ORALLY BIOAVAILABLE CCI-779 FORMULATIONS

摘要

A CCI-779 oral dosage form is provided in which, after oral administration to a subject, the CCI-779 has a whole blood peak concentration (C_max) of 5.4 ± 1.8 ng/niL and an area under the curve (AUC) of about 66 ± about 22 ng-hr/ml and the sirolimus has a C_max of 18.7 ± 9.6 ng/mL and an AUC of about 600 ± about 228 ng- hr/ml, for a 25 mg unit dose of CCI-779. Another CCI-779 oral dosage form is provided which, after oral administration thereof to a subject, the CCI-779 has a C_max of 5.7 ± 1.7 ng/mL and an AUC of about 60 ± about 20 ng-hr/ml and the sirolimus has a C_max of 17.1 ± 8.1 ng/mL and an AUC of about 548 ± about 187 ng-hr/ml in whole blood, for a 25 mg unit dose of CCI-779. Products containing these oral dosage forms, and methods of use thereof, are also described.