CCI-779 concentrate formulations
View Patent ↗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.
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-α-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-α-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-α-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-α-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.