Glossary (Ph. Eur.)
This glossary 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.
Equivalent terms: active ingredient, drug substance, medicinal substance, active pharmaceutical ingredient.
Basis is an alternative term for 'vehicle' in a semi-solid or moulded solid preparation. The basis may be single-phase or multiphase.
Conventional-release dosage form
A conventional-release dosage form is a preparation showing a release of the active substance(s) that 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, usually administered orally, where the onset of release of the active substance(s) is adjusted to take place after a specific time or at a specific location in the gastrointestinal tract. 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.
From a Ph. Eur. perspective, a dispersion is a system consisting of 2 or more phases.
- Colloidal dispersion
A colloidal dispersion is a system in which particles of colloidal size (a nominal diameter between approximately 1 nm and 1 μm) of any nature (solid, liquid or gas, including liposomes and nanosystems) are dispersed in a continuous phase of a different composition and/or state. The use of 'nominal diameter'is intended to convey that not all particles are spherical. Dispersions of particles below 1 μm are considered less likely to undergo sedimentation because of the effect of Brownian motion.
A suspension is a dispersed system comprising solid particles of a nominal diameter greater than approximately 1 μm, dispersed in a liquid or semi-solid continuous phase. If the solid particles are of a nominal diameter lower than approximately 1 μm, the system is a colloidal suspension.
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 of a diameter greater than approximately 1 μm. If the droplets are of a nominal diameter lower than approximately 1 μm, the system is a colloidal emulsion.
A large-volume parenteral is 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 onset, 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, intermittent release of the active substance(s). Pulsatile release is achieved by a special formulation design and/or manufacturing method.
A small-volume parenteral is an infusion or injection supplied in a container with a nominal content of 100 mL or less.
A solution is a homogeneous mixture forming a single phase containing one or more dissolved substances, i.e. substances in a molecular or ionic state dispersed in a solvent or in miscible solvents. The dissolved substances can be solids, liquids or gases.
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.
Standard Terms are approved terms for describing certain aspects of a medicinal product, namely the dosage form and route or method of administration, and certain important packaging items such as the container, closure and administration device. They are established by the European Pharmacopoeia Commission, which started working on the lists of Standard Terms in response to a request made by the EU Commission for use in the marketing authorisation application (MAA), summary of product characteristics (SmPC), labelling, and electronic communications. Standard Terms have the double purpose of bringing information to the patient/user/prescriber and distinguishing medicinal products having the same trade name, and are published in a specific Standard Terms database.
A vehicle is the carrier, composed of one or more excipients, in which the active substance(s) are contained, usually when referring to a liquid or semi-solid preparation.