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Claims for Patent: 8,299,116

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Claims for Patent: 8,299,116

Title:CCI-779 concentrate formulations
Abstract: This invention provides CCI-779 cosolvent concentrates which are useful in preparing a parenteral formulation of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid (CCI-779) following admixture with a diluent.
Inventor(s): Rubino; Joseph T (Towaco, NJ), Siskavich; Victoria (Lyon Mountain, NY), Harrison; Maureen M (Sugar Loaf, NY), Gandhi; Pooja (Highland Mills, NY)
Assignee: Wyeth LLC (Madison, NJ)
Application Number:13/206,641
Patent Claims: 1. A CCI-779 cosolvent concentrate for preparing a parenteral formulation upon admixture with a diluent, said concentrate comprising: about 1 mg/mL to about 25 mg/mL of CCI-779; about 15% w/v to about 60% w/v dehydrated ethanol; about 15% w/v to about 60% w/v propylene glycol; about 0.01% w/v to about 0.1% w/v of d,1-.alpha.-tocopherol; and about 0.001 to about 0.005% w/v of citric acid.

2. The CCI-779 cosolvent concentrate according to claim 1, wherein the citric acid is about 0.0025% w/v of the cosolvent concentrate.

3. The CCI-779 cosolvent concentrate according to claim 1, wherein the dehydrated ethanol is at least about 30% w/v of the cosolvent concentrate.

4. The CCI-779 cosolvent concentrate according to claim 1 , wherein the propylene glycol is about 35% w/v to about 50% w/v of the cosolvent concentrate.

5. The CCI-779 cosolvent concentrate according to claim 1, wherein the d,1-.alpha.-tocopherol is about 0.075% of the cosolvent concentrate.

6. The CCI-779 cosolvent concentrate according to claim 1, comprising about 25 mg/mL CCI-779; about 40% w/v of dehydrated ethanol; about 0.075% w/v of d,1-.alpha.-tocopherol; about 0.0025% w/v of citric acid; and about 35% w/v propylene glycol.

7. The CCI-779 cosolvent concentrate according to claim 1, which is diluted at a ratio of 1:1.5 to 1:2 concentrate to diluent to form the parenteral formulation.

8. A CCI-779 cosolvent concentrate for preparing a parenteral formulation upon admixture with a diluent, said concentrate consisting of about 1 to about 25 mg/mL of CCI-779, about 0.01 to 0.1% w/v of d,1-.alpha.-tocopherol, up to about 0.1% w/v of d,1-.alpha.-tocopherol, about 0.001 to about 0.005% w/v of citric acid, and about 15 to about 60% w/v of dehydrated ethanol and propylene glycol.

9. The CCI-779 cosolvent concentrate according to claim 8, comprising about 40% w/v dehydrated ethanol.

10. The CCI-779 cosolvent concentrate according to claim 8, comprising about 15% w/v to about 60% w/v propylene glycol.

11. The CCI-779 cosolvent concentrate according to claim 10, comprising about 50% w/v propylene glycol.

12. The CCI-779 cosolvent concentrate according to claim 8, comprising about 0.075% w/v of d,1-.alpha.-tocopherol.

13. The CCI-779 cosolvent concentrate according to claim 8, which is diluted at a ratio of 1:1.5 to 1:2 concentrate to diluent to form the parenteral formulation.
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