The influence of pregelatinized starch disintegrants on interacting variables that act on disintegrant properties

The purpose of this study was to study and compare the relative quantitative effects of the nature of a disintegrant (N), the concentration of a disintegrant (C), and the relative density (D) of tablets on the disintegration time (DT) and on the crushing strength-friability to DT (CSFR/DT) ratio of formulated paracetamol tablets. The results study show that: 1. Changing from a weak starch disintegrant to a strong starch disintegrant increases the DT value, but this decrease in DT depends on the type of starch disintegrant involved. 2. Combining various types of starch disintegrants may not cause a noticeable change in DT. 3. An increase in C can lead to a decrease in DT, although an increase in D leads to a decrease in DT. Generally, changing from a low to a high level of N and D reduces the CSFR/DT ratio. 4. All the interactions led to a decrease in DT, and the interaction of N with D only increased the CSFR/DT ratio. 5. Before any attempt to manipulate a tablet's disintegrant properties, the concentration and the nature of the starch disintegrant should first be considered. 6. A 2 to the 3rd power factorial analysis design such as the one described in this article could be useful in a pilot case study to determine which process variables should be optimized to achieve the maximum release of the active drug substance in a formulation.