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AssigneeCipla Limited
InventorsPradeep BHADAURIA, Arunprasath KALIAPERUMAL, Tushar RAJYAGURU, Harshad HARDE, Sandip KHAIRNAR
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The present invention relates to stable, sterile, ready-to-use aqueous pharmaceutical formulation comprising nimodipine or its pharmaceutically acceptable salts, and pharmaceutically acceptable excipients. The present invention also relates to a stable, sterile, ready-to-use aqueous pharmaceutical formulation comprising nimodipine containing no more than about 0.41% w/v of nitroso impurity and no more than about 0.41% w/v of di-isopropyl impurity. The formulation is suitable for parenteral administration and is provided in a suitable container. The invention further relates to method of manufacture and sterilization of such formulations and using the formulation for prophylaxis and treatment of ischemic neurological deficits caused by cerebral vasospasm following subarachnoid hemorrhage of aneurysmal origin.
A sterile, ready-to-use aqueous nimodipine injection comprising:
A sterile, ready-to-use aqueous nimodipine injection comprising about 0.02% w/v nimodipine, about 0.03% w/v anhydrous citric acid, about 0.2% w/v sodium citrate dihydrate, about 20% w/v ethanol, about 17% w/v polyethylene glycol 400, and water for injection q.s.,
Dependencies are inferred from the claim text.