Physicochemical Stability of Solid Dispersions of Enantiomeric or Racemic Ibuprofen in Stearic Acid
Langue
en
Article de revue
Ce document a été publié dans
Journal of Pharmaceutical Sciences. 2011, vol. 100, n° 12, p. 5235-5243
Wiley
Résumé en anglais
The aim of this study was to investigate the solid dispersion phase behavior of s- or rs-ibuprofen in stearic acid. By means of thermal analysis, we have demonstrated the total immiscibility, in solid state, of the ...Lire la suite >
The aim of this study was to investigate the solid dispersion phase behavior of s- or rs-ibuprofen in stearic acid. By means of thermal analysis, we have demonstrated the total immiscibility, in solid state, of the corresponding binary mixtures. This indicates that no specific interactions exist between the chosen excipient and active pharmaceutical ingredient (API) that lead to eutectic systems. Furthermore, based on calorimetric and X-ray diffraction experiments, we have showed that upon cooling of the molten state, only stearic acid recrystallizes in the presence of s-ibuprofen, whereas a quaternary phase mixture is obtained for the racemic ibuprofen/stearic acid preparation. The solubility of stearic acid in s-ibuprofen liquid in all proportions was also determined. Overall, the results presented here offer an approach for the study of API/excipient interactions.< Réduire
Mots clés en anglais
miscibility
melt-recrystallization process
solubility
polymorphism
solid-state stability
phase diagram
drug-excipient interactions
thermal analysis
X-ray powder diffraction
drug–excipient interactions
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