IP Library Granted Patent US 10,039,728
Granted Patent B1
US 10,039,728 · App. 15/616,157 · Granted Aug 7, 2018

More potent and less toxic formulations of epinephrine and methods of medical use

Inventor: Jugal K. Taneja (Tampa, FL)
A61K31/137A61J1/10A61K9/0019A61K9/08A61K47/02A61K47/36A61M5/178A61M5/34A61M25/0606A61M2202/0468
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Quick Facts
Patent No.
US 10,039,728
App. No.
15/616,157
Granted
Aug 7, 2018
Kind
B1
Abstract

The present invention provides pharmaceutical formulations of levorotatory-epinephrine, 1-epinephrine, more potent and less toxic than existing pharmaceutical formulations of epinephrine, along with methods of producing and using these pharmaceutical formulations of 1-epinephrine, including providing prefilled syringes of pharmaceutical formulations of 1-epinephrine and methods of using these prefilled syringes by treating patients with continuous intravenous infusion instead of bolus administration.

Claims (3)

1. A method of treating a patient having, developing, or recovering from septic shock or anaphylactic shock with a continuous intravenous infusion of l-epinephrine delivered via an at least one intravenous fluid bag with an at least one intravenous line and or an at least one intravenous catheter, said at least one intravenous fluid bag containing up to 1,000 mL of a saline solution or a dextrose and sodium chloride-containing solution, said method comprising the step of injecting an at least one prefilled syringe of a 1 mg injectable liquid pharmaceutical formulation of l-epinephrine into each said at least one intravenous fluid bag or medication port thereof: said at least one prefilled syringe injectable liquid pharmaceutical formulation of l-epinephrine including a tonicity agent and having no more than 12.5% total impurities or no more than 12% d-epinephrine: said method further comprising the diluting of l-epinephrine to a concentration of about 1 microgram per mL in each said at least one said intravenous fluid bag during said continuous intravenous infusion of l-epinephrine; said method optionally comprising protecting said at least one said intravenous fluid bag from light or UV-radiation after said step of injecting said prefilled syringe into said at least one intravenous fluid bag or medication port thereof to prevent l-epinephrine degradation and impurities from forming.

2. A method of treating a patient having, developing, or recovering from septic shock or anaphylactic shock with a continuous intravenous infusion of l-epinephrine delivered via an at least one intravenous fluid bag with an at least one intravenous line and or an at least one intravenous catheter, said at least one intravenous fluid bag containing up to 1,000 mL of a saline solution or a dextrose and sodium chloride-containing solution, said method comprising the step of injecting an at least one prefilled syringe of an at least 1 mL injectable liquid pharmaceutical formulation of l-epinephrine into each said at least one intravenous fluid bag or medication port thereof; said at least one prefilled syringe injectable liquid pharmaceutical formulation of l-epinephrine including a tonicity agent and having no more than 12.5% total impurities or no more than 12% l-epinephrine; said method further comprising the diluting of l-epinephrine to a concentration of about 1 microgram per mL in each said at least one intravenous fluid bag during said continuous intravenous infusion of l-epinephrine; said method optionally comprising protecting said at least one said intravenous fluid bag from light or UV-radiation after said step of injecting said prefilled syringe into said at least one intravenous fluid bag or medication port thereof to prevent l-epinephrine degradation and impurities from forming so that said continuous intravenous infusion of l-epinephrine has a ratio of 1-epinehrine:d-epinephrine greater than 4:1.

3. A method of treating a patient having, developing, or recovering from septic shock or anaphylactic shock with a continuous intravenous infusion of l-epinephrine delivered via an at least one intravenous fluid bag with an at least one intravenous line and or an at least one intravenous catheter, said at least one intravenous fluid bag containing up to 1,000 mL of a saline solution or a dextrose and sodium chloride-containing solution, said method comprising the step of injecting an at least one prefilled syringe of a 1 mL injectable liquid pharmaceutical formulation of l-epinephrine into each said at least one intravenous fluid bag or medication port thereof; thereof: said at least one prefilled syringe injectable liquid pharmaceutical formulation of l-epinephrine including a tonicity agent and having no more than 12.5% total impurities or no more than 12% d-epinephrine; said method further comprising the diluting of l-epinephrine epinephrine to a concentration of about 1 microgram per mL in each said at least one intravenous fluid bag during said continuous intravenous infusion of l-epinephrine; said method optionally comprising protecting said at least one said intravenous fluid bag from light or UV-radiation after said step of injecting said prefilled syringe into said at least one intravenous fluid bag or medication port thereof to prevent 1-epinephrine degradation and impurities from forming so that said continuous intravenous infusion of l-epinephrine having has a ratio of l-epinephrine:d-epinephrine greater than 4:1.

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2025
From: ETON PHARMACEUTICALS, INC.
To: RUBIN, DARREN
Reel/Frame 071358/0612 →
SECURITY INTEREST Recorded Feb 20, 2025
From: BELCHER PHARMACEUTICALS, LLC
To: TRUIST BANK, AS ADMINISTRATIVE AGENT
Reel/Frame 070279/0798 →
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY COLLATERAL Recorded Sep 16, 2021
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: BELCHER PHARMACEUTICALS, LLC
Reel/Frame 057525/0648 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Sep 14, 2021
From: BELCHER PHARMACEUTICALS, LLC
To: TRUIST BANK
Reel/Frame 057499/0790 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 13, 2021
From: RUBIN, DARREN
To: ETON PHARMACEUTICALS, INC.
Reel/Frame 057167/0949 →
SECURITY INTEREST Recorded Sep 10, 2020
From: BELCHER PHARMACEUTICALS, LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 053731/0843 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2018
From: TANEJA, JUGAL K.
To: BELCHER PHARMACEUTICALS, LLC
Reel/Frame 046582/0111 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2018
From: JUGAL K. TANEJA
To: BELCHER PHARMACEUTICALS, LLC
Reel/Frame 045587/0417 →
Continuity (2)
Continuation In Part 15596440 · May 16, 2017
Continuation In Part 14460845 · Aug 15, 2014
Cited By (6)
US 12,245,995 US 12,295,921 US 12,508,238 US 12,533,328 US 12,539,283 US 12,564,562