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Tags: Robustness

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  1. Continuous twin screw granulation: Robustness of lactose/MCC-based formulations

    Contributor(s):: Portier, Christoph, De Vriendt, Charlotte, Vigh, Tamas, Di Pretoro, Giustino, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie

    In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response...

  2. Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral dosage form

    Contributor(s):: Alam, MA, Liu, YADolph, S, Pawliczek, M, Peeters, E, Palm, A

    A Near Infrared (NIR) method was developed using a small benchtop feed frame system to quantify Saccharin potency in a powder blend during continuous manufacturing process. A 15-point Design of Experiments (DoE) was created based on the NIR spectral response and compositions of the formulation to...

  3. Analytical Validation

    Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.