A review of the State-of-the-Art: progress in ultrasonic and acoustic techniques for quality assessment in the development and manufacturing of oral solid dosage forms − Part II: Applications and emerging directions

Abstract

This review is presented in two parts: Part I addresses the theoretical foundations and principles of ultrasonic and acoustic techniques, while Part II—presented here—focuses on their practical applications and emerging directions in advanced pharmaceutical tablet manufacturing.

Building on the concepts established in Part I, this article (Part II) surveys real-world use cases and forward-looking innovations, highlighting how ultrasonic techniques enable rapid, non-destructive evaluation of Critical Quality Attributes (CQAs), including dissolution performance, tensile strength, porosity, friability, coating thickness, and subsurface defects. These methods are shown to align with United States Pharmacopeia (USP) reference tests and support regulatory frameworks and initiatives, including Process Analytical Technology (PAT), Quality by Design (QbD), Continuous Manufacturing (CM), and Real-Time Release Testing (RTRT).

Illustrative case studies from both industry and academia demonstrate the integration of ultrasonic tools into advanced manufacturing ecosystems. Key developments include the use of 3D printing for Oral Solid Dosage (OSD) forms, ML–driven quality analytics, cyber-physical systems for closed-loop control, and cloud-based Manufacturing Execution Systems (MES) secured by public blockchain and cloud computing infrastructure. Despite these advances, challenges persist—such as multi-scale material complexity, signal degradation from material irregularities, and the need for robust multimodal data integration—which necessitate the use of sophisticated software and ML-based predictive modeling.

Looking ahead, the convergence of wave sensing, robotics, industrial IoT, and digital twin technology is poised to transform pharmaceutical manufacturing into a highly automated, data-centric enterprise. This transformation promises not only to advance RTRT and CM but also to deliver unprecedented levels of quality, traceability, efficiency, and agility across the tablet formulation, design, and production lifecycle.

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Çetin Çetinkaya, Michael Bazzocchi, Vivek S. Dave, Bhakti Halkude, Ajaz S. Hussain, Chaitanya Krishna Prasad Vallabha, Sonia M. Razavi, James Stephens, Richard Steiner, Tipu Sultan, Changquan Calvin Sun, Anthony S. Tantuccio, Pirjo Tajarobi, Cenk Ündey, Håkan Wikström, Xiaochi Xu, A review of the State-of-the-Art: progress in ultrasonic and acoustic techniques for quality assessment in the development and manufacturing of oral solid dosage forms − Part II: Applications and emerging directions, International Journal of Pharmaceutics, Volume 698, 2026, 126925, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2026.126925.