ORAL POWDERS

(Ph. Eur. monograph 1165)

Oral Powders comply with the requirements of the European Pharmacopoeia. These requirements are reproduced below.

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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.

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.

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.

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).

Single-dose oral powders 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.

Unless otherwise prescribed or justified and authorised, single-dose oral powders 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 which correspond to the above conditions.

Single-dose oral powders 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.

Oral powders supplied in multidose containers comply with the test.

If the preparation contains volatile ingredients, or the contents have to be protected, store in an airtight container.

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 water before administration.

In an airtight container.

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