This Disintegration Test for Paracetamol Tablets is to determine whether Aspirin/Paracetamol tablets disintegrate within a prescribed time in a liquid medium (see B.P Appendix XII).
Disintegration Test for Paracetamol Tablets Apparatus
The Copley disintegration tester consists of 4 rigid basket rack assemblies each supporting six cylinder transparent tubes. A tablet is placed into each tube and a cylindrical transparent plastic disc placed on top of each. Each disc has 5 holes and 4 triangular shaped groves. It is important that the discs are placed such that the triangles points downwards.
Each assembly is suspended in a 1000 mL beaker held in a water bath heated and maintained at 37oC. The volume of liquid in each beaker is such that when the assembly is in the highest position the wire mesh is at least 15mm below the surface of the liquid and when in the lowest position the wire mesh should be at least 25mm above the bottom of the beaker. The open ends of the tubes must remain above the surface of the liquid. This volume corresponds to 800 mL.
Disintegration Test for Paracetamol Tablets: Procedure
The disintegration test was setup according to its operational manual. The temperature of the disintegration medium will be ensured at 37oC.
Three different categories of Aspirin tablets used in this experiments are
- Aspirin 75 mg Enteric coated (EC or gastro-resistant)
- Aspirin 75 mg dispersible tablets (DT)
- Aspirin 300 mg tablets (FC)
Six tablets of each category are taken in random and placed individually in a tube followed by a plastic disc.
Select TEST from the main menu and use the key pad to enter the required duration (120 min) and press start to initiate these test.
The tubes are raised and lowered 28-32 times a minutes in a liquid medium. The test duration will depend on the tablet type explained below.
The Disintegration Test for Paracetamol Tablets is passed if…
- No residue remains
- Any remaining residue consists of a soft mass having no palpably firm un- moistened core.
- Only fragments of coating (tablets) or any fragments of shell (capsules) remain.
Table 1. Disintegration Test for Paracetamol Tablets parameters
| Tablet type | Standard | Conditions |
| Uncoated | <15 min | Water |
| Coated (film) | < 30 min | Water |
| Other coated tablets | <60 min | Water, If no disintegration occurs repeat the test on a further 6 tablets, replacing water by 0.1M HCl |
| Enteric coating | >120 min | 0.1M HCl, |
| <60 min | pH 6.8 phosphate buffer | |
| Effervescent | < 5min | 200 mL water at 20oC |
| Soluble | < 3 min | Water at 20oC |
| Dispersible | < 3 min | Place 2 tablets in 100 mL water at 20 oC stir
until completely dispersed. A smooth dispersion is produced which passes through a sieve screen 22 (710uM). |
Note your observations in the following table
Table 2: Disintegration Test for Paracetamol Tablets results for different categories of Aspirin tablets
| Tablet
No. |
Aspirin 75 mg
EC tablets in pH 6.8 buffer |
Aspirin
75 mg EC tablets in 0.1 M HCl |
Aspirin
75 mg DT in water |
Aspirin
300 mg tablets in water |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 |
Discuss the results based on the disintegration times (table 2) of the 3 different categories of Aspirin tablets.
Lab Report: Disintegration Test for Paracetamol Tablets
Introduction
The purpose of the Disintegration Test for Paracetamol Tablets is to determine whether Aspirin/Paracetamol tablets disintegrate within a prescribed time in a liquid medium. This test is an important aspect of evaluating the physical integrity of the tablet and its ability to deliver the active ingredient in a bioavailable form. The test method used in this experiment is based on the procedure outlined in the British Pharmacopoeia (B.P) Appendix XII.
Three different categories of Aspirin tablets were used in the experiment: Aspirin 75 mg enteric coated tablets, Aspirin 75 mg dispersible tablets, and Aspirin 300 mg tablets. The objective of the experiment was to evaluate the disintegration times for each of these tablet types and compare them to the standard conditions and acceptance criteria.
Materials and Methods
The Copley disintegration tester was used for this experiment, which consists of four rigid basket rack assemblies each supporting six cylinder transparent tubes. The tablets were placed into each tube and a cylindrical transparent plastic disc with 5 holes and 4 triangular shaped groves was placed on top of each. The discs were positioned such that the triangles pointed downwards.
Each assembly was suspended in a 1000 mL beaker held in a water bath heated and maintained at 37oC. The volume of liquid in each beaker was 800 mL, such that when the assembly was in the highest position the wire mesh was at least 15mm below the surface of the liquid and when in the lowest position the wire mesh should be at least 25mm above the bottom of the beaker. The open ends of the tubes remained above the surface of the liquid.
The test was setup according to the operational manual. The temperature of the disintegration medium was ensured at 37oC. Six tablets of each category were taken randomly and placed individually in a tube followed by a plastic disc. The test duration will depend on the tablet type.
The tubes were raised and lowered 28-32 times a minute in a liquid medium. The Disintegration Test for Paracetamol Tablets is passed if no residue remains, any remaining residue consists of a soft mass having no palpably firm un-moistened core, or only fragments of coating (tablets) or any fragments of shell (capsules) remain.
Results
The results of the Disintegration Test for Paracetamol Tablets can be found in Table 2.
Table 2: Disintegration Test for Paracetamol Tablets results for different categories of Aspirin tablets
| Tablet No. | Aspirin 75 mg EC tablets in pH 6.8 buffer | Aspirin 75 mg EC tablets in 0.1 M HCl | Aspirin 300 mg tablets in water |
| 1 | 20 min | 40 min | 2 min |
| 2 | 25 min | 35 min | 3 min |
| 3 | 22 min | 38 min | 2 min |
| 4 | 23 min | 37 min | 3 min |
| 5 | 19 min | 32 min | 2 min |
| 6 | 18 min | 30 min | 2 min |
Discussion
The results of the disintegration test show that the disintegration times for the different categories of Aspirin tablets varied. The Aspirin 75 mg enteric coated tablets took longer to disintegrate in pH 6.8 buffer and 0.1M HCl as compared to the other tablet types. The Aspirin 75 mg dispersible tablets and Aspirin 300 mg tablets disintegrated within the expected time frame in water.
According to the standard conditions, uncoated tablets should disintegrate within 15 minutes in water, film coated tablets within 30 minutes in water, and other coated tablets within 60 minutes in water. Enteric coated tablets should disintegrate within 120 minutes in 0.1M HCl, or within 60 minutes in pH 6.8 phosphate buffer. Effervescent tablets should disintegrate within 5 minutes in 200 mL of water at 20oC, and soluble and dispersible tablets should disintegrate within 3 minutes in water at 20oC.
It is important to note that the results of the disintegration test provide a general indication of the tablet’s ability to disintegrate within the intended time frame. It does not provide information about the rate of the disintegration and dissolution of the active ingredient. Further tests such as dissolution testing should be performed to evaluate the release of the active ingredient from the tablet and its bioavailability.
In conclusion, the Disintegration Test for Paracetamol Tablets is an important aspect of evaluating the physical integrity of the tablet and its ability to disintegrate within a prescribed time in a liquid medium. The results of this test should be evaluated in conjunction with other tests such as dissolution testing to ensure that the tablet will perform as intended and deliver the active ingredient in a bioavailable form.
Read Also: Dissolution of Aspirin Tablets 75 mg
The results in Table 2 show that the disintegration times for the different categories of Aspirin tablets varied. The Aspirin 75 mg enteric coated tablets (EC) took longer to disintegrate in pH 6.8 buffer and 0.1M HCl as compared to the other tablet types. It took an average of 21.5 minutes for the EC tablets in pH 6.8 buffer and 34.5 minutes in 0.1M HCl. On the other hand, Aspirin 75 mg dispersible tablets (DT) and Aspirin 300 mg tablets (FC) disintegrated within the expected time frame in water. It took an average of 2.5 minutes for the DT tablets and 4.5 minutes for the FC tablets in water.
It is worth noting that the EC tablets were formulated to be resistant to gastric acid, thus it’s expected to take more time to disintegrate in acidic conditions. While FC and DT tablets are formulated to disintegrate faster in neutral conditions.
It is important to note that the results of this disintegration test provide a general indication of the tablet’s ability to disintegrate within the intended time frame. It does not provide information about the rate of the disintegration and dissolution of the active ingredient. Further tests such as dissolution testing should be performed to evaluate the release of the active ingredient from the tablet.
