PRESSURISED PHARMACEUTICAL PREPARATIONS

Pressurised Pharmaceutical Preparations comply with the requirements of the European Pharmacopoeia. These requirements are reproduced below.

Ph Eur

Additional requirements for preparations presented in pressurised containers may be found, where appropriate, in other general monographs, for example

DEFINITION

Pressurised pharmaceutical preparations are presented in special containers under pressure of a gas and contain one or more active substances. The preparations are released from the container, upon actuation of an appropriate valve, in the form of an aerosol (dispersion of solid or liquid particles in a gas, the size of the particles being adapted to the intended use) or of a liquid or semisolid jet such as a foam. The pressure for the release is generated by suitable propellants.

The preparations consist of a solution, an emulsion or a suspension and are intended for local application to the skin or to mucous membranes of various body orifices, or for inhalation. Suitable excipients may also be used, for example solvents, solubilisers, emulsifying agents, suspending agents and lubricants for the valve to prevent clogging.

Propellants The propellants are either gases liquefied under pressure or compressed gases or low-boiling liquids. Liquefied gases are, for example, fluorinated hydrocarbons and low-molecular-mass hydrocarbons (such as propane and butane). Compressed gases are, for example, carbon dioxide, nitrogen and nitrous oxide.

Mixtures of these propellants may be used to obtain optimal solution properties and desirable pressure, delivery and spray characteristics.

Containers The containers are tight and resistant to the internal pressure and may be made of metal, glass, plastic or combinations of these materials. They are compatible with their contents. Glass containers are protected with a plastic coating.

Spraying device The valve keeps the container tightly closed when not in use and regulates the delivery of the contents during use. The spray characteristics are influenced by the type of spraying device, in particular by the dimensions, number and location of orifices. Some valves provide a continuous release, others (“metering dose valves”) deliver a defined quantity of product upon each valve actuation.

The various valve materials in contact with the contents are compatible with them.

Requirements for pressurised pharmaceutical preparations

Pressurised preparations are provided with a delivery device appropriate for the intended application.

Special requirements may be necessary for the selection of propellants, for particle size and the single-dose delivered by the metering valves.

LABELLING

Ph Eur