# US 10,245,237 B2 · Compressed tablet containing cannabidiol, method for its manufacture and use of such tablet in oral treatment of psychosis or anxiety disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,245,237 B2 - Document ID: US10245237B2 - Status: Granted - Kind: B2 - Application number: 15/874,544 - Filed: 2018-01-18 - Published: 2018-05-24 - Granted: 2019-04-02 - Earliest claimed: 2013-10-29 - Assignees: Echo Pharmaceuticals B.V. - Applicants: Echo Pharmaceuticals B.V. - Inventors: Jan Albert De Vries; Maria Vanesa Fernandez Cid; Ana Maria Heredia Lopez; Cristina Maria Eiroa Martinez - Web page: https://patentgrep.com/patent/US10245237B2 ## CPC - A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol} - A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates} - A61K 9/2072: {characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms (A61K9/0004, A61K9/0056, A61K9/0065 take precedence)} - A61K 9/2095: {Tabletting processes} - A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia - A61P 25/22: Anxiolytics - 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 present invention relates to compressed tablets for peroral delivery of the cannabinoid cannabidiol (CBD). More particularly, the invention provides a compressed tablet having a tablet weight of 60-1200 mg, said tablet being composed of: 50-95 wt. % of a granulate; 5-50 wt. % of lactose; and 0-30 wt. % of other tablet excipients; wherein the granulate contains: a. 2-15 wt. % of cannabidiol; b. 2-30 wt. % of sucrose fatty acid mono-ester; c. 30-96 wt. % of lactose; and d. 0-25 wt. % of other granulate excipients. The compressed tablets according to the invention can conveniently be used in the treatment of psychosis disorders or anxiety disorders. The invention further provides a method for the manufacture of the compressed tablets. ## Claims ### Claim 1 A compressed tablet having a tablet weight of 60-1200 mg and comprising: (a) 50-95 wt. % of a granulate; (b) 5-50 wt. % of lactose; and (c) 0-30 wt. % of other tablet excipients; wherein the granulate comprises: (i) 2-15 wt. % of cannabidiol; (ii) 2-30 wt. % of sucrose fatty acid mono-ester; (iii) 30-96 wt. % of lactose; and (iv) 0-25 wt. % of other granulate excipients, wherein the granulate is composed of granules comprising lactose particles that are held together by a solid dispersion comprising cannabidiol and sucrose fatty acid mono-ester and optionally other granulate excipients; and wherein the compressed tablet is obtained by: (a) providing a lactose powder; (b) combining the lactose powder with a granulation fluid comprising a solution of cannabidiol, sucrose fatty acid mono-ester and optionally other granulate excipients in an organic solvent; (c) removing the organic solvent by evaporation to produce a granulate; (d) mixing the granulate with lactose and optionally other tablet excipients to produce a tablet mixture; and (e) compressing the tablet mixture into a tablet. ### Claim 2 (depends on 1) The compressed tablet according to claim 1, wherein the tablet comprises 2-100 mg cannabidiol. ### Claim 3 (depends on 1) The compressed tablet according to claim 1, wherein the granulate is composed of granules comprising lactose particles that are held together by a solid dispersion comprising cannabidiol, antioxidant and sucrose fatty acid mono-ester and optionally other granulate excipients. ### Claim 4 (depends on 3) The compressed tablet according to claim 3, wherein the granulate is composed of granules comprising lactose particles that are held together by a solid dispersion, wherein the solid dispersion contains a dispersed phase comprising cannabidiol, said dispersed phase having a volume weighted average diameter between 2 nm and 1 μm. ### Claim 5 (depends on 1) The compressed tablet according to claim 1, wherein the lactose is anhydrous lactose or lactose monohydrate. ### Claim 6 (depends on 1) The compressed tablet according to claim 1, wherein granules comprised in the granulate have a mass weighted average diameter of 50-1000 μm. ### Claim 7 (depends on 1) The compressed tablet according to claim 1, wherein the granulate comprises 0.2-1.5 wt. % of antioxidant. ### Claim 8 (depends on 1) The compressed tablet according to claim 1, wherein the sucrose fatty acid mono-ester comprises saturated C10-C18 fatty acids. ### Claim 9 (depends on 1) The compressed tablet according to claim 1, comprising 0-5% of Δ9-tetrahydrocannabinol by weight of cannabidiol. ### Claim 10 (depends on 1) The compressed tablet according to claim 1, wherein the lactose powder has a mass weighted average diameter of 32-250 μm. ### Claim 11 (depends on 1) The compressed tablet according to claim 1, wherein the granulation fluid comprises an anti-oxidant. ### Claim 12 (depends on 1) A method of treating psychosis disorders or anxiety disorders, comprising perorally administering one or more compressed tablets according to claim 1 in an amount that is equivalent to 5-1000 mg of cannabidiol. ### Claim 13 (depends on 12) The method according to claim 12, wherein the psychosis disorder is selected from schizophrenia, schizophreniform disorder, schizoaffective disorder, and/or paraphenia. ### Claim 14 (depends on 12) The method according to claim 12, wherein the anxiety disorder is selected from phobic disorder, generalized anxiety disorder, and/or post-traumatic stress disorder.