Physicochemical characterization of nedocromil bivalent metal salt hydrates. 3. Nedocromil calcium

Journal of Pharmaceutical Sciences
H ZhuD J Grant

Abstract

A crystalline pentahydrate and a crystalline 8/3 hydrate of nedocromil calcium (NC) were prepared. The relationships between these solid phases and the nature of the water interactions in their structures were studied through characterization by differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Karl Fischer titrimetry (KFT), hot-stage microscopy (HSM), ambient- or variable-temperature powder X-ray diffraction (PXRD), Fourier-transform infrared (FTIR) spectroscopy, solid-state nuclear magnetic resonance (SSNMR) spectroscopy, water uptake at various relative humidities (RH), intrinsic dissolution rate (IDR) and solubility measurements. The solubility and intrinsic dissolution rate of the pentahydrate in water at 25 degrees C are approximately 17% greater than the corresponding values for the 8/3 hydrate, corresponding to a greater Gibbs free energy of only 380 J.mol-1 (91 cal.mol-1) for the pentahydrate. The results of DSC, TGA, and FTIR and SSNMR spectroscopy indicate that the water of hydration is more loosely bound in the pentahydrate than in the 8/3 hydrate. On increasing the temperature in open-pan DSC and TGA, the water in the pentahydrate is released in four steps (three steps in crimped pans), whe...Continue Reading

References

Feb 1, 1978·Journal of Pharmaceutical Sciences·C A HirschJ L Brannon
Oct 1, 1987·The British Journal of Clinical Practice·J G Ayres
Sep 1, 1972·The Journal of Pharmacy and Pharmacology·J H CollettN A Dickinson

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Citations

Mar 16, 2001·International Journal of Pharmaceutics·H Zhu, D J Grant
Jan 16, 2002·International Journal of Pharmaceutics·Haijian Jim ZhuDavid J W Grant
Jul 29, 2000·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·F HirayamaK Uekama
Sep 2, 1998·Journal of Pharmaceutical Sciences·R KhankariD J Grant
Feb 1, 2006·Journal of Pharmaceutical Sciences·Ammar Khawam, Douglas R Flanagan
Feb 24, 2006·The Analyst·Robin K Harris

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