Advances in Quantitative Analytical Methods for Solid Drugs

The solid form of the drug can directly affect the physicochemical properties, bioavailability, safety, and efficacy of the drug, and its types mainly include amorphous state, single-component polycrystalline, hydrate, solvate, salt, and cocrystal. Polymorphic drugs are solid drugs whose active ingr...

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Main Authors: Yue Tao, Yuhan Gao, Baoxi Zhang, Kun Hu, Yifei Xie, Li Zhang, Shiying Yang, Yang Lu
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Crystals
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Online Access:https://www.mdpi.com/2073-4352/15/1/38
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author Yue Tao
Yuhan Gao
Baoxi Zhang
Kun Hu
Yifei Xie
Li Zhang
Shiying Yang
Yang Lu
author_facet Yue Tao
Yuhan Gao
Baoxi Zhang
Kun Hu
Yifei Xie
Li Zhang
Shiying Yang
Yang Lu
author_sort Yue Tao
collection DOAJ
description The solid form of the drug can directly affect the physicochemical properties, bioavailability, safety, and efficacy of the drug, and its types mainly include amorphous state, single-component polycrystalline, hydrate, solvate, salt, and cocrystal. Polymorphic drugs are solid drugs whose active ingredients exist in a specific crystalline state. Polymorphic drugs are solid drugs whose active ingredients exist in a specific crystalline state. Drug polymorphism refers to the presence of two or more different crystalline states of the drug. Pharmaceutical cocrystal is a new type of solid form that can improve the stability, solubility, and bioavailability of active pharmaceutical ingredients and many other physicochemical properties. The determination of the crystalline form of a drug and its content is of great significance in ensuring the quality of the polymorphic drug and its safety. In this paper, the quantitative analysis methods of polymorphs and pharmaceutical cocrystals are reviewed, the advantages and disadvantages of various methods are analyzed mainly from three types of techniques, namely, X-ray diffraction, spectroscopy, and thermal analysis, and the specific applications of various methods are commented on through examples. The analytical methods that can effectively determine the content of polymorphic drugs are comprehensively mastered to provide a reference for the establishment of quality standards for polymorphic drugs.
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institution Kabale University
issn 2073-4352
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publishDate 2024-12-01
publisher MDPI AG
record_format Article
series Crystals
spelling doaj-art-309e92be3b4344fb9fb9acf2b99d3d2a2025-01-24T13:28:05ZengMDPI AGCrystals2073-43522024-12-011513810.3390/cryst15010038Advances in Quantitative Analytical Methods for Solid DrugsYue Tao0Yuhan Gao1Baoxi Zhang2Kun Hu3Yifei Xie4Li Zhang5Shiying Yang6Yang Lu7Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, ChinaThe solid form of the drug can directly affect the physicochemical properties, bioavailability, safety, and efficacy of the drug, and its types mainly include amorphous state, single-component polycrystalline, hydrate, solvate, salt, and cocrystal. Polymorphic drugs are solid drugs whose active ingredients exist in a specific crystalline state. Polymorphic drugs are solid drugs whose active ingredients exist in a specific crystalline state. Drug polymorphism refers to the presence of two or more different crystalline states of the drug. Pharmaceutical cocrystal is a new type of solid form that can improve the stability, solubility, and bioavailability of active pharmaceutical ingredients and many other physicochemical properties. The determination of the crystalline form of a drug and its content is of great significance in ensuring the quality of the polymorphic drug and its safety. In this paper, the quantitative analysis methods of polymorphs and pharmaceutical cocrystals are reviewed, the advantages and disadvantages of various methods are analyzed mainly from three types of techniques, namely, X-ray diffraction, spectroscopy, and thermal analysis, and the specific applications of various methods are commented on through examples. The analytical methods that can effectively determine the content of polymorphic drugs are comprehensively mastered to provide a reference for the establishment of quality standards for polymorphic drugs.https://www.mdpi.com/2073-4352/15/1/38solid drugsquantificationx-ray diffractionthermal analysisspectroscopy
spellingShingle Yue Tao
Yuhan Gao
Baoxi Zhang
Kun Hu
Yifei Xie
Li Zhang
Shiying Yang
Yang Lu
Advances in Quantitative Analytical Methods for Solid Drugs
Crystals
solid drugs
quantification
x-ray diffraction
thermal analysis
spectroscopy
title Advances in Quantitative Analytical Methods for Solid Drugs
title_full Advances in Quantitative Analytical Methods for Solid Drugs
title_fullStr Advances in Quantitative Analytical Methods for Solid Drugs
title_full_unstemmed Advances in Quantitative Analytical Methods for Solid Drugs
title_short Advances in Quantitative Analytical Methods for Solid Drugs
title_sort advances in quantitative analytical methods for solid drugs
topic solid drugs
quantification
x-ray diffraction
thermal analysis
spectroscopy
url https://www.mdpi.com/2073-4352/15/1/38
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