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Quantitative Mineralogical Properties (Morphology-Chemistry-Structure) of Pharmaceutical Grade Kaolinites and Recommendations to Regulatory Agencies

Published online by Cambridge University Press:  18 January 2012

Meral Dogan ,
A. Umran Dogan ,
Aktham Aburub ,
Alta Botha  and
Dale Eric Wurster
Meral Dogan
Affiliation:
Department of Geological Engineering, Hacettepe University, Ankara, Turkey
A. Umran Dogan*
Affiliation:
Earth Science Department, King Fahd University of Petroleum & Minerals, Dhahran, Saudi Arabia Department of Chemical and Biochemical Engineering, University of Iowa, Iowa City, IA, USA
Aktham Aburub
Affiliation:
College of Pharmacy, University of Iowa, Iowa City, IA, USA
Alta Botha
Affiliation:
The Center for Advanced Drug Development, University of Iowa, Iowa City, IAUSA
Dale Eric Wurster
Affiliation:
Department of Chemical and Biochemical Engineering, University of Iowa, Iowa City, IA, USA College of Pharmacy, University of Iowa, Iowa City, IA, USA
*
Corresponding author. E-mail: umran-dogan@uiowa.edu
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Abstract

The physical and chemical characteristics of kaolinite (kaolin) may be variable, and minor amounts of other clay minerals, nonclay minerals, and other impurities may affect the properties of kaolinites. Thus specific technical properties of pharmaceutical grade kaolinites become very important because these clays are used in medical applications, e.g., as pharmaceutical excipients, and will be consumed by humans. Seven pharmaceutical grade kaolinite specimens were used in this study: K1004, KA105, 2242-01, K2-500, Acros, Acros-mono, and KX0007-1. In addition, two kaolinites from the Clay Minerals Society Source Clays, KGa-1b and KGa-2, were used for comparison purposes. The Acros-mono and 2242-01 kaolinites contained minor amounts of illite, which was demonstrated both compositionally and structurally by using inductively coupled plasma spectroscopy and powder X-ray diffraction. The KX0007-1 kaolinite powder was found to be heavily contaminated with quartz, cristobalite, and alunite. Crystal structure computations also showed excess Si in its tetrahedral site, and the mineral no longer has the typical kaolinite crystal structure. These widely-used industrial standards should be quantitatively characterized morphologically, compositionally, and structurally. Results of the mineralogical characteristics should be clearly labeled on the pharmaceutical grade kaolinites and reported to the relevant regulatory agencies.

Keywords

kaolinitekaolinpharmaceutical standardscrystal structurefield emission scanning electron microscopy (FESEM)powder X-ray diffraction (PXRD)inductively coupled plasma spectroscopy (ICP)Brunauer-Emmet-Teller (BET) specific surface arearegulatory agencies
Type
Biological Applications
Information
Microscopy and Microanalysis , Volume 18 , Issue 1 , February 2012 , pp. 143 - 151
Copyright
Copyright © Microscopy Society of America 2012

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Footnotes

Present address: Ely Lilly and Company, Pharmaceutical Sciences R&D, Indianapolis, IN, USA

Present address: Afrivet Business Management (Pty) Ltd, Faerie Glen 0043, South Africa

References

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