Moisture is a crucial factor influencing the physicochemical properties of drugs, as water absorption can affect the drug’s stability, crystal form, dissolution, and other properties, thereby impacting their efficacy and safety. In the processes of drug research and development, formulation technology screening, quality research, as well as the formulation of quality control strategies and standards, the interaction between water and drugs and its impact on drug performance should be thoroughly considered. Dynamic vapor sorption is a method used to study the interaction between substances and vapor, effectively exploring the interaction between water and drugs. This article introduces the working principle of dynamic vapor sorption, combines the principle with drug research, and outlines the application examples and research progress of dynamic vapor sorption in pharmaceutical analysis, aiming to provide a reference for drug development and quality control.

1.中国药典2025年版. 四部[S]. 2025: 211-213, 685.

2.龚利香, 张宝喜, 陶月, 等. DVS技术在药物晶型和共晶研究中的应用进展[J]. 中国医药工业杂志, 2023, 54(12): 1687-1693. [Gong LX, Zhang BX, Tao Y, et al. Application progress of DVS in the studies of drug polymorphism and cocrystals[J]. Chinese Journal of Pharmaceuticals, 2023, 54(12): 1687-1693.] DOI: 10.16522/j.cnki.cjph.2023.12.001.

3.张娜, 黄海伟, 熊婧, 等. 甲钴胺的引湿性探讨[J]. 中国药事, 2017, 31(10): 1181-1185. [Zhang N, Huang HW, Xiong J, et al. Discussion on hygroscopicity of mecobalamin[J]. Chinese Pharmaceutical Affairs, 2017, 31(10): 1181-1185.] DOI: 10.16153/j.1002-7777.2017.10.015.

4.刘毅, 耿颖, 覃玲, 等. 化学对照品引湿性研究路线的探讨 [J]. 中国药物警戒, 2024, 21(3): 280-282, 289. [Liu Y, Geng Y, Qin  L, et al. Research routes of hygroscopicity of chemical reference substances[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 280-282, 289.] DOI: 10.19803/j.1672-8629.20230331.

5.刘毅, 郭贤辉, 覃玲, 等. 国家药品标准物质阿卡波糖的引湿性研究[J]. 药物分析杂志, 2023, 43(8): 1429-1434. [Liu Y, Guo  XH, Qin L, et al. Study on the hygroscopicity of national reference substance of acarbose[J]. Chinese Journal of Pharmaceutical Analysis, 2023, 43(8): 1429-1434.] DOI: 10.16155/j.0254-1793.2023.08.20.

6.刘毅, 吴静芳, 丁怡, 等. 基于维生素B12的引湿性研究谈国家药品标准物质的管理方法[J]. 中国药事, 2024, 38(8): 922-926. [Liu Y, Wu JF, Ding Y, et al. Discussion on management methods for national drug reference standards based on the hygroscopicity study of vitamin B12[J]. Chinese Pharmaceutical Affairs, 2024, 38(8): 922-926.] DOI: 10.16153/j.1002-7777.20240330.

7.师军凤, 王丹, 田阳, 等. 药物晶型的影响因素及其筛选控制策略[J]. 中国药学杂志, 2022, 57(22): 1873-1880. [Shi JF, Wang D, Tian Y, et al. Influencing factors of drug crystal and its screening control strategy[J]. Chinese Pharmaceutical Journal, 2022, 57(22): 1873-1880.] DOI: 10.11669/cpj.2022.22.002.

8.刘慧娜, 张珂, 缪妍, 等. 甘露醇的药物晶体学研究进展[J].中国药科大学学报, 2025, 56(2): 264-270. [Liu HN, Zhang K, Miao Y, et al. Progress in pharmaceutical crystallographic study of mannitol[J]. Journal of China Pharmaceutical University, 2025, 56(2): 264-270.] DOI: 10.11665/j.issn.1000-5048.2024110401.

9.翁兴业, 庞遵霆, 钱帅, 等. 晶体工程学技术改善药物理化性质以提高成药性[J]. 药学学报, 2020, 55(12): 2883-2891. [Weng XY, Pang ZT, Qian S, et al. Druggability enhancement by modification of physicochemical properties of drugs via crystal engineering[J]. Acta Pharmaceutica Sinica, 2020, 55(12): 2883-2891.] DOI: 10.16438/j.0513-4870.2020-0813.

10.Naderi M, Khoo J, Manaswini A, et al. In-situ monitoring of a moisture-induced polymorphic transition using raman spectroscopy and gravimetric vapor sorption[EB/OL]. (2019-02-22) [2024-07-15] https://www.metrohm.com/zh_cn/applications/bw-tek-applikationen/410000037-a-.html.

11.Zhang DJ, Chen QX, Lin HW, et al. Toltrazuril polymorphs and the effect on hygroscopicity and dissolution rate[J]. Cryst Growth Des, 2024, 24(3): 1328-1338. DOI: 10.1021/acs.cgd.3c01301.

12.Tian F, Qu H, Zimmermann A, et al. Factors affecting crystallization of hydrates[J]. J Pharm Pharmacol, 2010, 62(11): 1534-1546. DOI: 10.1111/j.2042-7158.2010.01186.x.

13.Guidetti M, Hilfiker R, Kuentz M, et al. Water-mediated phase transformations of posaconazole: an intricate jungle of crystal forms[J]. Eur J Pharm Sci, 2024, 195: 106722. DOI: 10.1016/j.ejps.2024.106722.

14.齐创宇. 吸入制剂用原料药中无定型含量的定量方法研究进展[J]. 中国医药工业杂志, 2024, 55(4): 488-493. [Qi  CY. Research progress on quantification methods of amorphous content of bulk drugs for inhaled preparation[J]. Chinese Journal of Pharmaceuticals, 2024, 55(4): 488-493.] DOI: 10.16522/j.cnki.cjph.2024.04.006.

15.Sheokand S, Modi SR, Bansal AK. Quantification of low levels of amorphous content in crystalline celecoxib using dynamic vapor sorption (DVS)[J]. Eur J Pharm Biopharm, 2016, 102: 77-86. DOI: 10.1016/j.ejpb.2016.03.006.

16.Patel V, Mehetre J, Kumar V, et al. Qualitative and quantitative approach for amorphous content determination in active pharmaceuticals[J]. Asian Journal of Pharmaceutical Analysis, 2025, 15(2): 123-130. DOI: 10.52711/2231-5675.2025.00020.

17.Grönniger B, Kimpe K, Singh A, et al. Simultaneous water sorption and crystallization in ASDs 1: stability studies lasting for two years[J]. Mol Pharm, 2024, 21(2): 957-969. DOI: 10.1021/acs.molpharmaceut.3c01056.

18.Gao D, Zhu D, Zhou X, et al. Inhomogeneous phase significantly reduces oral bioavailability of felodipine/PVPVA amorphous solid dispersion[J]. Mol Pharm, 2022, 20(1): 409-418. DOI: 10.1021/acs.molpharmaceut.2c00695.

19.Zhao P, Wang H, Jia J, et al. Moisture-induced limited recrystallization may not reduce the dissolution of amorphous solid dispersions: a case of nitrendipine[J]. J Ind Eng Chem, 2024. DOI: 10.1016/j.jiec.2024.03.009.

20.王威, 严君喜, 苟鹏, 等. 水分扩散阻滞对西林瓶装疫苗冻干表观塌陷形成的影响[J]. 中国生物制品学杂志, 2020, 33(8): 864-866, 873. [Wang W, Yan JX, Gou P, et al. Effect of moisture diffusion block on appearance collapse of freeze-dried vaccine in vials[J]. Chinese Journal of Biologicals, 2020, 33(8): 864-866, 873.] DOI: 10.13200/j.cnki.cjb.003115.

21.Duralliu, Arnold, Paul Matejtschuk, et al. Humidity induced collapse in freeze dried cakes: a direct visualization study using DVS[J]. Eur J Pharm Biopharm, 2018, 127: 29-36. DOI: 10.1016/j.ejpb.2018.02.003.

22.Shi C, Fang Y, Liu Z, et al. Effect of moisture sorption and lactose type on tablet quality: a hygroscopicity study between lactose powder and tablets[J]. Mol Pharm, 2024, 22(1): 544-557. DOI: 10.1021/acs.molpharmaceut.4c01164.

23.Yang Q, Yuan F, Xu L, et al. An update of moisture barrier coating for drug delivery[J]. Pharmaceutics, 2019, 11(9): 436. DOI: 10.3390/pharmaceutics11090436.

24.Veronica N, Heng PWS, Liew CV, et al. Relative humidity cycling: implications on the stability of moisture-sensitive drugs in solid pharmaceutical products[J]. Mol Pharm, 2022, 20(2): 1072-1085. DOI: 10.1021/acs.molpharmaceut.2c00812.

25.Jeong Y, Ansari JR, Sadeghi K, et al. Applicability of polypropylene/polyethylene glycol/molecular sieve composites as desiccant pharmaceutical packaging materials[J]. Food Packaging Shelf, 2024, 42: 101266. DOI: 10.1016/j.fpsl.2024.101266.

26.Shah B, Kakumanu VK, Bansal AK. Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids[J]. J Pharm Sci, 2006, 95(8): 1641-1665. DOI: 10.1002/jps.20644.

27.Sheokand S, Modi SR, Bansal AK. Dynamic vapor sorption as a tool for characterization and quantification of amorphous content in predominantly crystalline materials[J]. J Pharm Sci, 2014, 103(11): 3364-3376. DOI: 10.1002/jps.24160.

28.Feth MP, Jurascheck J, Spitzenberg M, et al. New technology for the investigation of water vapor sorption-induced crystallographic form transformations of chemical compounds: a water vapor sorption gravimetry-dispersive raman spectroscopy coupling[J]. J Pharm Sci, 2011, 100(3): 1080-1092. DOI: 10.1002/jps.22317.