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Claims for Patent: 6,528,540

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Claims for Patent: 6,528,540

Title: Esmolol formulation
Abstract:An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), a buffering agent and an osmotic-adjusting agent, as well as a method for its manufacture, are disclosed.
Inventor(s): Liu; Jie (Scotch Plains, NJ), Pejaver; Satish K. (Bridgewater, NJ), Owoo; George (North Plainfield, NJ)
Assignee: Baxter International Inc. (Deerfield, IL)
Application Number:10/016,260
Patent Claims: 1. An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, having a pH between 3.5 and 6.5 comprising: a. 0.1-500 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (esmolol hydrochloride); b. 0.01-2 M buffering agent; and c. 1-500 mg/ml osmotic-adjusting agent.

2. The pharmaceutical composition of claim 1, wherein the pH is between 4.5 and 5.5.

3. The pharmaceutical composition of claim 1, wherein the buffering agent comprises at least one of acetate, glutamate, citrate, tartrate, benzoate, lactate, gluconate, phosphate and glycine.

4. The pharmaceutical composition of claim 1, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.

5. The pharmaceutical composition of claim 3, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.

6. The pharmaceutical composition of claim 1 comprising: a. 0.1-100 mg/ml esmolol hydrochloride; b. 0.01-0.5 M buffering agent; and c. 1-100 mg/ml osmotic-adjusting agent.

7. The pharmaceutical product of claim 1 comprising: a. 100-500 mg/ml esmolol hydrochloride; b. 0.5-2 M buffering agent; and c. 50-500 mg/ml osmotic-adjusting agent.

8. The pharmaceutical composition of claim 1, wherein the composition is provided in a heat sterilized container.

9. The pharmaceutical composition of claim 8, wherein the container is a vial, ampul, bag, bottle or syringe.

10. The pharmaceutical composition of claim 9, wherein the container is from 1-500 ml in volume.

11. The pharmaceutical composition of claim 4, having a pH of about 5 and comprising about 100-250 mg/ml of esmolol hydrochloride and 0.5-2 M buffering agent and 50-500 mg/ml osmotic-adjusting agent.

12. An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, having a pH of about 5.0 and comprising about 1-20 mg/ml esmolol hydrochloride, 0.02-0.1 M buffering agent and 1-100 mg/ml osmotic-adjusting agent, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.

13. A method for preparing an aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, comprising forming an aqueous composition having a pH between 3.5 and 6.5 comprising 0.1-500 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), 0.01-2 M buffering agent, and 1-500 mg/ml osmotic-adjusting agent in a sealed container and autoclaving for a period of time sufficient to render the composition sterile.

14. The method of claim 13, wherein the composition has a pH between 4.5 and 5.5.

15. The method of claim 13, wherein autoclaving is carried out a temperature ranging from 115.degree. C. to 130.degree. C. for a period of time ranging from 5 to 40 minutes.

16. The method of claim 14, wherein autoclaving is carried out a temperature ranging from 115.degree. C. to 130.degree. C. for a period of time ranging from 5 to 40 minutes.
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