Claims for Patent: 8,329,198

Summary for Patent: 8,329,198

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:	13/281,129
Patent Claims:	1. A capsule containing a composition comprising a suspension which comprises an admixture of a hydrophobic oily 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 polyvinylpyrrolidone is present in the composition at an amount of 3% or more by weight, and 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. 2. The capsule of claim 1, where the polyvinylpyrrolidone is present in the composition at an amount of about 5% to about 15% by weight. 3. The capsule of claim 1, wherein the polyvinylpyrrolidone has a molecular weight of about 3000. 4. The capsule of claim 1, wherein the medium chain fatty acid salt has a chain length from about 6 to about 14 carbon atoms. 5. The capsule of claim 4, 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. 6. The capsule of claim 5, wherein the medium chain fatty acid salt is sodium octanoate. 7. The capsule of claim 1, wherein the medium chain fatty acid salt is present in the capsule at an amount of 12% to 18% by weight. 8. The capsule of claim 1, wherein the hydrophobic oily 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. 9. The capsule of claim 1, wherein the medium chain fatty acid salt is a lithium, potassium or ammonium salt. 10. The capsule of claim 1, wherein the hydrophobic oily medium comprises glyceryl tricaprylate. 11. The capsule of claim 1, wherein the composition further comprises a surfactant. 12. The capsule of claim 1, wherein the composition comprises a therapeutically effective amount of octreotide and about 12-21% 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. 13. The capsule of claim 1, wherein the composition comprises a therapeutically effective amount of octreotide and about 12-21% 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. 14. The capsule of claim 13, wherein the octreotide is present at an amount of less than 33%. 15. The capsule of claim 14, wherein the composition comprises 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. 16. The capsule of claim 15, wherein the surfactant is glyceryl monocaprylate and polyoxyethylene sorbitan monooleate. 17. The capsule of claim 1, wherein the solid form comprises a particle or a plurality of particles. 18. The capsule of claim 1, wherein the solid form further comprises a stabilizer. 19. The capsule of claim 16, wherein the solid form further comprises a stabilizer. 20. The capsule of claim 1, which is additionally enteric coated. 21. The capsule of claim 19, which is additionally enteric coated. 22. The capsule of claim 8, wherein the fatty acid is octanoic acid. 23. The capsule of claim 13, wherein the octreotide is present at an amount of less than 25%. 24. The capsule of claim 13, wherein the octreotide is present at an amount of less than 10%. 25. The capsule of claim 13, wherein the octreotide is present at an amount of less than 1%. 26. The capsule of claim 13, wherein the octreotide is present at an amount of less than 0.1%.