Presented by

Nawfal Hasan Siam

University Id- 1910100
Department of Pharmacy
School of Pharmacy & Public Health
Independent University, Bangladesh
 Suppositorie
sSuppositories are solid, uniformly
medicated conical or torpedo shaped
formulations intended for insertion into
body orifices where they melt, soften or
dissolve, release medicaments and exert
local or systemic effects.
REASONS FOR CHOOSING RECTAL ROUTE FOR DRUG
ADMINISTRATION:
(ADVANTAGES)

❖ When the patient is not able to make use of the oral route e.g. nauseating or
unconscious; the patient may have a problem with the GI tract, then this route
is beneficial.

❖ To avoid the first pass metabolism in liver after absorption.

❖ Drugs with altered taste can be administered rectally.

❖ The rectal route is used in different therapies, intended either for local/systemic
effect.

❖ Useful for rapid and direct effect in rectum.

 SUPPOSITORY BASE
The vehicle used in a suppository, via which drugs reach to the site of
action to exert it’s therapeutic effect is termed as suppository base.
The composition of suppository base plays an important role in
both the rate and extent of release of medications.

Suppository bases may be classified according to their composition and

physical properties:
1. Oleaginous (fatty) bases
Ex. Cocoabutter (Theobroma), Glycerin Bases, synthetic fats

2. Water soluble or miscible bases

Ex.Glycero-Gelatin base, PEG-1000, 4000 (Poly Ethylene Glycol)
PREPARATION OF SUPPOSITORIES

Suppositories are prepared by three methods:

(a) Hand rolling and shaping

(b) Compression

(c) Molding from a melt/Fusion

HAND ROLLING AND
SHAPING
 COMPRESSION
MOLDING MACHINE
• Prepared mass C is placed in a cylinder A
•It is forced through a narrow opening D by means of
piston B into a mold.
•Threads of mass pass into the mold G and are compressed
until a homogenous fused mass is formed in E .
•The mass and the compression cylinder of the machine
may be chilled to prevent heat of compression from
making the mass toofluid.
• When the die is filled with the mass, a movable end
'plate-F’ at the back of the die is removed.
• Additional pressure is applied to eject the suppository.
 FUSION MOLDING
Fusion Molding involves:

Melting the suppository base

Dispersing or dissolving the drug in the melted base.

The mixture is removed from the heat and poured into

a suppository mold.

Allowing the melt to congeal

Removing the formed suppositories from

the mold
The fusion method can be used with all types of
suppositories.
AUTOMATIC SUPPOSITORIES MACHINE
 SPECIFICATION AND MAIN PARAMETERS
OF SUPPOSITORY FILLING MACHINE
SB-U-15 Automatic Suppository
Model Unit
Filling Machine
18000-23000 (depending on
Capacity PCS/Hour
producing)
Total Power KW 7.5Kw
Voltage, frequency V 3PH 380 +/-10% 50Hz
Dose per unit ML 0.5~5 (depending on product)
Deviation % ＜ ±2
Bullet, torpedo, duck-mouth ect
Suppository shape N/A
(depending on product)
Fatty acid glycerin, gelatin, glycol,
Adapting N/A
etc., (depending on product)
Volume L 50
Air pressure Mpa More than 0.6
Air consumption m3 1.5
Water consumption N/A 50kg per circle
Total weight KG 2600
Machine dimensions MM SB-U: 4000*3500*2000mm
 FEATURES
• PLC checking function: through PLC online checking function
to self-checking and alarm for running stoppage, and show the
reason of stoppage in order that the operator remedy it in time.

• Filling part within free static electricity system.

• Agitation vat speed adjustment system

• Cooling speed adjustment system

• Cutting gains speed adjustment system

• Notice: finished products can be set 4/5/6/7pcs. The machine
can product PVC/PE

• Meet cGMP