IP Library › Granted Patent US 11,505,521
Granted Patent B2
US 11,505,521 · App. 17/216,003 · Granted Nov 22, 2022

Crystalline epinephrine malonate salt

Inventors: Jean-Pierre Sommadossi (Boston, MA); Adel Moussa (Burlington, MA)
Assignee: Biothea Pharma, Inc.
C07C215/60A61K47/02A61K47/10A61K47/12A61K47/32A61K47/38C07B2200/13
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,505,521
App. No.
17/216,003
Granted
Nov 22, 2022
Kind
B2
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 (15)

1. A method for manufacturing an epinephrine malonate salt, said method comprising:

adding malonic acid to a solution comprising epinephrine and a solvent;

stirring the solution; and

precipitating the epinephrine malonate salt out of solution.

2. The method of claim 1 , further comprising filtering the precipitate.

3. The method of claim 2 , further comprising drying the precipitate.

4. The method of claim 1 , wherein malonic acid is added at a ratio of about 0.01:1 to 3:1 relative to epinephrine.

5. The method of claim 1 , wherein the solvent is selected from the group consisting of methanol, ethanol, n-propanol, iso-propanol, n-butanol, sec-butanol, tert-butanol, n-pentanol, 2-methyl-butanol, 3-methyl-butanol, and hexanol.

6. The method of claim 5 , wherein the solvent is ethanol.

7. A method of treating a patient suffering from an allergic condition, said method comprising:

administering a pharmaceutically effective amount of epinephrine malonate to the patient.

8. The method of claim 7 , wherein the epinephrine malonate is administered orally, rectally, intragastrically, topically, intracranially, intranasally, or parenterally.

9. The method of claim 7 , wherein the epinephrine malonate is administered via a buccal or sublingual tablet.

10. The method of claim 7 , wherein the allergic condition is selected from the group consisting of anaphylaxis, asthma, or bronchial asthma.

11. The method of claim 10 , wherein the allergic condition is anaphylaxis.

Continuity (4)
Division 16526286 · Jul 30, 2019
Provisional Application 62731442 · Sep 14, 2018
Provisional Application 62711936 · Jul 30, 2018
Related Publication 20210214301A1 · Jul 15, 2021