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Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review

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Abstract

In recent years, the pharmaceutical industry has been adversely affected by an upsurge in the recall instances of pharmaceutical products. This is due to the leaching of the chemical entities from the packaging material that have posed health hazards to the end-user. The recalls have led regulatory agencies like United States Food and Drug Administration, Product Quality Research Institute, International Standard Organization, BioPhorum Operations Groups, Bioprocess Systems Alliance, etc. to emphasize this issue and provide guidelines on the study of extractable and leachable. However, the chemically varied nature of the pharmaceutical packaging material and direct contact medical devices present many challenges in the design of the study. This review provides detailed information on the critical factors to be considered for the above-mentioned study. It not only addresses the challenges faced during the sample preparation but also suggests a state-of-the-art advancement called the “Quick, Easy, Cheap, Effective, Rugged and Safe”-QuEchERS approach that may be applicable for chemical analysis. It discusses details about the hyphenated analytical techniques like Gas Chromatography-Mass Spectrometry, Liquid Chromatography-Mass Spectrometry, Inductively Coupled Plasma-Mass Spectrometry employed for the analysis of extractables and leachables. This review provides flowchart for toxicological evaluation of identified extractable and leachable as well as thorough information on the calculation of Analytical Evaluation Threshold. From a broad perspective, the authors aim to provide insight into the design, identification, and characterization of extractables and leachables that may be found in pharmaceutical products and medical devices.

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Acknowledgements

The authors would like to express their gratitude towards NIPER Ahmedabad and the Ministry of Chemical and Fertilizers, India for providing necessary support and encouragement.

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  1. Nitish Sharma, Yashada Brahmankar, Diksha Babar, Tejas Bhogle, Ramdas Mirase and Rajeshwari Rathod have contributed equally.

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  1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Ahmedabad, Gandhinagar, Gujarat, India

    Nitish Sharma, Yashada Brahmankar, Diksha Babar, Tejas Bhogle, Ramdas Mirase, Rajeshwari Rathod & Ravi Shah

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Sharma, N., Brahmankar, Y., Babar, D. et al. Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review. J Package Technol Res 7, 127–145 (2023). https://doi.org/10.1007/s41783-023-00157-8

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