# US 2008/0188823 A1 · Method for Delivering Interferon-Beta

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- Number: US 2008/0188823 A1
- Document ID: US20080188823A1
- Status: Published application
- Kind: A1
- Application number: 11/795,092
- Filed: 2006-01-11
- Published: 2008-08-07
- Earliest claimed: 2005-01-12
- Assignees: Biogen Idec MA Inc.
- Inventors: Eric Anthony Faulkner; Mary Diana DiBiase
- Web page: https://patentgrep.com/patent/US20080188823A1

## 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 Interferon-β comprising:
providing a device including a housing for retaining a solution of Interferon-β;
filling the solution of Interferon-β into the housing, wherein, after filling the solution, the housing releases a concentration of an 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 an 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 an 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 an 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 an 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 an 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 an 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 an 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 an 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 an 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 an 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 comprising 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

A method for storing and delivering solutions of an Interferon-β comprising:
providing a device including a housing for retaining a solution of Interferon-β;
filling the solution of Interferon-β into the housing, wherein, after filling the solution, the housing releases a total concentration of aggregating metals into the solution of less than 500 parts per billion.

### Claim 19 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 10 minutes.

### Claim 20 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 120 minutes.

### Claim 21 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 360 minutes.

### Claim 22 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 480 minutes.

### Claim 23 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals 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 24 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals 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 25 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 250 parts per billion.

### Claim 26 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 100 parts per billion.

### Claim 27 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals 1 of less than about 75 parts per billion.

### Claim 28 (depends on 18)

The method of claim 18, wherein the housing releases a total concentration of aggregating metals of less than about 50 parts per billion.

### Claim 29

A method for storing and delivering solutions of Interferon-β comprising:
providing a device including a housing for retaining a solution of Interferon-β;
filling the solution of Interferon-β into the housing, wherein, after filling the solution, aggregation of Interferon-β caused by aggregating metals in the solution is less than 15% after storage.

### Claim 30 (depends on 29)

The method of claim 29, wherein aggregation of Interferon-β caused by aggregating metals in the solution is less than 10% after storage.

### Claim 31 (depends on 30)

The method of claim 30, wherein aggregation of Interferon-β caused by aggregating metals in the solution is less than 5% after storage.

### Claim 32 (depends on 29)

The method of claim 29, wherein aggregation of Interferon-β caused by aggregating metals in the solution is less than 2% after storage.

### Claim 33 (depends on 1)

The method of claim 1, wherein the Interferon-β is Interferon-β-1a.

### Claim 34

A device comprising:
a housing for retaining a solution;
a solution of Interferon-β retained within the housing, wherein the housing releases a total concentration of aggregating metals into the Interferon-β solution of less than 500 parts per billion.

### Claim 35 (depends on 34)

The device of claim 34 wherein the housing releases a total concentration of aggregating metals of less than about 250 parts per billion.

### Claim 36 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 100 parts per billion.

### Claim 37 (depends on 34)

The device of claim 34 wherein the housing releases a total concentration of aggregating metals 1 of less than about 75 parts per billion.

### Claim 38 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 50 parts per billion.

### Claim 39 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 10 minutes.

### Claim 40 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 120 minutes.

### Claim 41 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 360 minutes.

### Claim 42 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals of less than about 500 parts per billion after the solution is retained in the housing for greater than about 480 minutes.

### Claim 43 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals 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 44 (depends on 34)

The device of claim 34, wherein the housing releases a total concentration of aggregating metals 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 45 (depends on 34)

The device of claim 34, wherein the aggregation of Interferon-β caused by aggregating metals in the solution is less than 15% after storage.

### Claim 46 (depends on 34)

The device of claim 34, wherein the aggregation of Interferon-β caused by aggregating metals in the solution is less than 10% after storage.

### Claim 47 (depends on 34)

The device of claim 34, wherein the aggregation of Interferon-β caused by aggregating metals in the solution is less than 5% after storage.

### Claim 48 (depends on 34)

The device of claim 34, wherein the aggregation of Interferon-β caused by aggregating metals in the solution is less than 2% after storage.

### Claim 49 (depends on 34)

The device of claim 34, wherein the device is a syringe, bottle, vial or a bag.

### Claim 50 (depends on 34)

The device of claim 34, wherein the device is a syringe.

### Claim 51 (depends on 34)

The device of claim 34, wherein the housing of the device is constructed of glass, metal or plastic.

### Claim 52 (depends on 34)

The device of claim 34, wherein the housing is constructed of glass.

### Claim 53 (depends on 34)

The device of claim 34 wherein the Interferon-β is Interferon-β-1a.
