PREPARATION

METHODS OF PREPARATION

Four methods

1. Molding by hand

2. Compression

3. Pour molding

4. Compression in a tabletting machine

1. MOLDING BY HAND

Hand molding is useful when we arepreparing a small number of

suppositories

STEP 1 drug

fine powder

1. MOLDING BY HAND

STEP 2Drug (fine powder)

Base

1. MOLDING BY HAND

STEP 3

Trituration

in pestle and mortar

1. MOLDING BY HAND

STEP 4Mass

Rolled

Long rods

1. MOLDING BY HAND

STEP 5Rods

cut into pieces

1. MOLDING BY HAND

2. COMPRESSION MOLDING

The cold mass of the base containingthe drug is compressed into

suppositories using a hand operated machine.

STEP 1 drug

fine powder

2. COMPRESSION MOLDING

STEP 2Drug (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

2. COMPRESSION MOLDING

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 beoxidized by this air.

3. POUR MOLDING

The melted mass of the base containingthe drug is poured into suppository

moulds

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 5Molds are chilled

(lubricate if necessary)

3. POUR MOLDING

STEP 6Molten 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 shapedsuppositories are

removed.

3. POUR MOLDING

4. AUTOMATIC MOLDING MACHINE

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

Using this machine, up to about 10,000 suppositories per hour can be produced.

PRACTICAL PROCEDURE

STEP 1

Given by physicianDrug quantity e.g., 400 mg zinc oxideTotal weight of suppository e.g., 2gNo of suppositories e.g., 10Purpose e.g., For rectal use

STEP 2

Select mold

Specific shape and volume

STEP 3Pour only melted base into mold

Solidification

excessive removed

STEP 4melt

Check volume of remelted base

Confirm average weight of suppository

STEP 5Check 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 removed

STEP 8Melt the suppository

Homogeneous mixture

STEP 9pour into the mould

Solidification

Excessive removed

RESULT

Desired suppository

Note

it is normal practice to prepare for an excess quantity of suppositories

SUPPOSITORY PACKAGING

RULES AND PREVENTIONS

PACKAGING

Types of molds of different shapes and volumes

ReusableStainless steel moldAluminium moldBrass moldPlastic

DisposableSoft 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

High humidity—absorbs water from atmosphere

Low humidity—loose water to atmosphere--brittle

SUPPOSITORYDISCARD 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

In addition to standard rules for labelling

Followings are important to mention

For _____ use onlyRectalVaginal

Store below 150C

Questions?Thanks