EVALUATION OF SUPPOSITORIES

Appearance
Uniformity of weight
Disintegration
Test for uniformity of drug content
Breaking test
Softening time
Test of melting rang
 Test for Dissolution rate
 APPEARANCE
• Odor
• Color
• Surface condition
• Shape
• They may contain several layers
• Instabilities are identified based on changes in
surface texture ,color,odor
 WEIGHT VARIATION
• Weigh individually 20 suppositories
• Weigh 20 at a time
• Calculate average weight
• Limit: not more than 2 suppository differ from
the average weight by more than 5% and no
suppository differs from average weight by
more than 10%
 HARDNESS or BREAKING TEST

1. PLACE THE SUPPOSITORY IN THE INSTRUMENT

2. ADD 600g, leave it for 1min

3. If not broken add 200 gm every 1minute untill

suppository is broken
 MELTING RANGE TEST
• Macro-melting range is a measure of the time it
takes for the entire suppository to melt when
immersed in a constant-temperature (37ºC)
water bath.
• USP tablet disintegration apparatus is used
• THE SUPPOSITORY IS CONSIDERED
DISINTERGRATED if:
• It is completely dissolved
• Become soft “change in shape” with formation of
core which is not resistant to pressure with glass
rod
 Disintegration
• For each 3 suppositories examine the state of
the sample
1. After 30minutes – fat-based suppository
2. After 60min – water –based suppository
 Uniformity of mass
• Not more than 2 of the individual masses
should deviate from the average mass by
more than 5 % , and none by more than 10%
 Softening time test
• u tube is partially immersed in a constant
bath and is maintained at a temperature
between 35 to 37 c
• There is a constriction in the tube in which the
suppository is kept and above is a glass rod is
kept
• Time taken for a glass rod to go through the
suppository and reach the constriction is
known as liquefaction time or softening time
 Dissolution test
• Wire mesh basket or dialysis tubing is used for
invitro release from suppositories
 Stability testing
• Cocoa butter suppositories on storage , BLOOM
i.e they form a white powdery deposit on the
surface
• This can be avoided by storing them at uniform
cool temperatures and by wrapping them in foils
• Fat based suppositories harden on storage [ shift
in melting range to become more stable
polymorphic form of base ]
• Softening time test and DC can be used to test
stability