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COLLEGE OF PHARMACY
GC UNIVERSITYFAISALABAD
4th semester (E)SESSION 2007-2012
SUPPOSITORIESPharmaceutical unit dosage form
DEFINITION
Solid unit dosage form intended for insertion into the body orifices where it melts, softens, or dissolves—and exerts localized or systemic effects
PREPARATION FOUR METHODS
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