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