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Claims for Patent: 7,148,211

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Claims for Patent: 7,148,211

Title:Formulation for lipophilic agents
Abstract:The invention relates to pharmaceutical formulations of lipophilic therapeutic agents in which such agents are solubilized in largely aqueous vehicles, and processes for preparing and using the same.
Inventor(s): Mazess; Richard B. (Madison, WI), Driscoll; Jeffrey W. (Middleton, WI), Goldensoph; Creighton Reed (DeForest, WI), LeVan; Leon W. (Oregon, WI)
Assignee: Genzyme Corporation (Cambridge, MA)
Application Number:10/247,765
Patent Claims: 1. A parenteral formulation, comprising a lipophilic drug which is doxercalciferol, a non-ionic solubilizer which is polysorbate 20 present at a concentration of about 0.05% to about 5% w/w, a lipophilic antioxidant which is butylated hydroxytoluene (BHT) present at a concentration of about 20 to about 2000 ppm, an optional agent which is ethanol present at a concentration of 0 to 30% w/w, and an aqueous vehicle.

2. A formulation as set forth in claim 1, wherein the optional agent is present in a concentration of 0% to about 10% w/w.

3. A formulalion as set forth in claim 1, wherein the optional agent is present in a concentration of about 1% to about 3% w/w.

4. A formulation as set forth in claim 1, wherein the non-ionic solubilizer includes 0.5% 2.5% w/w polysorbate 20, the lipophilic antioxidant includes 20 ppm BHT and the optional agent includes 2.5% w/w ethanol.

5. A formulation as set forth in claim 1, wherein the doxercalciferol is present at a concentration of 2 10 .mu.g/mL.

6. A parenteral formulation suitable for treatment of secondary hyperparathyroidism comprising 2 10 .mu.g/mL of doxercalciferol 0.5% 2.5% w/w polysorbate 20, 20 ppm BHT and 2.5% w/w ethanol.
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