Animal exposure masks

Medicilon's toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. The toxicological evaluation from dose design, in-life studies to histology and pathology testing along with toxicokinetics studies are all compliant with GLP or NON-GLP standards. Our study platform is certified as one of the Shanghai Public Service Research Platforms.Email:marketing@medicilon.com.cn Web:www.medicilon.com

The present invention is an exposure mask (20) for administration of pharmaceutical aerosols to animals for drug safety testing. A preferred embodiment of the mask comprises a chamber (28) defined by a cone shaped structure (30), an inlet tube (40), and a central member (50) positioned within the chamber so the animal can clamp its teeth down onto the central member (50) so that one end (48) of the inlet tube (40) is situated within the animal's mouth. The base of the cone (34) is adapted to accommodate an animal's eyes. A flexible film (100) overlays at least a portion of the base (34) of the cone (30), with a hole (102) adapted to receive the mouth of the animal. A ventilation port (84) is present to provide a passageway (82) created by a conduit (80) for ventilating the mask chamber interior with the outside atmosphere. At least one strap (110) is provided to secure the mask (20) to the animal's head. Methods of exposing animals to pharmaceutical aerosols using an exposure mask are also presented.

Field of the Invention:The present invention relates to devices for aiding in the safety testing of medicinal drugs on animals, and more particularly to a mask to aid in the administration of aerosol compounds to a dog.

Background of the Invention:For many years, animals have been used to test the safety of human drugs or human medicines . After the efficacy of a given drug or pharmaceutical is proven, the drug is tested for safety by administering it to an animal . Often, the animal is a dog or cat.

Traditionally, many of the devices used in the area of veterinary medicine have been carried over to the field of animal testing. For example, a conventional anaesthesia mask for dogs has been used to test the safety of pharmaceutical aerosols (or aerosol compounds) , such as those found in inhalant medicines used by people suffering from asthma . Figure 1 shows a conventional anaesthesia mask that is used to deliver anaesthesia to a dog during a medical procedure or operation. This conventional anaesthesia mask 10 comprises a generally parabolic-shaped plastic cone 12 which has an inlet 14 through which the anaesthesia passes. The anaesthesia enters the inside of the cone 12 and the dog inhales the anaesthesia, typically through their nose by simply continuing to breathe.

The conventional anaesthesia mask 10 is currently used during the administration of pharmaceutical aerosols (or aerosol compounds) to dogs. In testing the safety of aerosol compounds, however, problems are inherently present which are not present when the mask is used to deliver anaesthesia.

The problems are due to a variety of differences between the two procedures. First, an aerosol compound is typically a spray, but may exist in vapor, liquid, or dry powder form, whereas anaesthesia typically has a less- invasive gaseous form.

Second, when anaesthesia is being delivered, the dog quickly succumbs to the anaesthesia and enters a very relaxed or unconscious state. During drug testing, however, the varying condition or reaction of the animal is of paramount importance. For this reason, the dog is not sedated. Consequently, the dog may not cooperate willingly even after conditioning (or acclimation to the mask) . The conventional anaesthesia mask was not designed for use with a conscious dog. The discomfort of the mask and the foreign nature of the aerosol compound may cause the dog to struggle . The conscious state of the dog also causes problems in administering the drug to the dog. Although typically muzzled, the dog will try to avoid the foreign substance and gag while attempting not to inhale the drug. Thus, administration of an aerosol drug to a dog is a very difficult procedure to perform and quite uncomfortable a procedure for the dog to undergo. The discomfort of such a restraint can also cause stress on the dog, thereby confounding the results of any drug testing. It is, therefore, desirable to provide a dog exposure mask for the administration of aerosol compounds to a dog for drug safety testing that is comfortable for the dog and makes the job of administering the drug easier. Unlike a human, a dog inhales through their nose more often than through their mouth. The relatively vast nasal passages in a dog's nose, however, impede proper administration of most medicines. Aerosol compounds, for example, will tend to clog the nasal passages in a dog's nose, making administration very difficult. This adds to the discomfort of the dog and further promotes gagging. It is, therefore, desirable to provide a dog exposure mask that administers aerosol compounds to a dog primarily by way of the dog's mouth, while avoiding the nose as much as possible. This is also more comparable with administration of pharmaceutical aerosols to humans.

Summary of the Invention:Exposure masks for the administration of pharmaceutical aerosols to animals for drug safety testing are provided. The exposure masks are designed for the administration of anaesthesia, pharmaceuticals, or aerosol compounds to a dogs or other animals.

Exposure masks according to the present invention are relatively comfortable for the dog and make the job of the person administering the drug easier. Preferred exposure masks comprise a chamber defined by a lateral surface extending between a first and a second end, an inlet tube having first and second ends, and a central member situated within the chamber and adapted for placement within the mouth of a dog. The first end of the lateral surface includes an inlet port and the second end is adapted to receive at least a nose and mouth of the dog. The inlet tube extends through the inlet port such that the first end of the inlet tube is within the chamber. The central member is in contact with the inlet tube between the first and second ends of the inlet tube.