The DustGun® System

ISAB has developed a unique set of tools and exposure systems called the DustGun® System for the development of drugs specifically intended for inhalation. This is a set of tools for early screening and preclinical evaluation of Candidate Drugs (CDs) and new drug formulations. The system has the potential to complete an exploratory IND and to take selected CDs into early clinical testing using a minimum amount of test substance, less than 500 mg, and minimum effort in formulation work.

The technology processing steps comprises (i) drug formulation/micronisation, (ii) aerosol delivery and (iii) aerosol exposure of different biological models:

(i) The first step consists of a spray dryer, “LaminarPace”, for formulating most solutes into manageable powders of micrometer-size particles (micronisation)

 

(ii) The second step is called “The DustGun Aerosol Delivery System” to create and deliver respirable dry powder aerosols. This system consists of two units; an aerosol generator and dispensing unit. The generator unit itself can be the replaced with a standard inlet adapter connecting the aerosol dispensing unit to almost any clinical inhaler on the market. (For details, please read below.) While the generator unit de-agglomerates powders to aerosols with high efficiency, the dispensing unit delivers the aerosols to different exposures models with high precision.

 

(iii) Four different Exposure Models can be linked to the aerosol dispensing unit for screening and selection of drug candidates;

  • an In Vitro system for simulating dissolution and absorption of particles in the lung epithelium,
 
  • an Ex Vivo rodent-isolated perfused lung system, which is well suited for studying lung-specific effects of drugs and toxicants,
 
  • an In Vivo system for exposure of laboratory animals in preclinical pharmacology- and toxicology studies
 
  • a Clinical exposure system for human volunteers

Schematic Overview of the DustGun Testing Services

The Inhaler Testing System

In addition to the exposures models that can easily be linked to the aerosol dispensing unit, the generator unit itself can be replaced for almost any clinical inhaler on the market. This allows different inhaler devices to be incorporated into our preclinical and clinical exposure systems and tested for PK with the aim of arriving at a maximum drug to patient performance (see below).

The Company recognizes that the development of successful aerosol therapies will require more than arriving at a promising formulation, it will also require the critical matching of a suitable inhaler to optimize drug to patient performance

In addition to the exposures models that can easily be linked to the aerosol dispensing unit, the generator unit itself can be replaced with a standard inlet adapter connecting the aerosol dispensing unit to almost any clinical inhaler on the market. This provides a unique integrated testing system that allows different inhaler devices on the market place to be incorporated into our preclinical and clinical exposure systems and tested for PK.

This will enable device manufacturers and pharmaceutical companies to develop early predictive PK data both for new device designs and for different pharmaceutical formulations in a manner that closely mimics the clinical situation. Also, device manufacturers can benchmark their inhalers and formulations against other manufacturers in the market place using the DustGun System as a reference.

Figure: The DustGun Clinical inhaler test rig with a Turbohaler attached

Schematic Overview of the Inhaler Testing Services

Inhalation Sciences AB is developing a “Tool Box” for Translational Inhalation Medicine

The technology platform and exposure models allow a swift assessment of the pharmacokinetics and preclinical toxicology of new substances and drug formulations followed by a rapid efficacy development that will soon translate basic research into real therapies for real patients.