Eye Preparations of the British Pharmacopoeia

Question 1

When would you use a preservative free eye drop?

Answer 1

choosing to use a preservative free eye drop preparation avoids the potential cytotoxic damage to the eyes that is associated with preserved formulations - preservatives can be toxic to the ocular surface, particularly with prolonged exposure or chronic eye conditions. They are especially recommended in the case of chronic treatment such as glaucoma and when the eye surface disorder is inflammatory e.g. allergy

Question 2

Eye preparation’s are

Answer 2

Eye preparations are sterile preparations intended for application to the eyeball and/or to the conjunctiva, or for insertion into the conjunctival sac, to deliver active substances for a local effect.

They are liquid, semi-solid or solid preparations containing one or more active substances in a suitable vehicle. They may contain excipients, for example to adjust the tonicity or viscosity of the preparation, 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.

Question 3

Several categories of eye preparations may be distinguished:

Answer 3

— eye drops;
— eye lotions;
— powders for eye drops and powders for eye lotions;
— semi-solid eye preparations;
— ophthalmic inserts.

Question 4

Eye preparation tests

Answer 4

Sterility
Particulate contamination: sub-visible particles
Particle size
Uniformity of mass
Uniformity of content
Uniformity of dosage units

Question 5

Eye drops are

Answer 5

Eye drops are sterile liquid eye preparations intended for instillation into the eye. They are aqueous or oil-based solutions, emulsions or suspensions.

Examined under suitable conditions of visibility, eye drops that are solutions are practically clear and practically free from particles.

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 remains sufficiently stable to enable the correct dose to be delivered.

Eye drops supplied in multidose containers allow successive drops of the preparation to be administered. The containers contain at most 10 mL of the preparation, unless otherwise justified and authorised.

Question 6

Eye drop labelling

Answer 6

The label states, for multidose containers, the period within which the preparation is to be used after opening. This period does not exceed 4 weeks, unless otherwise justified and authorised.

Question 7

Eye lotions are

Answer 7

Eye lotions are sterile aqueous liquid eye preparations intended for rinsing or bathing the eye or for impregnating eye dressings.

Examined under suitable conditions of visibility, eye lotions are practically clear and practically free from particles.

Multidose containers contain at most 200 mL of preparation unless otherwise justified and authorised.

Question 8

Eye lotion labelling

Answer 8

The label states:
— where applicable, that the contents are to be used on one occasion only;
— for multidose containers, the period within which the preparation is to be used after opening. This period does not exceed 4 weeks, unless otherwise justified and authorised.

Question 9

Semi-solid eye preparations are

Answer 9

Semi-solid eye preparations are sterile eye preparations intended for application to the conjunctiva or the eyelids. They are creams, gels or ointments with a homogeneous appearance.
Semi-solid eye preparations are supplied in small, sterilised, suitably designed single-dose or multidose containers fitted or provided with a sterilised cannula. The containers contain at most 10 g of preparation, unless otherwise justified and authorised. The containers must be well-closed to prevent microbial contamination and are of such a shape as to facilitate administration without contamination.

Question 10

Ophthalmic inserts are

Answer 10

Ophthalmic inserts are sterile, solid or semi-solid single-dose eye preparations of a size and shape suitable for insertion in the conjunctival sac. They generally consist of a reservoir of active substance embedded in a matrix or bounded by a rate-controlling membrane. The active substance, which is more or less soluble in lacrymal fluid, is released over a given period of time.
Ophthalmic inserts are supplied in sterile single-dose packaging.