P R E P A R A T I O N O F S U P P O S I T O R I E S

PREPARATION OF SUPPOSITORIES

BY:Daniel Thomas A. Berberabe

How to prepare suppositories??

1. Molding from a melt

2. Compression

3. Hand rolling and Shaping

Preparation by Molding

STEPS!(a) Melting the base(b) Incorporating any required medicaments(c) Pouring the melt into molds(d) Allowing the melt to cool and congeal into

suppositories(e) Removing the formed suppositories from the

mold

Preparation by Molding

Cocoa butter, Glycerinated gelatin, Polyethylene glycol and most other bases are suitable for MOLDING

What are Suppository Molds?

Molds are use to produce individual or large number of suppositories of various shapes and sizes.

Suppository Mold

Plastic Molds

Individual plastic molds may be used to form a single

suppository

Industrial Molds

Produces hundreds of suppositories from a single batch

Molds

Care must be exercised in cleaning molds.

Any scratches on the molding surface will take away from the desired smoothness of the suppositories

Temporary Molds

Pressing heavy aluminum foil about an object having the shape of the desired suppository.

Tips!

Round pencils or pens may be used to form molds for rectal suppositories.

Stirring rods for urethral suppositories

Any cone-shaped object for vaginal suppositories

Lubrication of the Mold

Lubrication is required before the melt is poured to facilitate clean and easy removal of the molded suppositories

Lubrication of the Mold

Lubrication is seldom necessary when the base is cocoa butter or polyethylene glycol.

Lubrication is necessary with glycerinated gelatin.

Mineral Oil applied on the molding surfaces is enough to lubricate it.

Calibration of the Mold

The first step is to prepare molded suppositories from base material alone

The suppository's combined and average weight is recorded.

Calibration of the Mold

To determine the volume of the mold, the suppositories are melted in a calibrated beaker, and the volume of the melt is determined

How to determine the amount of base required?

The physician indicates the amount of medicinal substance desired in a suppository

The pharmacist determines the amount of base in a suppository

Three methods in determining the amount of base required

1. Volume of the drug substance subtracted to the total volume of the mold = Volume of the base

2. Dissolve the active ingredient in a portion of the melted base and add the remaining base to fill one cavity

Three methods in determining the amount of base required

3. Place all the required medicaments for the preparation of the total number of suppositories in a calibrated beaker. Incorporate the drug substance with a portion of the melt base. Add enough melted base to fill all the required volume of the molds

Preparing and Pouring the Melt

The weighed suppository based material is melted in a water bath.

Prevent undissolved or suspended material to settle by stirring

Preparing and Pouring the Melt

Small quantity of silica gel can be incorporated to keep the active drug suspended

Pour excessively in each opening to ensure a completely filled mold upon congealing

Preparation by Compression

Forcing the mixed mass of the base and the medicaments into special molds using suppository making machines

Suppository-making machine

Compression

Compression is especially suited for making suppositories that contain heat-labile medicinal substances or substances that are insoluble in the base

Disadvantages of Compression Method

Suppository Machine is required

There are some limitation as to shapes of suppositories that can be made

Preparation by Hand Rolling and Shaping

A historic part of the art of pharmacist

With ready availability of suppository molds, there is little requirement for pharmacist to shape suppositories by hand