EAR PREPARATIONS

(Ph. Eur. monograph 0652)

Ear Preparations comply with the requirements of the European Pharmacopoeia. These requirements are reproduced below.

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Ear preparations are liquid, semi-solid or solid preparations intended for instillation, for spraying, for insufflation, for application to the auditory meatus or as an ear wash.

Ear preparations usually contain 1 or more active substances in a suitable vehicle. They may contain excipients, for example, to adjust tonicity or viscosity, to adjust or stabilise the pH, to increase the solubility of the active substances, to stabilise the preparation or to provide adequate antimicrobial properties. The excipients do not adversely affect the intended medicinal action of the preparation or, at the concentrations used, cause toxicity or undue local irritation.

Preparations for application to the injured ear, particularly where the eardrum is perforated, or prior to surgery are sterile and, unless otherwise justified and authorised, free from antimicrobial preservatives and supplied in single-dose containers.

Ear preparations are supplied in multidose or single-dose containers, provided, if necessary, with a suitable administration device, which may be designed to avoid the introduction of contaminants.

Unless otherwise justified and authorised, aqueous ear preparations supplied in multidose containers contain a suitable antimicrobial preservative at a suitable concentration, except where the preparation itself has adequate antimicrobial properties.

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

Several categories of ear preparations may be distinguished:

• — ear drops and sprays;

• — semi-solid ear preparations;

• — ear powders;

• — ear washes;

• — ear tampons.

During development of an ear preparation 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 chapter 5.1.3. Efficacy of antimicrobial preservation.

During development of ear washes, it must be demonstrated that the nominal content can be withdrawn from the container of preparations presented in single-dose containers.

In the manufacture, packaging, storage and distribution of ear preparations, suitable means are taken to ensure their microbial quality; recommendations on this aspect are provided in chapter 5.1.4. Microbiological quality of pharmaceutical preparations.

Sterile ear preparations 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 chapter 5.1.1. Methods of preparation of sterile products.

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

Single-dose ear preparations 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 ear preparations 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 ingredients that correspond to the above conditions.

Single-dose ear preparations 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.

Where the label indicates that the ear 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;

• — for multidose containers, the period after opening the container after which the contents must not be used. This period does not exceed 4 weeks, unless otherwise justified and authorised.

Ear drops and ear sprays are solutions, emulsions or suspensions of one or more active substances in liquids suitable for application to the auditory meatus without exerting harmful pressure on the eardrum (for example, water, glycols or fatty oils). They may also be placed in the auditory meatus by means of a tampon impregnated with the liquid.

Emulsions may show evidence of phase separation but are readily redispersed on shaking. Suspensions may show a sediment, which is readily dispersed on shaking to give a suspension that remains sufficiently stable to enable the correct dose to be delivered.

Ear drops are usually supplied in multidose containers of glass or suitable plastic material that are fitted with an integral dropper or with a screw cap of suitable materials incorporating a dropper and rubber or plastic teat. Alternatively, such a cap assembly is supplied separately. Ear sprays are usually supplied in multidose containers fitted with an appropriate applicator. When ear sprays are supplied in pressurised containers, these comply with the requirements of the monograph Pressurised pharmaceutical preparations (0523).

Semi-solid ear preparations are intended for application to the external auditory meatus, if necessary by means of a tampon impregnated with the preparation.

Semi-solid ear preparations comply with the requirements of the monograph Semi-solid preparations for cutaneous application (0132).

They are supplied in containers fitted with a suitable applicator.

Ear powders are intended for application or insufflation into the external auditory meatus. They comply with the requirements of the monograph Powders for cutaneous application (1166).

They are supplied in containers fitted with a suitable device for application or insufflation.

Ear washes are preparations intended to cleanse the external auditory meatus. They are usually aqueous solutions with a pH within physiological limits.

Ear washes intended for application to injured parts or prior to a surgical operation are sterile.

Ear tampons are intended to be inserted into the external auditory meatus. They comply with the requirements of the monograph Medicated tampons (1155).

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