Stable oxaliplatin formulation
A storage stable pharmaceutical composition comprising a solution of Oxaliplatin in water and a catalytic amount of a carbohydrate. A process for forming such pharmaceutical composition comprising dissolving a known amount of Oxaliplatin in water; adding an amount of carbohydrate in the range of 0.0010% to 0.05% w/v with respect to such solution; agitating the mixture to get clear solution; filtering it through a filter membrane under aseptic conditions; and filling the solution resulting into glass vials sealed with elastomeric stoppers and aluminium flip-off seals.
1. A storage stable pharmaceutical composition comprising:
Oxaliplatin;
water; and
0.0010% to 0.05% w/v of a carbohydrate;
the composition being a solution.
2. A pharmaceutical composition according to claim 1 , wherein the composition comprises 0.0010% to 0.02% w/v carbohydrate.
3. A pharmaceutical composition according to claim 1 , wherein the composition comprises 0.0010% to 0.005% w/v carbohydrate.
4. A pharmaceutical composition according to claim 1 , wherein the carbohydrate is selected from lactose, dextrose, sucrose and glucose.
5. A pharmaceutical composition according to claim 1 , wherein the carbohydrate is lactose.
6. A process for the preparation of a pharmaceutical composition comprising: Oxaliplatin, water, and 0.0010% to 0.05% w/v of a carbohydrate; the composition being a solution;
the process comprising:
(a) dissolving a known amount of Oxaliplatin in water;
(b) adding an amount of carbohydrate in the range of 0.0010% to 0.05% w/v with respect to the water of step (a);
(c) agitating the mixture of step (b) to get clear solution;
(d) filtering the clear solution of step (c) through a filter membrane under aseptic conditions; and
(e) filling the solution resulting from step (d) into glass vials sealed with elastomeric stoppers and aluminium flip-off seals.
7. A process for preparation of pharmaceutical composition according to claim 6 , wherein the water used in step (a) is water-for-injection.
8. A process for preparation of pharmaceutical composition according to claim 6 , wherein carbohydrate used in step (b) is selected from lactose, dextrose, sucrose and glucose.
9. A process for preparation of pharmaceutical composition according to claim 6 , wherein the carbohydrate is lactose.
10. The storage stable pharmaceutical composition of claim 1 , wherein the composition is stable at a temperature of up to 40° C. for 3 months at 75% relative humidity.
11. The storage stable pharmaceutical composition of claim 1 , wherein the amount of total impurities of the composition is less than the amount of total impurities of a solution of Oxaliplatin in water comprising 5% to 50% w/v of a carbohydrate.
12. The composition of claim 1 , comprising 5 mg/mL oxaliplatin.