Biorelevant characterization of inhalation products

Biorelevant tools provide a better assessment of the final product performance while supporting a quality-by-design approach with reduced development time.

Standard aerodynamic particle size distribution gives a narrow perspective on in vivo performance. Many other factors may determine the API fate: deposition pattern, dissolution rate, drug particle properties and physiological factors. Therefore, to support a lean development and a QbD approach, we offer a full range of standard automated characterization equipment:

Biorelevant Characterization Inhalation Products Dissolution | Hovione

Hovione characterization capabilities

Focused on dissolution, we incorporate into the development a state-of-the-art testing apparatus for dry powder inhalers (DPIs):



  • first stages of formulation development, as the formulation strategy is defined (eg. Carrier-based vs carrier free)
  • additional discrimination tool for formulation selection
Dissolution Profile Biorelevant Characterization Inhalation Product | Hovione

Dissolution profile for fluticasone propionate as API alone, formulated as a carrier-based and as a composite formulation.

The DissolvIt® (from Inhalation Sciences) is a fully automated in vitro simulation tool for absorption and dissolution of respirable particles in the lung epithelium. It is used in combination with a breath simulator PreciseInhale® to collect the inhalable fraction deposited after aerosolization.

drug product inhalation characterization capabilities | Hovione

Schematized DissolvIt equipment

The collected powder is automatically put in contact with a simulated mucus, where it dissolves and diffuses until it reaches a flow-through blood simulant. The blood simulant is collected and quantified, leading to a pharmacokinetic like dissolution profile. As the dissolution occurs the particle’s dissolution can be observed with the incorporated optical microscope. This is a significant step towards achieving a full DPI performance profile.

We understand the complexity of developing highly sophisticated inhalation formulations, from the particle engineering stage to the device design, characterization and performance prediction. With our characterization tools we offer a faster path to the clinic driven by a strong scientific knowledge.


Our commitment: less than 5 months from lab development to cGPM supply.

inhalation drug delivery techniques and products | Hovione

Contact our experts today.

With Hovione, you’re in safe hands. Our impeccable quality assurance track record means that you gain comfort and confidence from day one. 

Related files

Poster: A novel strategy to examine dry powder biorelevant dissolution in lung simulated mucus
pdf (4 MB)
Poster: Biorelevant Dissolution Testing of Orally Inhaled Drugs: Adding a Newly Designed Pre-Separator to PreciseInhale®
pdf (2.12 MB)
Poster: Dissolution of Orally Inhaled Drugs using DissolvIt®: Influence of a Newly Designed Pre-Separator for Particle Collection
pdf (4.33 MB)

Also in Inhalation

Development of Products for Pulmonary Delivery

We develop products together with our partners following Quality by Design principles to reach optimal product performance through robust processes.


Manufacturing for Pulmonary Delivery

Our One-Site Solution for inhalation and nasal products ensures a simplified supply chain reducing time, risk, and complexity.


Spray drying for inhalation

Innovative particle engineering platform by spray drying. Biopharmaceuticals and high dosage delivery. Ensure process robustness and scalability from lab to commercial.



Hovione offers simple, patented and globally competitive dry powder inhalers – Disposable, Capsule, Blister and Large Dose DPIs – which are available for fully integrated turn-key development with formulation and for licensing.