This document outlines the evaluation parameters and testing procedures for suppositories. Key tests include uniformity of weight, disintegration testing, content uniformity, melting point determination, drug assay, and general appearance. The document provides detailed procedures for each test, including using apparatus like disintegration cylinders, melting point testers, and dissolution equipment to assess qualities like drug release rates. The goal is to ensure suppositories are uniform and meet specifications for attributes like drug content and disintegration time.

1. Evaluation Parameters
1
PREPARED BY
PALI NARKHEDE
ASSISTANT PROFESSOR
PRESENTED BY
MS. PRAMILA
ASSISTANT PROFESSOR
SHRI RAWATPURA SARKAR INSTITUTE OF PHARMACY, KUMHARI, DURG

2. Suppositories are semisolid preparations administered through
the orifices, each contain one or more medicaments. They are
normally administered as a single dose for local or systemic
action.
TESTS FOR SUPPOSITORIES ARE:
 Uniformity of weight
 Disintegration test.
 Content uniformity test.
 Melting point determination test.
 Assay of active contents.
 General appearance test.

3. PROCEDURE-
 Weigh 20 suppositories individually.
 Determine their average weight.
 Limit-Not more than two of individual weights should deviate
from the average weight more than 5% and none deviates by
more than 10%.

4. PROCEDURE
 Place a suppository on the lower perforated disc of metal device and then
insert the device into the cylinder and attach this to the sleeve.
 Repeat the same operation with further two suppositories, metal device and
sleeve. Place each piece of apparatus in a vessel containing at least five liters
of water at 37C and fitted with a slow stirrer and by means of holding the
top of apparatus 90 mm below the surface of water. After every 10 minutes
invert each apparatus without removing it from water.
 Disintegration is complete when molded suppositories are:
 Disintegration occurs in not more than 30 minutes for fat based
suppositories and for water-soluble suppositories disintegration occurs in
not more than 60 minutes.
Completely dissolved.
Dispersed into its components.
Have become soft.

5.  For determination of drug content the suppositories are
dissolved in suitable solvent.
 After the solution is filtered and the filtrate is diluted suitably.
the absorbance is measured against blank at particular nm
using UV spectrophotometer.
 Assay 10 units individually as directed in the individual
monograph.

6.  Macro melting range test :measure the time it takes for the
entire suppositories to melt when immersed in a constant
temperature 37 C water bath.
 Micro melting range test :is the melting range measured in
capillary tubes for the fat base only.
 USP tablet disintegration apparatus is used.
 The suppositories is completely immersed in the constant
temp water bath ,and the entire suppositories to melt or
dispersed in the surrounding water is measured.
 The in-vitro drug release pattern is measured by using the
same melting range apparatus.

7. 80
m
m
n
m
n
m
n
m
Melting point tester

8. PROCEDURE
 Official limit for the active contents is 95- 105% e.g.
Glycerol Suppositories.
 Dissolve a number of suppositories equivalent to 8 grams
of glycerol in 50 ml of water and add quantity sufficient to
produce 250ml.
 Take 5ml of this solution and 150ml of water and 0.25ml of
Bromocresol purple solution and add 0.1M.NaOH to
neutralize the blue color of indicator.
 Add 1.6 grams of sodium metaphenolate and allow to
stand for 15 minutes and titrate with 0.1M NaOH to same
blue color.
 Each ml of 0.1M NaOH=0.00921 grams of glycerol.

9.  In this test, tensile strength of
suppositories is measured to assess their
ability to withstand the rigors of normal
handling.
 The apparatus used is called as breaking
test apparatus, It consists of a double-
wall chamber. Through the walls of the
chamber, water is pumped.
 The inner chamber consist of a disc
which holds the suppositories, To this
disc, a rod is attached, The other end of
the rod consists of another disc on which
weights are placed.

10.  It is the amount of dosage form that gets dissolved in body fluid in
unit time. It is a measure of the rate of drug release from the
suppository.
 Two types of apparatus are available for testing the dissolution
rate. They are:
 Suppository dialysis cell - Lipophilic suppositories are tested using
suppository dialysis cell, which is also called as modified flow-
through cell,
 Stationary basket - Rotating paddle apparatus ( USP dissolution
test apparatus) Hydrophilic suppositories are tested using
stationary basket - rotating paddle apparatus.

12.  All the suppositories
should be uniform in size
and shape.
 They should have elegant
appearance.
 Individual suppositories
should be examined for
cracks and pits due to
entrapment of air in the
molten mass.