PREPARATION AND CHARACTERIZATION OF
INCLUSION COMPLEXES FORMED BETWEEN
SIMVASTATIN AND HYDROXYPROPYL – β –
CYCLODEXTRIN
EMMA ADRIANA BUDURA¹*, DUMITRU LUPULEASA¹, CORINA
ARAMĂ², MIHAI NIŢULESCU³, TEODORA BALACI¹
University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, 6 Traian Vuia St., 020956, Bucharest, Romania
¹ Pharmaceutical Technology Department
² Analytical Chemistry Department
³ Pharmaceutical Chemistry Department
* corresponding author: emmacretu@aim.com
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Abstract:

The aim of the present study was to evaluate the formation of inclusion
complexes between simvastatin and hydroxypropyl-beta-cyclodextrin in aqueous solution and in solid state. Complexation in solution was assesed using Higuchi-Connors phase solubility studies. Phase solubility diagram was classified as AL type, indicating the formation of a 1:1 molar ratio inclusion complex, with an apparent stability constant (Kst) of 169 M^-1. The inclusion complexes in solid state were prepared by co-precipitation and
lyophilization techniques, and were subjected to physico-chemical characterization in comparison with the simple physical mixture prepared in the same 1:1 molar ratio. The complexes were evaluated by scanning electron microscopy (SEM), powder X-ray diffraction, differential scanning calorimetry (DSC), and Fourier-transform infrared spectroscopy (FT-IR). The lyophilization inclusion complexes between simvastatin and hydroxypropyl-beta-cyclodextrin, in 1:1 molar ratio, showed better results in all the studied parameters in comparison with the complexes prepared by the co-precipitation method.

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