Some applications of near-infrared reflectance analysis in the pharmaceutical industry.

A non-comprehensive overview of near-infrared (NIR) reflectance analysis in the pharmaceutical industry is presented. This survey will include background information defining NIR (i.e. spectral region and spectral features), the spectroscopic measurement, and the merits of this technique. This presentation comprises selected pharmaceutical applications of NIR used within Wellcome. One use of NIR is for the identification of tablets in bulk and non-invasively inside individual blister pack cells using several sample presentations including a fibre-optic probe. NIR has been used to determine moisture in freeze-dried parenterals by non-invasively measuring spectra through the bases of product vials. The viability of transferring moisture measuring equations between different instruments within the same site and between two different sites is examined. Another application of NIR involves a rapid assay of the active in whole tablets without any sample preparation. Finally, the use of NIR to validate blending processes for solid formulations is briefly discussed. There are many other applications of NIR in the pharmaceutical industry which are beyond the scope of this presentation. The applications presented here are those being pursued within our company, and provide an indication of the capabilities of NIR.