Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution Data - Pharmaceutical Technology

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Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution Data
The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.


Pharmaceutical Technology
Volume 33, Issue 3, pp. 126-134

Conclusion

Models have been developed for predicting relative powder-flow performance using PSD data. The PLS model, which used D10, D50, D90, and D[4,3] as input parameters, is suitable for predicting the FFC value for APIs and excipients and may also be appropriate for predicting PSD influences on other materials (e.g., active blends and active granulations). This empirical tool leverages a material and resource-sparing approach to the powder-flow performance characterization. In addition, the tool can be particularly useful during prototype drug-product design, especially with regard to risk assessments when little is known about the flow performance of a new API or excipient.

Acknowledgment

The authors would like to thank Bruno Hancock for reviewing this work and providing technical guidance.

Matthew P. Mullarney* and Norma Leyva are senior scientists at Pfizer, Inc., Eastern Point Rd., Groton, CT 06340, tel. 860.715.4139,
.

*To whom all correspondence should be addressed.

Submitted: June 16, 2008. Accepted: July 8, 2008.




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References

1. E.N. Hiestand, "Mechanics and Physical Principles for Powders and Compacts" (SSCI Inc., West Lafayette, IN, 2002), p 110.

2. J. Staniforth, "Powder Flow," in Pharmaceutics: The Science of Dosage Form Design, M.E. Aulton, Ed. (Churchill Livingstone, Edinburgh, UK, 2002) pp. 197–210.

3. G.E. Amidon and M.E. Houghton, "Powder Flow Testing in Preformulation and Formulation Development," Pharma. Manuf., 2 (7) 21–31 (1985).

4. A.W. Jenike, "Storage and Flow of Solids," in Utah Engineering Experiment Station Bulletin 123, 16th ed., (University of Utah, Salt Lake City, UT, 1964).

5. T. Kohler and H. Schubert, "Influence of Particle Size Distribution on the Flow Behavior of Fine Powders," Part. Syst. Charact. 8 (1–4), 101–104 (1991).

6. F. Podczeck and Y. Miah, "The Influence of Particle Size and Shape on the Angle of Internal Friction and the Flow Factor of Unlubricated and Lubricated Powders," Int. J. Pharm. 144 (2) 187–194 (1996).

7. L. Breiman et al., "Classification and Regression Trees" (Chapman & Hall/CRC, Boca Raton, FL, 1984).


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