2007 GSA Denver Annual Meeting (28–31 October 2007)

Paper No. 2
Presentation Time: 1:55 PM

BENEFICIAL MINERALS IN THE PHARMACEUTICAL INDUSTRY


SMOLIGA, John A., Analytical Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, 900 Ridgebury Rd, Ridgefield, CT 06877, john.smoliga@boehringer-ingelheim.com

Within the pharmaceutical industry approximately 30 minerals from both natural and synthetic sources are utilized for various purposes. These include active pharmaceutical ingredients (API's), excipients (non-active ingredients), and coloring agents along with fillers used in polymeric packaging materials. Examples of API's include "calkinsite (La)" used as a phosphate binder for dialysis patients and calcite used as an antacid. Excipient examples include brushite and monetite used as diluents. Minerals used as coloring agents include hematite and goethite. Finally, examples of packaging fillers include talc and kaolinite.

As with all pharmaceutical ingredients, the FDA requires that these minerals be controlled for quality and purity. As is typical in mineralogical laboratories, characterization and analyses of these minerals are conducted using polarized light microscopy, scanning electron microscopy, energy dispersive x-ray fluorescence spectroscopy, x-ray powder diffraction, Fourier transform infrared spectroscopy and Raman spectroscopy. A survey of minerals used in the pharmaceutical industry; there specific function along with the methods for characterization and control will be presented.