Segregation potential

Process ability Surface area, surface free energy, crystal defects, and deformation potential affect compressibility and machineability on high-speed tableting machines with reduced compression dwell times Particle size distribution and shape affect flow properties, efficiency of dry mixing process, and segregation potential Compressibility, flow ability, and dilution potential affect the choice of direct compression as a manufacturing process... 

Surface roughness Flow ability, segregation potential, dilution potential, lubricant sensitivity... 

Reduce the mobility of the API, by mechanically binding the API to the formulation excipients Quality Granulation fluidization and sifting segregation potential Tablet content uniformity... 

A fifth process challenge in the optimization of a dry granulation process is to achieve a granulation that is resistant to fluidization and sifting segregation forces. In general, process parameters that influence segregation potential are similar to those that influence variability in sieve cut potency. 

TABLE 6.15 Variability in Segregation Potential as a Function of Formulation and Roll Force... 

Since the properties that influence granulation blend uniformity (variability in sieve cut potency, segregation potential) have already been established during the dry granulation process, a minor secondary function of the final blending process... 

Compactibility, Flowability, and Segregation Studies. Designing and selecting a prototype formulation requires three studies related to manufacturability compactibility, flowability, and segregation potential of the powder blends. 

Hedden et al.65 reported that a modified fluidization tester offers several improvements over the current ASTM standardized method. This modified tester requires less than 20 mL of powder to characterize the fluidization segregation potential of a sample. In addition, the tester includes unique features for powder containment of potent compounds, in-process monitoring of the fluidization conditions, and sample retrieval without the need for sub-sampling or riffling for typical analyses. 

Have appropriate particle size distribution to minimize the segregation potential... 

Direct compression Simple, cheap process. No heat or moisture, so good for unstable compounds. Prime particle dissolution. Not suitable for all drugs, generally limited to low dose compounds. Segregation potential. Expensive excipients. 

More than sixty years ago. Rose [2] proposed a kinetic model to describe the simultaneous effects of the mixing and segregation. This was based on the supposition that the rate of segregation is proportional with a segregation potential O as... 

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