“Suppositories are solid dosage forms
intended for insertion in to body cavities or
orifices (Rectum, Vagina & Urethra) where
they melt or dissolved & exert localized or
systemic effect.”

www.DuloMix.com 2

It avoid first pass effect.
Melt at body temperature.
It gives localized and systemic action.
It can be given to unconscious patient.
It is easy to use for pediatric and geriatric
patients.
Useful to produce local effect.
Useful for rapid and direct effect in rectum.
Useful to promote evacuation of bowel
Convenient for those drug causes GIT
irritation , vomiting etc.

www.DuloMix.com 3

Irritant drug cant administered

Embarrassment to patients

Need to store at low temp.

Cant easily prepared

Cost-expensive.

fluid content of the rectum is much less than
that of the small intestine; this may effect
dissolution rate, etc.

Some drug may be degraded by the microbial
flora present in the rectum.

www.DuloMix.com 4

1. Rectal suppositories.
2. Vaginal suppositories.
3. Urethral suppositories.
4. Nasal suppositories.
5. Ear cones.

www.DuloMix.com 5

Tablet Suppositories

Layered Suppositories

Coated Suppositories

Capsule Suppositories

www.DuloMix.com 6

This type of tablets prepared by compression
like tablets.

Such type of suppositories used for rectal &
vaginal purposes.

Pessaries tablet suppositories are present in
almond like shape.

Rectal tablets covered with thin layers of
materials such as polyethylene glycol for
protecting.

www.DuloMix.com 7

In that type of suppositories are contains

different drugs in different layers.

So that, incompatibility drugs can be

separated from each other.

Similarly drugs having different melting

points can be incorporated to control the

absorption rate.

www.DuloMix.com 8

In that type of suppositories contains

polyethylene glycol, cetyl alcohol etc.

Those materials controls their disintegration

rate, to impart lubricant properties & to

provide protection action during storage.

www.DuloMix.com 9

Soft gelatin capsules of different shapes &

size are prepared in that type of

suppositories.

In that type of capsule suppositories are filled

with liquids, semisolids or solids.

These type of capsules are increasing in

popularity.

www.DuloMix.com 10

Suppository bases plays important role in

maintaining their shape, solidity & also play

important role when inserted into the body

cavity.

There are large number of bases used but

theobroma oil, glycerogelatin base &

polyethylene glycol fulfil l the above mentioned

requirements.

www.DuloMix.com 11

It must retain the shape and size.
It should melt at body temperature.
It should be non-irritant.
It should shrink sufficiently to remove from
mould.
It should not interfere in release or absorption
of drug.
It should permit incorporation of drug.
It should be compatible with variety of drugs.
It should be physically stable on storage.
It should not be soften or harden on storage.

www.DuloMix.com 12

Oily Bases or Oleaginous bases

Water Soluble & Water miscible bases
Or

Hydrophilic bases

Emulsifying/Synthetic bases

www.DuloMix.com 13

Cocoa butter or Theobroma Oil

Emulsified cocoa butter.

Hydrogenated oils.

www.DuloMix.com 14

Cocoa butter is fat obtained from the roasted seed
of Theobroma cocoa.

• At room temperature it is a yellowish, white solid
having a faint, agreeable chocolate like odour.

• Chemically, it is a triglyceride (combination of
glycerin and one or different fatty acids) primarily
of oleopalmitostearin and oleodistearine.

• It melts at 30 – 350C

www.DuloMix.com 15

Advantages

◦ Melting just below the body temperature.

◦ Maintaining its solidity at usual room temperatures.

◦ Readily liquefy on heating and solidify on cooling.

Disadvantages

◦ Rancidity.

◦ Stick to mould.

◦ Leakage from body cavity.

◦ Costly.

◦ Immiscibility with body fluid.

◦ Chloral hydrate or lactic acid liquefy it.

www.DuloMix.com 16

Emulsified theobroma oil may be used as a
base when large quantities of aqueous
solutions are to be incorporated.

5% glyceryl monostearate, 10% lanette wax, 2-
3% cetyl alcohol & 4% bees wax is
recommended for emulsified theobroma oil.

www.DuloMix.com 17

Hydrogenated oils are used as a substitute of

theobroma oil.

E.g. Hydrogenated edible oil, coconut oil,

hydrogenated pea oil, stearic acids, palm

kernel oil etc.

www.DuloMix.com 18

Advantages
▪ Overheating does not affect the solidifying point.
▪ They are resistant to oxidation.
▪ Lubrication of the mould is not required.
▪ Their emulsifying & water absorbing capacity are

good.

➢ Disadvantages
▪ On rapid cooling they become brittle.
▪ When melted they are more fluid than theobroma

oil & result in greater sedimentaion of the added
substance.

www.DuloMix.com 19

Glycero-gelatin base.

Soap-glycerin base.

Polyethylene glycol.

www.DuloMix.com 20

➢It is a mixture of glycerin and water which is made st iff
by the addition of gelatin.
This base is used to prepare all type of suppositories but
mainly used to prepare pessaries.
Properties:

➢it is colourless, transparent, translucent in nature.
➢ It is soft to touch.
➢It melts at 30 – 350C.
➢used for vaginal suppositories.

www.DuloMix.com 21

Advantages
: It melt at body temperature.
◦ It mix with body fluid.
◦ Not rancid.
◦ It can be used to prepare suppositories using boric acid,

chloral hydrate bromides, iodides, iodoform opium etc.
Disadvantages:
◦ Difficult to prepare and handle.
◦ Chance of bacterial growth.
◦ Hygroscopic in nature. (become hard on drying and soft in

cont with moisture)
◦ Laxative in action.
◦ Incompatible with tannic acid, ferric chloride etc.

www.DuloMix.com 22

Soap glycerin suppositories:

➢In this base the gelatin is replaced with either curd soap or

sodium stearate which makes the base sufficiently hard to

prepare good quality of suppositories.

➢The main disadvantage of this base is that they are very

hygroscopic in nature.

➢Therfore the suppositories prepared with this base must be

protected from atmosphere and wrapped in waxed paper .

These are commonly known as carbowaxes
& Polyglycols.
These are available in solid, liquid or semi-
solid state depending on molecular weight.
Those polymers having the molecular
weight betw. 200 to 1000 are liquids &
those having M.W higher than 1000 are wax
like solids.
They are chemically stable & physiologically
inert substances & do not allow the
bacterial or mold growth to take place.

www.DuloMix.com 24

They are chemically stable.
Inert, Non-irritant.
Do not allow bacterial growth.
Physical properties changes according to
molecular weight.
Provide prolonged action.
Do not stick to mould.
Suppositories are clean and smooth in
appearance.

www.DuloMix.com 25

Witepsol

Massa estarinum

Massuppol.

www.DuloMix.com 26

They solidify rapidly.
They are non-irritant.
The lubrication of mould is not required.
Overheat ing does not affect the physical
properties of the base.
They can absorb fairly large amount of
water or aqueous liquids.
The white, odourless, clean and attractive
suppositories are produced.
They are less liable to get rancid.

www.DuloMix.com 27

They should not be cooled rapidly in a
refrigerator because they become brittle.

They are not very viscous on melting, so the
medicaments incorporated with the base
settle down rapidly.

www.DuloMix.com 28

They consist of triglycerides of saturated
vegetable fatty acid with varying percentage
of partial esters.

A small amount of beeswax is added for use
in hot climate.

It should not be cooled rapidly as it become
brittle and fracture.

Lubrication is required.

www.DuloMix.com 29

It is a mixture of mono, di and triglycerides of
saturated fatty acids.

It is a white, brittle, almost odourless and
tasteless solid.

It has a m.p. 33.5 to 35.50C.

They are available in various grades but grade
B is commonly used in dispensing.

www.DuloMix.com 30

massuppol

➢It consists of glyceryl esters.

➢Small amount of glyceryl monostearate has been added to

improve its water absorbing capacity.

www.DuloMix.com 31

Hand rolling method

Hot process or fusion method

Cold compression method

www.DuloMix.com 32

It is the oldest and simplest method of suppository preparation
and may be used when only a few suppositories are to be
prepared in a cocoa butter base.
It has the advantage of avoiding the necessity of heating the
cocoa butter.
A plastic- l ike mass is prepared by tr i turat ing grated cocoa
butter and active ingredients in a mortar.

www.DuloMix.com 33

The mass is formed into a ball in the palm of the hands, then
rolled into a uniform cylinder with a large spatula or small flat
board on a pil l tile.

The cylinder is then cut into the appropriate number of pieces
which are rolled on one end to produce a conical shape.

Effective hand roll ing requires considerable practice and skill .
Now a days this method is not used.

www.DuloMix.com 34

➢ Melting the suppository base

➢ Dispersing or dissolving the drug in the melted base.

➢ The mixture is removed f ro m the heat and poured into a
suppository mold.

➢ Allowing the melt to congeal

➢ Removing the formed suppositories f ro m the mold.
➢ The fusion method can be used with all types of suppositories

and must be used with most of them.
➢ Small scale molds are capable of producing 6 or 12

suppositories in a single operation.
➢ Industrial m olds produce hundreds of suppositories f ro m a

single molding.

www.DuloMix.com 35

Method of prepration

➢Thoroughly clean and lubricate the mould with a suitable lubricant.
➢Keep the mould on ice in the inverted position to cool and drain an excess of the
lubricant.
➢The lubrication of the mould is not required in case the emulsifying base or
synthetic base is used.
➢Heat the china dish over a water bath.
➢To this add the required quantity of cocoa butter or any other base after taking
into account the displacement value of the medicament.
➢Allowance is made for unavoidable wastage during preparation by calculating
for two extra suppositories.
➢Remove the china dish from the water bath, when two third of the base melts
and stir thoroughly until whole of the mass melts.this process prevents
overheating of base.

www.DuloMix.com 36

➢Place the weighed quantity of powdered medicament to be incorporated with
the suppository base on an ointment tile.
➢Pour about half of the melted base over it and mix it thoroughly with a spatula.
➢Transfer the mixed mass to the china dish and mix thoroughly so that a
homogenous mass is formed.
➢Warm the china dish over a water bath for a few seconds with constant
stirring,so tht mass becomes pourable.
➢Pour the melted mass into the cavities of the suppository mould, kept over the
ice.
➢Fill each cavity to over flowing, in order to prevent the formation of hollows in
the tops of the finished suppoositories because cocoa butter contracts on cooling
and hollows are formed at the top of the suppositories.
➢The precautions must be taken while pouring the mass into the cavities.it must
be continuously stirred to ensure even distribution of the medicament in all the
suppositories.

www.DuloMix.com 37

➢The precautions must be taken while pouring the mass into the cavities.it must

be continuously stirred to ensure even distribution of the medicament in all the

suppositories.

➢Remove the excess mass with the help of sharp knife or blade when the mass is

properly set.

➢Keep the mould over ice or in cool place for 10 -15 min.

➢Open the mould and remove the suppositories.

➢Wipe off the suppository lightly with a clean cloth or filter paper

➢Wrap the individual suppository in a wax paper.

www.DuloMix.com 38

www.DuloMix.com 39

➢ The method is useful for thermolabile and insoluble drugs,
because heating and stirring of the base is not required.

➢ Cocoa butter is grated.
➢ The ingredients are mixed with an equal quantity of grated

cocoa butter.
➢ Add the remaining amount of grated cocoa butter.
➢ While calculating the amount of cocoa butter to be

incorporated with the medicaments, allowances are made for
unavoidable wastage during the preparation.

www.DuloMix.com 40

www.DuloMix.com 41

The frict ion of the process causing the base to soften into a
past- l ike consistency.
On a small scale, a mortar and pestle may be used (preheated
mortar facilitate softening of the base).

On large scale, mechanically operated kneading mixers and a
warmed mix ing vessel may be applied.

In the compression machine, the suppository mass is placed into
a cylinder which is then closed.
Pressure is applied f ro m one end to release the mass f ro m the
other end into the suppository mold or die.
When the die is fil led with the mass, a movable end plate at the
back of the die is removed and when additional pressure is
applied to the mass in the cylinder, the formed suppositories
are ejected.
The end plate is returned, and the process is repeated unti l all of
the suppository mass has been used.

www.DuloMix.com 42

Suppository mould

➢The suppository mould of various types and sizes are available .

➢These moulds are generally made up of stainless steel, nickel copper alloy,

brass,aluminium and plastic.

➢The suppository mould can be opened longitudinally by removing the screw in

the centre of the plates.

➢The mould is opened at the time of cleaning,lubrication and removal of

suppositories.

➢The mould is cleaned by removing the plates and immersed in a hot water

containing detergent.

➢After washing with water the mould is dried thoroughly.

www.DuloMix.com 43

Lubrication of mould:

➢The lubrication of the mould is essential in case of cocoa butter or glycerogelatin

base is used.

Cocoa butter –soft soap, glycerin, alcohol 90%

Glycerogelatin – liquid paraffin or arachis oil

➢The lubricant should be applied with the help of brush or swab made of gauze.

➢Exessive lubrication of the mould should be avoided.

➢The exess of lubricant can be drained by closingthe mould and put it in the

inverted position on a white tile.

www.DuloMix.com 44

Calibration of the mould

➢Generally a standard mould of 1 gm capacity is used.

➢The calibration of the mould is necessery because the size of the suppository

from a particular mould remains the same, but the the weight varies.

➢This is due to the reason, that the density of different bases and medicaments

are different.

➢So that the mould should be calibrated for individual base and medicament.

➢This is done by preparing a set of suppositories using the base, weighing the

suppositories and then find the avg,. Mean which will indicate the true capacity of

mould.
www.DuloMix.com 45

Displacement value

➢The volume of suppositoriy from a particular mould is uniform but its weight will

varies because of the densities of the medicaments usually differ from the densities

of the base with which the mould was calibrated.

➢To prepare the suppositories of uniform and accurate weight allowance must be

made for the change in density of the mass due to added medicaments.

➢For this purpose the displacement value of medicament is taken into

consideration.

➢Displacement value:

➢The quantity of drug which displaces one part of the base.

www.DuloMix.com 46

Determination of displacement value

➢Prepare and weigh 6 suppositories containing theobroma oil = a
gm
➢Pepare and weigh 6 suppositories containing say 40%
medicament = b gm
➢Calculate the amount of theobroma oil present in medicated
suppositories = 60/100(b)= c gm
➢Calculate the amount of medicament present in the medicated
suppositories = 40/100(b)= d gm
➢Calculate the amount of theobroma oil displcaed by d gm of
medicament = (a-c) gm
➢Displacement value of the medicament = d/a-c

www.DuloMix.com 47

e.g. Determine the displacement value of a medicament in
theobroma oil suppositories containing 40% medicament,
prepared in 1 gm mould. The weight of 10 suppositories is 14.66
gm.

Solution:
1. Wt.of 10 suppo. Cont. theobroma oil alone prepared in 1 gm

capacity mould=1 x 10=10 gm
2. Wt.of 10 suppo. Cont. 40% of medicament = 14.66gm
3. Amt. of theobroma oil present = 60/100 x 14.66=8.79 gm
4. Amt. of medicament present = 40/100 x 14.66= 5.86 gm
5. Amt. of theobroma oil displaced by 5.86 gm of medicament =

10 – 8.79 = 1.20 gm
So,

Displacement value of medicament = 5.86/1.20 = 5 (Approx.)

www.DuloMix.com 48

Suppositories are usually packed in t in or aluminum, paper or
plastic.

Poorly packed suppositories may give rise to staining, breakage
or deformation by melting.
Both cocoa butter and glycerinated gelatin suppositories stored
preferably in a refrigerator.
Polyethylene glycol suppositories stored at usual room
temperature without the requirement of refrigeration.

www.DuloMix.com 49

Evaluation of suppositories

Suppositories are evaluated for following parameters.

Appearance:
➢All the suppositories should be uniform in size and shape and should have
elegant appearance.
➢Suppositories are examined by visual inspection for cracks and pits on the
surface.
➢ when cut longitudinally , the internal and external surface should be same.

Physical strength:
➢The strength of suppositories is considerd to assess the their ability during
normal handling.
➢The apparatus used for this called as breaking test apparatus, which contains a
double walled chamber in which water is pumped to maintain 37 oc temp. In
btween two walls of the chamber.
➢The inner chamber contains a disc for holding the suppositories, to which a rod
is attached.
➢The other end of the rod contains a disc for holding the weights.

www.DuloMix.com 50

➢When weights are added (upto 200gms) at one minute time interval until the
suppository crumbles.
➢All the weights used are added which gives the tensile strength.
➢Tensile strength – max. Load that a material can support without fracture.
➢Higher tensile strentgh indicate less will be tendency to fracture.

Melting range:
➢it is also called as macro melting range test
➢It is used to measure the time it takes to melt in body temp.
➢It is the time taken by the entire suppository to melt in a constant temperature
(37 oc) water bath.
➢The test is conducted using the tablet disintegration test apparatus in which
suppository is immersed in a constant water bath , finally the melting range is
recorded.

www.DuloMix.com 51

Solidification point:
➢It is the time taken to become solidify.
Uniformity of weight:
➢Weigh twenty suppositories individually and determine their avg. Weight.
➢Limit: not more than two individual weights should deviate from the avg.
Weight and morethan 5% and none deviates by morethan 10%.
Content uniformity:
➢This ia carried out by performing assays for different suppositories.
➢All suppositories should contain the same labelled quantity.
➢Method:
➢Take 10 suppositories and determine the active ingredients of each of the ten
suppositories by using a suitble analytical method.

www.DuloMix.com 52

Limit : 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 outside the limit i.e. 25% of the average value.

Softening time:
➢This test measures the time required for supository to liquify under conditions that

stimulate in vivo conditions , which also indicates the hardness of the base.

www.DuloMix.com 53

Dissolution test:
➢It is used for in vitro assessment of product efficacy.
➢Used to determine the rate of drug release from the suppository.
➢The rate of drug release from suppositories can be determined by using the
same apparatus used for dissolution rate of compressed tablets i,e. apparatus 1,2,
or 3.
➢The test can be carried out by simple placement of the suppository in a beaker
containing the dissolution medium.