Patches, transdermal

EUROPEAN PHARMACOPOEIA 5.0

PRODUCTION
In the manufacture, packaging, storage and distribution
of transdermal patches suitable means are taken to ensure
their microbial quality ; recommendations on this aspect
are provided in the text on Microbiological quality of
pharmaceutical preparations (5.1.4).

LABELLING
The label states the instructions for the preparation of
injections and infusions.

Implants
DEFINITION
Implants are sterile, solid preparations of a size and shape
suitable for parenteral implantation and release the active
substance(s) over an extended period of time. Each dose is
provided in a sterile container.

TESTS
Uniformity of content (2.9.6). Unless otherwise prescribed
or justified and authorised, transdermal patches comply with
test C for uniformity of content of single-dose preparations.
Dissolution. A suitable test may be required to demonstrate
the appropriate release of the active substance(s), for
01/2005:1011 example one of the tests described in Dissolution test for
transdermal patches (2.9.4). The disc assembly method, the
cell method or the rotating cylinder method may be used,
PATCHES, TRANSDERMAL
as suitable, according to the composition, dimensions and
shape of the patch.
Emplastra transcutanea
A membrane may be used. It can be of various materials,
such as inert porous cellulose or silicones, and must not
DEFINITION
affect the release kinetics of the active substance(s) from
Transdermal patches are flexible pharmaceutical
the patch. Furthermore, it must be free of substances that
preparations of varying sizes, containing one or more active may interfere with its performance (for example grease).
substances. They are intended to be applied to the unbroken The membrane may be suitably treated before the tests,
skin in order to deliver the active substance(s) to the systemic for example, by maintaining it in the medium to be used in
circulation after passing through the skin barrier.
the test for 24 h. Apply the membrane above the releasing
surface of the patch, avoiding the formation of air bubbles.
Transdermal patches normally consist of an outer covering
which supports a preparation which contains the active
The test conditions and the requirements are to be authorised
substance(s). The transdermal patches are covered on the
by the competent authority.
site of the release surface of the preparation by a protective
liner, which is removed before applying the patch to the skin. STORAGE
Store at room temperature, unless otherwise indicated.
The outer covering is a backing sheet impermeable to the
active substance(s) and normally impermeable to water,
designed to support and protect the preparation. The outer LABELLING
covering may have the same dimensions as the preparation The label states, where applicable, the total quantity of active
substance(s) per patch, the dose released per unit time and
or it may be larger. In the latter case the overlapping
border of the outer covering is covered by pressure-sensitive the area of the releasing surface.
adhesive substances which assure the adhesion of the patch
to the skin.
The preparation contains the active substance(s) together
01/2005:1166
with excipients such as stabilisers, solubilisers or substances
intended to modify the release rate or to enhance transdermal
POWDERS FOR CUTANEOUS
absorption. It may be a single layer or multi-layer solid or
semi-solid matrix, and in this case it is the composition
APPLICATION
and structure of the matrix which determines the diffusion
pattern of the active substance(s) to the skin. The matrix
Pulveres ad usum dermicum
may contain pressure-sensitive adhesives which assure the
Where justified and authorised, the requirements of
adhesion of the preparation to the skin. The preparation
this monograph do not apply to powders for cutaneous
may exist as a semi-solid reservoir one side of which is a
application intended for veterinary use.
membrane which may control the release and the diffusion
of the active substance(s) from the preparation. The
pressure-sensitive adhesive substances may, in this case, be DEFINITION
applied to some or all parts of the membrane, or only around Powders for cutaneous application are preparations
consisting of solid, loose, dry particles of varying degrees of
the border of the membrane of the outer covering.
fineness. They contain one or more active substances, with
When applied to the dried, clean and unbroken skin, the
or without excipients and, if necessary, colouring matter
transdermal patch adheres firmly to the skin by gentle
authorised by the competent authority.
pressure of the hand or the fingers and can be peeled off
without causing appreciable injury to the skin or detachment Powders for cutaneous application are presented as
of the preparation from the outer covering. The patch must single-dose powders or multidose powders. They are free
not be irritant or sensitising to the skin, even after repeated from grittiness. Powders specifically intended for use on
large open wounds or on severely injured skin are sterile.
applications.
The protective liner generally consists of a sheet of plastic or Multidose powders for cutaneous application may be
metal material. When removed, the protective liner does not dispensed in sifter-top containers, containers equipped with
detach the preparation (matrix or reservoir) or the adhesive a mechanical spraying device or in pressurised containers.
from the patch.
Powders dispensed in pressurised containers comply
Transdermal patches are normally individually enclosed in
with the requirements of Pressurised pharmaceutical
sealed sachets.
preparations (0523).
616

See the information section on general monographs (cover pages)

Premixes for medicated feeding stuffs for veterinary use

EUROPEAN PHARMACOPOEIA 5.0

Where applicable, containers for powders comply with the

requirements of Materials used for the manufacture of
containers (3.1 and subsections) and Containers (3.2 and
subsections).
PRODUCTION
In the manufacture of powders for cutaneous application,
measures are taken to ensure a suitable particle size with
regard to the intended use.
In the manufacture, packaging, storage and distribution of
powders for cutaneous application, suitable means are taken
to ensure their microbial quality ; recommendations on this
aspect are provided in the text on Microbiological quality of
pharmaceutical preparations (5.1.4).
Sterile powders for cutaneous application are prepared
using materials and methods designed to ensure sterility and
to avoid the introduction of contaminants and the growth
of micro-organisms ; recommendations on this aspect are
provided in the text on Methods of preparation of sterile
products (5.1.1).

Where applicable, containers for oral powders comply with

the requirements of Materials used for the manufacture of
containers (3.1 and subsections) and Containers (3.2 and
subsections).
Multidose oral powders require the provision of a measuring
device capable of delivering the quantity prescribed.
Each dose of a single-dose powder is enclosed in an
individual container, for example a sachet or a vial.
PRODUCTION
In the manufacture of oral powders, means are taken to
ensure a suitable particle size with regard to the intended
use.
In the manufacture, packaging, storage and distribution
of oral powders, suitable means are taken to ensure
their microbial quality ; recommendations on this aspect
are provided in the text on Microbiological quality of
pharmaceutical preparations (5.1.4).

TESTS
Uniformity of content (2.9.6). Unless otherwise prescribed
TESTS
or justified and authorised, single-dose oral powders with a
Fineness. If prescribed, the fineness of a powder is
content of active substance less than 2 mg or less than 2 per
determined by the sieve test (2.9.12) or another appropriate cent of the total mass comply with test B for uniformity of
method.
content of single-dose preparations. If the preparation has
Uniformity of content (2.9.6). Unless otherwise prescribed more than one active substance, the requirement applies
only to those substances which correspond to the above
or justified and authorised, single-dose powders for
conditions.
cutaneous application with a content of active substance
less than 2 mg or less than 2 per cent of the total mass
Uniformity of mass (2.9.5). Single-dose oral powders
comply with test B for uniformity of content of single-dose
comply with the test for uniformity of mass of single-dose
preparations. If the preparation has more than one active
preparations. If the test for uniformity of content is
substance, the requirement applies only to those substances prescribed for all the active substances, the test for
which correspond to the above conditions.
uniformity of mass is not required.
Uniformity of mass (2.9.5). Single-dose powders for
Uniformity of mass of delivered doses from multidose
cutaneous application comply with the test for uniformity of containers (2.9.27). Oral powders supplied in multidose
mass of single-dose preparations. If the test for uniformity of containers comply with the test.
content is prescribed for all the active substances, the test
STORAGE
for uniformity of mass is not required.
If the preparation contains volatile ingredients, or the
Sterility (2.6.1). Where the label indicates that the
contents have to be protected, store in an airtight container.
preparation is sterile, it complies with the test for sterility.
LABELLING
The label states :
that the preparation is for external use,
where applicable, that the preparation is sterile.

Effervescent powders

Effervescent powders are presented as single-dose or

multidose preparations and generally contain acid
substances and carbonates or hydrogen carbonates which
react rapidly in the presence of water to release carbon
dioxide. They are intended to be dissolved or dispersed in
01/2005:1165
water before administration.

POWDERS, ORAL
Pulveres perorales
Requirements for powders to be used for the preparation of
oral solutions or suspensions are given in the monograph
for Liquid preparations for oral use (0672). Where justified
and authorised, the requirements of this monograph do not
apply to oral powders intended for veterinary use.
DEFINITION
Oral powders are preparations consisting of solid, loose, dry
particles of varying degrees of fineness. They contain one
or more active substances, with or without excipients and,
if necessary, colouring matter authorised by the competent
authority and flavouring substances. They are generally
administered in or with water or another suitable liquid.
They may also be swallowed directly. They are presented as
single-dose or multidose preparations.
General Notices (1) apply to all monographs and other texts

STORAGE
In an airtight container.
01/2005:1037

PREMIXES FOR MEDICATED FEEDING

STUFFS FOR VETERINARY USE
Praeadmixta ad alimenta medicata
ad usum veterinarium
DEFINITION
Mixtures of one or more active substances, usually in
suitable bases, that are prepared to facilitate feeding the
active substances to animals. They are used exclusively in
the preparation of medicated feeding stuffs.
617