Production of an Oxaliplatin Mixture and a Container and a Container Set for Said Mixture
OwnerMichaela Roth, Katrin Meyer-Wülfinginventors
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Abstract
The invention relates to a process for the preparation of an aqueous oxaliplatin solution in which oxaliplatin is dissolved in water by addition of an acid up to an oxaliplatin concentration greater than an acid-free aqueous oxaliplatin solution. The invention relates also to a container and a set of containers containing the solution.
Claims24
1:
- Process for the preparation of an aqueous oxaliplatin solution in which oxaliplatin is dissolved in water by addition of an acid up to an oxaliplatin concentration greater than an acid-free oxaliplatin solution.
2:
- Process according to claim 1 for the preparation of a solution consisting of oxaliplatin, an acid and water, in which oxaliplatin is dissolved in water by addition of an acid up to an oxaliplatin concentration greater than an acid-free aqueous oxaliplatin solution.
3:
- Process according to claim 1 in which oxaliplatin is dissolved in water by addition of the acid up to the highest oxaliplatin saturation concentration achievable with the aid of that acid.
4:
- Process according to claim 1 in which oxaliplatin concentration is stipulated that lies in the range between the saturation concentration of an acid-free aqueous oxaliplatin solution and the highest saturation concentration in the presence of the acid, and the acid is added until the stipulated concentration has been achieved.
5:
- Process according to claim 1, characterised in that no carbohydrate is added to the solution.
6:
- Process according to claim 5, in which an oxaliplatin concentration is established that is a whole-numbered value or half-numbered value of a customary concentration measurement unit, the measurement unit preferably being mg/ml or molar.
7:
- Process according to claim 1, in which an inorganic and/or organic acid is used.
8:
- Process according to claim 7, in which at least one inorganic acid selected from the group consisting of sulfuric acid, nitric acid and phosphoric acid is used.
9:
- Process according to claim 7, in which at least one organic acid selected from the group consisting of citric acid, succinic acid, ascorbic acid, oxalic acid, lactic acid and malonic acid is used.
10:
- Process according to claim 1, in which a buffering agent is additionally used.
11:
- Process according to claim 7, in which a pH value of from 1 to 7 is established.
12:
- Process according to claim 1, in which the prepared solution is introduced into a container and the container is closed.
13:
- Process according to claim 12, in which the container is closed under an inert gas.
14:
- Process according to claim 12, in which an injection bottle or vial, a screw closure bottle or an ampoule is provided as container.
15:
- Process according to claim 14, there being used as bottle an injection bottle in the form of a single dose or multiple dose container.
16:
- Container containing aqueous oxaliplatin solution, obtainable by a process according to claim 1.
17:
- Container containing an acidic aqueous oxaliplatin solution having an oxaliplatin concentration greater than an acid-free aqueous oxaliplatin solution.
Container according to claim 17 containing an acidic aqueous oxaliplatin solution having the highest oxaliplatin saturation concentration achievable with the aid of a selected acid or having the highest oxaliplatin saturation concentration that is characteristic of the selected acid.
Container according to claim 17 containing an acidic aqueous oxaliplatin solution having an oxaliplatin concentration that is a whole-numbered value or half-numbered value of a customary concentration measurement unit, the measurement unit preferably being mg oxaliplatin/ml solution or mg oxaliplatin/mg solution or molar.
20;
- Set of containers or set comprising. containers according to claim 19 each containing an acidic aqueous oxaliplatin solution having an oxaliplatin concentration that is a whole-numbered value or a half-numbered value of a customary concentration measurement unit, the measurement unit preferably being mg oxaliplatin/ml solution or mg oxaliplatin/mg solution or molar.
21:
- Set of containers or set comprising containers according to claim 17 each containing an acidic aqueous oxaliplatin solution having an oxaliplatin concentration that is a whole-numbered value or half-numbered value of a customary concentration measurement unit, the measurement unit preferably being mg oxaliplatin/ml solution or mg oxaliplatin/mg solution or molar, the oxaliplatin concentration of at least one container being different from the concentration of the other container.
22:
- Aqueous oxaliplatin solution, preparable by a process according to claim 1.
23:
- Use of an acid to increase the solubility of oxaliplatin in an aqueous solution.
24:
- Process according to claim 11 in which a pH value of from 1.5 to 4 is established.
Dependencies are inferred from the claim text.