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METHODS OF PREPARATION
Four methods
1. Molding by hand
2. Compression
3. Pour molding
4. Compression in a tabletting machine
2. COMPRESSION MOLDING
The cold mass of the base containingthe drug is compressed into
suppositories using a hand operated machine.
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.
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.
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 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
RESULT
Desired suppository
Note
it is normal practice to prepare for an excess quantity of suppositories
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
DISCARD DATES
Discard dates are w.r.t. official data
If official data is not available
Discard date = 3 months
after manufacturing
LABELLING
In addition to standard rules for labelling
Followings are important to mention
For _____ use onlyRectalVaginal
Store below 150C