In this study, the compaction properties of acetaminophen granules containing different amounts of moisture were investigated and compared with the compaction properties of acetaminophen granules containing different amounts of plasticizers. The prepared granules contained 0, 3, 6, 9 or 12% moisture, and or 0.25, 0.5 or 0.75% of propylene glycol, glycerin or polyethylene glycol 400, as the plasticizer. It was shown that the amount of moisture in granules has a major effect on the compaction properties of acetaminophen granules. Granules containing 3% moisture produced the hardest tablets with minimum friability. Decrease or increase in moisture content from 3%, decreased the hardness of tablets, especially when the moisture content was more than 6%.
It was also shown that incorporation of a plasticizer into the granules improved their compaction properties. Among the plasticizers used in this study, propylene glycol with concentration of 0.25% w/w produced tablets with the highest crushing strength. The friability of these tablets was even lower than the tablets containing 3% moisture. No capping and lamination were observed in tablets containing a plasticizer. The presence of the plasticizer also facilitated the ejection of tablets from the die.
The results of this study revealed that the presence of optimum moisture (3%) is necessary to produce proper tablets and therefore the control of moisture content in granules in drying stage is vital. However, in presence of small amounts of a suitable plasticizer, the granules can be dried completely and proper tablets can be also produced, therefore the control stage of moisture content in granules can be eliminated. Of course in absence of moisture the physico-chemical instability would be minimum.