Abstract: The stable liquid formulations for parenteral administration include fentanyl or a pharmaceutically acceptable salt thereof. The formulations include a diluent and buffer, either containing sodium, in an aqueous solution that has a pH of about 3 to about 4.5. The parenteral liquid formulations are stable formulations that are supplied as a ready-to-administer product in an infusion container or bag. The stable formulations are terminally sterilized in the infusion container. The stable formulations are suitable for administration to a patient in need of therapy with fentanyl or a pharmaceutically acceptable salt thereof.
Type:
Grant
Filed:
November 17, 2021
Date of Patent:
August 29, 2023
Assignee:
HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED
Inventors:
Andrew Conrad, Ragheb Al-Shakhshir, Ragheb AbuRmaileh
Abstract: This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
Type:
Grant
Filed:
October 6, 2021
Date of Patent:
October 18, 2022
Assignee:
Hikma Pharmaceuticals International Limited
Inventors:
David E. McAnany, Michael G. Parker, Sarah D. McCue
Abstract: This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
Type:
Grant
Filed:
August 5, 2016
Date of Patent:
January 4, 2022
Assignee:
Hikma Pharmaceuticals International Limited
Inventors:
David E. McAnany, Michael G. Parker, Sarah D. McCue
Abstract: The stable liquid formulations for parenteral administration include fentanyl or a pharmaceutically acceptable salt thereof. The formulations include a diluent and buffer, either containing sodium, in an aqueous solution that has a pH of about 3 to about 4.5. The parenteral liquid formulations are stable formulations that are supplied as a ready-to-administer product in an infusion container or bag. The stable formulations are terminally sterilized in the infusion container. The stable formulations are suitable for administration to a patient in need of therapy with fentanyl or a pharmaceutically acceptable salt thereof.
Type:
Grant
Filed:
October 31, 2019
Date of Patent:
December 28, 2021
Assignee:
Hikma Pharmaceuticals International Limited
Inventors:
Andrew Conrad, Ragheb Al-Shakhshir, Ragheb AbuRmaileh