Formulation
DC
First Claim
1. A method of treating a hormonal dependent benign or malignant disease of the breast or reproductive tract by administration to a human in need of such treatment an intra-muscular injection of a pharmaceutical formulation comprising fulvestrant, a mixture of 10% weight of ethanol per volume of formulation, 10% weight of benzyl alcohol per volume of formulation and 15% weight of benzyl benzoate per volume of formulation and a sufficient amount of a castor oil vehicle, whereby a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml−
- 1 is attained for at least 2 weeks after injection.
1 Assignment
Litigations
3 Petitions
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.
45 Citations
9 Claims
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1. A method of treating a hormonal dependent benign or malignant disease of the breast or reproductive tract by administration to a human in need of such treatment an intra-muscular injection of a pharmaceutical formulation comprising fulvestrant, a mixture of 10% weight of ethanol per volume of formulation, 10% weight of benzyl alcohol per volume of formulation and 15% weight of benzyl benzoate per volume of formulation and a sufficient amount of a castor oil vehicle, whereby a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml−
- 1 is attained for at least 2 weeks after injection.
- View Dependent Claims (2, 3, 4, 6, 7, 8)
- 5. A method of treating a hormonal dependent benign or malignant disease of the brass or reproductive tract by administration to a human in need of such treatment an intra-muscular injection of a pharmaceutical formulation comprising fulvestrant, a mixture of 10% weight of ethanol per volume of formulation, 10% weight of benzyl alcohol per volume of formulation and 15% weight of benzyl benzoate per volume of formulation and a sufficient amount of a castor oil vehicle whereby the formulation comprises at least 45 mgml of fulvestrant.
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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InventorsGrundy, Rosalind U, Evans, John R
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Primary Examiner(s)Padmanabhan, Sreeni
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Assistant Examiner(s)HUI, SAN MING R
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Application NumberUS09/756,291Publication NumberTime in Patent Office1,309 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
