Conclusion

Within the pharmaceutical industry there is increasing emphasis on processing efficiency and more effectively controlled manufacture. In production, it is impossible to eliminate all the possible sources of variability, but it is feasible to compensate for them and control their impact. This relies on identifying, measuring, and controlling those parameters that define processing efficiency and the quality of the finished product.

In solid-dosage manufacture, achieving this goal requires a relevant and sensitive powder testing toolkit capable of reliably generating parameters that can be directly correlated with process performance. Key to this is the ability of a technique to effectively simulate the specific processing environment, which, as an analysis of tableting reveals, can vary considerably. Instruments that combine established techniques, such as shear and bulk property testing, with newer methodologies, such as dynamic testing, can be valuable. The user can then tailor testing to the specific application, and access the most complete information for process design, optimization, and control.

*To whom all correspondence should be addressed.

References

1. M. Glodek et al., "Process Robustness: PQRI White Paper," online, http://www.pqri.org/, Oct., 2005.

2. G. Carlson and B. Hancock, AAPS Annual Meeting and Exposition (Atlanta, GA, 2008).

3. R. Freeman, Powder Technol. 174 (1–2) 25-33 (2007).