Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
Stabilized pharmaceutical formulations of insulin analogs and/or insulin derivatives are disclosed.
1. A pharmaceutical formulation consisting of:
(a) 3.5 mg/mL insulin aspart;
(b) 1.72 mg/mL metacresol;
(c) 1.50 mg/mL phenol;
(d) 0.04087 mg/mL zinc chloride;
(e) 6.8 mg/mL sodium chloride;
(f) 0.02 mg/mL polysorbate 20;
(g) sodium hydroxide and/or hydrochloric acid to adjust the pH to 7.4, and
(h) water.
2. The pharmaceutical formulation according to claim 1 , wherein the pharmaceutical formulation is an aqueous pharmaceutical formulation.
3. The pharmaceutical formulation as claimed in claim 1 , wherein the pharmaceutical formulation is formulated for injection.
4. A kit comprising one or more separate packages of
(a) the pharmaceutical formulation as claimed in claim 1 ; and
(b) a medical device.
5. A kit comprising one or more separate packages of
(a) the pharmaceutical formulation as claimed in claim 1 ; and
(b) at least one further active pharmaceutical ingredient;
(c) and optionally a medical device.
6. The kit according to claim 5 , wherein the further active pharmaceutical ingredient is an antidiabetic agent.
7. The kit as claimed in claim 5 , wherein the further active pharmaceutical ingredient is an antidiabetic agent selected from the group consisting of:
(a) a GLP-1 receptor agonist;
(b) a dual GLP-1 receptor/glucagon receptor agonist;
(c) human FGF-21;
(d) an FGF-21 analogue;
(e) an FGF-21 derivative;
(f) insulin;
(g) human insulin;
(h) an analogue of insulin; and
(i) a derivative of insulin.
8. A method of treating diabetes mellitus in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of claim 1 .
9. A method of treating hyperglycemia in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of claim 1 .
10. A method of lowering glucose levels in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of claim 1 .
11. A medical device comprising the pharmaceutical formulation as claimed in claim 1 , for administering the pharmaceutical formulation to an animal and/or human.
12. A process for preparing the pharmaceutical formulation according to claim 1 , wherein the components are mixed together in the form of a solution or suspension, the pH is adjusted to reach pH 7.4, and water is added to reach the final volume.