1. Hand Mould Suppositories:
This is the oldest and simplest method of preparing suppositories. A expert person is required for the preparation of suppositories.
General process for preparation of suppositories is as follows:
(a) Mix measured quantity of medicinal substances with sufficient quantity of theobroma oil.
(b) Triturate and, if required, soften with diluted alcohol and rub until a smooth paste is formed.
(c) Add remaining quantity of theobroma oil and add wool fat for consistency.
(d) When the mass becomes plastic by vigorous kneading of the pestle quickly remove from the mortar with a spatula.
(e) Transfer with spatula to a piece of filter paper and keep in hands during the kneading and rolling procedure.
(f) Roll the mass by quick rotating movements of the hands and immediately place on a pill tile.
(g) Rolling the mass on the tile with a level board forms a cylindrical suppository.
(h) Cut in pieces by spatula.
(i) Give the shape by rolling one end on the tile with a spatula.
(j) Pack in butter paper or in proper container and store in cool place.
2. Compression mould suppositories (Cold compression)
(a) Mix theobroma oil and treatment.
(b) Mixture is forced into a mould under pressure, using a wheel-operated press.
(c) Mould is removed, opened and replaced.
(d) On large-scale cold-compression machines are hydraulically operated by water- jacketed cooling and screw fed.
3. Fusion or melt mould suppositories
(a) Drug is dispersed or dissolved in a melted suppository base.
(b) Pour the mixture into suppository moulds and allow cooling in ice bath.
(c) Finished suppositories are removed by opening the mould.
(d) Various types and sizes of moulds are available for preparation of suppositories. Moulds are made of aluminum alloys, brass or plastic and are available with from six to several hundred cavities.
4. Automatic molding machine
Two types of molding machines are available: (a) turning molding machine and (b) straight-line molding machine
Manufacturing cycles in rotary molding machine:
1. Prepared mass is filled in a into a filling hopper where it is continuously mixed and maintained at constant heat.
2. The suppository molds are lubricate by combing or spraying lubricant solution.
3. The molten mass is filled in the molds to a slight excess.
4. The mass is cooled to solidify and the excess material is scrapped off and collected for re-use.
5. In the eject section the mold is opened and the suppositories are pushed out by steel rods.
6. The mold is closed, and then moved to the first step of the cycle.
The output of a typical rotary machine ranges from 3500 to 6000 suppositories an hour.
Manufacturing cycles in straight-line molding machine:
Here the cycle is similar to rotary molding machine but the person molds are carried on a track through a cooling tunnel, where scrape-off and ejection occur.
Two types of molding machines are available: (a) turning molding machine and (b) straight-line molding machine
Manufacturing cycles in rotary molding machine:
1. Prepared mass is filled in a into a filling hopper where it is continuously mixed and maintained at constant heat.
2. The suppository molds are lubricate by combing or spraying lubricant solution.
3. The molten mass is filled in the molds to a slight excess.
4. The mass is cooled to solidify and the excess material is scrapped off and collected for re-use.
5. In the eject section the mold is opened and the suppositories are pushed out by steel rods.
6. The mold is closed, and then moved to the first step of the cycle.
The output of a typical rotary machine ranges from 3500 to 6000 suppositories an hour.
Manufacturing cycles in straight-line molding machine:
Here the cycle is similar to rotary molding machine but the person molds are carried on a track through a cooling tunnel, where scrape-off and ejection occur.
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