R-Gel

R-Gel is supplied in a two-syringe system. One syringe contains oxidized dextran and the other syringe contains powders of active ingredients, excipients, and the cross-linking reagent, which is adipic acid dihydrazide. The syringes are connected and the contents mixed by reciprocations. The polymer is injected after which it gels in situ. Working time is one to two minutes. The residence time is 4-5 weeks and the material is very well tolerated as shown by toxicity studies at NAMSA and at Johns Hopkins University. Control over the release profile can be achieved by adjusting several parameters including the pH of the reaction mixture and the polymer concentration.

Clinical use of antibiotic R-Gel has yielded very promising results in treatment of diabetic foot infections. Numerous cases slated for amputation have been successfully treated by debridement and application of antibiotic R-Gel. Localized infections have also been treated in veterinary cases.

An important goal is a clinical trial of R-Gel 5-FU which is an anti-tumor formulation to be used for treatment of glioblastoma. The procedure is to fill the post-resection cavity with R-Gel 5-FU which makes the intimate contact with the margins of the original tumor bed. In addition to being a cytotoxic agent, 5-FU also acts as a radiation sensitizer. This feature enables better activity versus rapidly dividing tumor cells with less harm to normal cells as a consequence of adjuvant radiation.

The R-Gel Two-syringe System: