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Claims for Patent: 8,455,539

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Claims for Patent: 8,455,539

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:13/651,623
Patent Claims: 1. A CCI-779 cosolvent concentrate comprising: (i) about 25 mg/mL of CCI-779; (ii) about 40% w/v of dehydrated ethanol; (iii) about 50% w/v of propylene glycol; (iv) about 0.075% w/v of d,1-.alpha.-tocopherol; and (v) about 0.0025% w/v of citric acid.

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

3. A CCI-779 cosolvent concentrate comprising: (i) about 25 mg/mL of CCI-779; (ii) 39% w/v of dehydrated ethanol; (iii) about 50% w/v of propylene glycol; (iv) about 0.075% w/v of d,1-.alpha.-tocopherol; and (v) about 0.0025% w/v of citric acid.

4. The CCI-779 cosolvent concentrate according to claim 3, which is diluted at a ratio of 1:1.5 concentrate to diluent to form the parenteral formulation.

5. A CCI-779 cosolvent concentrate comprising: (i) about 25 mg/mL of CCI-779; (ii) about 40% w/v of dehydrated ethanol; (iii) 51% w/v of propylene glycol; (iv) about 0.075% w/v of d,1-.alpha.-tocopherol; and (v) about 0.0025% w/v of citric acid.

6. The CCI-779 cosolvent concentrate according to claim 5, which is diluted at a ratio of 1:1.5 concentrate to diluent to form the parenteral formulation.

7. A CCI-779 cosolvent concentrate comprising: (i) about 25 mg/mL of CCI-779; (ii) about 39% w/v of dehydrated ethanol; (iii) 51% w/v of propylene glycol; (iv) about 0.075% w/v of d,1-.alpha.-tocopherol; and (v) about 0.0025% w/v of citric acid.

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