Suspension formulation of interferon
A suspension formulation of interferon includes a non-aqueous, single-phase vehicle including at least one polymer and at least one solvent, the vehicle exhibiting viscous fluid characteristics, and an interferon contained in a particle formulation dispersed in the vehicle. The particle formulation includes a stabilizing component comprising one or more stabilizers selected from the group consisting of carbohydrates, antioxidants, and amino acids. The suspension formulation is characterized in that less than 10% of the interferon degrades over 3 months under an accelerated storage condition.
1 . A suspension formulation of interferon comprising:
a non-aqueous, single-phase vehicle including at least one polymer and at least one solvent, the vehicle exhibiting viscous fluid characteristics; and
an interferon contained in a particle formulation dispersed in the vehicle, the particle formulation including a stabilizing component comprising one or more stabilizers selected from the group consisting of carbohydrates, antioxidants, and amino acids;
characterized in that less than 10% of the interferon degrades over 3 months under an accelerated storage condition.
2 . The suspension formulation of claim 1 , wherein the solvent is selected from the group consisting of lauryl lactate, lauryl alcohol, and benzyl benzoate.
3 . The suspension formulation of claim 1 , wherein the polymer is selected from the group consisting of pyrrolidones.
4 . The suspension formulation of claim 1 , wherein the particle formulation optionally comprises a buffer.
5 . The suspension formulation of claim 1 , wherein the interferon is interferon omega.
6 . The suspension formulation of claim 1 , wherein the stabilizers are sucrose and methionine and the buffer is citrate.
7 . The suspension formulation of claim 1 , wherein the polymer is a pyrrolidone and the solvent is benzyl benzoate.
8 . The suspension formulation of claim 1 , wherein less than 5% of the interferon degrades over 6 months under a long term storage condition.
9 . The suspension formulation of claim 1 , which has an overall moisture content less than 5 wt %.
10 . The suspension formulation of claim 1 , wherein degradation in the suspension formulation from oxidation is less than 7% over 3 months at an accelerated storage condition.
11 . The suspension formulation of claim 1 , wherein degradation in the suspension formulation from deamidation is less than 7% over 3 months at an accelerated storage condition.
12 . The suspension formulation of claim 1 , wherein degradation in the suspension formulation from dimers is less than 3% over 3 months at an accelerated storage condition.
13 . The suspension formulation of claim 1 , wherein the particle formulation is spray dried.
14 . The suspension formulation of claim 1 , wherein the particle formulation is lyophilized.
15 . The suspension formulation of claim 1 , wherein the particle formulation has a main peak as measured by reversed phase high performance liquid chromatography of at least 85% after 1 month at an accelerated storage condition.
16 . A method of treating an interferon-responsive disorder comprising administering to a subject the suspension formulation of claim 1 .
17 . The method of claim 16 , wherein the disorder is hepatitis C virus disorder.