Monitoring of formation of diclofenac sodium salt hydrates and their influence on the drug dissolution from prepared tablets
Authors:
Petr Doležel; Jan Muselík; Michaela Králová; David Vetchý
Published in:
Čes. slov. Farm., 2013; 62, 259-263
Category:
Original Articles
Overview
NIR spectroscopy together with multivariate data analysis were used to analyze the hydrates of diclofenac sodium prepared from the non-aqueous solvents tetrahydrofuran and methanol under standard laboratory conditions at 20 °C and relative humidity less than 60%. It was confirmed that the developed PLS regression model can monitor the process of formation of hydrates. It was also found that the hydrated form of diclofenac sodium arises during the preparation of the dosage form the using technology of impregnating the solid carrier by non-aqueous solvents, which resulted in reducing of the drug release rate from prepared tablets up to twice. NIR spectroscopy was confirmed as one of the effective PAT (Process Analytical Technology) methods.
Keywords:
process analytical technology method, PLS regression, NIR spectroscopy, hydrates, impregnation, diclofenac sodium
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Labels
Pharmacy Clinical pharmacologyArticle was published in
Czech and Slovak Pharmacy
2013 Issue 6
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