# US 8,784,399 B2 · Method for delivering interferon-β > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,399 B2 - Document ID: US8784399B2 - Status: Granted - Kind: B2 - Application number: 11/795,092 - Filed: 2006-01-11 - Published: 2008-08-07 - Granted: 2014-07-22 - Earliest claimed: 2005-01-12 - Assignees: Biogen Idec MA Inc. - Applicants: Eric Anthony Faulkner; Mary Diana DiBiase - Inventors: Eric Anthony Faulkner; Mary Diana DiBiase - Web page: https://patentgrep.com/patent/US8784399B2 ## CPC - A61K 38/215: {IFN-beta} - A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) - A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)} - A61P 25/00: Drugs for disorders of the nervous system - A61P 31/12: Antivirals - A61P 35/00: Antineoplastic agents - A61M 2202/0007: introduced into the body - 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) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - 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 method described herein reduces the amount of aggregating metal released into solutions of Interferon-β. ## Claims ### Claim 1 A method for storing and delivering solutions of an Interferon-β comprising: providing a device including a housing, wherein the housing comprises an aggregating metal; removing or reducing an amount of the aggregating metal from the device; and filling the solution of the Interferon-β into the housing, wherein, after filling the solution, the housing releases a concentration of the aggregating metal into the solution of less than 500 parts per billion. ### Claim 2 (depends on 1) The method of claim 1, wherein the housing releases a concentration of the aggregating metal of less than 500 parts per billion after the solution is retained in the housing for greater than about 10 minutes. ### Claim 3 (depends on 2) The method of claim 2, wherein the housing releases a concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 120 minutes. ### Claim 4 (depends on 2) The method of claim 2, wherein the housing releases a concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 360 minutes. ### Claim 5 (depends on 2) The method of claim 2, wherein the housing releases a concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 480 minutes. ### Claim 6 (depends on 2) The method of claim 2, wherein the housing releases a concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for about 120 minutes to about 480 minutes. ### Claim 7 (depends on 2) The method of claim 2, wherein the housing releases a concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for about 300 minutes to about 420 minutes. ### Claim 8 (depends on 1) The method of claim 1, wherein the housing releases a concentration of the aggregating metal of less than about 250 parts per billion. ### Claim 9 (depends on 1) The method of claim 1, wherein the housing releases a concentration of the aggregating metal of less than about 100 parts per billion. ### Claim 10 (depends on 1) The method of claim 1, wherein the housing releases a concentration of the aggregating metal of less than about 75 parts per billion. ### Claim 11 (depends on 1) The method of claim 1, wherein the housing releases a concentration of the aggregating metal of less than about 50 parts per billion. ### Claim 12 (depends on 1) The method of claim 1, wherein the aggregating metal is selected from the group consisting of iron, copper, nickel, molybdenum and tungsten. ### Claim 13 (depends on 12) The method of claim 12, wherein the aggregating metal is tungsten. ### Claim 14 (depends on 1) The method of claim 1, wherein the device is a syringe, bottle, vial or a bag. ### Claim 15 (depends on 14) The method of claim 14, wherein the device is a syringe. ### Claim 16 (depends on 1) The method of claim 1, wherein the housing of the device is constructed of glass, metal or plastic. ### Claim 17 (depends on 16) The method of claim 16, wherein the housing is constructed of glass. ### Claim 18 (depends on 1) The method of claim 1 further comprising cleaning the device with an acid solution. ### Claim 19 (depends on 1) The method of claim 1 further comprising constructing the device to reduce the amount of aggregating metals to less than 500 parts per billion of tungsten. ### Claim 20 A method for storing and delivering solutions of an Interferon-β comprising: providing a device including a housing, wherein the housing comprises an aggregating metal; removing or reducing an amount of the aggregating metal from the device; and filling the solution of the Interferon-β into the housing, wherein, after filling the solution, the housing releases a total concentration of the aggregating metal into the solution of less than 500 parts per billion. ### Claim 21 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 10 minutes. ### Claim 22 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 120 minutes. ### Claim 23 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 360 minutes. ### Claim 24 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for greater than about 480 minutes. ### Claim 25 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for about 120 minutes to about 480 minutes. ### Claim 26 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 500 parts per billion after the solution is retained in the housing for about 300 minutes to about 420 minutes. ### Claim 27 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 250 parts per billion. ### Claim 28 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 100 parts per billion. ### Claim 29 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 75 parts per billion. ### Claim 30 (depends on 20) The method of claim 20, wherein the housing releases a total concentration of the aggregating metal of less than about 50 parts per billion. ### Claim 31 (depends on 20) The method of claim 20 further comprising cleaning the device with an acid solution. ### Claim 32 (depends on 20) The method of claim 20 comprising constructing the device to reduce the amount of aggregating metals to less than 500 parts per billion of tungsten. ### Claim 33 A method for storing and delivering solutions of an Interferon-β comprising: providing a device including a housing, wherein the housing comprises an aggregating metal; removing or reducing an amount of the aggregating metal from the device; and filling the solution of the Interferon-β into the housing, wherein, after filling the solution, aggregation of the Interferon-β caused by the aggregating metal in the solution is less than 15% after storage. ### Claim 34 (depends on 33) The method of claim 33, wherein aggregation of Interferon-β caused by the aggregating metal in the solution is less than 10% after storage. ### Claim 35 (depends on 34) The method of claim 34, wherein aggregation of Interferon-β caused by the aggregating metal in the solution is less than 5% after storage. ### Claim 36 (depends on 33) The method of claim 33, wherein aggregation of Interferon-β caused by the aggregating metal in the solution is less than 2% after storage. ### Claim 37 (depends on 1) The method of claim 1, wherein the Interferon-β is an Interferon-β-1a. ### Claim 38 (depends on 33) The method of claim 33 further comprising cleaning the device with an acid solution. ### Claim 39 (depends on 33) The method of claim 33 comprising constructing the device to reduce the amount of aggregating metals to less than 500 parts per billion of tungsten.