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US 9,750,704 B2Granted
Hydrocortisone controlled release formulation
AssigneeDiurnal Limited
InventorsHiep Huatan, Richard Ross, Martin Whitaker
Life of this patent
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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.
Claims15
An oral pharmaceutical composition, consisting of:
- a core comprising hydrocortisone, a binding agent, and a carrier;
- and
- a layer comprising a delayed release polymer, talc, and a plasticizer,
- wherein the layer comprising the delayed release polymer is in contact with said core,
- wherein said delayed release polymer is a mixture of (i) poly (methacrylic, methyl methyacrylic) in a ratio of 1:1 and (ii) poly (methacrylic, methyl methyacrylic) in a ratio of 1:2, wherein (i) and (ii) are at a ratio of 1:4 and at 6% to 7% w/w of the composition which is adapted to delay release of hydrocortisone from said core,
- wherein the hydrocortisone is at a concentration of 5-8% w/w of the composition,
- wherein the binding agent comprises povidone at a concentration of 0.5-4.0% w/w of the composition,
- wherein the carrier comprises microcrystalline cellulose particles, and wherein the carrier is 75-85% w/w of the composition, and
- wherein the plasticizer comprises dibutyl sebacate at 0.5-1.0% w/w of the composition.
6 more elements
A pharmaceutical composition, consisting of:
- a core comprising hydrocortisone, a binding agent, and a carrier;
- and
- a layer comprising a delayed release polymer, talc, and a plasticizer,
- wherein the layer comprising a delayed release polymer is in contact with said core,
- wherein said delayed release polymer is a pH sensitive enteric polymer, wherein the pH sensitive enteric polymer is a mixture of (i) poly (methacrylic acid, methyl methacrylate) in a ratio of 1:1 and (ii) poly (methacrylic acid, methyl methacrylate) in a ratio of 1:2, wherein (i) is 1.34% w/w of the composition and (ii) is 5.37% w/w of the composition,
- wherein the hydrocortisone is 6.09% w/w of the composition,
- wherein the binding agent comprises povidone at a concentration of 1.83% w/w of the composition,
- wherein the carrier comprises microcrystalline cellulose particles, and wherein the carrier is 81.36% w/w of the composition,
- wherein the talc is 3.34% w/w of the composition, and
- wherein the plasticizer comprises dibutyl sebacate at 0.67% w/w of the composition.
7 more elements
Dependencies are inferred from the claim text.