Claims for Patent: 11,969,471

Summary for Patent: 11,969,471

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):	Roni Mamluk, Moshe Tzabari, Karen Marom, Paul Salama, Irina Weinstein
Assignee:	Amryt Endo Inc
Application Number:	US17/879,430
Patent Claims:	1. An oral dosage form, comprising: 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 a medium chain fatty acid salt, wherein the composition comprises 12% to 21% by weight of the medium chain fatty acid salt, and at least 3% by weight of a matrix forming polymer. 2. The oral dosage form of claim 1, 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. 3. The oral dosage form of claim 1, wherein the medium chain fatty acid salt is sodium octanoate. 4. The oral dosage form of claim 1, wherein the composition comprises 12% to 18% by weight of the medium chain fatty acid salt. 5. The oral dosage form of claim 1, wherein the matrix forming polymer is dextran, polyvinylpyrrolidone (PVP), alginic acid, alginates, hydroxypropylmethyl cellulose, polyvinyl alcohol, polyacrylic acid, or poly methacrylic acid, or a combination thereof. 6. The oral dosage form of claim 1, wherein the matrix forming polymer comprises PVP. 7. The oral dosage form of claim 6, wherein the PVP has a molecular weight of about 2500 Da to about 3000 Da. 8. The oral dosage form of claim 1, wherein the composition comprises 3% to 20% by weight of the matrix forming polymer. 9. The oral dosage form of claim 1, wherein the composition comprises 5% to 15% by weight of the matrix forming polymer. 10. The oral dosage form of claim 1, wherein the composition comprises 3% to 20% by weight of the matrix forming polymer and 12% to 18% by weight of the medium chain fatty acid salt. 11. The oral dosage form of claim 1, wherein the composition comprises 5% to 15% by weight of the matrix forming polymer and 12% to 18% by weight of the medium chain fatty acid salt. 12. The oral dosage form 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. 13. The oral dosage form of claim 1, wherein the hydrophobic medium comprises glyceryl tricaprylate or castor oil. 14. The oral dosage form of claim 1, wherein hydrophobic medium comprises a surfactant. 15. The oral dosage form of claim 14, wherein the surfactant is lecithin, sorbitan monopalmitate, glyceryl monocaprylate or polyoxyethylene sorbitan monooleate, or a combination thereof. 16. The oral dosage form of claim 1, wherein the composition comprises about 3-10% by weight of a surfactant. 17. The oral dosage form of claim 1, wherein the oral dosage form is a capsule. 18. The oral dosage form of claim 1, wherein the oral dosage form is enterically coated.