Visual Inspection

The suppositories are visually inspected for its physical appearance, size, shape and texture. Individual suppositories should be examined for cracks and pits due to entrapment of air in the molten mass.

Disintegration Test

The disintegration test can be determined by using the tablet disintegration test apparatus with necessary modification in the test media. According to BP, the disintegration test determines whether the suppositories or pessaries soften or disintegrate within the prescribed time when placed in a liquid medium in the experimental conditions described here. Disintegration is considered to be achieved under the following conditions:

1. Dissolution is complete.
2. The components of the suppository or pessary have separated. Melted fatty substances collect on the surface of the liquid, insoluble powders fall to the bottom, and soluble components dissolve. Depending on the type of preparation, the components may be distributed in one or more of these ways.
3. There is softening of the sample, which may be accompanied by appreciable change of shape without complete separation of the components. The softening is such that the suppository or pessary no longer has a solid core offering resistance to the pressure of a glass rod.
4. Rupture of the gelatin shell of rectal or vaginal capsules occurs allowing release of the contents.
5. No residue remains on the perforated disk, or if a residue remains, it consists only of a soft or frothy mass, having no solid core offering resistance to the pressure of a glass rod (vaginal tablets).

Three suppositories or pessaries are used for the study. To pass the test, all the samples must have disintegrated.