IP Library › Patent Application 15455991
Patent Application
App. No. 15/455,991

EPINEPHRINE FORMULATIONS

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Patent No.
US None
App. No.
15/455,991
Abstract

Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.

Claims (27)

1 . A composition comprising:

epinephrine and/or salts thereof,

a tonicity regulating agent,

a pH raising agent,

an antioxidant,

a pH lowering agent, and

a transition metal complexing agent,

wherein the antioxidant comprises a thiol-containing organic compound.

2 . The composition according to claim 1 , wherein the thiol-containing organic compound comprises glutathione.

3 . The composition according to claim 1 , wherein the epinephrine and/or salts thereof is present at a concentration of in the range of about 0.1 to 2 mg/m L.

4 . The compositions according to claim 1 , wherein the tonicity regulating agent is present at a concentration of in the range of about 6 to 8 mg/m L.

5 . The compositions according to claim 1 , wherein the pH raising agent is present at a concentration of in the range of about 2.8 to 3.8 mg/m L.

6 . The compositions according to claim 1 , wherein the transition metal complexing agent is present at a concentration of in the range of about 0.01 to 0.4 mg/mL.

7 . The composition according to claim 1 , further comprising a solvent.

8 . The composition according to claim 7 , wherein the solvent is water.

9 . The composition of claim 1 , wherein the pH raising agent comprises a buffer system comprising at least two compounds.

10 . The composition of claim 1 , wherein the pH raising agent comprises at least one of tartaric acid and sodium hydroxide.

11 . The composition of claim 1 , wherein the pH lowering agent comprises hydrochloric acid.

12 . The composition of claim 1 , wherein the transition metal complexing agent comprises EDTA.

13 . The composition according to claim 1 , wherein the composition comprises about 5% or less total impurities after 3 months of storage in accelerated storage conditions.

14 . The composition according to claim 13 , wherein the total impurities comprise D-epinephrine.

15 . The composition according to claim 1 , wherein the composition comprises about 5% or less total impurities after 2 months of storage in accelerated storage conditions.

16 . The composition according to claim 15 , wherein the total impurities comprise D-epinephrine.

17 . The composition according to claim 1 , wherein the composition comprises about 5% or less total impurities after 3 months of storage in long term storage conditions.

18 . The composition according to claim 17 , wherein the total impurities comprise D-epinephrine.

19 . The composition according to claim 1 , wherein the composition comprises about 5% or less total impurities after 2 months of storage in long term storage conditions.

20 . The composition according to claim 19 , wherein the total impurities comprise D-epinephrine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2017
From: SANGHVI, SUKETU; KANNAN, VINAYAGAM; KENNEY, MATTHEW
To: PAR PHARMACEUTICAL, INC.
Reel/Frame 041681/0951 →