Effect of steam sterilization and biocompatibility studies of hyaluronic acid hydrogel for viscosupplementation

Intra-articular injection of hyaluronic acid (HA) hydrogel is one of the treatment methods recommended for osteoarthritis (OA). Here HA hydrogel (2000 kDa) has been developed, sterilized by steam sterilization and the important properties required for viscosupplementation such as equilibrium swelling, enzymatic degradation, carbazole assay and rheology analysis has been compared before and after steam sterilization. The effect of steam sterilization was studied by varying the temperature and time of sterilization and a suitable temperature and time such as 118 degrees C for 5 min was optimized. It was found that the optimized sterilization condition does not affect the material properties of HA hydrogel except equilibrium swelling. The stability of the steam sterilized hydrogel was evaluated for 3 months at two different conditions (5 degrees C and 25 degrees C at 60% RH) and it was found that 5 degrees C at 60% RH is the suitable condition of storage. The safety profiles of the HA hydrogel was checked by cytotoxicity analysis, intracutaneous reactivity, acute toxicity studies and found to be biocompatible. Hence It was found the HA hydrogel developed is highly biocompatible, retain its properties after sterilization and is stable upto 3 months when stored at 5 degrees C at 60% RH. (C) 2019 Elsevier Ltd. All rights reserved.