Hydrocortisone controlled release formulation
AssigneeDiurnal Limited
InventorsHiep Huatan, Richard Ross, Martin Whitaker
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Abstract
The disclosure relates to a pharmaceutical formulation comprising hydrocortisone and its use in the treatment of conditions that would benefit from a delayed release of hydrocortisone, in particular conditions such as adrenal insufficiency, inflammatory conditions and depression.
Claims49
A pharmaceutical composition adapted for oral administration comprising:
- a core comprising hydrocortisone and a carrier and contacting said core a layer comprising a delayed release polymer wherein said delayed release polymer is a single or blend of pH sensitive enteric polymer(s) and is adapted to delay release of hydrocortisone from said core characterized in that the carrier comprises microcrystalline cellulose which is 75-85% w/w of the composition.
A pharmaceutical composition adapted for oral administration comprising:
- a core comprising hydrocortisone and a carrier;
- and
- a layer comprising a delayed release polymer that contacts said core, wherein said delayed release polymer is a pH sensitive enteric polymer which is a mixture of poly (methacrylic acid, methyl methacrylate) in a ratio of 1:1 and poly (methacrylic acid, methyl methacrylate) in a ratio of 1:2 [1:4] at 6-7% w/w of the composition, which is adapted to delay release of hydrocortisone from said core.
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The method according to claim 44, wherein the inflammatory disease or condition is the result of an autoimmune disease.
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Dependencies are inferred from the claim text.