A novel pelletizing process, spheronization, was used to prepare spherical particles for use in tablet compression. Dibasic calcium phosphate, acetaminophen, magnesium hydroxide, and sulfadiazine granulations were prepared and compressed into acceptable tablets. Tests showed that the spheronizing process resulted in an improved granulation flow rate and narrow particlesize distribution as compared lo a conventionally processed wet granulation. Granulation reproducibility and change of size distribution with processing time were also studied. Tablets were compressed from all granulations, and hardness and disintegration times were determined.
Keyphrases 0 Spheronization---preparation of spherical particles for tablet compression, compared to conventional wet granulation method 0 Granulation-effect of spheronization on flow rate and particle-size distribution, compared to conventional wet method 0 Tablet granulations-spheronization method compared to conventional wet granulation, hardness, disintegration times Spherical particles formed using pelletizing equipment', described by Conine and Hadley (1) and Reynolds (2), afford several possible advantages over conventional wet granulations. This process of spheronizing, they reported, should result in faster drying times, shorter and less complex processing, minimal dust and cross-contamination, and optimal flow rate.
I n the early stages of investigating the properties of these spherical particles, it was observed that spheres could be prepared using only 10-20z inactive ingredients. Obviously, this process might present advantages in preparing granulations for large dose medications.
This report compares data obtained from a wet granulation of a common tablet diluent, dibasic calcium phosphate, by conventional and pelletizing techniques. In addition, three different granulations consisting of 80 % active ingredient and 20% binder were prepared and evaluated. Tablets were compressed from both conventional and pelletized granulations and compared with respect to hardness and disintegration properties.
Previous work (3, 4) showed microcrystalline cellulose to be an acceptable binder for the wet granulation process. Tablets compressed from granules containing microcrystalline cellulose binder exhibit acceptable disintegration characteristics without addition of a disintegrating agent. Microcrystalline cellulose as a dry binder for tablets was investigated in detail by Fox et al. (4) and Shangraw era]. ( 5 ) . ' Extruder type EXDS-60 and Marumerizer type Q-230, available