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Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen

DEVELOPMENT OF QUALITY BY DESIGN (QBD) GUIDANCE ELEMENTS ON DESIGN SPACE SPECIFICATIONS ACROSS SCALES WITH STABILITY CONSIDERATIONS Scale up consideration – NIR calibration. Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen

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Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen

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  1. DEVELOPMENT OF QUALITY BY DESIGN (QBD) GUIDANCE ELEMENTS ON DESIGN SPACE SPECIFICATIONS ACROSS SCALES WITH STABILITY CONSIDERATIONS Scale up consideration – NIR calibration Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen Duquesne University Center for Pharmaceutical Technology

  2. Blend Scale up issues • Volume of powder sampled decreased • Differences in fill volume • Blending dynamics changed • Blender shape changed • Different NIR sensors • ThermoFisher Spectral Probe to ExpoTech ePAT 601 Blend monitor

  3. Efficient calibration approach • Used limited number of levels • 0%, 100%, nominal, granule • Classical least squares based method • Regression vector is based on the pure components • Consequently, the differences in regression vector from scale to scale, from NIR sensor to NIR sensor was mainly a function of the instrument differences

  4. Efficient calibration approach • No unique samples • No degradation of sample • No transfer set / standardization method • Reduced time and effort for calibration model development: “calibration in hours”

  5. Calibration comparison Laboratory scale Scale-up API MCC HPC Starch RMSEC (%) = 1.40 0.95 1.08 0.70 RMSECnom (%) = 1.66 1.09 1.25 0.75 API MCC HPC Starch RMSEC (%) = 1.56 0.81 0.98 0.41 RMSECnom (%) = 1.93 1.58 1.38 0.50

  6. Blend end point • At laboratory scale • Both instruments gave similar outputs • RMSNV under error of validation • At scale up • RMSNV under error of validation • Blend was stopped in a similar manner, based on similar criteria • Similar definition of homogeneity • Differences in scales of scrutiny

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