Terminal Sterilization

The purpose of this study was to formulate a stable parenteral formulation of Palonosetron HCl 0.05 mg/mL which is pharmaceutically equivalent to Reference Drug Product. Preformulation study was performed to evaluate the compatibility of product with materials which come in contact with the product during manufacturing. Compatibility study was carried out with metal, silicon tubes, PVDF filters and stoppers. Thermal cycling and photostabilty study were also performed to ensure the stability of the product. Palonosetron injection was formulated by dissolving the API and excipients in WFI in a S.S vessel under continuous stirring. Stability studies at different conditions were also performed. Compatibility study results indicate that drug product was compatible with the product contact materials. Thermal cycling and photostabilty data indicates that there was no significant degradation in the formulation. As a part of Sterilization cycle development, terminal sterilization was performed at 1210C for 15, 20 and 30 minutes time intervals and finalized cycle was 20 minutes. A stable Palonosetron Injection was developed and evaluated. Compatibility and accelerated stability studies at different conditions were performed and it can be concluded that the product is compatible with product contact materials, thermal and photostable.