Formulation
DC
First 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;
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−
1 for at least four 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.
74 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;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−
1 for at least four weeks. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 17, 18)
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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:
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about 50 mgml−
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−
1 for at least four weeks. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 19, 20)
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Specification
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- Resources
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Current AssigneeAstrazeneca AB (Astrazeneca PLC)
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Original AssigneeAstrazeneca AB (Astrazeneca PLC)
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InventorsEvans, John R, Grundy, Rosalind U
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Primary Examiner(s)HUI, SAN MING R
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Application NumberUS12/285,887Publication NumberTime in Patent Office1,518 DaysField of Search514/177, 514/178US Class Current514/177CPC Class CodesA61K 31/565 not substituted in position...A61K 47/10 Alcohols; Phenols; Salts th...A61K 47/14 Esters of carboxylic acids,...A61K 47/44 Oils, fats or waxes accordi...A61K 9/0019 Injectable compositions; In...A61P 15/00 Drugs for genital or sexual...A61P 35/00 Antineoplastic agentsA61P 43/00 Drugs for specific purposes...A61P 5/24 of the sex hormonesA61P 5/32 Antioestrogens
