Near infrared spectroscopic calibration models for real time monitoring of powder density

Publication date: 15 October 2016 Source:International Journal of Pharmaceutics, Volume 512, Issue 1 Author(s): Andrés D. Román-Ospino, Ravendra Singh, Marianthi Ierapetritou, Rohit Ramachandran, Rafael Méndez, Carlos Ortega-Zuñiga, Fernando J. Muzzio, Rodolfo J. Romañach Near infrared spectroscopic (NIRS) calibration models for real time prediction of powder density (tap, bulk and consolidated) were developed for a pharmaceutical formulation. Powder density is a critical property in the manufacturing of solid oral dosages, related to critical quality attributes such as tablet mass, hardness and dissolution. The establishment of calibration techniques for powder density is highly desired towards the development of control strategies. Three techniques were evaluated to obtain the required variation in powder density for calibration sets: 1) different tap density levels (for a single component), 2) generating different strain levels in powders blends (and as consequence powder density), through a modified shear Couette Cell, and 3) applying normal forces during a compressibility test with a powder rheometer to a pharmaceutical blend. For each variation in powder density, near infrared spectra were acquired to develop partial least squares (PLS) calibration models. Test samples were predicted with a relative standard error of prediction of 0.38%, 7.65% and 0.93% for tap density (single component), shear and rheometer respectively. Spectra obtained in real time in ...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research