Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2006-06-27
2006-06-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S426000, C424S422000
Reexamination Certificate
active
07067143
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.
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Boury, F., et al.,“Interfacial Properties of Amiodarone: The Stabilizing Effect of Phosphate Anions,”Colloids and Surfaces B: Biointerfaces 20 (2001), pp. 219-227.
Weir, S. J., et al.,“Sorption of Amiodarone to Polyvinyl Chloride Infusion Bags and Administration Sets,”American Journal of Hospital Pharmacy, vol. 42, Dec., 1985, pp. 2679-2683.
Campbell, Suzanne, et al.,“Stability of Amiodarone Hydrochloride in Admixtures With Other Injectable Drugs,”American Journal of Hospital Pharmacy, vol. 43, Apr., 1986, pp. 917-921.
Doty Mark J.
Kipp James E.
Raghavan Neervalur V.
Rebbeck Christine L.
Baxter International Inc.
Bell Boyd & Lloyd LLC
Bennett Rachel M.
Kelly Paula J.
Page Thurman K.
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