(M1330-10-57) Enhancing Tablet Manufacturing Flexibility: Design Space Determination with Compaction Simulator

Purpose: A compaction simulator (Stylecam) was used to perform tablet formulation experiments on several machines. The StyleCam is a single-station eccentric tablet press where both punches follow a programmable electronic cam designed to simulate a rotary tablet press. The aim of this study was to determine a design space for tablet hardness and friability, providing a robust region for these parameters to produce the tablet formulation on various machines.

Methods: Tablets (420 mg) of the formulation given in Table 1 were produced using a Stylcam Compaction Simulator attached with an 11.8 mm flat-faced Euro B punch. Powder mixtures were prepared by blending all materials (except the lubricant) for 10 minutes in an Erweka cube blender at 100 rpm. The lubricant was then added, and the blending continued for another 5 minutes at the same settings. Two different tablet press profiles, Fette 102i and Killian S700, were used to compare breaking force and friability, measured using an Erweka hardness tester and Erweka friabilitor, respectively (Table 2). Experiments were set up using a DOE (Design of Experiments). Data modelling was a result of 16 experiments.

Results: Contour plots for breaking force (Figure 1) showed that tablets with acceptable strength were produced in the range of 20kN to 25kN compression force for both presses. Contour plots for breaking force and friability (Figure 2) exhibited compaction ranges for unacceptable strength and friability. The desired breaking force (100N to 150N) and friability (0.25% to 0.60%) were shown in the contour plots for compression force and tablet press speed as the linear design space (Figure 3).

Conclusion: The study concluded that a compaction simulator could effectively determine the design space for the critical quality attributes of tablet dosage forms, such as tablet strength and friability. The results indicated specific compaction force ranges to achieve desired tablet properties on different tablet presses.

References:

References:
1. C. Ruegger and M. Çelik, "Advanced Compaction Research Equipment, Compaction Simulators", in Pharmaceutical Powder Technology, Edited by M. Çelik, 2nd Edition, Informa Healthcare, Chapter 7 (2011).