Disintegration

Complete disintegration is defined as the state in which any residue of a drug product ,
except fragments of insoluble coating or capsule shell, remaining on the screen of the test
apparatus a soft mass having no palpably firm core. The disintegration test is provided to
determine compliance with the limits on disintegration stated in the individual
monographs except where the label states that the tablets or capsules are intended for use
as troches ,or are to be chewed, or are designed as modified-release dosage forms. The
disintegration test is often considered as an interim standard for solid dosage forms
where there is no dissolution test enforced. It determines whether tablets or capsules
disintegrate within a prescribed time when placed in a liquid medium under
controlled temperature and stirring motion. The test requires the use of an officially
calibrated apparatus. Generally, an NHP dosage form will disintegrate within 20
minutes under this standard disintegration procedure.

Apparatus
The apparatus is relatively simple. It consists of a basket rack holding six plastic tubes
open at the top and bottom. The bottom is covered with a 10 mesh screen. The rack is
immersed in a suitable liquid at 37 degrees C. It moves up and down at a specified rate.
One tablet is placed into each tube and the time to disintegrate and fall through the screen
is noted.

Dissolution

A dissolution test provides the dissolution rate of the active ingredients in a solid dosage
form. It tests whether the dosage form is formulated and manufactured appropriately in
order to ensure that the bioactive ingredients, or the marker compounds, will dissolve in
the gastrointestinal tract and be available for absorption. The parameters derived from
dissolution test are used to characterize the bioactive ingredient release property, and this
property is directly related to the bioavailability. The dissolution property is a very
essential quality indicator of time controlled release dosage forms.Official methods are
required for this test. The media solution for the test (often a buffer solution which
mimics the gastrointestinal fluid) is controlled at about body temperature, 37¢ªC. The test
material (tablet) is inserted into a basket which is submerged in the media. At a
prescribed interval, a measured amount of the solution is taken for analysis.

Factors that may influence a dissolution test result include the type of apparatus
used, composition and temperature of the medium, rotating speed of the basket or
the paddle, time and method of sampling as well as the method used for analysis.
The dissolution property for a solid dosage form is expressed as a percentage of the
ingredient released over the time.