Suppositories are a dosage form that consist of small solid cones or cylinders for insertion into body cavities in order to achieve a systemic or local effect using an active pharmaceutical ingredient. Suppositories (German translation: Zäpfchen) are commonly used to administer drugs through the anus (rectal suppositories; German: Rektalzäpfchen) or the vagina (vaginal suppositories; German: Vaginalzäpfchen). Suppositories are usually produced in a casting process. The active pharmaceutical ingredient is dissolved or dispersed in the molten base. This mixture is then poured into a mold and left to cool until the suppositories are solid and can be removed.

While the use of suppositories is perceived by many people as rather unpleasant, it also has some advantages, such as:

• Suppositories can be used for the local treatment of various conditions such as hemorrhoids, inflammation of the rectum, vaginal infections, constipation, etc.
• However, they also have a systemic effect (German translation: systemische Wirkung) and can be used as painkillers, antiemetics or antipyretics.
• Suppositories allow the drug to be administered directly at the site of action for a local effect. In the case of a systemic effect, bypassing the digestive tract also means avoiding the first-pass effect, meaning metabolization of the active pharmaceutical ingredient during the first passage through the liver is avoided.
• Peroral administration of drugs is not always possible. Rectal application is therefore a good alternative dosage form for toddlers, patients who have difficulties swallowing or unconscious patients.

The base ingredients of suppositories are usually excipients such as hard fat (translation into German: Hartfett) or cocoa butter. However, there are also water-soluble suppositories that consist of polyethylene glycols, for example. These are less sensitive to high temperatures, which is advantageous in terms of stability, especially at higher outside temperatures. Suppositories are designed to dissolve or melt at body temperature so that the active pharmaceutical ingredient is released quickly and can take effect.

Our experienced GMP translators and pharmaceutical interpreters will be happy to assist you should you need your pharmaceutical documents translated or require language support during a GMP inspection by foreign regulatory authorities. In addition, our range of services also includes various types of consultancy services, representation of foreign pharmaceutical companies as well as distribution of their products in Germany.