Mitigation of N-Nitrosamine Formation in Ranitidine Hydrochloride by Spray Drying Co-Precipitation with Mannitol, Dextrin, and Antioxidant-Pub

New Scientific Knowledge & Development
1

Highlights

  • RAN(ranitidine hydrochloride)-mannitol and RAN-dextrin dispersions are able to stabilize RAN and reduce NDMA formation

  • RAN-mannitol/dextrin dispersions’ effectiveness is governed by RAN-to-co-former ratio

  • NDMA mitigation of RAN-mannitol/dextrin decline after two months accelerated storage

  • RAN-mannitol dispersion is more stable than RAN-dextrin due to stable mannitol crystals

  • Adding ferulic acid antioxidant to RAN-mannitol has minimal impact on NDMA mitigation

Conclusions

Spray drying co-precipitation of RAN with mannitol or dextrin at the optimal co-former proportion was found to be effective in slowing down the RAN degradation and subsequent NDMA formation for up to two months of accelerated storage. For longer storage, the RAN-mannitol and RAN-dextrin solid dispersion were less effective, showing limited improvement, if any, compared to the native RAN.

1 Like