Disintegration INTRODUCTION >>>>>>>Jabs pharmatech

Approximately two thirds of all
medicines prescribed today take the
form of solid dosage forms and half
of these are tablets. These tablets
comprise a mixture of active drug and
other excipients, usually in powder
form, pressed or compacted into a
solid.
It has long been recognised that
before a tablet/hard gelatin capsule
can dissolve and hence allow the
active drug to be absorbed into the
body, it must first disintegrate into
smaller particles.
The current test apparatus described
in the Pharmacopoeia* was designed
to provide a reproducible and
standardised method of ensuring that
disintegration had taken place. Each
of the tablets to be tested is placed
in one of six vertical tubes each
measuring approx. 77.5 mm long x
21 mm inside diameter positioned in
a circular basket arrangement. The
lower end of the tubes is covered by
a 2 mm sieve mesh.
A larger basket is
available for large
tablets, capsules
and boluses
according to Ph.Eur.
Chapter 2.9.1 Test
B and for dietary
supplements
according to USP
Chapter <2040>.

Disintegration
The basket assembly is raised and
lowered in simulated gastric fluid
at body temperature (37 degrees
Celsius) through a distance of 55 mm
at a constant frequency of 30 cycles
per minute. A plastic disc of defined
proportions “hammers” the tablet
during the operation, thus assisting in
the disintegration process.
The tablet is said to pass the test
providing that no tablet residue
remains on the sieve mesh after the
designated time, typically 30 minutes
for ordinary tablets and 60 minutes
for enteric coated tablets.
All Copley Tablet Disintegration

Testers feature:
• Sturdy, robust design, including
novel “quick release” basket,
one-piece water bath and
independent heater/circulator
• Simple, easy-to-use operation
ensures that the number of
operations required to perform a
test are kept to a minimum
• Full supporting documentation
(including full IQ/OQ/PQ
qualification documentation if
required)
• Special accessories available for
hard/soft gelatin capsules and large
tablets, capsules and boluses