Quality control of suppositories

QUALITY CONTROL OF
SUPPOSITORIES
PRESENTED BY GROUP # 3

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
.

DISADVANTAGES OF
SUPPOSITORIES

QUALITY CONTROL OF SUPPOSITORIES

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

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%

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.

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.

 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.

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

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.

 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

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

 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.

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.

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

Quality control of suppositories

Quality control of suppositories

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Quality control of suppositories