Stability for injection solutions
AssigneeAstraZeneca AB
InventorsAnna Lundgren, Mats Sundgren
Life of this patent
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Abstract
A primary package containing a low molecular weight peptide-based thrombin inhibitors which package is sealed with a rubber stopper or plunger containing bromobutyl rubber.
Drawings
Claims18
A primary package containing an aqueous solution for parenteral administration comprising a low molecular weight peptide-based thrombin inhibitor or a salt thereof, having a pH in the range 3 to 8, the primary package being sealed with a rubber stopper or plunger containing bromobutyl rubber.
A primary package according to any of the preceding claims, wherein the solution is a NaCl solution.
A primary package according to any of the preceding claims, wherein the solution also comprises hydroxy-propyl-β-cyclodextrin.
A primary package according to any of the preceding claims, wherein the concentration of the thrombin inhibitor in the solution is in the range 0.001-100 mg/ml, preferably 2.5-20 mg/ml.
A primary package according to any of the preceding claims, wherein the pH of the solution is in the range 3-8.
A primary package according to any of the preceding claims, wherein the thrombin inhibitor is melagatran.
A primary package according to any of the preceding claims, wherein the thrombin inhibitor in the solution is inogatran.
A primary package according to any of the preceding claims, wherein the thrombin inhibitor in the solution is compound A.
A primary package according to any of the preceding claims, wherein the bromobutyl rubber material consists of, or correspond to, the quality PH 4023/53.
Use of a rubber stopper or plunger containing bromobutyl rubber for sealing a primary package, such as a vial, a bottle, a cartridge or a prefilled syringe, containing a low molecular weight peptide-based thrombin inhibitor in an aqueous solution.
Dependencies are inferred from the claim text.