Abstract

MUZZIO, Cristian Rodrigo; DINI, Nicolás Gabriel  and  SIMIONATO, Laura Daniela. Determination of moisture content in lyophilized mannitol through intact glass vials using NIR micro-spectrometers. Braz. J. Pharm. Sci. [online]. 2011, vol.47, n.2, pp. 289-297. ISSN 1984-8250.  http://dx.doi.org/10.1590/S1984-82502011000200010.

Determination of moisture content in lyophilized solids is fundamental to predict quality and stability of freeze-dried products, but conventional methods are time-consuming, invasive and destructive. The aim of this study was to develop and optimize a fast, inexpensive, noninvasive and nondestructive method for determination of moisture content in lyophilized mannitol, based on an NIR micro-spectrometer instead of a conventional NIR spectrometer. Measurements of lyophilized mannitol were performed through the bottom of rotating glass vials by means of a reflectance probe. The root mean standard error of prediction (RMSEP) and the correlation coefficient (R²_pred), yielded by the pre-treatments and calibration method proposed, was 0.233% (w/w) and 0.994, respectively.

Keywords : Near-infrared spectroscopy; Lyophilization; Multivariate analysis; Moisture content; Mannitol; Micro-spectrometer.