Practical 4 - Dosage Performance Tests (Disintegration)

Objective: 

The objectives for disintegration test is to determine how long the time taken needed to tablet for disintegrate and whether it is disintegrate properly when placed in a liquid medium under the experimental condition in this experiment

Introduction:

Disintegration testing determines whether tablets or capsules disintegrate within a defined period of time when placed in a liquid medium .Tablet disintegration testing is used as a quality-assurance measure. This is because, for some cases if the disintegration time is too high; it means that the tablet is too highly compressed or the capsule shell gelatine is not of pharmacopoeial quality.

Apparatus and Materials:

Tablets , Copley Disintegration Tester, Thermometer and Distilled Water,500 mL distilled water, 500 mL beaker, disintegration machine (include disc, mechanical device to control up-down movement (28-32 cpm), device to control temperature (37 °C))

Procedure:

1. The disintegration test equipment was set up by following the instruction in the manual of                    operation.

2. 500 mL of distilled water was added into the beaker and then added to the disintegration  machine.     Then, the water was left until the temperature of water is about 37°C .

3. The time was set up to 60 minutes. Three tablet of the same types was added into each tube with         another 3 tablet from another group. Then, the disk was added into each tube before started the           operation.

4. The tablet in each tube was checked whether it is pass the test or not at the end of the operation.

5. The tablets pass the test if all 3 tablets disintegrate within 60 minutes. If there is any tablet that           does not disintegrate, we must pressed the tablet and if the tablet was disintegrate when we press, it     also means that the tablet comply with the test

Results:

Tablets	Dissolving rate	Type of tablets
Mefenamic Acid	Fully dissolve	Uncoated tablets
Methyldopa	Fully dissolve	Uncoated tablets
Methyldopa	Fully dissolve	Uncoated tablets
Ibuprofen	Fully dissolve	Uncoated tablets
Uphamol	Fully dissolve	Uncoated tablets
Erythromycin	Fully dissolve but leaving a thin sheets	Enteric coated tablets
Erythromycin	Fully dissolve but leaving a thin sheets	Enteric coated tablets
Cephalin	Fully dissolve	Uncoated tablets

Discussion:

The drug must first disintegrate into smaller particles before a tablet/hard gelatin capsule can dissolve and hence allow the active drug to be absorbed into the body,

During testing, the basket assembly is raised and lowered in simulated gastric fluid at 37 degrees C whilst the tablet is continually “hammered” by a plastic disk of defined proportions to simulate in vivo conditions. The tablet is said to pass the test providing that no tablet residue remains on the mesh after the designated test period.

But as mentioned earlier, this test is not a true predictor of how well the dosage form will release its active ingredient in vivo. This is because of some limitations it cannot follow. Firstly, It does not mimic conditions of gastrointestinal tract such as the muscle movement. Thus there’s no guarantee of clinical efficacy. Secondly, this test is controlled by experimental variables.

The error during disintegration test experiment is the water in the beaker may not heat up adequately. So, these may affect the disintegration process. Then, the tablet was expired. So, it may affect the disintegration rate.

Conclusion:

All of the tablets passed the disintegration test as it disintegrates completely in less than the specified time which is 1 hour. The experiment is  a success.

References:

1.       http://www.pharmainfo.net/disintegration-test