Fulvestrant formulation

A pharmaceutical formulation adapted for intramuscular injection comprising fulvestrant, 30% or less weight of a pharmaceutically-acceptable alcohol per volume of formulation, at least 1% weight of a pharmaceutically-acceptable non-aqueous ester solvent miscible in a ricinoleate vehicle per volume of formulation and a sufficient amount of a ricinoleate vehicle so as to prepare a formulation which is capable after injection of attaining a therapeutically significant blood plasma fulvestrant concentration for at least 2 weeks.

A pharmaceutical formulation adapted for intra-muscular injection comprising fulvestrant, 30% or less weight of a pharmaceutically-acceptable alcohol per volume of formulation, at least 1% weight of a pharmaceutically-acceptable non-aqueous ester solvent miscible in a ricinoleate vehicle per volume of formulation and a sufficient amount of a ricinoleate vehicle so as to prepare a formulation of at least 45 mgml−1 of fulvestrant.

A pharmaceutical formulation as claimed in any claim from 1 to 6 which contains 60% w/v or less of a pharmaceutically-acceptable non-aqueous ester solvent.

A pharmaceutical formulation as claimed in any claim from 1 to 13 wherein the pharmaceutically-acceptable alcohol is a mixture of ethanol and benzyl alcohol.

A pharmaceutical formulation as claimed in any claim from 1 to 14 wherein the pharmaceutically-acceptable non-aqueous ester solvent is selected from benzyl benzoate, ethyl oleate, isopropyl myristate, isopropyl palmitate or a mixture of any thereof.

A pharmaceutical formulation as claimed in any claim from 1 to 15 wherein the pharmaceutically-acceptable non-aqueous ester solvent is benzyl benzoate.

A pharmaceutical formulation as claimed in any claim from 1 to 16 wherein the total volume of the formulation is 6 ml, or less, and the concentration of fulvestrant is at least 45 mgml−1.

A pharmaceutical formulation as claimed in any claim from 1 to 13 wherein the total amount of fulvestrant in the formulation is 250 mg, or more, and the total volume of the formulation is 6 ml, or less.

An pharmaceutical formulation adapted for intramuscular injection, as defined in any claim from 1 to 20, for use in medical therapy.

Use of fulvestrant in the preparation of a pharmaceutical formulation, as defined in any claim from 1 to 20, for the treatment of a benign or malignant disease of the breast or reproductive tract.