Pharmaceutical compositions and related methods of delivery

Abstract

The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.

1 . A composition comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid, and wherein the medium chain fatty acid salt is present in the composition at an amount of 10% or more by weight. 
     
     
         2 - 11 . (canceled) 
     
     
         12 . The composition of  claim 1 , wherein the medium chain fatty acid salt is present in the composition at an amount of 11% to 40% by weight. 
     
     
         13 . The composition of  claim 12  wherein the medium chain fatty acid salt is present in the composition at an amount of 12% to 18% by weight, preferably 15% by weight. 
     
     
         14 - 15 . (canceled) 
     
     
         16 . The composition of  claim 1 , which additionally comprises a matrix forming polymer. 
     
     
         17 . The composition of  claim 16  wherein the matrix forming polymer is dextran or polyvinylpyrrolidone (PVP). 
     
     
         18 . The composition of  claim 17  where the polyvinylpyrrolidone is present in the composition at an amount of about 2% to about 20% by weight. 
     
     
         19 . The composition of  claim 18  where the polyvinylpyrrolidone is present in the composition at an amount of about 5% to about 15% by weight. 
     
     
         20 - 59 . (canceled) 
     
     
         60 . A composition comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of a therapeutic agent, at least one salt of a medium chain fatty acid and a matrix forming polymer, and wherein the matrix forming polymer is present in the composition at an amount of 3% or more by weight. 
     
     
         61 - 74 . (canceled) 
     
     
         75 . A process for producing a pharmaceutical composition which comprises preparing a water-soluble composition comprising a therapeutically effective amount of at least one therapeutic agent and a medium chain fatty acid salt, drying the water soluble composition to obtain a solid powder, and suspending the solid powder in a hydrophobic medium, to produce a suspension containing in solid form the therapeutic agent and the medium chain fatty acid salt, thereby producing the pharmaceutical composition, wherein the pharmaceutical composition contains 10% or more by weight of medium chain fatty acid salt. 
     
     
         76 - 85 . (canceled) 
     
     
         86 . The process of  claim 75 , wherein the medium chain fatty acid salt is present in the composition at an amount of about 11% to about 40% by weight. 
     
     
         87 . The process of  claim 86  wherein the medium chain fatty acid salt is present in the composition at an amount of about 11% to about 28% by weight. 
     
     
         88 . The process of  claim 87  wherein the medium chain fatty acid salt is present in the composition at an amount of about 15% by weight. 
     
     
         89 - 90 . (canceled) 
     
     
         91 . The process of  claim 75  where the water soluble composition additionally comprises a matrix forming polymer. 
     
     
         92 . (canceled) 
     
     
         93 . The process of  claim 91 , where the matrix forming polymer is polyvinylpyrrolidone and the polyvinylpyrrolidone is present in the composition at an amount of about 2% to about 20% by weight. 
     
     
         94 . (canceled) 
     
     
         95 . The process of  claim 93  wherein the polyvinylpyrrolidone is present in the composition at an amount of about 10% by weight. 
     
     
         96 - 176 . (canceled) 
     
     
         177 . A composition comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of octreotide and at least one salt of a medium chain fatty acid. 
     
     
         178 - 183 . (canceled) 
     
     
         184 . The composition of  claim 177 , wherein the hydrophobic medium comprises glyceryl tricaprylate and the solid form additionally consists of PVP-12 and sodium octanoate. 
     
     
         185 . The composition of  claim 184  wherein the hydrophobic medium additionally consists essentially of castor oil or glyceryl monocaprylate or a combination thereof and a surfactant. 
     
     
         186 . The composition of  claim 185  wherein the hydrophobic medium consists of glyceryl tricaprylate, glyceryl monocaprylate, and polyoxyethylene sorbitan monooleate (Tween 80). 
     
     
         187 . The composition of  claim 186  wherein the solid form consists essentially of active octreotide, PVP-12 and sodium octanoate. 
     
     
         188 . The composition of  claim 187  containing about 41% of glyceryl tricaprylate, about 27% castor oil, about 4% glyceryl monocaprylate, about 2% Tween 80, about 15% sodium octanoate, about 10% PVP-12, about 1% water and about 0.058% octreotide. 
     
     
         189 . The composition of  claim 187  containing about 68% of glyceryl tricaprylate, about 4% glyceryl monocaprylate, about 2% Tween 80, about 15% sodium octanoate, about 10% PVP-12, about 1% water and about 0.058% octreotide. 
     
     
         190 . A method of treating a subject suffering from acromegaly, abnormal GI motility, flushing episodes associated with carcinoid syndrome, portal hypertension, an endocrine tumor, gastroparesis, diarrhea, pancreatic leak or pancreatic pseudo-cysts which comprises administering to the subject the composition of  claim 177  in an amount sufficient to treat the condition. 
     
     
         191 . A method of preventing variceal bleeding in a subject which comprises administering to the subject the composition of  claim 177  in an amount sufficient to prevent the bleeding. 
     
     
         192 - 195 . (canceled)