For Uncoated or Plain coated Tablets
Place 1 dosage unit in each of the 6 tubes of the basket-rack assemblyand, if prescribed, add a disk. Operatethe apparatus, using water orthe specified medium as the immersion fluid, maintained at 37 ± 2°. At the end of the time limitspecifiedin the monograph,lift the basket-rack assemblyfrom the fluid, and observe the tablets. All of thetabletsshouldhave disintegrated completely. If 1 or 2 tablets fail to disintegrate completely, repeat the test on12 additional tablets. The requirement is met if not fewer than 16 of the totals of 18 tablets are disintegrated.
For Delayed-Release Tablets and Capsules
Place 1 dosage unit in each of the 6 tubes of the basket. If the dosage units are not sugar-coated, proceed to the Acid stage. If testing tablets that have a soluble external sugar coating, immerse the basket in water at room temperature for 5 min and then immediately proceed to the Acid stage. If specified in the monograph, add 1 disk to each tube. 0.1 M hydrochloric acid, or simulated gastric fluid TS, or as specified in the monograph for Acid stage & pH 6.8 phosphate buffer, or simulated intestinal fluid TS, or as specified in the monograph for buffer stage. No dosage unit shows evidence of disintegration, cracking, or softening in Acid stage& Apply theCriteria for Uncoated or Plain-Coated Tablets for buffer stage.
For Buccal Tablets, Sublingual Tablets, Capsules, Tablets for Oral Suspension, Tablets for Oral Solution, Tablets for Topical Solution, Orally Disintegrating Tablets, and Chewable Tablets - Apply the Procedure and Criteria for Uncoated or Plain-Coated Tablets.
For Effervescent Tablets and Effervescent Granules for Oral Solution - Place 1 tablet or 1 dose of the effervescent granules in each of 6 beakers containing 200 mL of water. A suitable beaker will have a nominal volume of 250–400 ml. The requirement is 5 min or as specified in the individual monograph.
For Test A (normal size tablet and capsules):The apparatus consists of a basket-rack assembly, a 1000-mL low-form beaker 138–160 mm in height and having an insidediameter of 97–115 mm for the immersion fluid, a thermostatic arrangement for heating the fluid 35°–39°, and a device for raisingand lowering the basket in the immersion fluid at a constant frequency rate 29–32 cycles/min through a distance of NLT 53 mm andNMT 57 mm.
- The basket-rack assembly consists of 6 open-ended transparent tubes, each 75.0–80.0 mm long and having an inside diameter of 20.7–23 mm and a wall 1.0–2.8 mm thick; the tubes are held in a vertical position by two plates, each 88–92 mm in diameter and 5–8.5 mm in thickness, with 6 holes, each 22–26 mm in diameter, equidistant from the center of the plate and equally spaced from one another.
- The use of disks is permitted only where specified or allowed in the monograph. If specified in the individual monograph, each tube is provided with a cylindrical disk 9.35–9.65 mm thick and 20.55–20.85 mm in diameter.
For Test B (large tablets and capsules)- the main part of the apparatus (Figure 2) is a rigid basket-rack assembly supporting 3 cylindrical transparent tubes77.5 ± 2.5 mm long, 33.0 mm ± 0.5 mm in internal diameter and with a wall thickness of 2.5 ± 0.5 mm.Test 6 tablets or capsules either by using 2 basket-rack assemblies in parallel or by repeating the procedure. In each ofthe 3 tubes place 1 tablet or capsule and, if prescribed, add a disc; suspend the assembly in the beaker containing the specifiedliquid. Operate the apparatus using water as the immersion fluid unless another liquid is specified for the prescribed period,withdraw the assembly and examine the state of the tablets or capsules. To pass the test all 6 of the tablets or capsules must have disintegrated.
As per WHO IP:
- For uncoated tablets: Operate the apparatus for 15 minutes, unless otherwise specified in the individual monograph.
- For soluble tablets:Soluble tablets (that are intended to be dissolved in water giving a clear or slightly opalescent solution) disintegrate within 3 minutes and using water at 15–25° C.
- For dispersible tablets:disintegrate within 3 minutes and using water at 15–25° C.
- For effervescent tablets: disintegrate within 5 minutes and using 200 ml water at 15–25° C.
- For sugar coated tablets: operate the apparatus for 60 minutes, unless otherwise specified in the individual monograph.
- For film coated tablets: Operate the apparatus for 30 minutes.
- For Delayed-release tablets: In acid phase operate the apparatus for 2 hours, unless otherwise specified in the individual monograph (but in any case, for not less than 1 hour). In basic phase operate the apparatus for 60 minutes and examine the state of the tablets.
Reference:
- USP-NF 〈701〉
- WHO
