In another fine example of a formulation change, Biocompatibles International reported that its very small beads were used to sequester Doxorubicin (adriamycin). The resulting beads were delivered via a catheter directly into the liver of patients with liver tumors. The tumor growth was suppressed for long enough in 12 of 18 patients to receive a transplant.
We have previously reported the use of a special carbohydrate that sequesters a tumor fighting agent and delivers the drug directly to the tumor (click thumbnail below to enlarge).
These examples show the use of novel excipients in conjunction with previously approved drugs – a classic 505(b)(2) drug product.