White Paper on Sugammadex API
Sugammadex is a medication used to reverse the effects of certain muscle-relaxing drugs (rocuronium and vecuronium) during anaesthesia. It works by forming a complex with these drugs, neutralizing their effects, and restoring muscle function, allowing for a rapid reversal of muscle relaxation. Sugammadex works by forming a complex with muscle-relaxing drugs (rocuronium and vecuronium), neutralizing their effects. This complex helps rapidly reverse muscle relaxation, restoring muscle function.
Sugammadex sodium is one of the key molecules in Dr. Reddy’s API portfolio and an ideal use case on how a thorough understanding of the interaction between API and formulation can significantly improve the robustness of the formulation process considering the drug substance’s proneness to degradation in the formulation process.
Our development approach:
We adopted QbD (Quality by Design) and an integrated drug developmental approach, looking not only at the API but also studying the formulation. The QTPP (Quality Target Product Prole) of the API was determined considering the drug substance’s proneness to degradation in the formulation process, especially during the terminal sterilisation (TS) process for intravenous injection.
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