1. Evaluationofcapsules
By
Shaik Sana Banu,
Third year.
Rao’s college of pharmacy,
Nellore.

2. Capsule
Definition :
Capsule is a solid dosage form in which the
drug is enclosed in a hard or soft soluble
container, usually of a form of gelatin.

3. Evaluation tests for
capsules
Evaluation tests for capsules are listed below:
I. Stability tests
 Shell integrity test
 Determination of shelf life
II. Invariability tests
 weight variation
 Content uniformity
III. Disintegration test
IV. Dissolution test
V. Moisture permeation test

4. I. Stability tests
 Stability tests for capsules are performed to
know the integrity of gelatin capsule shell
(but not to known the stability of
therapeutically active agent) and for
determining the shelf life of capsules.
 The test helps in improving the quality of
contents of capsule shell and for choosing the
appropriate retail package.

5. Contd….
 Before actually performing the tests following fact:
The capsule shell are to be stabilized to know
atmospheric condition with relative humidity about 20-30%
and temperature about 21-24⁰c.
a) Shell integrity test:
This test is performed to find out the integrity of
capsule shell.The standard capsule shells kept at the room
temperature 40⁰c and 80% RH becomes more soft, sticky
and swollen.
b) Determination of shelf life:
Shelf life or the expiry date of packed capsules is
determined under normal storage conditions.

6. II. Invariability tests
 The invariability in the medicaments packed
in the capsule shells can be determined by
performing the following tests:
 Weight variation test
 Content uniformity test

7. III. Disintegration test
 Disintegration test is a method to evaluate the rate
of disintegration of solid dosage forms.
 Disintegration is defined as the breakdown of solid
dosage form into small particles after it is ingested.
 The shell pieces after disintegration may
agglomerate forming large mass of gelatin taking
more time to dissolve and may adhere to the mesh
thus, blocking the holes.
 According to USP, place one dosage unit in each of
the tubes of the basket with water or any other
specified medium (depends on individual
monograph) maintained at 37.3°C.

8. Contd…
 Attach a removable wire cloth with a plain
square weave of 1.8-2.2 mm of mesh aperture
and a wire diameter of 0.6-0.655mm to the
surface of upper rack of the basket assembly.
 Observe the capsules for a time limit , at the end
of prescribed time, all of the capsules must have
been disintegrated excluding the fragments
from the capsule shell.
 If 1 or 2 capsules fail, the test should be repeated
on additional of 12 capsules.
 Then, not fewer than 16 of the total 18 capsules
tested should disintegrate completely.

9. Disintegration apparatus

10. IV. Dissolution test
 Dissolution test is an official method to
determine the dissolution rate of a solid
dosage form.
 Dissolution rate is defined as the rate at
which the drug is released into the systemic
circulation from the dosage form.

11. Contd…
 Dissolution test apparatus:-
 Apparatus-I (rotating basket dissolution
apparatus):
 Small wire mesh size basket – 22
 Temperature - 37±5⁰c
 Rotated speed – 25-150rpm
 Dissolution medium height
from the bottom of the
vessel – 23-27mm.

12. Contd…
 Apparatus-2 (rotating paddle dissolution
apparatus):
 Small wire mesh size: 22
 Dissolution medium height from the bottom
of the vessel – 23-27mm
 Temperature - 37±5⁰c
 Rotated speed – 25-150rpm

13. V. Moisture permeation test
 This test is carried out to assure the suitability
of containers for packaging of capsules.The
moisture permeating feature of capsules
packaged in
• Single unit containers-blister pack or strip
pack.
• Unit dose containers glass or plastic bottle is
to be determined.