This document discusses quality control testing for suppositories. It describes several tests used to evaluate suppositories, including appearance tests to check odor, color, shape and surface condition. Weight uniformity, melting range, disintegration, liquefaction/softening time, hardness/breaking, dissolution and stability tests are also summarized. The tests ensure suppositories meet specifications for attributes like weight variation, melting/disintegration time and release of the active ingredient. Maintaining proper storage conditions can prevent issues like hardening or surface deposits on suppositories over time.

1. QUALITY CONTROL OF
SUPPOSITORIES
PRESENTED BY GROUP # 3

2. SUPPOSITORIES
 Suppositories are solid dosage forms intended
for insertion into body orifices where they melt,
soften, or dissolve and exert localized or
systemic effects.
 It is comes under semi solid preperation
because it is prepared by melting all ingredient
.

3. TYPES OF SUPPOSITORIES

4. TYPES OF SUPPOSITORIES

5. SIZE OF SUPPOSITOIRES

6. SIZE OF SUPPOSITORIES

7. ADVANTAGES AND DISADVANTAGES

8. ADVANTAGES OF
SUPPOSITOIRES

9. DISADVANTAGES OF
SUPPOSITORIES

10. QUALITY CONTROL OF SUPPOSITORIES

11. 1. APPEARANCE
 It includes
 Odour
 colour
 surface condition
 shape.

12. WEIGHT UNIFORMITY
 Weigh 20 suppositories individually. w1, w2,
w3….w20
 Weigh all the suppositories together
 Calculate the average weight = W/20.
 Limit: Not more than 2 suppositories differ from
the average weight by more than 5%, and no
suppository differs from the average weight by
more than 10%

13. MELTING RANGE TEST
 1-The suppository is completely immersed in
the constant temperature water bath, and the
time for the entire suppository to melt or
disperse in the surrounding water is
measured.

14. DISINTEGRATION TEST…
 The suppository is considered disintegrated
when:
 A- It is completely dissolved or
 B- Dispersed into its component part.
 C- Become soft “change in shape” with formation of
core which is not resistant to pressure with glass rod.

15.  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 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:
 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.

16. LIQUEFACATION TIME OR
SOFTENING
TIME TEST
 In this test a U tube is partially immersed in a
constant temperature 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 the suppository, a glass rod is
kept. The time taken for the glass rod to go
through the suppository and reach the constriction
is known as the liquefaction time or softening time
 Another apparatus is there for finding “softening
time” which mimics in vivo conditions. It uses a
cellophane tube, and the temperature is
maintained by water circulation. Time taken for the
suppository to melt is noted

17. BREAKING TEST (
HARDNESS)
 The breaking test is designed as a method for
measuring the brittleness of suppository.
 1-The suppository is placed in the instrument.
 2- Add 600 g; leave it for one min. (use a stop watch).
 3- If not broken, add 200 g every one min. until the
suppository is broken.

18.  Calculations: The hardness of the suppository
is calculated by adding the weights together.
 if the suppository is broken before the end of
the last min. the last weight is canceled

19. DISSOLUTION TEST
 By using different types of apparatus such as
wire mesh basket, or dialysis tubing is used to
test for in vitro release from suppositories

20.  Two types of apparatus are avaliable for
testing the dissolution rate. They are,
 SUPPOSITORY DIALYSIS CELL- lipophilic
suppositories are tested using suppository
dialysis cell.
 STATIONARY BASKET – rotating paddle
apparatus( USP dissolution test apparatus).
Hydrophilic suppositories are tested using
stationary basket.

21. 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 the suppositories at uniform cool
temperatures and by wrapping them in foils.

22. CONTINUED…
 Fat based suppository harden on storage
 There is an upward shift in melting range due to
slow crystalization to the more stable polymeric
forms of the base.
 The softening time test and differential scanning
calorimetry can be used as stability indicating test
methods.
 if we store the suppositories at an elevated
temperature, just below its melting range,
immediately after manufacture, the aging process
is speeded