Crystalline epinephrine malonate salt

Inventors: Jean-Pierre Sommadossi (Boston, MA); Adel Moussa (Burlington, MA)

Assignee: Biothea Pharma, Inc.

C07C215/60 A61K47/02 A61K47/10 A61K47/12 A61K47/32 A61K47/38 C07B2200/13

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Quick Facts

Patent No.: US 12,134,588
App. No.: 17/989,859
Granted: Nov 5, 2024
Kind: B2

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Abstract

Described herein are epinephrine salts, specifically the epinephrine malonate salt; the epinephrine malonate salt in crystalline form; a pharmaceutical composition comprising epinephrine malonate; a sublingual or buccal pharmaceutical composition comprising epinephrine malonate in crystalline form; and a method for treating a patient comprising administering a pharmaceutical composition of epinephrine malonate in crystalline form.

Claims (20)

1. A pharmaceutical composition comprising an epinephrine malonate salt having a purity of greater than 95%.

2. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 96%.

3. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 97%.

4. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 98%.

5. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99%.

6. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99.5%.

7. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99.6%.

8. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99.7%.

9. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99.8%.

10. The pharmaceutical composition of claim 1 comprising an epinephrine malonate salt having a purity of greater than 99.9%.

11. A pharmaceutical composition comprising an epinephrine malonate salt having a purity of greater than 95% after five months of storage at 30° C. with no humidity.

12. The pharmaceutical composition of claim 11 comprising an epinephrine malonate salt having a purity of greater than 96%.

13. The pharmaceutical composition of claim 11 comprising an epinephrine malonate salt having a purity of greater than 97%.

14. The e pharmaceutical composition of claim 11 comprising an epinephrine malonate salt having a purity of greater than 98%.

15. The pharmaceutical composition of claim 11 comprising an epinephrine malonate salt having a purity of greater than 99%.

16. A pharmaceutical composition comprising an epinephrine malonate salt having a purity of greater than 95% after five months of storage at 40° C. with no humidity.

17. The pharmaceutical composition of claim 16 comprising an epinephrine malonate salt having a purity of greater than 96%.

18. The pharmaceutical composition of claim 16 comprising an epinephrine malonate salt having a purity of greater than 97%.

19. The pharmaceutical composition of claim 16 comprising an epinephrine malonate salt having a purity of greater than 98%.

20. The pharmaceutical composition of claim 16 comprising an epinephrine malonate salt having a purity of greater than 99%.

Continuity (5)

Continuation 17216003 · Mar 29, 2021

Division 16526286 · Jul 30, 2019

Provisional Application 62731442 · Sep 14, 2018

Provisional Application 62711936 · Jul 30, 2018

Related Publication 20230086578A1 · Mar 23, 2023

Cited By (9)

US 12,414,916 US 12,502,498 US 12,605,517 US 12,653,778 US 12,653,972 US 12,661,315 US 12,678,404 US 12,678,574 US 12,728,092