(271) DoE-Optimized Process for Residual Ethanol Reduction in Codaewon-S Syrup
Introduction: Codaewon-S Syrup is a multi-component formulation with five active ingredients, including Pelargonium sidoides 11% ethanol extract. To meet stricter regulations, this study optimized an ethanol reduction process while maintaining formulation integrity. A vacuum-assisted evaporation method and Design of Experiments (DoE) were applied to refine process parameters. The validated process was tested at lab scale (3 kg, 10 kg, 20 kg) and successfully scaled up to 500 L. Additional sedimentation and stability tests ensured product quality.
Learning Objectives:
Develop and optimize ethanol reduction strategies using a DoE approach.
Evaluate the effects of ethanol reduction on formulation stability and active ingredient retention.
Apply DoE-based process control strategies to enhance large-scale pharmaceutical production quality.