# US 9,750,763 B2 · Solution for peritoneal dialysis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,763 B2 - Document ID: US9750763B2 - Status: Granted - Kind: B2 - Application number: 14/534,298 - Filed: 2014-11-06 - Published: 2015-06-04 - Granted: 2017-09-05 - Earliest claimed: 2002-04-18 - Assignees: Fresenius Medical Care Deutschland GmbH - Applicants: Fresenius Medical Care Deutschland GmbH - Inventors: Thomas Zimmeck - Web page: https://patentgrep.com/patent/US9750763B2 ## CPC - A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides - A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters - A61K 31/718: Starch or degraded starch, e.g. amylose, amylopectin - A61K 33/00: Medicinal preparations containing inorganic active ingredients - A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} - A61K 33/10: Carbonates; Bicarbonates - A61M 1/1668: {Details of containers} - A61M 1/287: {Dialysates therefor} - 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) - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to a solution for peritoneal dialysis, consisting of at least two single solutions which are combined after a heat sterilization and are administered to a patient, the first single solution containing an osmotic and the second single solution containing a buffer, and one of these single solutions or another single solution containing electrolyte salts. The avoidance of a glucose-like degradation as well as hydrolysis during sterilization and storage while maintaining a neutral mixture pH is achieved according to the invention by the osmotic comprising a glucose polymer and/or glucose polymer derivative, and the pH of the first single solution being between 3.5 and 5.0. The present invention further relates to a twin-chambered pouch consisting of a plastic pouch with at least one first chamber and a second chamber, the first single solution being included in the first chamber and the second single solution being included in the second chamber. ## Claims ### Claim 1 A multi-part solution, for peritoneal dialysis designed to be mixed prior to infusion, comprising at least a first single solution and a second single solution, the first single solution containing an osmotic, sodium ions, and chloride ions, and the second single solution containing a buffer and not containing the osmotic, wherein (1) the osmotic comprises at least one of a glucose polymer and a glucose polymer derivative, (2) the first single solution has a pH in the range between 4.0 and 5.0, (3) the buffer contains lactate, (4) bicarbonate ions and calcium ions are not present together in any solution prior to mixing, and (5) lactate and glucose polymer or lactate and glucose polymer derivative are not present together in any solution prior to mixing. ### Claim 2 (depends on 1) The multi-part solution according to claim 1, wherein the osmotic comprises a glucose polymer derivative having at least one modified functional group. ### Claim 3 (depends on 2) The multi-part solution according to claim 2, wherein a free carbonyl group of the glucose polymer derivative is not modified. ### Claim 4 (depends on 1) The multi-part solution according to claim 1, wherein the osmotic exclusively contains the glucose polymer derivative. ### Claim 5 (depends on 1) The multi-part solution according to claim 1, wherein the pH of the first single solution is in the range between 4.0 and 4.3. ### Claim 6 (depends on 4) The multi-part solution according to claim 4, wherein the pH of the first single solution is 4.2. ### Claim 7 (depends on 1) The multi-part solution according to claim 1, wherein the buffer contains a weak acid salt. ### Claim 8 (depends on 1) The multi-part solution according to claim 1, wherein the first single solution contains, in addition to the osmotic, the following components: sodium ions [mmol/L]: 180-200; calcium ions [mmol/L]: 2-4; magnesium ions [mmol/L]: 0.8-1.2; chloride ions [mmol/L]: 197-210. ### Claim 9 (depends on 1) The multi-part solution according to claim 1, wherein the first and second single solutions are stored separately in a multi-chambered pouch. ### Claim 10 A multi-part solution for peritoneal dialysis designed to be mixed prior to infusion, comprising at least a first single solution and a second single solution, the first single solution containing an osmotic and the second single solution containing a buffer and not containing the osmotic, and one of the first single solution, the second single solution, and a third single solution containing electrolyte salts, wherein (1) the osmotic comprises a glucose polymer and/or a glucose polymer derivative, (2) the pH of the first single solution is in the range between 4.0 and 5.0, (3) the buffer contains bicarbonate and lactate, (4) bicarbonate ions and calcium ions are not present together in any solution prior to mixing, and (5) lactate and glucose polymer or lactate and glucose polymer derivative are not present together in any solution prior to mixing. ### Claim 11 (depends on 10) The multi-part solution according to claim 10, wherein the bicarbonate concentration is adjusted according to the acidity of the first single solution according to the formula: bicarbonate concentration [mmol/L]=5×acidity of the first single solution [mmol/L]×VA/VB, with VA being the volume of the first single solution and VB being the volume of the second single solution. ### Claim 12 (depends on 10) The multi-part solution according to claim 10, wherein the bicarbonate concentration is between a lower limit determined according to the formula: bicarbonate concentration [mmol/L]=2×acidity of the first single solution [mmol/L]×VA/VB, and an upper limit determined by twice the bicarbonate concentration determined according to the formula: bicarbonate concentration [mmol/L]=10×acidity of the first single solution [mmol/L]×VA/VB, with VA being the volume of the first single solution and VB being the volume of the second single solution. ### Claim 13 (depends on 10) The multi-part solution according to claim 10, wherein the second single solution has a bicarbonate concentration in the range between 0.5 and 2.0 mmol/L. ### Claim 14 (depends on 13) The multi-part solution according to claim 13, wherein the bicarbonate concentration of the second single solution is 1.0 mmol/L. ### Claim 15 A multi-part solution for peritoneal dialysis designed to be mixed prior to infusion, comprising at least a first and a second single solution, the first single solution containing an osmotic and hydrochloric acid, and the second single solution containing a buffer and not containing the osmotic, and one of the first single solution, the second single solution, and a third single solution containing electrolyte salts, wherein (1) the osmotic comprises a glucose polymer and/or a glucose polymer derivative, (2) the pH of the first single solution is in the range between 4.0 and 5.0, (3) the buffer contains lactate, (4) bicarbonate ions and calcium ions are not present together in any solution prior to mixing, and (5) lactate and glucose polymer or lactate and glucose polymer derivative are not present together in any solution prior to mixing.