising: providing the microparticle composition of  claim 33 , and administering said microparticle composition to a vertebrate animal.  
     
     
         39 . A method of raising an immune response, comprising: providing the microparticle composition of  claim 34 , and administering said microparticle composition to a vertebrate animal.  
     
     
         40 . The microparticle of  claim 1 , comprising an immunological adjuvant adsorbed to said microparticle.  
     
     
         41 . The microparticle of  claim 3 , comprising an immunological adjuvant adsorbed to said microparticle.  
     
     
         42 . The microparticle of  claim 5 , comprising an immunological adjuvant adsorbed to said microparticle.  
     
     
         43 . A method of  claim 38  further comprising separately administering an immunological adjuvant in a separate composition.  
     
     
         44 . The composition of  claim 33 , comprising a plurality of antigens.

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