A Design of Experiments for Tablet Compression - Pharmaceutical Technology

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A Design of Experiments for Tablet Compression
The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.


Pharmaceutical Technology
Volume 35, Issue 9

Experimental process and screening-study results


Table I: Results of the screening study for the design envelop for manufacturing a simple tablet formulation.
Once pretrial experiments were completed, a broad design envelope was established using the five factors previously defined. A screening study was designed using a 25–1 -level fractional factorial approach, which produced 16 experiments, as opposed to a full factorial experimental design, which would require 32 experiments. Although only 16 experiments were performed in the screening study, the fractional factorial design produces the same resolution as the full factorial design. In addition to reducing time and material, this 25–1 fractional factorial design tests for interactions between each of the five factors. For the screening study, three centerpoint experiments were added to the design to test for nonlinearity (i.e., curvature in the data) and to help determine whether there was a significant lack of fit to the resulting model equation. Centerpoint experiments set all five factors to their midpoint between the low and high limits.


Table II: Analysis of variance for factorial model according to tablet hardness.
The screening study data is shown in various tables. Table I shows the design summary, Table II shows the analysis of variance (ANOVA) for tablet hardness, and Table III shows the ANOVA for tablet weight. All experimental run data was entered into Design-Ease software (Stat-Ease) for analysis.


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