​​Glossary (Ph. Eur.)
Glossa

The following introductory text provides definitions and/or explanations of terms that may be found in, or used in association with, the general monographs on dosage forms and the corresponding chapters on Pharmaceutical technical procedures (2.9), but that are not defined within them. Where relevant, reference is made to other equivalent terms that may be found in other publications or contexts.

This glossary is published for information.

Active substance

Equivalent terms: active ingredient, drug substance, medicinal substance, active pharmaceutical ingredient.

Basis

A basis is the carrier, composed of one or more excipients, for the active substance(s) in semi-solid and solid preparations.

Colloidal dispersion

A colloidal dispersion is a system in which particles of colloidal size (a dimension of approximately between 1 nm and 500 nm) of any nature (solid, liquid or gas) are dispersed in a continuous phase of a different composition and/or state.

Conventional-release dosage form

A conventional-release dosage form is a preparation showing a release of the active substance(s) which is not deliberately modified by a special formulation design and/or manufacturing method. In the case of a solid dosage form, the dissolution profile of the active substance depends essentially on its intrinsic properties. Equivalent term: immediate-release dosage form.

Delayed-release dosage form

A delayed-release dosage form is a modified-release dosage form showing a release of the active substance(s) which is delayed. Delayed release is achieved by a special formulation design and/or manufacturing method. Delayed-release dosage forms include gastro-resistant preparations as defined in the general monographs on solid oral dosage forms.

Emulsion

An emulsion is a dispersed system consisting of a mixture of at least 2 liquids that are not miscible with each other. One of the liquids is dispersed in the other as droplets.

Large-volume parenteral

An infusion or injection supplied in a container with a nominal content of more than 100 mL.

Modified-release dosage form

A modified-release dosage form is a preparation where the rate and/or place of release of the active substance(s) is different from that of a conventional-release dosage form administered by the same route. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Modified-release dosage forms include prolonged-release, delayed-release and pulsatile-release dosage forms.

Prolonged-release dosage form

A prolonged-release dosage form is a modified-release dosage form showing a slower release of the active substance(s) than that of a conventional-release dosage form administered by the same route. Prolonged-release is achieved by a special formulation design and/or manufacturing method. Equivalent term: extended-release dosage form.

Pulsatile-release dosage form

A pulsatile-release dosage form is a modified-release dosage form showing a sequential release of the active substance(s). Sequential release is achieved by a special formulation design and/or manufacturing method.

Small-volume parenteral

An infusion or injection supplied in a container with a nominal content of 100 mL or less.

Solution

A solution is a mixture forming a single phase containing one or more dissolved substances, i.e. substances in a molecular state dispersed in a solvent or in miscible solvents.

Spheroids

Spheroids are considered to be spherical or approximately spherical granules with a usually increased mechanical resistance compared to conventional granules (0499) They possess a smooth, uniform surface, with a typical size range of 200 µm to 2.8 mm. Spheroids may be prepared by any suitable method.

Suspension

A suspension is a dispersed system containing solid particles dispersed in a liquid or semi-solid, continuous phase, in which the solid particles are practically insoluble.

Standard Term

Standard Terms for describing the pharmaceutical form of a medicinal product, the routes of administration and the containers used have been established by the European Pharmacopoeia Commission and are provided in a separate publication on Standard Terms.

Vehicle

A vehicle is the carrier, composed of one or more excipients, for the active substance(s) in a liquid preparation. 
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Publisert: 03.04.2017