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Claims for Patent: 6,774,122

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Claims for Patent: 6,774,122

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)-t riene-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)-t riene-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:09/756,291
Patent Claims: 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.sup.-1 is attained for at least 2 weeks after injection.

2. The method as claimed in claim 1 wherein the benign or malignant disease is breast cancer.

3. The method as claimed in claim 1 wherein the blood plasma fulvestrant concentration is attained for at least 4 weeks after injection.

4. The method as claimed in claim 1 wherein the blood plasma fulvestrant concentration is attained for 2 to 5 weeks after injection.

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.

6. The method as claimed in claim 1 or 5 wherein the total volume of the formulation administered to said human is 6 ml or less, and the concentration of fulvestrant in said formulation is at least 45 mgm.sup.-1.

7. The method as claimed in claim 1 or 5 wherein the total volume of the formulation administered to said human is 6 ml or less, and the total amount of fulvestrant in said volume of formulation is 250 mg or more.

8. The method as claimed in claim 7 wherein the total volume of formulation is from 5 to 5.25 ml, and the total amount of fulvestrant in said volume of formulation is 250 mg.

9. The method as claimed in claim 5 wherein the benign or malignant disease is breast cancer.
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