Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Intramammary preparations for veterinary use are sterile preparations intended for introduction into the mammary gland via the teat canal. There are two main categories: those intended for administration to lactating animals, and those intended for administration to animals at the end of lactation or to non-lactating animals for the treatment or prevention of infection.
Intramammary preparations for veterinary use are solutions, emulsions or suspensions or semi-solid preparations containing one or more active substances in a suitable vehicle. They may contain excipients such as stabilising, emulsifying, suspending and thickening agents. Suspensions may show a sediment which is readily dispersed on shaking. Emulsions may show evidence of phase separation but are readily redispersed on shaking.
Unless otherwise justified and authorised, intramammary preparations for veterinary use are supplied in containers for use on one occasion only for introduction in a single teat canal of an animal.
If supplied in multidose containers, aqueous preparations contain a suitable antimicrobial preservative at a suitable concentration, except where the preparation itself has adequate antimicrobial properties. Precautions for administration and for storage between administrations must be taken.
Where applicable, containers for intramammary preparations for veterinary use comply with the requirements of Materials used for the manufacture of containers (3.1 and subsections) and Containers (3.2 and subsections).
PRODUCTION
During the development of a intramammary preparation for veterinary use, the formulation for which contains an antimicrobial preservative, the effectiveness 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).
Intramammary preparations for veterinary use 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 intramammary preparations for veterinary use containing dispersed particles, measures are taken to ensure a suitable and controlled particle size with regard to the intended use.
TESTS
Deliverable mass or volume
Squeeze out as much as possible of the contents of ten containers according to the instructions on the label. The mean mass or volume does not differ by more than 10 per cent from the nominal mass or volume.
Sterility (2.6.1)
Intramammary preparations for veterinary use comply with the test for sterility; use the technique of membrane filtration or, in justified cases, direct inoculation of the culture media. Squeeze out the contents of ten containers and mix thoroughly. For each medium, use 0.5 g to 1 g (or 0.5 mL to 1 mL as appropriate) taken from the mixed sample.
STORAGE
Store in a sterile, airtight, tamper-evident container.
LABELLING
The label states:
— the name of the active substance(s) and the mass or number of International Units of the active substance(s) that may be delivered from the container using normal technique;
— whether the preparation is intended for use in a lactating animal or a non-lactating animal;
— in the case of multidose containers, the name of any added antimicrobial preservative.
