Claims for Patent: 11,890,316

Summary for Patent: 11,890,316

Title:	Oral octreotide therapy and contraceptive methods
Abstract:	This invention relates to methods of administering oral octreotide therapy to a female subject relating to avoidance of combined oral contraceptives or use of a back-up method for contraception.
Inventor(s):	Asi Haviv, Ruth Engle Stevens, Jennings Ray Dawkins
Assignee:	Amryt Pharmaceuticals Inc
Application Number:	US17/470,836
Patent Claims:	1. A method of administering oral octreotide to a female subject in need thereof wherein the subject is in need of a contraceptive method, comprising (a) administering to the subject 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 (b) counseling the subject to avoid concomitant use of a combined oral contraceptive. 2. The method of claim 1, wherein the combined oral contraceptive comprises levonorgestrel. 3. A method of administering oral octreotide to a female subject in need thereof wherein the subject is administered a combined oral contraceptive, comprising (a) administering to the subject 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 (b) counseling the subject to use a back-up method of contraception or to use an alternative non-hormonal method of contraception. 4. The method of claim 3, wherein the combined oral contraceptive comprises levonorgestrel. 5. The method of claim 1, wherein the subject has acromegaly. 6. The method of claim 1, wherein the subject has severe diarrhea or flushing episodes associated with metastatic carcinoid tumor. 7. The method of claim 3, wherein the subject has acromegaly. 8. The method of claim 3, wherein the subject has severe diarrhea or flushing episodes associated with metastatic carcinoid tumor. 9. A method of administering oral octreotide to a female subject in need thereof wherein the subject is in need of a contraceptive method, comprising (a) administering to the subject 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 (b) counseling the subject to avoid concomitant use of a contraceptive which comprises levonorgestrel or to use a back-up method of contraception or to use an alternative method of contraception. 10. The method of claim 9, wherein the contraceptive which comprises levonorgestrel is an oral contraceptive. 11. The method of claim 9, wherein the contraceptive which comprises levonorgestrel is not an oral contraceptive. 12. The method of claim 9, 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 combination thereof. 13. The method of claim 9, wherein the medium chain fatty acid salt is sodium octanoate. 14. The method of claim 9, wherein the composition comprises 12% to 18% by weight of the medium chain fatty acid salt. 15. The method of claim 9, wherein the solid form further comprises polyvinylpyrrolidone (PVP). 16. The method of claim 15, wherein the PVP has a molecular weight of about 3000 Da. 17. The method of claim 15, wherein the composition comprises 5% to 10% by weight of PVP. 18. The method of claim 9, wherein the composition comprises 12% to 18% by weight of sodium octanoate. 19. The method of claim 9, wherein the composition comprises 5% to 10% by weight of PVP and 12% to 18% by weight of the medium chain fatty acid salt. 20. The method of claim 9, wherein the hydrophobic medium comprises a mineral oil, a paraffin, a fatty acid, a monoglyceride, a diglyceride, a triglyceride, or a combination thereof. 21. The method of claim 9, wherein the hydrophobic medium comprises glyceryl tricaprylate or castor oil. 22. The method of claim 9, wherein hydrophobic medium comprises a surfactant. 23. The method of claim 22, wherein the surfactant is glyceryl monocaprylate, polyoxyethylene sorbitan monooleate, or a combination thereof. 24. The method of claim 9, wherein the composition comprises about 3-10% by weight of a surfactant. 25. The method of claim 1, wherein the oral dosage form is a capsule. 26. The method of claim 25, wherein the capsule is enterically coated.