Details for Patent: 6,310,094
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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) |
Filing Date: | Jan 12, 2001 |
Application Number: | 09/759,547 |
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. |