Suppositories are divided into fat-based and water-soluble preparations. Fat-based suppositories are the better-known form.
Fat-based and water-soluble suppositories
Fat-based
The base is usually hard fat with a melting range close to body temperature. This allows the suppository to dissolve at the site of application. The hard fat therefore needs defined emulsifying and melting properties.
Water-soluble
These suppositories do not melt but dissolve in the water present and then release the active ingredient. Mixtures of different polyethylene glycols (macrogol) as well as gelatine and glycerol are used.
One challenge with water-soluble suppositories is the small amount of liquid at the site of application, for example in the rectum, in which the suppository has to dissolve.
Suppositories are made from emulsions, suspensions or solutions of various active ingredients and hard fats.
Requirements for the homogenising mixer
In addition to hygienic production, handling very different viscosities is crucial. Modern homogenising mixers can be used flexibly and efficiently for this:
- installation and equipment options on the homogeniser chamber, circulation line and lid for efficient induction, mixing and dosing
- pressure- and vacuum-tight seals for sterile processing in one homogenising step
- efficient radial and vertical mixing, even with highly viscous masses
- convenient induction and dispersion of powders or wax pellets
- aseptic valves as standard
Circulation agitator instead of anchor agitator
Many suppository masses can be produced entirely without an anchor agitator with scrapers. Instead, circulation agitators or similar agitators are used.
With a circulation agitator, fat phases can be melted and waxes incorporated. At the same time, the product is kept in constant motion – with minimal shear and intensive mixing if required.
Temperature control and documentation
Precise, infinitely adjustable temperature control ensures exactly coordinated heating and cooling phases. For this, all product-contact plant components must be temperature-controlled. In addition, all production steps are recorded, stored and can be retrieved at any time.
FAQ: Producing suppositories
What are suppositories made of?
Mostly hard fat with a melting range close to body temperature, or water-soluble bases such as macrogols (polyethylene glycols) or glycerol-gelatine. Actives are dissolved, emulsified or suspended.
How is the suppository mass produced?
The hard fat is melted, actives are incorporated and homogeneously dispersed. The mass is kept moving at controlled temperature so solids do not settle, then poured into moulds.
Which agitator is suitable?
Often a circulation agitator that achieves intensive mixing with low shear. An anchor agitator with scrapers is not required for many masses.
Why is temperature control so important?
The mass must be kept just above its melting point so that viscosity, sedimentation behaviour and pourability stay constant. All product-contact parts should be temperature-controlled.
Does SEEFRIED offer plants for suppository masses?
Yes, we plan plants and supply suitable agitator and homogenising mixers for suppositories and pessaries.