XSpray

Inhalable Particles

Although primarily used for lung-related diseases (Asthma, COPD etc.), inhaled drug delivery is becoming an increasingly attractive alternative to oral and parenteral delivery methods. It provides rapid action, low metabolism and high bioavailability.

Successful development of inhalable drugs requires the development technology to produce small particles with narrow size distribution at all production volumes.

  • Optimize particle size and shape for inhaled delivery
  • Minimize dose variation
  • Reduce formulation complexity

 

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Particle Sizing

RightSize Particle technology accurately and reproducibly produces small particles of specific sizes. It has excellent capabilities for particles in the 1-5 µm size range.

Both amorphous and crystalline particles can be formed, and the desired polymorph can be selected. If required, excipients can also be added. Or, powders can be produced from pure API/DS to achieve a high drug load.

Particles produced with different sizes, obtained by varying process parameters.

Narrow Particle Size Distribution

XSpray’s unique proprietary technology ensures a narrow particle size distribution, even when production is scaled up to manufacturing volumes.

Particle size, particle size distribution and polymorph selection are easily controlled by varying the process parameters of temperature, pressure, and solvent used. This simplifies particle engineering and supports a ‘quality by design’ approach to production.

Importantly, the process also delivers non cohesive particles. The production of free-flowing powder simplifies downstream processing.

Drug substance D10 µm D50 µm D90 µm
Budesonide 1.1 1.9 3.4
Substance X 0.5 1.3 2.9
Particles sized for inhalation.

Modifying Particle Shape

Fine-tuning of process parameters can also be used to modify particle shape. This allows particles to be produced with a more rounded form.

However, other particle shapes with beneficial properties can also be achieved. For example, needle form, consisting of extremely small and highly regular needle-shaped particles, also results in very free-flowing powders (contrary to what might be expected).

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Operating conditions can also be used to control particle shape.