A disintegration test is a pharmaceutical quality control test that assesses the ability of a solid dosage form, such as a tablet or capsule, to break down or disintegrate into smaller particles when exposed to a liquid environment. The test helps ensure that the medication can rapidly disintegrate in the digestive system, making the active ingredients available for absorption by the body. This is important for the effectiveness of the medication, as it affects how quickly the drug becomes bioavailable. The specific disintegration requirements and methods can vary depending on regulatory standards and the type of drug product being tested.
This test determines whether dosage forms such as tablets, capsules, boluses pessaries and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions.
DISINTEGRATION TEST PROCEDURE FOR TABLETS AND CAPSULE
Place 1 dosage unit in each of the 6 tubes of the basket and, if prescribed, add a disc. Operate the apparatus using the specified medium, maintained at 37 ± 2 °C, as the immersion fluid. At the end of the specified time, lift the basket from the fluid and observe the dosage units: all of the dosage units have disintegrated completely. If 1 or 2 dosage units fail to disintegrate, repeat the test on 12 additional dosage units. The requirements of the test are met if not less than 16 of the 18 dosage units tested have disintegrated.
Place 1 dosage unit in each of the 6 tubes of the basket and, if prescribed, add a disc. Operate the apparatus using the specified medium, maintained at 37 ± 2 °C, as the immersion fluid. At the end of the specified time, lift the basket from the fluid and observe the dosage units: The tablets or capsules pass the test if all of them have disintegrated.
If 1 or 2 tablets or capsules fail to disintegrate, repeat the test on 12 additional tablets or capsules; not less than 16 of the total of 18 tablets or capsules tested disintegrate.
If the tablets or capsules adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc. The preparation complies with the test if all the tablets or capsules in the repeat test disintegrate
- Acceptance criteria :
- Uncoated tablets : Not more than 15 minutes.
- Film coated tablets : Not more than 30 minutes
- Sugar coated tablets : Not more than 60 minutes.
- Capsules : Not more than 30 minutes
For operation and calibration of disintegration test apparatus click below link:
Operation and Calibration of Disintegration Test Apparatus SOP
ENTERIC-COATED TABLETS / GASTRO-RESISTANT TABLETS
Gastro-resistant tablets are delayed-release tablets that are intended to resist the gastric fluid and to release their active substance(s) in the intestinal fluid. Usually they are prepared from granules or particles already covered with a gastro-resistant coating or in certain cases by covering tablets with a gastro-resistant coating (enteric-coated tablets).
Disintegration Test Procedure : Put one tablet into each tube, suspend the assembly in the beaker containing 0.1 M hydrochloric acid and operate without the discs for 2 hours, unless otherwise stated in the individual monograph. Remove the assembly from the liquid. No tablet shows signs of cracks that would allow the escape of the contents or disintegration, apart from fragments of coating.
Replace the liquid in the beaker with mixed phosphate buffer pH 6.8, add a disc to each tube and operate the apparatus for a further 60 minutes. Remove the assembly from the liquid. If the tablet fails to comply because of adherence to the disc, repeat the test on a further 6 tablets without the discs. The tablets pass the test if all six have disintegrated.
- Acceptance criteria :
- Acid Stage : Should not disintegrated 120 minutes.
- Buffer stage : Not more than 60 minutes.
MODIFIED-RELEASE TABLETS
EFFERVESCENT TABLETS
Effervescent tablets are uncoated tablets generally containing acid substances and carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration.
Disintegration Test Procedure : Place 1 tablet in a beaker containing 200 mL of water at 15-25 °C; numerous bubbles of gas are evolved. When the evolution of gas around the tablet or its fragments ceases the tablet has disintegrated, being either dissolved or dispersed in the water so that no agglomerates of particles remain. Repeat the operation on 5 other tablets. The tablets comply with the test if each of the 6 tablets used disintegrates in the manner prescribed within 5 min, unless otherwise justified and authorised.
Acceptance criteria : Not more than 5.0 minutes.
SOLUBLE TABLETS
Soluble tablets are uncoated or film-coated tablets. They are intended to be dissolved in water before administration. The solution produced may be slightly opalescent due to the added excipients used in the manufacture of the tablets.
Disintegration Test Procedure : Soluble tablets disintegrate within 3 min, using water at 15-25 °C as the liquid medium.
Acceptance criteria : Not more than 3.0 minutes.
DISPERSIBLE TABLETS
Dispersible tablets are uncoated or film-coated tablets intended to be dispersed in water before administration, giving a homogeneous dispersion.
Disintegration Test Procedure : Dispersible tablets disintegrate within 3 min, using water at 15-25 °C as the liquid medium.
Acceptance criteria : Not more than 3.0 minutes.
ORODISPERSIBLE TABLETS
Orodispersible tablets are uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed.
Disintegration Test Procedure : Orodispersible tablets disintegrate within 3 min, using water as the liquid medium.
Acceptance criteria : Not more than 3.0 minutes.
CHEWABLE TABLETS
Chewable tablets are intended to be chewed before being swallowed.
Tablets For Use In The Mouth : Tablets for use in the mouth are usually uncoated tablets. They are formulated to effect a slow release and local action of the active substance(s) or the release and absorption of the active substance(s) at a defined part of the mouth.
ORAL LYOPHILISATES
Oral lyophilisates are solid preparations intended either to be placed in the mouth or to be dispersed (or dissolved) in water before administration.
Disintegration Test Procedure : Place 1 oral lyophilisate in a beaker containing 200 mL of water at 15-25 °C. It disintegrates within 3 min. Repeat the test on 5 other oral lyophilisates. They comply with the test if all 6 have disintegrated.
Acceptance criteria : Not more than 3.0 minutes.
MOULDED PESSARIES, MOULDED SUPPOSITORIES, SHELL PESSARIES AND SHELL SUPPOSITORIES
Disintegration Test Procedure : Place a pessary or suppository on the lower perforated disc of the metal device and then insert the device into the cylinder and attach this to the sleeves. Repeat the operation with a further two pessaries or suppositories and metal devices and sleeves. Unless otherwise specified, place each piece of apparatus in a vessel containing at least 4litres of water at 36° to 37° and fitted with a slow stirrer and a means of holding the top of the apparatus 90 min below the surface of the water. A suitable thermostatic arrangement may be provided for maintaining the temperature of the bath. Alternatively, all three pieces of apparatus may be placed together in a vessel containing at least 12 liters of water. After each 10 minutes invert each apparatus without removing it from the liquid.
- Disintegration is considered to be complete when the moulded pessary or suppository;
- Is completely dissolved or
- has dispersed into its component parts, which may remain on the surface (in the case of melted fatty substances), sink to the bottom (in case of insoluble powders) or dissolve (in case of soluble components) or may be distributed in one or more of these ways or
- has become soft with appreciable change in shape, without necessarily separating into its components, and the mass has no solid core which cannot be pressed with a glass rod.
COMPRESSED PESSARIES
Disintegration Test Procedure : Place the apparatus in a vessel of suitable diameter containing water at 36° to 37° .Adjust the level of the liquid by the gradual addition of water at 36° to 37° until the perforations in the metal disc are just covered by a uniform layer of water. Place one compressed pessary on the upper perforated disc and cover the apparatus with a glass plate to ensure a humid atmosphere. Repeat the operation with a further two compressed pessaries.
- Disintegration is considered to be complete when;
- there is no residue on the perforated plate or
- if a residue remains, it consists only of a soft mass having no solid core which cannot be pressed with a glass rod.
For Electrolab Disintegration Test Apparatus SOP click below link.
Electrolab Disintegration Test Apparatus SOP
