Paper No. 2
Presentation Time: 8:30 AM

CALCIUM CARBONATE MINERALS IN THE PHARMACEUTICAL INDUSTRY: SOURCES, FUNCTIONS AND PHYSICAL PROPERTIES


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

Well over 50 minerals from both natural and synthetic sources are utilized within the pharmaceutical industry 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. Calcium carbonate, predominately as calcite, is a versatile mineral which can be used as an API, a functional excipient or as filler in packaging materials.

Regulatory agencies such as the FDA require that these minerals be controlled for quality and purity. As is typical in mineralogical laboratories, characterization and analyses of these mineral phases are conducted using a variety of analytical techniques such as polarized light microscopy, scanning electron microscopy, energy dispersive x-ray fluorescence spectroscopy, x-ray powder diffraction, Fourier transform infrared spectroscopy and Raman spectroscopy.

This paper will review the sources of calcium carbonate minerals use in the pharmaceutical industry along with their specific functions. Additionally, data comparing the physical properties of naturally occurring vs. synthesized calcite will be presented.