Disintegration test is intended for various solid dosage forms like tablets, capsules and some semi-solid dosage forms like pessaries and suppositories. Procedure adopted for various dosage forms is as follows:
For Tablets and Capsules:
1.Add one tablet/ capsule to each of the tubes. 2.Suspend the assembly in the beaker with specified liquid. 3.Operate the apparatus for the specified time as specified in particular monograph. 4.Remove the set up from the liquid. 5.If no residue remains on the screen (if any residue remains it should be of insoluble coatings of tablets or shells), then all the six tablets/ capsules are said to be completely disintegrated. Note: a.If 1 or 2 tablets fail to disintegrate, repeat the same procedure on 12 additional such units, such that we must make sure that not less than 16 out of a total of 18 tablets tested disintegrate. b.If any monograph suggests the use of disc, then a disc is to be added.
For Enteric Coated Tablets:
1.Add one tablet into each of the six tubes. 2.Suspend the assembly in a beaker with 0.1 M Hcl. 3.Operate without discs for 2 hrs. (Unless otherwise stated in the monograph). 4.Remove the set up from the liquid. 5.Replace the liquid in beaker with mixed phosphate buffer of pH 6.8. 6.Add a disc to each tube and operate the apparatus for further 1 hr. 7.Remove the apparatus from the liquid. 8.If no residue remains on the screen, (if any residue remains it should be of insoluble coatings of tablets), then the six tablets are said to be completely disintegrated. Note: a.If the tablet fails to disintegrate because of adherence to the disc, the test is be repeated on a further 6 tablets without the discs.
For Moulded Pessaries and Suppositories:
1.Place a pessary or a suppository on the lower perforated disc of the metal device. 2.Insert the device into the cylinder and attach this to the sleeves. 3.The same operation is repeated with further two pessaries or suppositories and metal devices and sleeves. 4.If specified, place each piece of apparatus in a vessel containing 4 liters of water at a temperature of 36-37 oc, fitted with a slow stirrer and a means of holding the top of apparatus 90 mm below the surface of water. Alternatively, all the three pieces of apparatus may be placed together in a vessel containing 12 liters of water. 5.After each 10 min invert each apparatus without removing from the liquid. 6.Disintegration is said to be completed when the moulded pessary or suppository: -is completely dissolved -has dispersed into its component parts or *remains on the surface--- in the case of melted fatty substances *sinks to the bottom------- in the case of insoluble powders *dissolves------------------ in the case of soluble components or may be distributed in one or more of these ways -has become soft with appreciable change in shape, consisting of only a soft mass having no solid core which cannot be pressed with a glass rod.
For Compressed Pessaries:
1.Place the apparatus in a vessel with water maintained at a temperature of 36-37 oc. 2.Adjust the level of the liquid by the gradual addition of water at 36-37 oc until the perforations in the metal disc are just covered by a uniform layer of water. 3.A compressed pessary is placed on the upper perforated disc and covers the apparatus with a glass plate to ensure humid atmosphere. 4.The same operation is repeated with a further two compressed pessaries. 5.Disintegration is said to be complete: -If we find no residue on the perforated plate or -If there is any residue it should consists only of a solid mass having no solid core which cannot be pressed with a glass rod. In summary the usual medium used is water (neutral) for most of the dosage forms; in some cases we are using acidic and basic medium case of for ex: Enteric coated ones the usual procedure is first we are dipping in Hcl to mimic the gastric fluid medium and then we are using an alkaline medium to dissolve the enteric coated phalate layers mimicking the intestinal environment. In general the specification of temperature is not so important in case of solid dosage forms where as in case of semi-solid dosage forms being made of lipids temperature should be specified in-order to avoid melting of lipids. The use of discs is to avoid floating of dosage units ensuring uniform exposure of medium to all the surfaces of the dosage unit.
Indian Pharmacopeia, 2007, Volume 1, Published by The Indian Pharmacopeia Commission, Ghaziabad; Disintegration Tests 2.5.1