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4th semester (E)

SESSION 2007-2012

COLLEGE OF PHARMACY
GC UNIVERSITY
FAISALABAD
Pharmaceutical unit dosage form

SUPPOSITORIES
DEFINITION

Solid unit dosage form intended for


insertion into the body orifices where
it melts, softens, or dissolves—and
exerts localized or systemic effects
PREPARATION

FOUR METHODS

PREPARATION
METHODS OF PREPARATION

Four methods

3. Molding by hand
4. Compression
5. Pour molding
6. Compression in a tabletting machine
● MOLDING BY HAND

 Handmolding is useful when we are


preparing a small number of
suppositories
1. MOLDING BY HAND

STEP 1
drug

fine powder
1. MOLDING BY HAND

STEP 2
Drug (fine powder)

Base
1. MOLDING BY HAND

STEP 3
Trituration
in pestle and
mortar
1. MOLDING BY HAND

STEP 4
Mass

Rolled

Long rods
1. MOLDING BY HAND

STEP 5
Rods

cut into pieces


● COMPRESSION MOLDING

 Thecold mass of the base containing


the drug is compressed into
suppositories using a hand operated
machine.
2. COMPRESSION
MOLDING

STEP 1
drug

fine powder
2. COMPRESSION
MOLDING

STEP 2
Drug (fine powder)

Base
2. COMPRESSION MOLDING

STEP 3
Trituration
in pestle and
mortar
2. COMPRESSION
MOLDING
STEP 4
Compress the
mixture in the
compression mold
ADVANTAGES

1. It is a simple method
2. More elegant than hand molded
suppositories.
3. Sedimentation of solids in the base is
prevented.
DISADVANTAGES

1. Air entrapment may take place.


2. This air may cause weight variation.
3. The drug and/or the base may be
oxidized by this air.
● POUR MOLDING

The melted mass of the base containing


the drug is poured into suppository
moulds
3. POUR MOLDING

STEP 1
drug

fine powder
3. POUR MOLDING

STEP 2

Melt the base


3. POUR MOLDING

STEP 3

Drug incorporation
into melted base
3. POUR MOLDING

STEP 4

Cooling down
process
3. POUR MOLDING

STEP 5
Molds are chilled
(lubricate if
necessary)
3. POUR MOLDING

STEP 6
Molten liquid mass

chilled molds
3. POUR MOLDING

STEP 7

Warm spatula
3. POUR MOLDING

STEP 8

Removed
excessive part via
warm spatula
3. POUR
MOLDING

STEP 9

After solidification
the cone shaped
suppositories are
removed.
● AUTOMATIC MOLDING
MACHINE

 In
industry all the operations in pour
molding are done by automatic
machines.

 Usingthis machine, up to about 10,000


suppositories per hour can be produced.
PRACTICAL PROCEDURE

PRACTICAL
PROCEDURE
STEP 1

 Given by physician
Drug quantity e.g., 400 mg zinc oxide
Total weight of suppository e.g., 2g
No of suppositories e.g., 10
Purpose e.g., For rectal use
STEP 2
Select mold

Specific shape and


volume
STEP 3
Pour only melted
base into mold

Solidification

excessive removed
STEP 4
melt

Check volume of
remelted base

Confirm average
weight of suppository
STEP 5
Check the weight by
using formula
Mass= density × volume

Calculate total weight of


10 suppositories
= 20g
STEP 6

 Displacement value of drug to the base


e.g., 4.7g of ZnO= 1g of cocoa butter

 Means 400mg × 10 = 0.85 g of base

 Volume of base needed = 20g-0.85


=19.15g
STEP 7
Drug Solution into mold

Fill mold with base

Upon solidification Excess


STEP 8
Melt the suppository

Homogeneous
mixture
STEP 9
pour into the mould

Solidification

Excessive removed
RESULT

 Desired suppository

Note
it is normal practice to prepare for an
excess quantity of suppositories
RULES AND PREVENTIONS

SUPPOSITORY
PACKAGING
PACKAGING
Types of molds of different shapes and
volumes
 Reusable
Stainless steel mold
Aluminium mold
Brass mold
Plastic
 Disposable
Soft Plastic molds
PACKAGING
Suppositories manufactured in metal
moulds

Separated from moulds carefully

Wrapped individually by aluminium foil

Placed in container
PACKAGING
Suppositories manufactured in disposable
moulds

Dispensed to the patient as it is

 Note = It should be easy to release each


suppository from mould
PACKAGING
In General:
Best to keep all suppositories refrigerated

 Base of Cocoa Butter:


Store < 30oC
 Base of glycerinated gelatin:
Store <35oC
 Base of PEG:
High m.p. so usually OK slightly warm
PACKAGING

About Containers:

 Tightly closed glass


(i.e. glycerin is very hygroscopic)
 Individually wrapped foil
(Use: Unwrap & insert)
PACKAGING

Environmental Factors:
Important due to base

 Highhumidity—absorbs water from


atmosphere
 Low humidity—loose water to
atmosphere--brittle
SUPPOSITORY
DISCARD DATES

SUPPOSITORY
DISCARD DATES
DISCARD DATES

 Discard dates are w.r.t. official data

 If official data is not available

Discard date = 3 months


after manufacturing
SUPPOSITORY
LABELLING
LABELLING
 Inaddition to standard rules for labelling
Followings are important to mention

 For _____ use only


Rectal
Vaginal
 Store below 150C
Questions?

Thanks
Questions?

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