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Continuous Manufacture and Scale-Up of Theophylline-Nicotinamide Cocrystals

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  • معلومة اضافية
    • بيانات النشر:
      MDPI, 2021.
    • الموضوع:
      2021
    • نبذة مختصرة :
      The aim of the study was the manufacturing and scale-up of theophylline-nicotinamide (THL-NIC) pharmaceutical cocrystals processed by hot-melt extrusion (HME). The barrel temperature profile, feed rate and screw speed were found to be the critical processing parameters with a residence time of approximately 47 s for the scaled-up batches. Physicochemical characterization using scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and X-ray diffraction of bulk and extruded materials revealed the formation of high purity cocrystals (98.6%). The quality of THL-NIC remained unchanged under accelerated stability conditions.
    • File Description:
      application/pdf
    • ISSN:
      1999-4923
    • Rights:
      OPEN
    • الرقم المعرف:
      edsair.doi.dedup.....31dd29697b91062d61b4f8c8cc42e4af