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More time for an effect: With the PARI SINUS an aerosolized substance resides longer at the site of action

Tuesday, 22 March 2011

Data from a recent study suggest that compared to a nasal spray, the aerosol delivered by the PARI SINUS reached the parasnasal cavity with a longer residence time and may contribute to more efficient therapy.

An active substance with a long residence time is especially desirable when it can be delivered directly to the site of disease. As a rule, a longer residence time will help to better utilize the drug. However, further studies are needed to clarify the actual benefit of the active agents or if there is an advantage in specific disease indications. The slower clearance of a substance after aerosol administration via PARI SINUS compared to a nasal spray is not fully understood. A possible cause could be that the aerosol reaches areas with delayed mucociliary clearance. These areas include the anterior nasal cavity, the olfactory epithelium, and the paranasal sinuses. It has been documented in a number of studies that the sinuses are accessible only with the PARI SINUS device and not with a conventional nasal spray [e.g.1].

 

 

  Residence time of the radiolabeled test substance was much longer when administered with the PARI SINUS (left). The test agent given via a puff from the nasal spray, however, was quickly removed by mucociliary clearance (unpublished data)

The combination of effective drug deposition in the difficult to access paranasal cavities and the prolonged residence time could prove particularly beneficial for effective therapy. Accordingly, first clinical experience substantiates the potential of this promising therapeutic option [2,3,4]. There are now several additional clinical trials being conducted with the PARI SINUS for different indications.

So far gamma-camera videos have been generated with four healthy volunteers. All had been administered either a 100µl puff from a nasal spray or an aerosol dose for 20 seconds into the right and left nostril via PARI SINUS. The test substance (DTPA) was radiolabeled and gamma-camera images were taken immediately after administration of the aerosol. The total recorded observation time was 45 minutes. After 20 minutes the study participants were accorded a short break. Additional images were taken after 2, 4, 6 and 24 hours. Half-time values, indicating how fast half of the test substance cleared from the nose, were significantly reduced for the nasal spray. The nasal spray took 15 minutes for half of the DTPA to be removed from the nose compared to 70 minutes with the PARI SINUS.

The video animations were superimposed with a magnetic resonance tomography image to visualize the anatomic landmarks.

 

Sources:

  1. Möller et al. 2010 Otolaryngology-Head and Neck Surgery (142): 382-388
  2. Mainz et al. 2010 Journal of Cystic Fibrosis (9): S23
  3. Geppe et al. 2009 Poster auf dem Kongress der europäischen Lungengesellschaft ERS
  4. Mainz et al. 2009 Journal of Cystic Fibrosis (8): S69

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