Quality control of suppositories
Monitoring the quality of suppositories means monitoring and ensuring the quality of the suppositories, whether in terms of their appearance, smell, color, ensuring the distribution of the drug, the strength of the hardness of the suppositories, and the melting point range to ensure that they melt at a body temperature of 37 degrees Celsius, consider some of the following points:
1- Appearance: they include odor, color, and shape.
2- Weight Uniformity: Quality can be measured by taking the weight of 20 suppositories from the package, collecting them, then dividing by the number of suppositories to take the average,all suppositories must be similar in weight.
3- Suppository melting test: This test is necessary to do as it determines the effect of the release of the drug from the suppository. This test is done by taking a sample from the package group and then placing it in a water bath at 37 degrees Celsius (based on normal body temperature) and calculating the time required for the suppository to dissolve.,by changing the shape of the suppository.
4- breaking test ( hardness ): The cracking test was designed as a method of measurement
The brittleness and elasticity of the suppository is essentially an oily base support , The extent of hardness is measured by placing the suppositories in a specific device with a controlled temperature, then placing 600 grams on top of the suppositories and observing the time, and every minute 200 grams are added until we notice that the suppositories have become brittle and broken, sometimes the suppositories may need to put a weight on top of them from 1.8-2 kg .
5- Dissolution test: Using various types of devices such as a wire mesh basket or dialysis tubes are used to test the in vitro release of suppositories.
6- Liquefaction time: In this test, the U tube is partially immersed in a constant temperature bath and kept at a temperature between 35 to 37°C.
There is a constriction in the tube in which the suppository is kept
and over the suppository with a glass rod. time taken for
the glass rod passing through the suppository and reaching contractility is known as fluidization time or softening time.
7- stability test: It is a test in which the time required for the suppository to become liquid is measured under pressure similar to the pressure in a rectum, where the suppository is placed in a water bath at a temperature of 37 degrees Celsius.