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Last Updated: March 29, 2024

Claims for Patent: 8,962,572


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Summary for Patent: 8,962,572
Title:Bortezomib formulations
Abstract: A bortezomib composition includes bortezomib and boric acid in a mass ratio of boric acid to bortezomib is from 1:1 to 10:1. The composition is a solid, and may be prepared by forming a liquid mixture including a solvent, bortezomib and boric acid, and lyophilizing the liquid mixture.
Inventor(s): Usayapant; Arunya (Mundelein, IL), Bowman; David (Mattawan, MI)
Assignee: Fresenius Kabi USA, LLC (Lake Zurich, IL)
Application Number:13/252,421
Patent Claims: 1. A composition, comprising: bortezomib, and boric acid; where the composition is a solid, and the mass ratio of boric acid to bortezomib is from 1:1 to 10:1.

2. The composition of claim 1, where the mass ratio of boric acid to bortezomib is from 1:1 to 4:1.

3. The composition of claim 1, where the mass ratio of boric acid to bortezomib is from 2:1 to 3:1.

4. The composition of claim 1, further comprising at least one other substance selected from the group consisting of an amino acid and a saccharide.

5. The composition of claim 1, further comprising glycine, where the mass ratio of glycine to bortezomib is from 1:1 to 20:1.

6. The composition of claim 5, where the mass ratio of glycine to bortezomib is from 5:1 to 15:1.

7. The composition of claim 5, where the mass ratio of glycine to bortezomib is from 7:1 to 10:1.

8. The composition of claim 5, where the mass ratio of boric acid to bortezomib is about 3:1, and the mass ratio of glycine to bortezomib is about 7:1.

9. The composition of claim 8, comprising about 3.5 mg bortezomib, about 10.5 mg boric acid, and about 25 mg glycine.

10. The composition of claim 1, further comprising mannitol, where the mass ratio of mannitol to bortezomib is from 1:1 to 20:1.

11. The composition of claim 1, where at least a portion of the bortezomib is present in an anhydride structure.

12. The composition of claim 1, where at least a portion of the bortezomib and boric acid are present together in an anhydride structure.

13. The composition of claim 1, where when the composition is stored at 55.degree. C., at most 5% of the bortezomib degrades after 3 weeks.

14. The composition of claim 1, where when the composition is stored at 55.degree. C., at most 2% of the bortezomib degrades after 3 weeks.

15. The composition of claim 1, where when the composition is stored at 55.degree. C., at most 1% of the bortezomib degrades after 3 weeks.

16. The composition of claim 1, where when the composition is stored at 55.degree. C., at most 0.5% of the bortezomib degrades after 3 weeks.

17. The composition of claim 1, where when the composition is combined with a 0.9% NaCl saline solution at a bortezomib concentration of 1 mg/mL saline and manually shaken every 15 seconds, the composition forms a solution or an emulsion within 4 minutes.

18. The composition of claim 17, where the composition forms the solution or the emulsion within 3 minutes.

19. A method of making a solid composition, comprising: forming a liquid mixture comprising a solvent, bortezomib, and boric acid; and lyophilizing the liquid mixture, where the mass ratio of the boric acid to the bortezomib in the liquid mixture is from 1:1 to 10:1, and where the solvent includes water and 1-20% by volume of a water-miscible organic solvent selected from the group consisting of ethanol, isopropanol, and tert-butanol.

20. A composition, formed by a method comprising: forming a liquid mixture comprising a solvent, bortezomib, and boric acid, where the solvent includes water and 1-20% by volume of a water-miscible organic solvent selected from the group consisting of ethanol, isopropanol, and tert-butanol, where the mass ratio of boric acid to bortezomib in the liquid mixture is from 1:1 to 10:1; and lyophilizing the liquid mixture to form a solid composition.

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