This document discusses the preparation of suppositories. There are five main methods: molding, compression, heat molding/fusion, hand rolling and shaping, and automatic machine molding. For molding, suppository molds are lubricated and filled with the drug/base mixture that has been melted. Compression uses a machine to apply pressure to fill molds. Heat molding involves melting the base, mixing in the drug, filling molds, and allowing the mixture to cool. Hand rolling forms suppositories manually by shaping the mixture into rods or balls. Automatic machines can produce thousands of suppositories per hour using disposable molds. Suppositories are tested for appearance, strength, dissolution rate, softening, and melting

2. METHODS OF
PREPARATIONS
OF SUPPOSITORIES
November 18,2019

3. PREPARATION OF SUPPOSITORIES
 GROUP # 5
 ROLL # 41 TO 50
 PRESENTED TO : DR. MISBAH
SULTANA
 PRESENTED BY : EAMEN
SAEED (D18E46)

4. INDEX
DEFINITION OF SUPPOSITORIES
TYPES OF SUPPOSITORIES
METHODS OF PREPARATIONS OF SUPPOSITORIES
 1- BY MOLDING
 2- BY COMPRESSION
 3- HEAT MOLDING/ FUSION
 4- BY HAND ROLLING & SHAPING
 5- AUTOMATIC MACHINE MOLDING
PACKAGING
STORAGE
EVALUATION / TESTING

5.  DEFINITION
“Suppositories are solid dosage forms intended for
insertion into body orifice, where they melt, soften or
dissolve and exert local or systemic effects.”

6. TYPES OF SUPPOSITORIES
 Rectal suppositories
 Vaginalsuppositories (Pessaries)
 Urethral suppositories (Bougies)
 Nasal suppositories (Buginaria)
 Ear cone (Aurinaria)

7. TYPES OF PREPARATION
OF SUPPOSITORIES
1- preparation by molding
a) suppository molds
b) lubrication of molds
c) calliberation of molds
2- compression
3- heat molding /fusion
4- hand rolling and shaping
5- automatic molding machine

8. 1- Preparation by Molding
a- suppository molds
 commercially available molds can produce individual or large number
of suppositories.
Molds are made commonly from stainless-steel, aluminium, brass or
plastic.
Individual plastic molds are used to make single suppository.
Temporary molds formed by pressing aluminium foil by putting an object
having shape of desired suppository and then remove the object and
pour the melt .

9. CONT…
URETHRAL
SUPPOSITORY
MOLD
• GLASS STIRRING
RODS are used to form
mold for urethral
suppository.
RECTAL
SUPPOSITORY
MOLD
• CYLINDRICAL
PENCILS OR PEN
may be used to form rectal
suppository.
VAGINAL
SUPPOSITORY
MOLD
• CONE SHAPED
OBJECT maybe used to
form molds for vaginal
suppository.

10. b-lubrication of molds
• Depending on the formulation , molds may require lubrication before the melt is
poured , to facilitate clean and easy removal of the molded suppositories.
• Lubrication is seldom necessary when the base is :
 Coca butter
 Polyethylene glycol
 Glycerinated gelatin
• A thin coating of mineral oil applied with finger on the surface of mold.
• Any material which cause irritation to mucous membranes should not employed
as lubricant.

11. CONT…
 LUBRICANT SHOULD BE APPLIED WITH FAIRLY STIFF BRUSH.

12. c-calliberation of mold
 The pharmacist should calliberate each
suppository mold for the usual base so as
to prepare medicated suppositories ,each
having the propor quantity of
medicaments.
 Each individual mold is capable of holding
a specific volume of material in each of its
openings.

13. CONT….
1ST STEP
 Prepare molded
suppositories from base
material only.
2ND STEP
 After removal from mold,
suppositories are weighed.
 Total and average weight is
recorded.
3RD STEP
 Suppositories are melted in
calliberated beaker to
determine the volume for
total number and average of
one suppository.

14. 2- COMPRESSION
• COMPRESSION MACHINE CONSISTS OF CYLINDER, PISTON,
MOLDS AND A METALLIC STOP PLATE AT THE BOTTOM.
 1- PLACED THE MASS IN CYLINDER AND APPLY PRESSURE.
 2- FILLED MASS IN MOLD MOVE AND THEN SUPPOSITORIES
REMOVED FROM THERE AND KEPT IN COOL PLACE.
 3- AFTER COOLING ,THESE SUPPOSITORIES ARE REMOVED
FROM COMPRESSION MACHINE AND BEING PACKED.

15. 3-HEAT MOLDING/ FUSION
• IN THIS PROCESS, BASES ARE MELTED THEN DRUGS AND ADDITIVES ARE MIXED INTO IT.
• FOLLOWING METHODS ARE INVOLVED:
 A- MELTING THE BASE
 B- INCORPORATION OF DRUG & ADDITIVES INTO IT
 C- FILLING OF COLD
 D- COOLING &COLLECTION OF SUPPOSITORIES.
• SUPPOSITORIES OF COCOA BUTTER,GLYCERINATED GELATIN ,POLYETHYLENE GLYCOL ARE
PREPARED BY THIS METHOD.

16. STEPS…
1.FIRST, MELTING THE BASE.

17. 2- INCORPORATING ANY REQUIRED
MEDICAMENTS.

18. 3- THEN, POURING THE MELT INTO MOLD

19. 4-THEN, ALLOWING THE MELT TO COOL AND CONGEAL IN
SUPPOSITORIES.

20. 5- REMOVE FORMED SUPPOSITORIES FROM
MOLD.

21. 4-HAND ROLLING & SHAPING
• The simplest and the oldest method of preparing a suppository is by hand .
By rolling the well blended suppository base containing the active
ingredient into cylindrical rod of desired length and diameter, or into
vaginal balls of intended weight .
• Starch or talc powder on the rolling surface and hands prevent the mass
from adhering.
• Rods are cut into portions , and one end is pointed.
• This method is practicle and economical for smaller number of
suppositories.

22. STEPS
..
• 1- THE DRUG IS MADE INTO FINE POWDER.

23. • 2-IT IS INCORPORATED INTO BASE BY KNEADING
OR TRITURATION IN MORTAR.

24. • 3- NOW, RODS ARE CUT INTO
PORTIONS

25. • 4- THEN, MAKE ONE END POINTED AND
PACK IT.

26. 5- AUTOMATIC MOLDING MACHINE
• Using this machine,up to 10,000 suppositories per hour can be produced.
• The rate of production by automatic molding machine is higher than hand molding .
• In this, there is no chance of air entrapment or any contamination in suppositories.
• There are two types of machines used to run this process :
a- ROTARY machine
b- LINEAR machine
• Process of formation of suppositories is almost same in both types of machines but linear
machine is more efficient (i.e. rate of production) in working than the former one .

27.  Steps of
preparations

28. 1- DISPOSABLE MOLDS:
• THESE ARE MEANT FOR PACKING THE
SUPPOSITORIES.
• THESE ARE MADE OF PLASTIC OR
ALUMMINIUM FOIL.
2 - MODERN PACKING MACHINE:
• IT IS CONSIST OF ROLL OF PACKING
MATERIAL WHICH CUT IN THE REQUIRED
SIZE AND ROLLED AROUND EACH
SUPPOSITORY.
 PACKING OF SUPPOSITORIES

29. STORAGE
• It is stored at
10-15 ͦ C.
• Used air tight
container.
• Suppositories with
cocoa butter stored
at ≤ 30 ͦ C.
• Suppositories with
glycerol gelatin
stored at ≤ 35 ͦ C.

30.  SUCCESSFUL TESTING
Appearence
Physical
strength
Dissolution
rate
Softening test
Melting
range

31. Hence, suppositories are very
good dosage form to
administer the drugs.
Refrence :
.lachmen
.ansel

32. Thanks