Real-time characterization of pharmaceutical tablet coatings using Raman spectroscopy

摘要

Properties of pharmaceutical tablets, including surface roughness, gloss and temperature, are determined in real time by Raman spectroscopy. Provided is a plurality of coated pharmaceutical tablets having a distribution of known values of a surface property to be modeled. The Raman spectrum of each coated tablet is recorded to produce a distribution of Raman spectra. Then, a correlative model is developed based on the distribution of the acquired Raman spectra in proportion to the distribution of the known values of the measured property. The Raman spectrum of the pharmaceutical tablet is then detected during and / or after a coating process, and the value of the surface property of the tablet is determined using the correlative model. The steps involved in the model development are performed off-line while the step or steps associated with detecting the Raman spectra of the pharmaceutical tablet during (preferably) or after the on-line coating process online using a fiber-coupled probe for Remote measurements are (are) carried out.