Suppository: A suppository is a medicated solid dosage form which is meant to be used

in the body cavities. These are commonly used rectally, vaginally, and occasionally
urethrally.
PRINCIPLE:
In the body cavities this soften melt dissolve, and exert localized or systemic effect.
HISTORY: A suppository is not a modern invention. It was used since a few hundreds of
years and was well known to the Egyptians and other ancient races of people. Ancient
people used to employ a small wooden piece which was blunted so that it could be
inserted into the rectum. They used to dissolve the drug in honey or in some such viscous
liquid, dip the wooden piece in the viscous liquid and they used to insert it in the rectum
and remove it after usage. Gradually bases or vehicles for carrying the drugs used in the
rectum were discovered and the most prominent among them is Cocoa butter or
Theobroma oil.
Tests for suppositories:
1. General appearance
2. weight variation
3. Content uniformity
4. Assay of avtive ingredients
5. Disintegration test
6. liquification or dissolution test
7. Melting point determination
8. Breaking

1. GENRAL APPEARANCE:
They should be of uniform shape & size when cut longitudinally the external an
internal surface should be same
2. WEIGHT VARIATION TEST
• Select 20 suppositories, weigh them and determine average weight
• No suppository should deviate more than ± 5% of average weight, except
2 that may deviate but not more than ±7.5%
3. CONTENT UNIFORMITY TEST
• Select a representative sample of 30 suppositories
• Assay 10 of these as specified in monograph
• Requirement are met if not more than 1 of these is outside ±15%of average
value and none is outside ±25%
• If 2 or 3 are individual values are outside the limit of ±15% of average value
and none of these outside ±25% of average value
• Repeat the procedure by using another 20 suppositories
• Out of 30 not more than 3 should be outside ±15% and none is outside ±25%
and test is passed.
4. ASSAY OF ACTIVE INGREDIANT
• Perform the assay for active ingredients as specified in official monograph
e.g. glycerogelatin
• Dissolve no of suppositories equivalent of 8 gram of glycerol in 50 ml of
water and add q.s. water to 250ml
 • Take 5ml of this solution and add 150 ml of water and o.25ml of bromocresol
purple solution and 0.1M NaOH to neutralize the blue colour of indicator
• Add 1.6g of sodium metaphenodrate and allow standing for 15 minutes and
titrating with 0.1M NaOH to the same blue color.
• Each ml of 0.1M NaOH is equivalent to 0.00921g of glycerol.
5. DISINTEGRATION TEST
APPARATUS:
• A cylinder of glass or other transparent material, 60mm high, 52mm in internal
diameter
• 2 stainless metal dishes containing 39 holes, each of 4mm in diameter. The dishes
are repeated by a distance of 30mm
• The perforated holes are arranged annulary in rings consisting of 6,12& 20 holes
about central hole
• in rings consisting of 6,12& 20 holes about central hole
• A water bath of atleast of 4liter capacity maintaining a temperature 33-38Ċ fitted
with 2 stirrer
PROCEDURE

• Place a suppository on the lower perforated plate

• Insert the cylinder into water bath & operate for 30 min or specified in
monograph
• The suppository is considered disintegrated if
1. It has completely dissolve except for insoluble powder
2. The disintegrated product collect on the surface ( fatty substances) and
sink to the bottom (insoluble powder or dissolved)
3. Any matter left b/w plates is completely melted and has no longer a
solid core
4. Repeat the same operation with 2 more suppositories
5. all these suppositories should disintegrate within 30 min unless
otherwise specified

LIMIT:
• Fat based suppositories not more than 30min
• Water soluble suppositories not more than 60min

6. MELTING TEST
This is also called as macromelting range test.It is measures of
the time taken for entire suppositories to melt when immerse in a constant temperature
water bath (37Ċ)
The apparatus used in this test is completely immersed in a constant water bath and time
taken for entire suppository to melt is measured

7. LIQUIFICATION TEST
This test measures the liquification time of the rectal suppositories in vivo
condition
 APPARATUS:
It consist of celofine tube tight at both ends of a condenser. Water at 37Ċ
is circulated through the condenser.when water temperature is stabilized at
37Ċ the suppository is dropped into it
. The time for the suppository to melt is monitored

9. BREAKING TEST
This test is designed to measure friability or brittlness of suppository
APPARATUS:
• It consist of double water chamber through which water is circulated
at 37Ċ
• A disc on which a suppository is placed which is connected with a
rod linked with weight to be applied
• At first 600g of weight is applied on the upper plate at 1min interval
200g weight is added
• The wt. at which suppository collapse is the breaking point
• The force break the suppository should be sufficient to withstand
handling, production & shipping

OTHER TSET
1. Sponification test
2. Iodine value
3. water no.
4. Rancidity
5. Acid value

PACKAGING
• Extemporaneously prepared suppositories are usually
packed in shallow, partitioned, rigid, paperboard
boxes
• Preferably hygroscopic products such as
glycerogelatin and emulsified suppositories should
be supplied in well closed glss or plastic container

LABELLING
`Store in cool place` is necessary & the warning `not to
be taken` or `For rectal use only` is adviseable