01. March 2017

Abstract The purpose of the present study was to develop a near-infrared spectroscopy (NIRS) method to quickly, accurately, and precisely evaluate and control the coating process of the low dose drug, glimepiride on tablet. For this purpose, a calibration set for the drug was quantified using a partial least-squares regression method with a high-performance liquid chromatography (HPLC) as the reference method. The correlation coefficient (R2) between the NIRS method and the HPLC method in the...

11. January 2017

Abstract With the implementation of quality by design (QbD), critical attributes of raw material (drug substance and excipients) are of significantly importance in pharmaceutical manufacturing process. It is desirable for the quality control of critical material attributes (CMAs) of excipients to ensure the quality of end product. This paper explored the feasibility of an at-line method for the quantitative analysis of hydroxypropoxy group in hydroxypropyl methylcellulose (HPMC) with near...

14. November 2015

Using partial least square discriminate analysis (PLSDA), we studied the spectroscopic differences between the commonly used filler‐binder microcrystalline cellulose (MCC) from five manufactures. These samples had subtle differences in the chemical and physical properties, which are often the cause of differences in excipient performance. Studying these differences allowed us to build and validate a model to classify five manufacturers of MCC using near-infrared (NIR) spectra. More