Full range of formulation development

Hovione Technology relies in Hovione’s experience to offer a full range of inhalation formulation development solutions from proof of concept to commercial manufacturing.
With just one line of communication to Hovione, customers can obtain a full range of capabilities: from API to formulation development and to optimization with the device adapted to their target product profile, plus manufacturing.  
Hovione has comprehensive formulation development capabilities across formulation platforms and is able to develop:

  • Conventional carrier-based formulations 
  • Drug-alone formulations
  • Composite particle formulations

Conventional carrier-based formulations rely on lactose-based API blends and are commonly used in inhalation products using standard manufacturing equipment available off-the-shelf from suppliers. Hovione has both low-shear homogenizers and high-shear homogenizers for conventional carrier-based formulation development from only a couple of grams to full commercial scale on the kilogram range.

Neat or drug-alone formulations comprise formulations with multimodal particle size distributions of one or more APIs, which able to specifically target different regions of the airways. Hovione has significant experience developing drug alone formulations by spray drying and particle engineering technologies.

Composite particle formulations are a tailored universal particle formulation approach where aerodynamic performance is independent of the API loaded onto the particle but is instead a function of the excipient mix ratio. Hovione has experience with composite particle-based formulations using leucine-based and mannitol-based API formulations.

During development, formulations obtained are subsequently subject to start-of-the-art analytical characterization at Hovione using:

  • Particle size distribution by laser diffraction 
  • Computerized microscope imaging for particle characterization
  • Surface area by BET & Raman spectroscopy
  • Delivered dose uniformity determination (DDU)
  • Cascade impaction (Andersen, NGI) and breath simulators
  • Determination of amorphous content (DVS, XRPD, …)
  • Stability studies of inhalation powders (dose uniformity, HPLC for assay and impurities, …)
  • Microbiology characterization
  • Dissolution testing for close to in-vivo deposition analysis

With just one step and one line of communication to Hovione, customers can obtain a full range of capabilities for API manufacturing and formulation development to optimization of delivered dose to the lung and fine particle fraction with the device adapted to their target product profile, plus filling, packaging and manufacturing.  

Hovione is able supply proof of concept, feasibility study, clinical trial and commercial manufacturing material.

Contact us for more information

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