Compositions comprising an epothilone, hydroxyalkyl-beta-cyclodextrin and an excipient, and production methods

Disclosed is a method of producing a composition comprising the steps of (a) dissolving (1S, 3S, 7S, 10R, 11S, 12S, 16R)-7,11-dihydroxy-3-(2-methyl-benzothiazol-5-yl)-10-(prop-2-en-1-yl)-8,8, 12,16-tetramethyl-4,17-dioxabicyclo[14,1,0]heptadecane-5,9-dione in an organic solvent; b) dissolving hydroxyalkyl-beta-cyclodextrin in aqueous solution, together with at least one further pharmaceutically acceptable excipient; optionally c) adjusting the pH of the resulting mixture of b) to a pH ranging between 5 and 9 using an inorganic acid; d) mixing the resulting solvents a) and b) or a) and c); optionally e) carrying out sterile filtering of d) to achieve an original solution; and f) drying the original solution so as to remove the solvent resulting in a solid composition. A composition obtained by using the above method is also disclosed. Also disclosed is a composition comprising (1S, 3S, 7S, 10R, 11S, 12S, 16R)-7,11-dihydroxy-3-(2-methyl-benzothiazol-5-yl)-10-(prop-2-en-1-yl)-8,8, 12,16-tetramethyl-4,17-dioxabicyclo[14,1,0]heptadecane-5,9-dione, hydroxyalkyl-beta-cyclodextrin and at least one pharmaceutically acceptable excipient. The use of this composition for the manufacture of a medicament for the treatment of cancer is also disclosed.