Formulation
DCFirst Claim
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−
1 of fulvestrant;
a mixture of from 17-23% w/v of ethanol and benzyl alcohol;
12-18% w/v of benzyl benzoate; and
a sufficient amount of castor oil vehicle;
wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml−
1 for at least two weeks.
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Litigations
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Accused Products
Abstract
The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-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.
25 Citations
20 Claims
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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−
1 of fulvestrant;a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml−
1 for at least two weeks. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. 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−
1 of fulvestrant;a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml−
1 for at least two weeks. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification