Hygroscopicity, phase solubility and dissolution of various substituted sulfobutylether β-cyclodextrins (SBE) and danazol–SBE inclusion complexes

Ashwinkumar C. Jain; Moji Christianah Adeyeye

doi:10.1016/s0378-5173(00)00607-4

Hygroscopicity, phase solubility and dissolution of various substituted sulfobutylether β-cyclodextrins (SBE) and danazol–SBE inclusion complexes

Ashwinkumar C. Jain, Moji Christianah Adeyeye

In: International Journal of Pharmaceutics · 2001 · vol. 212(2) , pp. 177–186 · doi:10.1016/s0378-5173(00)00607-4 · PMID:11165075 · W2028854009

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This study investigated the hygroscopicity, phase solubility, and dissolution properties of several substituted sulfobutylether β-cyclodextrins and their danazol inclusion complexes.

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Abstract

The aim of the present work was to characterize hygroscopicity, phase solubility and dissolution properties for various substituted sulfobutylether beta-cyclodextrins (SBEs) and danazol-SBE inclusion complexes. Moisture sorption was measured using a symmetric gravimetric analyzer. The complexes were characterized by powder X-ray diffraction (XRD) and differential scanning calorimetry (DSC). Moisture sorption isotherms for the SBEs and the complexes showed low moisture sorption at RH SBE 4>SBE 5 at 95% RH. Powder XRD data for complexes showed the disappearance of characteristic crystalline peaks for danazol or the formation of amorphous entities and DSC showed the disappearance of the peak of fusion of danazol indicating complex formation. Phase solubility of danazol with various substituted SBEs indicated 1:1 stoichiometry of complexes. The apparent stability constant, as determined by the method of Higuchi and Connors, increased as the degree of substitution of SBEs increased and decreased as the temperature increased. The dissolution of the complexes was significantly greater than that of the corresponding physical mixtures indicating that the formation of amorphous complex increased the solubility of poorly soluble danazol. More than 85% of danazol was released in <10 min, compared to 15% danazol release from the physical mixtures.

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Cites (1)

A Study of the Complexation Between Danazol and Hydrophilic Cyclodextrin Derivatives 1996

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[1] A Study of the Complexation Between Danazol and Hydrophilic Cyclodextrin Derivatives 1996