Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Capsules

The capsule shell is usually made from gelatin. If it is important that the finished drug product be kosher or halal, certified bovine gelatin can be used instead of porcine gelatin.

Capsules are a solid, single-dose dosage form consisting of a shell made of gelatin or other materials and containing active pharmaceutical ingredients in the form of a powder, granules, liquid or another form. Capsules are mostly used for the peroral administration (i.e. orally) of drugs. However, there are also vaginal capsules as well as capsules used to dose the powder to be inhaled in powder inhalers. The shell of the capsule is usually made from gelatin (German translation: Gelatine). If it is important that the finished drug product is kosher or halal, certified bovine gelatin can be used instead of porcine gelatin. However, the tendency to use other raw materials such as cellulose is increasing. Unlike gelatin, cellulose is not only kosher/halal, it is also vegan.

There are two main types of capsules (German translation: Kapseln):

  • Hard capsules (German: Hartkapseln): As the name implies, these consist of a hard capsule shell and are filled with solid filling materials such as powders, granules or even small tablets. The shell consists of two parts that are fitted together.
  • Soft capsules (German: Weichkapseln): These consist of a soft, slightly thicker shell and contain liquid or semi-solid filling materials such as oils or macrogols. The shell is self-contained and may have a seam depending on the manufacturing process.

The benefits of capsules include:

  • Precise dosing: Capsules are single-dosed and therefore enable precise and simple dosing of the drug.
  • Taste masking: Capsules can be used to mask the unpleasant taste of active pharmaceutical ingredients.
  • Long-term effect: In the case of extended-release capsules, they can produce a long-lasting effect of the drug.
  • Protection against external influences: The capsule protects the active pharmaceutical ingredient from external influences such as oxygen, light, humidity and dust, thus ensuring its stability.

Capsules can also be used for the preparation of combination drugs, whereby several active pharmaceutical ingredients are combined in a single capsule.

It is important to remember that capsules should be taken according to the prescribing doctor’s instructions or the instructions for use, as some capsules may require special conditions when taking or dosing them. In general, capsules are a versatile and widely used dosage form (German translation: Arzneiform).

At GMP-inspection.com, you will find competent pharmaceutical interpreters and GMP translators to assist you with the GMP inspection of your pharmaceutical company. We interpret on site and translate pharmaceutical texts that are required for the preparation and follow-up of the inspection. We also offer various types of consultancy services, representation of foreign pharmaceutical companies and distribution of their products in Germany.

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