Real-time monitoring and control of high shear wet granulation (HSWG) using process analytical technologies is crucial to process design, scale-up, and reproducible manufacture. Although significant progress has been made in real-time measurement of granule size distribution using focused beam reflectance measurement (FBRM), real-time in-line assessment of granule densification remains challenging. In this study, a @entity450 ( @entity450 ) sensor was developed and used to probe wet mass consistency in real-time. In addition, responses from FBRM and @entity450 sensors were compared to assess complementarity of information on granulation progress from the two probes. A placebo and a @entity46821 formulation were granulated with different concentrations of binder or water, respectively, while measuring granule size growth, densification, and @entity450 sensor response. The @entity450 sensor was able to quantitatively characterize with high resolution a response of wet mass consistency distinct from granule size distribution. The wet mass consistency parameter correlated well with granule densification, which was shown as a critical material attribute that correlated with tablet dissolution. In addition, application of @entity450 sensor to scale-up of granulation was demonstrated. These results showed the value of wet mass consistency measurement using @entity450 for @entity2883 monitoring and control.    2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.

Real-Time Assessment of Granule Densification in High Shear Wet Granulation and Application to Scale-up of a Placebo and a XXXX Formulation.

@entity46821 :: ('MESH:C509922', 'Chemical') :: ['brivanib alaninate'] @entity450 :: ('MESH:D006940', 'Disease') :: ['DFF', 'drag force flow'] @entity2883 :: ('MESH:D014890', 'Disease') :: ['WG']
@entity46821 :: (MESH:C509922,Chemical) :: ['Brivanib Alaninate']
