(Ph. Eur. monograph 1808)
Veterinary Liquid Preparations for Cutaneous Application comply with the requirements of the European Pharmacopoeia.
These requirements are reproduced below.
Unless otherwise justified and authorised, veterinary liquid preparations for cutaneous application comply with the requirements of the monograph Liquid preparations for cutaneous application (0927). In addition to these requirements, the following statements apply to veterinary liquid preparations for cutaneous application.
DEFINITION
Veterinary liquid preparations for cutaneous application are liquid preparations intended to be applied to the skin to obtain a local and/or systemic effect. They are solutions, suspensions or emulsions that may contain one or more active substances in a suitable vehicle. They may be presented as concentrates in the form of wettable powders, pastes, solutions or suspensions, which are used to prepare diluted solutions, suspensions or emulsions of active substances.
They may contain suitable antimicrobial preservatives, antioxidants and other excipients such as stabilisers, emulsifiers and thickeners.
Several categories of veterinary liquid preparations for cutaneous application may be distinguished:
— cutaneous foams (see Liquid preparations for cutaneous application (0927));
— dip concentrates;
— pour-on preparations;
— shampoos (see Liquid preparations for cutaneous application (0927));
— spot-on preparations;
— sprays;
— teat dips;
— teat sprays;
— udder-washes.
DIP CONCENTRATES
DEFINITION
Dip concentrates are preparations containing one or more active substances, usually in the form of wettable powders, pastes, solutions or suspensions, which are used to prepare diluted solutions, suspensions or emulsions of active substances. The diluted preparations are applied by complete immersion of the animal. Veterinary Liquid Preparations for Cutaneous Application
POUR-ON PREPARATIONS
DEFINITION
Pour-on preparations contain one or more active substances for the prevention and treatment of ectoparasitic and/or endoparasitic infestations of animals. They are applied in volumes that are usually greater than 5 mL by pouring along the animal’s dorsal midline.
SPOT-ON PREPARATIONS
DEFINITION
Spot-on preparations contain one or more active substances for the prevention and treatment of ectoparasitic and/or endoparasitic infestations of animals. They are applied in volumes that are usually less than 10 mL, to a small area on the head or back, as appropriate, of the animal.
SPRAYS
DEFINITION
Sprays contain one or more active substances that are intended to be applied externally for therapeutic or prophylactic purposes. They are delivered in the form of an aerosol by the actuation of an appropriate valve or by means of a suitable atomising device that is either an integral part of the container or is supplied separately.
Sprays may be presented in pressurised containers (see Pressurised pharmaceutical preparations (0523)). When so presented, sprays usually consist of one or more active substances in a suitable vehicle held under pressure with suitable propellants or suitable mixtures of propellants. When otherwise presented, sprays are supplied in well-closed containers.
PRODUCTION
During the development and manufacture of a spray, measures are taken to ensure that the assembled product conforms to a defined spray rate and spray pattern.
TEAT DIPS
DEFINITION
Teat dips contain one or more active substances, usually in the form of solutions into which the teats of an animal are dipped pre- and post-milking, as appropriate, to reduce the population of pathogenic micro-organisms on the surfaces.
Teat dips may be supplied/presented as ready-to-use preparations or they may be prepared by dilution of teat dip concentrates. Pre- and post-milking teat dips often differ in formulation. Teat dips usually contain emollients to promote skin hydration, to soften the skin and allow healing of lesions that would otherwise harbour bacteria.
TEAT SPRAYS
DEFINITION
Teat sprays contain one or more active substances, usually in the form of solutions that are sprayed onto the teats of an animal pre- and post-milking, as appropriate, to reduce the population of pathogenic micro-organisms on the surfaces.
Teat sprays may be supplied/presented as ready-to-use preparations or they may be prepared by dilution of teat spray concentrates. Pre- and post-milking sprays often differ in formulation. Teat sprays usually contain emollients to promote skin hydration, to soften the skin and allow healing of lesions that would otherwise harbour bacteria.
UDDER-WASHES
DEFINITION
Udder-washes contain one or more active substances, usually in the form of solutions that are sprayed onto the udder and teats of an animal to remove mud and faecal contamination before the application of teat dips or sprays. Udder-washes are usually prepared by the dilution either of concentrated preparations or of ready-to-use teat dips or teat sprays.
