5.3 Disintegration test for tablets and capsules

Draft proposal for revision of a General Method in the 4th Edition of the International Pharmacopoeia (April 2011). Please addess any comments to Quality Assurance and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerland. Fax: [phone] or e-mail schmidth® who.int. Working documents are available for comment at http://who.int/ medicines.

[Note from Secretariat. During its meeting in October 2010, the Expert Committee on Specifications for Pharmaceutical Preparations recommended that the current method described in The International Pharmacopoeia for the disintegration test for tablets and capsules should be replaced by the internationally harmonized general test available. To this effect the following revision of method "5.3 Disintegration test for tablets and capsules" is proposed.

The revision implies both changes of and additions to dimensions and tolerances in the description of the disintegration apparatus. The possibility for retesting when one or two units fail in the first step of the procedure is introduced, as is the possibility to use automatic detection employing modified discs in cases where the use of discs is prescribed.]

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.

Apparatus

The apparatus...