MINERALOGY AND GEOLOGICAL/MINERALOGICAL CONCEPTS IN THE PHARMACEUTICAL INDUSTRY

Literature surveys show that a majority of health and geology papers tend to focus on the health hazards of geology and mineralogy. However there are also beneficial aspects of geology and mineralogy that are applicable to the healthcare industry. 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 pigments along with fillers in packaging materials. 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. In addition geological/mineralogical concepts are applicable to the pharmaceutical industry. In particular the areas of crystallography/solid-state chemistry have relatively recently become extremely important and examples will be discussed. The majority of API's are crystalline materials to ensure chemical purity, stability and control of bioavailability. This necessitates characterization of the crystalline phases, evaluation of polymorphism along with phase relationships in extended systems. Here again relying on concepts and analytical techniques commonly used in mineralogy. In addition petrographic thin-section techniques are utilized to monitor phase stability of API's within formulated drug tablets. Discussion of the composite formulations encountered in the pharmaceutical industry that involve geological/mineralogical concepts will be discussed.