Fulvestrant formulations

1. A fulvestrant-containing composition comprising:

a) fulvestrant from about 50 mg/ml to about 150 mg/ml;

b) a solvent selected from the group consisting of dimethyl sulfoxide (DMSO), glycofurol, and mixtures thereof;

c) an oil mixture of caprylic and capric triglycerides, said oil mixture containing about 50% to about 64% C 8 fatty acids and about 30% to about 45% C 10 fatty acids; and

d) benzyl benzoate as a sustained release member;

wherein said fulvestrant-containing composition is in the form of a solution having a long-term stability defined by less than about 5% total impurities after at least about 6 months of storage at a temperature of about 40° C.;

wherein said composition is substantially free of castor oil and castor oil derivatives; and

wherein the volume ratio of solvent:oil mixture:sustained release member is either (i) about 33%:about 25%:about 42%, or (ii) about 2:about 1:about 1 when the solvent is a two-solvent mixture.

2. The composition of claim 1 , wherein the solvent is DMSO.

3. The composition of claim 1 , wherein the solvent is a mixture of DMSO and glycofurol in a volume ratio of about 1:about 1.

4. The composition of claim 1 , wherein the fulvestrant concentration is from about 100 mg/ml to about 125 mg/ml.

5. The composition of claim 1 , wherein the fulvestrant concentration is about 50 mg/ml.

6. The composition of claim 4 , wherein the fulvestrant concentration is about 100 mg/ml.

7. The composition of claim 1 , having less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 36 months of storage at a temperature of from about 5° C. to about 25° C.

8. The composition of claim 1 , further comprising at least one antioxidant selected from the group consisting of lipoic acid, dihydrolipoic acid, methionine, sulpha-containing amino acids, acetone sodium bisulfate, propyl gallate, butylated hydroxytoluene (“BHT”), butylated hydroxyanisole (“BHA”) and sodium formaldehyde sulfoxylate.

9. A fulvestrant-containing composition comprising:

a) fulvestran from about 50 mg/ml to about 150 mg/ml;

b) DMSO;

c) a mixture of caprylic and capric triglycerides, said oil mixture containing about 50% to about 64% C 8 fatty acids and about 30% to about 45% C 10 fatty acids; and

d) benzyl benzoate;

wherein the DMSO is present in an amount of about 33% (v/v), the mixture of caprylic and capric triglycerides is present in an amount of about 25% (v/v), and the benzyl benzoate is present in an amount of about 42% (v/v);

said fulvestrant-containing composition being in the form of a solution having a long-term stability defined by less than about 5% total impurities after at least about 6 months of storage at a temperature of about 40° C.

10. The composition of claim 9 , having less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 36 months of storage at a temperature of from about 5° C. to about 25° C.

11. A fulvestrant-containing composition comprising:

a) fulvestrant from about 50 mg/ml to about 150 mg/ml;

b) DMSO;

c) a mixture of caprylic and capric triglycerides, said oil mixture containing about 50% to about 64% C 8 fatty acids and about 30% to about 45% C 10 fatty acids;

d) benzyl benzoate; and

e) glycofurol;

wherein the volume ratio of DMSO:mixture of caprylic and capric triglycerides:

benzyl benzoate:glycofurol is about 1:about 1:about 1:about 1;

said fulvestrant-containing composition is in the form of a solution having a long-term stability defined by less than about 5% total impurities after at least about 6 months of storage at a temperature of about 40° C.

12. The composition of claim 11 , having less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 36 months of storage at a temperature of from about 5° C. to about 25° C.

13. A liquid fulvestrant-containing composition consisting essentially of:

a) fulvestrant from about 50 mg/ml to about 150 mg/ml;

b) a solvent selected from the group consisting of dimethyl sulfoxide (DMSO), glycofurol, and mixtures thereof;

c) an oil mixture of caprylic and capric triglycerides, said oil mixture containing about 50% to about 64% C 8 fatty acids and about 30% to about 45% C 10 fatty acids; and

d) benzyl benzoate as a sustained release member;

wherein said fulvestrant-containing composition is in the form of a solution having a long-term stability defined by less than about 5% total impurities after at least about 6 months of storage at a temperature of about 40° C.;

wherein said composition is substantially free of castor oil and castor oil derivatives; and

wherein the volume ratio of solvent:oil mixture:sustained release member is either (i) about 33%:about 25%:about 42%, or (ii) about 2:about 1:about 1 when the solvent is a solvent mixture.

14. The composition of claim 1 , wherein the composition does not require refrigeration to maintain long-term stability.

15. The composition of claim 9 , wherein the composition does not require refrigeration to maintain long-term stability.

16. The composition of claim 11 , wherein the composition does not require refrigeration to maintain long-term stability.

17. The composition of claim 13 , wherein the composition does not require refrigeration to maintain long-term stability.