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Innovative Analytical Techniques in Pharmaceutical Drug Development and Quality Control

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Targeting and Design".

Deadline for manuscript submissions: 30 June 2026 | Viewed by 960

Special Issue Editors


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Guest Editor
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China
Interests: impurity profiling; drug screening; surface plasmon resonance

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Guest Editor
The Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100080, China
Interests: drug analysis; natural medicine; rapid detection; online monitoring technology

Special Issue Information

Dear Colleagues,

Pharmaceutical analysis encompasses the examination and quantification of active pharmaceutical ingredients, excipients, impurities, and metabolites. The analysis of drugs is essential for advancing drug discovery and ensuring the safety, efficacy, and quality control of pharmaceuticals, which are crucial for protecting public health. The continuous development of advanced analytical methods should remain a fundamental focus within the field of pharmaceutical analysis.

This Special Issue aims to showcase innovative methodologies in drug analysis. We invite submissions that address all facets of drug analysis, including active ingredients, metabolites and impurities, reflecting the current advancements in pharmaceutical analytical techniques.

In this Special Issue, we welcome original research articles as well as review papers. Research areas may include (but are not limited to) the development of sophisticated methods for analyzing drugs, impurities, active ingredients, metabolites, and drug–receptor interactions.

We look forward to receiving your contributions.

Dr. Guangzhi Shan
Dr. Jiaoyang Luo
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

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Keywords

  • method development
  • pharmacokinetics
  • pharmacodynamics
  • nanomaterials
  • drug screening

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Published Papers (1 paper)

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Research

14 pages, 2013 KB  
Article
Cost-Efficient and Fast At-Line Assessment of Content and Uniformity in Low-Dose Dimdazenil Capsules Using Transmission Raman Spectroscopy
by Xun Ma, Lianlian Shan, Shuangpeng Zhu, Zihan Zhu, Shuyu Lu, Mingzhe Xu and Lihui Yin
Pharmaceutics 2026, 18(3), 298; https://doi.org/10.3390/pharmaceutics18030298 - 27 Feb 2026
Viewed by 425
Abstract
Background/Objectives: Transmission Raman spectroscopy (TRS) is widely used for non-destructive quantification of solid dosage forms, yet most applications involve high-dose formulations (>5% w/w active pharmaceutical ingredient (API)). This study addresses the underexplored area of low-dose drug analysis by developing a [...] Read more.
Background/Objectives: Transmission Raman spectroscopy (TRS) is widely used for non-destructive quantification of solid dosage forms, yet most applications involve high-dose formulations (>5% w/w active pharmaceutical ingredient (API)). This study addresses the underexplored area of low-dose drug analysis by developing a TRS method for dimdazenil capsules containing only ~1.5% w/w API—a concentration rarely reported in the current TRS literature. Methods: A partial least squares (PLS) model was built using TRS spectra of dimdazenil capsules, with sample variability introduced via a design of experiments (DoE) approach. Model performance was validated against reference high-performance liquid chromatography (HPLC) data from independent samples and three commercial batches, incorporating specificity checks and greenness assessment via AGREEprep. Results: The TRS method achieved reliable variation assessment with acceptable accuracy, showing relative errors below 5.0% across all validation sets despite a minor systematic bias of ~−2.87%. Analysis required no sample preparation and took less than 150 s per capsule. Specificity was ensured by the unique 1628 cm−1 band of dimdazenil, with no interference from excipients confirmed by spectral examination and multivariate statistical methods. The method scored 0.86 on AGREEprep, highlighting its environmental superiority over HPLC. Conclusions: This work demonstrates that TRS can be reliably extended to low-dose solid dosage forms (~1.5% w/w), a concentration range rarely addressed in the existing TRS literature. This significantly broadens its applicability in pharmaceutical quality control and supports its potential integration into continuous manufacturing for challenging low-concentration products. Full article
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