# US 10,369,169 B1 · Proton-binding polymers for oral administration > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,169 B1 - Document ID: US10369169B1 - Status: Granted - Kind: B1 - Application number: 16/375,843 - Filed: 2019-04-04 - Published: 2019-08-01 - Granted: 2019-08-06 - Earliest claimed: 2013-06-05 - Assignees: Tricida, Inc. - Applicants: Tricida, Inc. - Inventors: Gerrit Klaerner; Eric F. Connor; Randi K. Gbur; Matthew J. Kade; Paul H. Kierstead; Jerry M. Buysse; Michael J. Cope; Kalpesh N. Biyani; Son H. Nguyen; Scott M. Tabakman - Web page: https://patentgrep.com/patent/US10369169B1 ## CPC - A61K 31/785: Polymers containing nitrogen - A61P 3/12: for electrolyte homeostasis - C08F 226/02: by a single or double bond to nitrogen - C08G 73/02: Polyamines - C08G 73/024: {Polyamines containing oxygen in the form of ether bonds in the main chain} - G01N 1/4077: {by other techniques involving separation of suspended solids} - G01N 2001/4083: {sedimentation} - G01N 2001/4088: {filtration} - Y10T 428/2982: Particulate matter [e.g., sphere, flake, etc.] - 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 - C08F: MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS - C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Pharmaceutical compositions for and methods of treating an animal, including a human, and methods of preparing such compositions. The pharmaceutical compositions contain crosslinked amine polymers and may be used, for example, to treat diseases or other metabolic conditions in which removal of protons and/or chloride ions from the gastrointestinal tract would provide physiological benefits such as normalizing serum bicarbonate concentrations and the blood pH in an animal, including a human. ## Claims ### Claim 1 A method of treating metabolic acidosis in a patient, the method comprising orally administering to the patient a pharmaceutical composition comprising a proton-binding, crosslinked amine polymer comprising the residue of an amine corresponding to Formula 1: wherein R1, R2 and R3 are independently hydrogen, hydrocarbyl, substituted hydrocarbyl provided, however, at least one of R1, R2 and R3 is other than hydrogen, the crosslinked amine polymer has an equilibrium swelling ratio in deionized water of less than 2, and the crosslinked amine polymer has an equilibrium proton binding capacity and a chloride binding capacity of at least 5 mmol/g in Simulated Gastric Fluid (“SGF”) containing 35 mM NaCl and 63 mM HCl at pH1.2 and 37° C. ### Claim 2 (depends on 1) The method of claim 1, wherein the crosslinked amine polymer comprises the residue of an amine corresponding to Formula 1a and the crosslinked amine polymer is prepared by radical polymerization of an amine corresponding to Formula 1a: wherein R4 and R5 are independently hydrogen, hydrocarbyl, or substituted hydrocarbyl. ### Claim 3 (depends on 2) The method of claim 2, wherein R4 and R5 are independently hydrogen, aliphatic or heteroaliphatic. ### Claim 4 (depends on 1) The method of claim 1, wherein the patient is a human patient. ### Claim 5 (depends on 1) The method according to claim 1, wherein the serum bicarbonate is controlled or normalized. ### Claim 6 (depends on 1) The method according to claim 1, wherein the pharmaceutical composition is administered to the patient as a daily dose. ### Claim 7 (depends on 6) The method according to claim 6, wherein the daily dose administered is less than 20 g. ### Claim 8 (depends on 6) The method according to claim 6, wherein the daily dose administered is less than 15 g. ### Claim 9 (depends on 6) The method according to claim 6, wherein the daily dose administered is less than 10 g. ### Claim 10 (depends on 6) The method according to claim 6, wherein the daily dose administered is less than 5 g. ### Claim 11 (depends on 6) The method according to claim 6, wherein the daily dose is administered once a day. ### Claim 12 (depends on 6) The method according to claim 6, wherein the daily dose results in a sustained serum bicarbonate increase of ≥3 mEq/L. ### Claim 13 (depends on 6) The method according to claim 6, wherein a daily dose of 10 g or less per day results in an increase in serum bicarbonate of ≥3 mEq/L. ### Claim 14 (depends on 2) The method according to claim 2, wherein the pharmaceutical composition is administered to the patient as a daily dose. ### Claim 15 (depends on 14) The method according to claim 14, wherein the daily dose administered is less than 20 g. ### Claim 16 (depends on 14) The method according to claim 14, wherein the daily dose administered is less than 15 g. ### Claim 17 (depends on 14) The method according to claim 14, wherein the daily dose administered is less than 10 g. ### Claim 18 (depends on 14) The method according to claim 14, wherein the daily dose administered is less than 5 g. ### Claim 19 (depends on 14) The method according to claim 14, wherein the daily dose is administered once a day. ### Claim 20 (depends on 14) The method according to claim 14, wherein the daily dose results in a sustained serum bicarbonate increase of ≥3 mEq/L. ### Claim 21 (depends on 14) The method according to claim 14, wherein a daily dose of 10 g or less per day results in an increase in serum bicarbonate of ≥3 mEq/L.