Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 565, Issue -, Pages 325-332Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2019.05.017
Keywords
Amorphous solid dispersion; Formulation; Near-infrared spectroscopy; Partial least square regression; Raman spectroscopy
Categories
Funding
- Japan Society for the Promotion of Science (JSPS) KAKENHI [JP 16H03882]
- Research Center for Biomedical Engineering [2055]
Ask authors/readers for more resources
It is important to quantify amorphous solid in active pharmaceutical ingredients (API) of formulations to guarantee high-quality pharmaceutical products. In this study, we aimed to quantify amorphous solid in API by transmission Raman spectroscopy (TRS) and transmission near-infra-red spectroscopy (NIRS). To quantify the amount of trace amorphous solids contained in the API of a formulation, calibration curves of tablets containing 40% or 3% solifenacin succinate (SLFS) in the pharmaceutical formulations were prepared. The tablets varied in the ratio of amorphous solids in the API. TRS and NIRS were carried out with the calibration tablets and partial least square regression (PLSR) analysis was performed. Good results were obtained by both TRS and NIRS with the calibration model containing 40% SLFS. On the contrary, with the calibration model containing 3% SLFS, the PLSR analysis results using the TRS data were better than those using the NIRS data. The low content calibration model based on TRS showed good results with R-2 of 0.999, RMSECV of 1.236, and LOD of 0.12. TRS can be used to specifically detect trace amorphous solids contained in the API of a formulation.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available