Pharmaceutical technology
according to Pharmacopoeias (PH.EUR. / USP / JP).
Overview of methods:
This test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions presented below.
For the purposes of this test, disintegration does not imply complete dissolution of the unit or even of its active constituent. Complete disintegration is defined as that state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the discs, if used, is a soft mass having no palpably firm core.
This test is provided to determine compliance with the dissolution requirements for solid dosage forms administered orally. In this chapter, a dosage unit is defined as 1 tablet or 1 capsule or the amount specified.