Inhalation Product Characterisation

Aerosol characterisation according to clients needs and specifications.

Procedures that are standardised or matched to customer requirements with high level of quality. Repeatable and effective execution.

In silico modelling of lung deposition and PK outcome based on in vitro data.

Impactor Based Tests (APSD):

  • Next Generation Impactor (NGI), Andersen Impactor (ACI), Multi-stage Liquid Impinger (MLI)
  • Standard USP throat or anatomically realistic mouth throat model of different sizes
  • Lung Simulator for generation of tidal breathing (nebulizers) or replay of inhalation profiles by using the mixing inlet method
  • Mechanical hand for fire off pMDI inhalers at certain and different time points at inhalation profiles
  • By adapting a suitable AIM set-up, the fine particle dose uniformity can be assessed

DD: Delivered Dose

  • Standard DUSA as specified in Pharmacopeia, but also faster and less laborious methods
  • Bespoke dose collection system, adapted to clients need
  • Semi- and full automation systems designed together with client and installed at client site

SP: Spray Pattern/PG: Plume Geometry
(Envision system from Oxford Lasers)

  • Open system up to 500Hz sampling rate
  • At variable distances
  • Pneumatic actuation unit
  • SP and PG can be used with inhaler specific housing for “push through” air flow for triggering

PSD: Droplet and Particle Size Distribution

  • Laser diffraction (Malvern Spraytec, Mastersizer S, Malvern 3000 + Aero S)
  • Aerodynamic Particle Sizer (APS 3321) combined with Impactor inlet for screening tests
  • Open and closed Inhalation cells so that a bolus inhalation can be generated when using a lung simulator
  • PSD of liquid and powder products
  • PSD powder formulations alone without device
  • Investigations of dose release and PSD over time
  • Characterisation of the emptying process of the dose out of a device
  • Pneumatic actuation unit

MISC

  • Characterization of dissolution rate of the lung dose/fine particle dose
  • Stability testing in any kind of T/RH settings
  • Possibility to perform dose withdrawal in different temperatures and relative humidities
  • Anatomical models of the nasal cavity available for deposition testing
  • In silico modelling of lung deposition and subsequent PK outcome based on in vitro data
  • Determination of the air volume required to empty the powder dose from a DPI
  • Pressure drop testing
  • Manufacturing of silicone-based adapters (e.g. inhaler vs USP throat)

Download the pdf MVIC_Inhalation Product Characterisation

Spray pattern and plume geometry
Anatomical throat Models and inlets