POWDERS FOR CUTANEOUS APPLICATION
(Ph. Eur. monograph 1166)
Unless otherwise justified and authorised, Topical Powders comply with the requirements of the European Pharmacopoeia monograph for Powders for Cutaneous Application. These requirements are reproduced in the British Pharmacopoeia.
Where justified and authorised, the requirements of this monograph do not apply to powders for cutaneous application intended for veterinary use.
DEFINITION
Powders for cutaneous application 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.
Powders for cutaneous application are presented as single-dose powders or multidose powders. They are free from grittiness. Powders specifically intended for use on large open wounds or on severely injured skin are sterile.
Multidose powders for cutaneous application may be dispensed in sifter-top containers, containers equipped with a mechanical spraying device or in pressurised containers.
Powders dispensed in pressurised containers comply with the requirements of Pressurised pharmaceutical preparations (0523).
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 measures are taken to ensure their microbial quality; recommendations on this aspect are provided in general chapter 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use.
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 general chapter 5.1.1. Methods of preparation of sterile products.
TESTS
Fineness
If prescribed, the fineness of a powder is determined by the sieve test (2.9.35) or another appropriate method.
Uniformity of dosage units
Single-dose powders for cutaneous application comply with the test for uniformity of dosage units (2.9.40) or, where justified and authorised, with the tests for uniformity of content and/or uniformity of mass shown below. Herbal drugs and herbal drug preparations present in the dosage form are not subject to the provisions of this paragraph.
Uniformity of content (2.9.6)
Unless otherwise prescribed or justified and authorised, single-dose powders for cutaneous application with a content of active substance less than 2 mg or less than 2 per cent of the total mass comply with test B for uniformity of content of single-dose preparations. If the preparation has more than one active substance, the requirement applies only to those substances that correspond to the above conditions.
Uniformity of mass (2.9.5)
Single-dose powders for cutaneous application comply with the test for uniformity of mass of single-dose preparations. If the test for uniformity of content is prescribed for all the active substances, the test for uniformity of mass is not required.
Sterility (2.6.1)
Where the label indicates that the preparation is sterile, it complies with the test for sterility.
LABELLING
The label states, where applicable, that the preparation is sterile.
