Super Critical Precipitation Respiratory Case Studies

SCP Technology is an Effective Tool for Developing Respiratory Drugs

 

A Platform for Respiratory Drug Development

 

Particle
Size

SCP
Paclitaxel

SCP
Ciprofloxacin
Free Base

SCP
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 SCP Paclitaxel, CritiTech has engineered particles of ciprofloxacin and fluticasone with the SCP Technology
  • Much like SCP Paclitaxel, SCP Ciprofloxacin and SCP 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 SCP Technology are very consistent

 

 

Supercritical Precipitation Respiratory Case Study: NanoPac®

 

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

 

 

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

 

Supercritical Precipitation Respiratory Case Study: SCP Fluticasone

SCP Fluticasone – Animal Inhalation Studies

 

  • Lung tissue and plasma data was obtained for inhaled SCP 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 SCP Fluticasone particle characterization studies exceeded expectations even though the SCP Fluticasone was not optimized.

 

NGI Analysis of SCP-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%

 

SCP 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 SCP Fluticasone powders from the DPI yielded results that were very consistent over multiple runs.

 

Supercritical Precipitation Respiratory Case Study: SCP Ciprofloxacin

 

 

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

 

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