Ready-to-administer solution of fentanyl citrate
AssigneeSun Pharmacuetical Industries Ltd.
InventorsSamarth Kumar, Prashant Kane, Subhas Balaram Bhowmick, Milan Natvarbhai Thakkar, Kandarp Maheshkumar Dave
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Abstract
A method of treating a patient in need of therapy with fentanyl or a salt thereof, the method comprising providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol and water for injection, the solution having a pH in the range of 3.5 to 7.5, and parenterally administering the solution to the patient.
Claims8
A method of administering anesthesia and/or analgesia to a patient by parenterally administering fentanyl or a salt thereof, said method comprising:
- a. providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol, and water for injection, wherein said solution has a pH in the range of 3.5 to 7.5, has a volume from 50 ml to 500 ml in an infusion container, has been sterilized by autoclaving, and is physically and chemically stable when stored at room temperature for at least 12 months;
- and
- b. parenterally administering said solution to a patient selected from the group consisting of a patient undergoing a surgical procedure, a patient in need of fentanyl as an adjunct to regional or general anesthesia, and a patient in need of fentanyl as a general anesthetic,
- wherein the solution is directly administered intravenously to the patient and does not require any intervening steps of reconstitution and/or dilution or mixing.
Dependencies are inferred from the claim text.