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Elucidating Raw Material Variability—Importance of Surface Properties and Functionality in Pharmaceutical Powders

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Abstract

The purpose of this study is to illustrate, with a controlled example, the influence of raw material variability on the excipient’s functionality during processing. Soluble starch was used as model raw material to investigate the effect of variability on its compaction properties. Soluble starch used in pharmaceutical applications has undergone a purification procedure including washing steps. In this study, a lot of commercially available starch was divided into two parts. One was left intact and the other was subjected to an extra washing step. The two resulting lots were subjected to a series of physical characterization tests typical of those used to qualify raw materials. The two resulting lots gave virtually identical results from the tests. From the physical testing point of view, the two lots can be considered as two equivalent lots of the same excipient. However, when tested for their functionality when subjected to a compaction process, the two lots were found to be completely different. The compaction properties of the two lots were distinctly different under all environmental and processing conditions tested. From the functionality point of view, the two lots are two very different materials. The similar physical testing results but different functionality can be reconciled by considering the surface properties of the powders. It was found that the washing step significantly altered the surface energetic properties of the excipient. The washed lot consistently produced stronger compacts. These results are attributable to the measurably higher surface energy of induced by the additional washing step.

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Acknowledgment

National Science Foundation 000364-EEC, Dane O. Kildsig Center for Pharmaceutical Processing Research.

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Author notes

  1. Sai P. Chamarthy

    Present address: Oral and respiratory Product Development, Schering-Plough Research Institute, 556 Morris Avenue, Summit, New Jersey, 07901, USA

Authors and Affiliations

  1. Department of Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA

    Sai P. Chamarthy, Rodolfo Pinal & M. Teresa Carvajal

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  1. Sai P. Chamarthy
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Correspondence to M. Teresa Carvajal.

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Chamarthy, S.P., Pinal, R. & Carvajal, M.T. Elucidating Raw Material Variability—Importance of Surface Properties and Functionality in Pharmaceutical Powders. AAPS PharmSciTech 10, 780–788 (2009). https://doi.org/10.1208/s12249-009-9267-5

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