We do disintegration tests on the tablets. The test involves:
- Running 3 tablets each placed in vertical tubes 25mm x 90mm with a filter mesh of 2mm.
- Water is added and maintained at a temperature of 37 degrees Celsius to simulate the gastric fluid temperature.
- The flasks are rotated at 30 cycles per minute for 30/60 minutes with the inclusion of a plastic disc to assist disintegration.
The tablets pass if the residue has passed through the mesh in 30 minutes, or 60 minutes for coated tablets. We use microcrystalline cellulose (explotab) as an excipient which is designed to force the tablet apart when entering the stomach.
This test method used if from European Pharmacopoeia is standardised and designed to provide a reproducible method of ensuring that tablet disintegration will take place. The test is designed to stimulate the gastric fluid digestive process.