What is Disintegration:
It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (environmental) for a group of tablets/capsules to disintegrate into particles.
Disintegration is to be Performed to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
Since its inception in the 1930s, disintegration testing has become an important quality control (QC) test in pharmaceutical industry, and disintegration test procedures for various dosage forms have been described by the different pharmacopoeias.
In 1948, the British Pharmacopoeia (BP) adopted a disintegration test for tablets based on observing the disintegration behavior in test tubes.
The basket-rack assembly apparatus, first adopted by the United States Pharmacopoeia (USP) in 1950.
Basket-Rack Assembly Parameters & Specification :
|Beakers||1000 mL each|
|Height of beaker||138 – 160 mm|
|Inside diameter||97- 115 mm|
|Frequency of shaft raising and lowering basket||29 – 32 CPM|
|Distance of shaft for raising & lowering the basket||53 – 57 mm|
|Diameter of tube holding plates||88 – 92 mm|
|Thickness of tube holding plates||5 – 8.5 mm|
|Six open-ended transparent tubes of length||75 – 80 mm|
|Inner tube diameter||20.7 – 23 mm|
|Stainless steel wire cloth (square weave aperture)||1.8 – 2.2 mm|
|Wire diameter||0.57 – 0.66 mm|
Disks : The use of disks is permitted only where specified or allowed in the monograph.
MOC (Material of construction) = Plastic material having a specific gravity between 1.18 – 1.20
Thickness & Diameter = 9.5 ± 0.15 mm & 20.7 ± 0.15 mm
How to perform Disintegration test :
Place 1 dosage form in each of six tubes of basket and add a disk (if prescribed)
Operate the apparatus using water or specified medium as the immersion fluid, maintained at 37 ± 2º C.
At the end of the time limit as specified, lift the basket from fluid and observe the tablets, all the tablets have to disintegrate completely.
Disintegration Time :
- Uncoated Tablet 15 min as per BP & 30 min as per USP
- Sugar Coated Tablet 60 min as per BP
- Film Coated Tablet 30 min as per BP
- Plain Coated Tablets DT in specific medium for 30 min as per USP
- Enteric Coated Tablets DT in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.
- Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
- Effervescent Tablets 1 tablet in 200 mL water for 5 min ( 15- 25º C )
as per BP
- Buccal Tablets 4 hrs as per USP.
- Soluble Tablets 3 min ( 15- 25º C ) as per BP.
- Chewable Tablets are not require to comply with test.
- Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl and phosphate buffer pH 6.8 for further 60 min as per BP.
- Hard gelatin capsule DT 30 min as per BP & USP.
- Soft gelatin capsule DT 30 min as per BP .
- Oral lyophilizates DT disintegrate within 3 min Using a beaker containing 200 mL of water at 15 °C–25 °C. Six units tested, 1 at a time as per BP & phEur.
- Cycles of shaft holding the tube basket (1 min) = Limit 29-32 Cycles Per Minutes
- Distance covered by the shaft = Limit 55 ± 2 mm
- Beaker Temperature (60 min) = Limit 37º ± 2º C
- Sieve integrity check (Aperture opening) = Limit 1.8 – 2.2 mm
- Time in 3 min = Limit 3 min ± 3 sec
- Time in 15 min = Limit 15 min ± 18 sec
- Time in 30 min = Limit 30 min ± 36 sec
- Time in 60 min = Limit 60 min ± 1 min 12 sec
- Time in 120 min = Limit 120 min ± 2 min 24 sec
- Start the instrument and record the time with calibrated stop watch
Sieve integrity check :
- Intactness of each sieve opening
- any cracks, abrasion
- Aperture opening a = L – 5W/6 where L= Length of 6 opening and W= Wire diameter and No. of opening =6
- Acceptance Criteria 1.8 – 2.2 mm
- Measure the length of six aperture of basket mesh with the help of calibrated vernier calliper
- Measure the Diameter of basket mesh wire with the help of calibrated vernier calliper.
- Generally the test is carried out once.
- In case at the end of the time limit if 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets.
- The requirement is met if not less than 16 of the total of 18 tablets tested are disintegrated.