Solid compositions containing fluoxetine and a coating

A solid fluoxetine composition comprising, by weight based on the total weight of the composition:

• (a) a tablet core comprising, by weight based on the core weight, from 30 to 80% of fluoxetine, where the core is comprised of granules compressed together;
• and
• (b) a coating comprising, based on the weight of the coating, from 50 to 90% of a gastroresistant polymer which is comprised of an anionic copolymer on the basis of methacrylic acid and acrylic acid ethyl ester and from 3 to 20% by weight of polyethyleneglycol;
• exhibiting a dissolution profile, as determined in a basket at 100 rpm and a buffer pH 7.5, such that after 15 minutes, from 30 to 70% of the fluoxetine is released, after 30 minutes, from 70 to 98% of the fluoxetine is released, after 45 minutes, more than 90% of the fluoxetine is released.

A process for the manufacture of a fluoxetine solid composition, comprising the steps of:

• (i) granulating fluoxetine and excipients into granules;
• (ii) compressing the granules obtained at step (i) into tablet cores, where the tablet core comprises, by weight based on the core weight, from 30 to 80% of fluoxetine;
• and
• (ii) coating said tablet cores obtained at step (ii) with a gastroresistant polymer, where the coating comprises, based on the weight of the coating, from 50 to 90% of a gastroresistant polymer;
• wherein the thus-obtained fluoxetine solid composition exhibits a dissolution profile, as determined in a basket at 100 rpm and a buffer pH 7.5, such that after 15 minutes, from 30 to 70% of the fluoxetine is released, after 30 minutes, from 70 to 98% of the fluoxetine is released, after 45 minutes, more than 90% of the fluoxetine is released.