Pharmaceutical Compositions and Methods for Treating or Preventing Oxalate-Related Disease

Abstract

The present invention comprises methods and compositions for the reduction of oxalate in humans, animals and plants. For example, the invention provides methods and compositions for the delivery of one or more oxalate-reducing pharmaceutical compositions to the intestinal tracts of persons and animals. The methods and compositions can be used in treating and preventing oxalate-related conditions.

1 - 96 . (canceled) 
   
   
       97 . A composition for reducing an oxalate concentration in a human or animal comprising, an oral delivery vehicle comprising an oxalate reducing composition comprising,
 a) from about 0.5% to about 95% of an oxalate reducing bacteria;   b) from about 0.1% to about 50% of a disaccharide;   c) from about 3% to about 85% of a maltodextrin;   d) from about 0.5% to about 25% of an alginate; and   e) from about 1.0% to about 60% of an oligofructose.   
   
   
       98 . The composition of  claim 97 , wherein the oral delivery vehicle comprises a powder, a capsule, a pill, a granule or a tablet. 
   
   
       99 . The composition of  claim 97 , further comprising an enteric coating on the oral delivery vehicle. 
   
   
       100 . The composition of  claim 99 , wherein the enteric coating is a polymeric material. 
   
   
       101 . The composition of  claim 97 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes, Pseudomonas, Clostridia, Lactobacilli, Bifidobacteria,  or a bacteria transformed with one or more vectors comprising exogeneous or endogenous polynucleotide sequences coding for oxalate-reducing enzymes. 
   
   
       102 . The composition of  claim 97 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes.    
   
   
       103 . The composition of  claim 102 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes  strain HC1. 
   
   
       104 . The composition of  claim 97 , wherein the oxalate reducing composition comprises a lyophilized powder. 
   
   
       105 . The composition of  claim 104 , wherein the powder has a particle size of about 10 microns to about 2000 microns. 
   
   
       106 . The composition of  claim 97 , wherein the disaccharide is trehalose. 
   
   
       107 . The composition of  claim 97 , wherein the alginate is sodium alginate. 
   
   
       108 . The composition of  claim 97 , wherein the oxalate reducing composition has a cfu/gm of at least from about 1E+03 to about 1E+13 of oxalate reducing bacteria. 
   
   
       109 . The composition of  claim 97 , wherein the oxalate reducing composition has an oxalate enzyme reducing activity/gm of at least from about 2 mg oxalate degraded/hr to about 2500 mg oxalate degraded/hr. 
   
   
       110 . A composition for oxalate reduction, comprising an effective amount of oxalate-reducing activity that will reduce a portion of oxalate present comprising,
 a) from about 0.5% to about 95% of a viable, lyophilized, oxalate reducing bacteria; and   b) from about 95% to about 0.5% of a pharmaceutically acceptable excipient.   
   
   
       111 . A method for reducing an oxalate concentration in a human or animal comprising, administering to a human or animal an effective amount of a composition comprising a delivery vehicle comprising an oxalate reducing composition comprising,
 a) from about 0.5% to about 95% 3% to about 25% of an oxalate reducing bacteria;   b) from about 0.1% to about 50% 1.5% to about 6% of a disaccharide;   c) from about 3% to about 85% 45% to about 60% of a maltodextrin;   d) from about 0.5% to about 25% 4% to about 6% of an alginate; and   e) from about 1.0% to about 60% 20% to about 35% of an oligofructose.   
   
   
       112 . The method of  claim 111 , wherein the delivery vehicle comprises a suppository, a capsule, a capsule, a pill, a granule or a tablet. 
   
   
       113 . The method of  claim 111 , further comprising an enteric coating on the delivery vehicle. 
   
   
       114 . The method of  claim 111 , wherein the enteric coating is a polymeric material. 
   
   
       115 . The method of  claim 111 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes, Pseudomonas, Clostridia, Lactobacilli, Bifidobacteria,  or a bacteria transformed with one or more vectors comprising exogeneous or endogenous polynucleotide sequences coding for oxalate-reducing enzymes. 
   
   
       116 . The method of  claim 111 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes.    
   
   
       117 . The method of  claim 116 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes strain  HC1. 
   
   
       118 . The method of  claim 111 , wherein the oral delivery vehicle comprises an oxalate reducing composition comprising a lyophilized powder. 
   
   
       119 . The method of  claim 118 , wherein the powder has a particle size of about 10 microns to about 2000 microns. 
   
   
       120 . The method of  claim 111 , wherein the disaccharide is trehalose. 
   
   
       121 . The method of  claim 111 , wherein the alginate is sodium alginate. 
   
   
       122 . The method of  claim 111 , wherein the oxalate reducing composition has a cfu/gm of at least from about 1E+03 to about 1E+13 of oxalate reducing bacteria. 
   
   
       123 . The method of  claim 111 , wherein the oxalate reducing composition has an oxalate enzyme reducing activity/gm of at least from about 2 mg oxalate degraded/hr to about 2500 mg oxalate degraded/hr. 
   
   
       124 . The method of  claim 111 , wherein the administering is by oral routes of administration. 
   
   
       125 . A method for preventing or treating an oxalate-related condition comprising, administering to a human or animal an effective amount of a composition, comprising an oral delivery vehicle comprising an oxalate reducing composition comprising,
 a) from about 0.5% to about 95% 3% to about 25% of an oxalate reducing bacteria;   b) from about 0.1% to about 50% 1.5% to about 6% of a disaccharide;   c) from about 3% to about 85% 45% to about 60% of a maltodextrin;   d) from about 0.5% to about 25% 4% to about 6% of an alginate; and   e) from about 1.0% to about 60% 20% to about 35% of an oligofructose.   
   
   
       126 . The method of  claim 125 , wherein the oral delivery vehicle comprises a capsule, a pill, a granule or a tablet. 
   
   
       127 . The method of  claim 126 , further comprising an enteric coating on the oral delivery vehicle. 
   
   
       128 . The method of  claim 127 , wherein the enteric coating is a polymeric material. 
   
   
       129 . The method of  claim 125 , wherein the oral delivery vehicle comprises a capsule with an enteric coating comprising a polymeric material. 
   
   
       130 . The method of  claim 125 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes, Pseudomonas, Clostridia, Lactobacilli, Bifidobacteria,  or a bacteria transformed with one or more vectors comprising exogeneous or endogenous polynucleotide sequences coding for oxalate-reducing enzymes. 
   
   
       131 . The method of  claim 125 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes.    
   
   
       132 . The method of  claim 131 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes  strain HC1. 
   
   
       133 . The method of  claim 125 , wherein the oral delivery vehicle comprises a oxalate reducing composition that comprises a lyophilized powder. 
   
   
       134 . The method of  claim 133 , wherein the powder has a particle size of about 10 microns to about 2000 microns. 
   
   
       135 . The method of  claim 125 , wherein the disaccharide is trehalose. 
   
   
       136 . The method of  claim 125 , wherein the alginate is sodium alginate. 
   
   
       137 . The method of  claim 125 , wherein the oxalate reducing composition has a cfu/gm of at least from about 1E+03 to about 1E+13 of oxalate reducing bacteria. 
   
   
       138 . The method of  claim 125 , wherein the oxalate reducing composition has an oxalate enzyme reducing activity/gm of at least from about 2 mg oxalate degraded/hr to about 2500 mg oxalate degraded/hr. 
   
   
       139 . The method of  claim 125 , wherein the oxalate related condition is hyperoxaluria, primary hyperoxaluria, idiopathic calcium oxalate kidney stone disease (urolithiasis), enteric hyperoxaluria, vulvodynia, oxalosis associated with end-stage renal disease, cardiac conductance disorders, inflammatory bowel disease, ulcerative colitis, Crohn's disease, steatorrhea, patients who have undergone gastrointestinal surgery such as jejunoileal bypass surgery, or have undergone antibiotic treatment. 
   
   
       140 . The method of  claim 125 , wherein the composition is administered more than one time a day. 
   
   
       141 . A method of making an oxalate reducing pharmaceutical composition, comprising,
 a) providing oxalate reducing bacteria in a concentration of at least from about 1E+03 to about 1E+13;   b) optionally mixing the oxalate reducing bacteria one or more pharmaceutically acceptable excipients;   c) lyophilizing the bacteria; and   d) loading the bacteria in a pharmaceutical delivery vehicle.   
   
   
       142 . The method of  claim 141 , wherein the excipients comprise one or more of disaccharide, maltodextrin, algicide, or oligofructose. 
   
   
       143 . The method of  claim 141 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes, Pseudomonas, Clostridia, Lactobacilli, Bifidobacteria,  or a bacteria transformed with one or more vectors comprising exogeneous or endogenous polynucleotide sequences coding for oxalate-reducing enzymes. 
   
   
       144 . The method of  claim 141 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes.    
   
   
       145 . The method of  claim 144 , wherein the oxalate reducing bacteria is  Oxalobacter formigenes  strain HC1. 
   
   
       146 . The method of  claim 141 , wherein the pharmaceutical delivery vehicle comprises a powder, a capsule, a pill, a granule, a suppository, or a tablet. 
   
   
       147 . The method of  claim 146 , wherein the pharmaceutical delivery vehicle comprises a capsule. 
   
   
       148 . The method of  claim 147 , further comprising e) providing an enteric coating on the capsule. 
   
   
       149 . The method of  claim 148 , wherein the enteric coating is a polymeric material.