EUROPEAN PHARMACOPOEIA 9.

0 Rectal preparations

The various valve materials in contact with the contents are TESTS
compatible with them. Uniformity of dosage units (2.9.40). Liquid and semi-solid
Requirements for pressurised pharmaceutical preparations. single-dose rectal preparations comply with the test. Solid
Pressurised preparations are provided with a delivery device single-dose rectal preparations comply with the test or, where
appropriate for the intended application. justified and authorised, with the tests for uniformity of
Special requirements may be necessary for the selection of content and/or uniformity of mass shown below. Herbal drugs
and herbal drug preparations present in the dosage form are
propellants, for particle size and the single-dose delivered by
the metering valves. not subject to the provisions of this paragraph.
Uniformity of content (2.9.6). Unless otherwise prescribed or
LABELLING justified and authorised, solid single-dose rectal preparations
The label states : with a content of active substance less than 2 mg or less than
– the method of use ; 2 per cent of the total mass comply with test A (tablets) or
test B (suppositories, rectal capsules). If the preparation
– any precautions to be taken ; contains more than one active substance, this requirement
– for a container with a metering dose valve, the amount of applies only to those substances that correspond to the above
active substance in a unit-spray. conditions.
Uniformity of mass (2.9.5). Solid single-dose rectal
preparations comply with the test. If the test for uniformity
of content is prescribed for all active substances, the test for
01/2008:1145 uniformity of mass is not required.
corrected 7.6
Dissolution. A suitable test may be required to demonstrate
the appropriate release of the active substance(s) from solid
single-dose rectal preparations, for example 2.9.42. Dissolution
test for lipophilic solid dosage forms.
RECTAL PREPARATIONS Where a dissolution test is prescribed, a disintegration test
may not be required.

Rectalia LABELLING
The label states the name of any added antimicrobial
DEFINITION
preservative.
Rectal preparations are intended for rectal use in order to
obtain a systemic or local effect, or they may be intended for
diagnostic purposes. Suppositories
Where applicable, containers for rectal preparations comply DEFINITION
with the requirements for materials used for the manufacture
of containers (3.1 and subsections) and containers (3.2 and Suppositories are solid, single-dose preparations. The
subsections). shape, volume and consistency of suppositories are suitable
for rectal administration.
Several categories of rectal preparations may be distinguished :
– suppositories ; They contain 1 or more active substances dispersed or
dissolved in a suitable basis that may be soluble or dispersible
– rectal capsules ; in water or may melt at body temperature. Excipients such
– rectal solutions, emulsions and suspensions ; as diluents, adsorbents, surface-active agents, lubricants,
– powders and tablets for rectal solutions and suspensions ; antimicrobial preservatives and colouring matter, authorised
by the competent authority, may be added if necessary.
– semi-solid rectal preparations ;
– rectal foams ; PRODUCTION
– rectal tampons. Suppositories are prepared by compression or moulding. If
necessary, the active substance(s) are previously ground and
PRODUCTION sieved through a suitable sieve. When prepared by moulding,
During the development of a rectal preparation whose the medicated mass, sufficiently liquefied by heating, is poured
formulation contains an antimicrobial preservative, the into suitable moulds. The suppository solidifies on cooling.
need for and the efficacy of the chosen preservative shall be Various excipients are available for this process, such as hard
demonstrated to the satisfaction of the competent authority. fat, macrogols, cocoa butter, and various gelatinous mixtures
A suitable test method together with criteria for judging the consisting of, for example, gelatin, water and glycerol. The
preservative properties of the formulation are provided in determination of the softening time of lipophilic suppositories
chapter 5.1.3. Efficacy of antimicrobial preservation. (2.9.22) is carried out.
During development, it must be demonstrated that the A suitable test is carried out to demonstrate the appropriate
nominal contents can be withdrawn from the container release of the active substance(s) from suppositories intended
of liquid and semi-solid rectal preparations presented in for modified release or for prolonged local action.
single-dose containers. In the manufacture of suppositories containing dispersed
In the manufacture, packaging, storage and distribution of active substances, measures are taken to ensure a suitable and
rectal preparations, suitable measures are taken to ensure controlled particle size.
their microbial quality ; recommendations on this aspect
are provided in chapter 5.1.4. Microbiological quality of TESTS
pharmaceutical preparations. Disintegration (2.9.2). Unless intended for modified release
In the manufacture of semi-solid and liquid rectal preparations or for prolonged local action, they comply with the test. For
containing dispersed particles, measures are taken to ensure suppositories with a fatty base, examine after 30 min, and for
a suitable and controlled particle size with regard to the suppositories with a water-soluble base, examine after 60 min,
intended use. unless otherwise justified and authorised.

General Notices (1) apply to all monographs and other texts 881
Semi-solid preparations for cutaneous application EUROPEAN PHARMACOPOEIA 9.0

Rectal capsules – the conditions and duration of storage of the solution or

suspension after constitution.
DEFINITION
Rectal capsules (shell suppositories) are solid, single-dose Semi-solid rectal preparations
preparations generally similar to soft capsules as defined in
the monograph Capsules (0016) except that they may have DEFINITION
lubricating coatings. They are of elongated shape, are smooth Semi-solid rectal preparations are ointments, creams or gels.
and have a uniform external appearance.
They are often supplied as single-dose preparations in
PRODUCTION containers provided with a suitable applicator.
A suitable test is carried out to demonstrate the appropriate Semi-solid rectal preparations comply with the requirements
release of the active substance(s) from rectal capsules intended of the monograph Semi-solid preparations for cutaneous
for modified release or for prolonged local action. application (0132).

TESTS Rectal foams

Disintegration (2.9.2). Unless intended for modified
release or for prolonged local action, they comply with the DEFINITION
test. Examine the state of the capsules after 30 min, unless Rectal foams comply with the requirements of the monograph
otherwise justified and authorised. Medicated foams (1105).

Rectal solutions, emulsions and suspensions Rectal tampons

DEFINITION DEFINITION
Rectal solutions, emulsions and suspensions are liquid Rectal tampons are solid, single-dose preparations intended to
preparations intended for rectal use in order to obtain a be inserted into the lower part of the rectum for a limited time.
systemic or local effect, or they may be intended for diagnostic They comply with the requirements of the monograph
purposes. Medicated tampons (1155).
Rectal solutions, emulsions and suspensions are supplied in
single-dose containers and contain 1 or more active substances
dissolved or dispersed in water, glycerol or macrogols or other 04/2010:0132
suitable solvents. Emulsions may show evidence of phase
separation but are readily redispersed on shaking. Suspensions
may show a sediment that is readily dispersible on shaking to
give a suspension that remains sufficiently stable to enable the
correct dose to be delivered.
SEMI-SOLID PREPARATIONS FOR
Rectal solutions, emulsions and suspensions may contain
excipients, for example to adjust the viscosity of the CUTANEOUS APPLICATION
preparation, to adjust or stabilise the pH, to increase the
solubility of the active substance(s) or to stabilise the Praeparationes molles ad usum dermicum
preparation. These substances do not adversely affect the
intended medical action or, at the concentrations used, cause The requirements of this monograph apply to all semi-solid
undue local irritation. preparations for cutaneous application. Where appropriate,
Rectal solutions, emulsions and suspensions are supplied in additional requirements specific to semi-solid preparations
containers containing a volume in the range of 2.5 mL to intended to be applied to particular surfaces or mucous
2000 mL. The container is adapted to deliver the preparation membranes may be found in other general monographs, for
to the rectum or is accompanied by a suitable applicator. example Ear preparations (0652), Nasal preparations (0676),
Rectal preparations (1145), Eye preparations (1163) and
Vaginal preparations (1164).
Powders and tablets for rectal solutions and
DEFINITION
suspensions
Semi-solid preparations for cutaneous application are intended
DEFINITION for local or transdermal delivery of active substances, or for
Powders and tablets intended for the preparation of rectal their emollient or protective action. They are of homogeneous
solutions or suspensions are single-dose preparations that are appearance.
dissolved or dispersed in water or other suitable solvents at Semi-solid preparations for cutaneous application consist
the time of administration. They may contain excipients to of a simple or compound basis in which, usually, 1 or more
facilitate dissolution or dispersion or to prevent aggregation of active substances are dissolved or dispersed. According to
the particles. its composition, the basis may influence the activity of the
After dissolution or suspension, they comply with the preparation.
requirements for rectal solutions or rectal suspensions, as The basis may consist of natural or synthetic substances
appropriate. and may be single phase or multiphase. According to the
nature of the basis, the preparation may have hydrophilic or
TESTS hydrophobic properties ; it may contain suitable excipients
Disintegration (2.9.1). Tablets for rectal solutions or such as antimicrobial preservatives, antioxidants, stabilisers,
suspensions disintegrate within 3 min, using water R at emulsifiers, thickeners and penetration enhancers.
15-25 °C as the liquid medium. Semi-solid preparations for cutaneous application intended
for use on severely injured skin are sterile.
LABELLING
Where applicable, containers for semi-solid preparations
The label states : for cutaneous application comply with the requirements of
– the method of preparation of the rectal solution or Materials used for the manufacture of containers (3.1 and
suspension ; subsections) and Containers (3.2 and subsections).

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