Pharmaceutical manufacturers are required to be critical in checking the quality of their products. This is encouraged mainly by the Food and Drug Administration (FDA) which pushes for the use of modern process analytical technologies (PATs). A PAT is a mechanism that designs, analyzes, and controls pharmaceutical manufacturing processes. It is mainly used to ensure the quality of the final product.
A large number of concerns in the FDA's PAT initiative can be addressed using Fourier transform near-infrared FT NIR spectroscopy. For drug manufacturers, for instance, NIR spectroscopy can be utilized in virtually every step of tablet manufacture, including raw material identification, tablet characterization, blend homogeneity, and content uniformity analysis. It is fairly easy to maintain and deploy in various manufacturing environments, making it one of the most efficient PAT tools available today.
This NIR spectroscopy is a non-destructive method used for detecting and quantifying the physical and chemical characteristics of tablets. It can quantify a tablet's drug content, dissolution, and hardness, all from a single measurement. Because of its versatility, numerous research articles have been written about it that it has now become an industry standard PAT tool for tablet manufacture.
The NIR spectrophotometers are mainly comprised of a sample holder, a monochromator, and a detector. The tool's most common uses in pharmaceutical applications involve transmittance, reflectance, and diffuse reflectance. These uses are defined by the properties of the sample and are non-destructive in any way.
The NIR spectroscopy, unlike ultraviolet-visible spectroscopy, yields a multivariate spectrum. The spectrum of NIR contains information about both the chemical (e.g. drug content) and physical (e.g. hardness) properties of the samples. Special processing techniques must be used to extract the information out of the spectrum as they relate to the property of interest, whether physical or chemical. These special processing techniques are referred to as Chemometrics.
The NIR spectroscopy is employed in different pharmaceutical equipment made by the Foss Manufacturing Company LLC, including the Foss XDS Masterlab. This product offers pharmaceutical manufacturers a fast and efficient way of testing their products, whether they come layered, coated, or cored and be they in the form of caplets, tablets, geltabs, gelcaps, and capsules. You can learn more about NIR spectroscopy on americanpharmaceuticalreview.com/Featured-Articles/116128-Primer-on-NIR-Spectroscopy-as-a-PAT-tool-in-the-Tablet-Manufacture-Process/.
FT NIR Spectroscopy and its Applications