Loading patent…
AssigneeMedtronic, Inc.
InventorsMichael C. Schmitz, Roger E. Harrington, Carmen E. Snaza, Keith R. Hildebrand, Ngoc N. Lu
Estimating the term…
Compositions and methods are provided that utilize an injectable ropinirole having a therapeutically effective amount of ropinirole in an aqueous solvent, the composition having a pH of from about 3.0 to about 6.5. The compositions and methods provided contain less than 3% by weight of impurities and are suitable for administration by infusion pumps. In some embodiments, the compositions are made in an oxygen free environment and/or are made with an antioxidant to reduce impurities and improve stability. In some embodiments, the compositions provided are utilized to treat Parkinson's disease.
An injectable ropinirole composition comprising a therapeutically effective amount of ropinirole in an aqueous solvent, the composition having a pH of from about 3.0 to about 6.5.
An injectable ropinirole composition comprising a therapeutically effective amount of lyophilized ropinirole in powdered form and comprising less than 3% by weight of (4-[2-(dipropylamino)ethyl]indoline-2,3-dione hydrochloride).
A method of preparing a terminally sterilized injectable ropinirole composition, the method comprising adjusting a pH of ropinirole in an aqueous solvent to between about 3.0 to about 6.5, wherein the concentration of ropinirole in the aqueous solvent is between 0.05 mg/mL and 133 mg/mL;
A method according to claim 17, wherein the ropinirole comprises ropinirole hydrochloride and the composition further comprises at least one buffering agent, a bulking agent, pH adjustment agent, or antioxidant.
A method of preparing a lyophilized injectable ropinirole composition, the method comprising adjusting a pH of ropinirole in an aqueous solvent to between about 3.0 to about 6.5, wherein the concentration of ropinirole in the aqueous solvent is between 0.05 mg/mL and 133 mg/mL;
A method of reducing formation of (4-[2-(dipropylamino)ethyl]indoline-2,3-dione hydrochloride) in an injectable ropinirole composition, the method comprising adjusting a pH of ropinirole in an aqueous solvent to between about 3.0 to about 6.5, wherein the concentration of ropinirole in the aqueous solvent is between 0.05 mg/mL and 133 mg/mL and the composition comprises less than 3% by weight of (4-[2-(dipropylamino)ethyl]indoline-2,3-dione hydrochloride) based on a total weight of the composition.
A method of treating Parkinson's disease in a patient suffering therefrom, the method comprising administering an injectable ropinirole composition comprising a therapeutically effective amount of ropinirole in an aqueous solvent, the composition having a pH of from about 3.0 to about 6.5.
Dependencies are inferred from the claim text.