PREPARATION

METHODS OF PREPARATION Four methods Molding by hand Compression Pour molding Compression in a tabletting machine

MOLDING BY HAND Hand molding is useful when we are preparing a small number of suppositories

MOLDING BY HAND STEP 1 drug fine powder

MOLDING BY HAND STEP 2 Drug (fine powder) Base

MOLDING BY HAND STEP 3 Trituration in pestle and mortar

MOLDING BY HAND STEP 4 Mass Rolled Long rods

MOLDING BY HAND STEP 5 Rods cut into pieces

COMPRESSION MOLDING The cold mass of the base containing the drug is compressed into suppositories using a hand operated machine.

COMPRESSION MOLDING STEP 1 drug fine powder

COMPRESSION MOLDING STEP 2 Drug (fine powder) Base

COMPRESSION MOLDING STEP 3 Trituration in pestle and mortar

Compress the mixture in the compression mold COMPRESSION MOLDING STEP 4 Compress the mixture in the compression mold

ADVANTAGES It is a simple method More elegant than hand molded suppositories. Sedimentation of solids in the base is prevented.

DISADVANTAGES Air entrapment may take place. This air may cause weight variation. 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

POUR MOLDING STEP 1 drug fine powder

POUR MOLDING STEP 2 Melt the base

Drug incorporation into melted base POUR MOLDING STEP 3 Drug incorporation into melted base

POUR MOLDING STEP 4 Cooling down process

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

POUR MOLDING STEP 6 Molten liquid mass chilled molds

POUR MOLDING STEP 7 Warm spatula

Removed excessive part via warm spatula POUR MOLDING STEP 8 Removed excessive part via warm spatula

After solidification the cone shaped suppositories are removed. 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. Using this machine, up to about 10,000 suppositories per hour can be produced.

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

Specific shape and volume STEP 2 Select mold Specific shape and volume

Pour only melted base into mold 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 removed

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

SUPPOSITORY PACKAGING 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

Best to keep all suppositories refrigerated 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

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 In addition to standard rules for labelling Followings are important to mention For _____ use only Rectal Vaginal Store below 150C

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