Stable Preserved Compositions of Interferon-Beta
Stable preserved compositions of interferon-β and pegylated-interferon-β are described.
1 . An aqueous pharmaceutical composition comprising interferon beta at a concentration of about 0.05 mg/ml to about 0.2 mg/ml, phenol at about 1 mg/ml to 6 mg/ml and sucrose at about 250 mM to 350 mM, a salt and a surfactant.
2 . The composition of claim 1 , wherein the interferon beta is interferon beta-1a.
3 . The composition of claim 1 , wherein the interferon beta is pegylated interferon beta-1a.
4 . The composition of claim 1 , wherein the interferon beta is interferon beta-1b.
5 . The composition of claim 1 , wherein the interferon beta is pegylated interferon beta-1b.
6 . The composition of claim 1 , wherein the interferon beta is at a concentration of 0.1 mg/ml.
7 . The composition of claim 1 , wherein the interferon beta is at a concentration of 0.2 mg/ml.
8 . The composition of claim 1 , wherein the interferon beta is at a concentration of about 0.1 to about 0.2 mg/ml.
9 . The composition of claim 1 , wherein the phenol is at a concentration of about 2.5 mg/ml to about 3.5 mg/ml.
10 . The composition of claim 1 , wherein the sucrose is at a concentration of about 250 mM to 350 mM
11 . The composition of claim 1 , wherein the sucrose is at a concentration of 300 mM.
12 . The composition of claim 1 , wherein the salt is sodium acetate.
13 . The composition of claim 1 , wherein the surfactant is polysorbate.
14 . The composition of claim 1 , wherein the pH is about 4.5 to about 6.0.
15 . The composition of claim 1 , wherein the pH is about 4.8.
16 . The composition of claim 1 , wherein the composition is stable after freeze-thaw cycling.
17 . The composition of claim 1 , wherein the composition is stable after agitation stress.
18 . The composition of claim 1 , wherein the composition is stable for at least 1 month at room temperature as measured by % monomer loss of interferon-beta.
19 . The composition of claim 1 , wherein the composition is stable for at least 1 month at room temperature as measured by % soluble aggregates of interferon-beta.
20 . The composition of claim 1 , wherein the composition is formulated as a multi-use pharmaceutical formulation.