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DING Tiantian, SU Meiling, QIAN Shuai, et al. Progress of research on quantitative techniques for trace amount of crystals in solid state drugs[J]. J China Pharm Univ, 2024, 55(2): 181 − 193. DOI: 10.11665/j.issn.1000-5048.2023081404
Citation: DING Tiantian, SU Meiling, QIAN Shuai, et al. Progress of research on quantitative techniques for trace amount of crystals in solid state drugs[J]. J China Pharm Univ, 2024, 55(2): 181 − 193. DOI: 10.11665/j.issn.1000-5048.2023081404
shu

Progress of research on quantitative techniques for trace amount of crystals in solid state drugs

  • 1.

    School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing 211198

  • 2.

    School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China

Funds: This study was supported by the National Natural Science Foundation of China (No. 82373824, No. 82104401, No. 82274217, No. 82204636) and the Key Project of the Fundamental Research Funds for the Central Universities (No. 2632021ZD15)
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  • Received Date: August 13, 2023
    Graphical Abstract
    • Abstract

  • It is well-known that crystal form of a drug is a key factor impacting the physicochemical properties of the drug, which in turn affects its in vivo efficacy, safety and stability. The study on crystal forms of solid-state drugs is crucial for drug quality control, selection of production process and evaluation of clinical efficacy. The combination of chemometric and analytical techniques exhibited its great ability to analyze a large amount of multidimensional data, providing the possibility for quantification of trace amount of crystals (< 1%). Meanwhile, using the process analytical technology (PAT) to monitor the crystal content real-time during prescription preparation process can further realize the control on formulation quality and serve as a core technology to support the patent protection of crystalline forms. In this review, the combined application of crystal analytical techniques and chemometric methods for the quantitative analysis of trace crystals were summarized, aiming to provide guidance for the manufacturing of pharmaceutical preparations and their quality control.

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    • References (60)
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