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Claims for Patent: 6,310,094

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Claims for Patent: 6,310,094

Title: Ready-to-use esmolol solution
Abstract:A ready-to-use injectable, aqueous pharmaceutical composition 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 in a container, is 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:09/759,547
Patent Claims: 1. An injectable, aqueous pharmaceutical composition for the treatment of cardiac conditions, having a pH between 3.5 and 6.5 and comprising

a. 0.1-100 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy] phenylpropionate hydrochloride (esmolol hydrochloride),

b. 0.1-5.0 mg/ml buffering agent, and

c. 1-100 mg/ml osmotic-adjusting agent.

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

3. The 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.

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

5. The method of claim 4 wherein the composition comprises 0.1-100 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy] phenylpropionate hydrochloride (esmolol hydrochloride), 0.1-5.0 mg/ml buffering agent, and 1-100 mg/ml osmotic-adjusting agent.

6. The method of claim 4 wherein the composition is autoclaved at a temperature ranging from 115 to 130.degree. C. for a period of time ranging from 5 to 40 minutes.

7. The method of claim 4 wherein the container is a flexible polymeric container free from polyvinyl chloride.

8. The method of claim 4 further comprising providing the container with a moisture barrier.

9. The method of claim 8 wherein the moisture barrier is an aluminum overpouch.
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