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Discussion of development and validation of dissolution methods for solid oral dosage forms
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Yue-qing ZHAO, Shi-hai ZHOU, Wen-jie LIU, Ze-neng CHENG*
Acta Pharmaceutica Sinica | 2018, 53(2) : 202 - 209
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Acta Pharmaceutica Sinica | 2018, 53(2): 202-209
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Discussion of development and validation of dissolution methods for solid oral dosage forms
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Yue-qing ZHAO, Shi-hai ZHOU, Wen-jie LIU, Ze-neng CHENG*
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  • Xiangya School of Pharmaceutical Science, Central South University, Changsha 410000, China
Published: 2018-02-12 doi: 10.16438/j.0513-4870.2017-0985
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It is generally assumed that study of in vitro dissolution can reveal the in vivo behavior and bioavailability of a drug. The dissolution test indisputably plays a vital role in the research and development of pharmaceutical preparations as well as routine quality control of approved drugs. In order to develop an ideal dissolution method, the physicochemical properties of drug and the characteristics of its dosage form should be considered, and a proper dissolution condition be established to simulate the in vivo dissolution behavior of drugs. The new dissolution method should have the required characteristics of accuracy and durability, but also could distinguish pharmaceutic preparations with different quality. In recent years, there have been more and more reports on the establishment and verification of dissolution methods for oral solid dosage forms. However, there is very few review articles on the topic. According to the latest guidelines by domestic and foreign drug organizations, this review paper is prepared to summarize the most important skills and progress in the development of dissolution methods for oral solid preparations. The aim is to provide a reference for the development and validation of new dissolution methods.

orally administrated formulation  /  dissolution procedure  /  development and validation  /  in vitro and in vivo correlation
Yue-qing ZHAO, Shi-hai ZHOU, Wen-jie LIU, Ze-neng CHENG. Discussion of development and validation of dissolution methods for solid oral dosage forms[J]. Acta Pharmaceutica Sinica, 2018 , 53 (2) : 202 -209 . DOI: 10.16438/j.0513-4870.2017-0985
Year 2018 volume 53 Issue 2
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doi: 10.16438/j.0513-4870.2017-0985
  • Receive Date:2017-10-09
  • Online Date:2026-01-15
  • Published:2018-02-12
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  • Received:2017-10-09
  • Revised:2017-11-13
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    Xiangya School of Pharmaceutical Science, Central South University, Changsha 410000, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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