In vivo PK studies

Inhalation Sciences de-risks your clinical trials by offering accurate preclinical in vivo studies, with high correlation to human PK data. This is achieved through the PreciseInhale aerosol generator, which also allows for minimal amounts of substance to be used for a complete PK study.

Our scientists are particularly skilled in the intra-tracheal exposure modality, which allows to bypass the rodents’ nasal cavity, allowing a much clearer understanding of the compound’s behavior in the lungs. A typical inhalation tower would require 700mg of nebulized substance to expose 12 rodents to a target dose of 250mg, while PreciseInhale would only require 55mg. Inhalation Sciences can offer rodent studies with tidal breathing exposures, ideal to model patient inhalation via nebulizers, and large lung models with bolus delivery, ideal to model dry powders inhalation via DPI inhalers.

Estimate of human PK profiles and clinical doses; small scale toxicity studies

  • Based on two species, rodents and a large-lung model
  • Species
    – Rodents (I-T or N-O, tidal breathing/bolus)
    – Large lung exposures (Intra-Tracheal, bolus delivery)
  • Access to bio-safety level 2 and 3 labs

Systemic blood circulation PK-data of inhaled Fluticasone

In vivo PK studies – benefits

  1. One animal at the time: in vivo accurate PK curves -> Improve In Vitro In Vivo Correlation to clinical data and de-risk clinical trials
  2. High concentration aerosol delivery -> Short exposure times
  3. Active monitoring of aerosol concentration and breathing parameters -> Unparalleled precision dosing of dry powders or solutions
  4. Full PK test with minimal amounts of substance -> Save significant sums on manufacturing of NCEs/biologics in early stages
  5. Aerosol characterization and Intra-Tracheal modality -> Delivering the drug product where it should be


Nose-Only

With Nose-Only Inhalation Research Services offer systemic PK- or tox data of precision dosed rodents, from minimal amount of substance.

  • Absorption profile of test substance in the systemic blood stream
  • For repeated exposure series
  • Flexible time-points for post-exposure samplings

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Nose-only in vivo

DOWNLOAD
IRS Brochure – Inhalation Research Services
Nose-Only Exposure Module – Technical Specifications


Intra-tracheal

Lung-specific aerosol delivery bypassing the nasal airways.

  • Report: Full report including plasma and lung PK-data, Cmax and t1/2, and substance retained in lung

 

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Intratracheal in vivo

DOWNLOAD
IRS Brochure – Inhalation Research Services
Intratracheal Exposure Module – Technical Specifications