New pH-neutral peritoneal dialysis solution, low in glucose degradation products, in a double-chamber bag.

Fresenius Medical Care-North America has developed a neutral-pH version of its Delflex peritoneal dialysis (PD) solution with low glucose degradation products (GDPs): Delflex Neutral pH. The Delflex Neutral pH system stores the PD solution in a dual-chamber bag. The product is admixed by the patient before use. The new design facilitates GDP reduction in two ways. First, GDPs are reduced because the dextrose solution is stored at a pH that minimizes degradation during sterilization and that optimizes dextrose stability over time. Second, the design minimizes generation of acetaldehyde by separating dextrose from lactate during heat sterilization of the product. Mixing the contents of the two chambers before use produces a physiologically compatible pH of approximately 7.0, with minimal GDPs. Analysis of GDP content was conducted by high-performance liquid chromatography. The GDP reduction across all sizes and formulations of Delflex Neutral pH ranged between 74% and 93% as compared with conventional Delflex PD solution. Testing of the new delivery system by prevalent PD patients demonstrated that, with minimal training, patients can obtain a homogeneous PD solution low in GDPs with a physiologically compatible pH of approximately 7.0.