(93m) Off-Line Moisture Analysis for Wet Granulation Using Nir Spectroscopy

The wide use of wet granulation in the pharmaceutical industry and the effect of binder on the granule size have inspired the development of a multivariate mathematical model to determine the moisture content of pharmaceutical powders. The granule size affects the granule flowability, drug delivery, and tablet hardness. Off-line determination of moisture content using near Infrared (NIR) spectroscopy with multivariate analysis was the first step for implementation of in-line moisture measurements during the wet granulation process. In-line moisture measurements from NIR spectrometer is a technique that would be applied in pharmaceutical process analytical technology (PAT). Wet granulation of monohydrated and anhydride lactose was carried out with a water and Povidone solution. The studied factor was binder viscosity, which had values of 1 cP, 2.5 cP and 5 cP. The samples were analyzed in a NIR region from 7154.4 to 4575.6 cm-1. The NIR technique indicated high precision with a standard deviation of about 0.143% w/w and 1.61% relative standard deviation. The accuracy indicated by the root mean standard error prediction (RAMSEP) was 0.34 % w/w.

Keywords: Wet granulation; Moisture content; Near infrared; PAT