# US 8,568,792 B2 · Metal compounds, mixed or sulphated, as phosphate binders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,568,792 B2 - Document ID: US8568792B2 - Status: Granted - Kind: B2 - Application number: 12/828,462 - Filed: 2010-07-01 - Published: 2011-01-20 - Granted: 2013-10-29 - Earliest claimed: 1997-09-19 - Assignees: Cytochroma Development Inc. - Applicants: Norman B Roberts; Maurice Webb; Benjamin J Rankin - Inventors: Norman B Roberts; Maurice Webb; Benjamin J Rankin - Web page: https://patentgrep.com/patent/US8568792B2 ## CPC - C01F 11/18: Carbonates - A61K 33/244: Lanthanides; Compounds thereof (medicinal preparations containing radioactive lanthanides for use in therapy or testing in vivo A61K51/00) - A61K 33/26: Iron; Compounds thereof - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 3/12: for electrolyte homeostasis - A61P 7/00: Drugs for disorders of the blood or the extracellular fluid - A61P 7/08: Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04) - A61P 13/12: of the kidneys - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C01F 5/24: Magnesium carbonates - C01G 49/009: {Compounds containing iron, with or without oxygen or hydrogen, and containing two or more other elements} - C01F: COMPOUNDS OF THE METALS BERYLLIUM, MAGNESIUM, ALUMINIUM, CALCIUM, STRONTIUM, BARIUM, RADIUM, THORIUM, OR OF THE RARE-EARTH METALS (metal hydrides {monoborane, diborane or addition complexes thereof} C01B6/00; salts of oxyacids of halogens C01B11/00; peroxides, salts of peroxyacids C01B15/00; sulfides or polysulfides of magnesium, calcium, strontium, or barium C01B17/42; thiosulfates, dithionites, polythionates C01B17/64; compounds containing selenium or tellurium C01B19/00; binary compounds of nitrogen with metals C01B21/06; azides C01B21/08; {compounds other than ammonia or cyanogen containing nitrogen and non-metals and optionally metals C01B21/082; amides or imides of silicon C01B21/087}; metal {imides or} amides C01B21/092, {C01B21/0923}; nitrites C01B21/50; {compounds of noble gases C01B23/0005}; phosphides C01B25/08; salts of oxyacids of phosphorus C01B25/16; carbides C01B32/90; compounds containing silicon C01B33/00; compounds containing boron C01B35/00; compounds having molecular sieve properties but not having base-exchange properties C01B37/00; compounds having molecular sieve and base-exchange properties, e.g. crystalline zeolites, C01B39/00; cyanides C01C3/08; salts of cyanic acid C01C3/14; salts of cyanamide C01C3/16; thiocyanates C01C3/20; {double sulfates of magnesium with sodium or potassium C01D5/12; with other alkali metals C01D15/00, C01D17/00}) - 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 - C01G: COMPOUNDS CONTAINING METALS NOT COVERED BY SUBCLASSES C01D OR C01F (metal hydrides {monoborane, diborane or addition complexes thereof} C01B6/00; salts of oxyacids of halogens C01B11/00; peroxides, salts or peroxyacids C01B15/00; thiosulfates, dithionites, polythionates C01B17/64; compounds containing selenium, or tellurium C01B19/00; binary compounds of nitrogen with metals C01B21/06; azides C01B21/08; {compounds containing nitrogen, other non-metals and metal C01B21/082}; metal amides C01B21/092; nitrites C01B21/50; {compounds of noble gases C01B23/0005}; phosphides C01B25/08; salts of oxyacids of phosphorus C01B25/16; carbides C01B32/90; compounds containing silicon C01B33/00; compounds containing boron C01B35/00; compounds having molecular sieve properties but not having base-exchange properties C01B37/00; compounds having molecular sieve and base-exchange properties, e.g. crystalline zeolites, C01B39/00; cyanides C01C3/08; salts of cyanamide C01C3/16; thiocyanates C01C3/20) ## Abstract A mixed metal compound for pharmaceutical use is free from aluminium and has a phosphate binding capacity of at least 30%, by weight of the total weight of phosphate present, over a pH range of from 2-8. The compound is especially useful for treatment of hyperphosphataemia. The metals are preferably iron (III) and at least one of calcium, magnesium, lanthanum and cerium. A metal sulphate for pharmaceutical use is selected from at least one of calcium, lanthanum and cerium sulphate compounds and has a phosphate binding capacity of at least 30% by weight of the total phosphate present, over a pH range from 2-8. ## Claims ### Claim 1 A pharmaceutical composition comprising a pharmaceutically acceptable phosphate-binding, mixed metal compound, wherein said compound is free from aluminum and contains iron (III), at least one additional metal M selected from the group consisting of magnesium, calcium, lanthanum and cerium, and a metal sulphate, and wherein the composition is effective for binding phosphate in animal. ### Claim 2 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which the ratio M:Fe for the compound is at least 1.7:1. ### Claim 3 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which the ratio M:Fe for the compound is up to 5:1. ### Claim 4 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which the at least one additional metal is calcium. ### Claim 5 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which the at least one additional metal is magnesium. ### Claim 6 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which the compound additionally contains at least one of a chloride and oxide. ### Claim 7 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which said compound has a phosphate binding capacity of at least 30% by weight, as measured by any of the following methods (1) or (2), over a pH range of 3to 7: (1) adding 1 gram of said mixed metal compound to 25mL of 40 mmol I-1 sodium phosphate buffer solution, homogenizing and gently agitating at room temperature temperature for 30 minutes, centrifuging at 3000 rpm for 5 minutes, filtering through 0.22μm millipore filter and measuring the soluble phosphate in the supernatant thus produced; (2) adding 1 gram of said mixed metal compound to 25 mL of 20 mmol I-1 sodium phosphate buffer solution, homogenizing and gently agitating at room temperature temperature for 30 minutes, centrifuging at 3000 rpm for 5 minutes, filtering through 0.22 μm millipore filter and measuring the soluble phosphate in the supernatant thus produced. ### Claim 8 (depends on 7) A pharmaceutical composition as claimed in claim 7 in which said compound has a phosphate binding capacity of at least 30% by weight of the total weight of phosphate present as measured by said method (1) or by said method (2) over a pH range of 2 to 8. ### Claim 9 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which said metal compound contains hydroxyl and/or carbonate ions. ### Claim 10 (depends on 1) A pharmaceutical composition as claimed in claim 1 in which said compound has a hydrotalcite type structure. ### Claim 11 (depends on 1) The pharmaceutical composition according to claim 1, wherein the mixed metal compound is unaged. ### Claim 12 (depends on 1) The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is in the form of a unit dose. ### Claim 13 A method for binding phosphate in an animal in need thereof, which comprises administering to said animal, a therapeutically effective amount of a pharmaceutically acceptable phosphate-binding, inorganic mixed metal compound, wherein said compound is free of aluminum and contains iron (III) and at least one additional metal M selected from the group consisting of magnesium, calcium, lanthanum and cerium. ### Claim 14 (depends on 13) A method as claimed in claim 13 in which the ratio M:Fe for the compound is at least 1.7:1. ### Claim 15 (depends on 13) A method as claimed in claim 13 in which the ratio of M:Fe for the compound is up to 5:1. ### Claim 16 (depends on 13) A method as claimed in claim 13 in which the at least one additional metal is calcium. ### Claim 17 (depends on 13) A method as claimed in claim 13 in which the at least one additional metal is magnesium. ### Claim 18 (depends on 13) A method as claimed in claim 13 in which the compound additionally contains at least one of sulphate, chloride and oxide. ### Claim 19 (depends on 13) A method as claimed in claim 13 in which said compound has a phosphate binding capacity of at least 30% by weight, as measured by any of the following methods (1) or (2), over a pH range of 3 to 7: (1) adding 1 gram of said mixed metal compound to 25 mL of 40 mmol I-1 sodium phosphate buffer solution, homogenizing and gently agitating at room temperature temperature for 30 minutes, centrifuging at 3000 rpm for 5 minutes, filtering through 0.22 μm millipore filter and measuring the soluble phosphate in the supernatant thus produced; (2) adding 1 gram of said mixed metal compound to 25 mL of 20 mmol I-1 sodium phosphate buffer solution, homogenizing and gently agitating at room temperature temperature for 30 minutes, centrifuging at 3000 rpm for 5 minutes, filtering through 0.22 μm millipore filter and measuring the soluble phosphate in the supernatant thus produced. ### Claim 20 (depends on 19) A method as claimed in claim 19 in which said compound has a phosphate binding capacity of at least 30% by weight of the total weight of phosphate present as measured by said method (1) or by said method (2) over a pH range of 2 to 8. ### Claim 21 (depends on 13) A method as claimed in claim 13 in which said metal compound contains hydroxyl and/or carbonate ions. ### Claim 22 (depends on 13) A method as claimed in claim 13 in which said compound has a hydrotalcite type structure.