Near infrared spectroscopy in the development of solid dosage forms

Abstract

The use of near infrared (NIR) spectroscopy has rapidly grown partly due to demands of process analytical applications in the pharmaceutical industry. Furthermore, newest regulatory guidelines have advanced the increase of the use of NIR technologies. The non-destructive and non-invasive nature of measurements makes NIR a powerful tool in characterization of pharmaceutical solids. These benefits among others often make NIR advantageous over traditional analytical methods. However, in addition to NIR, a wide variety of other tools are naturally also available for analysis in pharmaceutical development and manufacturing, and those can often be more suitable for a given application. The versatility and rapidness of NIR will ensure its contribution to increased process understanding, better process control and improved quality of drug products. This review concentrates on the use of NIR spectroscopy from a process research perspective and highlights recent applications in the field.

In-line NIR spectroscopy for the understanding of polymer–drug interaction during pharmaceutical hot-melt extrusion

“…Because of its unique properties [14] , like high analysis speed, no need for sample preparations, its non-destructive and noninvasive nature of analysis and the use of fibre optical probes, NIR spectroscopy is an ideal process analyzer for hot-melt extrusion. Furthermore, due to the fact that NIR spectra are sensitive to changes in hydrogen bonding and packing in the crystal lattice, NIR can be applied for solid state analysis and the understanding of molecular interactions [15] .…”

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

“…Räsänen and Sandler [7] provide a comprehensive review on the applications of NIRS in the development of solid dosage forms, documenting the usefulness of this technique for each of the manufacturing steps, from raw material screening to assessment of the final dosage form. Reich [5] reviewed the regulatory status of NIR analysis in the pharmaceutical industry, noting that although many pharmaceutical companies have successfully implemented NIR systems in QC labs for raw material identification and qualification, only a few quantitative NIR methods have yet gained regulatory approval.…”

Chemometrics (PCA) in Pharmaceutics: Tablet Development, Manufacturing and Quality Assurance

“…They are frequently used for in-line monitoring of processes, e.g. particle size growing during granulation or the water content in the granule (Räsänen & Sandler, 2007;Rantanen 2007). NIR is also used for monitoring the final quality of the single tablets, because it is possible to quantify the active ingredient in a none-destructive manner (Tabasi et al, 2008), and can be applied to indentify counterfeit drugs (Rodionova et al, 2005).…”