Glossary (Ph. Eur.)
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, 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.
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.
Active substance
Equivalent terms: active ingredient, drug substance, medicinal substance, active pharmaceutical ingredient.
Vehicle
A vehicle is the carrier, composed of one or more excipients, for the active substance(s) in a liquid preparation.
Basis
A basis is the carrier, composed of one or more excipients, for the active substance(s) in semi-solid and solid preparations.
Conventional-release dosage forms
Conventional-release dosage forms are preparations 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.
Modified-release dosage forms
Modified-release dosage forms are preparations 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 forms
Prolonged-release dosage forms are modified-release dosage forms 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.
Delayed-release dosage forms
Delayed-release dosage forms are modified-release dosage forms 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.
Pulsatile-release dosage forms
Pulsatile-release dosage forms are modified-release dosage forms showing a sequential release of the active substance(s). Sequential release is achieved by a special formulation design and/or manufacturing method.
Large-volume parenterals
Infusions and injections supplied in containers with a nominal content of more than 100 ml.
Small-volume parenterals
Infusions and injections supplied in containers with a nominal content of 100 ml or less.