Formulation Development for Acid Labile Novel Compound TRAM-34

The development and evaluation of oral acid resistant formulation for a novel compound (TRAM-34). The formulation is intended for monkeys oral dosing. The preformulation phase will identify the strategies to be pursued during formulation development phase which will include HPLC analysis for the TRAM-34 peak. Formulation phase will include selection of additives, formulation processing and characterization (i.e. observation for physical stability, particle size analysis). The dosage regimen for TRAM-34 will depend very much on the bioavailability of the acid resistant formulation per Dr. Wulff studies. The current i.v. or i.p. doses her lab used in rodents are 10 mg/kg once or twice a day. The acid resistant formulation ofTRAM-34 will be intended for use in monkeys once a day orally. However, depending on the availability the dose, it might be as low as 20 mg/kg or as high as 100 mg/kg for a 10-15 kg monkey. * Dr. Heike Wulff lab will provide TRAM-34