Oral octreotide therapy and contraceptive methods
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.
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.