Nondestructive techniques for pharmaceutical drug product characterization

• Published in: Drug discovery today 2025-01, Vol.30 (1), p.104249, Article 104249
• Main Authors: Beg, Sarwar, Ahirwar, Kailash, Almalki, Waleed H., Almujri, Salem S., Alhamyani, Abdulrahman, Rahman, Mahfoozur, Shukla, Rahul
• Format: Article
• Language: English
• Subjects: Analytical characterization; Critical quality attributes; Nondestructive techniques; Pharmaceutical quality; Spectroscopy
• ISSN: 1359-6446; 1878-5832; 1878-5832
• DOI: 10.1016/j.drudis.2024.104249

[Display omitted] •Nondestructive techniques for application in pharmaceutical product development are highlighted.•Opportunities and challenges associated with nondestructive techniques are emphasized.•Regulatory and ethical considerations are discussed.•Chemometric tools for accelerated quality control in manufacturing are discussed. Pharmaceutical product development involves multiple steps; therefore product quality must be assessed to ensure robustness and acceptability. Raw components, production methods, and ambient conditions yield highly variable end products with low batch-to-batch consistency. Although end testing is performed to ensure product quality, intermediate quality checks are limited. Nondestructive techniques like terahertz, near-infrared, X-ray, and Raman spectroscopy are common tools for in-line quality checks and real-time data monitoring. Handheld devices based on these analytical techniques also help in identifying counterfeit drugs products. This review discusses modern regulatory perspectives on the use of nondestructive tools in pharmaceutical quality monitoring.