Stable bortezomib formulations
First Claim
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1. A ready to inject pharmaceutical parenteral composition, comprising:
- a liquid formulation comprising Bortezomib and an acidic buffer;
wherein the liquid formulation is a substantially non-aqueous solvent system suitable for injection, and present in a container in a quantity suitable for at least two independent administrations;
wherein the solvent system comprises at least 50 vol % propylene glycol;
wherein the Bortezomib is present at a pharmaceutically effective concentration; and
wherein the solvent system is formulated to maintain degradation of the Bortezomib at a level of less than 10 wt % when the liquid formulation is stored over at least three months at ambient conditions.
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Abstract
Multi-dose formulations for bortezomib are presented in which bortezomib has significantly improved stability. Especially preferred formulations include those in which bortezomib is in a liquid form suitable for injection, wherein the solvent system predominantly comprises propylene glycol. In other preferred aspects, bortezomib is present as a Lewis donor-acceptor complex with a hetero-bifunctional Lewis base.
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Citations
12 Claims
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1. A ready to inject pharmaceutical parenteral composition, comprising:
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a liquid formulation comprising Bortezomib and an acidic buffer; wherein the liquid formulation is a substantially non-aqueous solvent system suitable for injection, and present in a container in a quantity suitable for at least two independent administrations; wherein the solvent system comprises at least 50 vol % propylene glycol; wherein the Bortezomib is present at a pharmaceutically effective concentration; and wherein the solvent system is formulated to maintain degradation of the Bortezomib at a level of less than 10 wt % when the liquid formulation is stored over at least three months at ambient conditions. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A storage stable pharmaceutical parenteral composition comprising:
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a liquid formulation comprising Bortezomib and an acidic buffer; wherein the liquid formulation is a substantially non-aqueous solvent system for injection; wherein the solvent system comprises at least 50 vol % propylene glycol; wherein the Bortezomib is present at a pharmaceutically effective concentration; wherein the solvent system is formulated to maintain degradation of the Bortezomib at a level of less than 10 wt % when the liquid formulation is stored over at least three months at ambient conditions. - View Dependent Claims (12)
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Specification