EUROPEAN PHARMACOPOEIA 11.
0 Pressurised pharmaceutical preparations
Fine particle dose. Using an apparatus and procedure 01/2019:0523
described in general chapter 2.9.18. Preparations for
inhalation : aerodynamic assessment of fine particles
(apparatus C, D or E), calculate the fine particle dose.
Number of deliveries per inhaler for multidose inhalers.
Take 1 inhaler and discharge the contents to waste until PRESSURISED PHARMACEUTICAL
empty, at the predetermined flow rate. Record the deliveries
discharged. The total number of deliveries discharged from PREPARATIONS
the inhaler is not less than the number stated on the label
(this test may be combined with the test for uniformity of Praeparationes pharmaceuticae in vasis cum
delivered dose). pressu
Additional requirements for preparations presented in
pressurised containers may be found, where appropriate,
01/2008:1116 in other general monographs, for example Preparations
for inhalation (0671), Liquid preparations for cutaneous
application (0927), Powders for cutaneous application (1166),
Nasal preparations (0676) and Ear preparations (0652).
DEFINITION
PREPARATIONS FOR IRRIGATION Pressurised pharmaceutical preparations are usually multidose
preparations presented in special containers under pressure of
Praeparationes ad irrigationem a gas and often fitted with a metering valve, and contain one
or more active substances. The preparations are released from
DEFINITION the container, upon actuation of an appropriate valve, in the
Preparations for irrigation are sterile, aqueous, large-volume form of an aerosol (dispersion of solid or liquid particles in a
preparations intended to be used for irrigation of body cavities, gas, the size of the particles being adapted to the intended use)
wounds and surfaces, for example during surgical procedures. or of a liquid or semisolid jet such as a foam. The pressure for
Preparations for irrigation are either solutions prepared by the release is generated by suitable propellants.
dissolving one or more active substances, electrolytes or The preparations are intended for local application to the
osmotically active substances in water complying with the skin or to mucous membranes of various body orifices, or
requirements for Water for injections (0169) or they consist for inhalation. Pressurised pharmaceutical preparations are
of such water alone. In the latter case, the preparation may provided with a delivery device appropriate for the intended
be labelled as ‘water for irrigation’. Irrigation solutions are application. Pressurised pharmaceutical preparations intended
usually adjusted to make the preparation isotonic with respect to be used on severely injured skin or large open wounds
to blood. are sterile and comply with the test for sterility. Suitable
Examined in suitable conditions of visibility, preparations for excipients may also be used, for example solvents, solubilisers,
irrigation are clear and practically free from particles. emulsifying agents, suspending agents and lubricants for the
valve to prevent clogging.
Preparations for irrigation are supplied in single-dose
containers. The containers and closures comply with the Pressurised pharmaceutical preparations may have the
requirements for containers for preparations for parenteral following components.
administration (3.2.1 and 3.2.2), but the administration port of Propellants. The propellants are either gases liquefied
the container is incompatible with intravenous administration under pressure or compressed gases or low-boiling liquids.
equipment and does not allow the preparation for irrigation Liquefied gases are, for example, fluorinated hydrocarbons
to be administered with such equipment. and low-molecular-mass hydrocarbons (such as propane and
butane). Compressed gases are, for example, carbon dioxide,
PRODUCTION nitrogen and nitrous oxide.
Preparations for irrigation are prepared using materials Mixtures of these propellants may be used to obtain optimal
and methods designed to ensure sterility and to avoid solution properties and desirable pressure, delivery and spray
the introduction of contaminants and the growth of characteristics.
micro-organisms ; recommendations on this aspect are Containers. The containers are tight and resistant to the
provided in the text on Methods of preparation of sterile internal pressure and may be made of metal, glass, plastic or
products (5.1.1). combinations of these materials. They are compatible with
During development, it must be demonstrated that the their contents. Glass containers are protected with a plastic
nominal content can be withdrawn from the container. coating.
Spraying device. The valve keeps the container tightly closed
TESTS
when not in use and regulates the delivery of the contents
Sterility (2.6.1). Preparations for irrigation comply with the during use. The spray characteristics are influenced by the
test for sterility. type of spraying device, in particular by the dimensions,
Bacterial endotoxins (2.6.14) : less than 0.5 IU/mL. number and location of orifices. Some valves provide a
continuous release, others (metering valves) deliver a defined
Pyrogens (2.6.8). Preparations for which a validated test for quantity of product upon each valve actuation.
bacterial endotoxins cannot be carried out comply with the test
for pyrogens. Inject per kilogram of the rabbit’s mass 10 mL of The various valve materials in contact with the contents are
the preparation, unless otherwise justified and authorised. compatible with them.
LABELLING PRODUCTION
Special requirements may be necessary regarding the
The label states :
selection of propellants, the particle size and the dose
– that the preparation is not to be used for injection ; delivered by the metering valve, depending on the intended
– that the preparation is to be used on one occasion only application. Sterile pressurised preparations are prepared
and that any unused portion of the preparation is to be using materials and methods designed to ensure sterility and
discarded. to avoid the introduction of contaminants and the growth
General Notices (1) apply to all monographs and other texts 999
www.webofpharma.com
