Phytonadione compositions and related methods
AssigneeExela Holdings, Inc.
InventorsPhanesh Koneru, Sreerarama Murthy Mallipeddi, Jonathan E. Sterling
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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.
Claims12
A stable, injectable, sterile, particulate-matter-free, aqueous phytonadione composition comprising Phytonadione in its (E) isomer form that has less than or equal to 3% w/w of its (Z) isomer, at a concentration of from about 100 ug/ml to about 20 mg/ml;
- and is free of benzyl alcohol.
A method of reducing an anaphylactic reaction associated with phytonadione administration comprising:
- administering a composition comprising Phytonadione in its (E) isomer form that is substantially free of its (Z) isomer, at a concentration of from about 0.1 mg/ml to about 20 mg/ml;
- and optionally a pH adjuster, wherein the composition has a pH of from about 3.5 to about 8.0, wherein said (Z) isomer is present at about 3% w/w or less of the (E) isomer;
- and wherein said composition is free of benzyl alcohol and cremophor, and comprises a polysorbate at a concentration of less than about 1:10 ratio of (E) isomer of phytonadione:
- polysorbate.
Dependencies are inferred from the claim text.