Stable gamma interferon formulation

Claim 2

A biologically stable lyophilized gamma interferon formulation comprising gamma interferon and a compatible buffer, wherein the buffer maintains the pH of a solution reconstituted with water to a concentration of from 0.001, preferably 0.05, to 10 mg gamma interferon per ml within the range of 4.0 to 6.0.

Claim 3

A formulation according to claim 1 wherein said formulation additionally contains a solubilizing agent, preferably human serum albumin in an amount of up to 30 mg per ml of reconstituted solution.

Claim 4

A formulation according to claim 1 or claim 2 wherein said formulation additionally contains an antioxidant selected from sulfhydryl-specific reducing agents and a combination of ascorbic acid and cysteine or a pharmaceutically acceptable salt thereof, preferably a combination of ascorbic acid and cysteine.

Claim 5

A formulation according to any of claims 1 to 3 wherein said formulation contains 0 to 100 mg/ml reconstituted solution of one or more bulking agents selected from neutral amino acids, monosaccharides, disaccharides, and polyhydric sugar alcohols, preferably glycine.

Claim 6

A formulation according to any of claims 1 to 4 wherein said formulation additionally contains a chelating aqent, preferably disodium edetate.

Claim 7

A formulation according to any of claims 1 to 5 wherein the buffer comprises citric acid and dibasic sodium phosphate and preferably maintains a pH of 4.5 to 5.0 in the reconstituted solution.

Claim 8

A formulation according to any of claims 1 to 6 wherein the gamma interferon is present in the range of 0.1 to 2 mg/ml reconstituted solution, preferably 1 mg/ml, and is especially gamma interferon-A.

Claim 9

A formulation according to any of claims 1 to 7 which further contains alpha or beta interferon.

Claim 10

A formulation comprisinq: 0.05 to 10 mg gamma interferon/ml of reconstituted solution, a buffer system composed of citric acid and dibasic sodium phosphate to maintain a pH range of 4.0 to 6.0, preferably 4.5, 0 to 30 mg human serum albumin/ml of reconstituted solution, preferably 1 mg/ml, 0.1 to 5 mg ascorbic acid, preferably 2 mg, and 0.1 to 5 mq, preferably 1 mg, cysteine/ml reconstituted solution, 0 to 100 mg glycine/ml reconstituted solution, preferably 20 mg, and 0 to 0.5 mg disodium edetate/ml reconstituted solution, preferably 0.1 mg.

Claim 11

A formulation comprisinq: 0.05 to 10 mg gamma interferon/ml of reconstituted solution, a buffer system composed of citric acid and dibasic sodium phosphate to maintain a pH range of 4.0 to 6.0, preferably 4.5, 0 to 30 mg human serum albumin/ml of reconstituted solution, preferably 1 mg/ml, 0.1 to 5 mg ascorbic acid, preferably 2 mg, and 0.1 to 5 mq, preferably 1 mg, cysteine/ml reconstituted solution, 0 to 100 mg glycine/ml reconstituted solution, preferably 20 mg, and 0 to 0.5 mg disodium edetate/ml reconstituted solution, preferably 0.1 mg.

Claim 12

A reconstituted formulation according to any of claims 1 to 9 suitable for injection.

Claim 15

A method according to claim 11 wherein the buffer comprises citric acid and dibasic sodium phosphate, the pH of the solution is preferably 5.0 and the antioxidant is preferably cysteine.

Claim 16

A solution according to claim 11 or claim 12 stored at or below its freezing temperature.