Abstract: Stable Phytonadione compositions for parenteral administration are provided which comprise (E) isomer of phytonadione at or greater than 97% w/w as the active ingredient, and is substantially free of (Z) isomer. Said compositions are stable, sterile, and particulate-free. Further, said compositions reduce or avoid allergic reactions to benzyl alcohol and polysorbate. In some aspects, the compositions are free or substantially free of benzyl alcohol and/or reduced amounts of polysorbate. Methods of manufacture and methods of administration also provided.
Type:
Grant
Filed:
July 24, 2018
Date of Patent:
August 24, 2021
Assignee:
Exela Holdings, Inc.
Inventors:
Phanesh Koneru, Sreerarama Murthy Mallipeddi, Jonathan E. Sterling
Abstract: Stable Phytonadione compositions for parenteral administration are provided which comprise (E) isomer of phytonadione at or greater than 97% w/w as the active ingredient, and is substantially free of (Z) isomer. Said compositions are stable, sterile, and particulate-free. Further, said compositions reduce or avoid allergic reactions to benzyl alcohol and polysorbate. In some aspects, the compositions are free or substantially free of benzyl alcohol and/or reduced amounts of polysorbate. Methods of manufacture and methods of administration also provided.
Type:
Grant
Filed:
July 24, 2018
Date of Patent:
August 3, 2021
Assignee:
Exela Holdings, Inc.
Inventors:
Phanesh Koneru, Sreerarama Murthy Mallipeddi, Jonathan E. Sterling
Abstract: Stable Phytonadione compositions for parenteral administration are provided which comprise (E) isomer of phytonadione at or greater than 97% w/w as the active ingredient, and is substantially free of (Z) isomer. Said compositions are stable, sterile, and particulate-free. Further, said compositions reduce or avoid allergic reactions to benzyl alcohol and polysorbate. In some aspects, the compositions are free or substantially free of benzyl alcohol and/or reduced amounts of polysorbate. Methods of manufacture and methods of administration also provided.
Type:
Grant
Filed:
February 26, 2016
Date of Patent:
July 24, 2018
Assignee:
EXELA HOLDINGS, INC
Inventors:
Phanesh Koneru, Sreerarama Murthy Mallipeddi, Jonathan E. Sterling