ISAB and Chiesi Poster at RDD Europe 2015 reveals ‘most competitive PK data possible in preclinical tests’

  • 27 april, 2015
  • 11:14

The detailed PK profiles generated by ISAB’s dry powder testing system PreciseInhale will be presented in a Poster at the Respiratory Drug Delivery (RDD) Europe conference in Antibes, France, May 5-8. Ex vivo (Isolated Perfused Lung) and in vivo (intratracheal intubated and nose-only) modules of PreciseInhale were used: no other system in the world can offer this combination of pre-clinical models.

 

Can inhaled drug developers get reliable, detailed PK (pharmacokinetic) data on their compounds in early stage, preclinical tests? A poster at this year’s RDD Europe conference shows the detailed PK data generated by the ex vivo and in vivo modules of PreciseInhale on the Chiesi compound CHF6001 – a PDE4 inhibitor for the treatment of asthma and COPD. The poster was co-written by scientists from ISAB and Chiesi Farmaceutici, Parma, Italy, including ISAB founder and CSO Dr Per Gerde, Associate Professor at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.

Exceptionally detailed PK data

The poster shows the incredible volume and detail of PK data the system delivers to researchers. The test’s PK parameters and results include:

  • Required robustness, accuracy and precision, calculated by non compartmental analysis
  • Mean accuracy in lung deposition included targeted dose and deposited dose
  • Fractions of substance deposited in the trachea and extra pulmonary bronchi compared with the total lung deposition
  • Comparison with theoretical deposition models (MPPD)
  • t1/2 (h)
  • AUC substance concentration in the lung
  • AUC substance concentration in plasma
  • Tmax results
  • Cmax results

ISAB CEO Fredrik Sjövall says: “Once again PreciseInhale has successfully challenged the old truth that no relevant preclinical data can be generated in the early stages of inhaled drug development. Our new poster, co-written with Chiesi, shows that the tools to generate highly qualitative, strategic PK data in preclinical tests, are available here and now. They offer a strategic headstart for inhaled pharma developers. They’re the most competitive PK data possible, and they’re of urgent interest to anyone in the field of inhalation.”

Milligrams not grams

With PreciseInhale, powders are de?agglomerated and aerosolized so efficiently that an even distribution in the lungs can be achieved from less than 100 mg of test substance. The poster shows results achieved with IPL providing target doses from 10 to 100 micrograms of Chiesi’s CHF6001 compound, a PDE4 inhibitor for the treatment of asthma and COPD, while spending no more than 50 mg test substance.

Unique intratracheal inhalation testing

PreciseInhale’s controlled dosing, one-animal-at-a-time methodology produces an even distribution of powder, and so exceptionally reliable data, on lungs ex vivo (IPL) or in vivo (intratracheal and nose- only.) PreciseInhale is the only dry powder testing system in the world that can carry out intratracheal inhalation testing of micronized pure drug, or of clinical inhaler aerosols.

Using IPL and in vivo modules together allows researchers to match detailed lung-specific data of the IPL against the systemic distribution of the same substance from an identical inhalation exposure of the in vivo model.

Eight modules in one system

A complete, compact inhalation lab on the benchtop, PreciseInhale provides a whole range of dry powder exposure modules that can carry researchers from cell studies to preclinical all the way to clinical testing. The modules are:

  • Intratracheal inhalation in vivo module
  • Nose-only inhalation in vivo module
  • IPL (Isolated Perfused Lung) ex vivo module
  • DissolvIt, in vitro dissolution module
  • XposeALI in vitro cell culture exposure module
  • Clinical exposures

    SEE PRECISEINHALE FOR YOURSELF. BOOK A TIME AT RDD EUROPE 2015

    Dr Per Gerde or CEO Fredrik Sjövall will talk you through the system. Contact them at:

    CEO Fredrik Sjövall at fredrik.sjovall@inhalation-v2.mkdev.se Mob: +46 (0)70 64 508 75

    CSO Dr Per Gerde at per.gerde@inhalation-v2.mkdev.se Mob: +46 (0)72 21 984 49