Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
Disclosed are bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-β)-Hydroxy-4-Androsten-3-one.
1. A pharmaceutical composition comprising or prepared from a crystalline (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate form having a melting point in the range of 68-75° C. and a pharmaceutically acceptable carrier.
2. The pharmaceutical composition of claim 1 comprising a crystalline (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate form having a melting point in the range of 68-75° C.
3. The pharmaceutical composition of claim 1 prepared from a crystalline (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate form having a melting point in the range of 68-75° C.
4. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a lipophilic surfactant.
5. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a hydrophilic surfactant.
6. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a fatty acid.
7. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a monoglyceride.
8. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a diglyceride.
9. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a polyethylene glycol.
10. The pharmaceutical composition of claim 1 formulated as a capsule or tablet.
11. The pharmaceutical composition of claim 1 formulated for oral administration.
12. The pharmaceutical composition of claim 1 crystalline (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate form having a melting point in the range of 69-73° C.
13. The pharmaceutical composition of claim 1 when tested with a USP type 2 apparatus in about 1000 mL 8% Octoxynol-9 solution in water at 37° C. (±0.5)) at 100 rpm releases at least 40% of the (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate at 60 minutes.
14. The pharmaceutical composition of claim 1 that releases greater than 70% of the (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate at 2 hours when tested with a USP type 2 apparatus in about 1000 mL 8% Octoxynol-9 solution in water at 37° C. (±0.5)) at 100 rpm.
15. The pharmaceutical composition of claim 1 that releases less than 100% of the (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate at 30 minutes when tested in a USP type 2 apparatus in about 1000 mL 8% Octoxynol-9 solution in water at 37° C. (±0.5)) at 100 rpm.
16. The pharmaceutical composition of claim 1 that releases greater than 70% of the (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate at 2 hours and less than 100% at 30 minutes when tested with a USP type 2 apparatus in about 1000 mL 8% Octoxynol-9 solution in water at 37° C. (±0.5)) at 100 rpm.
17. The pharmaceutical composition of claim 1 having from about 200 mg to about 300 mg (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate.
18. The pharmaceutical composition of claim 1 wherein said pharmaceutically acceptable carrier comprises a polyethylene glycol having an average molecular weight of about 8000 grams per mole (PEG 8000).