Premixed amiodarone parenteral solution and method for making the same
AssigneeBaxter International Inc.
InventorsMark J. Doty, Christine L. Rebbeck, James E. Kipp, Neervalur V. Raghavan
Life of this patent
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Abstract
A premix parenteral solution for intravenous administration having amiodarone, as an active ingredient, solubilized in a solution of water for injection and about 0.4-12 mg/ml of a non-ionic surfactant to a concentration range of from 0.2 to 6 mg/ml is disclosed. The solution optionally may include an osmotic agent. No dilution of the solution is required before administering to a patient and the sterile packaged solution has an initial pH within the range of from about 2.9 to about 3.2, preferably about 3.1. Additionally, a method for producing an amiodarone solution suitable for intravenous administration is further disclosed.
Claims29
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution requires no dilution before administering and has a pH within the range of from about 2.9 to about 3.2.
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution is a sterilized premix and has a pH within the range of from about 2.9 to about 3.2.
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized in a solution of water for injection and a non-ionic surfactant and wherein the solution requires no dilution before administering, has a pH within the range of from about 2.9 to about 3.2 and has a drug degradation over time of less than 3% per year at room temperature.
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution requires no dilution before administering, has a pH within the range of from about 2.9 to about 3.2 and has a rate of total impurity formation of less than about 0.02% (w/v) total impurities/week at room temperature.
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution requires no dilution before administering, has a pH within the range of from about 2.9 to about 3.2 and has a drug adsorption of less than 3% in a plastic container which has a plastic surface area to solution volume ratio of approximately 4 cm31 1 at room temperature.
A solution for intravenous administration consisting of:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and about 0.4-12 mg/ml of a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution has a pH within the range of from about 2.9 to about 3.2.
A solution for intravenous administration comprising:
- amiodarone, as an active ingredient, solubilized to a concentration range of from 0.2 to 6 mg/ml. in a solution of water for injection and a non-ionic surfactant;
- optionally, an osmotic agent;
- and
- wherein the solution requires no dilution before administering, has a pH within the range of from about 2.9 to about 3.2 and has minimal insoluble particle formation in a plastic container at room temperature.
Dependencies are inferred from the claim text.