This document discusses suppositories, including what they are, types of suppositories, trends in suppository development, and methods for evaluating suppositories. Suppositories are solid dosage forms that are inserted into body cavities like the rectum or vagina to release medication. Common types include rectal, vaginal, nasal, and ear suppositories. Evaluation methods ensure suppositories meet specifications and include tests for uniformity, disintegration, drug content, and dissolution.

1. SUPPOSITORIES
NAME-Rudradeep hazra
First year first semester
Roll-57 section -b
session=2018-19
BENGAL SCHOOL OF TECHNOLOGY

2. SUPPOSITORIES
Evaluation of Suppositories

3. WHAT ARE SUPPOSITORIES?
They are solid dosage form of medicament for
insertion into body cavities other than mouth.they
may be inserted into rectum,vagina or nasal
cavity.The medicament is incorporated into the
suppository base and the product is formulated in
such a way that they will either melt or dissolve in the
body cavity fluid to release the medicament.

5. TYPES OF SUPPOSITORIES.
So, the types are….
 Rectal Suppositories-these are meant for
introduction into rectum for their Systemic effect.
 Vaginal Suppositories-these are meant or
introduction into the vagina.
 Nasal Suppositories-these are meant for
intoduction into nasal cavities and are also known
as nasal bougies.
 Urethral Suppositories-these are meant for
introduction into the urethra and are also known as
urethral bougies.
 Ear cones-these are meant for introduction into the
ear and are also known as aurinaria.

6. NEW TRENDS OF SUPPOSITORIES.
Tablet suppositories.
Layered suppositories.
Capsule suppositories.
Coated suppositories.
Disposable moulds.

7. EVALUATION OF
SUPPOSITORIES

8. VARIOUS WAYS BY WHICH
SUPPOSITORIES ARE SECURED:
Appropriate test methods and
specifications are developed,
which are capable of
guaranteeing that the purpose
for which suppositories are
used will be fulfilled.

9. TESTS FOR SUPPOSITORIES ARE:
 Uniformity of weight.
 Disintegration test.
 Content uniformity test.
 Melting point determination test.
 General appearance test.
 Assay of active contents.
 Liquefaction or Softening Time Tests of Rectal Suppositories.
 Breaking test .
 Dissolution test.

10. UNIFORMITY OF WEIGHT:
 Weigh 20 suppositories individually.
 Determine their average weight.
 Not more than two of individual weights should
deviate from the average weight more than 5% and
none deviates by more than 10%.

11. DISINTEGRATION TEST:
 APPARATUS: A transparent sleeve of glass or
suitable plastic of height 60mm with an internal
diameter of 52mm.
 A metal device consisting of two stainless discs
each of which contain 39 holes, each 4mm in
diameter.
 Diameter of the disc is closely similar to the internal
diameter of the sleeve.
 Discs are separated by a distance of 30mm. Metal
device is attached to outer sleeve by means of
three equally spaced hooks.

12.  Method: 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 fitted with a slow stirrer and by
holding the top of apparatus 90 mm below the surface of
water.
 Disintegration is complete when molded suppositories
are:
 Completely dissolved.
 Dispersed into its components.
 Have become soft.
 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.

13. CONTENT UNIFORMITY TEST:
 Take 10 suppositories; determine the active
ingredients of each of the 10 suppositories by using
a suitable analytical method.
 If not more than one of the individual values
thus obtained is outside the limit i.e.% of the
average value and none of them is outside the limit
i.e. 25% of the average value.

14. MELTING POINT DETERMINATION
TEST:
 Melt the suppositories rapidly at a temperature not more
than 10C above the point of complete fusion. Insert one
end of glass capillary tube into the melted substance so
that a column of substance become 8-12 high rise into
it.
 Cool the tube to 15C and maintain the temperature at
15-17C for not less than 16 hours. Attached the tube to
thermometer in the heating vessel containing water at
15C so that the lower end of the column of substance is
30mm below the surface of water. Heat the water with
constant stirring, so that the temperature rise at a rate of
2C per minute.
 The temperature at which partially melted substance
begins to rise in the tube is regarded as the melting
point. The melting point of suppositories should not rise
more than that given in the monograph.

15. GENERAL APPEARANCE:
 The suppository when cut longitudinally and
examined with the naked eye the internal and
external surfaces of the suppository should be
uniform in appearance.
 Compliance with the standard indicates
satisfactory subdivision and dispersion of
suspended material.
 Surface appearance and colour can be verified
usually to assess absence of fissuring, absence of
fissuring, absence of pitting, absence of
exudation, absence of migration of the active
ingredients.

16. ASSAY OF ACTIVE CONTENTS:
 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.

17. LIQUEFACTION OR SOFTENING TIME
TESTS OF RECTAL SUPPOSITORIES.
 A Modification of the method developed by krowcynski
is another useful test of finished suppositories. It consists
of a U-tube partially submersed in a constant-
temperature water bath.
 A constriction on one side hold the suppository in place
in the tube. A glass rod is placed on top of the
suppository, and the time for the rod to pass through to
the constriction is recorded as the softening time.
 This can be carried out at various temperatures from 35.5
to 37oc, as a quality control check and can also be
studied as a measure of physical stability over time.

18.  Brittleness of suppositories is a problem for which
various solutions have already been described. The
breaking test is designed as a method for measuring the
fragility or brittleness of suppositories.
 The apparatus used for the test consists of a double-wall
chamber in which the test suppository is placed. Water at
37oc is pumped through the double walls of the chamber,
and the suppository contained in the dry inner chamber,
supports a disc to which a rod is attached.
 The other end of the rod consists of another disc to
which weights are applied. The test is conducted by
placing 600 g on the platform.
BREAKING TEST:

19.  At 1-min intervals, 200-g weights are added, and the
weight at which the suppository collapses is the breaking
point, or the force that determines the fragility or
brittleness characteristics of the suppository.
 Differently shaped suppositories have different breaking
points. The desired breaking point of each of these
variously shaped suppositories is established as the level
that withstands the break forces caused by various types
of handling i.e., production, packaging etc.

20. DISSOLUTION TESTING
 Testing for the rate of in vitro release of drug substances
from suppositories has always posed a difficult problem,
owing to melting deformation, and dispersion in the
dissolution medium. Early testing was carried out by
simple placement in a beaker containing a medium.
 In an effort to control the variation in mass or medium
interface, various means have been employed, including
a wire mesh basket, or a membrane, to separate the
sample chamber from the reservoir.
 Samples sealed in dialysis tubing or natural membranes
have also been studied. Flow cell apparatus have been
used, holding the sample in place with cotton, wire
screening and most recently with glass beads.

21. CONCLUSION:
 Advantages of Suppositories:
1. These can be administered to children ,old person
and to unconcious patients who cannot swallow
the drug easily.
2. These are inserted into the rectum to exert a
direct and rapid action on the rectum.
 Disadvantages of suppositories:
1. The irritant drugs cannot be administered by this
route.
2. The suppositories are required to be stored at low
temperatures (10- 20 degree celsius).

22. BIBLIOGRAPHY:
 I am very much thankful to my professors to let me
work on such a wonderful topic.
Source:Pharmaceutics 2 by Rm Mehta and
internet.
Thank you.