Inhalation Toxicology and Aerosol Sciences

GLP inhalation toxicology studies are at the core of our expertise.

Our Experience

Vectura Fertin Pharma Laboratories has more than 12 years of extensive experience conducting inhalation studies of various durations to identify acute to chronic toxicity effects and carcinogenicity.

Specialized capabilities include generation of aerosols from test articles, delivery of aerosols to exposure chambers of various capacity, and characterization of aerosols to ensure the requisite size, the right concentration and quality throughout the exposure duration for effective delivery to test system. 

Preclinical GLP Inhalation Studies

Our studies are performed in accordance to GLP standards and internationally accepted guidelines, including the 28-day (OECD TG412) and 90-day inhalation toxicity studies (OECD TG413). 

Studies performed include:

  • Dose range finding studies
  • Single dose toxicity studies 
  • Repeated dose toxicity studies (up to 18 months) to identify acute, sub-acute, sub-chronic effects
  • Chronic and carcinogenicity studies 

Study Endpoints

Exposure conditions

  • Aerosol parameters, where applicable (e.g. Total Particulate Matter (TPM), carbon monoxide (CO), chamber pressure, chamber flow rates, Particle Size Distribution (PSD)
  • Test item concentration collected from chamber breathing zone

In life endpoints

  • General health parameters (e.g. daily or systematic health observations, body weight, food consumption, ophthalmology)
  • Biomarkers of uptake or exposure. Compound or constituent may be measured in blood (serum or plasma) or urine
  • Respiratory physiology (e.g. tidal volume, breathing rate, minute volume, peak inspiratory flow)

Terminal endpoints

  • Clinical chemistry
  • Hematology
  • Urinalysis
  • BALF analysis (e.g. LDH, albumin, differential cell counts) 
  • Cell-free BALF protein analysis
  • Necropsy (e.g. organ weights, gross pathological findings)
  • Histopathology (sample processing, and histopathological evaluation)

Aerosol Science

In addition to our expertise in inhalation toxicology studies, Vectura Fertin Pharma Laboratories (VFPL) also provides specialized capabilities in aerosol generation, delivery and characterization via our in-house aerosol lab to help evaluate and optimize the generation of aerosols from your API formulations for further toxicology studies.

Our Experience

Aerosol generation, characterization and delivery of aerosols to test systems are essential aspects of nonclinical inhalation studies. This requires specialized capabilities and technical expertise to deliver aerosols of appropriate particle size, concentration and quality effectively to the target regions in the lungs. Globally, few labs are able to handle the technical challenges associated with aerosol generation, monitoring, and delivery to animals. At Vectura Fertin Pharma Laboratories (VFPL), we have more than 14 years of experience navigating complex challenges with innovative solutions and a team of skilled scientists, engineers and technicians capable of providing customized solutions based on your needs.

Early Stage and Proof-of-Concept with APIs

Whether your test articles are of biological, chemical origin, or of a different media such as liquid and dry powders, we have a wide range of aerosol generators to aerosolize them.

From the start of your project, our scientists will work hand in hand with you to find the best aerosol generation solutions for your product

Aerosol Generation, Formulation Development and Characterization

At the core of all inhalation studies is the ability to generate inhalable aerosols of the appropriate concentration and particle size. At Vectura Fertin Pharma Laboratories, we have an extensive selection of aerosol generators to aerosolize test articles of various forms.

Our generators can be broadly classified into 2 categories: liquid and powder aerosol generators. We understand that certain test items might come in limited quantities owing to their high costs of synthesis. For such, we can also efficiently generate aerosols from small amount of test items and conduct precise dosing to optimize use of aerosols.

Aerosol Delivery via Inhalation

We work with exposure chambers of various capacity. Our exposure chambers can accommodate single animal and up to 192 rodents (mice, rats and guinea pigs) at any one time, enabling us to conduct single animal to large-scale animal exposure studies.

Our range of chambers include nose-only chambers, whole body chambers and plethysmographs for individual animals. We can also perform intratracheal delivery of liquids and powders. Depending on your needs, our team of engineers can design aerosol delivery setups to meet your study requirements. 

At Vectura Fertin Pharma Laboratories, your research goals are our priority