LIQUIDS FOR CUTANEOUS APPLICATION

(Liquid Preparations for Cutaneous Application, Ph Eur monograph 0927)

Liquids for Cutaneous Application comply with the requirements of the European Pharmacopoeia monograph for Liquid Preparations for Cutaneous Application. These requirements are reproduced below.

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Where justified and authorised, the requirements of this monograph do not apply to preparations intended for systemic and veterinary use.

Liquid preparations for cutaneous application are preparations of a variety of viscosities intended for local or transdermal delivery of active ingredients. They are solutions, emulsions or suspensions that may contain 1 or more active substances in a suitable vehicle. They may contain suitable antimicrobial preservatives, antioxidants and other excipients such as stabilisers, emulsifiers and thickeners.

Emulsions may show evidence of phase separation but are readily redispersed on shaking. Suspensions may show a sediment that is readily dispersed on shaking to give a suspension that is sufficiently stable to enable a homogeneous preparation to be delivered.

Where applicable, containers for liquid preparations for cutaneous application comply with the requirements of Materials used for the manufacture of containers (3.1 and subsections) and Containers (3.2 and subsections).

When liquid preparations for cutaneous application are dispensed in pressurised containers, the containers comply with the requirements of the monograph on Pressurised pharmaceutical preparations (0523).

Preparations specifically intended for use on severely injured skin are sterile.

Several categories of liquid preparations for cutaneous application may be distinguished, for example:

• — shampoos;

• — cutaneous foams.

During development of a liquid preparation for cutaneous application whose formulation contains an antimicrobial preservative, the need for and the efficacy of the chosen preservative shall be demonstrated to the satisfaction of the competent authority. A suitable test method together with criteria for judging the preservative properties of the formulation are provided in the text on Efficacy of antimicrobial preservation (5.1.3).

During development, it must be demonstrated that the nominal content can be withdrawn from the container of liquid preparations for cutaneous application presented in single-dose containers.

In the manufacture, packaging, storage and distribution of liquid preparations for cutaneous application, suitable measures 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 liquid preparations 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).

In the manufacture of liquid preparations for cutaneous application containing dispersed particles, measures are taken to ensure a suitable and controlled particle size with regard to the intended use.

Where the label indicates that the preparation is sterile, it complies with the test for sterility.

If the preparation is sterile, store in a sterile, airtight, tamper-proof container.

The label states:

• — the name of any added antimicrobial preservative;

• — where applicable, that the preparation is sterile.

Shampoos are liquid or, occasionally, semi-solid preparations intended for application to the scalp and subsequent washing away with water. Upon rubbing with water they usually form a foam.

They are emulsions, suspensions or solutions. Shampoos normally contain surface active agents.

Cutaneous foams comply with the requirements of the monograph on Medicated foams (1105).

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