Effect of temperature and humidity on hardness and friability of packaged paracetamol tablet formulations.

The influence of various temperature and relative humidity conditions on changes in hardness and friability of five commercial brands of packaged paracetamol tablets stored over a period of six months has been investigated. At 75% RH all sample show deterioration in hardness at 25 degrees (5-10%) and at 45 degrees (10-39%). At 100% RH there is a little difference in deterioration in hardness at 25 degrees (16-24%) and 45 masculine (20-28%) suggesting that once the critical moisture content is reached by the tablets, further increase in relative humidity has little effect on changes in hardness. Under the same conditions, all tablets show an increase in friability ranging from 2.83 to 8.02%. The overall increase in friability with an increase in temperature from 25 degrees to 45 degrees at 75% and 100% RH is 0.0 to 25.2%. The results indicate that moisture sorption by tablet matrix through certain packaging materials may adversely affect the hardness and friability characteristics.