Granted Patent B1

US 12,409,155 · App. 17/685,792 · Granted Sep 9, 2025

Inventors: Travis A. Leeah (Sugar Land, TX); Jianping Chen (Sugar Land, TX)

Assignee: QuVa Pharma Inc.

A61K31/167A61K9/06A61K31/137A61K31/245

Abstract

Claims (27)

1. A ready-to-use pharmaceutical formulation, consisting of:

a) lidocaine hydrochloride in an amount of 40 mg/mL;

b) epinephrine hydrochloride in an amount of 0.61 mg/mL;

c) tetracaine hydrochloride in an amount of 5 mg/mL;

d) propylene glycol in an amount of 10 mg/mL;

e) sodium metabisulfite in an amount of 0.265 mg/mL;

f) a disodium salt of ethylenediaminetetraacetic acid dihydrate (Na 2 EDTA DH) in an amount of 0.2 mg/mL;

g) methylparaben in an amount of 1.8 mg/mL;

h) hydroxyethylcellulose in an amount of 0 mg/mL, 17.6 mg/mL, or 35.2 ma/mL; and

i) a sufficient amount of sterile water for injection;

wherein the ready-to-use pharmaceutical formulation has a pH of from 3.6 to 3.9; and

wherein the ready-to-use pharmaceutical formulation has epinephrine hydrochloride content of 90% to 115% of the epinephrine hydrochloride content of 0.61 mg/mL after storage at a temperature ranging from 22° C. to 25° C. for 380 days.

2. A method for providing procedural analgesia to a patient in need thereof, which comprises topically administering an effective amount of the ready-to-use pharmaceutical formulation of claim 1 to the patient in need of analgesia.

3. A process for preparing the ready-to-use pharmaceutical formulation of claim 1 , which comprises:

a) dissolving methylparaben in propylene glycol to obtain a preservative solution;

b) dissolving the preservative solution in water for injection to obtain a preserved water solution;

c) dissolving in the preserved water solution: (i) the lidocaine hydrochloride; (ii) the tetracaine hydrochloride; (iii) the sodium metabisulfite; and (iv) the Na 2 EDTA DH;

d) optionally, adjusting the pH of the step c) solution to a pH of from 3.6 to 3.9;

e) dissolving the epinephrine hydrochloride in the step c) solution or the step d) solution;

f) optionally, adjusting the pH of the step e) solution to a pH of from 3.6 to 3.9;

g) filtering the solution of step e) or the solution of step f) using a 0.2 micron polyethersulfone filter; and

h) optionally adding the hydroxyethylcellulose to the step g) solution.

4. The ready-to-use pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation contains 0 mg/mL of hydroxyethylcellulose.

5. The ready-to-use pharmaceutical formulation of claim 1 , wherein the hydroxyethylcellulose is present in an amount of 17.6 mg/mL.

6. The ready-to-use pharmaceutical formulation of claim 1 , wherein hydroxyethylcellulose is present in an amount of about 35.2 mg/mL.

7. The ready-to-use pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation has a pH of from 3.6 to 3.8.

8. The ready-to-use pharmaceutical formulation of claim 1 , wherein the formulation is contained in an amber-colored syringe.

Assignments (1)

Continuity (1)

References Cited (39)