Details for Patent: 8,889,346

Title:	Propofol formulations with non-reactive container closures
Abstract:	A container storing an anesthetic is disclosed. The container is sealed by a closure and stores a liquid anesthetic solution. The anesthetic is from 0.1% to 10% by weight of the liquid anesthetic solution. The container is made of a material that is inert to the anesthetic and the closure is made of siliconized rubber or a metal. A concentration of the anesthetic in a liquid anesthetic solution stored in the container following a predetermined time period is at least 93% of a concentration of the anesthetic in a liquid anesthetic solution before the liquid anesthetic solution is stored in the container.
Inventor(s):	Desai; Neil P. (Pacific Palisades, CA), Yang; Andrew (Rosemead, CA), Ci; Sherry Xiaopei (San Marino, CA)
Assignee:	Fresenius Kabi USA, LLC (Lake Zurich, IL)
Filing Date:	Jun 04, 2013
Application Number:	13/909,961
Claims:	1. A container storing an anesthetic, wherein the anesthetic is propofol, comprising: a container sealed by a closure and storing an oil-in water anesthetic emulsion, the anesthetic being from 0.1% to 10% by weight of the oil-in water anesthetic emulsion, the container being made of a material that is inert to the anesthetic, and the closure being made of siliconized bromobutyl rubber or siliconized chlorobutyl rubber, wherein a concentration of the anesthetic in the oil-in water anesthetic emulsion stored in the container following a predetermined time period is at least 93% of a concentration of the anesthetic in the oil-in water anesthetic emulsion before the oil-in water anesthetic emulsion is stored in the container. 2. The container of claim 1, wherein the container is selected from the group consisting of a vial, a bottle, a cartridge, a syringe, and a pre-filled syringe. 3. The container of claim 1, wherein the material that is inert to the anesthetic is glass. 4. The container of claim 3, wherein the glass is siliconized glass. 5. The container of claim 1, wherein the material that is inert to the anesthetic is plastic. 6. The container of claim 1, wherein the closure is selected from the group consisting of a stopper, a plunger, a lid, and a top. 7. The container of claim 1, wherein the closure is made of siliconized bromobutyl rubber. 8. The container of claim 1, wherein the closure is made of siliconized chlorobutyl rubber. 9. The container of claim 1, wherein the predetermined time period is 16 hours, and the concentration of the anesthetic in the oil-in water anesthetic emulsion stored in the container following 16 hours is at least 93% of a concentration of the anesthetic in the oil-in water anesthetic emulsion before the oil-in water anesthetic emulsion is stored in the container. 10. The container of claim 1, wherein the oil-in water anesthetic emulsion further comprises a solvent. 11. The container of claim 10, wherein the solvent is less than 10% by weight of the oil-in water anesthetic emulsion. 12. The container of claim 10, wherein the solvent is a water-immiscible solvent. 13. The container of claim 12, wherein the water-immiscible solvent is selected from the group consisting of soybean oil, safflower oil, cottonseed oil, corn oil, coconut oil, sunflower oil, arachis oil, castor sesame oil, orange oil, limonene oil, olive oil, hydrogenated castor oil, marine oil, fractionated oil, an ester of a medium-chain fatty acid, an ester of a long-chain fatty acid, a chemically modified palmitate, a glyceral ester, a polyoxyl, and mixtures thereof. 14. The container of claim 1, wherein the oil-in water anesthetic emulsion further comprises a surfactant. 15. The container of claim 14, wherein the surfactant is selected from the group consisting of phosphatides, synthetic phospholipids, natural phospholipids, lecithins, ethoxylated ethers, ethoxylated esters, tocopherol polyethylene glycol stearate, polypropylene-polyethylene block co-polymers, polyvinyl pyrrolidone, polyvinylalcohol, and combinations thereof. 16. The container of claim 15, wherein the surfactant is selected from the group consisting of egg phosphatides, soya phosphatides, egg lecithins, soya lecithins, and combinations thereof. 17. A container storing propofol, comprising: a container sealed by a closure and storing a oil-in water propofol emulsion, the oil-in water propofol emulsion comprising: propofol from 0.1% to 10% by weight of the oil-in water propofol emulsion, water, a solvent, a surfactant, and a tonicity agent, wherein: the container is made of a material that is inert to the propofol, the closure is made of siliconized bromobutyl rubber or siliconized chlorobutyl rubber, and a concentration of the propofol in the oil-in water propofol emulsion stored in the container following a predetermined time period is at least 93% of a concentration of the propofol in the oil-in water propofol emulsion before the oil-in water propofol emulsion is stored in the container. 18. A container storing propofol, comprising: a container sealed by a closure and storing a oil-in water propofol emulsion, the oil-in water propofol emulsion comprising: propofol from 0.1% to 10% by weight of the oil-in water propofol emulsion, water, soybean oil, egg phosphatide, and glycerin, wherein: the container is made of a material that is inert to the propofol, the closure is made of siliconized bromobutyl rubber or siliconized chlorobutyl rubber, and a concentration of the propofol in the oil-in water propofol emulsion stored in the container following a predetermined time period is at least 93% of a concentration of the propofol in the oil-in water propofol emulsion before the oil-in water propofol emulsion is stored in the container. 19. The container storing propofol of claim 18, wherein the oil-in water propofol emulsion is a soybean oil-in-water propofol emulsion. 20. The container storing propofol of claim 17, wherein the solvent is less than 10% by weight of the oil-in water propofol emulsion. 21. The container storing propofol of claim 18, wherein the soybean oil is less than 10% by weight of the oil-in water propofol emulsion.