Inhalation formulation development strategies

Within inhalation drug development services, Hovione focuses on formulation development to add further value to the services we offer. With just one step and one line of communication, customers can obtain a full service for both API manufacturing and formulation development adapted to their target product profile, plus capsule filling, packaging and manufacturing.

In the specific case for Inhalation drug formulations, Hovione is able to develop:

Conventional carrier based formulations
Examples of carrier based formulations:

• Lactose based API formulations

in low-shear (Turbula) homogenizers and high-shear (Diosna 1-6 and Diosna 10-60) homogenizers.

Neat (drug-alone) formulations
Non-Carrier based formulations

• Formulations with multimodal particle size distributions of one or more APIs, i.e. able to specifically target different regions of the airways.
• Drug alone (or quasi-drug alone) formulations by spray drying, i.e. depending on API properties (e. g. flowability) and particle engineering technology applications.

Composite particle formulations

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.

Examples of composite particle based formulations:

• Leucine based API formulations
• Mannitol based API formulations

These formulations can then be used to fill capsules for inhalation (HPMC size 3) and be supplied for proof of concept, feasibility study, clinical trial and commercial manufacturing material.

The formulations so obtained are subsequently tested in Hovione’s excellence center for inhalation product development, notably:

• Particle size distribution by laser diffraction (Malvern)
• Emitted dose determination by gravimetric determination – “Shotweight”
• Cascade impaction (Andersen and NGI)
• Determination of amorphous content (DVS, XRPD, …)
• Stability studies of inhalation powders (dose uniformity, HPLC for assay and impurities, …)
• Inhalation formulations - blending for carrier based formulations and for multimodal particle size distributions of API
• Excipient identification, sourcing and characterization
• Dose content uniformity - Dose Uniformity Sampling Apparatus (DUSA)

And can be seamlessly integrated with inhaler development services to fine tune emitted dose and fine particle fraction (delivered dose to the lung).

Hovione has pioneered inhalation-grade API's. These are products that while meeting compendial requirements are especially manufactured for inhalation delivery and meet stringent inhalation specification. Click here to learn more about Hovione Inhalation Grade API's