Storage stable aqueous injectable solution comprising diclofenac
AssigneeCadila Healthcare Limited
InventorsSushilkumar Dhanaji Patil, Nirav Ishwarlal Khatri, Alex Kochukunju George, Sushrut Krishnaji Kulkarni
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Abstract
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.
Claims19
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.
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.
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.
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.
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.
Dependencies are inferred from the claim text.