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Serving leading biopharmaceutical companies globally:

Accenture
Teva
QuintilesIMS
Citi
US Department of Justice
Julphar
Daiichi Sankyo
Boehringer Ingelheim
Queensland Health
McKinsey

Generated: January 21, 2018

DrugPatentWatch Database Preview

Claims for Patent: 7,456,160

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Summary for Patent: 7,456,160
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:10/872,784
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 from 10 to 30% weight of ethanol and benzyl alcohol per volume of formulation and 10 to 25% 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. 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 from 10 to 30% weight of a mixture of ethanol and benzyl alcohol per volume of formulation and from 10 to 25% 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.sup.-1 of fulvestrant.

3. The method as claimed in claim 1 or 2 wherein the formulation comprises a mixture of from 15 to 25% weight of a mixture of ethanol and benzyl alcohol per volume of formulation and from 12 to 20% weight of benzyl benzoate per volume of formulation.

4. The method as claimed in claim 1 or 2 wherein the formulation comprises a mixture of from 8.5 to 11.5% weight of ethanol per volume of formulation and from 8.5 to 11.5% weight of benzyl alcohos per volume of formulation an 12 to18% weight of benzyl benzoate per volume of formulation.

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

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

7. The method as claimed in claim 1 wherein a therapeutically significant blood plasma fulvestrant concentration of at least 3 ngml.sup.-1 is attained for at least 2 weeks after injection.

8. The method as claimed in claim 1 wherein a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ngml.sup.-1 is attained for at least 2 weeks after injection.

9. The method as claimed in claim 1 wherein a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ngml.sup.-1 is attained for at least 4 weeks after injection.

10. The method as claimed in claim 1 or 2 wherein the total volume of the formulation administered to said human is 6m1 or less, and the concentration of fulvestrant in said formulation is at least 45 mgml.sup.-1.

11. The method as claimed in claim 1 or 2 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.

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

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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Cipla
Teva
QuintilesIMS
Cantor Fitzgerald
Medtronic
Cerilliant
Fish and Richardson

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