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Claims for Patent: 8,329,680

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Claims for Patent: 8,329,680

Title:Formulation
Abstract: The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7.alpha.-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1- ,3,5(10)-triene-3,17.beta.-diol, more particularly to a formulation adapted for administration by injection containing the compound 7.alpha.-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-- triene-3,17.beta.-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.
Inventor(s): Evans; John R (Macclesfield, GB), Grundy; Rosalind U (Macclesfield, GB)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:12/285,887
Patent Claims: 1. A method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml.sup.-1 of fulvestrant; about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; about 15% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml.sup.-1 for at least four weeks.

2. The method of claim 1, wherein the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml.sup.-1.

3. The method of claim 1, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

4. The method of claim 1, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 mL of the formulation.

5. The method of claim 1, wherein the method further comprises once monthly administration of the formulation.

6. The method of claim 2, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

7. The method of claim 6, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 mL of the formulation.

8. The method of claim 7, wherein the method further comprises once monthly administration of the formulation.

9. A method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation consisting essentially of: about 50 mgml.sup.-1 of fulvestrant; about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; about 15% w/v of benzyl benzoate; and wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml.sup.-1 for at least four weeks.

10. The method of claim 9, wherein the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml.sup.-1.

11. The method of claim 9, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

12. The method of claim 9, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 mL of the formulation.

13. The method of claim 9, wherein the method further comprises once monthly administration of the formulation.

14. The method of claim 10, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

15. The method of claim 14, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 mL of the formulation.

16. The method of claim 15, wherein the method further comprises once monthly administration of the formulation.

17. The method according to claim 1, wherein the formulation is administered in a divided dose.

18. The method according to claim 8, wherein the formulation is administered in a divided dose.

19. The method according to claim 9, wherein the formulation is administered in a divided dose.

20. The method according to claim 16, wherein the formulation is administered in a divided dose.
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