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Experimental and thermodynamic modeling decitabine anti cancer drug solubility in supercritical carbon dioxide.

Abstract：

:Design and development of efficient processes for continuous manufacturing of solid dosage oral formulations is of crucial importance for pharmaceutical industry in order to implement the Quality-by-Design paradigm. Supercritical solvent-based manufacturing can be utilized in pharmaceutical processing owing to its inherent operational advantages. However, in order to evaluate the possibility of supercritical processing for a particular medicine, solubility measurement needs to be carried out prior to process design. The current work reports a systematic solubility analysis on decitabine as an anti-cancer medicine. The solvent is supercritical carbon dioxide at different conditions (temperatures and pressures), while gravimetric technique is used to obtain the solubility data for decitabine. The results indicated that the solubility of decitabine varies between 2.84 × 10-05 and 1.07 × 10-03 mol fraction depending on the temperature and pressure. In the experiments, temperature and pressure varied between 308-338 K and 12-40 MPa, respectively. The solubility of decitabine was plotted against temperature and pressure, and it turned out that the solubility had direct relation with the pressure due to the effect of pressure on solvating power of solvent. The effect of temperature on solubility was shown to be dependent on the cross-over pressure. Below the cross-over pressure, there is a reverse relation between temperature and solubility, while a direct relation was observed above the cross-over pressure (16 MPa). Theoretical study was carried out to correlate the solubility data using several thermodynamic-based models. The fitting and model calibration indicated that the examined models were of linear nature and capable to predict the measured decitabine solubilities with the highest average absolute relative deviation percent (AARD %) of 8.9%.

journal_name

Sci Rep

journal_title

Scientific reports

authors

Pishnamazi M,Zabihi S,Jamshidian S,Borousan F,Hezave AZ,Marjani A,Shirazian S

doi

10.1038/s41598-020-80399-7

subject

Has Abstract

pub_date

2021-01-13 00:00:00

pages

1075

issue

1

issn

2045-2322

pii

10.1038/s41598-020-80399-7

journal_volume

11

pub_type

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