Inhalation safety assessment

Toxicity testing of your product through an inhaled route of administration can be one of the most challenging studies you will face.  Whether you have a pharmaceutical, crop protection, or industrial chemical product, the knowledge you can gain from inhalation studies can be priceless, but you need a reliable ally who knows the most successful ways to conduct respiratory safety assessment studies. 

With fully integrated facilities in the UK and US, Envigo offers the largest and most experienced inhalation contract capability globally.  As a result, transfer of programs, individual studies, or staff is a simple process that enables you to have a significantly larger global resource.  Our 50 years of experience has enabled us to conduct repeat dose studies across a wide variety of designs, test article classes (NCE and biologics) and species, including hundreds of studies in the past five years alone. 

Envigo provides the following respiratory safety assessment services:

  • Routine studies in rats, mice, hamsters, rabbits, guinea pigs, dogs, macaques, minipigs and occasional work with a variety of less common species
  • Inhalation delivery for general and reproductive toxicology, safety pharmacology and micronucleus studies
  • Cardiovascular and respiratory models using telemetered animals and external (large animal jackets and small animal restraint tube or chamber) plethysmography
  • In-house developed minimal restraint methods for inhalation exposure in dogs and primates
  • Intra-tracheal delivery in rats and large animals
  • Rodent and rabbit snout only exposure using directed flow or flow through systems
  • Whole body exposure of rodents, rabbits, dogs, and minipigs
  • Oropharyngeal delivery in dogs and primates
  • Clinical delivery platform modification to permit use in non-clinical studies
  • Delivery of powders, liquids vapors and gasses by commercially available and in-house designed generation systems
  • Aerosol concentration monitoring including real-time determinations of concentration and particle size
  • Inhalation Engineering Services support of in-house and sponsor inhalation laboratories with design and manufacture of inhalation equipment and exposure systems
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With 90+ staff and over 60 purpose-designed and built exposure suites dedicated to inhalation studies, we provide expertise and capabilities in the following areas: 

  • Aerosol technology
  • Pharmacy powder blending
  • Formulation and inhalation assessment
  • Inhalation toxicology
  • Inhalation safety pharmacology
  • Inhalation engineering and equipment design
  • Regulatory submission consultancy 

The range of analytical instruments available includes but is not limited to the following:

  • UPLC
  • HPLC
  • LC-MS/MS
  • GC
  • AA
  • IR including on-line capability
  • UV spectrophotometry
  • Spectrofluorimetry
  • Microscopy
  • Test article specific analysers.

Additionally, we maintain an Envigo Inhalation Engineering Group, unique in the non-clinical CRO sector, which permits the in-house design and manufacture of study and compound specific equipment. 

The future of inhaled medications and inhalation technology

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