Ultrasonic Methods for Real-Time Release Testing of Compressed Orals Solid Dosage Forms

Cetin Cetinkayaa, Vivek S. Daveb

a Clarkson University, Dept. of Mechanical and Aerospace Eng., Potsdam, New York, USA
b St. John Fisher College, Wegmans School of Pharmacy, Rochester, New York, USA

Purpose. Provide a review of ultrasonic methods that can be used in real-time release testing and discuss their critical applications of ultrasound in tablet design, formulation development, and manufacturing (batch and continuous).

Methods. As in medical ultrasound, ultrasonic pressure and shear strain waves can be launched into a sample and acquired by piezoelectric transducers. Elastic waves propagating in a composite medium are modulated by its elasticity, visco-elasticity, inertia (e.g., mass density distribution), as well as its defects/irregularities (e.g., cracks, delamination), and micro-texture (e.g., microstructure and granular make-up). The medium’s such properties can be extracted by analyzing the changes in the dispersive and attenuative properties of these transmitted ultrasonic waves, and defects can be detected rapidly in a non-destructive manner.

Results. Characterization and evaluationresults supporting several standard tests and characterization methods for assessing critical quality attributes are reported, and their specific use cases are discussed.

Conclusions. Ultrasonic can be used for characterizing several physical properties of tablets and evaluating defects and cracks in tablets, which are critical in real-time release testing and quality assurance.