ABIRATERONE PRODRUGS
Sustained-release abiraterone prodrug formulations, methods, and kits for parenteral administration to a subject having a sex hormone-dependent benign or malignant disorder such as prostate cancer, a syndrome due to androgen excess, and/or a syndrome due to glucocorticoid excess such as hypercortisolemia.
1 . (canceled)
2 . (canceled)
3 . A method of treating prostate cancer in a subject in need thereof, the method comprising administering to the subject abiraterone decanoate via intramuscular injection, intradermal injection, or subcutaneous injection, once a week or once in more than a week, with each dose at about 50 mg to about 2000 mg of abiraterone decanoate, wherein the abiraterone decanoate has the following formula,
4 . The method of claim 3 , wherein the abiraterone decanoate is administered via intramuscular injection.
5 . The method of claim 3 , wherein the abiraterone decanoate is administered at a dosing frequency ranging from once a month or once in more than a month.
6 . The method of claim 3 , wherein the abiraterone decanoate is administered at a dosing frequency ranging from once a week to once every three months.
7 . The method of claim 3 , wherein the prostate cancer is castration resistant prostate cancer or castration sensitive prostate cancer.
8 . The method of claim 3 , wherein the prostate cancer is metastatic castration resistant prostate cancer or metastatic castration sensitive prostate cancer.
9 . A method of treating prostate cancer in a subject in need thereof, the method comprising intramuscularly administering to the subject a pharmaceutical composition comprising:
1) abiraterone decanoate having the following formula,
2) a pharmaceutically acceptable oil, and
3) a pharmaceutically acceptable solvent,
wherein the abiraterone decanoate is in its basic form, which is present at a concentration of about 100 mg/ml to about 300 mg/ml,
wherein the administering is at a dosing frequency of once a week or once in more than a week with each dose at about 50 mg to about 2000 mg of abiraterone decanoate.
10 . The method of claim 9 , wherein the pharmaceutically acceptable oil is corn oil.
11 . The method of claim 9 , wherein the pharmaceutically acceptable solvent is benzyl alcohol and benzyl benzoate.
12 . The method of claim 10 , wherein the pharmaceutically acceptable solvent is benzyl alcohol and benzyl benzoate.
13 . The method of claim 9 , wherein the abiraterone decanoate is in a concentration of about 150 mg/ml to about 250 mg/ml.
14 . The method of claim 9 , wherein the pharmaceutical composition is in a unit dosage form.
15 . The method of claim 9 , wherein the dosing frequency ranges from once a week to once every three months.
16 . The method of claim 9 , wherein the prostate cancer is castration resistant prostate cancer or castration sensitive prostate cancer.
17 . The method of claim 9 , wherein the prostate cancer is metastatic castration resistant prostate cancer or metastatic castration sensitive prostate cancer.
18 . The method of claim 9 , further comprising administering to the subject hydrocortisone, prednisone, prednisolone, methylprednisolone, and/or dexamethasone.
19 . A method of delivering abiraterone to a subject in need thereof, the method comprising intramuscularly administering to the subject a pharmaceutical composition comprising:
1) abiraterone decanoate having the following formula,
a pharmaceutically acceptable oil, and
a pharmaceutically acceptable solvent,
wherein the abiraterone decanoate is in its basic form, which is present at a concentration of about 100 mg/ml to about 300 mg/ml,
wherein the administering is at a dosing frequency of once a week or once in more than a week with each dose at about 50 mg to about 2000 mg of abiraterone decanoate.
20 . The method of claim 19 , wherein the pharmaceutically acceptable oil is corn oil.
21 . The method of claim 19 , wherein the pharmaceutically acceptable solvent is benzyl alcohol and benzyl benzoate.
22 . The method of claim 20 , wherein the pharmaceutically acceptable solvent is benzyl alcohol and benzyl benzoate.
23 . The method of claim 19 , wherein the abiraterone decanoate is in a concentration of about 150 mg/ml to about 250 mg/ml.
24 . The method of claim 19 , wherein the dosing frequency ranges from once a week to once every three months.
25 . A method of inhibiting CYP17A1 in a subject in need thereof, the method comprising intramuscularly administering to the subject a pharmaceutical composition comprising:
1) abiraterone decanoate having the following formula,
2) a pharmaceutically acceptable oil, and
3) a pharmaceutically acceptable solvent,
wherein the abiraterone decanoate is in its basic form, which is present at a concentration of about 100 mg/ml to about 300 mg/ml,
wherein the administering is at a dosing frequency of once a week or once in more than a week with each dose at about 50 mg to about 2000 mg of abiraterone decanoate.