Method for obtaining aqueous formulations of oxidation-sensitive active principles
DC CAFCFirst Claim
1. A method for preparing an aqueous solution with an active nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.
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Abstract
A method for obtaining aqueous formulations with easily oxidizable active principles, notably phenols, stable over a prolonged period, comprising subjecting them to extreme deoxygenation by bubbling with an inert gas and/or placing wider vaccum, protecting them against possible resorption of oxygen by keeping them under an inert gas atmosphere, by filling, under inert gas, into bottles previously cleared of air by insufflation with inert gas, then subjecting them, while stoppering, to low pressure as obtained in the bottle, of 65,000 Pa maximum, to obtain aqueous solutions having a residual oxygen concentration in the solution below 2 ppm, and preferably of the order of 1 ppm and even 0.5 ppm useful as injectable preparations having an oxygen concentration in the solution below 2 ppm.
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19 Claims
- 1. A method for preparing an aqueous solution with an active nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.
Specification