Quality control tests for
capsules
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Quality control tests for capsules
Finished capsules are subjected to a
number of tests in accordance with
compendial standards and regulatory
requirements for unit dose capsule
products. These batteries of tests help
identify whether the batch is acceptable
for marketing or its intended usage.
Finished capsules are evaluated by the
following tests:
a. Permeability and sealing
Soft gelatin capsules are tested for
physical integrity (absence of leakage)
by visual inspection. Similarly, hard
gelatin capsules are tested for any
breach of physical integrity (breakage
or opened cap and body).
b. Potency and impurity content
All capsules are tested for drug content
(potency, as a per cent of label claim).
In addition, most drug products are
tested for related substances or
impurities. These must meet predefined
specifications for a batch to be
acceptable.
c. Weight variation test
The uniformity of dosage units may be
demonstrated by determining weight
variation or content uniformity. The
weight variation method is as follows.
d. Weight variation test for hard gelatin
capsules
Ten hard gelatin capsules are usually
weighed individually and the contents
are removed. The emptied shells are
individually weighed and the net
weight of the contents is calculated by
subtracting the weight of the shell from
the respective gross weight. The content
of active ingredient in each capsule
may be determined by calculation
based on the per cent drug content in
the formulation.
e. Weight variation test for soft gelatin
capsules
For soft gelatin capsules, the gross
weight of 10 gelatin capsules is
determined individually. Then each
capsule is cut open with a suitable
clean, dry cutting instrument (e.g.,
scissors or a sharp open blade), and the
contents are removed by washing with
a suitable solvent (that dissolves the fill
but not the shell). The solvent is allowed
to evaporate at room temperature over
a period of about 30 minutes, followed
by weighing of the individual washed
shells. The net contents are calculated
by subtraction and the content of active
ingredient in each of the capsules can
be determined by calculation based on
the per cent drug content in the
formulation.
Fill-weight variation of capsules is
often a function of equipment setup
and filling operation. An automated
capsule sizing machine and/or weight
checker is frequently used to discard
over- or underfilled capsules.
f. Uniformity of content
This test is performed only when the
content is specified in the individual
monographs and when capsules fail
weight variation test. If the weight of
capsules is completely filled no need of
this test.
g. Disintegration time test for capsules
Disintegration of hard and soft gelatin
capsules is evaluated to ensure that the
drug substance is fully available for
dissolution and absorption from the
gastrointestinal tract. The compendial
disintegration test for hard and soft
gelatin capsules follows the same
procedure and uses the same apparatus
described in the article “Quality
Control Tests for Tablets”.
The capsules are placed in the
basket-rack assembly, which is
repeatedly lowered 30 times per minute
into a thermostatically controlled bath
of fluid at 37 ± 2 ˚C and observed over
the time described in the individual
monograph.
To fully satisfy the test, the capsules
disintegrate completely into a soft mass
with no firm core and only some
fragments of the capsule shell.
h. Dissolution test for capsules
Drug absorption and physiological
availability depend on the drug
substance being in the dissolved state
at the site of drug absorption. The rate
and extent of dissolution of the drug
from the capsule dosage form is tested
by a dissolution test. This test provides
means of quality control in ensuring
that different batches of the drug
product have similar drug release
characteristics and
that a given batch has similar
dissolution as the batch of capsules that
was shown initially to be clinically
effective.
The compendial dissolution test for
capsules uses the same apparatus,
dissolution medium, and test as that
for uncoated and plain coated tablets.
However, in instances in which the
capsule shells interfere with the
analysis, the contents of a specified
number of capsules can be removed
and the empty capsule shells dissolved
in the dissolution medium before
proceeding with the sampling and
chemical analysis.
If the capsule floats on the surface of
the dissolution fluid, a small, loose
piece of nonreactive material, such as a
few turns of a wire helix, may be
attached to the dosage form to force it
to sink to the bottom of the vessel.
i. Moisture content
Water content of the entire capsule or
the capsule contents are determined by
Karl Fisher titrimetry to enable the
correlation of water content with the
degradation profile or drug-release
characteristics of capsules.
j. Moisture permeation test
The USP requires determination of the
moisture-permeation characteristics of
single-unit and unit dose containers to
assure their suitability for packaging
capsules. The degree and rate of
moisture penetration is determined by
packaging the dosage unit together
with a colour-revealing desiccant
pellet, exposing the packaged unit to
known relative humidity over a
specified time, observing the desiccant
pellet for colour change (indicating
absorption of moisture) and comparing
the pre-test and post-test weight of the
packaged unit.
