Romanian Society of Pharmaceutical Sciences
 

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SOLID-STATE CHARACTERIZATION OF BIFONAZOLE-β-CYCLODEXTRIN BINARY SYSTEMS. NOTE I

CRISTINA TRANDAFIRESCU1, ÁRPÁD GYÉRESI2, ZOLTÁN SZABADAI3, MIHÁLY KATA4, ZOLTÁN AIGNER4

1Victor Babeş University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, 1st Eftimie Murgu Str., Timişoara, România
2 University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, 38th Gheorghe Marinescu Str., Târgu-Mureş, România
3 Victor Babeş University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Drug Analysis, 1st Eftimie Murgu Str., Timişoara, România
4 University of Szeged, Faculty of Pharmacy, Department of Pharmaceutical Technology, 6th Eötvös Str., Szeged, Hungary

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Antimycotic bifonazole (BIF) is a very hydrophobic compound, which is a major drawback for obtaining topical pharmaceutical formulations with optimal bioavailabiliy and for the penetration into hydrophilic human nail matrices. Cyclodextrins may increase local drug delivery by enhancing the drug release and/or permeation. The binary systems between bifonazole and β-cyclodextrin were prepared in two (BIF:β-CD) molar ratios - by physical-mixture and kneaded method. Hot-stage microscopy (HSM), differential scanning calorimetry (DSC), X-ray diffractometry and Fourier-transformed infrared spectroscopy (FT-IR) were used to characterize solid state interactions between bifonazole and β- cyclodextrin (β-CD) in their binary systems. The X-ray diffractograms, as well as the FTIR analysis suggest the formation of a new solid phase, indicating a molecular interaction between the components.The HSM analysis and the DSC analysis sustain the hypothesis of formation of partial inclusion complexes between BIF and β-CD.