Nasal preparations EUROPEAN PHARMACOPOEIA 5.

administered by means of a device suitable for measuring — nasal powders,

the prescribed volume. The device is usually a spoon or a — semi-solid nasal preparations,
cup for volumes of 5 ml or multiples thereof. — nasal washes,
LABELLING — nasal sticks.
The label states the name and concentration of the polyol PRODUCTION
or sweetening agent.
During the development of a nasal preparation, the
formulation for which contains an antimicrobial preservative,
Powders and granules for syrups the effectiveness of the chosen preservative shall be
DEFINITION demonstrated to the satisfaction of the competent authority.
A suitable test method together with criteria for judging the
Powders and granules for syrups generally conform to the preservative properties of the formulation are provided in
definitions in the monograph on Oral powders (1165) or the text on Efficacy of antimicrobial preservation (5.1.3).
Granules (0499). They may contain excipients to facilitate
dissolution. In the manufacture, packaging, storage and distribution
of nasal preparations, suitable means are taken to ensure
After dissolution, they comply with the requirements for their microbial quality ; recommendations on this aspect
syrups. are provided in the text on Microbiological quality of
TESTS pharmaceutical preparations (5.1.4).
Sterile nasal preparations are prepared using materials
Uniformity of content (2.9.6). Unless otherwise prescribed
and methods designed to ensure sterility and to avoid
or justified and authorised, single-dose powders and
the introduction of contaminants and the growth of
granules for syrups with a content of active substance
micro-organisms ; recommendations on this aspect are
less than 2 mg or less than 2 per cent of the total mass
provided in the text on Methods of preparation of sterile
comply with test B for uniformity of content of single-dose
products (5.1.1).
preparations. If the preparation has more than one active
substance, the requirement applies only to those substances In the manufacture of nasal preparations containing
that correspond to the above conditions. dispersed particles, measures are taken to ensure a suitable
and controlled particle size with regard to the intended use.
Uniformity of mass (2.9.5). Single-dose powders and
granules for syrups comply with the test for uniformity of TESTS
mass of single-dose preparations. If the test for uniformity of Sterility (2.6.1). Where the label states that the preparation
content is prescribed for all the active substances, the test is sterile, it complies with the test for sterility.
for uniformity of mass is not required.
STORAGE
If the preparation is sterile, store in a sterile, airtight,
01/2005:0676 tamper-proof container.

NASAL PREPARATIONS LABELLING

The label states :
Nasalia — the name of any added antimicrobial preservative,
— where applicable, that the preparation is sterile.
DEFINITION
Nasal preparations are liquid, semi-solid or solid preparations
intended for administration to the nasal cavities to obtain
Nasal drops and liquid nasal sprays
a systemic or local effect. They contain one or more active DEFINITION
substances. Nasal preparations are as far as possible Nasal drops and liquid nasal sprays are solutions, emulsions
non-irritating and do not adversely affect the functions of the or suspensions intended for instillation or spraying into the
nasal mucosa and its cilia. Aqueous nasal preparations are nasal cavities.
usually isotonic and may contain excipients, for example, to
adjust the viscosity of the preparation, to adjust or stabilise Emulsions may show evidence of phase separation but are
the pH, to increase the solubility of the active substance, or easily redispersed on shaking. Suspensions may show a
to stabilise the preparation. sediment which is readily dispersed on shaking to give a
suspension which remains sufficiently stable to enable the
Nasal preparations are supplied in multidose or single-dose correct dose to be delivered.
containers, provided, if necessary, with a suitable
administration device which may be designed to avoid the Nasal drops are usually supplied in multidose containers
introduction of contaminants. provided with a suitable applicator.
Unless otherwise justified and authorised, aqueous nasal Liquid nasal sprays are supplied in containers with atomising
preparations supplied in multidose containers contain devices or in pressurised containers fitted with a suitable
a suitable antimicrobial preservative in appropriate adapter and with or without a metering dose valve, which
concentration, except where the preparation itself has comply with the requirements of the monograph on
adequate antimicrobial properties. Pressurised pharmaceutical preparations (0523).
Where applicable, the containers comply with the The size of droplets of the spray is such as to localise their
requirements of Materials used for the manufacture of deposition in the nasal cavity.
containers (3.1 and subsections) and Containers (3.2 and TESTS
subsections).
Unless otherwise prescribed or justified and authorised,
Several categories of nasal preparations may be nasal drops supplied in single-dose containers and
distinguished : single doses of metered nasal sprays intended for systemic
— nasal drops and liquid nasal sprays, action, comply with the following tests.

610 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.0 Oromucosal preparations

Uniformity of mass. Nasal drops that are solutions comply The containers are adapted to deliver the product to the site
with the following test : weigh individually the contents of application.
of ten containers emptied as completely as possible, and
determine the average mass. Not more than two of the Nasal washes
individual masses deviate by more than 10 per cent from the
average mass and none deviates by more than 20 per cent. DEFINITION
Metered-dose nasal sprays that are solutions comply with Nasal washes are generally aqueous isotonic solutions
the following test : discharge once to waste. Wait for not intended to cleanse the nasal cavities.
less than 5 s and discharge again to waste. Repeat this Nasal washes intended for application to injured parts or
procedure for a further three actuations. Weigh the mass prior to a surgical operation are sterile.
of the container, discharge once to waste and weigh the
remaining mass of the container. Calculate the difference TESTS
between the two masses. Repeat the procedure for a further Deliverable mass or volume (2.9.28). Nasal washes supplied
nine containers. They comply with the test if not more than in single-dose containers comply with the test.
two of the individual values deviate by more than 25 per
cent from the average value and none deviates by more than Nasal sticks
35 per cent.
Uniformity of content (2.9.6). Nasal drops that are DEFINITION
suspensions or emulsions comply with the following test : Nasal sticks comply with the monograph on Sticks (1154).
empty each container as completely as possible and carry
out the test on the individual content. They comply with 01/2005:1807
test B of uniformity of content.
Uniformity of delivered dose. Metered-dose nasal sprays OROMUCOSAL PREPARATIONS
that are suspensions or emulsions comply with the following
test. Use an apparatus capable of quantitatively retaining Praeparationes buccales
the dose leaving the actuator of the atomising device. This monograph does not apply to dental preparations or
Shake a container for 5 s and discharge once to waste. Wait to preparations such as chewable tablets (0478) , medicated
for not less than 5 s, shake for 5 s and discharge again to chewing gums (1239), oral lyophilisates and other solid
waste. Repeat this procedure for a further three actuations. or semi-solid preparations that are intended to be chewed
After 2 s, fire one dose of the metered-dose nasal spray or dispersed in the saliva before being swallowed. Where
into the collecting vessel by actuating the atomising device. justified and authorised, this monograph does not apply to
Collect the contents of the collecting vessel by successive preparations for veterinary use.
rinses. Determine the content of active substance in the
combined rinses. DEFINITION
Repeat the procedure for a further nine containers. Oromucosal preparations are solid, semi-solid or liquid
preparations, containing one or more active substances
Unless otherwise justified and authorised, the preparation
intended for administration to the oral cavity and/or the
complies with the test if not more than one of the individual
throat to obtain a local or systemic effect. Preparations
contents is outside the limits of 75 per cent to 125 per cent
intended for a local effect may be designed for application to a
and none is outside the limits of 65 per cent and 135 per
specific site within the oral cavity such as the gums (gingival
cent of the average content.
preparations) or the throat (oropharyngeal preparations).
If two or three individual contents are outside the limits Preparations intended for a systemic effect are designed to be
of 75 per cent to 125 per cent but within the limits of absorbed primarily at one or more sites on the oral mucosa
65 per cent to 135 per cent, repeat the test for twenty more (e.g. sublingual preparations). Mucoadhesive preparations
containers. The preparation complies with the test if not are intended to be retained in the oral cavity by adhesion
more than three individual contents of the thirty individual to the mucosal epithelium and may modify systemic drug
contents are outside the limits of 75 per cent to 125 per cent absorption at the site of application. For many oromucosal
and none is outside the limits of 65 per cent to 135 per cent preparations, it is likely that some proportion of the active
of the average content. substance(s) will be swallowed and may be absorbed via the
gastrointestinal tract.
Nasal powders Oromucosal preparations may contain suitable antimicrobial
preservatives and other excipients such as dispersing,
DEFINITION suspending, thickening, emulsifying, buffering, wetting,
Nasal powders are powders intended for insufflation into the solubilising, stabilising, flavouring and sweetening agents.
nasal cavity by means of a suitable device. Solid preparations may in addition contain glidants,
They comply with the requirements of the monograph on lubricants and excipients capable of modifying the release of
Powders for cutaneous application (1166). the active substance(s).
Where applicable, containers for oromucosal preparations
The size of the particles is such as to localise their deposition comply with the requirements for Materials used for the
in the nasal cavity and verified by adequate methods of manufacture of containers (3.1 and subsections) and
particle-size determination. Containers (3.2 and subsections).
Several categories of preparations for oromucosal use may
Semi-solid nasal preparations be distinguished :
DEFINITION — gargles,
Semi-solid nasal preparations comply with the requirements — mouthwashes,
of the monograph on Semi-solid preparations for cutaneous — gingival solutions,
application (0132). — oromucosal solutions and oromucosal suspensions,

General Notices (1) apply to all monographs and other texts 611