Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 99, Issue 12, Pages 5019-5029Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.22193
Keywords
milling; physicochemical properties; FTIR; solid state NMR; inclusion compounds; X-ray powder diffractometry; crystallization; cyclodextrins; thermal analysis; interaction
Funding
- Ministry of Education, Culture, Sports, Science and Technology of Japan
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Fentanyl base and beta-cyclodextrin (beta-CD) were coground at 1: 1 and 1: 2 molar ratios (fentanyl: beta-CD) and the physicochemical characteristics of the mixtures were studied using differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), solid state C-13 nuclear magnetic resonance (NMR) spectroscopy and powder X-ray diffraction (PXRD) measurement. Additionally, portions of the coground samples were exposed to high relative humidity to investigate fentanyl and beta-CD interactions. The results of DSC and PXRD analyses indicate that the ground mixtures are in an amorphous state, and the FTIR measurements show hydrogen bonding interactions between fentanyl and beta-CD. Solid state C-13 NMR indicates that a fentanyl/beta-CD inclusion compound is formed in the humidified mixture. Furthermore, PXRD data from the humidified mixtures are similar to the PXRD patterns from the inclusion complex. (C) 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:5019-5029, 2010
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