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Claims for Patent: 8,658,676

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Claims for Patent: 8,658,676

Title:Clevidipine emulsion formulations containing antimicrobial agents
Abstract: Pharmaceutical formulations comprising clevidipine in an oil-in-water formulation that is resistant to microbial growth and stable against the formation of impurities.
Inventor(s): Motheram; Rajeshwar (Dayton, NJ), Williams; Gregory Charles (Bernardsville, NJ)
Assignee: The Medicines Company (Parsippany, NJ)
Application Number:13/765,613
Patent Claims: 1. A pharmaceutical formulation comprising (a) an effective amount of clevidipine, or a pharmaceutically acceptable salt or ester, (b) an antimicrobial agent, EDTA, present at about 0.001 to about 1.5% w/v, (c) a lipid, (d) an emulsifier, (e) a tonicity modifier, and (f) water wherein the formulation is resistant to microbial growth.

2. The pharmaceutical formulation of claim 1, wherein EDTA is present at about 0.001 to about 0.025% w/v.

3. The pharmaceutical formulation of claim 1, wherein the lipid is selected from the group consisting of soybean oil, safflower seed oil, olive oil, cottonseed oil, sunflower oil, sesame oil, peanut oil, corn oil, medium chain triglycerides, triacetin, propylene glycol diesters, monoglycerides, and a mixture of two or more thereof.

4. The pharmaceutical formulation of claim 1, wherein the emulsifier is selected from the group consisting of egg yolk phospholipids, soybean phospholipids, synthetic phosphatidyl cholines, purified phosphatidyl cholines and hydrogenated phosphatidyl choline, and mixtures of two or more thereof.

5. The pharmaceutical formulation of claim 1, further comprising an antioxidant selected from the group consisting of sodium ascorbate, sodium citrate, cysteine hydrochloride, sodium bisulfate, sodium metabisulfite, sodium sulfite ascorbyl palmitate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, tocopherol, and a pharmaceutically acceptable salt thereof.

6. The pharmaceutical formulation of claim 1 having a pH of about 6.0 to about 8.8.

7. The pharmaceutical formulation of claim 2, further comprising a co-emulsifier wherein the co-emulsifier is selected from the group consisting of glycerin, poloxamers, polyoxyethylene castor oil derivative, poloxamines, polyoxyethylene stearates, polyoxyethylene sorbitan fatty acid esters, sorbitan fatty acid esters, polysorbates, tocopherol PEG succinate, cholic acid, deoxycholic acid, oleic acid, and pharmaceutically acceptable salts thereof.

8. The formulation of claim 1 wherein microbial growth is delayed or retarded such that there is less than 10-fold (1 log) increase in viable microbial colonies over a 24-hour period.
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