Deconvolution of Chemical Physical Information from Intact Tablets NIR Spectra: Two-Three-Way Multivariate Calibration Strategies for Drug Quantitation

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra

“…The differences in compaction force were expected since several studies have also shown that compaction pressure affects NIR spectra. [17][18][19][20][21][22] However, the effect of strain is a new observation discussed in this study. At 8 kN the spectra from the three strain levels are clearly separated confirming the results shown in Figure 3(a).…”

Towards Better Process Understanding: Chemometrics and Multivariate Measurements in Manufacturing of Solid Dosage Forms

“…It should be noted that NIR and Raman together with multivariate data analysis have been utilised for predicting mechanical properties of tablets, for example crushing strength and disintegration, which affect the quality. These studies have established the relationship between spectra and physical information by examining tablets compressed with varying forces25,57,, 200,, 201,202,212,213,214 and showing that the baseline of raw spectra changes as a function of tablet hardness 215,216,217. In these studies, physical information in spectra is the matter of interest, which is usually considered as an interferent‐–for example with prediction of API‐–and is thus not removed using pre‐processing methods such as the standard normal variate, multiplicative scatter correction and derivatives 29…”

Process analytical technology: a critical view of the chemometricians

“…Paper uses the QbD approach to study calibration design that had large variations in drug concentration (15%–85% w/w) and compaction pressure (100–500 MPa). These properties are used as process variables in the development of a pharmaceutical formulation.…”