# US 9,750,704 B2 · Hydrocortisone controlled release formulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,704 B2 - Document ID: US9750704B2 - Status: Granted - Kind: B2 - Application number: 14/374,179 - Filed: 2013-02-12 - Published: 2014-12-18 - Granted: 2017-09-05 - Earliest claimed: 2012-02-13 - Assignees: Diurnal Limited - Applicants: Diurnal Limited - Inventors: Hiep Huatan; Richard Ross; Martin Whitaker - Web page: https://patentgrep.com/patent/US9750704B2 ## CPC - A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 9/5078: {with drug-free core} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants - A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics - A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents - A61P 5/00: Drugs for disorders of the endocrine system - A61P 5/38: of the suprarenal hormones - A61P 13/12: of the kidneys - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 21/00: Drugs for disorders of the muscular or neuromuscular system - A61P 25/04: Centrally acting analgesics, e.g. opioids - A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia - A61P 25/24: Antidepressants - A61P 25/30: for treating abuse or dependence - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 37/00: Drugs for immunological or allergic disorders - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### Claim 1 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. ### Claim 2 (depends on 1) The composition according to claim 1, wherein said microcrystalline cellulose particles have a diameter of 200 μm to 1200 μm. ### Claim 3 (depends on 2) The composition according to claim 2, wherein the diameter of said microcrystalline cellulose particles is 500 μm to 800 μm. ### Claim 4 (depends on 1) The composition according to claim 1, wherein said composition comprises 80-82% w/w microcrystalline cellulose particles. ### Claim 5 (depends on 4) The composition according to claim 4, wherein said composition comprises 81.36% w/w microcrystalline cellulose particles. ### Claim 6 (depends on 1) The composition according to claim 1, wherein the hydrocortisone is 6.09% w/w of the composition. ### Claim 7 (depends on 1) The composition according to claim 1, wherein the concentration of hydrocortisone is 6% w/w of the composition. ### Claim 8 (depends on 1) The composition according to claim 1, wherein the concentration of povidone is 1.5-3.0% w/w of the composition. ### Claim 9 (depends on 8) The composition according to claim 8, wherein the povidone is at a concentration of 1.83% w/w of the composition. ### Claim 10 (depends on 1) The composition according to claim 1, wherein dissolution of said composition is pH 5.5 to 7.0. ### Claim 11 (depends on 1) The composition according to claim 1, wherein said delayed release polymer is 5-10% w/w of the composition. ### Claim 12 (depends on 1) The composition according to claim 1, wherein said delayed release polymer is 6-8% w/w of the composition. ### Claim 13 (depends on 1) The composition according to claim 1, wherein (i) is 1.34% w/w of the composition and (ii) is 5.37% w/w of the composition. ### Claim 14 (depends on 1) The composition according to claim 1, wherein the dibutyl sebacate is 0.67% w/w of the composition. ### Claim 15 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.