Long-acting formulations of insulin
First Claim
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1. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
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Abstract
The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.
65 Citations
59 Claims
- 1. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
- 9. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin] wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6.
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16. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], 90 μ
- g/mL zinc chloride, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%, wherein the pH of the aqueous pharmaceutical formulation is 4.0.
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17. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], 90 μ
- g/mL zinc chloride, 2.7 mg/mL m-cresol, 20 μ
g/mL polysorbate 20, and 20 mg/mL glycerol 85%, wherein the pH of the aqueous pharmaceutical formulation is 4.0.
- g/mL zinc chloride, 2.7 mg/mL m-cresol, 20 μ
- 18. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], wherein the pharmacokinetic profile and the pharmacodynamic profile of the 300 U/mL aqueous pharmaceutical formulation are flatter than the pharmacokinetic profile and the pharmacodynamic profile of an aqueous pharmaceutical formulation comprising 100 U/mL of insulin glargine, and wherein the pH of the 300 U/mL aqueous pharmaceutical formulation is between 3.4 and 4.6.
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25. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin] providing a peakless long acting basal insulin, wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6.
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26. An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin] exhibiting an extended duration of exposure of insulin glargine than an aqueous pharmaceutical formulation comprising 100 U/mL insulin glargine, wherein the pH of the U300 U/mL aqueous formulation is between 3.4 and 4.6.
- 32. A method of treating Type I or Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to the patient an aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
- 34. A method of extending the duration of exposure of a long acting insulin in the treatment of Type I or Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to the patient an aqueous pharmaceutical formulation comprising 300 U/mL insulin glargine [equimolar to 300 IU human insulin].
- 36. A method of reducing the incidence of hypoglycaemia in the treatment of Type I or Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to the patient an aqueous pharmaceutical formulation comprising 300 U/mL insulin glargine [equimolar to 300 IU human insulin].
- 38. A method of providing a peakless long acting basal insulin in the treatment of Type I or Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to the patient an aqueous pharmaceutical formulation comprising 300 U/mL insulin glargine [equimolar to 300 IU human insulin].
- 48. A method of treating Type I or Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to the patient an aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6.
Specification