Formulation comprising a gemcitabine-prodrug
AssigneeNuCana plc
InventorsHugh Griffith, Gordon Kennovin
Life of this patent
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Abstract
This invention relates to pharmaceutical formulations of gemcitabine-[phenyl-benzoxy-L-alaninyl)]-phosphate, a monophosphate derivative of the well-known oncology drug gemcitabine. In particular, the invention relates to formulations which comprise a polar aprotic solvent, preferably dimethyl acetamide (DMA). Formulations comprising these solvent provide therapeutically effective treatments of gemcitabine-[phenyl-benzoxy-L-alaninyl)]-phosphate. The invention also relates to methods of using said formulations and kits comprising said formulations.
Claims29
A pharmaceutical formulation comprising:
- gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate;
- dimethyl acetamide (DMA);
- and
- optionally one or more pharmaceutically acceptable excipients.
A method of treating cancer, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical formulation comprising:
- gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate;
- and
- dimethyl acetamide (DMA).
A method of preparing a pharmaceutical formulation of gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate for infusion or injection, comprising:
- diluting a solution comprising gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate and dimethyl acetamide (DMA) with an aqueous vehicle to provide the formulation for infusion or injection.
A kit comprising:
- a first formulation comprising:
- from 30% to 95% by volume dimethyl acetamide (DMA);
- from 5% to 50% by volume aqueous vehicle;
- and
- from 100 mg to 400 mg per ml gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate;
- and
- a second formulation comprising:
- from 10% to 40% by volume DMA;
- from 20% to 60% by volume a first solubilizer;
- and
- from 30% to 80% by volume a second solubilizer.
Dependencies are inferred from the claim text.