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Claims for Patent: 8,835,505

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Claims for Patent: 8,835,505

Title:Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol. The ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is capable of being stored in a modified flexible plastic container that may be heat-sterilized without deformation and/or without having the integrity of the closure system being compromised. A method for the manufacture of the ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is also disclosed.
Inventor(s): Owoo; George (Lindenhurst, IL), Castagna; Erica (Tirano, IT)
Assignee: Welgrace Research Group (Lindenhurst, IL) HQ Specialty Pharma Corporation (Paramus, NJ)
Application Number:13/840,153
Patent Claims: 1. A co-solvent sterile premixed pharmaceutical product stored in a non-PVC flexible plastic container, wherein said pharmaceutical product has a solution pH between 4.5 and 5.5 and comprises: a. 5 to 22.5 mg/mL methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), b. a buffering agent to maintain a solution pH between 4.5 and 5.5, c. 0.1% to 3 w/v % of ethyl alcohol, and d. 0.1% to 3 w/v % of one of propylene glycol or glycerin; and wherein said pharmaceutical product is contained in a sealed container and heat-moist sterilized for a period of time sufficient to render the composition sterile.

2. The pharmaceutical product of claim 1, wherein the non-PVC flexible plastic container comprises a 3-7 multi-layer, polyolefin based co-extruded film, non-PVC, latex free, plasticizer free, tubing ports are made of a two layer material that is suitable for terminal sterilization.

3. The pharmaceutical product of claim 2, wherein the polyolefin based co-extruded film is selected polypropylene, cycloolefin, polyethylene and copolymerized ethylene vinyl acetate.

4. The pharmaceutical composition of claim 1, wherein the non-PVC flexible plastic container comprises modified tubing ports and closure systems made of a material that is suitable for terminal sterilization.

5. The pharmaceutical product of claim 1, wherein the buffering agent comprises at least one of acetate, tartrate, malate and furmarate.

6. The pharmaceutical product of claim 1, wherein the buffering agent is sodium acetate.

7. The pharmaceutical product of claim 1, wherein the buffering agent is sodium tartrate.

8. The pharmaceutical product of claim 1, wherein the esmolol hydrochloride is contained in an amount ranging from 10 to 30 mg/mL.

9. The pharmaceutical product of claim 1, wherein (d) is propylene glycol.

10. The pharmaceutical product of claim 1, wherein (d) is glycerin.

11. The pharmaceutical product of claim 1, wherein the container is made of a rigid or flexible plastic container and exhibits (i) less than a 2% decrease in the concentration of Esmolol or pharmaceutically acceptable salt thereof after autoclaving (terminal sterilization) and (ii) having formation of related Esmolol esters less than about 0.5% (ii) having co-solvents composition between 0.15% to 5% stored in a non-PVC flexible plastic container and comprising wherein in at least the inner most layer which contacts the esmolol solution comprises a copolymer of ethylene and vinyl acetate.

12. A method of controlling bradycardia and/or controlling hypotension in the diagnosis of cardiac conditions using computerized cardiac tomography in humans comprising administering to a subject in need thereof an effective amount of the pharmaceutical product of claim 1.

13. A method of preparing a pharmaceutical product of claim 1, comprising preparing a composition comprising: a. 5 to 22.5 mg/mL methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), b. a buffering agent to maintain a solution pH between 4.5 and 5.5, c. 0.1% to 3 w/v % of ethyl alcohol, and d. 0.1% to 3 w/v % of one of propylene glycol or glycerin; adding said composition to a non-PVC flexible plastic container; sealing said container; and subjecting the sealed container to heat-moist sterilization for a period of time sufficient to render the composition sterile thereby forming said pharmaceutical product.

14. The method of claim 13, wherein said heat-moist sterilization is autoclaving.

15. The method of claim 14, wherein said autoclaving is at a temperature ranging from 110 to 130.degree. C. for a period of time ranging from 7 to 60 minutes.

16. A method of preparing a pharmaceutical product of claim 1, comprising preparing in a non-PVC flexible plastic container a composition comprising: a. 5 to 22.5 mg/mL methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), b. a buffering agent to maintain a solution pH between 4.5 and 5.5, c. 0.1% to 3 w/v % of ethyl alcohol, and d. 0.1% to 3 w/v % of one of propylene glycol or glycerin; sealing said container; and subjecting the sealed container to heat-moist sterilization for a period of time sufficient to render the composition sterile thereby forming said pharmaceutical product.

17. The method of claim 16, wherein said heat-moist sterilization is autoclaving.

18. The method of claim 17, wherein said autoclaving is at a temperature ranging from 110 to 130.degree. C. for a period of time ranging from 7 to 60 minutes.
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