DEVELOPMENT OF AN IMPLANTABLE, BIODEGRADABLE, CONTROLLED DRUG-DELIVERY SYSTEM FOR LOCAL ANTIBIOTIC-THERAPY

A novel drug delivery system was developed using a monoglyceride (Glyc erol Monostearate) and a water-soluble release rate modifier as the ma trix. Cefuroxime sodium (Zinacef(R)) was chosen as a model drug in thi s study. Formulations (cylindrical implants 6 x 6 mm) were prepared by a melt-dispersion method. Dissolution studies were performed using US P paddle method. The effect of glycerol, PEG 400 and their combination on drug release profiles was studied. Two assay methods (UV and HPLC) for cefuroxime analysis were compared. Percent recovery from four for mulations (A-D) was higher with UV than HPLC assay. While both UV and HPLC assay methods were developed for cefuroxime, only HPLC assay is s tability indicating. Glycerol showed higher accelerating effect than P EG 400 on the drug release. All formulations exhibited extended releas e of cefuroxime. Degradation of cefuroxime occurred mainly during diss olution suggesting drug stability in the formulations.