Importance of evaluating the consolidation of granules manufactured by high shear mixer.
The effects of the process parameters of high shear wet granulation on the granule properties and dissolution properties of mefenamic acid from tablets have been studied, and the importance of evaluating the consolidation of granules has been considered. The process parameters selected for investigation were the amount of water added, the impeller rotation speed and the kneading time. Increases in the amount of water and the kneading time led to increases in the particle diameter of the granules and to decreases in the mean pore diameter. The mean pore diameter decreased with increases in the impeller rotation speed, while the particle diameters were independent of the impeller rotation speed. The process parameters affected the surface morphology and the internal morphology of the granules. The mean particle diameter and the mean pore diameter of the granules basically correlated with the dissolution properties of the tablets. The contribution of the mean pore diameter to this correlation was higher than that of mean particle diameter. Therefore, it was concluded that evaluation of the granule consolidated state, such as the mean pore diameter, was important in order to assure the dissolution properties of drug products.
Ohno
Ikumasa
I
Pharmaceutical Development Laboratories, Sankyo Co. Ltd., 1-12-1, Shinomiya, Hiratsuka-shi, Kanagawa 254-0014, Japan. ikohno@sankyo.co.jp
Hasegawa
Susumu
S
Yada
Shuichi
S
Kusai
Akira
A
Moribe
Kunikazu
K
Yamamoto
Keiji
K
D008528:Mefenamic Acid / Q000737:chemistry; D010316:Particle Size; D011208:Powders; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical
D011208:Powders; D013607:Tablets; D008528:Mefenamic Acid