A distinction is made between fatty and water-soluble suppository preparations. Fatty suppositories are the better-known form.
Fatty and water-soluble suppositories
Fatty
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. For this, the hard fat 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 various polyethylene glycols (macrogol) as well as gelatine and glycerol are used.
One challenge with water-soluble suppositories is the small amount of fluid at the site of application, for example in the rectum, in which the suppository must 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 manufacturing, the handling of very different viscosities is decisive. 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 drawing-in, mixing and dosing
- Pressure- and vacuum-resistant seals for sterile processing in one homogenising step
- Efficient radial and vertical mixing, even with highly viscous masses
- Convenient drawing-in and dispersing of powders or wax pellets
- Aseptic valves and fittings as standard
Circulation agitator instead of anchor agitator
Many suppository masses can be produced entirely without an anchor agitator with scrapers. Circulation agitators or similar agitators are used instead.
With a circulation agitator, fat phases can be melted and waxes incorporated. At the same time, the product is kept in constant motion – on request with minimal shear and intensive mixing.
Temperature control and documentation
Accurate, infinitely adjustable temperature control ensures precisely coordinated heating and cooling phases. For this, all product-contact plant components must be temperature-controllable. In addition, all production steps are recorded, stored and can be retrieved at any time.
FAQ: Manufacturing suppositories
What are suppositories made of?
Usually hard fat with a melting range close to body temperature, alternatively water-soluble bases such as macrogols (polyethylene glycols) or glycerol-gelatine. Active ingredients are dissolved, emulsified or suspended.
How is the suppository mass produced?
The hard fat is melted, and active ingredients are incorporated and homogeneously dispersed. The mass is kept in motion at a controlled temperature so that solids do not settle, and is then poured into moulds.
Which agitator is suitable?
Often a circulation agitator, which produces intensive mixing with low shear. An anchor agitator with scrapers is not necessary for many masses.
Why is temperature control so important?
The mass must be kept just above the melting point so that viscosity, sedimentation behaviour and pourability remain constant. All product-contact parts should be temperature-controllable.
Does SEEFRIED offer plants for suppository masses?
Yes, we design plants and supply suitable agitating and homogenising mixers for suppositories and pessaries.