PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY
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)