GB201202433D0 — Controlled drug release

USPTO Abstract

A pharmaceutical composition adapted for oral administration comprising: a core comprising hydrocortisone and a carrier and contacting the core a layer comprising a delayed release polymer wherein the delayed release polymer is a single or blend of pH sensitive enteric polymer(s) and is adapted to delay the release of hydrocortisone from the core characterised in that the core comprises microcrystalline cellulose which is 75-85% w/w of the composition. Preferably, the enteric polymer is selected from the group consisting of acrylic and/or poly [methyl] acrylic polymers, cellulose acetate succinate or polyvinylacetate phthalate. A pharmaceutical composition adapted for oral administration comprising: a core comprising hydrocortisone and a carrier; a layer comprising a delayed release polymer contacting the core wherein the delayed release is a pH sensitive enteric polymer which is a mixture of EudragitRTM L100 and EudragitRTM S100 [1:4] and about 6-7% w/w of the composition, which is adapted to delay release of hydrocortisone from the core is also provided. A process for the manufacture of a delayed release hydrocortisone formulation is also outlined. Preferably, the composition is useful in the treatment of conditions that would benefit from delayed release of hydrocortisone, in particular, conditions such as adrenal insufficiency, inflammatory conditions and depression.