Evaluation of the Release Rate of a Chemotherapeutic Agent Incorporated as a Coating on a Biodegradable Ureteral Stent. in Vitro Study

Abstract

INTRODUCTION To assess the release rate of Mitomycin C (MMC) after its adherence to a biodegradable ureteral stent (BraidStent™-MMC) by dip coating in order to evaluate its potential application as an adjuvant treatment for upper tract urothelial carcinoma. MATERIAL AND METHODS The dip coating technique is applied to a total of 10 fragments of the BraidStent™ catheter which has a polymeric matrix as a coating. Each 3 cm fragment is immersed 10 times in pure MMC crystallising in methanol and finally obtaining the formation of microlayers on its surface. After drying, each fraction of the stent is immersed in 5 ml of artificial urine to study its interaction with this medium. The samples remain in an orbital shaker at 36ºC and the medium is exchanged under sterile conditions after 12, 24, 48, 48, 72, 96 and 120h. At each replacement, the remaining urine is analysed by HPLC-DAD to quantify the presence of the cytotoxic agent. RESULTS During the first 12h, MMC is completely released reaching a mean concentration of 52.22 mg/L. Comparing this result with those previously obtained with the first BraidStent ™ -MMC formulation (10.82mg/L), it is determined that this technique allows to increase the release rate up to 5 times. CONCLUSIONS The release rate of Mitomycin C from a biodegradable ureteral stent is increased by integrating a polymeric matrix with microlayers in its coating. Further trials are needed to achieve the therapeutic dose for clinical application in oncology patients.