Bendamustine compositions and methods therefore
AssigneeInnoPharma, Inc.
InventorsKumaresh Soppimath, Udaya Toti, Satish Pejaver, Navneet Puri
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Abstract
Aqueous Bendamustine formulations with improved stability are disclosed. Especially preferred formulations are low-dose ready-to-use liquid formulations in which Bendamustine is in a non-aqueous vehicle in combination with an aqueous phase that contains significant quantities of chloride.
Claims20
A ready-to-use liquid Bendamustine formulation for injection, comprising:
- a mixture of a non-aqueous solvent system and an aqueous chloride-containing water phase;
- wherein Bendamustine is present in the mixture in a therapeutically effective amount;
- wherein the chloride is present in the mixture at a precipitating amount with respect to Bendamustine in the water phase, and wherein the non-aqueous solvent system is present in the mixture in an amount effective to prevent Bendamustine precipitation from the water phase;
- and
- wherein the precipitating amount of chloride is effective to stabilize Bendamustine as compared to a mixture without chloride.
A reconstitution solution for lyophilized Bendamustine to thereby produce a ready-to-use liquid formulation for injection, comprising:
- a mixture of a non-aqueous solvent system and an aqueous chloride-containing water phase;
- wherein the chloride is present in the mixture at a precipitating amount with respect to Bendamustine in the water phase, and wherein the non-aqueous solvent system is present in the mixture in an amount effective to prevent Bendamustine precipitation from the water phase;
- and
- wherein the precipitating amount of chloride is effective to stabilize Bendamustine in the mixture when the mixture is combined with the lyophilized Bendamustine.
A method of stabilizing Bendamustine in a ready-to-use aqueous liquid formulation for multiple independent injections, comprising:
- providing a mixture of a non-aqueous solvent system and an aqueous chloride-containing water phase;
- wherein the chloride is present in the mixture at a precipitating amount with respect to Bendamustine in the water phase, and wherein the non-aqueous solvent system is present in the mixture in an amount effective to prevent Bendamustine precipitation from the water phase;
- wherein the precipitating amount of chloride is effective to stabilize Bendamustine in the mixture when the mixture is combined with the lyophilized Bendamustine;
- and
- dissolving the Bendamustine in a volume of the mixture to thereby form the ready-to-use liquid formulation for injection, wherein the volume is sufficient to form the ready-to-use liquid formulation for multiple independent injections.
Dependencies are inferred from the claim text.