Effect of pulverization and dehydration on the pharmaceutical properties of calcium lactate pentahydrate tablets.
The effects of heat conduction and pulverization on dehydration kinetics and tablet hardness were studied by a variety of kinetic equations and physical models. The dehydration behavior of unpulverized calcium lactate pentahydrate (UCLP) and pulverized calcium lactate pentahydrate (PCLP) tablets was investigated by using differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD). The hardness of both UCLP and PCLP tablets was significantly decreased after dehydration. The relationship between the extent of dehydration and the tablet hardness of both UCLP and PCLP tablets was linear. The results suggest that the reduction in tablet hardness is dependent on the dehydration of crystal water, and the values of the slopes indicate that the bonding energy of the UCLP was stronger than that of the PCLP. The dehydration of both UCLP and PCLP tablets at 55 degrees C followed a one-dimensional diffusion mechanism, whereas dehydration at storage temperatures of 60-80 degrees C followed a three-dimensional diffusion mechanism. UCLP and PCLP tablets contracted in thickness and diameter during dehydration, but final contraction ratios showed that PCLP tablets were more affected than UCLP tablets. In contrast, the micropore radius of both UCLP and PCLP tablets increased after dehydration. Thus, the pharmaceutical properties of calcium lactate pentahydrate (CLP) tablets are affected both by pulverization and by the extent of dehydration of the bulk powder in the tablet formulation.
Sakata
Yukoh
Y
Healthcare Research Institute, Wakunaga Pharmaceutical Co., Ltd., Akitakata-shi, Hiroshima 739-1195, Japan. sakata_y@wakunaga.co.jp
Shiraishi
Sumihiro
S
Takayama
Kozo
K
Otsuka
Makoto
M
D017610:Calcium Compounds / Q000737:chemistry*; D002152:Calorimetry, Differential Scanning; D003681:Dehydration; D007773:Lactates / Q000737:chemistry*; D011208:Powders / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry*; D014867:Water / Q000737:chemistry*; D017155:Wettability; D014961:X-Ray Diffraction
D017610:Calcium Compounds; D007773:Lactates; D011208:Powders; D013607:Tablets; D014867:Water; C110051:calcium lactate