Pharmaceutically stable oxaliplatinum preparation for parenteral administration
View Patent ↗The invention concerns a pharmaceutically stable oxaliplatinum preparation for parenteral administration, the oxaliplatinum being in a precipitate-free, colorless and clear solution after being preserved for a pharmaceutical acceptable duration. In said preparation, the oxaliplatinum is contained in a solution in a solvent at a concentration of at least 7 mg/ml and the solvent comprises a sufficient amount of at least a hydroxylated derivative selected among 1,2-propane-diol, glycerol, maltitol, saccharose and inositol. The invention also concerns a method for preparing said solution.
1. Oxaliplatinum stable pharmaceutical preparation for parenteral administration, characterized in that the oxaliplatinum is contained in a solution in a solvent at a concentration of at least 7 mg/ml and in that said solvent comprises a sufficient quantity of a hydroxylated derivative selected among 1,2-propanediol, glycerol, maltitol, saccharose and inositol.
2. Pharmaceutical preparation according to claim 1 , characterized in that the oxaliplatinum is contained in a solution in said solvent at a concentration of at least 9 mg/ml and in that 1 ml of said solvent comprises at least 100 mg of one or several of said hydroxylated derivatives.
3. Pharmaceutical preparation according to claim 2 , characterized in that said solvent further comprises water.
4. Pharmaceutical preparation according to claim 3 , characterized in that the oxaliplatinum is contained in a solution in said solvent at a concentration comprised between about 10 mg/ml and about 15 mg/ml.
5. Pharmaceutical preparation according to claim 1 , characterized in that it is packed in an appropriate container for parenteral administration.
6. Pharmaceutical preparation according to claim 5 , characterized in that said container is a multidoses flask.
7. Pharmaceutical preparation according to claim 5 , characterized in that said container is a prefilled syringe.
8. Pharmaceutical preparation according to claim 5 , characterized in that said container is a soft perfusion bag.
9. Pharmaceutical preparation according to claim 5 , characterized in that said container is an ampoule.
10. Method for the preparation of a pharmaceutical preparation according to claim 1 comprising a step of mixing oxaliplatinum with a solvent comprising a sufficient quantity of at least one hydroxylated derivative selected among 1,2-propanediol, glycerol, maltitol, saccharose and inositol.
11. Method according to claim 10 , characterized in that it comprises the following steps:
a) put in contact at a temperature less than 80° C. a quantity of oxaliplatinum with a sufficient quantity of the said solvent to obtain an oxaliplatinum concentration of at least 7 mg/ml;
b) establish the mixture obtained at the step a) at a temperature comprised between 15–30° C.;
c) submit the mixture obtained at the step b) to an aseptic filtration; and
d) the conservation in an adapted container for a parenteral administration of the mixture obtained at the step c) at a temperature comprised between 2–30° C.
12. A multidoses flask containing the pharmaceutical preparation according to claim 1 .
13. A prefilled syringe containing the pharmaceutical preparation according to claim 1 .
14. A soft perfusion bag containing the pharmaceutical preparation according to claim 1 .