QUALITY CONTROL OF

SUPPOSITORIES

Ms. RIFFAT
 Objectives
• Discuss the liquifaction test
• Discuss about Fragiltiy/Breaking Test.
• Discuss about chemical testing methods such
as Dissolution test
 Liquefaction/Softening Time Test
• Modified form of Melting range test.
• U-tube immersed partially in
constant temperature water bath.
• It is a measure of physical stability of product
• Temp: 35.5 -37 C
• Ref: Leon Lachmann or hand out
 Breaking/Fragibility test
• Fragibility test/breaking/mechanical strength
test/crushing test
• Test is designed to measure the mechanical
strength of suppository.
• A good result is at least 1.8–2 kg pressure.
 Mechanical strength/breaking
apparatus:

. Double wall chamber

. Test suppository
. Rod
. Disc for weights
. Weights
 Contd.
• Purpose: To verify that the suppository can
be transported under normal conditions, and
administered to the patient
• Limit: A good result is at least 1.8–2
kg pressure.
 Chemical testing

• Prior to chemical testing the size of batch

is considered
• API analysis is important for batch to
batch uniformity control
• API analysis is important for within
batch content uniformity
CHEMICAL TESTING
 Dissolution Test

• Testing for the rate of in vitro release of API

from suppository
• The test measures the rate and extent of a
drug dissolving in a defined medium under
defined conditions.
 Methods

• Dissolution testing methods include the

paddle method, basket method, membrane
diffusion method/dialysis method, and the
continuous flow/bead method.

• REFERENCE : HAND OUT

 Contd.
• The investigators also concluded that
suppositories containing a surfactant behave
differently from those without and produce
the fastest dissolution rates of paracetamol.
• The presence of the surfactant makes the
suppository more sensitive to the differences
in the dissolution techniques.
Do you have any question…?

THANK YOU
 Reference
• On line book chapter” Quality control
of Suppositories”
• B.P 2011
• USP/NF