Purcision™ Respiratory Case Studies

Purcision – Our Patented Supercritical Precipitation (SCP) Technology – is an Effective Tool for Developing Respiratory Drugs

 

A Platform for Respiratory Drug Development

 

Particle
Size

Purcision
Paclitaxel

Purcision
Ciprofloxacin
Free Base

Purcision
Fluticasone
Propionate
MMAD 1.8μm – 2.3μmA 2.1μmB 2.1um – 2.3μmB
GSD 1.9μm – 2.0μmA 1.5μmB 1.55μm – 1.66μmB

 

Notes
A – Aerodynamic particle size was measured with Mercer-style cascade impactor
B – Aerodynamic particle size was measured using an Aerodynamic Particle Sizer (TSI, Inc.)

Ciprofloxacin Particle Size Distribution

 

  • In addition to Purcision Paclitaxel, CritiTech has engineered particles of ciprofloxacin and fluticasone with the Purcision technology
  • Much like Purcision Paclitaxel, Purcision Ciprofloxacin and Purcision Fluticasone consist of agglomerated, high-surface area, low bulk density particles that are ideal for pulmonary delivery
  • The MMAD values of all three drugs processed with the Purcision technology are very consistent

 

 

Purcision Respiratory Case Study: NanoPac®

 

The development of inhaled NanoPac® (Purcision Paclitaxel) generated compelling evidence that Purcision is an effective tool for developing respiratory drugs.

 

 

  • High concentration and long duration of Purcision Paclitaxel in the lungs
  • Lung half-life for Purcision Paclitaxel was 56 hours vs 19.9 hours for IV nab-paclitaxel (Abraxane®)
  • Lower systemic exposure of Purcision paclitaxel compared to the IV route of delivery

 

Purcision Respiratory Case Study: Fluticasone

Purcision Fluticasone – Animal Inhalation Studies

 

  • Lung tissue and plasma data was obtained for inhaled Purcision Fluticasone in two separate studies in rats
  • The results for the two studies were very consistent and show the high concentrations and long residence times in the lung tissue

 

Results from the Purcision Fluticasone particle characterization studies exceeded expectations even though the Purcision Fluticasone was not optimized.

 

NGI Analysis of Purcision-Processed Fluticasone

 

MMAD
(um)

GSD

FPF
% < 5 um

% Drug Delivered
Run 1 3.5 1.6 79% 74%
Run 2 3.7 1.6 73% 80%
Run3 3.7 1.6 74% 73%
Average 3.63 1.6 75.3%

75.6%

 

Purcision Fluticasone delivers ~75% of the drug in a capsule versus ~30% with some of the fluticasone products on the market.

 

Partner tests of the mass distribution of Purcision Fluticasone powders from the DPI yielded results that were very consistent over multiple runs.

 

Purcision Respiratory Case Study: Ciprofloxacin

 

 

  • Inhaled Purcision Ciprofloxacin (free base) was compared to inhaled Purcision Ciprofloxacin (hydrochloride) (both at 3mg/Kg) and to an IV solution of ciprofloxacin (at 5mg/Kg)
  • The inhaled Purcision Ciprofloxacin (free base) showed high concentration and a long residence time in the lung tissue compared to the inhaled Purcision CIP hydrochloride which was similar to the IV administered ciprofloxacin

 

Partner tests of the mass distribution of Purcision Ciprofloxacin powders from the DPI yielded results that were very consistent over multiple runs.