Development, validation and comparison of near infrared and Raman spectroscopic methods for fast characterization of tablets with amlodipine and valsartan

Scaled-up preparation of drug-loaded electrospun polymer fibres and investigation of their continuous processing to tablet form

“…Utilization of the potential advantages of continuous technologies requires real-time process monitoring. Thus the pharmaceutical industry is increasingly focusing on process analytical technologies (PAT), which means basically, a large number of analytical tools, such as Raman, near infrared (NIR) or UV spectrometers, monitoring the products and processes [36,37]. These methods have been applied successfully as in-line techniques in many cases.…”

Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

“…The diversity of the types of device configurations allows amplifying the sensitivity of the technique and allows a variety of applications, ranging from the quantification of drug substances in tablets and mixtures of powders to multiplex samples (3,(10)(11)(12)(13)(14)(15)(16)(17), samples in low concentrations (18,19), molecular traces (20)(21)(22), samples inside packs (23) and materials in nanometric scale (Table 1) (24,25). Conventional Raman spectroscopy requires high sample concentration and it is affected by fluorescence.…”

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

“…Casian et al developed NIR and Raman methods for the quantification of two APIs found in significantly different concentrations from immediate release tablets. The calibration set was built on a full-factorial design with two factors and five levels with a total of 25 formulations [10]. The use of full-factorial designs is feasible with two factors if five levels of variation are used [52].…”

“…Sylvester et al developed an in-line NIR-monitoring method for a freeze-drying process using the SNV pre-processing in order to remove multiplicative interferences caused by scatter and particle size variations and the first Savitzky-Golay derivative to reduce baseline shifts and to improve the spectral resolution [9]. The successful development of a real-time method for monitoring continuous powder flow from a tableting machine feeder was described by Alam et al Savitzky-Golay derivatization was first applied for smoothing, followed by SNV for scatter correction [10]. Environmental interferences can be caused by sample, instrument, or even laboratory variations; this type of interferences causes misalignments or shifts of the spectra and is commonly overcome by applying alignment/warping techniques to the data [3].…”

“…In case of Raman spectroscopy, the spectra are generated by inelastic scattering, caused by chemical groups that undergo a change in polarizability when excited with an incident light beam. These differences in molecular contribution to the generation of spectral data make the two methods complementary [10].…”