Near-infrared spectroscopic applications in pharmaceutical particle technology

Abstract

Near-infrared spectroscopy (NIRS) is nowadays an established analytical technique in the pharmaceutical industry. The aim of this review is to present the progress of NIRS in providing useful information for pharmaceutical particle technology. NIR methods are now developed to characterize a wide variety of materials (active pharmaceutical ingredients, excipients, co-processed powders, and physical mixtures) and pharmaceutical dosage forms (conventional, modified drug release technologies, and phytomedicines). This review also provides a number of spectra to illustrate the fundamental understanding of NIRS which has been gained. The sampling that must occur prior to the acquisition of near-infrared spectra is also discussed, as well as developments in monitoring mixing, tableting, and coating. This review will be valuable for product formulation and process engineering specialists.

Keywords:

• Particle technology
• near-infrared spectroscopy
• diffuse reflection
• transmission
• process analytical technology (PAT)
• chemometrics
• continuous manufacturing
• blend uniformity

Acknowledgments

The authors thank Javier L. Vitale (PLAPIQUI) for his technical support.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

Financial support was received from CONICET [PIP 11220150100704CO], UNS [PGI 24/B252, Programa de apoyo a estudios de posgrado Res.CSU-337/2017] and FONCYT [PICT-2016– 0976]. The support of the National Science Foundation [ERC research grant EEC-054085] is also acknowledged.