Sounding Out Pharmaceutical Processes

Abstract

High-resolution ultrasonic spectroscopy is a novel technique with enormous potential for analysis of a wide range of samples and processes. This technique is based on precision measurements of velocity and attenuation of acoustical waves at high frequencies propagating through materials. It allows fast at/on line measurements analysis of formulation consistency (composition, structure) of raw materials, ingredients and intermediates, process impurity analysis, particle sizing, batch to batch variation, stability assessment etc in pharmaceutical industry. The technology can be used for static fingerprint measurements or for dynamic analysis of systems. Optical transparency is not required as ultrasonic waves propagate through opaque samples. The analysis is fast and non-destructive. High-resolution ultrasonic spectrometers were developed, patented and brought to the market by Ultrasonic Scientific Ltd. and recognised with various international awards. These instruments require small sample volumes, down to 0.03 ml, and give excellent resolution. They can be used for the analysis of composition, aggregation, particle sizing, gelation, micellisation, crystallisation, sedimentation, enzymatic activity, conformational transitions in polymers, biopolymer-ligand binding and antigen-antibody interactions, etc. This article describes main features of High-Resolution Ultrasonic Spectroscopy and area of applications of new high-resolution HR-US series of ultrasonic spectrometers. Several applications are illustrated including the monitoring of denaturation and aggregation of proteins in antibody solution, the measurements of the particle size in emulsions, precipitation in synthetic blood substitutes and crystallisation.