. In the current studies, the investigators wish to investigate a totally non-solvent technique for formulation of the isoniazid/PLGA controlled release system, as well as study the effect of high pressure compaction on polymer/drug release rate, this aspect to reduce the early undesirable """"""""burst"""""""" effect. The goal is developing a single dose treatment for the 6-month short- course chemotherapy regimens for tuberculosis. The investigators plan to use preparations which can give effective levels of drug for up to 2 to 3 months and thus deliver the whole six month regimen with 2 or 3 bimonthly doses. Various technological aspects of formulation and characterizing such polymer preparations are included in the current study, as well as investigation of the bio-availability of drug polymer preparations and in vivo chemotherapeutic potential using the well-established man-mouse model. The investigator believes that the results will offer a practical input to solving patient compliance problems and thereby assist in the control of opportunistic infections and that more practical GMP production and more ready FDA approval should result, thus facilitating clinical evaluation and timely use.
Hsu, Y Y; Gresser, J D; Trantolo, D J et al. (1997) Effect of polymer foam morphology and density on kinetics of in vitro controlled release of isoniazid from compressed foam matrices. J Biomed Mater Res 35:107-16 |
Hsu, Y Y; Gresser, J D; Stewart, R R et al. (1996) Mechanisms of isoniazid release from poly(d,l-lactide-co-glycolide) matrices prepared by dry-mixing and low density polymeric foam methods. J Pharm Sci 85:706-13 |