Water-soluble prodrugs of lopinavir, ritonavir and new investigational HIV PIs

MEDI 98

David A. DeGoey, david.degoey@abbott.com, William J. Flosi, David J. Grampovnik, Kennan C. Marsh, Larry L. Klein, Michelle A. Long, and Dale J. Kempf. Global Pharmaceutical Research and Development, Abbott Laboratories, Department R4CQ, Building AP52, 200 Abbott Park Road, Abbott Park, IL 60064
HIV protease inhibitors (PIs) are relatively lipophilic molecules, and are poorly soluble in water. Some PIs are not absorbed efficiently from the solid state, and require formulations to solubilize the drug. Consequently, PIs have been associated with high pill counts and large capsules. Water-soluble prodrugs could reduce the pill count for these important therapies. We studied the synthesis, cleavage rates, and oral administration of prodrugs of lopinavir/ritonavir (Kaletra™), and some new HIV PIs. We concluded that phosphate and carboxylic acid esters attached directly to the central hydroxy group of these PI cores had slow cleavage rates. We developed a two-step synthesis to introduce a linker that improved the rate of cleavage, and oxymethylphosphate (OMP) and oxyethylphosphate (OEP) prodrugs provided high levels of aqueous solubility and oral bioavailability. The novel OEP prodrugs released acetaldehyde upon cleavage, instead of formaldehyde, and the new synthetic method may be applicable to other drug classes.
 

Poster Session
7:00 PM-9:00 PM, Sunday, August 19, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Medicinal Chemistry

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007