FTIR, Raman spectroscopy and HT-XRD in compatibility study between naproxen and excipients

Barbara Rojek; Maria Gazda; Anna Plenis

doi:10.1016/j.saa.2023.123048

FTIR, Raman spectroscopy and HT-XRD in compatibility study between naproxen and excipients

Abstract

Detection of incompatibility between an active pharmaceutical ingredient (API) and excipients, including the selection of the most biopharmaceutical advantageous excipients is extremely important in the pre-formulation process of developing a solid dosage form technology. Therefore, having fast and reliable methods for identifying incompatibility is fundamental in pharmaceutical technology. For this purpose, combined Fourier transform infrared (FTIR) and Raman spectroscopy as well as high-temperature X-ray diffraction (HT-XRD) were used as a new approach for incompatibility detection, whereas differential scanning calorimetry (DSC) was applied as a reference method. In addition, to facilitate the interpretation of FTIR and Raman data, a multivariate analysis was used – hierarchical cluster analysis (HCA). The tests were carried out in mixtures of naproxen (NPX) with eight selected polymer excipients, mixed at a 1:1 ratio. The results of spectroscopic analyses have shown the physical incompatibility of NPX with methylcellulose (MC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose (HEC), sodium starch glycolate (SSG) and sodium carboxymethylcellulose (CMC). HT-XRD studies performed when these mixtures were heated to 156 °C and then cooled to 25 °C showed a decrease in naproxen crystallinity in these mixtures. Furthermore, the results obtained with spectroscopic methods were confirmed by DSC tests and an intrinsic dissolution rate study.

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Authors (3)

Barbara Rojek
- Medical University of Gdańsk
Maria Gazda prof. dr hab. inż.
Anna Plenis
- Medical University of Gdańsk

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Articles

Type:

artykuły w czasopismach

Published in:

SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY no. 302,
ISSN: 1386-1425

Language:

English

Publication year:

2023

Bibliographic description:

Rojek B., Gazda M., Plenis A.: FTIR, Raman spectroscopy and HT-XRD in compatibility study between naproxen and excipients// SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY -Vol. 302, (2023), s.123048-

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