Safety assessment for inhalation toxicology requires experience and specialized capabilities to successfully test the effects of inhaled compounds. Medicilon’s preclinical research department the complete inhalation toxicity assessment service system focusing on evaluating safety of new inhaled drugs for clients whenever needed.
A broad range of project types can be offered, from the development of evaluation concepts to the realization of complex test designs. We are capable of:
- PK study
- Tissue Distribution Test
- Acute Toxicity Test
- Repeated Dose Toxicity Test
- Irritation Test
- Allergic Test
- Safety Pharmacology
We offer different ways of complex inhaled administration:
- Long-term treatment period up to 56 days.
- Long-time exposure up to 4 hours, which is in compliance of OECD guidelines.
- Powder and liquid aerosol generating system
- Varieties of animal species including rodents, canine and non-human primates.
- Simultaneous drug administration to 30 small animals or 10 large animals.
During the delivery of aerosols, the concentration of aerosols, particle size and the particle size distribution is fluctuating. Therefore, it’s necessary to closely monitor the concentration of the aerosols and the particle size in order to give the right dosage.
Monitoring the particle size is also important in the PK process for in vivo tests. Only particles of which diameters are between 1-4 μm can be absorbed by lungs effectively.
Our team has many years of experience in the R&D of inhaled drugs. The general process of one inhaled drug toxicity assessment are as follows,
- Before the experiment, we will explore the particle size, concentration and aerosol generation.
- During the experiment, aerosol concentration, temperature and humidity, oxygen / carbon dioxide and particle size are detected regularly and frequently.
- After the experiment, the detailed clinical observation, gross anatomy and histopathological evaluation of various tissues of the respiratory system will be carried out.
In our state-of-the-art facility, we are equipped with,
- Professional particle size monitoring and analyzing system paired with different sampling methods for different sample properties;
- Aerosol inhalation device for both large and small animals, including clean air generation system, aerosol generation system, real-time monitoring and control system of temperature, humidity and gases, real-time sampling system, real-time sample concentration regulation system.