Influence of particle size and preparation methods on the physical and chemical stability of amorphous simvastatin
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Influence of particle size and preparation methods on the physical and chemical stability of amorphous simvastatin. / Zhang, Fang; Aaltonen, Jaakko; Tian, Fang; Saville, Dorothy J; Rades, Thomas.
In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 71, No. 1, 2009, p. 64-70.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Influence of particle size and preparation methods on the physical and chemical stability of amorphous simvastatin
AU - Zhang, Fang
AU - Aaltonen, Jaakko
AU - Tian, Fang
AU - Saville, Dorothy J
AU - Rades, Thomas
PY - 2009
Y1 - 2009
N2 - This study investigated the factors influencing the stability of amorphous simvastatin. Quench-cooled amorphous simvastatin in two particle size ranges, 150-180 microm (QC-big) and CM>crystalline. For the physical stability, the highest crystallization rate was observed for CM, and the slowest rate was detected for QC-big, with an intermediate rate occurring for QC-small. QC exhibited lower molecular mobility and higher chemical degradation than CM. Therefore, the current study demonstrated that QC and CM have obvious differences in both physical and chemical properties. It was concluded that care should be taken when choosing preparation methods for making amorphous materials. Furthermore, particle size, a factor that has often been overlooked when dealing with amorphous materials, was shown to have an influence on physical stability of amorphous simvastatin.
AB - This study investigated the factors influencing the stability of amorphous simvastatin. Quench-cooled amorphous simvastatin in two particle size ranges, 150-180 microm (QC-big) and CM>crystalline. For the physical stability, the highest crystallization rate was observed for CM, and the slowest rate was detected for QC-big, with an intermediate rate occurring for QC-small. QC exhibited lower molecular mobility and higher chemical degradation than CM. Therefore, the current study demonstrated that QC and CM have obvious differences in both physical and chemical properties. It was concluded that care should be taken when choosing preparation methods for making amorphous materials. Furthermore, particle size, a factor that has often been overlooked when dealing with amorphous materials, was shown to have an influence on physical stability of amorphous simvastatin.
KW - Calorimetry, Differential Scanning
KW - Chemistry, Pharmaceutical
KW - Chromatography, High Pressure Liquid
KW - Crystallization
KW - Drug Stability
KW - Particle Size
KW - Simvastatin
KW - Solubility
KW - Spectroscopy, Fourier Transform Infrared
KW - Technology, Pharmaceutical
KW - Thermodynamics
KW - X-Ray Diffraction
U2 - 10.1016/j.ejpb.2008.07.010
DO - 10.1016/j.ejpb.2008.07.010
M3 - Journal article
C2 - 18703139
VL - 71
SP - 64
EP - 70
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
SN - 0939-6411
IS - 1
ER -
ID: 13674386