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).

Dosage form

Definition: A dosage form is a preparation of a drug that differs depending on its administration route, the way it is used, and with which the required therapeutic effect can be achieved.

A dosage form is a preparation of a drug that differs depending on the administration route, the way it is used, and with which the required therapeutic effect can be achieved.

The dosage form (translation into German: Arzneiform) determines how a drug (British English: medicinal product) interacts with the body, how it is absorbed and how it fulfills its function. According to GMP guidelines, every dosage form must be designed, manufactured and prepared in accordance with strict regulations in order to guarantee its quality, safety and efficacy.

All dosage forms are categorized into 4 groups according to their aggregate state:

  • solid (German: fest);
  • semi-solid (German: halbfest);
  • liquid (German: flüssig);
  • gaseous (German: gasförmig).

Solid dosage forms

Tablets — dosage form manufactured by pressing or compacting the active pharmaceutical ingredient and the excipients (German translation: Hilfsstoffe).

A sugar-coated tablet is a spherical dosage form that is produced by repeatedly layering excipients onto a tablet or granulate.

Granules — small granules, each granule being an agglomerate of powder particles, round, cylindrical or irregular in shape, 0.2-0.3 mm in size.

Powders are disperse dosage forms; they are classified as follows:

  • simple and complex (consisting of 2 or more components) powders;
  • divided into individual doses or not divided.

Tea blends are mixtures of various cut, coarsely powdered or whole herbal drugs.

Capsules — single-dose dosage form consisting of a powdered, granulated or sometimes liquid filling, encased in a capsule shell made of gelatine, starch or another biopolymer.

Pharmaceutical films — dosage form in the shape of a polymer film that is applied sublingually.

Semi-solid dosage forms

Ointments are dosage forms with a soft consistency and are usually intended for external use; if the content of powdery substances in an ointment is greater than 25%, such an ointment is referred to as a paste.

Transdermal patch — a dosage form for external use that is applied to the skin and releases the active pharmaceutical ingredient from a matrix or reservoir.

Suppositories — single-dose dosage forms that are solid at room temperature and melt at body temperature for administration into body cavities (rectal and vaginal suppositories); suppositories can be in the form of a sphere, cone or cylinder.

Pill — obsolete dosage form in the form of a sphere weighing 0.1 to 0.5 g, manufactured from a homogeneous plastic mass containing the active pharmaceutical ingredient and the excipients; a pill weighing more than 0.5 g is called a bolus.

Liquid dosage forms

Solutions are dosage forms obtained by dissolving one or more active pharmaceutical ingredients in a solvent.

Suspensions are systems in which solids are suspended in a liquid and the particle size is between 0.1 and 10 µm.

Emulsions are mixtures that consist of liquids that are insoluble in each other and where very fine droplets of one liquid are dispersed in the other.

Infusions and decoctions are aqueous extracts from medicinal plants or aqueous solutions of standardized extracts.

Syrup — a solution of an active pharmaceutical ingredient, often in a thick sugar solution.

Tinctures — alcoholic, aqueous-alcoholic or alcohol-ether-transparent extracts from herbal raw materials, obtained without heating and removal of the extracting agents.

Extracts are concentrated extracts from medicinal plants; there are liquid, viscous and dry extract types.

Gaseous dosage forms

Aerosols are dosage forms in which solid or liquid active pharmaceutical ingredients are nebulized in a gas (often air) and then inhaled.

If you would also like professional language support during a GMP inspection or audit of your pharmaceutical company, we look forward to hearing from you. Our pharmaceutical interpreters and GMP translators will come to your company or interpret online if required.

Moreover, we also offer additional services, such as consultancy services in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with a large number of pharmaceutical companies around the world, we can also support you if you are looking for a new position in the pharmaceutical industry.

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