Storage stable aqueous injectable solution comprising diclofenac
The present invention relates to a stable, aqueous, injectable solution comprising diclofenac and polyvinylpyrrolidone. The present invention also relates to processes for preparing the injectable solution.
1. An aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80 and polyvinylpyrrolidone, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C.
2. The aqueous solution according to claim 1 , wherein the diclofenac sodium is present in a concentration of about 75 mg/mL.
3. The aqueous solution according to claim 1 , wherein the diclofenac sodium is present in a concentration of about 37.5 mg/mL.
4. The aqueous solution according to claim 1 , wherein the diclofenac sodium is present in a concentration of about 25 mg/mL.
5. The aqueous solution according to claim 1 , wherein the polyvinylpyrrolidone is present in a concentration of about 160 mg/mL.
6. The aqueous solution according to claim 1 , wherein the polyvinylpyrrolidone is present in a concentration of about 80 mg/mL.
7. The aqueous solution according to claim 1 , wherein the polyvinylpyrrolidone is present in a concentration of about 70 mg/mL.
8. The aqueous solution according to claim 1 further comprising one or more antioxidants and/or one or more pH adjusting agents.
9. The aqueous solution according to claim 8 , wherein the antioxidant is monothioglycerol.
10. The aqueous solution according to claim 9 , wherein the monothioglycerol is present in a concentration of about 5 mg/mL.
11. The aqueous solution according to claim 1 , wherein the polysorbate 80 is present in a concentration between about 5 mg/mL and about 20 mg/mL.
12. The aqueous solution according to claim 8 , wherein the pH adjusting agent is sodium hydroxide and/or hydrochloric acid.
13. The aqueous solution according to claim 1 , wherein the solution has a viscosity between about 1.5 cP and about 7.5 cP.
14. The aqueous solution according to claim 1 , wherein the solution has a transmittance value of not less than 90%.
15. The aqueous solution according to claim 1 , wherein the solution has an absorbance value of not more than 1.
16. A stable aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80 and polyvinylpyrrolidone, wherein the solution does not contain impurity A (1-(2,6-dichlorophenyl) indolin-2-one) more than 0.3% by weight of diclofenac, as measured by HPLC, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C.
17. A storage stable aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80, and polyvinylpyrrolidone, wherein the solution retains at least 95% of the diclofenac after storage for 3 months at 25° C. and 60% relative humidity, and wherein the solution has a pH between about 7 and about 10.
18. An aqueous solution for parenteral administration consisting of diclofenac sodium, polyvinylpyrrolidone, polysorbate 80, sodium chloride, one or more pH adjusting agents, water, optionally one or more preservatives, optionally one or more antioxidants and optionally one or more buffering agents, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C.
19. A method for treatment of pain by administering an aqueous solution via parenteral route, wherein the solution comprises diclofenac sodium, polyvinylpyrrolidone and polysorbate 80 wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C.