Claims for Patent: 8,535,695

Summary for Patent: 8,535,695

Title:	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.
Inventor(s):	Salama; Paul (Ashdod, IL), Mamluk; Roni (Modiin, IL), Marom; Karen (Mevaseret Zion, IL), Weinstein; Irina (Maale Adummim, IL), Tzabari; Moshe (Jerusalem, IL)
Assignee:	Chiasma Inc. (Newton Centre, MA)
Application Number:	13/233,824
Patent Claims:	1. 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, the method comprising orally administering to the subject a pharmaceutical 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, at least one salt of a medium chain fatty acid and polyvinylpyrrolidone (PVP), wherein the at least one salt of a medium chain fatty acid is present in the composition at an amount of at least 12% by weight and wherein the polyvinylpyrrolidone is present in the composition at an amount of 3% or more by weight. 2. The method of claim 1, wherein the polyvinylpyrrolidone has a molecular weight of about 3000. 3. The method of claim 1, wherein the medium chain fatty acid salt has a chain length from about 6 to about 14 carbon atoms. 4. The method of claim 3, wherein the medium chain fatty acid salt is sodium hexanoate, sodium heptanoate, sodium octanoate, sodium nonanoate, sodium decanoate, sodium undecanoate, sodium dodecanoate, sodium tridecanoate or sodium tetradecanoate, or a corresponding potassium or lithium or ammonium salt or a combination thereof. 5. The method of claim 4, wherein the fatty acid salt is sodium octanoate. 6. The method of claim 1, wherein the medium chain fatty acid salt is present in the composition at an amount of 12% to 18% by weight. 7. The method of claim 1, wherein the hydrophobic medium comprises a mineral oil, a paraffin, a fatty acid, a monoglyceride, a diglyceride, a triglyceride, an ether or an ester, or a combination thereof. 8. The method of claim 1, wherein the medium chain fatty acid salt is a lithium, potassium or ammonium salt. 9. The method of claim 1, wherein the hydrophobic medium comprises glyceryl tricaprylate. 10. The method of claim 1, wherein the pharmaceutical composition further comprises a surfactant. 11. The method of claim 1, wherein the pharmaceutical composition comprises a therapeutically effective amount of octreotide and 12-20% of sodium octanoate, about 5-10% of polyvinylpyrrolidone with a molecular weight of about 3000, about 20-80% of glyceryl tricaprylate, about 0-50% castor oil, about 3-10% surfactant and about 1% water. 12. The method of claim 1, wherein the pharmaceutical composition comprises a therapeutically effective amount of octreotide and 12-20% of sodium octanoate, about 5-10% of polyvinylpyrrolidone with a molecular weight of about 3000, about 20-80% of glyceryl tricaprylate, about 3-10% surfactant and about 1% water. 13. The method of claim 12, wherein the octreotide is present at an amount of less than 33%. 14. The method of claim 13, comprising about 15% of sodium octanoate, about 10% of polyvinylpyrrolidone with a molecular weight of about 3000, about 30-70% glyceryl tricaprylate and about 6% of surfactant. 15. The method of claim 14, wherein the surfactant is glyceryl monocaprylate or polyoxyethylene sorbitan monooleate. 16. The method of claim 1, wherein the solid form comprises a particle or a plurality of particles. 17. The method of claim 1, wherein the solid form further comprises a stabilizer. 18. The method of claim 15, wherein the solid form further comprises a stabilizer. 19. The method of claim 1, wherein the pharmaceutical composition is additionally enteric coated. 20. The method of claim 7, wherein the fatty acid is octanoic acid. 21. The method of claim 1, 2-18 or 19, wherein the method is a method of treating a subject suffering from acromegaly. 22. The method of claim 1, 2-18 or 19, wherein the method is a method of treating a subject suffering from diarrhea. 23. The method of claim 1, 2-18 or 19, wherein the method is a method of treating a subject suffering from portal hypertension. 24. The method of claim 1, 2-18 or 19, wherein the method is a method of treating a subject suffering from an endocrine tumor. 25. The method of claim 7, wherein the triglyceride is a medium chain triglyceride. 26. The method of claim 12, wherein the octreotide is present at an amount of less than 25%. 27. The method of claim 12, wherein the octreotide is present at an amount of less than 10%. 28. The method of claim 12, wherein the octreotide is present at an amount of less than 1%. 29. The method of claim 12, wherein the octreotide is present at an amount of less than 0.1%.