Safety Evaluation of Inhalation Preparations

The treatment of cardiovascular disorders (coronary heart disease, angina pectoris, etc), cerebrovascular diseases (stroke, cerebral infarction, some pain, etc), and endocrine diseases (diabetes, etc) all benefit from non-invasive and painless inhalation drug delivery. Drugs that are breathed present numerous difficulties for preclinical animal studies because of the unusual method of administration.

Special laboratory apparatus is needed for the preclinical effectiveness, pharmacokinetic, and safety evaluation of inhaled formulations. 

Studies include a number of topics, including acute, subchronic, chronic, and carcinogenicity. 

Inhalation toxicology studies are conducted in vitro or in vivo to assess the potential toxicity of materials that will/may be inhaled. 

• Experimental animal species: rats, mice, guinea pigs, dogs, and monkeys.
• 56 days of long-term dosing operation.
• Long-term dosing of 4 hours, which meets the OECD dosing time requirements.
• Powder and liquid drug aerosol generation system for powder and liquid dosing.
• Pulmonary dosing for nebulized drug delivery. Accurate and quantitative aerosolization of liquid samples directly into aerosols in the animal's trachea for aerosol lung administration.
• Oral and nasal contact dynamic inhalation poisoning.