IFN-β liquid formulations
View Patent ↗Interferon-β liquid formulations stabilized with a polyol, a non-reducing sugar or an amino acid. In particular, the formulations are stabilized with a polyol, such as mannitol. The formulations, preferably, furthermore comprise a buffer, such as acetate buffer, at a pH comprised between 3.0 and 4.0 and human albumin at a minimum quantity. The interferon-β is preferably recombinant.
1. A liquid pharmaceutical formulation consisting of from about 0.6 to 24 MIU/ml of interferon-β, mannitol, an acetate buffer at a pH between 3.0 and 4.0 and, optionally, albumin.
2. A liquid pharmaceutical formulation according to claim 1 , in which interferon-β is recombinant.
3. A liquid pharmaceutical formulation according to claim 1 , in which interferon-β is in a quantity between 0.6 and 1 MIU/ml.
4. A liquid pharmaceutical formulation according to claim 3 , in which the buffer solution has a concentration of 0.01 M.
5. A liquid pharmaceutical formulation according to claim 1 , in which the optional albumin is present and comprises human albumin.
6. A liquid pharmaceutical formulation according to claim 1 , comprising 1 MIU/ml of interferon-β, 54.6 mg/ml of mannitol, 0.5 mg/ml of albumin in a solution of 0.01 M acetate buffer at pH 3.5.
7. A process for the preparation of a liquid pharmaceutical formulation according to claim 1 , comprising combining interferon-β with mannitol, an acetate buffer at a pH between 3.0 and 4.0 and, optionally, albumin.
8. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 1 and appropriate for storage prior to use.
9. A process for the preparation of a liquid pharmaceutical formulation according to claim 7 in which interferon-β is recombinant and is in a quantity between 0.6 and 1 MIU/ml.
10. A process for the preparation of a liquid pharmaceutical formulation according to claim 9 in which conditions comprising interferon-β at 1 MIU/ml, mannitol at 54.6 mg/ml, and 0.5 mg/ml of albumin in a solution of 0.01 M acetate buffer at pH 3.5 are employed.
11. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 6 and appropriate for storage prior to use.
12. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 2 and appropriate for storage prior to use.
13. A liquid pharmaceutical formulation according to claim 6 , in which interferon-β is recombinant.